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1996 Guidelines
Decision Trees and Management

PCS Consensus Committees
The starting point for quality assessment for the Pat- terns of Care Study is to establish by consensus the
current management guidelines for each site. This article presents decision trees, recommended treatment
systems, and brief summaries of the guidelines developed for cancer of the esophagus, rectum, anus,
breast, cervix, seminoma of the testis and prostate. Copyright 9 1997by W.B. Saunders Company
O Patterns ne goal of of the Care disease Study site (PCS) committees was to develop of the
current management guidelines for evaluation and treatment of patients with cancer of the breast, cervix, rectum, esophagus,
anus, prostate, and seminoma. A review of the literature provided the basis for these guidelines. The committees sought to
achieve consensus using a modified Delphi process that tbcused on key issues. Decision trees and recommended treatment
systems show these guidelines schematically. This article provides a brief summary of the recommendations.
Esophagus Decision Tree Primary Histology

Esophageal cancer accounts fbr 2% of all cancer deaths in the United States. I Howeww, the importance of this condition
should not be underestimated: although the incidence of rectal cancer is tbur times that of esophageal cancer, there are more
deaths annually (approximately 10,000) duc to esophageal cancer than due to rectal cancer. In considering esophageal cancer
treatment, the committee chose to consider both adenocarcinuma and squamnus cell cancer histologies, which comprise over
95% of all esophageal cancers. ~ It is important to note the increasing incidence of adenocarcinoma. Ahhough the ratio of
squamous cell carcinoma to adenocarcinoma was previously nearly 9 to l, the incidence of adenocarcinoma now approximates
that of squamous cell cancer. :~ Ahhough the rate of increase of
From the PCS Consensus Committee~, American College of Radiology, Philadelphia, PA.
Supported by Grants No. CA65435 and CA15978 and C}mtract No. NO I-CM-8727.~/fi~m the National Cancer Institute,
Bethesda, AdD.
The opinions and a~sertions herein are the private views qf the author~ and are not to be construed as representing the
o[fidal views of the National Cancer Institute.
Address reprint requests to Jean ()wen, PhD, American (,bllege of Radiology, 1101 Market St, 14th fl, Philadelphia, PA
19107.
Copyright 9 1997 t~ W.B. Saunder~ Company 1053-4296/97/0702-0011505.00/0
esophageal adenocarcinoma over the past decade exceeded that of most other cancers, information addressing management of
patients with adenocarcinoma may be incomplete, ie, fewer patients in randomized clinical trials and shorter follow up.
However, it is clear that esophageal adenocarcinoma, like squamous cell cancer, is an aggressive cancer that may cause death due
to local tumor progression or distant dissemination.
Performance Status
Most patients in the United States present with advanced esophageal cancer; nonetheless, few (less than 10%) have a Karnot~ky
pertbrmance status (KPS) of less than 50%, which might preclude aggressive treatment. Therelbre, the Committee limited
treatment guidelines to the 90% of patients with relatively good perlbrmance status.
Stage of Tumor
The 1983 American Joint Commission on Cancer (AJC) staging system was used in treatment guideline development fin" Ibm"
reasons. (1) It is a clinical system that is easy to use because it is based on examinations that are readily available. (2) It has
correlated with survival in patients managed with radiation, chemoradiation, and preoperatiw'~ chemoradiation. ~~ (3) As
patients are often initially treated with chemotherapy or chemoradiation, a clinical staging system is relevant to a common pattern
of practice. (4) It provides a conw~nient means tbr identit)ing patients who can be approached with a cm-ative treatment strategy
compared with those in whom the sole objective is symptom palliation.
Clinical Stage I or H
Patients with cancer clinically confiued to the esophagus (stage I or II) can be treated with curative intent. The primmy
treatment could be either chemoradiation or esophagectomy. The results of an Intergroup
Seminars in Radiation Oncology, Vol 7, No 2 (April), 1997:pp 163-181 163

164 PCS Consensus Committees
Study reported by Herskovic et al 7 demonstrated that chemoradiation was superior to radiation alone. The chemoradiation
approach consisted of 50 Gy with Cisplatin (75 mg/m 2 weeks 1, 5, 8, and 11) and 5-fluorouracil (5-FU; 1 g/m2/d as a continuous
4-day infusion during the same weeks as Cisplatin). There is considerable interest in surgical adjuvant treatment (particularly
preoperative), and there is recent evidence from a randomized clinical trial that indicates such treatment impacts on survival
compared with esophagectomy alone (see "TS 1B").
Clinical Stage III
Patients who have extraesophageal tumor spread as defined by the 1983 AJC staging system are incur- able; thus, symptom
palliation is the major goal of therapy. Chemoradiation may improve swallowing function in approximately 80% of patients. ~
Intracavi- troy radiation can be given alone, but in patients with good performance status, it is often combined with external beam
radiation. The use of chemotherapy concurrent with intracavitary brachytherapy is investigational. 9
Treatment Systems
Figure 1 shows the PCS esophagus decision tree.
TSIA Patients with good performance status and clinical stage I or II with either squamous cell carcinoma or
pat hology/Adenccarcinoma/Sq uamous
Out / N~/ / ~ ~ophagea, Distant metastases spread or
*
~inical Stage
adenocarcinoma are candidates for primary chemoradiation. The chemoradiation regimen most acceptable is that used by
Herskovic et al, 7 which combined 50 Gy with chemotherapy as detailed above. When treating with chemoradiation, doses below
50 Gy or above 65 Gy are not considered appropriate, while doses of between 50 Gy and 65 Gy are considered acceptable.
TS1B Patients considered for TS1A who are operative candidates can also be managed by esphagectomy as an alternative.
The use of preoperative chemoradiation is viewed as probably acceptable, considering promising data f'om phase II studies,
although randomized definitive trials in this area are largely lacking. However, one recent randomized trial for patients with
adenocarcinoma of the esophagus showed a more than fivefold survival for preoperative chemoradiation compared with
esophagectomy alone.l~ When treating with preoperative chemoradiation, the most acceptable radiation dose range is 40 to 50
Gy/1 Although 50 to 60 Gy is considered acceptable, 6 doses of under 40 Gy or over 60 Gy are not advocated. The use of
postoperative radiation or chemoradiation are most acceptable if margins are positive or if nodes are positive; however, the ap-
proaches are generally not acceptable with negative nodes and negative margins. Randomized trials of postoperative radiation
suggest that radiation may decrease local tumor recurrence but has no effect on survival. 12 A consensus on the appropriate dose
of postoperative chemoradiation was not reached, although doses of less than 40 Gy or of 60 Gy or over are unacceptable. It
was noted that Saito et a113 reported a 5-year survival rate of 31% with postoperative radiation of 50 Gy with concurrent
chemotherapy. The use of preoperative or postoperative chemotherapy alone is viewed as investigational and probably
unacceptable, at least until the results of defnitive III] I
Clinical Stage I
I, II I
randomized trials become available. 13
21 ExtemN radiation TS, Intracavitary radiation
beam + chemo ]
] J | 2 A B 1 pra Primary Primary ~, no adjuvant or post ChemoRT
Surgery op Rx
chemo 3 4 post-op Pre-op chemoRT
RT (~ chemo)
TS2A For the patient with clinical stage III cancer (eg, recurrent laryngeal nerve involvement), either squamous cell carcinoma
or adenocarcinoma, and good KPS, there is consensus that chemoradiation is the Figure 1. Esophagus decision tree. Stagingis by
1983AJC criteria. *, Extraesophageal spread is defined by evidence of (a) recurrent laryngeal phrenic or sympathetic nerve
involvement, (b) fistula formation, (c) involvement of the tracheal or bronchial tree, (d) vena cava or azygous vein
most appropriate management. The recommended radiation dose is 50 Gy, as given in the trial reported by Herskovic et all
although doses of 60 to 65 Gy given with chemotherapy are believed to be probably obstruction, or (e) malignant effusion.
acceptable. 5 There is consensus that such patients

1996 Decision Trees and Management Guideline~ 165
should not be treated with esophagectomy or radiation ahme. Although studies of brachytherapy are warranted, there was no
consensus on the use of brachytherapy alone or in combination with chemotherapy in this setting.
TS2B For the patient with a similar presentation to that in TS2A but with a KPS of 40 or less, a variety of treatments are
available, including external beam radiation alone or in combination with chemotherapy or intracavitary radiation.14 Consensus
could not be reached regarding the most acceptable treatment in this situation.
Rectum Decision Tree

Primary Histology
The most common histologic type of rectal cancer is adenocarcinoma, which accounts tbr 90% to 95% of all large bowel tumors.
15 It is further classified by grade. There is no uniform agreement on the grading criteria, but most agree on the use of a three-
grade system, similar to that described fiw other adenocarcinomas. Colloid or mutinous adenocarcinoma represents
approximately 17% of rectal cancers. I~ These adenocarcinomas are defined by large amounts of extracellular mucin. Signet
ring cell carcinomas account tbr 2% to 4% of mutinous carcinomas and contain intracellular mucin, pushing the nucleus to one
side. Some signet-ring tumors appear to tbrm a linitis plastica type appearance. Rare variants of epithelial tumors such as
squamous cell, adenosquamous, and undifferentiated carcinomas, as well as carcinoids, sarcomas, and melanomas, are excluded
from this discussion.
tion regarding the difference between microscopic and gross extension of tumor through the bowel wall. Despite this
shortcoming, we strongly recommend the use of the AJCC/UICC TNM system for report- ing results.
The impact of clinicopathologic features on the patterns of failure and survival alter surgery for colorectal cancer has been the
subject of numerous investigations. By univariate analysis, a number of features have been reported to be of prognostic
importance. Many of these features are interrelated and are merely reflections of the same overall characteristic of the cancer.
By multivariate analysis, some have been reported to be independent factors of survival. However, the majority of investigators
agree that the most important independent pathologic feature tbr survival and/or recurrence after surgery is the TNM stage (depth
of penetration through the bowel wall and the presence and number of positive lymph nodes). 2~
The TNM system is a pathologic staging system; there is no widely accepted clinical staging system. As preoperative therapy
is being used more frequently in patients with both clinically resectable and unresec- table disease, some investigators have
proposect clinical staging systems. '~4,'~ None have been adopted by the AJC or UICC. For the purpose of this discussion,
clinically rescctable T3 disease will be detined as a primary tumor with radiulugic evidence (computed tomography [CT],
uhrasound, magnetic resonance imaging [MRI]) of transmural disease. Clinical T4 disease, which is commonly described as
locally advanced/unresectablc, will be defined as a primary tumor with clinical and/or radiologic evidence of adherence or
invasion into an adjacent organ or structure. As pathologic lymph node staging is not available, the N stage is Nx.
Stage of Tumor The staging ofcolorectal carcinoma has been compli- cated by the fact that it has evolved over more than 50
years. Furthermore, various investigators have developed systems that use the same nomenclature to represent different stages. In
1988 the AJC and the Union Internationale Contre le Cancer (UICC) proposed a joint TNM staging system. In the TNM staging
system, the determinants of stage include the depth of penetration through the bowel wall and the presence and number of
positive lymph nodes. In contrast with the Gunderson-Sosin modification of the Astler-Coller staging system, I~ the AJCCAJICC
TNM staging system does not incorporate informa-
Treatment Recommendations by TNM and Clinical Stages

The tolluwing treatment recommendations are based on the results of the treatment systems clinical scenarios. They are limited to
patients treated in the adjuvant setting (primary disease with negative margins of resection). The PCS decision tree for primary
adenocarcinoma of the rectum is shown in Figure 2.
AJC Stages I and 1I In patients with stages Tis to T2N0 disease who undergo conventional surgery (low anterior resection or
abdominoperineal resection), no adjuvant therapy

166 PCSCbnsensusCommittees
Adenocarctnoma edtoneal Yes
reflection
at or below
the
~Medlcally suitable for
definitive therapy
Able to perform a full thickness
Clinically
ResectaNe
local excision with negative margins
Clinically Resectable with sphincter preserving surgery
Trans-rectal Ultrasound (TRUS)
(TRUS)T3{_~ ~ RUS)T2
with Complete negative resection
margins
and/or N,. 2
Observation
Figure 2. Decision tree for T1-4,N0-2,M0 primary adenocarcinoma of the rectum.
is needed. In the subset of stage II patients with T3N0 to T4N0 disease, postoperative combined modality therapy
is recommended. This includes six cycles of 5-FU-based chemotherapy plus concurrent pelvic radiation during
cycles 3 and 4 of chemotherapy. Doses include 4,500 to 4,680 cGy to the whole pelvis followed by a boost of 0 to
540 cGy to a total dose of 5,040 cGy if there is small bowel in the boost field. If the small bowel can be excluded
from the boost field, then the total dose (pelvis plus boost) can be as high as 5,400 cGy.
In patients who undergo a full thickness local excision with negative margins, the recommendations are based
on the T stage. If the stage is T1Nx without adverse pathologic features (lymphatic vessel invasion [LVI] and/or
poorly differentiated), then no further therapy is recommended. If the stage is T2Nx or T1Nx with adverse
pathologic features, then postoperative combined modality therapy is recommended. This includes 4,500 to 4,680
cGy to the whole pelvis followed by a boost of 0 to 540 cGy to a total dose of 5,040 cGy if there is small bowel in
the boost field. If the small bowel can be excluded from the boost field, then the total dose can be as high as 5,400
cGy. This is combined with six cycles of 5-FU- based chemotherapy beginning concurrently with day 1 of radiation.
AJC Stage Ill All patients should receive postoperative combined modality therapy. This includes six cycles of
5-FU- based chemotherapy plus pelvic radiation during cycles 3 and 4 of chemotherapy. Doses include 4,500 to
4,680 cGy to the whole pelvis followed by a boost of 0 to 540 cGy to a total dose of 5,040 cGy if there is small
bowel in the boost field. If the small bowel can
be excluded from the boost field, then the total dose (peMs plus boost) can be as high as 5,400 cGy.
AJC Stage IV Patients with stage IV disease have metastatic disease, and the therapy is individualized.
Clinical Stage T3NxM0 Patients should receive preoperative radiation therapy. Doses include 4,500 to 4,680 cGy
to the whole pelvis followed by a boost of 0 to 540 cGy to a total dose of 5,040 cGy if there is small bowel in the
boost field. If the small bowel can be excluded from the boost field, then the total dose (pelvis plus boost) can be as
high as 5,400 cGy. The addition of six cycles of 5-FU based chemotherapy (two cycles concurrent with the radiation
therapy and four cycles postoperatively) is encouraged but is not required.
Clinical Stage T4NxM0 Patients should receive preoperative radiation therapy. Doses include 4,500 to 4,680 cGy
to the whole pelvis followed by a boost of 0 to 540 eGy to a total dose of 5,040 cGy if there is small bowel in the
boost field. If the small bowel can be excluded from the boost field, then the total dose (pelvis plus boost) can be as
high as 5,940 cGy. Two cycles of 5-FU- based chemotherapy should be given concurrently with the radiation
therapy. An additional four cycles postoperatively is encouraged but is not required. Likewise, intraoperative
radiation therapy is encouraged but is not required.
Treatment Systems In the following presentation of treatment systems, "adverse pathologic features" are
characterized by LVI and/or poorly differentiated disease.

1996 Decision Trees and Management Guidelines 167
TS1. For T1 without adverse pathologic features, observation only is recommended. For T2 or T1 with adverse pathologic
f?atures, postoperative combined modality therapy is recommended. This includes pelvic radiation (4,500 to 4,680 cGy) tbllowed
by a boost of 360 to 540 cGy to a total dose of 5,040 cGy. Six months of 5-FU based chemotherapy beginning concurrently with
day 1 of radiation is also recommended.
TS2. TS2 consists of combined modality therapy. This includes pelvic radiation (4,500 to 4,680 cGy) tbllowed by a boost of
360 to 540 cGy to a total dose of 5,040 cGy if there is small bowel in the boost field. If the small bowel can be excluded from the
boost field, then the total dose can be as high as 5,940 cGy. Six months of 5-FU-based chemotherapy beginning concurrently
with day 1 of radiation is also recommended.
TS3. TS3 consists of preoperative combined modality therapy. This includes pelvic radiation (4,500 to 4,680 cGy) followed
by a boost of 360 to 540 cGy to a total dose of 5,040 cGy. If available, intraoperative radiation therapy is recommended. Six
months of 5-FU-based chemotherapy (two cycles concurrent with preoperative radiation and tbur cycles postoperatively) is also
recommended.
TS4. TS4 consists of preoperative radiation thera W. This includes pelvic radiation (4,500 to 4,680 cGy) tbllowed by a boost
of 360 to 540 cGy to a total dose of 5,040 cGy. If the pelvic lymph nt~les are pathologically positive at surgc.ry, then patients re-
ceived 6 months ofpostoperatiw" 5-FU based chemotherapy.
TS5. TS5 consists of postoperative combined modality therapy. This includes pelvic radiation (4,500 to 4,680 cGy) tbllowed
by a boost of 360 to 541) cGy to a total dose of 5,040 cGy if there is small bowel in the boost field. If the small bowel can be
excluded fiom the boost field, then the total dose can be as high as 5,400 cGy. Six months of 5-FU-based chemotherapy with
radiation beginning concurrently with cycle 3 of chemotherapy is also recommended.
Anus Cancer Decision Tree Background

Beginning in the early 1980s, the traditional management of abdominoperineal resection (APR) for tumors of the anal region
was progressively replaced by radiotherapy alone and, eventually, by chemoradiation. In spite of a lack of randomized trials
comparing
these management methods, chemoradiation has supplanted other tbrms of therapy primarily because of its perceived (and
perhaps tactual) superiority in terms of colostomy-free survival. APR (and radiotherapy to a lesser degree) results in a
permanent colostomy with its attendant functional, anatomic, and psychologic complications.
Cancers of the anal region are relatively rare. Yet, this paradigm shift in their treatment has served as the prototype for
attempts at functionaL/anatomic preservation of several other sites affected by cancer. Moreover, the marked improvement in
cure rate seen in early chemoradiation series for anal cancer may yet be validated, as our experience with the complexities of
combining radiotherapy and chemotherapy growsfl 6-3~
Histology
Tumors of the anal region can be keratinizing or nonkeratinizing. :~1 Basaloid/cloacogenic cancers arise fi'om the thnctional
zone,just above the dentate line and are considered by some investigators to be a type of squamous cancer. The experience in
treating the rare ademrcarcinoma and small cell cm-cinonm of the anal region is so limited that they thll outside the purview of
this decision tree.
Distant Metastases
Systemic spread of anal cancer occurs in less than 10% of cases. :~2 The most common sites of spread are the liver and lungs.
The treatment of such patients is varied. :~:~
Suitohility for Definitive Treatment
Most anal cancer patients, and even those with locally advanced disease, have good or acceptable general performance status
(>50%). Patients who are immunologically suppressed, such as those with acquired immunodeficiency syndrome (AIDS), are not
suited for some of the treatments outlined below. :~4 However, patients with human immunodeficiency virus (HIV) infections
and without the syndrome may not be excluded from definitive treatment? 5
Other relative reasons that might preclude definitive treatment include previous pelvic radiotherapy/ surgery and various
medical, psychiatric, and eco- nomic reasons.

Tumors of the Anal Margin

The definition of the anal margin as an area within a 5-cm radius of the anal verge is generally accepted. Due to their location and
consequent proclivity for early diagnosis, these tumors tend to have a better prognosis. Patients with very early stage (T1MoNo)
anal margin cancer are ve~ y well managed by local wide excision or by radiotherapy alone, s6,37 The recommended radiation
dose in these cases is between 60 and 65 Gy in 6 to 7 weeks. More advanced diseases at the anal margin are managed with
treatment options similar to anal canal cancers, stage for stage.
Staging Systems
Several clinical staging systems have been proposed and used in the past, including classifications from the Mayo Clinic, Roswell
Park, and the Centrel L'eon B'erard. The recently modified TNM classification (1992) has been used in the treatment guidelines
because it is a clinical system that is suitable for a disease now treated primarily with nonsurgical means and because of its
increasing acceptance in the literature. 38
Treatment Systems
The PCS decision tree for the anal region is shown in Figure 3.
TSI For T2NoMo tumors of the anal margin and T1 or T2NoMo tmnors of the anal canal, the treatment of choice is a
concurrent combination of two cycles of 5-FU and mitomyein C (Mito C) and 45 to 54.9 Gy. The 5-FU (1 g/m2/24 h) is given by
continuous infusion for 4 consecutive days and Mito C (I0 mg/m 2) is given by intravenous bolus on the first/ second day of
5-FU infusion. These drugs are given on weeks 1 and 4 or 5 of radiotherapy (RT). RT doses to the primary tumor greater than 60
Gy are inappropriate, whereas doses between 40 and 44 Gy may be acceptable for selected small cancers. The dose to the
grossly uninvolved inguinal nodes should be between 30 and 45 Gy.
Patients who have poor renal function may be treated with 5-FU and RT without Mito C. Patients who refuse chemotherapy,
or who for some reason cannot receive chemotherapy, may be treated with RT alone to a dose of 60 to 65 Gy. Doses below 55
Gy and above 65 Gy are considered inappropriate.
TS2 For patients with T1 or T2 primary tumors and biopsy-proven inguinal nodes, the treatment of choice is again
chemoradiation. RT doses of 45 to 59.9 Gy to the primary site are acceptable. Doses of 35 to 45 Gy to the involved inguinal
nodes are acceptable. (Nodal doses between 30 and 34.9 Gy and between 45 and
Squamy2usJBas~dold/Cloacogenic
Ou hie for definitive treatment
0 of anal margiNperianal
O 5 era)
o.det Wideexci$1on T1 /, NO I 1 , I I
d.,,oo, TSIlTS21T$3 ./...__ All others I I .( ~' / / ../ ~/~ y \.

/~ ~T?*4, \
NO or N* (> 5 ore)
,== / \
/ ~Resldual disease after T3~ , / TS1/TS2/TS3
/ /
Figure 3. Anal region decision tree.

49.9 Gy are probably acceptable in some cases, whereas doses above 50 Gy are probably not acceptable.)
Treatment with RT and 5-FU alone or with RT alone may be appropriate treatments under circumstances described in TS 1.
TS3 With primary tumors greater than 5 cm in size or attached to surrounding structures (T3/T4 lesions with or without
involved inguinal lymph nodes), the treatment of choice is chemoradiation with 50 to 60 Gy RT to the primary tumor site and
two concurrent cycles of 5-FU and Mito C. (Doses to the primary tumor of 45 to 49.9 Gy may be acceptable, but doses of less
than 44.9 Gy are probably inappropriate.)
The inguinal nodes are best treated with doses between 35 and 45 Gy, though doses between 30 and 34.9 Gy (for uninvolved
nodes) and between 45 and 49.9 Gy (tbr involved nodes) may be appropriate.
The treatment of involved inguinal lymph nodes by resection with or without follow-up RT was believed to be probably
inappropriate therapy.
TS4 Salvage chemoradiation is the treatment of choice for patients who develop clinical progression of disease after TSI,
TS2, or TS3. This treatment consists of 10 to 16 Gy RT to the primary site and/or inguinal nodes with concurrent 5-FU (same
dose as in TSI) and cisplatin (75 mg/m ) on day l or 2 of 5-FU infusion. Such treatment is based on the Radiation Therapy
Oncology Group (RTOG) experience with salvage chemoradiation for patients who had re- ceived up to 50.4 Gy of RT with
chemotherapy betbre local failure. 27
TS5 APR is the treatment oi" choice for patients with failure at the primary tumor site after TS4 or in patients treated with
TSI/TS2/TS3 with RT doses greater than 60 Gy.
Posttreatment Biopsies
In patients showing no clinical progression of disease after treatment with TS1/TS2/TS3, salvage treatment with TS4 or TS5 is
inappropriate [br positive biopsies performed within a month of treatment but is acceptable if the biopsy is performed 12 months
or more after treatment. No consensus was achieved for
situations where biopsies were performed between 1 and 12 months.
In patients with clinical signs of disease progression and a positive biopsy, the treatment of salvage chemoradiation or APR
is appropriate. No consensus was reached regarding the use of radiation implants in this situation.
Breast Decision Tree

Conservative Management of Early Stage Breast Cancer
Clinical Stages I-II It is estimated that 184,300 new cases of invasive breast cancer will have been diagnosed in 1996. 39 Of
these, roughly 75% will be AJC stages I-II, 4~ for an estimate of 138,000 new patients. It is this group of patients with early
stage breast cancer that is eligible for breast-conserving treatment. Despite nearly 15 years of follow up from the randomized
trials that continues to demonstrate equivalent survival for breast conservation therapy in comparison with mastectomy, the use
of this treatment has been less than anticipated. 41 The decision tree from this point serves to exclude patients who are not
candidates for preservation techniques.
Contraindications to Radiation Pregnancy, preexisting collagen vascular disease, previous radiation. Pregnancy is an absolute
contraindication to breast irradiation. Preexisting collagen vascular disease has been considered a relative contraindication by
some 4~ and absolute by others. 4:~,+~ This is based on observed severe late radiation reactions reported in a small number of
patients. 45"47 Collagen vascular diseases include a heterogeneous group of patients, and whether all who have this diagnosis
are at risk for these toxicities is not clear. Previous radiation is a contraindication depending on the previous dose delivered and
areas treated.
Distant metastases. Conservation techniques are generally not indicated in patients whose work ups reveal distant metastases.
Solita~ lesions. Patients who have gross multicen- tricity or mammograms with diffuse microcalcifica- tions are not
considered candidates due to unaccept- ably high breast recurrence rates after conservation techniques.48, 49

Breast-conserving surgery. Adequate excision of the primary tumor is necessary before initiation of breast irradiation.
Pathologic T1, T2. Tumor size up to 4 to 5 cm has not been significantly associated with an increased risk of local recurrence)
~ There is limited pub- lished data for breast conservation therapy when tumors are greater than 5 cm in size, 53,54 and in
general, treatment as such should be considered investigational.
Clinical axillary node status. The presence of axillary nodal metastases does not affect a patient's eligibility for breast
conservation. Breast recurrence is not related to pathologic nodal status. 49,5~
AxiUary dissection. Axillary treatment is considered a standard part of conservation techniques. Axillary dissection is
preferable as it provides important prognostic information along with its therapeutic effect. Increasingly, there is controversy
regarding whether a group of patients with sufficiently low risk can be identified so that axillary treatment can be omitted. 56-58
At present, observation alone should be considered investigational.
Assess final resection margin of the primary tumor. It is necessary that the presence or absence of gross or microscopic
carcinoma at the resection margins of excision is known by marking them with India ink or another suitable technique.
Treatment Systems
The breast decision tree is shown in Figure 4.
TS1 and TS2: Pathologically Positive Axillary Lymph Nodes These systems are designed for patients with axillary nodal
metastases and differ by whether there is involvement of the final pathologic margin of excision in the breast. In each system,
treatment consists minimally of breast irradiation. Whether regional nodal irradiation is warranted depends on the degree of
axillary nodal involvement. There was consensus for supraclavicular and axillary apex irradiation for patients with three to four
or more positive axillary lymph nodes. No consensus was reached regarding the acceptability of full axillary irradiation using a
posterior axillary (PA) boost in the setting of an adequate level I to II axillary node dissection.
TS1 applies to cases where the final surgical margin in the breast is positive. In this case, a boost is consistently
recommended. TS2 is applicable when
e I~H breast cancer
\No Distant metastasis Solitary lesion (grossly and/or mammographically)
\ j Breast conserving surgery (Iumpectomy,
X~uadrantectomy, \Yes
excisional biopsy)
Pathologic T1, T2
node Status
dissection
XRT
Yes
Yes
Yes
Inadequate staging
~Positive \~gative
Assess final resection margins of pdmary tumor
- +J\-
TSI TS2
TS3 TS4 TS5 TS6 Breast Yes Yes Yes Yes Yes Yes
Boost Yes Optional Yes Optional Yes Optional
Nodeo Optional Optional No No Yes Yes
Figure 4. Breast decision
tree.
this margin is negative. Consensus reflected that boosting in this situation is acceptable.
TS3 and TS4: Pathologically Negative Axillary Lymph Nodes These systems apply to patients without pathologic evidence of
axillary nodal involvement and also differ by the presence or absence of the primary tumor at the margin of excision. Treatment
consists of breast irradiation. Regional nodal irradiation is not indicated. TS3 is designed for patients with positive final surgical
margins in the breast, and in this setting, boosting the tumor bed is consistently recommended. For TS4, which applies to
negative final surgical margins, consensus reflected that use of a boost is considered acceptable.
TS5 and TS6: Undissected Axilla These systems are germane to those patients who have not had an axillary node dissection.
Treatment should include breast irradiation and regional nodal irradiation to include the entire axilla. In this setting, a PA boost as
part of full axillary irradiation is

1996 Decision Trees and Manaeement Guidelines 171
recommended. TS5 and TS6 apply depending on whether the breast primary tumor has positive or negative final margins of
resection, respectively. As stated above, when margins of excision within the breast are involved by carcinoma, a boost to the
tumor bed is consistently indicated.
Radiation therapy. For whole breast irradiation, doses of 45 to 50 Gy with standard fractionation are considered acceptable.
When a boost is used, cumulative tumor bed doses of 60 to 65 Gy are most acceptable. Consensus suggested that a cumulative
tumor bed dose of greater than 65 Gy is probably acceptable in the setting of positive margins but unacceptable when margins are
negative. There was less consensus regarding boost doses resulting in a cumulative tumor bed dose of less than or equal to 55Gy.
Cervix Decision Tree
Although the incidence of invasive cervical cancer in the United States has decreased dramatically with the institution of
aggressive cytologic screening pro- grams, it continues to be the leading cause of cancer deaths tbr women in underdevcloped
countries and is still a serious heahh problem tbr high-risk and medically underserved women in the United States. Radiation
therapy is the mainstay of treatment tbr most patients with locally advanced cervical cancer and is an excellent option for many
patients with earlier invasive disease. The critically important role of intracavitary irradiation in the curative management of
cervical cancer is well documented; the balance and timing of brachytherapy and external beam may also influence the likelihood
of local control and complications. Accurate assessment of locoregional disease extent is important, because patients with nodal
metastases can often be cured with regional treatment. These aspects of cervical cancer treatment demand unique skills of the
radiation oncologist. It is critically important that clinicians maintain a detailed knowledge of successful treatment metht,ts,
particularly now that the decreas- ing incidence of invasiw: cervical cancer has reduced many clinicians' exlx)sure to patients
with this disease.
Staging and Clinical Evaluation

The most widely accepted staging system for carcinoma of the cervix is defined by the International Federation of Gynecology
and Obstetrics (FIGO).
This is a clinical staging system) 9 Categories are based on findings from clinical examination and specific radiologic
examinations. To make the staging system consistent and applicable to patients in developing countries, a number of studies
that may be helpful in planning treatment (CT, MRI, lymphan- giography, surgical staging procedures) are specifically excluded
fiom consideration in assigning a FIGO stage. Until recently, tumor size----~me of the most powerful predictors of outcome and
the basis for many treatment decisions--was not considered in the staging system. In 1994 tumors confined to the cervix (stage
IB) were subdivided according to the clinical diameter of the cervix into stage IB 1 (-<4 cm) and 1B2 (>4 cm). However, the bulk
of central disease still does not influence staging of tumors that extend beyond the cervix to the upper vagina (stage IIA),
parametrium (stage IIB), or pelvic wall (stage IIIB), except to the extent that size is roughly correlated with the degree of local
extension.
Although the extent of regional involvement and size of central tumor are not specifically addressed in the staging system,
these factors have a powerful impact on outcome and influence the choice and character of treatment in many cases.
Treatment
The decision tree for carcinoma of the cervix is shown in Figure 5.
Disease Outside the Pelvis Patients whose extrapelvic disease is confined to the paraaortic nodes may be cured with extended
field irradiation, particularly if their pelvic disease can be controlled with radiotherapy. "<m Patients who have hematogenous
metastases are rarely, if ever, curable. Palliative pelvic irradiation may control bleeding and pain from locoregional disease.
Ahhough chemotherapy has been investigated in patients with advanced disease, its palliatiw', benefit is uncertain.
Microscopic Tumor Less Than 3 mm Without Lymph Vascular Space Invasion (Stage IAI) A standard treatment for early
microinvasive disease is a total (type I) hysterectomy. Intracavitary irradiation alone is also an excellent treatment, particularly
for patients who are at high risk of complications from surgery. A total dose of 70 to 75 Gy to point A is usually recommended.
62,63 Selected patients who wish to preserve fertility may be treated with a therapeutic conization of the cervix if there is no
lymph

Disease
peMs
outside
Yes l a
N•o
> invasion,
3 mm stromal k
Extra confined pelvic to disease PA Yes
i
] I I
~'-"] Tumor/patient characteristic i o
LVSI
~ Treatment l O~ ~ ]
Controversial treatment option
No (IA2,1B', small IIA) Pelvi&wall c' Ira~ r ] l IIA) I bladder "amv~ ~
2-IIB) I
Bladder involved
or rectum
~o (nlA-B/
~ Pelvic,vail ]
Yes
'~
i o
(IAI)
No (IV
operative High No a
risk t /
Yes I
Radical Hysterectomy,'~
No
I
Figure 5. Decision tree for carcinoma of the cervix. ICRT, intracavitary radiation therapy; LVSI, lymph vascular space invasion;
LND, lymph node dissection; EBRT, external beam radiation therapy.
vascular space invasion and if the margins of the cone biopsy are negative. 64,65
Tumor Less Than or Equal to 4 cm (Stages IA2, IB1, or Small IIA, With Clinically Negative Nodes) Patients may be treated
surgicallywith radical hysterectomy and pelvic lymph node dissection, or radio- therapeutically with a combination of external
beam and intracavitary irradiation. In most cases these treatments are believed to yield comparable local control and cure rates.
66-68 Diffuse cervical involvement, extensive lymph vascular space invasion, and high-grade adenocarcinoma may be relative
indications for treatment with primary irradiation, because these features are often associated with other high- risk surgical
findings that lead to a recommendation for postoperative irradiation. G9-73 Young patients benefit from the ability to preserve
ovarian function with surgical treatment. Very obese, elderly, and medically unfit patients may tolerate radiation therapy better
than radical surgical treatment. However, the relative indications for recommending one treatment
over the other are controversial. When treatment is with radical irradiation, the total dose given to point A is usually between 75
Gy (for stage IA2 disease) and 85 Gy.
Stages IB2-IIB Patients with bulkier stage I or stage II disease and patients who have clinical evidence of pelvic lymph node
involvement are usually treated with radical radiation therapy using a combination of external beam and intracavitary irradiation.
Most tumors should be treated with a dose to point A of 85 to 90 Gy to achieve the best chance of local control with acceptable
morbidity. A number of factors, including the bulk of central disease, response to initial external beam irradiation, and the
quality of intracavitary placements, should be considered in selecting the precise dose of irradiation for an individual patient.
Some oncologists recommend that selected patients with bulky tumors be treated with a combination of radiation therapy (usually
with a somewhat reduced dose of brachytherapy) and extrafascial hysterectomy.
74-76
However, because the benefit of adjunctive

hysterectomy has never been clearly demonstrated, this approach continues to be controversial. 77
Patients who have no clinical evidence of pelvic wall involvement are usually treated with 40 to 45 Gy of
external beam irradiation in addition to the dose delivered to the pelvic walls from intracavitary irradiation. Most
clinicians give some additional treatment to clinically positive nodes, to deliver a total dose of 60 to 65 Gy. A
randomized study from the RTOG
TM demonstrated an improved survival rate for patients with stages IB2-IIB disease when prophylactic paraaortic
irradiation was added to standard pelvic therapy. Though extended field irradiation has not yet been universally
adopted as standard for this population, it is probably the preferred treatment for patients who have not had surgical
or at least lymphangiographic evaluation of the paraaortic nodes. Several groups are currently investigating the use
of neoadjuvant chemotherapy followed by radical hysterectomy with or without radiation for patients with bulky
disease. 79,a~ This approach should still be considered highly experimental. Preradiation chemotherapy has not
been demonstrated to be of value. Concurrent chemoradiation is being investigated in several randomized studies,
none of which has yet been reported.
Stage HI Stage III tumors should also be treated with radiation therapy using a combination of external beam
irradiation and brachytherapy. Although radiation oncologists have sometimes chosen to weight the external
component of treatment more heavily because of the tumor's lateral extension, evidence suggests that brachytherapy
is still an extremely important component of curative treatment. Several studies, including one from the PCS, have
demonstrated significantly lower survival rates for patients treated with external beam radiotherapy alone, al,a2
Whenever possible, an effort should be made to deliver at least 85 to 90 Gy to point A using a combination of pelvic
radiotherapy and intracavitary treatment. Pelvic wall disease is usually boosted with external beam irradiation to
deliver a total dose (including the brachytherapy contribution) to the lateral pelvic wall of 60 to 65 Gy. Several
groups have advocated the use of interstitial (rather than intracavitary) brachytherapy to treat cervical cancers that
involve the lateral parametrium or pelvic wall. a3-a5 Early reports suggested acceptable local control rates.
However, the only relatively large series with long-term follow up had disappointing results, and the role of
interstitial
brachytherapy remains controversial. 86 Interstitial implants are sometimes used in combination with intracavitary
therapy to treat the distal vagina of patients with stage IIIA disease or with bulky stage IIIB tumors involving the
lower one third of the vagina.
The role of prophylactic paraaortic irradiation in patients with stage III disease is unclear. A European
Organization for Research and Treatment of Cancer (EORTC) study comparing pelvic and extended field irradiation
7 demonstrated no significant difference in disease-specific survival, possibly because many of these patients died
with uncontrolled pelvic disease. The role of concurrent chemotherapy and irradiation is also being studied in these
patients.
Stage IVA Fortunately, stage IVA disease is rare, as the prognosis is usually very poor. If possible,
brachytherapy should be included in the treatment, but massive pelvic disease with necrotic, fistulous communica-
tions between the vagina and adjacent structures often compromises attempts at radical radiation therapy. Rarely,
exenteration (alone or combined with irradiation) may play a role in patients who have bladder invasion from a
relatively small tumor, particularly if a vesicovaginal fistula has already compromised bladder function.
Seminoma Decision Tree
Whereas testicular seminoma is a rare disease, with an incidence of only 3.8 per 100,000 males in the United States,
it is the most common malignancy in men between the ages of 20 and 34 years. As testicular seminoma is highly
curable, it is important that treatment is optimized to ensure maximal cure rates while minimizing long-term
complications of therapy. The fact that radiation constitutes the primal',/postorchidectomy therapy for the majority
of patients means that attention must be paid to the details of radiation, including the doses used and volumes to be
irradiated, to optimize the therapeutic ratio.
Staging
The commonly used staging system for testicular seminoma is a modification of the Royal Marsden Hospital
system, s~ The UICC and AJC systems are also used but use T stagings that are not associated with any recognized
prognostic value in seminomas. The staging system is based on clinical and radiologic

examination, including lymphography or CT scanning, and the chest x-ray. The staging system is correlated with survival when
appropriate therapies are given. In the stage I category are patients with disease confined to the testis including those with
invasion of the tunica albuginea, epididymis, sper- matic cord, and scrotum. Stage II includes those with infradiaphragmatic
lymph nodes in the paraaortic, pelvic, and inguinal regions. The stage II category is subdivided into A, B, C, and D according to a
maximum diameter of metastases of less than 2 cm, 2 to 5 cm, 5 to 10 cm, and greater than 10 cm, respectively. Stage III includes
those with involvement of supradiaphragmatic lymph nodes and may include infradiaphragmatic lymph node involvement but
without evidence of extra lymphatic metastases. If abdominal nodes are present, the subcategories of stage II (ie, A, B, C, and D)
are used. Stage IV constitutes less than 3% of the total population at presentation and includes those with extralymphatic
metastases subcategorized into those with abdominal stages A, B, C, and D.
Treatment Systems
The decision tree for seminoma is shown in Figure 6.
TS1 Patients with stage I disease are traditionally managed with radiation therapy to the paraaortic and ipsilateral iliac nodes
using a dose of 25 to 30 Gy in 15 to 20 fractions. 89 Radiation therapy confined to the paraaortic nodes in a dose of 25 to 30 Gy
in 15 to 20 fractions is probably an acceptable treatment, although no consensus on this choice has been reached. Appropriate
surveillance of the pelvic and inguinal regions should be performed, because the risk of recurrence in these sites may be up to
5%. 9o Surveil- lance with appropriate CT scanning of the retroperi-
TS1 RT to Para-Aortics only
25 Gy in 15-20 fx RT to Para-Aortics & ipsileteral iliac nodes
25 Gy in 15-20 fx Surveillance
TS2a RT to Para-Aortics only
25 Gy in 15-20 fx RT to Para-Aortics &
ipsiMtaral lilac nodes
25 Gy in 15-20 fx RT to inguinal region
no consensus Surveillance
TS2b RT to Para-Aortiss only
25 Gy in 15-20 Ix RT to Pare-Aortics & ipsilateral iliac nodes
25 Gy in 15-20 fx Rt to scrotum
25 Gy Surveillance
TS3a RT to Para-eorlics + ipsilateral Iliac nodes
25 Gy in 15-20 fx
TS3b RT to Para-aortics + ipsileteral Iliac nodes +_ contraMteral lilac nodes if involved nodes are at or below L4
25 Gy in 15-20 fx plus 10 Gy boost to involved nodes
TS3c Chemotherapy Residual mass - watch end treat if progression occurs or consolidation RT to mass
20 Gy
TS3a, b, c may be modified to include inguina[ RT for previous inguinal surgery ol to add scrota1 RT for trans-scrotal
surgery
25 Gy to scrotum
Histology: Pure seminoma 7 o,o, / X..o,=,mot.=o,,,e0 7,<,~pre-dlaph,agmatic metaetasesl

.....
/ ~/~troperitoneal nodes ~ut + stage,,/
/
TS2b Trans-scrotal
Figure 6. Seminoma decision tree.

19961)ecision Trees and Management Guideliner 175
toneum is also considered acceptable treatment: it results in survival rates similar to those where radiation is used and spares
approximately 85% of unnecessary therapy." 1
T2A and T2B Patients with stage I disease who have had previous inguinal or transscrotal surgery can be treated similarly to
those in the TS1 category. Controversy surrounds whether radiation to the inguinal region (S) and/or scrotum is necessary, and no
consensus has been reached. If given, the dose should be confined to 25 Gy in similar fractionation to that used for the remainder
of the field.
TS3A Patients with stage II disease with the maximum transverse diameter of retroperitoneal nodes less than 2 cm should be
treated with paraaortic and ipsilateral lilac nodal irradiation to a dose of 25 to 30 Gy in 15 to 20 fractions. ~'92
TS3B Patients with stage II disease with nodal masses 2 to 5 cm in maximum transverse diameter Should be treated with
radiation to the paraaortic and ipsilateral iliac n~les. It is controversial as to whether contralateral iliac nodes need to be treated.
It is suggested that if" the inwJlved nodes are low-lying, ie, at or below the level oflA, it is acceptable to treat the contralateral
lilac n~xles. The radiation dose recommended is 25 Gy in 15 to 2(1 fractions to the, whole w)lume, tbllowed by a 10-Gy boost
to inwflved nr
TS3C For patients with stage II disease and nodes in excess of 5 cm but less than l0 cm in diameter, acceptable treatments
include primary cisplatin-based chemotherapy (eg, with bleomycin, etoposide, and plati- num) 9:~ tbllowed by observation.
Some facilities consider giving consolidation radiation to the site of the original mass in a dose of2(I Gy, but this will result in
overtreatment in 85% of patients. Also considered acceptable therapy tbr this group is radiation therapy to the paraaortics and
bilateral pelvic nodes. The recommended dose is the same as for TS3B. Alter infradiaphragmatic irradiation, the patient should
be monitored for relapse in the mediastinum or distant sites, as the frequency of expected relapse after radiation is 20%. 94,~r'
Prophylactic mediastinal irradiation is not recommended tbr any patients with stage II disease. ~<~6 For patients with masses
greater than
10 cm in diameter, primary cisplatin-containing chemotherapy is recommended. 97,!~
For TS3A, TS3B, and TS3C, radiation treatment may be modified to include inguinal radiation tbr a previous inguinal surgery
or to add scrotal radiation tbr transscrotal surgery in a dose of 25 Gy.
For patients with stage III (supradiaphragmatic metastases) or stage 1V (parenchymal metastases) disease, primary
cisplatin-containing chemotherapy is recommended with observation of residual masses. If progression occurs, consolidation RT
may be delivered to residual masses, providing disease relapse is not systemic or multifocal.
Prostate Decision Tree
Prostate cancer accounted for 41% of newly diagnosed malignancies in American males in 1996: 317,000 cases? ~ A recently
discovered laboratory test, prostate-specific antigen (PSA), increased public awareness, and greater emphasis on screening for
early detection has led to successively higher inci- dences each year. PSA has also provided a more sensitive and objective
method tbr earlier assessment of treatment outcome than was possible previously using clinical means ahme. Untbrtunately, this
laboratory test also showed us with alarming fi'equency just how often tumoJ" was not co,nl)letely eradicated by locally applied
therapy. Theretore, treatment strategies are being evaluated, and, often times, combined methods are applied.
Tumor Stage, Tumor Grade, and PSA

The three prognostic thctors most often used to make therapeutic decisions are tumor stage, PSA, and tumor grade. Tumor stage
attempts to clinically quantitate the amount of local tumor present within the prostate (Tla to Tic and T2a to T2c) or to define the
areas of local extension (T3a to T3c), regional involvement (N0 to N3), or distant involw:nmnt (M0 to M l). PSA serves a similar
purpose, as it also tends to measure the amount of disease present and predict whether it has escaped the confines of the prostate.
In multivariate analysis, PSA has been shown to be the most significant predictor of outcome after irradiation, ml~,u)l Tumor
grade is a measure of the inherent aggressiveness of the malignant process and the associated risk tbr disease extension locally
and dissemination regionally and distantly.
Although many histologic grading systems have been proposed, Gleason score correlates well with

176 PC S Consensus Committees
outcome and has been widely accepted. 1~ These three factors, then, form the basis for treatment choices as outlined
by the prostate decision tree (Figure 7).
Age and Life Expectancy

As prostate cancer can be a slowly progressive disease with a relatively low risk of death if left untreated, care must
be taken to select as carefully as possible those patients who might benefit significantly from curative treatment.
Recent metaanalysis showed a 10-year disease-specific death rate of only 13% for low and moderate grade prostate
cancer left untreated, t~ Average life expectancy, family longevity, and comor- bid conditions must be considered
also to balance the benefit of aggressive therapy with the risk of induced morbidity and compromised quality of life.
Radiation Dose
In general, doses in the range of 65 to 72 Gy are recommended for relatively early stage disease (TI, T2a). The
higher end of this range, 70 to 72 Gy, is advocated for bulkier lesions (T2b, T2c, and T3), and doses greater than 72
Gy are being applied in clinical trials using three-dimensional conformal therapy) ~ When the risk of seminal vesicle
involvement is substantial, these structures are included within the treatment portal to a dose of 50 to 55 Gy. When
seminal vesicle disease is documented, the dose range is usually higher: 55 to 65 Gy. When pelvic lymph nodes are
irradiated, a dose of 45 to 50 Gy is usually applied.
Treatment Systems
TSN It has been shown that few patients with metastati- cally involved pelvic lymph nodes are potentially
curable because of the high risk of associated distant disease) ~ Randomized studies comparing locoregional
radiation plus androgen deprivation with androgen deprecation alone are lacking. Most would agree that androgen
suppression is appropriate, but whether pelvic radiation adds to the clinical disease- free interval or overall survival
remains questionable. There seems to be less controversy regarding early versus late hormonal therapy, based on
PCS Consen- sus respondents who indicated that treatment at diagnosis is preferred.
TSla and TSlb Although TSla pertains to relatively early clinical stage disease and TSlb to later stage tumors, the
serum PSA (>20 ng/mL) indicates a high likelihood of substantial disease burden and compromised prognosis.
Therefore, the treatment applied should be effective against potentially extensive disease. Under these
circumstances, most would advocate locoregional therapy, which has the advantage of treating areas of potential
extracapsular extension, seminal vesicle involvement, and lymph node involvement. This therapy may be external
beam therapy alone or external beam therapy plus radioisotopic implant. More controversially, radical prostatectomy
is included as an option for stage I and lI tumors. Androgen suppression is combined with these definitive
modalities to decrease the tumor burden) ~176
Pat hology/Aden0carclnoma es
Candidate for evaluation
es
Distant metastases or
oslitve P-A nodes Out o
Out Positive pelvic nodes
No
Out PSA 9 20
NO
TS PSA 10 - 20
NO
TS~. Gleason_<. 6 /
T2c,T3 * / TS3d Gleason 9 6 * T3 unusual with PSA < 10
Figure 7. Prostate decision tree.

1996Decision Trees and Management Guidelines 177
TS2a through TS2d These treatment systems apply to patients with midrange PSA levels and are differentiated on the basis of
tumor grade and stage. These PSA levels indicate a moderate disease burden and similar associated risk for extension outside the
prostate. The higher the tumor stage and grade, the more likely this occurs. Therefore, treatment must be applied accordingly.
Combination therapy to include androgen deprivation should be considered, as treatment localized to the prostate gland only,
such as implant and prostatectomy, may not treat the total disease extent.
TS3a through TS3d Based on PSA level, this group should include those patients with the least amount of tumor, the highest
chance that is truly localized, and, therefore, the best prognosis. T3 lesions are rarely seen in this category, but may indicate a
non-PSA-producing cancer. For early stage (T1, T2a and T2b) and low-grade lesions (Gleason score less than 6), treatment may
be very locally applied. Radical prostatectomy, external beam therapy, and radioisotopic implant are all acceptable methods. The
RTOG is conducting a clinical trial addressing the need for androgen suppression in those patients with high-grade lesions.
Patients with locally advanced disease (bulky T2c and T3) must be treated similarly to the group of patients with the same stage
tumor but higher PSA levels (TSI and TS2).
Prostatectomy Decision Tree

The decision tree for prostatectomy is shown in Figure 8. After prostatectomy, if margins or seminal vesicles are positive but
PSA is undetectable, two options are available: immediate postoperative therapy as described in TS-RP1 or surveillance to
include serial serum PSA levels. Available data would seem to indicate that if treatment is applied expedi- tiously, the patient is
not disadvantaged. ~~ Further- more, this approach will spare up to 50% of patients unnecessary therapy./]0 When serum PSA is
increasing (TS-RP2) or there is a palpable nodule within the prostatic fossa (TS-RP3) and the metastatic work up is negative,
the local area can be irradiated. The dose tends to be slightly higher for clinically detectable disease (65 to 70 Gy) than for
increasing PSA (60 to 65 Gy), especially if detected early. Androgen deprivation may also be used, although no comparative
data have been reported to date.
adlcal pr~tateGtomy
TS-RP1
TS-RP2
TS-RP3
~dagy \ nodule rising kl PSA prostatic without fossa
palpable
+/- dalng PSA
Figure
8. Prostatectomy decision tree.
Acknowledgment
The Consensus Committees thank Irene Mahon, PCS Research Associate, For her clinical support.
Appendix: PCS Consensus Committees

Gastrointestinal Committee
(,'hair." Lawrence R. Cola; E~ophagus Consensus Chair." Lawrence R. Cola; Rectum Cousensus Chair: Bruce D. Minsky;Anus
Consensus (`'hair." Madhu John; Committee rnemberv Daniel Hailer, John Hoffman, .Jerome Landry, Thomas Pisansky, and
Christopher Willet.
Breast Committee
(,'hair: J. Frank Wilson; Breust Consensus Chair: J. Frank Wilson; Committee memberv Barbara Fowble,,Jay Harris, Robert R.
Kuske, Michael D. Lagios, Marsha McNeese, Barbara Monsces, Monica Mnrrow, Abram Recht, Christopher M. Rose, Brenda
M. Shank, Julia R. White, and David Winchester.
Cervix Committee
Chair: Patricia Elf el; Cen~ix Consensus Chair: Patricia Eifel; Commit- tee memberv Perry Grigsby, Rachelle Lanciann,
Clifton Ling, Gus- tavo Montana, Lynda D. Roman, Sonja Schoeppel,Judith Stitt, and Gillian M. Thomas.
Genitourinary Committee
Chair." Gerald E. Hanks; Seminoma Consensus Chair: Gillian M. Thomas; Prostate Consensus Chair: Deborah A. Kuban;
Committee member~: Mitchell Benson, Gerald Chodak, George E. Laramore, Carlos A. Perez, Mack Roach, Howard M.
Sandier, Howard Scher, Timothy E. Schuhheiss, and Anthony L. Zietman.

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1996Decision Trees and Management Guidelines 181
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1996 Guidelines

Decision Trees and Management

Esophagus Decision Tree Primary Histology

Rectum Decision Tree

Treatment Recommendations by TNM and Clinical Stages

Anus Cancer Decision Tree Background

Tumors of the Anal Margin

d.,,oo, TSIlTS21T$3 ./...__ All others I I .( ~' / / ../ ~/~ y \.

Breast Decision Tree

Staging and Clinical Evaluation

Histology: Pure seminoma 7 o,o, / X..o,=,mot.=o,,,e0 7,<,~pre-dlaph,agmatic metaetasesl

Tumor Stage, Tumor Grade, and PSA

Age and Life Expectancy

Prostatectomy Decision Tree

Appendix: PCS Consensus Committees

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