Scope:

The assignment is designed to evaluate your attention to

detail, and you are expected to review this manuscript and fix
the following:
 
• Ensuring scientific accuracy of the data/claims/graphical
elements/figures in the manuscript. Reference articles are
provided along with this manuscript to perform the data
validation
• Check and fix the grammatical/typographical/formatting errors, if
any
• Check and fix the errors in citation/referencing
• Review and ensure the language & typography followed across
the manuscript is in UK English style
• Review the referencing style (bibliography) to ensure it is in
American Medical Association (AMA) standards and fix if there
are any errors
 
Note:
• Highlight the changes you make in a different colour and
leave a comment wherever required to justify the change
you have made.
• Keep a track of the effort hours required to complete this
assignment and share it along with the assignment.
 Add goserelin
to the Advanced
Breast Cancer
Treatment Plan
ZOLADEX 3.6 mg is indicated only as an addition to the existing chemotherapy in the standard of care for pre- and
perimenopausal women with estrogen receptor-positive early breast cancer and, advanced breast cancer
postmenopausal women suitable for hormonal manipulation.
 Advanced Breast Cancer
Treatment guidelines recommend ovarian suppression/ablation for premenopausal women
diagnosed with advanced breast cancer (ABC) for whom endocrine therapy is decided. 1,2

Patient Profile*
• Recently diagnosed with
estrogen receptor
positive (ER-)/human
epidermal growth factor
receptor 2 negative
(HER2-) prostate cancer
• Age = 49 years
• Clinical Stage = T3 N2 M1

*Fictitious patient.

Guidelines for Treatment of breast cancer in Premenopausal Woman

ABC 4 recommends ovarian suppression (OS)/ablation combined with

additional endocrine therapy as the preferred choice for premenopausal
women for whom endocrine therapy was decided. 1

National Comprehensive Cancer Network (NCCN) recommends OS/ablation

plus endocrine therapy as for postmenopausal women. 2
ZOLADEX Achieves Similar Overall Survival and Disease-free Survival in Patients With
Advanced Breast Cancer3

Disease-free Survival
Failure At Risk
Oophorectomy 67 65
Goserelin 69 62
Failure-free survival (%)

Months after registration

Overall Survival
At Risk Deaths
Oophorectomy 67 48
Progression free survival (%)

Goserelin 69 44

Years after registration

ZOLADEX Oophorectomy HR; 95% CI

Objective Response Rates 31% 27% –

Failure-free Survival (FFS) 4 months 6 months HR = 0.73; 95% CI: 0.51-1.40

Overall Survival (OS) 37 months 33 months HR = 0.80; 95% CI: 0.53-1.20

The affects of ZOLODEX are reversible: With ZOLODEX, the majority of patients have a return of menses
within a year of completing therapy, 4 unlike oophorectomy where the ovaries are removed permanently.
A multicenter, randomized clinical trial evaluating PFS and OS for patients with positive estrogen receptor (ER) and/or
progestorone-receptor metastatic breast cancer treated with goserelin versus surgical ovariectomy.2

CI = confidence interval; HR = hazard ratio.

Tolerability Profile of ZOLADEX5

System Organ Class Common Very Common

Psychitric disorders Libido decreased Mood changes, depression

Vascular diseases Hot flush Blood pressure abnormal

Skin and subcutaneous tissue disorders Hyperhidrosis, acne Rash, alopesia

Reproductive system and breast disorders Vulvovaginal dryness, –

breast enlargement

General disorders and administration site Injection site reactions Tumor flair, tumor pain (on
conditions initiation of treatment)

Nervous system disorders – Parasthesia, headache

Musculoskeletal, connective tissue and - Arthralgia

bone disorders

Abridged Prescribing Information

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dolor sit amet, consectetuer adipiscing elit. Aenean commodo ligula eget dolor. Aenean massa. Cum sociis natoque
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ut metus varius laoreet. Quisque rutrum. Aenean imperdiet. Etiam Lorem ipsum dolor sit amet, consectetuer adipiscing
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References: 1. Cardoso F, Senkus E, Costa A et al. 4th ESO-ESMO International Consensus Guidelines for Early Breast
Cancer (ABC 4). Annals of Oncology. 2018; 29(8):1634-57. 2. National Comprehensive Network. NCCN Clinical Practice
Guidelines in Oncology – Breast Cancer. Version 2.2019-July 2019. NCCN Web site.
https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed August 12, 2020. 3. Taylor CW, Green S,
Dalton WS, et al. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients
with receptor-positive metastatic breast cancer: an intergroup study. J Clin Oncol. 1998; 16(3): 994 - 9. 4. Jonat W,
Kaufmann M, Sauerbrei W, et al. Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy
in premenopausal patients with node-positive breast cancer: The Zoladex Early Breast Cancer Research Association
Study. J Clin Oncol. 2002: 15 (12) 4628–4635. 5. Zoladex [summary of product characteristics]. Luton, UK: AstraZeneca
UK Ltd; 2017.

©2019 Indegene. All rights reserved.

Job ID: XXXX Preparation date: 08 2019 Expiry date: 08 2020