Beruflich Dokumente
Kultur Dokumente
January 2013
This briefing is
based on
information
available at the time
of research and a
limited literature
search. It is not
intended to be a
definitive statement
on the safety,
efficacy or
effectiveness of the
health technology
covered and should
not be used for
commercial
purposes or
commissioning
without additional
information.
TECHNOLOGY
DESCRIPTION
Abraxane (ABI-007) is an albumin-bound formulation of paclitaxel designed to overcome the
insolubility problems associated with conventional paclitaxel formulations. Abraxane utilises
albumin binding proteins, such as (gp60)/caveolin-1 (CAV1) and SPARC (secreted protein
acidic and rich in cysteine) to achieve high intratumoral paclitaxel accumulation. It eliminates
the need for toxic solvents like cremophor, which are associated with allergic reactions,
allowing for the delivery of higher doses and shorter infusion times compared with solventbased paclitaxel. Abraxane is intended to be used as first line treatment for metastatic
adenocarcinoma of the pancreas and is administered by intravenous (IV) infusion at
125mg/m2 on days 1, 8 and 15 of a 28 day cycle in combination with gemcitabine.
Abraxane is licensed for the second line treatment of metastatic breast cancer. Common
recognised adverse effects (10%) include: neutropenia, anaemia, leukopenia,
thrombocytopenia, lymphopenia, anorexia, neuropathy, hypoaesthesia, paraesthesia,
nausea, diarrhoea, vomiting, constipation, stomatitis, alopecia, rash, arthralgia, myalgia,
fatigue, asthenia and pyrexia 1.
Abraxane is in phase III trials for non-small cell lung cancer and melanoma. It is also in
phase II trials for bladder cancer, gastric cancer and ovarian cancer.
DEVELOPER
Celgene.
PATIENT GROUP
BACKGROUND
Pancreatic cancer is the ninth most common cancer in the UK and the fifth most common
cause of death from cancer 2. It may arise in the head, body or tail of the pancreas and
symptoms, which include jaundice, nausea, diarrhoea, weight loss, loss of appetite and
severe pain, vary depending on the tumour site 3,4. There are three main types described:
PATIENT PATHWAY
RELEVANT GUIDANCE
NICE Guidance
Other Guidance
European Society for Medical Oncology and European Society of Digestive Oncology.
Pancreatic adenocarcinoma: ESMO-ESDO clinical practice. Guidelines for diagnosis,
treatment and follow-up. 2012 16.
ESMO. Pancreatic cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment
and follow-up. 20105.
Expert personal communication.
Sponsor
Status
Source of
information
Location
Design
Participants
Schedule
Follow-up
USA.
Non-randomised, open-label.
n=67; 18 years; pancreatic cancer;
adenocarcinoma; metastatic; no prior
therapy for metastatic disease.
Key results
Adverse
effects (AEs)
Expected
reporting
date
Dose
2
1,000mg/m once weekly infusion for 7 weeks of an 8 week
cycle, followed by 3 weekly infusions in 4 week cycles.
12mg/kg for three days, then 6mg/kg on alternate days for a
further 3 doses. Repeated every 4 weeks.
172
IMPACT - SPECULATIVE
Impact on Patients and Carers
Reduced mortality/increased length of survival
Other:
No impact identified
c
d
None identified
Impact on Costs
Increased drug treatment costs
Other:
None identified
Other Issues
Clinical uncertainty or other research question
identified: Expert opinion suggests the
benefits of abraxane with gemcitabine should
be investigated in other patient groups e.g.
locally advanced disease, previously treated
patients (second line setting) and in the
perioperative setting. Expert opinion also
suggests additional research is required to
compare the benefits of abraxane with
gemcitabine to other standard of care options,
such as FOLFIRINOX and gemcitabine in
combination with capecitabine. In addition, the
value of abraxane monotherapy is not known.
Also, as previous data has suggested that
abraxane in combination with gemcitabine
may be more beneficial in patients with
tumours that express high levels of SPARC,
expert opinion suggests further research into
SPARC expression in pancreatic tumours
would be valuable in identifying patients most
likely to benefit from this treatment regimen
and in determining the utility of SPARC as a
predictive biomarker for pancreatic cancer.
None identified
REFERENCES
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European Society for Medical Oncology. Pancreatic cancer: ESMO clinical practice guidelines for
diagnosis, treatment and follow-up. Annals of Oncology 2010; 21(suppl5):v55-v58.
El Kamar F, Grossbard L, Kozuch P. Metastatic pancreatic cancer: emerging strategies in
chemotherapy and palliative care. The Oncologist. 2003; 8:18-34.
Pancreatic Cancer UK. Pancreatic cancer UK study for survival 2011.
http://www.pancreaticcancer.org.uk/media/100292/report_final_for_web.pdf
Cancer Research UK. Pancreatic cancer survival statistics.
http://info.cancerresearchuk.org/cancerstats/types/pancreas/survival/ Accessed 12 December
2012.
National Cancer Intelligence Network. One-year relative survival rates for patients diagnosed with
cancer of the oesophagus, stomach, primary liver, gallbladder, biliary tract and pancreas in
England, 1985-2009.
http://www.ncin.org.uk/cancer_type_and_topic_specific_work/cancer_type_specific_work/upper_g
i_cancers/default.aspx Accessed 24 January 2013.
Cancer Research UK. Pancreatic cancer UK incidence statistics.
http://info.cancerresearchuk.org/cancerstats/types/pancreas/incidence/ Accessed 12 December
2012.
Pancreatic Section of the British Society of Gastroenterology, Pancreatic Society of Great Britain
and Ireland, Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland, Royal
College of Pathologists, Special Interest Group for Gastro-Intestinal Radiology. Guidelines for the
management of patients with pancreatic cancer periampullary and ampullary carcinomas. Gut.
2005;54:1-16.
Office for National Statistics. Mortality statistics: deaths registered in England and Wales (Series
DR). 2011. www.ons.gov.uk
NHS Hospital episode statistics. NHS England 2011-12. HES data 2012. www.hesonline.nhs.uk
National Institute for Health and Clinical Excellence. Masitinib for the treatment of locally
advanced or metastatic pancreatic cancer. Technology appraisal in development (ID566).
London: NICE; expected January 2014.
National Institute for Health and Clinical Excellence. IRE for the treatment of pancreatic cancer.
Interventional procedure guidance in development. Expected winter 2013.
Cascinu S, Falconi M, Valentini V et al. Pancreatic cancer: ESMO-ESDO clinical practice
guidelines for diagnosis, treatment and follow-up. Annuals of Oncology. 2012;23(7):33-40.
National Cancer Intelligence Network (NCIN). Major surgical resections England, 2004-2006.
http://www.ncin.org.uk/view.aspx?rid=540 Accessed 24 January 2013.
Cancer Research UK. Types of treatment for pancreatic cancer.
http://www.cancerresearchuk.org/cancer-help/type/pancreatic-cancer/treatment/which-treatmentfor-pancreatic-cancer Accessed 13 December 2012.
ClinicalTrials.gov. Phase III study of ABI-007 (albumin-bound paclitaxel) plus gemcitabine versus
gemcitabine in metastatic adenocarcinoma of the pancreas.
http://www.clinicaltrials.gov/ct2/show/NCT00844649?term=nct00844649&rank=1 Accessed 13
December 2012.
Von Hoff D, Ervin T, Arena F et al. randomised phase III study of weekly nab-paclitaxel plus
gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the
pancreas (MPACT). American Society of Clinical Oncology. 2013; Abstract LBA148.
ClinicalTrials.gov. Gemcitabine (GEMZAR) plus ABI-007 (abraxane) in patients with advanced
metastatic pancreatic cancer.
http://www.clinicaltrials.gov/ct2/show/NCT00398086?term=NCT00398086&rank=1 Accessed 13
December 2012.
Von Hoff D, Ramanathan R, Borad M et al. Gemcitabine plus nab-paclitaxel is an active regimen
in patients with advanced pancreatic cancer: A phase I/II trial. Journal of Clinical Oncology. 2011;
29:4548-4554.
British Medical Association and Royal Pharmaceutical Society of Great Britain. British National
Formulary. BNF 64. London: BMJ Group and RPS Publishing, September 2012.