Multicentre international study of capecitabine +/- bevacizumab as adjuvanttreatment of colorectal cancer

Multicentre international study of capecitabine +/- bevacizumab as adjuvanttreatment of colorectal cancer

Multicentre international study of capecitabine +/- bevacizumab as adjuvanttreatment of colorectal cancer (10524)

Eva Segelov ¹

St Vincent's Hospital, Darlinghurst, NSW, Australia

Aims - QUASAR2 tests the hypothesis that the combination of capecitabine (an oral chemotherapy agent) and bevacizumab (a molecularly targeted therapy against VEGF) is superior to capecitabine alone in preventing relapse in Stage II and III CRC.

This worldwide investigator driven phase III study, run by the OCTO group, recruited 2240 patients with stage III or high risk stage II CRC. Patients were randomised to capecitabine alone or capecitabine + bevacizumab. The primary endpoint of the study is disease free survival. Secondary endpoints include overall survival, side effect profile and translational science.

Study progress – QUASAR2 recruited patients in ANZ though the AGITG from July 2007 until September 2010. Initial allocation was 100 patients, which was later increased to 200 patients and then 250 due to rapid uptake. Final ANZ recruitment was 219/250 from 31 participating sites. Recruitment was above target (average 6 patients per month) until the allocation for Stage II was completed, then slowed.

Following an OCTO DSMC review of preliminary results from the AVANT study, the study was closed and AGITG complied with the recommendation that all QUASAR2 patients still on therapy cease treatment with bevacizumab. This was implemented at ANZ sites on 18^th October 2010, at which time 25 patients were still enrolled (17 on the bevacizumab arm).

All QUASAR2 CRF submission will cease in October 2013. Data cleaning is expected to be completed during first quarter 2014, when final analysis will take place. A toxicity data poster was presented at ESMO 2012. A late breaking abstract may be submitted for ASCO 2014 depending on data cleaning timetables.

Translational Research – Consent to donate tissue for research was optional. Tissue collection is underway with 107 blocks of 163 being collected. Translational research studies are planned, with protocols being developed.

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Authors contributing to this presentation.

Segelov, E

Professor Eva Segelov was appointed as the Professor and Director of Oncology at Monash Health and Monash University in February 2017. She is an Honorary Associate of the NHMRC Clinical Trials Centre, Sydney Medical School and previously Associate Professor at the University of New South Wales and Senior Medical Oncologist at St Vincent’s Hospital, Sydney. She is a recognised national and international expert in the fields of gastrointestinal cancer, including neuroendocrine tumours, and breast cancer, with a 20-year history of management of patients in a multidisciplinary setting. Professor Segelov is an active member of the Australian Gastrointestinal Trials Group (AGITG), as a Board Member and Convenor of the Annual Scientific Meeting. She is Chair of the Gastrointestinal Group of the Clinical Oncological Society of Australia (COSA). In 2016 she was nominated as a European Society of Medical Oncology (ESMO) faculty member for the CUP, Endocrine Tumours, and Others group. She is an Associate Editor of Journal of Global Oncology (ASCO); Editorial Board member of JoVE Cancer Research; ESMO 2019 Scientific Sub-Committee member for Neuroendocrine cancer; co-Track Chair of Gastrointestinal Cancer for the 2017 ESMO Asia Annual Scientific Meeting and co-founder of the Commonwealth Neuroendocrine Tumour Society (CommNETS), an international research collaborative. Professor Segelov has led multiple national and international oncology clinical trials, including investigator-initiated studies. Her research interests relate to translational studies of targeted therapies in defined subpopulations to increase benefit and reduce the toxicity of cancer treatments. She has published over 80 articles, expert reviews, and book chapters and is a frequent invited speaker at national and international conferences. Professor Segelov has a particular interest in professional development using innovative learning techniques and has developed the Seminal Advances Preceptorship in Cancer courses, now being run through Monash University. She was awarded the UNSW Vice Chancellors Award for Teaching Excellence in 2006.

Multicentre international study of capecitabine +/- bevacizumab as adjuvanttreatment of colorectal cancer (10524)

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