NE Oncology Issue – June 2007

Background

No data exist on the effects of bevacizumab beyond first progression (BBP) or on the optimal duration of VEGF inhibition, including long-term safety and efficacy of using BBP. BRiTE (Bevacizumab Regimens: Investigation of Treatment Effects and Safety) is an observational, non-controlled bevacizumab treatment registry that was initiated early in 2004 to evaluate the safety and efficacy of bevacizumab in combination with chemotherapy in a large, less-selected, community-based population of patients with previously untreated mCRC. Grothey A, et al. discussed the results of the ongoing BRiTE trial in their presentation.1

Study design

  • A group of 1,953 evaluable patients with metastatic or locally advanced and unresectable CRC who did not receive prior therapy for their metastatic disease were enrolled from 248 study sites in 49 states between February 2004 and June 2005.
  • The investigator decided on the dose, schedule, and duration of bevacizumab, as well as the choice, dose, and schedule per duration of the chemotherapy regimen.
  • Patients with poor ECOG PS were also included in the study.
  • Primary endpoint of the study was survival beyond first progression.
  • Secondary endpoints were TTP, and OS or study termination.

Key findings

  • Longer survival beyond first progression and longer median OS were observed in the BPP subgroup.
  • There was no appreciable difference in bevacizumab-associated safety events between the BBP and No BBP subgroups.
  • No appreciable increase in the incidence of bevacizumab-associated safety events (ATE, grade 3 or 4 bleeding events, and GI perforation) post–first progression was observed in the BBP subgroup.
  • There was no apparent increase in the incidence of BV-specific AEs in the BBP subgroup.

Key conclusions

  • Median OS in BRiTE is 25.1 months, longer than the OS previously reported from pivotal phase III trial AVF2107 (median OS 20.3 months) despite an unselected population.
  • Substantially longer median OS and survival beyond first progression in the BBP versus the No BPP subgroups were observed.
  • There were similar overall rates of bevacizumab-associated safety events prior to first progression or after first progression in the BBP subgroup, compared to patients who received bevacizumab only during first-line therapy.
  • This is the first report of an improvement in survival outcomes associated with BBP for patients who started bevacizumab in the first-line setting.

References: 1. Grothey A, Sugrue M, Hedrick E, et al. Association between exposure to bevacizumab (BV) beyond first progression (BBP) and overall survival (OS) in patients (pts) with metastatic colorectal cancer (mCRC): results from a large observational study (BRiTE). Program and abstracts of the 43rd American Society of Clinical Oncology Annual Meeting; June 1–5, 2007; Chicago, Illinois; Abstract 4036.

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Contributors

dr-hirsh
Vera Hirsh, MD, FRCPC
Chief of the Hematology-Oncology Service, Santa Cabrini Hospital
Associate Professor, Medicine and Oncology, McGill University
Associate Physician, Oncology Service, at the Royal Victoria, Montreal General, and Montreal Chest Hospitals
With a current practice in both hematology and oncology, Dr. Vera Hirsh is an associate professor of medicine and oncology at McGill University. Her research at the Quebec Pulmonary Unit focuses on the treatment of lung cancer, and she continues to chair ongoing international chemotherapy trials. Dr. Hirsh chaired the Quebec Lung Cancer Committee to establish guidelines for the treatment of lung cancer. In addition, she has published abstracts, articles, and book chapters. Dr. Hirsh is a member of advisory boards for many pharmaceutical companies and the Medical Oncology Standing Committee of RTOG.

dr-cripps
Christine Cripps, MD, FRCPC
Medical Oncologist, Director,
Continuing Medical Education,
Ottawa Hospital Regional Cancer Centre
Dr. Christine Cripps is a medical oncologist and director of the Continuing Medical Education Department at the Ottawa Hospital Regional Cancer Centre. She also holds a position of Associate Professor, Medicine at the University of Ottawa. A keen teacher, Dr. Cripps’ main areas of interest include gastrointestinal cancer and head and neck cancer. She also enjoys cycling, skiing, and sailing when time permits.

dr-chia
Stephen K. L. Chia, MD, FRCPC
Assistant Professor of Medicine Department of Medicine
University of British Columbia
British Columbia Cancer Agency
Dr. Chia is a staff oncologist with the British Columbia Cancer Agency (BCCA), Vancouver, Canada. He also serves as physician coordinator for both the breast cancer and head and neck cancer clinical trials at the BCCA – Vancouver Cancer Centre. He is an active researcher in phase I-III trials in breast cancer, head and neck cancer and investigational new drugs. He is currently carrying out studies in breast cancer with grant funded research from the National Cancer Institute of Canada, Canadian Breast Cancer Alliance and Canadian Breast Cancer Foundation – British Columbia/Yukon Chapter. Dr. Chia is an active member of the British Columbia Breast Tumor Group, Breast Cancer Systemic Policy Group and Head and Neck Tumor Group.

dr-chang
José Chang, MD, FRCPC
Head of Medical Oncology, RS
McLaughlin Durham Regional Cancer Centre, Oshawa
Dr. José Chang is the principal investigator and site representative for the National Cancer Institute of Canada Clinical Trials Group, and is an examiner for the Medical Council of Canada. His research interests lie in the areas of breast cancer, melanoma, lymphoma, and quality of life during chemotherapy. Dr Chang has presented at major oncology meetings of the American Society of Clinical Oncology, San Antonio Breast Cancer Symposia, and European Breast Cancer Conference. A member of the editorial board of the journal Current Oncology, Dr. Chang has published in journals such as the Journal of Clinical Oncology, European Journal of Cancer, and Canadian Medical Association Journal.