NE Oncology Issue – September 2011

Background

The Gynecologic Oncology Group (GOG) 218 is a phase III, randomized, double-blind, placebo-controlled trial with three arms comparing placebo in combination with carboplatin and paclitaxel (CP) chemotherapy followed by placebo alone; bevacizumab in combination with carboplatin and paclitaxel chemotherapy followed by placebo alone; and bevacizumab in combination with carboplatin and paclitaxel chemotherapy followed by the maintenance with bevacizumab alone.

Data from this trial presented at ASCO 2010 suggested statistically significant improvements in progression-free survival (PFS) in previously untreated women with advanced epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC) who received a bevacizumab-based regimen, when compared with CP therapy alone.1

At ASCO 2011, Burger and colleagues presented the results from an independent review of blinded radiologic and clinical data, to determine the reliability of response evaluation critiera in solid tumours (RECIST) in assessing progression in ovarian cancer and confirm these results.2

Study design

  • Scans were performed at regular intervals, as described in the study protocol.
  • Radiographic images and clinical data were provided to the independent review committee (IRC).
  • Data were reviewed in a blinded fashion, in accordance with a pre-specified charter following RECIST criteria.
  • PFS was analyzed as an intent-to-treat analysis of all randomized subjects.
  • The primary analysis of PFS as determined by the IRC was a stratified log-rank test comparing each experimental arm to the control arm.

Key findings

  • 91% of patients participated in the IRC analysis.
    • Patients must have been on therapy for at least nine weeks and must have submitted baseline scans and at least one subsequent protocolrequired set of scans to the IRC.
  • For patients in the IRC analysis, 97.2% had all protocol-required scans submitted to the IRC.
  • Subgroup analyses of PFS determined by the IRC were consistent with the primary PFS analysis by the IRC (Table 1) and with the previous investigator-assessed subgroup analysis.
  • There was a high concordance between investigatordetermined was observed for PD status (77%) and PD date (73%). (Tables 2 and 3)

Key conclusions

  • The data from GOG218 represent the largest IRC analysis ever conducted in patients with ovarian cancer.
  • Results from this study show that the IRC- and investigator-determined PFS analyses are highly consistent, with both confirming a significant increase in PFS for subjects treated with concurrent plus continued bevacizumab versus CP alone.
  • The size of the IRC, high participation rate, and strong concordance observed between IRC- and investigatordetermined data suggest that RECIST criteria can be applied objectively in primary ovarian cancers.

References: 1. Burger RA, Brady MF, Bookmanet MA et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal (PPC) or Fallopian tube cancer (FTC): A Gynaecologic Oncology Group study. J Clin Oncol 2010;28:946s (Abstract LBA1). 2. Burger RA, Brady MF, Rhee J, et al. Independent radiologic review of GOG218, a phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian (EOC), primary peritoneal (PPC) or Fallopian tube cancer (FTC). J Clin Oncol (ASCO Annual Meeting Abstracts) 2011;29:5023.

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Canadian Perspectives

dr-lachance
Silvy Lachance, MD, FRCPC, CSPQ
Dr. Silvy Lachance is currently a hematologist, clinical researcher, and Director of the Stem Cell Transplant Program at the MaisonneuveRosement Hospital in Montreal, Quebec, and Professor of Medicine and Director of the Fellowship Program in Stem Cell Transplantation at the University of Montreal. In 1995, Dr. Lachance established the first Stem Cell Transplant Unit at the University Health Centre (CUSE) in Sherbrooke, Quebec. She joined the Hematology and Oncology Division of the Montreal General Hospital as a transplant physician in 1997 and became an Associate Professor of Medicine at McGill University in 2005, holding both positions until 2006. Dr. Lachance has served as chair of the Continuing Medical Education Committee of the Quebec Association of Hematologists and Oncologists, and is currently treasurer of the executive committee. She has also served as chair of the jury for the hematology specialty exam board of the Collège des Médecins du Québec (CMQ). Her research interests include stem cell transplant, graft-versus-host-disease, and lymphoproliferative disorders.

dr-petrella
Teresa Petrella, BSc, MD, MSc, FRCPC
Teresa Petrella is a Medical Oncologist at the Odette Cancer Centre (OCC) in Toronto, Canada and an Assistant Professor at the University of Toronto. Dr. Petrella has a BSc in Molecular Biology from the University of Western Ontario and she completed her MD at Queen’s University. Her Internal Medicine and Medical Oncology training was at McMaster University. She subsequently completed a fellowship in Melanoma and Breast Cancer at the Toronto Sunnybrook Regional Cancer Centre along with a Masters degree in Health Research Methodology at McMaster University. She was the recipient of a CIHR/CAMO award for her research in vaccine therapy in combination with interferon for melanoma patients. Dr. Petrella joined the staff at OCC in 2002 and became the head of the Melanoma Site Group. She also chairs the Provincial Guidelines Melanoma Disease Site Group Program in Evidence Based Care the National Cancer Institute of Canada (NCIC) Melanoma Clinical Trials Group. Her research interests are in melanoma and breast cancer and she is currently the Principal Investigator for several multicentre trials investigating novel therapies in melanoma.