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Rose PG , Tian CQ , Bookman MA
Assessment of tumor response as a surrogate endpoint of survival in recurrent/platinum-resistant ovarian carcinoma: A Gynecologic Oncology Group study
Gynecologic Oncology. 2010 May;117(2) :324-329
PMID: ISI:000277538600030   
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Purpose. We investigated whether tumor response rate (TRR), disease control rate (OCR), or progression-free survival (PFS) was a valid surrogate for overall survival (OS) in phase II trials of second-line therapies for patients with platinum-resistant ovarian carcinoma (PROC). Methods. We retrospectively evaluated data from 11 second-line phase II trials conducted for PROC by the Gynecologic Oncology Group (COG). TRR included complete response and partial response (CR/PR) and OCR was defined as either tumor response or stable disease (CR/PR + SD). Survival by tumor response was analyzed using a landmark approach. Correlations of OS with TRR, DCR, and PFS were estimated. Results. Among 407 patients analyzed the TRR was 13.8% (56/407) and DCR was 38.8% (158/407). Median OS was 10.2 months while median PFS was only 2.4 months. Median OS among patients with a best response of CR/PR, SD, and progressive disease (PD) was 13.3, 12.1 and 5.7 months, respectively, showing no difference between CR/PR and SD. From a protocol level, DCR correlated better with OS (Pearson r = 0.748: Tau-b r = 0.514) compared to TRR (Pearson r=0.564; Tau-b r=0.404). PFS rate at 6 months (Pearson r = 0.661; Tau-b r=0.514) also correlated strongly with OS. Conclusions. This study demonstrates the limitations of the use of response rate alone in PROC. Clinical benefit, as defined by OS, appeared similar for patients with an objective response and those with SD. The DCR, by including tumor response and SD may have utility as a surrogate endpoint for survival in phase II therapeutic trials in PROC. (C) 2010 Published by Elsevier Inc.
Rose, Peter G. Tian, Chunqiao Bookman, Michael A. National Cancer Institute [CA 27469]; Gynecologic Oncology Group Statistical and Data Center [CA 37517] This study was supported by the National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical and Data Center (CA 37517). The following Gynecologic Oncology Group member institutions participated in this study: Roswell Park Cancer Institute, University of Alabama at Birmingham, Oregon Health Sciences University, Duke University Medical Center, Abington Memorial Hospital, University of Rochester Medical Center, Walter Reed Army Medical Center, Wayne State University, University of Minnesota Medical School, Emory University Clinic, University of Southern California at Los Angeles, University of Mississippi Medical Center, University of California at Los Angeles, University of Washington, University of Pennsylvania Cancer Center, Milton S. Hershey Medical Center, Georgetown University Hospital, University of Cincinnati, University of North Carolina School of Medicine, University of Iowa Hospitals and Clinics, University of Texas Southwestern Medical Center at Dallas, Indiana University School of Medicine, Wake Forest University School of Medicine, Albany Medical College, University of California Medical Center at Irvine, Tufts-New England Medical Center, Rush-Presbyterian-St. Luke's Medical Center, SUNY Downstate Medical Center, University of Kentucky, Eastern Virginia Medical School, Community Clinical Oncology Program, The Cleveland Clinic Foundation, Johns Hopkins Oncology Center, State University of New York at Stony Brook, Eastern Pennsylvania GYN/ONC Center, P.C., Washington University School of Medicine, Cooper Hospital/University Medical Center, Columbus Cancer Council, MD Anderson Cancer Center, University of Massachusetts Medical School, Fox Chase Cancer Center, Medical University of South Carolina, University of Oklahoma, University of Virginia Health Sciences Center, University of Chicago, University of Arizona Health Science Center, Tacoma General Hospital, Thomas Jefferson University Hospital, Mayo Clinic, Case Western Reserve University, Long Island Jewish Medical Center, Tampa Bay Cancer Consortium, University of Toronto/Sunybrook Regional Cancer Center, North Shore University Hospital, Gynecologic Oncology Network, Ellis Fischel Cancer Center, MD Anderson CCOP, and University of Wisconsin Hospital. 31 Academic press inc elsevier science; 525 b st, ste 1900, san diego, ca 92101-4495 usa 594lg