Randomized phase III trial of carboplatin/paclitaxel alone (CP) or in combination with bevacizumab followed by bevacizumab (CPB) and secondary cytoreduction surgery in platinum-sensitive recurrent ovarian cancer: GOG0213, an NRG Oncology/GOG Study—Analysis of patient reported outcomes (PRO) on chemotherapy randomization.

Authors

Karen Basen-Engquist

Karen Basen-Engquist

The University of Texas MD Anderson Cancer Center, Houston, TX

Karen Basen-Engquist , Helen Q Huang , Thomas J Herzog , Deborah Kay Armstrong , Paul Sabbatini , Joan L. Walker , Byoung Gie Kim , Keiichi Fujiwara , Krishnansu Sujata Tewari , David M. O'Malley , Robert L. Coleman

Organizations

The University of Texas MD Anderson Cancer Center, Houston, TX, GOG Statistical and Data Center, Rochester, NY, Division of Gynecologic Oncology, The University of Cincinnati Cancer Institute, Cincinnati, OH, Johns Hopkins Kimmel Cancer Ctr, Baltimore, MD, Memorial Sloan Kettering Cancer Center, New York, NY, Stephenson Cancer Center, OUHSC, Oklahoma City, OK, Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Saitama Medical University International Medical Center, Hidaka, Japan, UC Irvine Medical Center, Orange, CA, The Ohio State University College of Medicine, Columbus, OH

Research Funding

NIH

Purpose: GOG 213 is a bifactorial, phase III, randomized trial studying the efficacy and tolerability of the incorporation of B and secondary cytoreduction in women with platinum sensitive recurrent EOC. The primary endpoint was OS. Here we report intervention related PROs. Methods: PRO’s were assessed using the ovarian Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-O TOI, QoL endpoint for chemotherapy objective), treatment side effects related to B (TSE-B), physical function (PF) subscale of the Rand SF-36 (QoL endpoint for surgical randomization), and treatment side-effects related to surgery (TSE-Surg). Assessment time points were baseline, prior to cycles 1, 3 and cycle 6, 6 mo. after cycle 1, and 12 mo. after cycle 1. QoL scores were compared using a linear mixed model adjusting for baseline score, age, and assignment to secondary surgery. Mixed effects mixed distribution model evaluated treatment differences in physical functioning on the RAND SF-36. Results: Patients randomized to CT (n = 298 (88%)) or CTB (n = 302 (90%)) were evaluable for QoL. Treatment compliance was 93% at baseline, 88% at cycle 3, 83% at cycle 6, 82% at 6 months and 78% at 12 months. More CTB patients completed PRO assessments (P = 0.037). FACT-O TOI scores at baseline were similar. Subscales of FACT-O showed no differences in TSE-Bev, except pre-cycle 3 physical well-being, which was negatively impacted by treatment (p = 0.028). CPB patients had significantly worse physical functioning (P = 0.0156): treatment difference of 3.4 points (95% CI: 0.05-6.7, p = 0.048) at cycle 3 and 6.8 points (95%CI: 3.0-10.6, p = 0.0004) at cycle 6. Conclusion: Treatment with CPB was not associated with a significant difference in health-related QoL measured by the FACT-O TOI. While receiving CPB, patients may experience lower physical functioning with recovery to baseline during maintenance B. Clinical trial information: NCT00565851

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT00565851

Citation

J Clin Oncol 33, 2015 (suppl; abstr 5525)

DOI

10.1200/jco.2015.33.15_suppl.5525

Abstract #

5525

Poster Bd #

83

Abstract Disclosures