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
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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