PURPOSE: A Gynecologic Oncology Group (GOG) randomized phase III trial (GOG 172) in optimal stage III epithelial ovarian cancer showed that intravenous (IV) paclitaxel plus intraperitoneal (IP) cisplatin and paclitaxel significantly lengthened progression-free survival and overall survival compared with IV paclitaxel and cisplatin. The purpose of this report is to comprehensively evaluate the patient-reported outcomes associated with IP versus IV therapy. PATIENTS AND METHODS: Four hundred fifteen eligible women were enrolled onto GOG 172 at member institutions. The Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI; which includes physical, functional, and ovarian subscales) and neurotoxicity (Ntx) and abdominal discomfort (AD) subscales were used to assess patient-reported outcomes. Assessments were completed before random assignment, before cycle 4, and 3 to 6 weeks and 12 months after treatment. RESULTS:Physical and functional well-being and ovarian cancer symptoms were significantly worse in the IP arm before cycle 4 (P < .001) and 3 to 6 weeks after treatment (P = .001 for FACT-TOI). Patients in the IP arm also reported significantly worse AD before cycle 4 (P < .001) and significantly worse Ntx 3 to 6 weeks (P = .001) and 12 months (P = .003) after completing IP treatment. In general, however, the quality of life of both groups improved over time. CONCLUSION: During active treatment, patients on the IP arm experienced more health-related quality-of-life disruption, AD, and Ntx compared with patients receiving conventional IV therapy. However, only Ntx remained significantly greater for IP patients 12 months after treatment. This trade-off should be included when discussing treatment options with patients. Future studies to mitigate the added burden associated with IP therapy are planned.
RCT Entities:
PURPOSE: A Gynecologic Oncology Group (GOG) randomized phase III trial (GOG 172) in optimal stage III epithelial ovarian cancer showed that intravenous (IV) paclitaxel plus intraperitoneal (IP) cisplatin and paclitaxel significantly lengthened progression-free survival and overall survival compared with IV paclitaxel and cisplatin. The purpose of this report is to comprehensively evaluate the patient-reported outcomes associated with IP versus IV therapy. PATIENTS AND METHODS: Four hundred fifteen eligible women were enrolled onto GOG 172 at member institutions. The Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI; which includes physical, functional, and ovarian subscales) and neurotoxicity (Ntx) and abdominal discomfort (AD) subscales were used to assess patient-reported outcomes. Assessments were completed before random assignment, before cycle 4, and 3 to 6 weeks and 12 months after treatment. RESULTS: Physical and functional well-being and ovarian cancer symptoms were significantly worse in the IP arm before cycle 4 (P < .001) and 3 to 6 weeks after treatment (P = .001 for FACT-TOI). Patients in the IP arm also reported significantly worse AD before cycle 4 (P < .001) and significantly worse Ntx 3 to 6 weeks (P = .001) and 12 months (P = .003) after completing IP treatment. In general, however, the quality of life of both groups improved over time. CONCLUSION: During active treatment, patients on the IP arm experienced more health-related quality-of-life disruption, AD, and Ntx compared with patients receiving conventional IV therapy. However, only Ntx remained significantly greater for IP patients 12 months after treatment. This trade-off should be included when discussing treatment options with patients. Future studies to mitigate the added burden associated with IP therapy are planned.
Authors: Vivian E von Gruenigen; Helen Q Huang; Jan H Beumer; Heather A Lankes; William Tew; Thomas Herzog; Arti Hurria; Robert S Mannel; Tina Rizack; Lisa M Landrum; Peter G Rose; Ritu Salani; William H Bradley; Thomas J Rutherford; Robert V Higgins; Angeles Alvarez Secord; Gini Fleming Journal: Gynecol Oncol Date: 2017-01-13 Impact factor: 5.482
Authors: Jennifer Le-Rademacher; Rahul Kanwar; Drew Seisler; Deirdre R Pachman; Rui Qin; Alexej Abyzov; Kathryn J Ruddy; Michaela S Banck; Ellen M Lavoie Smith; Susan G Dorsey; Neil K Aaronson; Jeff Sloan; Charles L Loprinzi; Andreas S Beutler Journal: Support Care Cancer Date: 2017-06-20 Impact factor: 3.603