Patient reported outcomes of a randomized, placebo-controlled trial of bevacizumab in the front-line treatment of ovarian cancer: a Gynecologic Oncology Group Study

Abstract

Purpose: To analyze quality of life (QOL) in a randomized, placebo-controlled phase III trial concluding that the addition of concurrent and maintenance bevacizumab (Arm 3) to carboplatin and paclitaxel prolongs progression-free survival in front-line treatment of advanced ovarian cancer compared to chemotherapy alone (Arm 1) or chemotherapy with bevacizumab in cycles 2-6 only (Arm 2).

Patients and methods: The Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) was used to assess QOL before cycles 1, 4, 7, 13, and 21; and 6months after completing study therapy. Differences in QOL scores were assessed using a linear mixed model, adjusting for baseline score, and age. The significance level was set at 0.0167 to account for multiple comparisons.

Results: 1693 patients were queried. Arm 2 (p<0.001) and Arm 3 (p<0.001) reported lower QOL scores than those in Arm 1. The treatment differences were observed mainly at cycle 4, when the patients receiving bevacizumab (Arm 2 and Arm 3) reported 2.72 points (98.3% CI: 0.88-4.57; effect size=0.18) and 2.96 points (98.3% CI: 1.13-4.78; effect size=0.20) lower QOL respectively, than those in Arm 1. The difference in QOL scores between Arm 1 and Arm 3 remained statistically significant up to cycle 7. The percentage of patients who reported abdominal discomfort dropped over time, without significant differences among study arms.

Conclusion: The small QOL difference observed during chemotherapy did not persist during maintenance bevacizumab.

Trial registration: ClinicalTrials.gov NCT00262847.

Conflict of interest statement

Conflicts of Interest

Dr. Monk discloses that he has received a research grant from Genentech to his institution along with serving on the Genentech – Speakers bureaus for which he received an honorarium as a consultant. Additionally, Dr. Robert Burger wishes to disclose that he participates in Advisory Board Meetings for Champions Biotech, Clovis Oncology, Endocyte, Genentech, Boehringer Ingelheim and Marshall-Edwards. Dr. Robert Mannel receives Honoraria for Advisory Board work with Genentech. Finally, Dr. Lari Wenzel serves as a consultant to Roche. There are no further conflicts of interest to disclose.

Copyright © 2012. Published by Elsevier Inc.

Figures

Figure 1

Quality of Life (QOL) Assessment Time Points

Figure 2

Figure 2A. Mean Patient reported Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) Over Time Figure 2B. Fraction of patients reporting Abdominal Discomfort (AD>0) and the mean AD Scores reported by those having abdominal discomfort. Note: The numbers above the bar are patient-reported AD scores by those reporting AD>0.

Figure 2

Figure 2A. Mean Patient reported Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) Over Time Figure 2B. Fraction of patients reporting Abdominal Discomfort (AD>0) and the mean AD Scores reported by those having abdominal discomfort. Note: The numbers above the bar are patient-reported AD scores by those reporting AD>0.