To analyze patient reported outcomes (PROs) in GOG 240, the practice-changing, randomized phase 3 trial that concluded that chemotherapy (cisplatin-paclitaxel or topotecan-paclitaxel) plus bevacizumab significantly improves overall survival (OS), progression-free survival (PFS), and response rates compared to chemotherapy alone in advanced cervical cancer. Trial registration number: NCT00803062.

Patients were assessed pre-cycle 1, 2, and 5 and at 6 and 9 months post-cycle 1 with the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index (FACT-Cx TOI), and items from the FACT/GOG-Neurotoxicity (Ntx) subscale, and a worst pain item from the Brief Pain Inventory (BPI). Differences in FACT-Cx TOI scores were assessed using a linear mixed model adjusting for baseline score and age. A mixed effects mixed distributions model was fitted to evaluate treatment differences of likelihood to report neurotoxicity and pain, and severity of these symptoms, once reported. The association between baseline health-related quality of life and survival was analyzed using Cox proportional hazards models.

Among 390 evaluable patients, PRO completion rates declined from 96% (baseline) to 63% (9 months post-cycle 1). Completion rates were not statistically different among treatment regimens (p=0.67). Patients receiving chemotherapy plus bevacizumab reported 1.2 points lower on average (98.75% CI: −4.1, 1.7; p=0.30) in the FACT-Cx TOI scores than those with chemotherapy alone. Patients treated with chemotherapy plus bevacizumab were less likely to report neurotoxicty (overall odds ratio: 0.58; 98.75% CI: 0.17, 0.98; p=0.01). Severity of neurotoxic symptoms did not differ between the two groups (p=0.69). Both groups had similar odds of complaining of pain (odds ratio=0.96; 95% CI: 0.39, 1.52; p=0.78) and reported similar severity of pain (p=0.1). For the entire population, the baseline FACT-Cx TOI score was significantly associated with OS (HR 0.80; 95% CI 0.74, 0.87; p<0.001) and PFS (0.88; 95% CI: 0.83, 0.95; p<0.001).

Improvements in OS and PFS attributed to the incorporation of bevacizumab in the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life. Study supported by NIH funding.