Bevacizumab does not hinder quality of life for women with advanced cervical cancer
The addition of bevacizumab to treatment regimens for patients with advanced cervical cancer improved survival without sacrificing quality of life, according to patient-reported outcomes of a randomized phase 3 trial.
Last year, the FDA approved use of bevacizumab (Avastin, Genentech) in combination with cisplatin and paclitaxel or topotecan and paclitaxel for patients with advanced cervical cancer.
Richard T. Penson
Previously published results of the Gynecologic Oncology Group 240 trial showed patients assigned bevacizumab plus chemotherapy experienced longer median OS than those assigned chemotherapy alone (17 months vs. 13.3 months; HR = 0.71; 98% CI, 0.54-0.95).
In the current analysis, Richard T. Penson, MD, clinical director of the division of hematology and oncology at Massachusetts General Hospital, and colleagues analyzed patient-reported outcomes from that trial to assess the effect of bevacizumab on quality of life.
The trial included 452 patients randomly assigned 1:1:1:1 to one of four treatment groups: cisplatin and paclitaxel; topotecan and paclitaxel; bevacizumab combined with cisplatin and paclitaxel; and bevacizumab combined with topotecan and paclitaxel. Treatment continued until disease progression or unacceptable toxicity.
Researchers assessed quality of life via the Functional Assessment of Cancer Therapy-Cervix (FACT-CX) Trial Outcome Index (TOI), on which a higher score indicated better health-related quality of life. They also incorporated the FACT/GOG-NTX-4 — a neurotoxicity four-item subscale on which higher scores equate to lower toxicity — and a worst pain item from the Brief Pain Inventory.
Penson and colleagues measured patient-reported outcomes prior to treatment cycles 1, 2 and 5, as well as at 6 months and 9 months after treatment initiation.
Compliance for quality of life analysis started at 94% prior to cycle 1 and then declined at each subsequent evaluation point, falling to 63% at 9 months post-treatment initiation. Compliance did not differ considerably between treatment regimens.
The final analysis included 390 patients — representing a cross-section of the four study arms — who completed baseline quality-of-life outcomes and completed at least one additional assessment. Of that group, 39% had GOG performance status 1, 83% had recurrent disease and 73% had received previous chemotherapy.
The FACT-Cx TOI scores did not differ significantly between patients treated with bevacizumab and those who were not.
Across all time points, patients who received bevacizumab had FACT-Cx TOI scores that averaged 1.2 points lower than those of patients who received chemotherapy alone (98.75% CI, –4.1 to 1.7).
After adjustments for patients’ age and baseline scores, those assigned the bevacizumab–cisplatin–paclitaxel combination had FACT-Cx TOI scores that averaged 2.1 points lower (95% CI, –1.2 to 5.3) across all time points than those assigned cisplatin and paclitaxel alone.
Patients who received bevacizumab were less likely to report neurotoxicity than those who did not receive the agent (OR = 0.58; 98.75% CI, 0.17-0.98). Researchers observed no significant differences in FACT/GOG-Ntx scores between these groups.
Patients who received the bevacizumab–topotecan–paclitaxel regimen were less likely to report neurotoxicity than those who received topotecan and paclitaxel alone (OR = 0.51; 95% CI, 0.11-0.91). FACT/GOG-Ntx scores did not differ between the two treatment groups.
Researchers observed no significant difference in brief pain inventory scores between patients who received bevacizumab and those who did not. The odds of experiencing pain (OR = 0.96; 95% CI, 0.39-1.52) — as well as the severity of pain experienced (difference, 0.5; 95% CI, –0.14 to 1.14). — were similar between groups.
“The reported improvement in overall survival attributed to bevacizumab did not come at the cost of a significant deterioration in quality of life,” Penson and colleagues wrote. “Although patients living for 3.7 months longer might be another small incremental improvement, if this survival gains considered in context of a sustained quality of life, the therapeutic effect becomes clinically meaningful.” – by Anthony SanFilippo
Disclosure: The researchers report research funding from, consultant/advisory and speakers bureau roles with and honoraria from Roche/Genentech.