No Reduction in Quality of Life With Addition of Bevacizumab to Chemotherapy in GOG 240 Trial in Advanced Cervical Cancer
The phase III Gynecologic Oncology Group (GOG) 240 trial showed that the addition of bevacizumab (Avastin) to chemotherapy prolonged survival in patients with advanced cervical cancer. An analysis reported in The Lancet Oncology by Penson et al showed no reduction in quality of life among patients receiving bevacizumab-chemotherapy vs chemotherapy in the trial.
Study Details
In the trial, patients were randomly assigned 1:1:1:1 to cisplatin-paclitaxel with or without bevacizumab or paclitaxel-topotecan with or without bevacizumab. Quality of life was assessed by the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index (FACT-Cx TOI) before treatment, after cycles 1, 2, and 5, and at 6 and 9 months after the start of cycle 1. Patients were also assessed using the FACT-GOG-neurotoxicity subscale and the worst pain item from the Brief Pain Inventory.
No Quality-of-Life Difference
Of a total of 452 patients enrolled, 390 completed baseline quality-of-life assessment and at least one further assessment and were evaluable for quality-of-life outcome. There was no difference in baseline FACT-Cx TOI scores between patients who received bevacizumab-chemotherapy vs those who received chemotherapy alone (mean 75.8 vs 77.9, P = .27). No differences were observed after cycle 2 (76.9 vs 77.4, P = .703) or cycle 5 (74.7 vs 77.6, P = .056) or at 6 months (71.2 vs 74.0, P = .120) or 9 months (72.7 vs 74.5, P = .395). There was a borderline significant difference in favor of the cisplatin-paclitaxel group vs bevacizumab-chemotherapy after cycle 5 (73.5 vs 77.9, P = .05), but no other differences between the two chemotherapy regimens vs bevacizumab-chemotherapy were observed.
Patients receiving bevacizumab were less likely to report neurotoxic symptoms (odds ratio [OR] = 0.58, P = .01), but FACT/GOG-neurotoxicity scores did not differ between the chemotherapy group vs the bevacizumab-chemotherapy group in patients experiencing neurotoxicity (P = .69).
Bevacizumab treatment did not significantly increase risk of pain (OR = 1.43, P = .54, vs cisplatin-paclitaxel; OR = 0.65, P = .16, vs paclitaxel-topotecan) or worst pain score in those experiencing pain (P = .09 vs cisplatin-paclitaxel, P = .51 vs paclitaxel-topotecan).
The investigators concluded: “Improvements in overall survival and progression-free survival attributed to the incorporation of bevacizumab into the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life. Patients responding to anti-angiogenesis therapy who maintain an acceptable quality of life could be suitable at progression for treatment with other novel therapies that might confer additional benefit.”
Richard T. Penson, MD, of Massachusetts General Hospital, is the corresponding author for The Lancet Oncology article.
The study was funded by the National Institutes of Health. For full disclosures of the study authors, visit www.thelancet.com.
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