27 juni 2019: Bron: ASCO 

Uit een fase III studie blijkt dat toevoeging van bevacizumab - avastin aan de chemocombinatie gemcitabine plus cisplatin geen effect heeft op de mediane overall overleving en progressievrije ziekte. Overall overleving was respectievelijk 15,5 vs 15,3 maanden voor de placebogroep.

Hier de resultaten die ik maar niet vertaal zoals gepresenteerd op ASCO 2019:

Dr. Rosenberg, in collaboration with Alliance and National Clinical Trials Network (NCTN) investigators, randomized 506 patients with metastatic urothelial carcinoma who had received no prior chemotherapy for metastatic disease to gemcitabine 1000 mg/m2 intravenously (IV) on days 1 and 8 plus cisplatin IV 70 mg/m2 on day 1 in combination with bevacizumab 15 mg/kg IV (n = 252) or placebo (n = 254) on day 1, every 21 days. All patients were > 12 months from prior (neo)adjuvant chemotherapy, and all had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Randomization was stratified by the presence of visceral metastases and prior chemotherapy.

The primary endpoint was OS, defined as the time from randomization to death or last follow-up. Secondary endpoints included PFS, objective response rate, and grade ≥ 3 toxicity.

Alliance Data Safety and Monitoring Board approved the final OS analysis to be performed at 420 events, due to lower than expected event rates. At this time, the median follow-up for patients still alive was 46.2 months.

Based on an intent-to-treat analysis, median OS was 14.5 months for patients treated in the bevacizumab-containing arm and 14.3 months for patients in the placebo-containing arm, for a hazard ratio of 0.87 (95% confidence interval 0.72–1.06; P = .17). The hazard ratio for PFS was 0.79 (95% confidence interval 0.66–0.95; P = .013) in favor of the bevacizumab-containing arm. A per-protocol analysis yielded similar findings. No differences in overall response rates was observed in clinical subgroups of patients.

The grade ≥ 3 adverse event rate was 83.5% with those who received bevacizumab, compared with 80.7% for those who received the placebo.

“The addition of bevacizumab did not improve OS when added to gemcitabine and cisplatin chemotherapy as first-line therapy for metastatic urothelial cancer,” concluded Dr. Rosenberg. “The addition of bevacizumab did improve PFS, although the improvement was not clinically significant. The toxicity of gemcitabine, cisplatin, and bevacizumab was similar to historical data. And currently, the standard of care remains cisplatin-based combination chemotherapy without the addition of biologic agents. Ongoing correlative work from this clinical trial might identify subset of patients who might benefit from antiangiogenic therapy. CALGB 90601 shows the importance of confirming phase II trials in randomized phase III trials. Pretreatment prognostic factors and unmeasured variables can heavily influence outcomes in advanced cancer and in particular in advanced urothelial cancer.”


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