Adding bevacizumab to second-line chemotherapy does not improve survival in patients with advanced neuroendocrine carcinoma, according to research published in The Lancet Oncology.
Researchers found that patients who received bevacizumab plus folinic acid, fluorouracil, and irinotecan (FOLFIRI) had similar overall survival (OS) as patients who received FOLFIRI alone.
The researchers compared these regimens in the phase 2 PRODIGE 41-BEVANEC study (ClinicalTrials.gov Identifier: NCT02820857). The trial enrolled patients who had locally advanced or metastatic gastroenteropancreatic neuroendocrine carcinoma or neuroendocrine carcinoma of unknown origin that progressed during or after first-line platinum-etoposide chemotherapy.
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There were 126 patients who received at least 1 cycle of FOLFIRI, including 59 patients who received bevacizumab plus FOLFIRI and 67 who received FOLFIRI alone.
In the entire cohort, the median age at baseline was 67 years, and 66% of patients were men. Primary tumor locations were colorectal (30%), pancreatic (27%), gastroesophageal (17%), biliary tract (6%), and unknown (18%).
The median treatment duration was 3.3 months in the bevacizumab arm and 2.7 months in the FOLFIRI-alone arm.
At a median follow-up of 25.7 months, the median OS was 6.6 months in the bevacizumab arm and 8.9 months in the FOLFIRI-alone arm. The 6-month OS rate was 53% and 60%, respectively. In a multivariate analysis, there was no significant difference in OS between the treatment arms (hazard ratio, 0.97; 95% CI, 0.64-1.47; P =.88).
The objective response rate was 25% in the bevacizumab arm and 18% in the FOLFIRI-alone arm. The median duration of response was 7.5 months and 5.8 months, respectively.
The median progression-free survival was 3.7 months in the bevacizumab arm and 3.5 months in the FOLFIRI-alone arm.
The rate of grade 3 or higher treatment-related adverse events (AEs) was 44% in the bevacizumab arm and 21% in the FOLFIRI-alone arm. The most common grade 3 or higher AEs in the bevacizumab arm were neutropenia (14%), diarrhea (10%), and asthenia (8%). In the FOLFIRI-alone arm, the most common grade 3 or higher AE was neutropenia (10%).
There was 1 treatment-related death (due to ischemic stroke) in the bevacizumab arm. There were no treatment-related deaths in the FOLFIRI-alone arm.
The researchers concluded that these results do not support further study of bevacizumab plus FOLFIRI in this patient population, and FOLFIRI should be the standard second-line chemotherapy regimen for this group.
Disclosures: This research was partly supported by Roche SAS. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Walter T, Lievre A, Coriat R, et al. Bevacizumab plus FOLFIRI after failure of platinum–etoposide first-line chemotherapy in patients with advanced neuroendocrine carcinoma (PRODIGE 41-BEVANEC): A randomised, multicentre, non-comparative, open-label, phase 2 trial. Lancet Oncol. Published online February 2, 2023. doi.org/10.1016/S1470-2045(23)00001-3
