The following is a summary of “Randomized phase II BGOG/ENGOT-cx1 study of paclitaxel-carboplatin with or without nintedanib in first-line recurrent or advanced cervical cancer,” published in the July 2023 issue of Gynecologic Oncology by Vergote et al.

Nintedanib is an oral tyrosine kinase inhibitor that targets vascular endothelial growth factor receptors, among other targets. The objective was to determine the function of nintedanib in addition to paclitaxel and carboplatin in treating recurrent/metastatic cervical cancer in the first-line setting. They randomized phase II study with first-line recurrent or primary advanced (FIGO stage IVB) cervical cancer patients. Patients received carboplatin-paclitaxel along with 200 mg BID of nintedanib or placebo orally. The primary endpoint was progression-free survival (PFS) at 1.5 years, with α= 0.15, β= 80%, and one-sided significance. 

Randomization occurred with 120 patients (62N, 58C). The median duration of follow-up was 35 months. Both groups had comparable baseline characteristics (total population: 62% squamous cell carcinoma, 64% prior radiotherapy, 25% primary advanced, 75% recurrent). PFS at 1.5 years was 15.1% versus 12.8% in favor of the nintedanib arm (p = 0.057), meeting the primary endpoint. N and C had a median overall survival (OS) of 21.7 and 16.4 months, respectively. 

The confirmed RECIST response rate for N was 48%, and for C, it was 38%. No new adverse events associated with N. N were associated with numerically more severe adverse events for anemia and febrile neutropenia. The global health status of both study arms was comparable during and after the study. The study attained its primary objective with an extended PFS in the N arm. There were no newly observed safety signals.

Source: sciencedirect.com/science/article/abs/pii/S009082582300207X