Carboplatin Paclitaxel In Patients Research Articles

Overall survival in patients with endometrial cancer treated with dostarlimab plus carboplatin–paclitaxel in the randomized ENGOT-EN6/GOG-3031/RUBY trial

Part 1 of the RUBY trial (NCT03981796) evaluated dostarlimab plus carboplatin-paclitaxel compared with placebo plus carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer (EC). At the first interim analysis, the trial met one of its dual primary endpoints with statistically significant progression-free survival benefits in the mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) and overall populations. Overall survival (OS) results are reported from the second interim analysis. RUBY is a phase III, global, double-blind, randomized, placebo-controlled trial. Part 1 of RUBY enrolled eligible patients with primary advanced stage III or IV or first recurrent EC who were randomly assigned (1 : 1) to receive either dostarlimab (500 mg) or placebo, plus carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab (1000 mg) or placebo every 6 weeks for up to 3 years. OS was a dual primary endpoint. A total of 494 patients were randomized (245 in the dostarlimab arm; 249 in the placebo arm). In the overall population, with 51% maturity, RUBY met the dual primary endpoint for OS at this second interim analysis, with a statistically significant reduction in the risk of death [hazard ratio (HR)= 0.69, 95% confidence interval (CI) 0.54-0.89, P= 0.0020] in patients treated with dostarlimab plus carboplatin-paclitaxel versus carboplatin-paclitaxel alone. The risk of death was lower in the dMMR/MSI-H population (HR= 0.32, 95% CI 0.17-0.63, nominal P= 0.0002) and a trend in favor of dostarlimab was seen in the mismatch repair-proficient/microsatellite stable population (HR= 0.79, 95% CI 0.60-1.04, nominal P= 0.0493). The safety profile for dostarlimab plus carboplatin-paclitaxel was consistent with the first interim analysis. Dostarlimab in combination with carboplatin-paclitaxel demonstrated a statistically significant and clinically meaningful OS benefit in the overall population of patients with primary advanced or recurrent EC while demonstrating an acceptable safety profile.

140O Veliparib plus carboplatin-paclitaxel in patients with HER2-negative advanced/metastatic gBRCA-associated breast cancer: Results in hormone receptor-positive and triple-negative breast cancer subgroups from the phase III BROCADE3 trial

In BROCADE3 (NCT02163694), addition of the PARP1/2 inhibitor veliparib (Vel) to carboplatin-paclitaxel (C-P) significantly prolonged progression-free survival (PFS) in patients (pts) with HER2-negative locally advanced/metastatic gBRCA-associated breast cancer (BC; hazard ratio=0.71 [95% CI 0.57, 0.88], P=.002). Here we report efficacy and safety in hormone receptor-positive (HR+) and triple-negative BC (TNBC) subgroups separately.

90TiP FRAIL-IMMUNE: A multicenter, prospective, single arm phase II of the combination of durvalumab with carboplatin and paclitaxel as first-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck not eligible to standard chemotherapy (GORTEC 2018-03)

Abstract Background One third of patients with (R/M SCCHN) are not eligible to receive the standard first-line chemotherapy EXTREME (cisplatin, fluorouracile and cetuximab). In this population, the weekly scheme of carboplatin-paclitaxel demonstrated clinical efficacy an overall survival (OS) of 4.9-12.8 months and a response rate of 20-52%. In a study conducted in our center, patients ineligible to EXTREME due to performance status (PS) 2 or other reasons (excluding PS2) reached a median OS of 3.6 months and 11.5 months, respectively. Trial Design A prospective, multicenter, single-arm phase II trial to study the efficacy and safety of durvalumab (anti-PD-L1) combined with carboplatin-paclitaxel in patients with R/M SCCHN ineligible to cisplatin. A first cohort of patients (n = 64) with PS0-1 will be accrued, then a cohort of patients with PS2 (n = 38) if results of the cohort PS0-1 are positive. Patients will receive four 28-day cycles (carboplatin AUC2 and paclitaxel 80mg/m², D1, D8, D15) with 4-weekly infusions of 1500mg durvalumab (pursued for a maximum of 12 months). An initial safety run-in step with predefined stopping rules is being conducted in the first 6 patients of the cohort PS0-1. The primary objective will be to determine the efficacy (12-month OS rate) of the combination. The treatment will be considered for further investigations, if at least 38 successes and 10 successes are observed in cohorts PS0-1 and PS2, respectively. Secondary endpoints will also be investigated: progression-free survival, time-to-treatment failure, OS, response rates, quality of life (QLQ-C30 and QLQ-HN Honoraria (self), Research grant / Funding (self): AstraZeneca; Honoraria (self): MSD; Honoraria (self): Innate Pharma; Honoraria (self): Merck; Honoraria (self): Rakuten; Honoraria (self): Biogen.