Details

Autor(en) / Beteiligte

• Scheck, Magdalena
• Goetze, Thorsten Oliver
• Ettrich, Thomas Jens
• Schmalenberg, Harald
• Clemens, Michael
• Mahlberg, Rolf
• Heeg, Steffen
• Kanzler, Stephan
• Hapke, Gunnar
• Thuss-Patience, Peter C.
• Kestler, Angelika
• Treschl, Anne
• Frost, Gregg
• Schiemer, Moritz
• Junge, Sabine
• Pauligk, Claudia
• Al-Batran, Salah-Eddin
• Lorenzen, Sylvie

Titel

Paclitaxel + ramucirumab versus paclitaxel alone in patients with squamous-cell carcinoma of the esophagus, refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs: Final results from the randomized phase 2 IKF-S627/RAMOS trial of the AIO

Ist Teil von

• Journal of clinical oncology, 2023-06, Vol.41 (16_suppl), p.e16043-e16043

Erscheinungsjahr

2023

Quelle

EZB Free E-Journals

Beschreibungen/Notizen

• e16043 Background: Ramucirumab (Ram) in combination with docetaxel is an approved 2nd-line treatment in patients (pts) with squamous cell carcinomas (SCC) of the lung (REVEL study) and with paclitaxel for esophagogastric adenocarcinoma (RAINBOW study). In SCC of the esophagus, nivolumab is currently the only evidence-based 2 nd -line treatment option. This study evaluates the safety and efficacy of the combination of Ram plus paclitaxel. Methods: This prospective, randomized, open-label, multicenter, phase II trial evaluated paclitaxel plus Ram (Ram 8 mg/kg d1 and d15 and paclitaxel 80 mg/m 2 d1, 8, 15) Arm A vs. paclitaxel alone (80 mg/m 2 d1, 8, 15) Arm B, both q4w. Primary endpoint was overall survival rate at 6months (mos) (OS@6), main secondary endpoints were OS, PFS, objective response rate (ORR) and safety. Results: From 3/2019 to 4/2021, 21/186 planned pts were treated within the study protocol (Arm A 11 pts; Arm B 10 pts) in 10 German centers. Due to slow accrual, the study was terminated prematurely. Median age was 63y, 71% were male and 86% had relevant concomitant disease. Pts. received a median of 9 and 10 cycles Arms A and B, respectively. The most common treatment related AEs in Arm A were leucopenia (54.5%), fatigue (27.3%) and peripheral sensory neuropathy (18.2%). Treatment related adverse events (AEs) ≥ grade 3 occurred in 27% in Arm A and 50% in Arm B with neutropenia being most frequent in Arm B (n=3; 30%). Serious adverse events (SAE) occurred in 36% and 50% in Arms A and B respectively. Median follow-up was 9 months (0.7 – 32.4 months). OS@6 in Arm A was 73% for Ram/paclitaxel and 50% for paclitaxel. However, the study design did not allow for statistical comparison of the arms. ORR (CR+PR 18% vs. 20%) and DCR (55% vs. 60%) were in the same range, as well as median PFS (3.8 vs. 3.5 mos) and OS (12.1 vs. 9.2 mos), for Arms A and B, respectively. Conclusions: Ram and Paclitaxel is considered to show an acceptable tolerability and numerically improved OS@6. Due to the small number of pts the current trial must be considered exploratory and more data are needed in this indication. Clinical trial information: NCT03762564 .