P-174 Ramucirumab and paclitaxel in platin refractory advanced or metastatic gastric or gastrooesophageal junction adenocarcinoma – a single center experience

Abstract

Introduction: Ramucirumab is a VEGFR-2 antibody that has proven to prolong overall survival (OS) in patients with pretreated metastatic gastric/gastrooesophageal junction (GEJ) adenocarcinoma.We present data of 20 patients treated with Ramucirumab and Paclitaxel after failure of at least one platinum and 5-FU-containing chemotherapy regimen at our center. Methods: Twenty patients (median age: 64 years, range (44-83), 75% male with metastatic gastric cancer (65%) or adenocarcinoma of the gatrooesophageal junction (25%) were treated with Paclitaxel and Ramucirumab in second-line (85%) or >second-line (25%). Two-thirds of patients presented with a good performance status (ECOG < 1). 15 % of patients received adjuvant or neoadjuvant radiation therapy in their first-line regimen. Ramucirumab was given with 8mg/kg on day 1,15 every four weeks and Paclitaxel was given with 80 mg/m2 as licenced on day 1,8,15 of a 28 day cycle. Results: Between December 2014 and February 2016 20 patients were treated with Ramucirumab and Paclitaxel at our center. Adverse events were observed as follows: neutropenia (all grades: 50%, >grade 3: 5%), febrile neutropenia 5%, thrombopenia (all grades: 5%, grade 3: 0%), hypertension (all grades: 10%, grade 3: 2%), fatigue (all grades: 5%, no grade 3), polyneuropathy (all grades: 15%, grade 3: 0%) and infection (35%). Dose reductions were necessary in only 5% of patients, 35% of patients had any kind of dose delay. The median progression-free survival ( pfs) and overall survival (OS) time for patients treated with Ramucirumab and Paclitaxel was 2.6 months (95% CI: 1.7 - 3.4) and 3.2 months (1.7-4.7 months), respectively. The OS time from the time of diagnosis of advanced or metastatic gastric cancer was 18.1 months (95% CI: 12-24.2). Conclusion: In patients with adenocarcinoma of GEJ or gastric cancer the combination of Paclitaxel and Ramucirumab after failure of a platinum and 5-FU based regimen was safe and had a good tolerability. The excellent pfs and OS data of the RAINBOW trial were not reproducible in the «real world» setting. At our center patients had a short OS of only 3.2 months after start of Ramucirumab and Paclitaxel. A possible reason could be the fact that one quart of patients receiving Taxol/Ramucirumab was heavily pre-treated and not true second-line.