A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer

摘要

Abstract Background Nanoparticle albumin-bound (nab)-paclitaxel was developed to improve paclitaxel solubility and does not need premedication to avoid infusion-related reactions associated with solvent-based (sb)-paclitaxel. We conducted a phase II trial to investigate the efficacy and safety of nab-paclitaxel plus ramucirumab combination therapy for previously treated advanced gastric cancer. Patients and methods Patients with unresectable advanced gastric cancer refractory to first-line chemotherapy were administered nab-paclitaxel 100?mg/m 2 intravenously on days 1, 8 and 15, plus ramucirumab 8?mg/kg intravenously on days 1 and 15 of a 28-day cycle. The primary end-point was Independent Review Committee (IRC)–assessed overall response rate (ORR). Secondary end-points were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety?and quality of life (QOL). Results Forty-five patients were enrolled; 43 received the study treatment. The ORR assessed by the IRC was 54.8% (90% confidence interval [CI] 41.0–68.0) and the primary end-point was met. The DCR was 92.9% (95% CI 80.5–98.5). The IRC-assessed median PFS was 7.6 months (95% CI 5.4–8.1). The median OS was not reached at the data cutoff. The main treatment-related grade 3 or 4 adverse events were decreased neutrophil count (76.7%), decreased white blood cell count?(27.9%), anaemia (11.6%), decreased appetite (7.0%), febrile neutropenia (4.7%), hypertension (4.7%)?and proteinuria (4.7%). No treatment-related deaths occurred. No QOL deterioration was observed during study treatment. Conclusion Nab-paclitaxel plus ramucirumab combination therapy shows promising activity and manageable toxicities?and could be a useful second-line treatment option for patients with previously treated advanced gastric cancer. Highlights ? This study is a first trial to assess the efficacy and safety of this therapy. ? Overall response rate assessed by the independent review was 54.8%. ? Progression-free survival assessed by the independent review was 7.6 months. ? Toxicities were manageable. ? This therapy could be a useful treatment option for advanced gastric cancer.