A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer. (March 2018)

• Record Type: Journal Article
• Authors: Bando, Hideaki; Shimodaira, Hideki; Fujitani, Kazumasa; Takashima, Atsuo; Yamaguchi, Kensei; Nakayama, Norisuke; Takahashi, Takehiro; Oki, Eiji; Azuma, Mizutomo; Nishina, Tomohiro; Hironaka, Shuichi; Komatsu, Yoshito; Shitara, Kohei
• Is Part Of: European journal of cancer. Volume 91(2018)
• Page Start: 86
• Page End: 91
• Publication Date: 2018-03
• Subjects: Advanced gastric cancer -- Nab-paclitaxel -- Paclitaxel -- Ramucirumab -- Overall response rate -- Second-line chemotherapy; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2017.11.032
• Languages: English
• ISSNs: 0959-8049

Abstract

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.