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

European Journal of Cancer Feb 07, 2018

Bando H, et al. - Efficacy as well as safety of nab-paclitaxel + ramucirumab combination therapy for previously treated advanced gastric cancer, was assessed in phase II trial. With promising activity and manageable toxicities, nab-paclitaxel + ramucirumab combination therapy could be a useful second-line treatment option for patients with previously treated advanced gastric cancer.

Methods
  • This study included patients with unresectable advanced gastric cancer refractory to first-line chemotherapy
  • These patients were administered nab-paclitaxel 100 mg/m2 intravenously on days 1, 8 and 15, plus ramucirumab 8 mg/kg intravenously on days 1 and 15 of a 28-day cycle.
  • Independent Review Committee (IRC)–assessed overall response rate (ORR) was the primary end-point, and progression-free survival (PFS), overall survival (OS), disease control rate (DCR), safety and quality of life (QOL) were included as secondary end-points.

Results
  • A total of 45 patients were enrolled; 43 received the study treatment.
  • Data showed that 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) and 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.
  • Primarily reported treatment-related grade 3 or 4 adverse events included 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%).
  • Researchers reported no occurrence of treatment-related deaths.
  • Also, they noted that QOL did not deteriorate during study treatment.
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