Elsevier

European Journal of Cancer

Volume 91, March 2018, Pages 86-91
European Journal of Cancer

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

https://doi.org/10.1016/j.ejca.2017.11.032Get rights and content
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open access

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.

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/m2 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.

Keywords

Advanced gastric cancer
Nab-paclitaxel
Paclitaxel
Ramucirumab
Overall response rate
Second-line chemotherapy

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