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

Hideaki Bando, Hideki Shimodaira, Kazumasa Fujitani, Atsuo Takashima, Kensei Yamaguchi, Norisuke Nakayama, Takehiro Takahashi, Eiji Oki, Mizutomo Azuma, Tomohiro Nishina, Shuichi Hironaka, Yoshito Komatsu, Kohei Shitara

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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.

Original languageEnglish
Pages (from-to)86-91
Number of pages6
JournalEuropean Journal of Cancer
Volume91
DOIs
Publication statusPublished - Mar 1 2018

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Nanoparticles
Stomach Neoplasms
Advisory Committees
Confidence Intervals
Paclitaxel
Therapeutics
Disease-Free Survival
Quality of Life
Safety
Febrile Neutropenia
Survival
Premedication
Appetite
ramucirumab
Albumin-Bound Paclitaxel
Leukocyte Count
Proteinuria
Solubility
Anemia
Neutrophils

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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

In: European Journal of Cancer, Vol. 91, 01.03.2018, p. 86-91.

Research output: Contribution to journalArticle

Bando, H, Shimodaira, H, Fujitani, K, Takashima, A, Yamaguchi, K, Nakayama, N, Takahashi, T, Oki, E, Azuma, M, Nishina, T, Hironaka, S, Komatsu, Y & Shitara, K 2018, 'A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer', European Journal of Cancer, vol. 91, pp. 86-91. https://doi.org/10.1016/j.ejca.2017.11.032
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. / A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer. In: European Journal of Cancer. 2018 ; Vol. 91. pp. 86-91.
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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.",
author = "Hideaki Bando and Hideki Shimodaira and Kazumasa Fujitani and Atsuo Takashima and Kensei Yamaguchi and Norisuke Nakayama and Takehiro Takahashi and Eiji Oki and Mizutomo Azuma and Tomohiro Nishina and Shuichi Hironaka and Yoshito Komatsu and Kohei Shitara",
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T1 - A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer

AU - Bando, Hideaki

AU - Shimodaira, Hideki

AU - Fujitani, Kazumasa

AU - Takashima, Atsuo

AU - Yamaguchi, Kensei

AU - Nakayama, Norisuke

AU - Takahashi, Takehiro

AU - Oki, Eiji

AU - Azuma, Mizutomo

AU - Nishina, Tomohiro

AU - Hironaka, Shuichi

AU - Komatsu, Yoshito

AU - Shitara, Kohei

PY - 2018/3/1

Y1 - 2018/3/1

N2 - 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.

AB - 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.

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