TY - JOUR
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
N1 - Funding Information:
The authors thank the participating patients, their families, and site staff; Kazuo Tamura (Fukuoka University School of Medicine), Keisuke Aiba (Jikei University School of Medicine) and Yusuke Tanigawara (Keio University School of Medicine) for their work in the Data and Safety Monitoring Committee; Atsushi Sato (Hirosaki University) and Kohki Yoshikawa (Komazawa University) for their work in the Independent Review Committee; and Yuh Sakata (Misawa City Hospital) for medical advice. This trial was sponsored by Taiho Pharmaceutical , Japan. They acknowledge editorial and submission support from Edanz Medical Writing, which was funded by Taiho Pharmaceutical .
Funding Information:
HB, EO, MA, TN and YK have received honoraria from Eli Lilly Japan and Taiho Pharma. KY has received grants and honoraria from Taiho Pharma. SH has received honoraria from Eli Lilly Japan and Taiho Pharma and travel expense from Eli Lilly Japan. KS has received personal fees from Astellas, Bristol-Myers Squibb, Takeda, Pfizer, Novartis, Abbvie and Yakult, grants and personal fees from Eli Lilly and Ono Pharma, grants from Sumitomo Dainippon Pharma, MSD, Daiichi-Sankyo, Taiho Pharma and Chugai Pharma. All remaining authors have declared no conflicts of interest.
Publisher Copyright:
© 2017 The Author(s)
PY - 2018/3
Y1 - 2018/3
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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U2 - 10.1016/j.ejca.2017.11.032
DO - 10.1016/j.ejca.2017.11.032
M3 - Article
C2 - 29353164
AN - SCOPUS:85040681588
SN - 0959-8049
VL - 91
SP - 86
EP - 91
JO - European Journal of Cancer and Clinical Oncology
JF - European Journal of Cancer and Clinical Oncology
ER -
