Reduced-dose nanoparticle albumin-bound-paclitaxel combined with ramucirumab as second-line treatment for advanced gastric cancer: a multicenter phase II study
9 affiliations
- 1Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
- 2Department of Surgery, Tokuyama Central Hospital
- 3Department of Surgery, Ube Central Hospital
- 4Department of Surgery, NHO Kanmon Medical Center
- 5Department of Surgery, Tsushimi Hospital
- 6Department of Surgery, Nagato General Hospital
- 7Department of Surgery, Onoda Municipal Hospital
- 8Department of Data Science, Faculty of Data Science, Shimonoseki City University
- 9Oncology Center, Yamaguchi University Hospital
Abstract
Background Weekly paclitaxel combined with ramucirumab is the standard second-line chemotherapy regimen for advanced gastric cancer. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is increasingly used as it lowers the risk of hypersensitivity reactions; however, full-dose nab-paclitaxel (100 mg/m²) combined with ramucirumab frequently leads to severe myelosuppression. In clinical practice, dose reduction is often required, particularly in older patients or those with a poor performance status. However, the clinical efficacy and safety of a reduced-dose regimen of nab-paclitaxel combined with ramucirumab have not yet been prospectively evaluated. Accordingly, this multicenter phase II study aimed to assess the efficacy and tolerability of reduced-dose nab-paclitaxel combined with ramucirumab as second-line treatment for advanced gastric cancer. Methods This open-label, single-arm, multicenter phase II trial was conducted at nine institutions between March 2018 and August 2021 and enrolled 50 patients with unresectable or recurrent gastric or esophagogastric junction adenocarcinoma who had previously undergone treatment with fluoropyrimidine-based chemotherapy. Nab-paclitaxel (80 mg/m²) was administered intravenously on days 1, 8, and 15 in combination with ramucirumab (8 mg/kg) on days 1 and 15 of each 28-day cycle. The primary endpoint was progression-free survival. The secondary endpoints included overall survival, response rate, disease control rate, relative dose intensity, and safety. Tumor responses were assessed using the Response Evaluation Criteria in Solid Tumors v1.1. Results The median progression-free survival was 5.8 months (95% confidence interval [CI], 4.6–7.0). The median overall survival was 12.5 months (95% CI, 10.6–14.5). Among patients with measurable lesions, the objective response rate was 33.3%, including one case of complete response. The disease control rate was 80%. Grade ≥ 3 neutropenia occurred in 50% of patients, whereas febrile neutropenia occurred in 2%. The relative dose intensity was 86.5% for nab-paclitaxel and 92.8% for ramucirumab. Conclusions Reduced-dose nab-paclitaxel combined with ramucirumab demonstrated modest efficacy and favorable tolerability as second-line chemotherapy for advanced gastric cancer. This regimen may represent a practical treatment alternative for patients deemed unsuitable for full-dose nab-paclitaxel due to concerns regarding its toxicity. Trial registration This study was registered in the UMIN Clinical Trials Registry on February 14, 2018 (UMIN000031285).
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BibTeX
@article{iida2026reduceddose,
title = {{Reduced-dose nanoparticle albumin-bound-paclitaxel combined with ramucirumab as second-line treatment for advanced gastric cancer: a multicenter phase II study}},
author = {Michihisa Iida and Chiyo Nakashima and Toru Kawaoka and Junya Kondo and Tsunenori Yamamoto and Shigefumi Yoshino and Kazuhisa Tokuno and Takayuki Kuga and Koji Dairaku and Yuki Nakagami and Yusaku Watanabe and Hiroto Matsui and Yoshitaro Shindo and Hidenori Takahashi and Tatsuya Ioka and Hiroaki Nagano},
journal = {BMC Cancer},
year = {2026},
month = jul,
doi = {10.1186/s12885-026-16587-x},
url = {https://doi.org/10.1186/s12885-026-16587-x},
note = {CC BY},
}
RIS
TY - JOUR
TI - Reduced-dose nanoparticle albumin-bound-paclitaxel combined with ramucirumab as second-line treatment for advanced gastric cancer: a multicenter phase II study
AU - Michihisa Iida
AU - Chiyo Nakashima
AU - Toru Kawaoka
AU - Junya Kondo
AU - Tsunenori Yamamoto
AU - Shigefumi Yoshino
AU - Kazuhisa Tokuno
AU - Takayuki Kuga
AU - Koji Dairaku
AU - Yuki Nakagami
AU - Yusaku Watanabe
AU - Hiroto Matsui
AU - Yoshitaro Shindo
AU - Hidenori Takahashi
AU - Tatsuya Ioka
AU - Hiroaki Nagano
PY - 2026
DA - 2026/07/01
JO - BMC Cancer
DO - 10.1186/s12885-026-16587-x
UR - https://doi.org/10.1186/s12885-026-16587-x
AB - Background Weekly paclitaxel combined with ramucirumab is the standard second-line chemotherapy regimen for advanced gastric cancer. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is increasingly used as it lowers the risk of hypersensitivity reactions; however, full-dose nab-paclitaxel (100 mg/m²) combined with ramucirumab frequently leads to severe myelosuppression. In clinical practice, dose reduction is often required, particularly in older patients or those with a poor performance status. However, the clinical efficacy and safety of a reduced-dose regimen of nab-paclitaxel combined with ramucirumab have not yet been prospectively evaluated. Accordingly, this multicenter phase II study aimed to assess the efficacy and tolerability of reduced-dose nab-paclitaxel combined with ramucirumab as second-line treatment for advanced gastric cancer. Methods This open-label, single-arm, multicenter phase II trial was conducted at nine institutions between March 2018 and August 2021 and enrolled 50 patients with unresectable or recurrent gastric or esophagogastric junction adenocarcinoma who had previously undergone treatment with fluoropyrimidine-based chemotherapy. Nab-paclitaxel (80 mg/m²) was administered intravenously on days 1, 8, and 15 in combination with ramucirumab (8 mg/kg) on days 1 and 15 of each 28-day cycle. The primary endpoint was progression-free survival. The secondary endpoints included overall survival, response rate, disease control rate, relative dose intensity, and safety. Tumor responses were assessed using the Response Evaluation Criteria in Solid Tumors v1.1. Results The median progression-free survival was 5.8 months (95% confidence interval [CI], 4.6–7.0). The median overall survival was 12.5 months (95% CI, 10.6–14.5). Among patients with measurable lesions, the objective response rate was 33.3%, including one case of complete response. The disease control rate was 80%. Grade ≥ 3 neutropenia occurred in 50% of patients, whereas febrile neutropenia occurred in 2%. The relative dose intensity was 86.5% for nab-paclitaxel and 92.8% for ramucirumab. Conclusions Reduced-dose nab-paclitaxel combined with ramucirumab demonstrated modest efficacy and favorable tolerability as second-line chemotherapy for advanced gastric cancer. This regimen may represent a practical treatment alternative for patients deemed unsuitable for full-dose nab-paclitaxel due to concerns regarding its toxicity. Trial registration This study was registered in the UMIN Clinical Trials Registry on February 14, 2018 (UMIN000031285).
SN - 1471-2407
ER -