A prospective phase II single-arm study and predictive factor analysis of irinotecan as third-line treatment in patients with metastatic gastric cancer

Nuoya Yu; Sha Huang; Zhe Zhang; Mingzhu Huang; Yusheng Wang; Wen Zhang; Xiaowei Zhang; Xiaodong Zhu; Xuedan Sheng; Kaiyue Yu; Zhiyu Chen; Weijian Guo

doi:10.1177/17588359241229433

A prospective phase II single-arm study and predictive factor analysis of irinotecan as third-line treatment in patients with metastatic gastric cancer

Ther Adv Med Oncol. 2024 Feb 28:16:17588359241229433. doi: 10.1177/17588359241229433. eCollection 2024.

Authors

Nuoya Yu^{1

2

3}, Sha Huang⁴, Zhe Zhang^{1

2}, Mingzhu Huang^{1

2}, Yusheng Wang⁵, Wen Zhang^{1

2}, Xiaowei Zhang^{1

2}, Xiaodong Zhu^{1

2}, Xuedan Sheng^{1

2}, Kaiyue Yu^{1

2}, Zhiyu Chen^{6

7}, Weijian Guo^{6

7}

Affiliations

¹ Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.
² Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
³ Department of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
⁴ Department of Medical Oncology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, Fujian, China.
⁵ Department of Digestive, Shanxi Province Cancer Hospital, Taiyuan, Shanxi, China.
⁶ Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer Center, No. 270, Dongan Road, Shanghai 200032, China.
⁷ Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China.

Abstract

Background: Currently, there is no recommended standard third-line chemotherapy for metastatic gastric cancer.

Objectives: In this study, we aimed to evaluate irinotecan's efficacy and safety in treating metastatic gastric cancer after the failure of first- and second-line chemotherapy.

Design: Prospective single-arm, two-center, phase II trial.

Methods: Patients were aged 18-70 years, with histologically confirmed gastric adenocarcinoma and an Eastern Cooperative Oncology Group performance status of 0-1, progressed during or within 3 months following the last administration of second-line chemotherapy and had no other severe hematologic, cardiac, pulmonary, hepatic, or renal functional abnormalities or immunodeficiency diseases. Eligible patients received 28-day cycles of irinotecan (180 mg/m² intravenously, days 1 and 15) and were assessed according to the RECIST 1.1 criteria every two cycles. Patients who discontinued treatment for any reason were followed up every 2 months until death. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and toxicity.

Results: A total of 98 eligible patients were enrolled in this study. In the intention-to-treat population, the median OS was 7.17 months, the median PFS was 3.47 months, and the ORR and DCR were 4.08% and 47.96%, respectively. In the per-protocol population, the median OS was 7.77 months, the median PFS was 3.47 months, and the ORR and DCR were 4.82% and 50.60%, respectively. The incidence of grade 3 or 4 hematological and non-hematological toxicities was 19.4%, and none of the patients died owing to adverse events. Cox regression analysis revealed neutropenia and baseline thrombocyte levels were independently correlated with PFS and OS.

Conclusion: Irinotecan monotherapy is an efficient, well-tolerated, and economical third-line treatment for patients with metastatic gastric cancer as a third-line treatment.

Trial registration: ClinicalTrials.gov identifier: NCT02662959.

Keywords: irinotecan; metastatic gastric cancer; phase II; prospective; third-line chemotherapy.

Associated data

ClinicalTrials.gov/NCT02662959