Dataset Information

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

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.

SUBMITTER: Yu N

PROVIDER: S-EPMC10903192 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Yu Nuoya N Huang Sha S Zhang Zhe Z Huang Mingzhu M Wang Yusheng Y Zhang Wen W Zhang Xiaowei X Zhu Xiaodong X Sheng Xuedan X Yu Kaiyue K Chen Zhiyu Z Guo Weijian W

Therapeutic advances in medical oncology 20240228

<h4>Background</h4>Currently, there is no recommended standard third-line chemotherapy for metastatic gastric cancer.<h4>Objectives</h4>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.<h4>Design</h4>Prospective single-arm, two-center, phase II trial.<h4>Methods</h4>Patients were aged 18-70 years, with histologically confirmed gastric adenocarcinoma and an Eastern Cooperative Oncolo ...[more]

PMID: 38425987

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Dataset Information

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

Background

Objectives

Design

Methods

Results

Conclusion

Trial registration

Publications

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

Similar Datasets

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