A Phase II Study of Irinotecan for Patients with Previously Treated Small-Cell Lung Cancer.

Abstract

OBJECTIVE:

Chemotherapy with irinotecan plus cisplatin has shown promise in chemo-naïve small-cell lung cancer (SCLC) patients. However, irinotecan treatment for relapsed or refractory SCLC has not been adequately evaluated. This phase II study evaluated the appropriate treatment schedule of irinotecan as a single agent. This study was designed to determine the antitumor activity, toxicity, and survival in previously treated SCLC patients.

METHODS:

Previously treated SCLC patients with at least one platinum-based regimen received irinotecan (100 mg/m2) on days 1 and 8, every 3 weeks, until disease progression. The assessment of the response rate was the primary endpoint.

RESULTS:

Thirty patients were enrolled, with an objective response rate of 41.3% (95% confidence interval [CI] 25.5-59.3), and a disease control rate of 69%. Median progression-free and overall survival was 4.1 months (95% CI, 2.2-5.4) and 10.4 months (95% CI, 8.1-14), respectively. The grade 3/4 hematological toxicities were neutropenia (36.7%), thrombocytopenia (3.3%), anemia (13.3%), and febrile neutropenia (6.6%). There were no grade 4 nonhematological toxicities. Frequent grade 3 nonhematological toxicities included diarrhea (10%), anorexia (6.6%), and hyponatremia (6.6%).

CONCLUSIONS:

This phase II study showed a high objective response rate and long survival. Irinotecan monotherapy schedule used was well tolerated, and could be an active treatment option for these patients.

• Authors: Rie Kondo, Satoshi Watanabe, Satoshi Shoji, Kosuke Ichikawa, Tetsuya Abe, Junko Baba, Junta Tanaka, Hiroki Tsukada, Masaki Terada, Kazuhiro Sato, Yoshie Maruyama, Masato Makino, Akira Hirata, Hiroshi Tanaka, Toshiyuki Koya, Hirohisa Yoshizawa, Toshiaki Kikuchi
• Journal: Oncology (Oncology) Vol. 94 Issue 4 Pg. 223-232 ( 2018) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 29444512 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: © 2018 S. Karger AG, Basel.

Chemical References

• Antineoplastic Agents, Phytogenic
• Irinotecan
• Camptothecin

Topics

• Aged
• Anorexia (chemically induced)
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects)
• Camptothecin (administration & dosage, adverse effects, analogs & derivatives)
• Chemotherapy-Induced Febrile Neutropenia (etiology)
• Diarrhea (chemically induced)
• Disease-Free Survival
• Drug Administration Schedule
• Female
• Humans
• Hyponatremia (chemically induced)
• Irinotecan
• Lung Neoplasms (drug therapy)
• Male
• Middle Aged
• Response Evaluation Criteria in Solid Tumors
• Retreatment
• Small Cell Lung Carcinoma (drug therapy)
• Survival Rate
• Thrombocytopenia (chemically induced)