A Phase II Study of Irinotecan for Patients with Previously Treated Small-Cell Lung Cancer.
Oncology
; 94(4): 223-232, 2018.
Article
in En
| MEDLINE
| ID: mdl-29444512
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Camptothecin
/
Small Cell Lung Carcinoma
/
Lung Neoplasms
/
Antineoplastic Agents, Phytogenic
Type of study:
Clinical_trials
/
Etiology_studies
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Oncology
Year:
2018
Type:
Article
Affiliation country:
Japan