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Phase II trial of daily S-1 combined with weekly irinotecan in previously treated patients with advanced or recurrent squamous cell lung cancer: North Japan lung cancer group 1101.
Kawashima, Yosuke; Ishimoto, Osamu; Miyauchi, Eisaku; Sakakibara, Tomohiro; Harada, Toshiyuki; Usui, Kazuhiro; Inoue, Akira; Sugawara, Shunichi.
Affiliation
  • Kawashima Y; Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
  • Ishimoto O; Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
  • Miyauchi E; Okino Medical Clinic, Sendai, Japan.
  • Sakakibara T; Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
  • Harada T; Department of Respiratory Medicine, Tohoku Rosai Hospital, Sendai, Japan.
  • Usui K; Department of Respiratory Medicine, JCHO Hokkaido Hospital, Sapporo, Japan.
  • Inoue A; Division of Respirology, NTT Medical Center Tokyo, Tokyo, Japan.
  • Sugawara S; Department of Palliative Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Thorac Cancer ; 14(27): 2804-2810, 2023 09.
Article in En | MEDLINE | ID: mdl-37589158
BACKGROUND: This phase II trial was designed to evaluate the efficacy and safety of S-1 combined with weekly irinotecan as a second- or third-line treatment for patients with advanced or recurrent squamous cell lung cancer. METHODS: Patients with a body surface area <1.25, 1.25-1.50, and >1.50 m2 received oral S-1 on days 1-14 at 80, 100, and 120 mg/day, respectively, and irinotecan on days 1 and 8 at 70 mg/m2 every 3 weeks. The primary endpoint was the overall response rate, and the secondary endpoints were progression-free survival, overall survival, and the incidence and severity of adverse effects. RESULTS: Between September 2011 and December 2014, 30 patients were enrolled in this study. The overall response rate was 6.7% (95% confidence interval [CI]: 0.8%-22.1%), and the disease control rate was 73.3%. The median progression-free survival was 3.0 months (95% CI: 2.5-3.4 months), and the median overall survival was 10.5 months (95% CI: 5.6-13.7 months). Grade 3/4 treatment-related adverse events were reported in ≥10% of the patients, including leukopenia (21%), neutropenia (21%), anemia (17%), anorexia (10%), and hypokalemia (10%). CONCLUSIONS: Although the treatment-related adverse events were manageable, the combination of weekly irinotecan and S-1 did not have the expected effect.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Carcinoma, Squamous Cell / Carcinoma, Non-Small-Cell Lung / Lung Neoplasms Type of study: Etiology_studies Limits: Humans Country/Region as subject: Asia Language: En Journal: Thorac Cancer Year: 2023 Document type: Article Affiliation country: Country of publication:

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Carcinoma, Squamous Cell / Carcinoma, Non-Small-Cell Lung / Lung Neoplasms Type of study: Etiology_studies Limits: Humans Country/Region as subject: Asia Language: En Journal: Thorac Cancer Year: 2023 Document type: Article Affiliation country: Country of publication: