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

Author:

Kawashima Yosuke1ORCID,Ishimoto Osamu12,Miyauchi Eisaku3ORCID,Sakakibara Tomohiro4,Harada Toshiyuki5,Usui Kazuhiro6,Inoue Akira7,Sugawara Shunichi1

Affiliation:

1. Department of Pulmonary Medicine Sendai Kousei Hospital Sendai Japan

2. Okino Medical Clinic Sendai Japan

3. Department of Respiratory Medicine Tohoku University Graduate School of Medicine Sendai Japan

4. Department of Respiratory Medicine Tohoku Rosai Hospital Sendai Japan

5. Department of Respiratory Medicine JCHO Hokkaido Hospital Sapporo Japan

6. Division of Respirology NTT Medical Center Tokyo Tokyo Japan

7. Department of Palliative Medicine Tohoku University Graduate School of Medicine Sendai Japan

Abstract

AbstractBackgroundThis 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.MethodsPatients 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.ResultsBetween 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%).ConclusionsAlthough the treatment‐related adverse events were manageable, the combination of weekly irinotecan and S‐1 did not have the expected effect.

Publisher

Wiley

Subject

Pulmonary and Respiratory Medicine,Oncology,General Medicine

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