Phase II study of S-1 with patient-reported outcome evaluation in elderly patients with previously untreated advanced non-small cell lung cancer

Background and Objectives: The assessment of the treatment including the evaluation of quality of life is important in the elderly patients. We performed the phase II study to evaluate the efficacy and safety of S-1 and the quality of life in elderly patients with advanced non-small cell lung cancer (NSCLC). Methods: Chemotherapy-naive patients aged ≥75 years with stage IIIB or IV NSCLC and performance status 2 or lower were eligible. A tailored dose of S-1 was administrated orally for 14 days followed by 7 days of no treatment. This treatment course was repeated until disease progression or the emergence of intolerable toxicities. The primary end point was the disease control rate. Secondary end points were progression-free survival, overall survival, toxicity and quality of life. Results: Among 40 patients enrolled, 38 patients were evaluable for the response. The median age was 78 years. The disease control rate was 89.5% (CR/PR/SD/PD; 0/4/32/4). The progression-free survival and overall survival was 4.4 months and 17.0 months, respectively. Neutropenia, anorexia, hyponatremia, hypokalemia, and pneumonia of grade ≥3 occurred in 5.0, 7.5, 5.0, 2.5, and 2.5%, respectively. In the patient-reported outcome, most individual factors in patients’ quality of life including upper intestine-related symptoms were improved with the treatment, although only dyspnea slightly but continuously worsened throughout the study. Conclusions: These results indicate that 2-week treatment of tailored S-1 monotherapy with 1-week rest in elderly patients is well tolerated and demonstrates encouraging activity.