Dose escalation of once weekly oral vinorelbine concurrent with weekly split dose hypofractionated chest radiation for palliation of advanced non-small cell lung cancer: A phase I/II study

Introduction: Daily chest radiation schedules can be cumbersome for some patients and could also delay the administration of higher, systemic doses of chemotherapy. Methods: Thirty-six patients with advanced non-small cell lung cancer (stages IIIB and IV) were treated using a once weekly hypofractionated chest irradiation schedule (5 Gy divided in 2 fractions 6 hours apart × 12 weeks), concurrently with escalating doses of oral vinorelbine. Results: The maximum tolerated dose of vinorelbine was 80 mg/m; 28 patients were treated at 70 mg/m. Dose-limiting toxicity was hematopoietic. A mean of 8.5 cycles per patient was administered, with 53% receiving all 12 cycles. Median overall survival was 9.9 months (95% confidence interval, 5.6-14.2 months). Within the radiation field, 1 patient (4%) had a complete response, 13 (54%) a partial response, and 10 (42%) had stable disease. Nine patients could be assessed for disease outside the radiation field, of whom 7 had stable disease and 2 progressed. Conclusions: Weekly, hypofractionated chest radiation is well tolerated and can be administered safely concurrently with vinorelbine at systemic doses. This simplified, convenient regimen could benefit patients in need for both local and systemic palliation.