Phase II multicentric study of concurrent chemoradiation (CCR) with biweekly gemcitabine after induction chemotherapy with cisplatin and gemcitabine in unresectable stage III non small cell lung cancer (NSCLC)

Abstract

7322 Background: CCR in unresectable NSCLC has been superior to sequential approach in several studies. However, concurrence often precludes administration of full-dose chemotherapy. So, induction chemotherapy followed by CCR seems a promising alternative. A phase I study confirmed the feasibility of CCR with biweekly, low-dose, gemcitabine in NSCLC patients (Blackstock, ASTRO99). Methods: Inclusion criteria: unresectable stage III NSCLC, Karnofsky >70,adequate pulmonary, hematologic, renal and liver functions, and planned treated volume <2200cc. Treatment: 3 cycles of cisplatin (100 mg/m2, d1) and gemcitabine (1250 mg/m2, d1&8) q3w followed by CCR (gemcitabine 50 mg/m2 Monday & Thursday and radiotherapy 68.4 Gy, 1.8 Gy qd). After 22 patients included (Group A), unacceptable toxicity was detected and we reduced induction cisplatin dose (70 mg/m2) and CCR gemcitabine dose (35 mg/m2). Another 34 patients (33 eligible, Group B) were included. Results: Toxicity: Non-hematological toxicity of chemo-radiation w...