Randomized phase II study of induction chemotherapy with gemcitabine plus cisplatin followed by sequential radiotherapy versus radiotherapy alone in patients with stage III non-small cell lung cancer.

PURPOSE: This randomized phase II trial was conducted to compare the overall response rate (ORR) of gemcitabine plus cisplatin combination followed by sequential radiotherapy (RT) (arm A) versus RT alone (arm B) in chemonaive patients with stage IIIA or IIIB non-small cell lung cancer (NSCLC). Secondary objectives were to evaluate time to progressive disease (TTPD), overall survival, and treatment tolerability in both arms. PATIENTS AND METHODS: Eligible patients were required to have stage IIIA or stage IIIB NSCLC, no previous chemotherapy, ECOG performance status of 0-2, bidimensionally measurable disease, and age 18 to 75 years. Patients randomized in arm A were given 3 cycles of induction chemotherapy with gemcitabine 1250 mg/m(2) on days 1 and 8, plus cisplatin 80 mg/m(2) on day 1, every 21 days, followed by RT. In both arms, total dosage of RT was 63 Gy given in 34 fractions. Treatment continued until disease progression or unacceptable toxicity. RESULTS: Enrolled patients in both arms (30 in each arm) were well balanced for demographics and disease characteristics. The ORR, median TTPD and overall survival duration were 46.6/26.6%, 9.9/7.1 months and 12.5/10.0 months for arm A and arm B, respectively. The chemoradiation arm (arm A) was associated with significantly higher hematologic toxicities (anemia, neutropenia and thrombocytopenia) and nonhematologic toxicities (nausea, vomiting, paresthesias and alopecia). CONCLUSION: Sequential chemoradiation seems to be more effective than radiation alone, with acceptable toxicity profile. Confirmation phase III studies are warranted.