Phase II trial with carboplatin/gemcitabine (Cb/G) induction chemotherapy (CT) followed by radiotherapy concomitantly with paclitaxel/gemcitabine (P/G) in stage III non small cell lung cancer (NSCLC): Preliminary report

7122 Background: The optimal combination of concomitant thoracic radiotherapy (TRT) and CT in stage III unresectable NSCLC remains unclear. The role of induction CT with Cb/G, regimen less toxic than Cisplatin/G, has not been studied in stage III NSCLC. Methods: Forty-two patients (pts), 41 evaluable, entered this trial between January 2003 and November 2004, 27 males, 14 females, median age 60 (37–70), 19 pts with ECOG PS 0, 22 pts with PS 1, 22 pts with stage III A (N2), and 19 pts with stage III B (N2, N3). They received Cb AUC 5 i.v. on day 1 and G 1000 mg/m2 i.v. on days 1 + 8 every three weeks x 2 cycles, followed on day 50 by TRT, 60 Gy over 6 weeks, concomitantly with P 50 mg/m2 i.v. and G 100 mg/m2 i.v. on days 1 + 8 every three weeks x 2 cycles. Results: Of first 38 evaluable pts, after induction chemotherapy, partial response (PR) was 74% (28 pts), stable disease (SD) 24% (9 pts), and 2% (1 pt) had progressive disease (PD). After TRT and P/G, 21% (8 pts) had CR, 74% (28 pts) PR, and 5% (2 pts) ...