Carboplatin (C), paclitaxel (P) and gemcitabine (G) induction therapy followed by thoracic conformal radiation therapy (TCRT) with or without concurrent CP in stage IIIA/B non-small cell lung cancer (NSCLC)

Abstract

7241 Background: Combined thoracic radiation and chemotherapy has become the treatment of choice for unresectable stage III NSCLC, but the optimal strategy remain undefined. Methods: 94 patients (pts) with unresectable locally advanced NSCLC, stage IIIAN2/IIIB (no pleural T4), were included in a phase II study with a scheme of induction with CPG and, if no surgery, followed by TCRT with (Group-1/concomitant) or without (Gr-2) CP. The CPG scheme is: C AUC-5 mgr/iv d1, P 175 mgr/m2/iv d1, and G 1000 mgr/m2/iv on d 1 and 8 every 3 weeks through 2 (Gr1) or 3 (Gr2) cycles; if no surgery, treatment in Gr-1 consisted of TCRT (60Gys, 180 cGy/day) with concomitant C AUC-2 mgr/iv and P 45 mgr/m2/ iv weekly during 7 weeks and in Gr-2 only TCRT (60 Gys, 200 cGy/day over 6 weeks). The primary objective: overall survival; secondary: progression free survival, response rate (RR) and toxicity. Results: The pts characteristics were: mean age 58.9 yrs (37–74); ECOG 0/1 in 23/71 pts; stage IIIAN2: 30 pts and stage IIIB 64 pts. 85 pts were evaluables for response and 91 pts for toxicity. Induction CPG response: 5 CR and 44 PR (RR 57.5%), 27 SD (31.8%) and 9 PD (10.7%). 15 pts went to surgery: 3 pCR, 11 pPR and 1 pSD. 33 pts in Gr-1 completed treatment with 6 CR, 20 PR, 2 SD and 5 PD (RR 78.7%) and 12 pts in Gr-2 with 1 CR, 7 PR and 4 PD (RR 57.1%). The median time to progression was 9 mo (9 mo in Gr-1 and 8 mo in Gr-2) and median overall survival was 16 mo (15 mo in Gr-1 and 17 mo in Gr-2). A total of 239 cycles of CPG were administered (2.3 per pts), with the hematologic toxicity (NCI-CTC) per pts Grade (g) 1–2/3–4 (%) as follows: neutropenia 28.5/17.5; anemia 40.6/3.2; thrombocytopenia 9.8/6.5; neutropenic fever in 5 pts.The main toxicities (RTOG) in consolidation treatment were in Gr-1: g1–2 neutropenia/anemia/ thrombocytopenia 40/60/11.5% of pts; g1–2/3 esophagitis in 45.7/8.5% and g1–2 pneumonitis in 17% of pts; hospitalizations was necessary in 6 pts with 1 toxic death. Conclusions: CPG is active against stage III NSCLC with moderate toxicity and overall survival is not improved by concomitant CP and TCRT, to expense of a higger toxicity. No significant financial relationships to disclose.