Induction chemotherapy and following simultaneous radiochemotherapy versus induction chemotherapy and radiotherapy alone in inoperable NSCLC (Stage IIIA/IIIB): Update of CT/RT 99/97

Abstract

7075 Background: In NSCLC simultaneous or induction radiochemotherapy is superior to chemo- or radiotherapy alone. Our study proves, weather after induction chemotherapy simultaneous radiochemotherapy is superior to radiotherapy alone. Methods: Patients (pts) with inoperable NSCLC IIIA/B are included. They get 2 cycles q3w of Paclitaxel 200mg/m2 and Carboplatinum AUC 6. If the tumor is not progressive the pts are randomized to radiotherapy alone (total dose at least 60 Gy per fraction) or simultaneous chemotherapy with weekly Paclitaxel 60mg/m2 and the same radiotherapy. Primary objective is survival; secondary endpoints are time to progression, response and toxicity. Results: Inclusion ended 05/02. The last follow-up was 11/03. As planned, 303 pts are included in the trial. 275 pts finished induction-therapy. 219 pts could be randomized: radiotherapy 115 pts, simultaneous radiochemotherapy 104 pts. Median survival is higher in the simultaneous arm: 18.67 months (95%CI 14.05–23.29) versus 14.1 months (95%CI 11.64–16.56). Progression free survival is statistically superior (log rank: p=0.0003) in the simultaneous arm: median 11.43 months (95%CI 7.88–14.98) versus 5.57 months (95%CI 3.88–7.25). In the simultaneous arm there are also statistically less recurrences (Pearson Chi-Square: p<0.001): 62.1% vs. 83.8%. The reduction on recurrences can be seen in local as in distant relapses. Toxicities are not statistically different. Conclusions: The combination of induction chemotherapy and then simultaneous radiochemotherapy with weekly Paclitaxel is superior to induction alone regarding progression-free survival, without increased toxicities. Also the survival seems to be better (not yet statistically significant). Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Germany Bristol-Myers Squibb