Randomized phase III PITCAP trial and meta-analysis of induction chemotherapy followed by thoracic irradiation with or without concurrent taxane-based chemotherapy in locally advanced NSCLC

BACKGROUND: Chemo-radiotherapy is standard of care in the treatment of unresectable stage III NSCLC. We aimed at assessing whether the addition of concurrent taxane-chemotherapy to thoracic irradiation following chemotherapy was able to improve treatment outcome. MATERIAL AND METHODS: In PITCAP trial, patients with unresectable stage III NSCLC were randomized to receive 2 cycles of platinum-paclitaxel followed by 60-61.2Gy thoracic irradiation (control arm) or by same radiotherapy with concomitant weekly paclitaxel (experimental arm). A literature-based meta-analysis including all studies with same design was also performed. RESULTS: At the time of the second interim analysis, when 151 patients were randomized, accrual was terminated. With a median follow-up of 6.1 years, median survival was 13.2 vs 15.1 months, with a 3-year survival rate of 19.5 vs 21.2% in the control and experimental arm, respectively (HR: 0.97; 95% CI 0.69-1.36; p=0.845). Treatment toxicity was manageable in both arms. The meta-analysis of 5 trials (n=866) confirmed the lack of a meaningful effect on 1-year overall survival of a taxane added concurrently to radiotherapy. CONCLUSIONS: These results do not support a meaningful survival benefit with the addition of single agent taxane given concurrently to radiotherapy after platinum-based induction in locally advanced NSCLC.

• Ardizzoni, A.
• Tiseo, M.
• Boni, L.
• Di Maio, M.
• Buffoni, L.
• Belvedere, O.
• Grossi, F.
• D'Alessandro, V.
• de Marinis, F.
• Barbera, S.
• Caroti, C.
• Favaretto, A.
• Cortinovis, D.
• Morrica, B.
• Tixi, L.
• Ceschia, T.
• Parisi, S.
• Ricardi, U.
• Grimaldi, A.
• Loreggian, L.
• Navarria, P.
• Huber, R. M.
• Belani, C.
• Brunsvig, P. F.
• Scagliotti, G. V.
• Scolaro, T.