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Ardizzoni, Andrea; Tiseo, Marcello; Boni, Luca; Di Maio, Massimo; Buffoni, Lucio; Belvedere, Ornella; Grossi, Francesco; D'Alessandro, Vito; De Marinis, Filippo; Barbera, Santi; Caroti, Cinzia; Favaretto, Adolfo; Cortinovis, Diego; Monica, Brunello; Tixi, Lucia; Ceschia, Tino; Parisi, Salvatore; Ricardi, Umberto; Grimaldi, Andrea; Loreggian, Lucio; Navarriat, Pierina; Huber, Rudolf M.; Belani, Chandra; Bruswig, Paal Fr.; Scagliotti, Giorgio Vittorio; Scolaro, Tindaro (2016): 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. In: Lung Cancer, Vol. 100: pp. 30-37
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Abstract

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 60-61.2 Gy 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. (C) 2016 ELSEVIER. All rights reserved.