Andrea Ardizzoni1, Marcello Tiseo2, Luca Boni3, Massimo Di Maio4, Lucio Buffoni4, Ornella Belvedere5, Francesco Grossi6, Vito D'Alessandro7, Filippo de Marinis8, Santi Barbera9, Cinzia Caroti10, Adolfo Favaretto11, Diego Cortinovis12, Brunello Morrica13, Lucia Tixi14, Tino Ceschia15, Salvatore Parisi16, Umberto Ricardi17, Andrea Grimaldi18, Lucio Loreggian19, Pierina Navarria20, Rudolf M Huber21, Chandra Belani22, Paal Fr Brunsvig23, Giorgio Vittorio Scagliotti4, Tindaro Scolaro24. 1. Medical Oncology Unit, Sant'Orsola-Malpighi University Hospital, Bologna, Italy. 2. Medical Oncology Unit, University Hospital, Parma, Italy. Electronic address: mtiseo@ao.pr.it. 3. Clinical Trials Coordinating Center, Istituto Toscano Tumori, University Hospital Careggi, Firenze, Italy. 4. Department of Oncology, University of Torino, Orbassano, Torino, Italy. 5. Department of Oncology, Medical Oncology Unit, University Hospital, Udine, Italy. 6. Medical Oncology Unit A, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy. 7. Respiratory Oncology Section, I Internal Medicine Department, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. 8. Division of Thoracic Oncology, European Institute of Oncology (IEO), Milan, Italy. 9. Division of Oncologic Pneumology, Mariano Santo Hospital, Cosenza, Italy. 10. Academic Unit of Medical Oncology, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy. 11. Department of Clinical and Experimental Oncology, Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padova, Italy. 12. Medical Oncology Unit, San Gerardo Hospital, Monza, Italy. 13. Radiotherapy Unit, Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy. 14. Department of Internal Medicine, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy. 15. Department of Oncology, Radiotherapy Unit, University Hospital, Udine, Italy. 16. Radiotherapy Department, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. 17. Department of Oncology, Radiation Oncology, University of Torino, Italy. 18. Radiotherapy Unit, Galliera Hospital, Genova, Italy. 19. Radiotherapy Department, Istituto Oncologico Veneto IRCCS, Padova, Italy. 20. Radiotherapy and Radiosurgery Department, Humanitas Research Hospital, Rozzano, Milano, Italy. 21. Pneumologie, Medizinische Klinik Innenstadt, University of Munich, Munich, Germany. 22. University of Pittsburgh Cancer Institute, Pittsburgh, PA, United States. 23. Norwegian Radium Hospital, Oslo, Norway. 24. Radiotherapy Unit, La Spezia Hospital, Italy.
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 stageIII 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.
RCT Entities:
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.