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

A. Ardizzoni, Marcello Tiseo, L. Boni, Massimo Di Maio, Lucio Buffoni, Ornella Belvedere, Francesco Grossi, Vito D'Alessandro, Filippo De Marinis, S. Barbera, C. Caroti, Adolfo Gino Favaretto, D. L. Cortinovis, B. Morrica, L. Tixi, Tino Ceschia, Salvatore Parisi, Umberto Ricardi, A. Grimaldi, Lucio LoreggianPierina Navarria, Rudolf Huber, Chandra P. Belani, Paal Fr Bruswig, Giorgio Vittorio Scagliotti, Tindaro Scolaro

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)30-37
Number of pages8
JournalLung Cancer
Volume100
DOIs
Publication statusPublished - Oct 1 2016

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Keywords

  • Chemotherapy
  • Concurrent treatment
  • NSCLC
  • Radiotherapy
  • Stage III

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

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. G., Cortinovis, D. L., Morrica, B., Tixi, L., Ceschia, T., Parisi, S., Ricardi, U., Grimaldi, A., ... Scolaro, T. (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. Lung Cancer, 100, 30-37. https://doi.org/10.1016/j.lungcan.2016.07.026