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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Induction Chemotherapy
Meta-Analysis
Radiotherapy
Thorax
Drug Therapy
Paclitaxel
Platinum
Survival
Standard of Care
Survival Rate
taxane
Therapeutics

Keywords

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

ASJC Scopus subject areas

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

Cite this

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

In: Lung Cancer, Vol. 100, 01.10.2016, p. 30-37.

Research output: Contribution to journalArticle

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, AG, Cortinovis, DL, Morrica, B, Tixi, L, Ceschia, T, Parisi, S, Ricardi, U, Grimaldi, A, Loreggian, L, Navarria, P, Huber, R, Belani, CP, Bruswig, PF, Scagliotti, GV & 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, vol. 100, pp. 30-37. https://doi.org/10.1016/j.lungcan.2016.07.026
Ardizzoni, A. ; Tiseo, Marcello ; Boni, L. ; Di Maio, Massimo ; Buffoni, Lucio ; Belvedere, Ornella ; Grossi, Francesco ; D'Alessandro, Vito ; De Marinis, Filippo ; Barbera, S. ; Caroti, C. ; Favaretto, Adolfo Gino ; Cortinovis, D. L. ; Morrica, B. ; Tixi, L. ; Ceschia, Tino ; Parisi, Salvatore ; Ricardi, Umberto ; Grimaldi, A. ; Loreggian, Lucio ; Navarria, Pierina ; Huber, Rudolf ; Belani, Chandra P. ; Bruswig, Paal Fr ; Scagliotti, Giorgio Vittorio ; Scolaro, Tindaro. / 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. 2016 ; 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.",
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T1 - 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

AU - Ardizzoni, A.

AU - Tiseo, Marcello

AU - Boni, L.

AU - Di Maio, Massimo

AU - Buffoni, Lucio

AU - Belvedere, Ornella

AU - Grossi, Francesco

AU - D'Alessandro, Vito

AU - De Marinis, Filippo

AU - Barbera, S.

AU - Caroti, C.

AU - Favaretto, Adolfo Gino

AU - Cortinovis, D. L.

AU - Morrica, B.

AU - Tixi, L.

AU - Ceschia, Tino

AU - Parisi, Salvatore

AU - Ricardi, Umberto

AU - Grimaldi, A.

AU - Loreggian, Lucio

AU - Navarria, Pierina

AU - Huber, Rudolf

AU - Belani, Chandra P.

AU - Bruswig, Paal Fr

AU - Scagliotti, Giorgio Vittorio

AU - Scolaro, Tindaro

PY - 2016/10/1

Y1 - 2016/10/1

N2 - 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.

AB - 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.

KW - Chemotherapy

KW - Concurrent treatment

KW - NSCLC

KW - Radiotherapy

KW - Stage III

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