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. 2016 Oct:100:30-37. doi: 10.1016/j.lungcan.2016.07.026. Epub 2016 Jul 27.


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.

Keywords: Chemotherapy; Concurrent treatment; NSCLC; Radiotherapy; Stage III.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Bridged-Ring Compounds / administration & dosage*
  • Bridged-Ring Compounds / therapeutic use
  • Carboplatin / administration & dosage*
  • Carboplatin / therapeutic use
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / radiotherapy*
  • Combined Modality Therapy / methods*
  • Female
  • Humans
  • Induction Chemotherapy
  • Male
  • Meta-Analysis as Topic*
  • Middle Aged
  • Neoplasm Staging
  • Paclitaxel / administration & dosage*
  • Paclitaxel / therapeutic use
  • Survival Rate
  • Taxoids / administration & dosage*
  • Taxoids / therapeutic use
  • Treatment Outcome


  • Antineoplastic Agents
  • Bridged-Ring Compounds
  • Taxoids
  • taxane
  • Carboplatin
  • Paclitaxel