Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study)

PLoS One. 2015 May 28;10(5):e0125364. doi: 10.1371/journal.pone.0125364. eCollection 2015.

Abstract

Background: Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles.

Methods: Between 01/2007 and 03/2010 41 patients with primarily resectable NSCLC stage IB to IIIA were included. Treatment consisted of two cycles cisplatin (40 mg/m2 d1+2) and docetaxel (75 mg/m2 d1) q3 weeks, accompanied by the administration of cetuximab (400 mg/m2 d1, then 250 mg weekly). The primary endpoint was radiological response according to RECIST.

Results: 40 patients were evaluable for toxicity, 39 for response. The main grade 3/4 toxicities were: neutropenia 25%, leucopenia 11%, febrile neutropenia 6%, nausea 8% and rash 8%. 20 patients achieved a partial response, 17 a stable disease, 2 were not evaluable. 37 patients (95%) underwent surgery and in three of them a complete pathological response was achieved. At a median follow-up of 44.2 months, 41% of the patients had died, median progression-free survival was 22.5 months.

Conclusions: Two cycles of cisplatin/ docetaxel/ cetuximab showed promising efficacy in the neoadjuvant treatment of early-stage NSCLC and rapid operation was possible in 95% of patients. Toxicities were manageable and as expected.

Trial registration: EU Clinical Trials Register; Eudract-Nr: 2006-004639-31.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / pathology
  • Carcinoma, Non-Small-Cell Lung / surgery*
  • Cetuximab / administration & dosage
  • Cetuximab / adverse effects
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Docetaxel
  • Drug Administration Schedule
  • Female
  • Humans
  • Induction Chemotherapy / methods*
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / pathology
  • Lung Neoplasms / surgery*
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Survival Analysis
  • Taxoids / administration & dosage
  • Taxoids / adverse effects
  • Treatment Outcome

Substances

  • Taxoids
  • Docetaxel
  • Cetuximab
  • Cisplatin

Associated data

  • EudraCT/2006-004639-31

Grants and funding

This academic study was in part financed by two unrestricted grants offered by the companies Sanofi-Aventis and Merck. Drug supply concerning Cetuximab was donated by Merck. Additional fundings were granted by the Association of Cancer Research (“Verein für Tumorforschung”). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Fundings do not alter our adherence to PLOS ONE policies on sharing data and materials.