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A phase III trial comparing concomitant radiochemotherapy (RT-CT) with cisplatin (P) and docetaxel (D) as induction versus consolidation in patients with locally advanced unresectable non-small cell lung cancer (NSCLC). An ELCWP study

Thierry Berghmans, Jean-Jacques Lafitte, Marianne Paesmans, Anne-Pascale Meert, Arnaud Scherpereel, Oswald Van Cutsem, Benoit Colinet, Paul Van Houtte, Martine Roelandts, Nathalie Leclercq, Jean-Paul Sculier
European Respiratory Journal 2015 46: OA270; DOI: 10.1183/13993003.congress-2015.OA270
Thierry Berghmans
1Intensive Care and Thoracic Oncology, Institut Jules Bordet, Brussels, Belgium
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Jean-Jacques Lafitte
2Pneumology, CHU Lille, Lille, France
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Marianne Paesmans
3Data Centre, Institut Jules Bordet, Brussels, Belgium
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Anne-Pascale Meert
1Intensive Care and Thoracic Oncology, Institut Jules Bordet, Brussels, Belgium
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Arnaud Scherpereel
2Pneumology, CHU Lille, Lille, France
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Oswald Van Cutsem
4Pneumology, Clinique Saint-Luc, Bouge, Belgium
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Benoit Colinet
5Pneumology, Hôpital Saint-Joseph, Gilly, Belgium
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Paul Van Houtte
6Radiotherapy, Institut Jules Bordet, Brussels, Belgium
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Martine Roelandts
6Radiotherapy, Institut Jules Bordet, Brussels, Belgium
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Nathalie Leclercq
1Intensive Care and Thoracic Oncology, Institut Jules Bordet, Brussels, Belgium
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Jean-Paul Sculier
1Intensive Care and Thoracic Oncology, Institut Jules Bordet, Brussels, Belgium
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Abstract

Rationale: Concomitant RT-CT demonstrated survival advantage for stage III NSCLC. A few phase II studies comparing induction to consolidation RT-CT cannot allow definitive conclusion. The ELCWP designed a phase III trial with survival as primary endpoint.

Methods: Previously untreated locally advanced unresectable non metastatic NSCLC were centrally randomised. CT consisted of P (60 mg/m²) and D (75 mg/m²) every 3 weeks. During RT-CT, P and D were given both at 20 mg/m² weekly for up to 6 cycles. Radiotherapy consisted in a 5fx/week schedule, 2Gy per fx for a total dose of 66Gy. Due to poor accrual, a futility analysis was performed and the trial was prematurely closed.

Results: From 01/2007 to 10/2013, 125 patients were randomised. There was no imbalance between arms for the main patients' characteristics. Median survival times were, respectively in the induction and the consolidation arms, 22.7 months (95% CI 16.0-39.2) and 19.5 months (95% CI 11.5-27.0). Hazard ratio was 0.89 (95% CI 0.56-1.40). Response rates and median PFS were 51% (95% CI 37%-64%) and 7.4 months (95% CI 6.2-11.7) in the induction RT-CT arm and 57% (95% CI 44%-70%) and 10.2 months (95% CI 8.1-15.0) in the consolidation RT-CT arm. Induction RT-CT was associated with more leucopenia (p = 0.002) and stomatitis (p = 0.03).

Conclusion: In this prematurely closed phase III trial, we are confirming the results from our individual data meta-analysis (Radiother Oncol 111 suppl 1, p34, 2014) concluding to the absence of any detectable difference between induction and consolidation RT-CT.

  • Lung cancer / Oncology
  • Thoracic oncology
  • Copyright ©ERS 2015
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A phase III trial comparing concomitant radiochemotherapy (RT-CT) with cisplatin (P) and docetaxel (D) as induction versus consolidation in patients with locally advanced unresectable non-small cell lung cancer (NSCLC). An ELCWP study
Thierry Berghmans, Jean-Jacques Lafitte, Marianne Paesmans, Anne-Pascale Meert, Arnaud Scherpereel, Oswald Van Cutsem, Benoit Colinet, Paul Van Houtte, Martine Roelandts, Nathalie Leclercq, Jean-Paul Sculier
European Respiratory Journal Sep 2015, 46 (suppl 59) OA270; DOI: 10.1183/13993003.congress-2015.OA270

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A phase III trial comparing concomitant radiochemotherapy (RT-CT) with cisplatin (P) and docetaxel (D) as induction versus consolidation in patients with locally advanced unresectable non-small cell lung cancer (NSCLC). An ELCWP study
Thierry Berghmans, Jean-Jacques Lafitte, Marianne Paesmans, Anne-Pascale Meert, Arnaud Scherpereel, Oswald Van Cutsem, Benoit Colinet, Paul Van Houtte, Martine Roelandts, Nathalie Leclercq, Jean-Paul Sculier
European Respiratory Journal Sep 2015, 46 (suppl 59) OA270; DOI: 10.1183/13993003.congress-2015.OA270
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