A phase III randomised study comparing concomitant radiochemotherapy as induction versus consolidation treatment in patients with locally advanced unresectable non-small cell lung cancer

Berghmans, T.; Van Houtte, P.; Paesmans, M.; Giner, V.; Lecomte, J.; Koumakis, G.; Richez, M.; Holbrechts, S.; Roelandts, M.; Meert, A.P.; Alard, S.; Leclercq, N.; Sculier, J.P.

doi:10.1016/j.lungcan.2008.08.004

« Previous Next »Lung Cancer
Volume 64, Issue 2 , Pages 187-193, May 2009

A phase III randomised study comparing concomitant radiochemotherapy as induction versus consolidation treatment in patients with locally advanced unresectable non-small cell lung cancer☆

T. Berghmans
- Department of Intensive Care Unit and Thoracic Oncology, Institut Jules Bordet, Centre des Tumeurs de l’Université Libre de Bruxelles (ULB), Brussels, Belgium
- Corresponding author at: Institut Jules Bordet, Rue Héger-Bordet 1, 1000 Bruxelles, Belgium. Tel.: +32 2 541 31 91; fax: +32 2 534 37 56.
P. Van Houtte
- Department of Radiotherapy, Institut Jules Bordet, Centre des Tumeurs de l’Université Libre de Bruxelles (ULB), Brussels, Belgium
M. Paesmans
- Data Centre, Institut Jules Bordet, Centre des Tumeurs de l’Université Libre de Bruxelles ELCWP, Brussels, Belgium
V. Giner
- Department of Oncology, Hospital de Sagunto, Valencia, Spain
J. Lecomte
- Department of Pneumology, Hôpital Civil de Charleroi, Charleroi, Belgium
G. Koumakis
- Department of Oncology, St. Savas Hospital-Hellenic Cancer Institute, Greece
M. Richez
- Department of Pneumology, CHR St. Joseph, Warquignies, Belgium
S. Holbrechts
- Department of Oncology, Hôpital Ambroise Paré, Mons, Belgium
M. Roelandts
- Department of Radiotherapy, Institut Jules Bordet, Centre des Tumeurs de l’Université Libre de Bruxelles (ULB), Brussels, Belgium
A.P. Meert
- Department of Intensive Care Unit and Thoracic Oncology, Institut Jules Bordet, Centre des Tumeurs de l’Université Libre de Bruxelles (ULB), Brussels, Belgium
S. Alard
- Department of Radiology, Hôpital Saint-Pierre, Bruxelles, Belgium
N. Leclercq
- Department of Intensive Care Unit and Thoracic Oncology, Institut Jules Bordet, Centre des Tumeurs de l’Université Libre de Bruxelles (ULB), Brussels, Belgium
J.P. Sculier
- Department of Intensive Care Unit and Thoracic Oncology, Institut Jules Bordet, Centre des Tumeurs de l’Université Libre de Bruxelles (ULB), Brussels, Belgium

Received 11 June 2008; received in revised form 30 July 2008; accepted 2 August 2008. published online 22 September 2008.

Abstract

As concomitant chemoradiotherapy for stage III NSCLC is associated with survival advantage in comparison to a sequential approach, we conducted a phase III randomised study aiming to determine the best sequence and safety of chemotherapy (CT) and chemoradiotherapy (CT-RT), using a regimen with cisplatin (CDDP), gemcitabine (GEM) and vinorelbine (VNR). Unresectable stage III NSCLC patients received CDDP (60mg/m²), GEM (1g/m², days 1 and 8) and VNR (25mg/m², days 1 and 8) with reduced dosage of GEM and VNR during radiotherapy (66Gy). Two cycles of CT with radiotherapy followed by two further cycles of CT alone were administered in arm A or the reverse sequence in arm B. The study was prematurely closed for poor accrual due to administrative problems. Forty-nine eligible patients were randomised. Response rates and median survival times were, respectively 57% (95% CI: 36–78%) and 17 months (95% CI: 9.3–24.6 months) in arm A and 79% (95% CI: 64–94%) and 23.9 months (95% CI: 13.3–34.5 months) in arm B (p>0.05). Chemotherapy dose-intensity was significantly reduced in arm A. Grade 3–4 oesophagitis occurred in 5 patients. One case of grade 5 radiation pneumonitis was observed. In conclusion, chemoradiotherapy with CDDP, GEM and VNR appears feasible as initial treatment or after induction chemotherapy. Consolidation chemoradiotherapy seems less toxic with a better observed response rates and survival although no valid conclusion can be drawn from the comparison of both arms.