Annals of Oncology Advance Access originally published online on April 2, 2007
Annals of Oncology 2007 18(6):1037-1042; doi:10.1093/annonc/mdm084
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© 2007 European Society for Medical Oncology
lung cancer |
A phase III randomised trial comparing sequential chemotherapy using cisplatin-based regimen and paclitaxel to cisplatin-based chemotherapy alone in advanced non-small-cell lung cancer
1 Institut Jules Bordet, Department of Intensive Care and Thoracic Oncology, Brussels, Belgium
2 Département de Pneumologie, CHU de Lille, Lille, France
3 Service de Pneumologie, CHU de Charleroi, Charleroi, Belgium
4 Department of Medical Oncology, Evangelismos General Hospital, Athens, Greece
5 Service de Pneumologie, Clinique Saint-Luc, Bouge, Belgium
6 Department of Medical Oncology, Hospital de Sagunto, Avda Ramon y Cajal s/n, Valencia, Puerto de Sagunto, Spain, 46520
7 Department of Medical Oncology, Hellenic, Athens, Greece
8 Département de Pneumologie, Hôpital de Hayange, Hayange
9 Département de Pneumologie, Centre Hospitalier Intercommunal, Montfermeil
10 Département de Pneumologie, CHRU de Lille, Lille, France
11 Service de Pneumologie, Hôpital Saint-Pierre, Brussels
12 Service de Biostatistics, Institut Jules Bordet, Brussels, Belgium
* Correspondence to: Prof. J.P. Sculier, Department of Critical Care and Thoracic Oncology, Institut Jules Bordet, 1 Rue Héger-Bordet, B-1000 Brussels, Belgium. Tel: +32-2-541-31-85; Fax: +32-2-534-37-56; E-mail: sculier{at}bordet.be
Background: The purpose of this study is to determine whether in advanced non-small-cell lung cancer (NSCLC), the sequential administration of cisplatin-based chemotherapy and paclitaxel (Taxol) is superior to a cisplatin-based chemotherapy, followed by paclitaxel as salvage treatment.
Patients and methods: A total of 485 chemotherapy naive patients with advanced NSCLC were treated with three courses of GIP (gemcitibine + ifosfamide + cisplatin), consisting of cisplatin 50 mg/m2 on day 1, ifosfamide 3 g/m2 on day 1 and gemcitabine 1 g/m2 on days 1 and 8. Patients with nonprogressive disease were then randomised to further similar courses of GIP or courses of paclitaxel (225 mg/m2 over 3 h every 3 weeks).
Results: Objective response or nonprogression after induction GIP occurred in 174 and 115 patients, respectively. After randomisation, there were 140 patients in the GIP arm and 141 in the paclitaxel arm. In terms of postrandomisation survival, there was no statistically significant difference (P = 0.17) between the two arms. Median times were 9.7 [95% confidence interval (CI) 7.8–11.6] and 11.9 (95% CI 9.4–14.3) months for paclitaxel and GIP, respectively. Multivariate analysis demonstrated that sex and haemoglobin were independent prognostic factors. After adjustment for these factors, the observed hazard ratio was 0.81 (95% CI 0.63–1.04) in favour of GIP (P = 0.10). Toxicity was tolerable; there was a significantly higher rate of grades III/IV thrombocytopenia with GIP and more alopecia with paclitaxel.
Conclusion: Sequential chemotherapy using cisplatin-based regimen followed by paclitaxel does not result in better outcome than cisplatin-based chemotherapy using taxane as salvage treatment.
Key words: chemotherapy, cisplatin, non-small cell lung cancer, paclitaxel, sequential
Current address: Department of Critical Care, Institut Jules Bordet, 1 Rue Heger-Bordet, B-1000 Brussels, Belgium.
Current address: Department of Medical Oncology, Iatriko Medical Center, 5-7 Distomou street, 151 25 Marousi, Athens, Greece.
Current address: Department of Medical Oncology, Anticancer-Oncology Hospital of Athens St Savvas, 33 Zakynthinou, 15669 Papagou, Athens, Greece.
Received for publication November 14, 2006. Revision received January 22, 2007. Accepted for publication February 6, 2007.
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