Annals of Oncology Advance Access originally published online on April 7, 2006
Annals of Oncology 2006 17(7):1111-1119; doi:10.1093/annonc/mdl078
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© 2006 European Society for Medical Oncology
A phase III trial of docetaxel/carboplatin versus mitomycin C/ifosfamide/cisplatin (MIC) or mitomycin C/vinblastine/cisplatin (MVP) in patients with advanced non-small-cell lung cancer: a randomised multicentre trial of the British Thoracic Oncology Group (BTOG1)
1 Christie Hospital, Manchester, UK; 2 Wythenshawe Hospital, Manchester, UK; 3 Aberdeen Royal Infirmary, Aberdeen, UK; 4 Royal Marsden Hospital, London, UK; 5 Beetson Oncology Centre, Glasgow, UK; 6 St James Hospital, Dublin, Eire; 7 Poole Hospital, Poole, UK; 8 Cookridge Hospital, Leeds, UK; 9 Newcastle General Hospital, Newcastle, UK
* Correspondence to: Dr P. Lorigan, Christie Hospital NHS Trust, Wilmslow Road, Manchester M20 4BX, UK. Tel: +44-161-446-3172; Fax: +44-161-446-3299; E-mail: paul.lorigan{at}manchester.ac.uk
Background: Phase III studies suggest that non-small-cell lung cancer (NSCLC) patients treated with cisplatin–docetaxel may have higher response rates and better survival compared with other platinum-based regimens. We report the final results of a randomised phase III study of docetaxel and carboplatin versus MIC or MVP in patients with advanced NSCLC.
Patients and methods: Patients with biopsy proven stage III–IV NSCLC not suitable for curative surgery or radiotherapy were randomised to receive four cycles of either DCb (docetaxel 75 mg/m2, carboplatin AUC 6), or MIC/MVP (mitomycin 6 mg/m2, ifosfamide 3 g/m2 and cisplatin 50 mg/m2 or mitomycin 6 mg/m2, vinblastine 6 mg/m2 and cisplatin 50 mg/m2, respectively), 3 weekly. The primary end point was survival, secondary end points included response rates, toxicity and quality of life.
Results: The median follow-up was 17.4 months. Overall response rate was 32% for both arms (partial response = 31%, complete response = 1%); 32% of MIC/MVP and 26% of DCb patients had stable disease. One-year survival was 39% and 35% for DCb and MIC/MVP, respectively. Two-year survival was 13% with both arms. Grade 3/4 neutropenia (74% versus 43%, P < 0.005), infection (18% versus 9%, P = 0.01) and mucositis (5% versus 1%, P = 0.02) were more common with DCb than MIC/MVP. The MIC/MVP arm had significant worsening in overall EORTC score and global health status whereas the DCb arm showed no significant change.
Conclusions: The combination of DCb had similar efficacy to MIC/MVP but quality of life was better maintained.
Key words: chemotherapy, docetaxel, lung cancer, quality of life
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