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)
Booton, R., Lorigan, P., Anderson, H., Baka, S., Ashcroft, L., Nicolson, M., O'Brien, Mary, Dunlop, D., O'Byrne, Kenneth J., Laurence, V., Snee, Michael, Dark, G., & Thatcher, N. (2006) 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). Annals of Oncology, 17(7), pp. 1111-1119.
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/m 2, carboplatin AUC 6), or MIC/MVP (mitomycin 6 mg/m 2, ifosfamide 3 g/m 2 and cisplatin 50 mg/m 2 or mitomycin 6 mg/ m 2, vinblastine 6 mg/m 2 and cisplatin 50 mg/m 2, 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. © 2006 European Society for Medical Oncology.
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|Item Type:||Journal Article|
|Additional Information:||Articles free to read on journal website after 12 months|
|Keywords:||Chemotherapy, Docetaxel, Lung cancer, Quality of life, antibiotic agent, carboplatin, cisplatin, ifosfamide, mitomycin C, vinblastine, adult, advanced cancer, aged, alopecia, anemia, article, cancer combination chemotherapy, cancer patient, cancer staging, cancer survival, clinical trial, controlled clinical trial, controlled study, drug efficacy, drug eruption, drug response, female, follow up, health status, human, infection, leukopenia, lung non small cell cancer, major clinical study, male, mucosa inflammation, multicenter study, nausea, nephrotoxicity, neuropathy, neutropenia, phase 3 clinical trial, priority journal, randomized controlled trial, scoring system, statistical analysis, survival time, thrombocytopenia, tumor biopsy, vomiting, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Middle Aged, Mitomycin, Neoplasm Staging, Survival Analysis, Taxoids|
|Divisions:||Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
|Copyright Owner:||Copyright 2006 Oxford University Press|
|Deposited On:||26 Nov 2013 05:28|
|Last Modified:||27 Jan 2015 04:47|
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