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Journal of Clinical Oncology, Vol 22, No 7 (April 1), 2004: pp. 1347 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.99.348
In Reply:
Department of Medical Oncology, Guy's and St Thomas' Hospital, London, UK Dr Dediu raises important issues in his letter. The clinical trials will usually compare a gold standard treatment against the potential new treatment and in the past, such trials were usually sized to look for a 20% improvement in survival. More recently, oncologists have accepted that they are unlikely to reach that end point, and have sized their trials more appropriately for looking at smaller differences. Most recently, quality of life has become an essential component of the assessment of the overall cancer strategy. Response assessment and response duration remain, as we reviewed, a mark of the drug activity and patient outcome measures, just as survival and quality of life are markers of the drug efficacy. A drug becomes registered on the basis of a clinical trial, whereas the outcomes are considered sufficiently important to allow that drug to be marketed. The dose within that trial is the licensed dose. Once a drug is licensed, in every day clinical practice, the dose and schedule are frequently modified. As discussed in our review article,1 Fossella et al2 used the well established regimen of cisplatin and vinorelbine as one of their control arms. They based their dosing and schedule of the cisplatin and vinorelbine on four randomized phase III trials, totaling 1,426 patients.3-7 Phase II trials, looking at other doses and schedules, were not considered as evidence by Fossella et al and we are in agreement with that. We are, as oncologists, also in agreement with Dr Dediu, that the platinum dose at 100 mg/m2 did contribute to the toxicity of the study, but accept that Fossella et al2 had no alternative but to use this as the comparator arm, based on the evidence published. Authors' Disclosures of Potential Conflicts of Interest The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Owns stock (not including shares held through a public mutual fund): David Khayat, Bristol-Myers Squibb. Received more than $2,000 a year from a company for either of the last 2 years: David Khayat, Bristol-Myers Squibb. REFERENCES
1. Harper P, Plunkett T, Khayat D: Quality trials and quality of life in non–small-cell lung cancer. J Clin Oncol 21:3007-3008, 2003
2. Fossella F, Pereira J, von Powel J, et al: Randomized, multinational, phase III study of docetaxel plus platinum combination versus, vinorelbine plus cisplatin for advanced non-small cell lung cancer; the TAX 326 study group. J Clin Oncol 21:3016-3024, 2003
3. Gridelli C, Gallo C, Shepherd FA, et al: Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus Gemcitabine for advanced non-small cell lung cancer: A phase III trial of the Italian GEMVIN investigators and the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 21:3025-3034, 2003 4. Wozniak AJ, Crowley JJ, Balcerzak SP, et al: Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non–small-cell lung cancer: A Southwest Oncology Group Study. J Clin Oncol 16:2459-2465, 1998[Abstract]
5. Kelly K, Crowley J, Bunn PA, et al: Randomized Phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non–small-cell lung cancer: A Southwest Oncology Group Trial. J Clin Oncol 19:3210-3218, 2001 6. Le Chevalier T, Brisgand D, Douillard JY, et al: Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non–small-cell lung cancer: Results of a European Multicenter Trial including 612 patients. J Clin Oncol 12:360-367, 1994[Abstract]
7. Comella P, Frasci G, Panza N, et al: Randomized trial comparing cisplatin, gemcitabine and vinorelbine with either cisplatin and gemcitabine or cisplatin and vinorelbine in advanced non–small-cell lung cancer: Interim analysis of a Phase III trial of the Southern Italy Cooperative Oncology Group. J Clin Oncol 18:1451-1457, 2000
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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