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| |  ASCO MEETING: Taxol Plus Carboplatin Fails To Show Clinical Advantage Over Standard Regimen In NSCLC ATLANTA, GA -- May 17, 1999 -- Total drug costs for Bristol-Myers Squibb Co.’s Taxol (paclitaxel) Injection plus carboplatin for non-small-cell lung cancer (NSCLC) were five times those of Glaxo Wellcome Inc.’s Navelbine (vinorelbine tartrate) Injection plus cisplatin according to results of the phase III, multicentre Southwest Oncology Group (SWOG) Study 9509. The study of 444 patients was presented at the 35th annual meeting of the American Society of Clinical Oncology (ASCO) and made available to the media by Glaxo Wellcome. Navelbine-cisplatin was established as the SWOG standard of care in a study presented at ASCO in 1996. The resource utilisation results of SWOG 9509 showed that drug costs and total medical costs (median per patient) were lower for the Navelbine-cisplatin arm ($4,116 US and $17,876 US) than for the Taxol-carboplatin arm ($19,895 US and $34,693 US). These results were the only significant difference between the two treatment regimens -- no significant differences in survival, response rates or quality of life were seen between the Navelbine-cisplatin and the Taxol-carboplatin treatment arms. The primary objective of the, according to Karen Kelly, MD, University of Colorado, the study's lead investigator, was to determine whether Taxol-carboplatin offers a survival advantage over the SWOG standard regimen Navelbine-cisplatin. Based on the study design, the Taxol-carboplatin combination would have been superior if median survival was increased by 50 percent. The study showed that both treatment arms had median survival, the most important clinical endpoint, of eight months and response rates of 27 percent. One-year overall survival was also reported to be similar for the Navelbine-cisplatin and Taxol-carboplatin arms (36 percent and 38 percent, respectively). It is notable that the Navelbine-cisplatin results of this study were remarkably consistent with those of the SWOG 9308 study, after which Navelbine-cisplatin became the new SWOG standard regimen for NSCLC. A comparison of toxicities showed that the Navelbine-cisplatin arm was associated with significantly more grade IV neutropenia, leukopenia and nausea and vomiting; whereas the Taxol-carboplatin arm was associated with significantly more grade III peripheral neuropathy. Quality of life was maintained (improved or stable) in both treatment arms, which may indicate that although the two arms had different toxicity profiles, tolerability was similar based on patient quality of life assessments. Nausea and vomiting are treatable short-term effects of therapy. In contrast, peripheral neuropathy may have long-term consequences. Navelbine Injection is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced NSCLC. Navelbine is the only single agent approved by the FDA in 20 years for the treatment of advanced NSCLC. In addition, Navelbine is indicated in combination with cisplatin and offers clinical benefit as evidenced by response rates and overall survival. Navelbine is contraindicated in patients with pre-treatment granulocyte counts less than 1,000 cells/mm3. Granulocytopenia is dose limiting but is generally reversible and noncumulative over time. In two large phase III studies, Navelbine plus cisplatin demonstrated an increase in overall response rate and median survival time, compared with cisplatin alone or cisplatin combined with vindesine.(A-C) The ASCO non-small-cell lung cancer expert panel has recommended this combination as among those that are effective first-line therapies in advanced unresectable disease. Related Links: Taxol, Navelbine
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