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LUNG CANCER: Hycamtin (Topotecan) Active In First-Line Combo Treatment For Advanced Non-Small Cell Lung Cancer TOKYO, JAPAN -- September 14, 2000 -- A new study demonstrates that treatment with SmithKline Beecham's Hycamtin® (topotecan HC for Injection) in combination with carboplatin, is an active, first-line agent in the treatment of advanced non-small cell lung cancer. The results were presented at the 9th World Congress on Lung Cancer in Tokyo. Hycamtin currently is not approved for treatment of patients with non-small cell lung cancer. The noncomparative, multi-center study, conducted by L'Hospital Arnaud de Villeneuve, in conjunction with SmithKline Beecham, evaluated the activity of Hycamtin in combination with carboplatin in chemotherapy-naive patients. Results from the trial indicate that combination treatment with Hycamtin produced an overall response rate of 14 percent in evaluable patients, with 49 percent of patients achieving an arrest in tumor progression. "These results indicate that Hycamtin is active in solid tumors other than ovarian and small-cell lung cancer," said J. Pujol, MD, L'Hospital Arnaud de Villeneuve, Montpellier, France. "They also underscore the fact that combination treatment with Hycamtin may offer patients with non-small cell lung cancer an additional therapeutic option." In this phase II trial, 47 chemotherapy-naive, non-small cell lung cancer patients were treated with 0.5mg/m2 Hycamtin IV daily for five days, with an AUC 5 dose of carboplatin administered on the first day of treatment. The treatment regimen was repeated every 21 days. The median number of treatment courses was four per patient. Hycamtin dose reductions and escalations were made based on the incidence of toxicity and/or adverse events. Of the 42 patients who were evaluable for efficacy, 14 percent achieved an objective response (1 CR, 5 PR). Thirty-six percent of patients (n=17) had sustained stable disease that lasted at least 56 days. When the overall response rate was combined with disease stabilization, 49 percent of patients achieved an arrest in tumor progression. The median duration of response with the Hycamtin/carboplatin regimen was 16 weeks, with a median survival of 32.7 weeks. Trial investigators noted that all objective responses were confirmed by independent radiologic review. "The study results are interesting in light of the Eastern Cooperative Oncology Group (ECOG) study 1594 comparing three front-line non-small cell lung cancer regimens to the standard of care that was presented at the American Society of Clinical Oncology (ASCO) this spring, where the median survival across the four regimens ranged from 31 to 36 weeks," notes Dr. Pujol. Hematologic toxicities were the most frequent adverse events and they were reversible in most patients. The most common hematologic events observed included grade 3-4 anemia, neutropenia and thrombocytopenia in 36 percent, 53 percent, and 58 percent of patients, respectively. The non-hematologic events observed in the study were asthenia, dyspnea and infection in 11 percent, 6 percent and 6 percent of patients, respectively. These toxicities were mild or moderate in severity and manageable with the usual methods of supportive care. In additional presentations at the 9th World Congress on Lung Cancer, results of a phase I and a phase II study were reported evaluating the activity of oral Hycamtin in combination with either paclitaxel or cisplatin, in the treatment of chemotherapy-naive patients with non-small cell lung cancer. According to the data from the phase I trial, oral Hycamtin in combination with paclitaxel produced an overall response rate of 12 percent of the patients who were evaluable for a response (n=33). Further, 27 percent of the patients treated achieved disease stabilization lasting at least 56 days. The investigators noted that it was premature to evaluate survival. Grade 3 and 4 hematologic toxicities included neutropenia and anemia in 68 percent and 18 percent of patients, respectively. The most frequent grade 3 and 4 non-hematologic toxicities included dyspnea, nausea and vomiting occurring in 17 percent, 12 percent and 12 percent of patients at the maximally tolerated dose. In the phase II study of 50 patients, 28 percent (n=14) of patients treated with oral Hycamtin and cisplatin achieved a partial response to therapy, while 16 percent (n=8) experienced disease stabilization greater than 56 days. In this study, the median survival was 35.4 weeks. The most common adverse events included grade 3-4 neutropenia, anemia and thrombocytopenia in 70 percent, 48 percent and 46 percent of patients, respectively. All of the non-hematologic toxicities were mild or moderate and manageable and included vomiting, anorexia and diarrhea in 27 percent, 20 percent and 20 percent of patients, respectively. "These data illustrate that oral Hycamtin in combination with paclitaxel or cisplatin produces activity with acceptable tolerability and an acceptable AE profile," said Professor T. Palshof, MD, Arhus Kommunehospital, Copenhagen, Denmark. "These results, together with those of the Hycamtin and carboplatin study, indicate that Hycamtin has the potential to provide patients with an additional therapeutic option. Further, the 56 day sustained disease stabilization observed in these trials bodes well for the use of Hycamtin in this treatment population." Studies assessing the safety and efficacy of oral Hycamtin in various tumor types are currently ongoing. Related Links: Hycamtin (topotecan), carboplatin and SmithKline Beecham. E-mail this page to a friend or colleague! To print, use this version