Seminars in oncology
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Seminars in oncology · Jun 1996
Multicenter Study Clinical TrialIfosfamide-based combination chemotherapy in advanced non-small cell lung cancer: two phase I studies.
Two studies were performed to determine the maximum tolerated dose (MTD) of paclitaxel and vinorelbine, respectively, in combination with a fixed dose of ifosfamide in previously untreated patients with stage IIIB or IV non-small cell lung cancer. Response rate and survival were also assessed. Both regimens were given with mesna and granulocyte colony-stimulating factor support. ⋯ Among 42 patients treated with ifosfamide/vinorelbine, responses have been encouraging, and final analysis is pending. The dose-limiting toxicity for both regimens was neutropenia. These findings indicate that ifosfamide-containing combination chemotherapy regimens have activity in advanced non-small cell lung cancer and are well tolerated when administered with granulocyte colony-stimulating factor.
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In the United States and in Europe, curative resections are possible in only 50% to 60% of newly diagnosed gastric cancer patients chosen to undergo surgery. For patients with higher stage tumors (T3-N(any)M0, T34N(any)M0, stages II, IIIa or IIIb), even after resection of all gross disease with negative margins, the recurrence risk is high. In the absence of earlier diagnosis, there is a clear need to develop new innovative treatment strategies that will increase the potentially curative resection rate and decrease the risk of recurrence after operation. ⋯ National or international trials testing the hypothesis that these types of approaches are superior to expectant observation have a high priority. A large American intergroup trial is underway testing the concept of postoperative adjuvant chemoradiation. Additional trials involving preoperative and postoperative therapy are in the advanced planning stage.
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Seminars in oncology · Apr 1996
Comparative StudyCost-effectiveness analysis of three regimens using vinorelbine (Navelbine) for non-small cell lung cancer.
The costs and cost-effectiveness of different treatments are increasing concerns in healthcare. Vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France), the first new agent approved for the treatment of metastatic non-small cell lung cancer (NSCLC) in more than a decade, was recently approved in the United States. In this report the terminology of cost-effectiveness analysis is reviewed and the findings from a comparative cost-effectiveness analysis of three regimens for NSCLC are discussed. ⋯ If vinorelbine is preferred because of its more favorable toxicity profile, adding cisplatin to the treatment regimen substantially increases efficacy at an acceptable cost. The study demonstrated that, compared with other available medical interventions, chemotherapy for NSCLC has acceptable efficacy and cost effectiveness. Access to treatment should not be denied on the basis of clinical or economic grounds.
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Pancreatic cancer is one of the most lethal neoplasms. Incidence in the United States has remained fairly stable over the past 25 years, with about 25,000 cases annually. Almost 100% of cases are fatal. ⋯ Alcohol and coffee consumption have been reported as possible risks in some (but not in most) studies. Diet is probably a significant factor, but is difficult to evaluate quantitatively. Other putative associations, including diabetes, probably are unimportant.
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Seminars in oncology · Apr 1996
Clinical Trial Controlled Clinical TrialCisplatin and ifosfamide with various doses of vinorelbine (navelbine) in advanced non-small lung cancer.
From November 1992 to March 1994 we concluded a phase II trial of the combination of cisplatin 75 mg/m2 and ifosfamide 3 g/m2 on day 1 and increasing doses of vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France). Group A was given vinorelbine 25 mg/m2 on day 1, group B 25 mg/m2 on days 1 and 8, and group C 25 mg/m2 on days 1 and 15 and 12.5 mg/m2 on day 8. Inclusion criteria were histologically proven non-small cell lung cancer, stage IIIB or IV disease, no underlying disease, performance status < 2, no previous chemotherapy or radiotherapy, not older than 75 years, and informed consent. ⋯ Dose intensity for vinorelbine was 8.1 mg/m2/wk in group A, 14.7 mg/m2/wk in group B, and 16.9 mg/m2/wk in group C. This study shows that increased dose intensity with vinorelbine is feasible and seems to increase the response rate and median survival, which was 28 weeks in group A and 38 weeks in group B. Median survival had not been reached in group C.