Seminars in oncology
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Seminars in oncology · Oct 1994
Randomized Controlled Trial Clinical TrialA phase II study of cisplatin, 5-fluorouracil, and leucovorin augmented by vinorelbine (Navelbine) for advanced non-small cell lung cancer: rationale and study design.
In a randomized phase II study by the Cancer and Leukemia Group B, the cisplatin/5-fluorouracil/leucovorin (PFL) combination produced a 29% response rate in advanced, unresectable non-small cell lung cancer. Vinorelbine (Navelbine; Burroughs Wellcome, Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France), a semisynthetic vinca alkaloid, has also demonstrated single-agent activity in this disease. Therefore, a phase I-II study was designed to investigate the addition of vinorelbine in escalating doses to the PFL combination. ⋯ It was concluded that this dose level was not feasible. During a preliminary analysis, one complete response and three partial responses were observed in 16 patients evaluated; one of these patients had a pathologic complete remission. This early analysis indicates activity for the regimen.
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Seminars in oncology · Oct 1994
Clinical Trial Controlled Clinical TrialHigh-dose ifosfamide/carboplatin/etoposide: maximum tolerable doses, toxicities, and hematopoietic recovery after autologous stem cell reinfusion.
We treated 115 patients in a phase I/II dose-escalation study of ifosfamide/carboplatin/etoposide (ICE) followed by autologous stem cell rescue. Patients treated had a variety of diagnoses, including breast cancer (high-risk stage II disease with eight or more positive nodes, stage III disease, and responsive metastatic disease), non-Hodgkin's lymphoma, Hodgkin's disease, acute leukemia in first remission, and various solid tumors that were responsive to induction therapy. Patients received autologous bone marrow stem cells or peripheral blood stem cells primed by one of several methods. ⋯ Neutrophil recovery times varied based on the source of stem cells used, with the earliest engraftment times seen for patients receiving peripheral blood stem cells primed with cyclophosphamide and granulocyte colony-stimulating factor. Platelet recovery times were not statistically different for any of the subsets. In conclusion, the maximum tolerated dose of ICE has been defined, and the source of stem cells and the use of hematopoietic growth factors influence hematopoietic recovery.
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Seminars in oncology · Oct 1994
Clinical TrialCarboplatin and radiotherapy in the treatment of head and neck cancer: six years' experience.
Between 1987 and 1991, 103 patients with advanced head and neck carcinoma were treated with radiochemotherapy plus carboplatin. Tumors were located in the oral cavity in 33 patients, the oropharynx in eight, and the hypopharynx in seven. Four patients had a tumor of the epipharynx and three, tumor of the larynx. ⋯ Patients with advanced head and neck carcinomas are either randomized for conventional radiotherapy plus carboplatin or hyperfractionated accelerated irradiation plus carboplatin. As of July 1994, 178 patients have been entered in the study. Results will be evaluated after the study is completed.
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Seminars in oncology · Oct 1994
Vinorelbine (Navelbine)--a new agent for the treatment of non-small cell lung cancer: a summary.
A large body of preclinical and clinical data concerning the new semisynthetic vinca alkaloid vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France) are now available. At both the cellular and clinical levels, this drug shows reduced neurotoxicity compared with other vinca alkaloids. In phase III clinical trials of patients with advanced non-small cell lung cancer (NSCLC), treatment with the combination of vinorelbine and cisplatin resulted in survival advantages greater than those achieved by vindesine plus cisplatin. ⋯ Vinorelbine is now being actively investigated in combination and multimodality regimens in patients with various stages of NSCLC. New strategies to avoid vinorelbine-related granulocytopenia are also being developed. Vinorelbine-containing regimens hold the promise of providing effective, well-tolerated treatment for patients with NSCLC.