Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line chemotherapy in patients with small-cell lung cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organization for Research and Treatment of Cancer
| Autor: | Frances A. Shepherd, Vera Hirsh, Lesley Seymour, C. Debruyne, Michael Smylie, Anna Sadura, Alan Lamont, Heidi Martins, Maciej Krzakowski, Sheldon Rubin, Giuseppe Giaccone, Andrea Bezjak, Benny Zee |
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| Rok vydání: | 2002 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Canada Lung Neoplasms medicine.medical_treatment Placebo-controlled study Antineoplastic Agents Placebo Hydroxamic Acids Small-cell carcinoma Double-Blind Method Internal medicine medicine Humans Prospective Studies Carcinoma Small Cell Enzyme Inhibitors Lung cancer Aged Proportional Hazards Models Aged 80 and over business.industry Cancer Metalloendopeptidases Middle Aged medicine.disease Survival Analysis Surgery Radiation therapy Clinical trial Europe Treatment Outcome Quality of Life Patient Compliance Female business Marimastat medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 20(22) |
| ISSN: | 0732-183X |
| Popis: | PURPOSE: Increased expression of metalloproteinases is associated with poor prognosis in small-cell lung cancer (SCLC). This trial was undertaken to determine whether adjuvant treatment with the metalloproteinase inhibitor marimastat could prolong survival in responding patients with SCLC after chemotherapy. PATIENTS AND METHODS: SCLC patients in complete or partial remission were eligible. They were stratified by radiotherapy (early, late, or none), stage (extensive or limited), response (complete or partial), and cooperative group (National Cancer Institute of Canada-Clinical Trials Group or European Organization for Research and Treatment of Cancer). They were randomized to receive marimastat 10 mg or placebo orally bid for up to 2 years. RESULTS: There were 532 eligible patients (266 marimastat and 266 placebo). Stage was limited for 279 patients (52%) and extensive for 253 (48%). Best response to induction therapy was complete remission for 176 patients (33%), partial remission for 341 (64%), and 15 patients (3%) had undergone surgical resection. The median time to progression for marimastat patients was 4.3 months compared with 4.4 months for placebo patients (P = .81). Median survivals for marimastat and placebo patients were 9.3 months and 9.7 months, respectively (P = .90) Toxicity was generally limited to musculoskeletal symptoms (18% grade 3/4 for marimastat). Dose modifications for musculoskeletal toxicity were required in 90 patients (33%) on the marimastat arm, and 87 (32%) permanently stopped marimastat because of toxicity. Patients on marimastat had significantly poorer quality of life at 3 and 6 months. CONCLUSION: Treatment with marimastat after induction therapy for SCLC did not result in improved survival and had a negative impact on quality of life. |
| Databáze: | OpenAIRE |
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