© 1993 by Oxford University Press
Journal of the National Cancer Institute, Vol. 85, No. 10, 794-800,
May 19, 1993
© 1993 Oxford University Press
Cisplatin-Cyclophosphamide-Mitomycin Combination Chemotherapy With Supportive Care Versus Supportive Care Alone for Treatment of Metastatic Non-Small-Cell Lung Cancer
Division of Medical Oncology and Cancer Center Udine, Italy
Division and Institute of Radiology and Radiotherapy, General Hospital and University of Pisa Italy
Division of Internal Medicine, General Hospital Bassano del Grappa (VI), Italy
Division of Internal Medicine, General Hospital Marostica
Medical Day Hospital, Geriatric Hospital Padova, Italy
Division of Internal Medicine, General Hospital Rovigo, Italy
Surgical Division, General Hospital San Bonifacio (VR), Italy
Section of Pharmacology, Department of Biomedical Sciences and Technologies, University of Udine Italy
Correspondence to: Prof. G. Cartei, Divisione di Oncologia Medica e Centro di Prevenzione dei Tumori, USL7, 33100 Udine, Italy.
Background: Patients with TNM stage IV non-small-cell lung cancer have short survival times. Previous controlled studies comparing chemotherapy and supportive care for the treatment of this type of cancer have not given consistent results, have included patients with different disease stages, and have rarely reported drug dose intensity. Purpose: The present trial was designed to assess the safety and the effect on survival of supportive care alone versus chemotherapy with cisplatin, cyclophosphamide, and mitomycin combined with appropriate supportive care in patients with stage IV non-small-cell lung cancer. Methods: Patients (n = 102) with stage IV non-small-cell lung cancer were randomly assigned to one of two treatment regimens. The combined modality group (52 patients) received supportive care along with cisplatin (75 mg/m2), cyclophosphamide (400 mg/m2), and mitomycin (10 mg/m2) given intravenously at 3-week intervals. The supportive care group (50 patients) received supportive care alone. Randomization was stratified on the basis of histology (squamous versus nonsquamous cell carcinoma), performance status (Karnofsky), and weight loss (during the 6 months preceding randomization). The two groups were well matched for age and sex. Survival analysis was performed after the last patient died. Results: The median number of chemotherapy cycles was 3.5 per patient. Mean weekly delivered doses of drugs were as follows: cisplatin, 22.1 mg/m2; cyclophosphamide, 118 mg/m2; and mitomycin, 2.9 mg/m2. Toxic effects due to chemotherapy were generally mild, but peripheral neuropathy and hematologic and renal toxic effects were observed. In the supportive care group, mean survival was 6.1 months (median, 4.0 months); six patients lived at least 12 months and two lived at least 18 months. In the combined modality group, mean survival was 11.3 months (median, 8.5 months); 20 patients lived at least 12 months, 13 lived at least 18 months, and five lived at least 24 months. Difference in survival was statistically significant (P<.0001). Survival was directly related to initial performance status in both groups (P<.01) and was significantly (P<.01) longer for patients with squamous cell carcinoma than for those with nonsquamous cell carcinoma. Conclusions: The combination of supportive care and cisplatin-cyclophosphamide-mitomycin therapy offers a survival advantage over supportive care alone in patients with advanced non-small-cell lung cancer. Implications: Metastatic non-small-cell lung cancer, generally considered to be unresponsive or marginally responsive to chemotherapy, can be treated with chemotherapy, with an expectation of prolonging patient survival. Although the results of the present study are encouraging, clinical research should continue to be directed toward developing more effective treatments for this disease. [J Natl Cancer Inst 85:794–800, 1993]
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