Uracil and tegafur modulated with leucovorin: an effective regimen with low toxicity for the treatment of colorectal carcinoma in the elderly. Oncopaz Cooperative Group.

BACKGROUND: In spite of the high prevalence of cancer in the elderly, little information is available about the efficacy and toxicity of chemotherapy in elderly patients. In a previous study, the authors demonstrated that the combination of uracil and tegafur (UFT) with leucovorin (LV) was active and well tolerated in patients with advanced colorectal carcinoma (ACC). The objective of the current study was to determine the efficacy and toxicity of this regimen in elderly patients with ACC. METHODS: Thirty-eight unselected patients older than 70 years (median age, 74 years) with measurable ACC were included. All patients were evaluable for toxicity and response. The regimen consisted of intravenous LV 500 mg/m2 on Day 1, oral LV 15 mg every 12 hours on Days 2-14, and oral UFT 390 mg/m2 on Days 1-14. Treatment was repeated every 28 days for a minimum of 4 courses per patient. RESULTS: Two hundred eighty-eight cycles of chemotherapy were delivered (median, 7 per patient). Two patients (5%) achieved a complete response and 9 (24%) a partial response, for an overall response rate of 29%. Toxicity was mild, without dose-limiting myelosuppression. Four patients (10%) experienced Grade 3-4 diarrhea, 1 patient had Grade 3-4 nausea/vomiting, and 1 had Grade 3-4 mucositis. Grade 3-4 toxicity was more frequent among women than men (38% vs. 4%, P < 0.05). CONCLUSIONS: Treatment with oral UFT modulated with LV is effective, well tolerated, and feasible on an outpatient basis for elderly patients with ACC. However, elderly women should be followed closely for the early detection of toxicity.

Phase I study of UFT plus leucovorin in advanced colorectal cancer: a double modulation proposal.

Twenty-six patients with advanced colorectal cancer were treated with UFT and leucovorin (LV). On day 1, patients received LV 500 mg/m2 in IV infusion, followed by 15 mg/12 h for 13 days. On days 1 to 14, patients took oral UFT twice daily. Three cycles were given every 28 days, unless grade III-IV toxicity appeared. The initial dose of UFT (200 mg/day) was increased until 800 mg/day. Dose limiting toxicities were stomatitis, diarrhea and epigastralgia. The maximum tolerated dose of UFT was 390 +/- 10 mg/m2. Three out of 24 evaluable patients achieved a partial response and 1 a complete response with UFT doses of 260 to 390 mg/m2. These results warrant confirmation in phase II studies.

[Lung cancer in patients under 40 years of age: a different problem?]. / Cáncer de pulmón en enfermos menores de 40 años: un problema diferente?

BACKGROUND: Less than 5% of the cases of lung cancer diagnosed are found in young patients. Although there are few studies concerning this problem it has been suggested that in this age group the behavior of the disease is more aggressive and the prognosis worse. METHODS: In order to study the clinical characteristics, histology, and evolution of bronchogenic lung cancer diagnosed in patients under 40 years of age the data of 56 patients with this neoplasm and age was compared with those obtained from 500 patients, equal to or over 40 years of age, diagnosed during the same period of time. RESULTS: The proportion of males/females among the patients under 40 years of age was 4:1, while in those patients over this age it was 13:1 (p less than 0.001). Epidermal cancer was the most frequent histological variety found among the patients over 40, while microcytic cancer of the lung was more frequent in those under 40 (p less than 0.05). In the group of patients under 40, 8 patients under 30 had special characteristics: male/female proportion 1:1 (p = 0.078), histological predominance of the adenocarcinoma variety and undifferentiated carcinoma of large cells (p = 0.008) and lower number of smokers (p = 0.035). The time of evolution of symptoms, the extension of the disease at the time of diagnosis and survival of the patients over or under the age of 40 was similar. CONCLUSIONS: Despite the presentation of special characteristics in young patients with bronchogenic lung cancer, the behavior of the disease is similar to that observed in other age groups.

Combination chemotherapy with ifosfamide, mitomycin, and cisplatin in advanced non-small cell lung cancer.

Thirty-two evaluable patients with stage III non-small cell lung cancer were treated with the combination of ifosfamide (4 g/m2), with uroprotective mesna, mitomycin (6 mg/m2), and cisplatin (100 mg/m2). The overall response rate was 68.8% (complete response rate, 21.9%; partial response rate, 46.9%). Toxicity was moderate and manageable. Based on the response rate observed, this three-drug combination could be considered for future randomized phase III trials against non-small cell lung cancer.