Phase II study of uracil-tegafur plus cisplatin in patients with previously untreated advanced non-small cell lung cancer.

BACKGROUND AND OBJECTIVE: A multi-institutional phase II trial combining uracil-tegafur (UFT) and cisplatin (CDDP) was conducted in patients with previously untreated advanced non-small cell lung cancer (NSCLC) to evaluate the safety and efficacy of this combined treatment regimen. METHODS: The entry criteria for this study were previously untreated NSCLC, measurable disease, age <80 years, performance status <2, and adequate haematological, hepatic and renal function. Patients were treated with 400 mg/m(2) oral UFT from day 1 to day 14 and 80 mg/m(2) cisplatin on day 15. The treatment course was repeated every 3 weeks. RESULTS: Of the 68 patients enrolled, 64 (27 with stage IIIB and 37 with stage IV disease) were eligible for treatment. Twenty of the 64 patients responded to the chemotherapy (response rate 31.3%; 95% CI 21.2-43.4%). The median survival time was 8.6 months, and the 1-year survival was 41.5%. Haematological toxicity >or=WHO grade 3 was seen in 3 (4.7%) patients. For non-haematological toxicities, anorexia with WHO grade 3 was seen in 8 (12.5%) patients, nausea and vomiting with WHO grade 3 in 4 (6.3%), diarrhoea with WHO grade 4 in 1 (1.6%), and liver dysfunction with WHO grade 4 in 1 (1.6%) patient. CONCLUSIONS: The combination of oral UFT plus cisplatin was found to be a safe and active treatment against advanced NSCLC. The observed low toxicity of this combined regimen may warrant its application to the treatment of elderly patients.

Phase II study of amrubicin, 9-amino-anthracycline, in patients with advanced non-small-cell lung cancer: a West Japan Thoracic Oncology Group (WJTOG) study.

PURPOSE: We conducted a multicenter phase II study of amrubicin, a novel 9-aminoanthracycline, to evaluate its efficacy and safety in patients with non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Entry requirements included cytologically or histologically proven measurable NSCLC, stage III or IV, no prior therapy, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and adequate organ function. Amrubicin was given by daily intravenous injection at 45 mg/m2/day for three consecutive days, repeated at 3 week intervals. Each patient received at least three treatment cycles. RESULTS: Sixty-two patients were enrolled in this study. Of the 62 registered patients, 60 were eligible and assessable for efficacy, and 59 for toxicity. Overall response rate was 18.3% (95% confidence interval [CI], 9.5 to 30.4%) and median survival time was 8.2 months (95% CI, 6.7 to 10.4 months). Major toxicity was myelosuppression, with incidences of grade 3 or 4 toxicity of 78.0% for neutropenia, 54.2% for leukopenia, 30.5% for anemia, and 28.8% for thrombocytopenia. Non-hematological toxicities with a greater than 50% incidence were anorexia (69.5%), nausea/vomiting (55.9%), and alopecia (75.9%), but were relatively mild, with grade 3 toxicities observed in only one patient each (1.7%). CONCLUSION: Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.

A multicenter phase II study of carboplatin and paclitaxel with a biweekly schedule in patients with advanced non-small-cell lung cancer: Kyushu thoracic oncology group trial.

PURPOSE: This multicenter phase II study was conducted to investigate the efficacy and safety of carboplatin in combination with paclitaxel administered according to a biweekly schedule as a first-line chemotherapy for advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Eligibility criteria included histologically or cytologically confirmed NSCLC (stage IIIb or IV), no prior treatment, and measurable or evaluable disease. Paclitaxel (140 mg/m(2)) was administered intravenously on day 1, in combination with carboplatin at an area under the concentration time curve (AUC) of 3, every 2 weeks. RESULTS: Seventy-four patients (45 men) with a median age of 62 years (range 40-74) and a median ECOG performance status of 1 (range 0-2) were enrolled. The response rate was 35.1% [95% confidence interval (CI): 24.4-47.1%], with 26 partial responses. The median survival was 357 days, and the median time to progression was 218 days. Toxicity was generally mild; National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grades 3 and 4 neutropenia was observed in 50.0% of the patients, and grades 3 and 4 nausea/vomiting in 4.1%. CONCLUSIONS: Biweekly carboplatin combined with paclitaxel demonstrated anti-tumor activity in advanced NSCLC, with response and survival rates similar to those of carboplatin combined with paclitaxel administered every 3 weeks but with a more favorable toxicity profile, and the present data indicate that the regimen is suitable for use on an outpatient basis.

Smoking history before surgery and prognosis in patients with stage IA non-small-cell lung cancer--a multicenter study.

The prognosis of lung cancer patients with surgically resected non-small-cell lung cancer (NSCLC) can be predicted generally from age, sex, histologic type, stage at diagnosis, and additional treatment. Nine studies have reported that a history of smoking before diagnosis influences the prognosis of the disease in lung cancer patients. In this study, a total of 3082 patients who underwent surgery and were diagnosed with primary pathological stage IA NSCLC at 36 national hospitals from 1982 to 1997 were analyzed for the effect of smoking on survival. Smoking history and other factors influencing either the overall survival or the disease-specific survival rates of patients were estimated with the Cox proportional hazards model. Multivariate analysis demonstrated significant associations between overall survival and age (P < 0.0001), sex (P = 0.0002), and performance status (PS) (P < 0.0001). Disease-specific survival was associated with age (P = 0.0063), sex (0.00161), and PS (P = 0.0029). In males, disease-specific survival was associated with age (P = 0.0120), PS (P = 0.0022), and pack-years (number of cigarette packs per day, and years of smoking) (P = 0.0463). These results indicate that smoking history (pack-years) is important clinical prognostic factor in estimating disease-specific survival, in male patients with stage IA primary NSCLC that has been surgically resected.

[A case of aspergillus bronchitis with effective oral itraconazole].

A 62-year-old woman with diabetes mellitus and chronic hepatitis C was admitted to our hospital because of fever and productive cough. A thoracic CT scan demonstrated a cavity in the left upper lobe, thickening of the bronchial walls and multiple subpleural infiltrates. Fiberoptic bronchoscopy revealed aspergillus bronchitis. The patient was treated with 200 mg/day of oral itraconazole, but no effect was seen. Treatment with 300 mg/day of oral itraconazole, however, resulted in improvement of the symptoms and resolution of the radiographic abnormalities. We report a rare case of aspergillus bronchitis.