A phase II trial of oral UFT plus cisplatin (CDDP) in patients with non-small cell lung cancer (NSCLC)
| Autor: | Yoshio Yamane, Junichi Saito, Yasuo Saijo, Yushi Nakai, Tomei Tsukamoto, Tsuneo Sayama, Sadahiro Koinumaru, Noboru Aso, Takehito Nakabayashi, Toshihiro Nukiwa, Yoshifumi Matsuura |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Pulmonary and Respiratory Medicine
Adult Male Cancer Research medicine.medical_specialty Antimetabolites Antineoplastic Lung Neoplasms Neutropenia medicine.medical_treatment non-small cell lung cancer (NSCLC) Phases of clinical research Administration Oral Gastroenterology Tegafur Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Humans Uracil Aged Chemotherapy business.industry Combination chemotherapy Anemia Middle Aged medicine.disease Survival Analysis Thrombocytopenia Surgery Regimen Treatment Outcome Oncology Epidermoid carcinoma Female Cisplatin business medicine.drug |
| Zdroj: | Lung cancer (Amsterdam, Netherlands). 31(2-3) |
| ISSN: | 0169-5002 |
| Popis: | Based on the results of our previous pilot study, we conducted a multi-institutional phase II study of combination chemotherapy consisting of oral UFT (Taiho Pharmaceutical Co. Ltd, Tokyo) plus cisplatin (CDDP) in patients with advanced non-small cell lung cancer (NSCLC). UFT capsule containing 100 mg tegafur and 224 mg uracil was orally administered in two divided doses on days 1 through 21 making the total tegafur dose 400 mg/m2/day (maximum 600 mg/body). CDDP was administered by drip infusion at a dose of 20 mg/m2 on a 5-day schedule from day 8 to 12. Treatment was repeated every 4 weeks as long as the criteria for initiation of therapy were still met. Between April 1995 and March 1997, 51 patients were entered into the study. The mean age of all 50 eligible patients was 64 years(range: 40–78). There were 21 patients with clinical stage IIIB disease and 29 patients with IV disease. Thirty-two patients had adenocarcinoma, 14 had epidermoid carcinoma, and four had large cell carcinoma. Of the 47 assessable patients, 18 achieved a partial response with an overall response rate of 38.3% (95% confidence interval: 24.4–52.2%). The median response duration was 113 days. The median survival time of the eligible patients was 12.8 months, and the 1-year suvival rate was 54%. Among the 51 patients enrolled, grade 3 or 4 leukopenia developed in one patient (2%), neutropenia in six patients (11. 8%), thrombocytopenia in six patients (11. 8%), and anemia in three patients (5. 9%). Non-hematological grade 3 or 4 toxicities included anorexia in 10 patients (19.6%), nausea in ten (19.6%), vomiting in two (3.9%), and diarrhea in two (3. 9%). Grade 3 abnormal laboratory data included bilirubinemia in four (7. 8%), GPT elevation in one (2.0%), and hematuria in one (2.0%). In conclusion, combination of CDDP plus oral UFT is efficacious, with low toxicity, in the treatment of advanced NSCLC. In particular, the low hematological toxicity may warrant application of this regimen to the treatment of elderly patients and in trials of concurrent chemoradiotherapy in patients with locally advanced NSCLC. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect