A Phase I Dose Escalation Study of Weekly Docetaxel and Carboplatin in Elderly Patients With Nonsmall Cell Lung Cancer
| Autor: | Noriko Yanagitani, Hisao Imai, Tamotsu Ishizuka, Ryusei Saito, Satoshi Tsuchiya, Satoru Watanabe, Masatomo Mori, Takeshi Hisada, Kyoichi Kaira, Noriaki Sunaga |
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| Rok vydání: | 2007 |
| Předmět: |
Male
Oncology Cancer Research medicine.medical_specialty Lung Neoplasms Anemia medicine.medical_treatment Phases of clinical research Docetaxel Adenocarcinoma Neutropenia Gastroenterology Drug Administration Schedule Carboplatin chemistry.chemical_compound Carcinoma Non-Small-Cell Lung Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans neoplasms Aged Neoplasm Staging Aged 80 and over Chemotherapy Dose-Response Relationship Drug Performance status business.industry medicine.disease Regimen Treatment Outcome chemistry Carcinoma Squamous Cell Carcinoma Large Cell Female Taxoids business therapeutics medicine.drug |
| Zdroj: | American Journal of Clinical Oncology. 30:51-56 |
| ISSN: | 0277-3732 |
| Popis: | Objective : We conducted a phase I dose escalation study to determine the maximum tolerated dose (MTD), the recommended dose (RD), and the safety profile of a weekly docetaxel and carboplatin combination regimen in the treatment of elderly patients with advanced nonsmall cell lung cancer (NSCLC). Patients and methods : Chemotherapy-naive patients with stage IIIB and IV NSCLC, >70 years of age, performance status (ECOG) 0-2, with adequate bone marrow, renal, liver and cardiac function, were treated with docetaxel and carboplatin. Docetaxel was given at escalated doses starting from 20 mg/m 2 /wk on days 1, 8, and 15, with an increment of 5 mg/m 2 followed by carboplatin also administered at escalated doses starting from AUC 4 to 6 (mg/ml/min); the regimen was administered every 4 weeks. The dose limiting toxicity (DLT) of the regimen was assessed during the first chemotherapy cycle. Results : There were 25 patients enrolled in this study and assessed for safety. Neutropenia was the main DLT of the regimen; grade 3/4 neutropenia occurred in 5 patients (20%). Hematologic toxicities were mild, and included grade 3 thrombocytopenia in 1 patient (4%) and grade 3 anemia in 1 patient (4%). Nonhematologic toxicities were generally mild, and included grade 3 constipation in 1 patient (4%) and grade 3 renal disorder in 1 patient (4%). Objective responses were seen in 9 patients (response rate 36%). Conclusions : The MTD was carboplatin AUC 5 on day 1 and docetaxel 30 mg/m 2 on days 1, 8, and 15; therefore, the RD for the phase II study is carboplatin AUC 5 and docetaxel 30 mg/m 2 . The combination of docetaxel and carboplatin is a feasible and well-tolerated regimen for the treatment of elderly patients with advanced NSCLC. This regimen merits further investigation in phase II trials. |
| Databáze: | OpenAIRE |
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