Paclitaxel by 96-hour continuous infusion in combination with cisplatin: a phase I trial in patients with advanced lung cancer
| Autor: | W H Wilson, L V Kieffer, Chris H. Takimoto, Bruce E. Johnson, Seth M. Steinberg, B. S. Schuler, Mark S. Georgiadis, J E Brown, Michael J. Kelley |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Lung Neoplasms Paclitaxel medicine.medical_treatment Urology Antineoplastic Agents Neutropenia Small-cell carcinoma Disease-Free Survival chemistry.chemical_compound Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Mucositis Humans Carcinoma Small Cell Infusions Intravenous Lung cancer Aged Cisplatin Chemotherapy business.industry Respiratory disease Middle Aged medicine.disease Antineoplastic Agents Phytogenic Surgery Treatment Outcome Oncology chemistry Injections Intravenous Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 15:735-743 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | PURPOSE To determine the maximum-tolerated dose (MTD) of paclitaxel administered by 96-hour continuous infusion in combination with cisplatin, to determine if the addition of granulocyte colony-stimulating factor (G-CSF) permits significant paclitaxel dose escalation, and to assess the toxicity and preliminary activity of this combination in patients with advanced lung cancer. PATIENTS AND METHODS Fifty patients with untreated lung cancer were enrolled: 42 had advanced non-small-cell lung cancer (NSCLC) and eight had extensive-stage small-cell lung cancer (SCLC). Patients received paclitaxel doses of 100 to 180 mg/m2/96 hours and cisplatin doses of 60 to 80 mg/m2 as a single 30-minute bolus injection at the end of the paclitaxel infusion. RESULTS Two of six patients experienced dose-limiting neutropenia at a dose of paclitaxel 140 mg/m2/96 hours and cisplatin 80 mg/m2. With G-CSF support, one of three patients experienced both dose-limiting mucositis and fatal neutropenic sepsis at a dose of paclitaxel 180 mg/m2/96 hours and cisplatin 80 mg/m2. Significant peripheral neuropathy developed in five patients and occurred after six or more cycles of therapy. Thirty-three of 42 patients with NSCLC had measurable disease; the objective response rate was 55%, with two complete responses and 16 partial responses. For all 42 patients with NSCLC, the median time to progression and median survival duration were 5 months and 10 months, respectively. The actuarial 1-year survival rate was 41%. Of eight SCLC patients, four responded to therapy, and the median survival duration for all SCLC patients was 11 months. CONCLUSION The MTD without G-CSF is paclitaxel 120 mg/m2/96 hours and cisplatin 80 mg/m2, and the MTD with G-CSF is paclitaxel 160 mg/m2/96 hours and cisplatin 80 mg/m2. Infusional paclitaxel with cisplatin is well tolerated and active in patients with advanced NSCLC. |
| Databáze: | OpenAIRE |
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