A Phase II Tolerability Study of Cisplatin Plus Docetaxel as Adjuvant Chemotherapy for Resected Non-small Cell Lung Cancer
| Autor: | Lee M. Krug, Barbara Coleman, Barbara Pizzo, Lauren Lastinger, Teresa Seeger, Christopher G. Azzoli, Amy Farmer, Charles M. Rudin, Mark G. Kris, Erin Moore, Naiyer A. Rizvi, Vincent A. Miller, Leslie B. Tyson, Ennapadam Venkatraman, Megan Dunne |
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| Rok vydání: | 2007 |
| Předmět: |
Oncology
Adult Male Pulmonary and Respiratory Medicine medicine.medical_specialty Radiation-Sensitizing Agents Lung Neoplasms medicine.medical_treatment Urology New York Phases of clinical research Antineoplastic Agents Docetaxel Article Disease-Free Survival Drug Administration Schedule Non-small cell lung cancer Internal medicine Carcinoma Non-Small-Cell Lung medicine Humans Lung cancer Survival rate Aged Retrospective Studies Cisplatin Chemotherapy Dose-Response Relationship Drug Maryland business.industry Middle Aged medicine.disease Adjuvant chemotherapy Survival Rate Regimen Treatment Outcome Chemotherapy Adjuvant Injections Intravenous Drug Therapy Combination Female Taxoids business Febrile neutropenia medicine.drug Follow-Up Studies |
| Zdroj: | Journal of Thoracic Oncology. 2(7):638-644 |
| ISSN: | 1556-0864 |
| DOI: | 10.1097/jto.0b013e318074bbd0 |
| Popis: | Introduction We undertook this phase II study to measure postoperative drug delivery and toxicity of cisplatin plus docetaxel in patients with resected stage I-III non-small cell lung cancer. Methods The primary endpoint was amount of cisplatin delivered over a planned four cycles of adjuvant chemotherapy. Statistical design required a cohort to close if the regimen proved unlikely to improve cisplatin delivery compared with published phase III data. The first cohort was treated with docetaxel 35 mg/m 2 intravenously (IV) on days 1, 8, and 15, and cisplatin 80 mg/m 2 IV on day 15, every 4 weeks for four planned cycles. A second cohort was treated with docetaxel 75 mg/m 2 IV plus cisplatin 80 mg/m 2 IV on day 1 every 3 weeks for four planned cycles. Results Sixteen patients were treated with weekly docetaxel and cisplatin every 4 weeks, with five of 16 (31%) unable to complete three cycles. Subsequently, 11 patients were treated with docetaxel and cisplatin every 3 weeks, with six of 11 (55%) unable to complete three cycles. Among the 11 patients who failed to complete three cycles, the reasons for stopping included one or more of the following: fatigue ( n = 8), nausea ( n = 4), febrile neutropenia ( n = 1), hypotension ( n = 1), and nephrotoxicity ( n = 1). Conclusions The combination of cisplatin at 80 mg/m 2 with docetaxel 35 mg/m 2 weekly or 75 mg/m 2 every 3 weeks is no better tolerated than older chemotherapy regimens. The most common reason to stop chemotherapy was intolerable fatigue. These results suggest that the most common dose-limiting toxicities are attributable to the cisplatin, given similar problems were encountered whether the docetaxel was delivered as a single dose every 3 weeks or as a lower weekly dose. |
| Databáze: | OpenAIRE |
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