| Abstract: |
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 intravenously (IV) on days 1, 8, and 15, and cisplatin 80 mg/m IV on day 15, every 4 weeks for four planned cycles. A second cohort was treated with docetaxel 75 mg/m IV plus cisplatin 80 mg/m 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 with docetaxel 35 mg/m weekly or 75 mg/m 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. © 2007International Association for the Study of Lung Cancer. |
| Keywords: |
adult; cancer chemotherapy; controlled study; treatment outcome; aged; disease-free survival; middle aged; cancer surgery; survival rate; retrospective studies; clinical trial; cisplatin; drug efficacy; drug safety; unspecified side effect; antineoplastic agents; postoperative care; chemotherapy, adjuvant; follow-up studies; controlled clinical trial; multiple cycle treatment; phase 2 clinical trial; anemia; lung non small cell cancer; nausea; vomiting; carcinoma, non-small-cell lung; lung neoplasms; drug administration schedule; lorazepam; dexamethasone; dose-response relationship, drug; docetaxel; drug therapy, combination; multicenter study; adjuvant chemotherapy; granisetron; ondansetron; taxoids; new york; radiation-sensitizing agents; metoclopramide; non-small cell lung cancer; injections, intravenous; aprepitant; novel erythropoiesis stimulating protein; dolasetron mesilate; palonosetron; maryland
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