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.
机构:
Division of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto
Division of Pulmonary Medicine, Tokai University, School of Medicine, Isehara, Kanagawa 259-1193Division of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto
Seto T.
Takezako Y.
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Division of Respiratory Diseases, Kumamoto Regional Medical Center, KumamotoDivision of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto
Takezako Y.
Nakamura H.
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Division of Respiratory Diseases, Kumamoto Regional Medical Center, KumamotoDivision of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto
Nakamura H.
Takeda K.
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Division of Respiratory Diseases, Kumamoto Regional Medical Center, KumamotoDivision of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto
Takeda K.
Inoue F.
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Division of Respiratory Diseases, Kumamoto Regional Medical Center, KumamotoDivision of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto
Inoue F.
Semba H.
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Division of Respiratory Diseases, Kumamoto Regional Medical Center, KumamotoDivision of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto
Semba H.
Eguchi K.
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机构:
Division of Pulmonary Medicine, Tokai University, School of Medicine, Isehara, Kanagawa 259-1193Division of Respiratory Diseases, Kumamoto Regional Medical Center, Kumamoto
机构:
Univ N Carolina, Multidisciplinary Thorac Oncol Program, Chapel Hill, NC 27599 USAUniv N Carolina, Multidisciplinary Thorac Oncol Program, Chapel Hill, NC 27599 USA