TY - JOUR
T1 - A phase II tolerability study of cisplatin plus docetaxel as adjuvant chemotherapy for resected non-small cell lung cancer
AU - Azzoli, Christopher G.
AU - Krug, Lee M.
AU - Miller, Vincent A.
AU - Rizvi, Naiyer A.
AU - Kris, Mark G.
AU - Dunne, Megan
AU - Farmer, Amy
AU - Pizzo, Barbara
AU - Tyson, Leslie
AU - Seeger, Teresa
AU - Coleman, Barbara
AU - Moore, Erin
AU - Lastinger, Lauren
AU - Venkatraman, Ennapadam
AU - Rudin, Charles M.
PY - 2007/7
Y1 - 2007/7
N2 - 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.
AB - 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.
KW - Adjuvant chemotherapy
KW - Cisplatin
KW - Docetaxel
KW - Non-small cell lung cancer
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U2 - 10.1097/JTO.0b013e318074bbd0
DO - 10.1097/JTO.0b013e318074bbd0
M3 - Article
C2 - 17607120
AN - SCOPUS:34547486588
SN - 1556-0864
VL - 2
SP - 638
EP - 644
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 7
ER -