Randomized phase II trial of two different schedules of docetaxel plus cisplatin as first-line therapy in advanced nonsmall cell lung cancer.

Park, Se Hoon; Choi, Soo Jin; Kyung, Sun Young; An, Chang Hyeok; Lee, Sang Pyo; Park, Jeong Woong; Jeong, Sung Hwan; Cho, Eun Kyung; Shin, Dong Bok; Hoon Lee, Jae
Cancer
2007Feb ; 109 ( 4 ) :732-40.
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Park, Se Hoon -
Choi, Soo Jin -
Kyung, Sun Young -
An, Chang Hyeok -
Lee, Sang Pyo -
Park, Jeong Woong -
Jeong, Sung Hwan -
Cho, Eun Kyung -
Shin, Dong Bok -
Hoon Lee, Jae -
ABSTRACT
BACKGROUND: There is increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. The purpose of the current randomized study was to evaluate the toxicity and efficacy of docetaxel plus cisplatin combination on 2 schedules in patients with previously untreated, advanced nonsmall-cell lung cancer (NSCLC).

METHODS: Consenting patients with advanced NSCLC were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) on Day 1, plus 3-weekly (75 mg/m(2) on Day 1) or weekly (35 mg/m(2) on Days 1, 8, and 15 of a 4-week cycle) docetaxel, for up to 6 cycles.

RESULTS: Of 86 patients accrued, 41 patients were treated with 3-weekly and 43 with weekly docetaxel plus cisplatin. The most frequent grade 3/4 toxicity in the 3-weekly arm was neutropenia (56% of patients). In those receiving the weekly regimen, the frequent grade 3/4 toxicities were fatigue (44%) and nausea/vomiting (35%). The overall response rate was 40% with the 3-weekly and 39% with the weekly arm (P = .74). The median progression-free survival was 4.3 months in the 3-weekly arm and 3.9 months in the weekly arm (P = .08) and the median survival was 10.3 and 10.0 months, respectively (P = .76). Quality of life data showed no relevant difference between the arms.

CONCLUSIONS: The weekly schedule of docetaxel plus cisplatin combination as first-line chemotherapy for advanced NSCLC, while feasible, has no clear advantage over the standard 3-weekly regimen.
nonsmall cell lung cancer, docetaxel, cisplatin
MESH
Adenocarcinoma/drug therapy/mortality/secondary, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/*therapeutic use, Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology, Carcinoma, Squamous Cell/drug therapy/mortality/secondary, Cisplatin/administration & dosage, Female, Follow-Up Studies, Humans, Lung Neoplasms/*drug therapy/mortality/pathology, Male, Middle Aged, Neoplasm Staging, Prognosis, Survival Rate, Taxoids/administration & dosage
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Randomized phase II trial of two different schedules of docetaxel plus cisplatin as first-line therapy in advanced nonsmall cell lung cancer
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DOI
10.1002/cncr.22446
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ICD 03
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