In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 23, No. 33 ( 2005-11-20), p. 8389-8395
Abstract:
A phase III study to determine whether a weekly docetaxel schedule improves the therapeutic index compared with the classic 3-weekly schedule. Patients and Methods Patients with stage IIIB-IV non–small-cell lung cancer (NSCLC) were randomly assigned to docetaxel 75 mg/m 2 on day 1 every 3 weeks (3-weekly) and 35 mg/m 2 on days 1, 8, and 15 (weekly) for ≤ eight cycles. End points included survival (primary), toxicity, and response. Results Of 215 patients enrolled, 208 (103 in the 3-weekly arm and 105 in the weekly arm) were assessable for response. At baseline, 24.5% of patients (51 out of 208) had received prior paclitaxel therapy and 43.3% of patients (90 out of 208) had been progression-free for more than 3 months after first-line therapy. After 12 months' follow-up, median survival was 6.3 months (95% CI, 4.68 to 7.84 months) with 3-weekly docetaxel and 9.2 months (95% CI, 5.83 to 12.59 months) with weekly docetaxel (P = .07) after a median of four (range, one to eight) and two (range, one to eight) treatment cycles, respectively. Overall, response rates were 12.6% v 10.5% with 3-weekly versus weekly docetaxel. Significantly fewer patients reported grade 3 to 4 toxicities with weekly docetaxel versus 3-weekly docetaxel (P ≤ .05). There were significantly lower rates of grade 3 to 4 anemia (P ≤ .05), leucopenia (P 〈 .0001), and neutropenia (P ≤ .001) with weekly versus 3-weekly treatment. No grade 3 to 4 thrombocytopenia or mucositis was reported. Conclusion Weekly docetaxel 35 mg/m 2 demonstrated similar efficacy and better tolerability than standard 3-weekly docetaxel 75 mg/m 2 and can be recommended as a feasible alternative second-line treatment option for patients with advanced NSCLC.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2005.02.3739
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2005
detail.hit.zdb_id:
2005181-5
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