Phase III Study of Second-Line Chemotherapy for Advanced Non–Small-Cell Lung Cancer With Weekly Compared With 3-Weekly Docetaxel

A phase III study to determine whether a weekly docetaxel schedule improves the therapeutic index compared with the classic 3-weekly schedule. Patients with stage IIIB-IV non-small-cell lung cancer (NSCLC) were randomly assigned to docetaxel 75 mg/m2 on day 1 every 3 weeks (3-weekly) and 35 mg/m2 on...

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Bibliographic Details
Published in:	Journal of clinical oncology Vol. 23; no. 33; pp. 8389 - 8395
Main Authors:	SCHUETTE, Wolfgang, NAGEL, Sylke, REIFIIG, Angelika, SERKE, Monika, BLANKENBURG, Thomas, LAUTENSCHLAEGER, Christine, HANS, Klaus, SCHMIDT, Ernst-Wilhelm, DITTRICH, Ina, SCHWEISFURTH, Hans, VON WEIKERSTHAL, Ludwig Fischer, RAGHAVACHAR, Aruna
Format:	Journal Article
Language:	English
Published:	Baltimore, MD American Society of Clinical Oncology 20-11-2005 Lippincott Williams & Wilkins
Subjects:	Adult Aged Aged, 80 and over Antineoplastic Agents, Phytogenic - administration & dosage Antineoplastic Agents, Phytogenic - adverse effects Biological and medical sciences Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - mortality Carcinoma, Non-Small-Cell Lung - pathology Disease-Free Survival Drug Administration Schedule Female Humans Lung Neoplasms - drug therapy Lung Neoplasms - mortality Lung Neoplasms - pathology Male Medical sciences Middle Aged Pneumology Quality of Life Survival Analysis Taxoids - administration & dosage Taxoids - adverse effects Tumors Tumors of the respiratory system and mediastinum Antineoplastic agent Phase III trial Lung disease Respiratory disease Lung cancer Docetaxel Malignant tumor non-small cell lung carcinoma Chemotherapy Cancerology Treatment Taxane derivatives Bronchus disease Antimitotic
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Summary:	A phase III study to determine whether a weekly docetaxel schedule improves the therapeutic index compared with the classic 3-weekly schedule. Patients with stage IIIB-IV non-small-cell lung cancer (NSCLC) were randomly assigned to docetaxel 75 mg/m2 on day 1 every 3 weeks (3-weekly) and 35 mg/m2 on days 1, 8, and 15 (weekly) for < or = eight cycles. End points included survival (primary), toxicity, and response. 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 < or = .05). There were significantly lower rates of grade 3 to 4 anemia (P < or = .05), leucopenia (P < .0001), and neutropenia (P < or = .001) with weekly versus 3-weekly treatment. No grade 3 to 4 thrombocytopenia or mucositis was reported. Weekly docetaxel 35 mg/m2 demonstrated similar efficacy and better tolerability than standard 3-weekly docetaxel 75 mg/m2 and can be recommended as a feasible alternative second-line treatment option for patients with advanced NSCLC.
ISSN:	0732-183X 1527-7755
DOI:	10.1200/JCO.2005.02.3739