Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: Results of sarcoma alliance for research through collaboration study 002 Journal Article


Authors: Maki, R. G.; Wathen, J. K.; Patel, S. R.; Priebat, D. A.; Okuno, S. H.; Samuels, B.; Fanucchi, M.; Harmon, D. C.; Schuetze, S. M.; Reinke, D.; Thall, P. F.; Benjamin, R. S.; Baker, L. H.; Hensley, M. L.
Article Title: Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: Results of sarcoma alliance for research through collaboration study 002
Abstract: Purpose: Gemcitabine as a single agent and the combination of gemcitabine and docetaxel have activity in patients with metastatic soft tissue sarcoma. To determine if the addition of docetaxel to gemcitabine improved clinical outcome of patients with metastatic soft tissue sarcomas, we compared a fixed dose rate infusion of gemcitabine versus a lower dose of gemcitabine with docetaxel. Patients and Methods: In this open-label phase II clinical trial, the primary end point was tumor response, defined as complete or partial response or stable disease lasting at least 24 weeks. A Bayesian adaptive randomization procedure was used to produce an imbalance in the randomization in favor of the superior treatment, accounting for treatment-subgroup interactions. Results: One hundred nineteen of 122 randomly assigned patients had assessable outcomes. The adaptive randomization assigned 73 patients (60%) to gemcitabine-docetaxel and 49 patients (40%) to gemcitabine alone, indicating gemcitabine-docetaxel was superior. The objective Response Evaluation Criteria in Solid Tumors response rates were 16% (gemcitabine-docetaxel) and 8% (gemcitabine). Given the data, the posterior probabilities that gemcitabine-docetaxel was superior for progression-free and overall survival were 0.98 and 0.97, respectively. Median progression-free survival was 6.2 months for gemcitabine-docetaxel and 3.0 months for gemcitabine alone; median overall survival was 17.9 months for gemcitabine-docetaxel and 11.5 months for gemcitabine. The posterior probability that patients receiving gemcitabine-docetaxel had a shorter time to discontinuation for toxicity compared with gemcitabine alone was .999. Conclusion: Gemcitabine-docetaxel yielded superior progression-free and overall survival to gemcitabine alone, but with increased toxicity. Adaptive randomization is an effective method to reduce the number of patients receiving inferior therapy. © 2007 by American Society of Clinical Oncology.
Keywords: adult; cancer survival; controlled study; treatment outcome; treatment response; aged; aged, 80 and over; disease-free survival; middle aged; major clinical study; clinical trial; drug tolerability; cancer combination chemotherapy; cancer growth; drug dose comparison; drug efficacy; drug safety; monotherapy; gemcitabine; disease free survival; antineoplastic agent; metastasis; controlled clinical trial; multiple cycle treatment; phase 2 clinical trial; bayes theorem; blood toxicity; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; myalgia; combination chemotherapy; docetaxel; febrile neutropenia; sarcoma; multicenter study; neoplasm metastasis; drug derivative; soft tissue sarcoma; cancer fatigue; taxoids; recombinant granulocyte colony stimulating factor; deoxycytidine; taxoid; dose time effect relation; neutrophilia
Journal Title: Journal of Clinical Oncology
Volume: 25
Issue: 19
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2007-07-01
Start Page: 2755
End Page: 2763
Language: English
DOI: 10.1200/jco.2006.10.4117
PUBMED: 17602081
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 108" - "Export Date: 17 November 2011" - "CODEN: JCOND" - "Source: Scopus"
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MSK Authors
  1. Robert Maki
    211 Maki
  2. Martee L Hensley
    221 Hensley