Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial

作者：Beatrice M. Seddon, Sandra J. Strauss, Jeremy Whelan, Michael Gordon Leahy, Penella J. Woll, Fiona J. Cowie, Christian Alexander Rothermundt, Zoë Wood, Charlotte Benson, Nasim Ali, Maria Marples, Gareth J. Veal, David W. Jamieson, Katja Küver, Roberto Tirabosco, Sharon Forsyth, Stephen Nash, Hakim‐Moulay Dehbi, Sandy Beare · 发表于：The Lancet Oncology · 年份：2017 · DOI：10.1016/s1470-2045(17)30622-8 · 被引用次数：537 · 研究领域：Sarcoma Diagnosis and Treatment、Vascular Tumors and Angiosarcomas、Cancer Research and Treatments

BACKGROUND: For many years, first-line treatment for locally advanced or metastatic soft-tissue sarcoma has been doxorubicin. This study compared gemcitabine and docetaxel versus doxorubicin as first-line treatment for advanced or metastatic soft-tissue sarcoma. METHODS: on day 8 every 3 weeks. Treatment was assigned using a minimisation algorithm incorporating a random element. Randomisation was stratified by age (≤18 years vs >18 years) and histological subtype. The primary endpoint was the proportion of patients alive and progression free at 24 weeks in the intention-to-treat population. Adherence to treatment and toxicity were analysed in the safety population, consisting of all patients who received at least one dose of their randomised treatment. The trial was registered with the European Clinical Trials (EudraCT) database (no 2009-014907-29) and with the International Standard Randomised Controlled Trial registry (ISRCTN07742377), and is now closed to patient entry. FINDINGS: Between Dec 3, 2010, and Jan 20, 2014, 257 patients were enrolled and randomly assigned to the two treatment groups (129 to doxorubicin and 128 to gemcitabine and docetaxel). Median follow-up was 22 months (IQR 15·7-29·3). The proportion of patients alive and progression free at 24 weeks did not differ between those who received doxorubicin versus those who received gemcitabine and docetaxel (46·3% [95% CI 37·5-54·6] vs 46·4% [37·5-54·8]); median progression-free survival (23·3 weeks [95% CI 19·6-...