A randomised, open-label, phase II study of neo/adjuvant doxorubicin and ifosfamide versus gemcitabine and docetaxel in patients with localised, high-risk, soft tissue sarcoma. Issue 13 (September 2015)

• Record Type: Journal Article
• Authors: Davis, Elizabeth J.; Chugh, Rashmi; Zhao, Lili; Lucas, David R.; Biermann, J. Sybil; Zalupski, Mark M.; Feng, Mary; Wong, Sandra L.; Jacobson, Jon; Zyczynski, Laurie; Reinke, Denise; Metko, Gino; Baker, Laurence H.; Schuetze, Scott M.
• Is Part Of: European journal of cancer. Volume 51:Issue 13(2015:Sep.)
• Page Start: 1794
• Page End: 1802
• Publication Date: 2015-09
• Subjects: Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2015.05.010
• Languages: English
• ISSNs: 0959-8049

Abstract

<abstract xml:lang="en" abstract-type="author" id="ab005"> <title id="st005">Abstract</title> <sec> <title id="st010">Background</title> <p id="sp0005">Doxorubicin and ifosfamide (AI) is standard therapy for high-risk soft tissue sarcoma (STS) but often causes severe toxicities resulting in hospitalisation. Gemcitabine and docetaxel (GD) has efficacy in metastatic STS and may be better tolerated. We conducted a study to compare toxicities and efficacies of these regimens.</p> </sec> <sec> <title id="st015">Methods</title> <p id="sp0010">This open-label, phase II, single institution trial randomised 80 patients with localised, resectable, high grade STS ⩾5 cm to either neo/adjuvant AI or GD. AI was doxorubicin (75 mg/m<sup>2</sup>) and ifosfamide (2.5 g/m<sup>2</sup>/d) on days 1–3 with mesna 500 mg/m<sup>2</sup>/dose. GD was gemcitabine 900 mg/m<sup>2</sup> on days 1, 8 and docetaxel 100 mg/m<sup>2</sup> day 8. Both arms included filgrastim. The primary end-point was hospitalisation rate. Secondary end-points included disease-free survival (DFS) and overall survival (OS).</p> </sec> <sec> <title id="st020">Results</title> <p id="sp0015">Between November 2004 and August 2012, 80 evaluable patients were randomised, 37 to AI and 43 to GT. In the AI arm, 13/37 (35%) patients were hospitalised versus 11/43 (26%) in the GD arm (<italic>p</italic> = 0.25). Hospitalisation rates were not significantly different after adjusting for age, gender, location, chemotherapy and number of cycles (<italic>p</italic> = 0.17). The 2-year and median DFS in the AI arm were 57% and 37 months, respectively, and 74% and not yet reached, respectively, in the GD arm. The most common serious adverse events with AI were haematologic. Metabolic derangements and constitutional symptoms were most common with GD.</p> </sec> <sec> <title id="st025">Conclusions</title> <p id="sp0020">Hospitalisation rate was less with GD but not statistically significant. There was a trend towards longer DFS with GD, and the regimen was tolerable, suggesting GD merits further study.</p> </sec> <sec> <title id="st030">Funding</title> <p id="sp0025">Eli Lilly and Sanofi-Aventis.</p> </sec> </abstract>