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Eur J Cancer. 2015 Sep;51(13):1794-802. doi: 10.1016/j.ejca.2015.05.010. Epub 2015 Jun 9.

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.

Author information

1
Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI, United States.
2
Department of Biostatistics, University of Michigan, Ann Arbor, MI, United States.
3
Department of Pathology, University of Michigan, Ann Arbor, MI, United States.
4
Department of Surgery, University of Michigan, Ann Arbor, MI, United States.
5
Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, United States.
6
Department of Radiology, University of Michigan, Ann Arbor, MI, United States.
7
Clinical Trials Office, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, United States.
8
Division of Hematology/Oncology, University of Michigan, Ann Arbor, MI, United States. Electronic address: scotschu@med.umich.edu.

Abstract

BACKGROUND:

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.

METHODS:

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(2)) and ifosfamide (2.5 g/m(2)/d) on days 1-3 with mesna 500 mg/m(2)/dose. GD was gemcitabine 900 mg/m(2) on days 1, 8 and docetaxel 100mg/m(2) 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).

RESULTS:

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 (p=0.25). Hospitalisation rates were not significantly different after adjusting for age, gender, location, chemotherapy and number of cycles (p=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.

CONCLUSIONS:

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.

KEYWORDS:

Docetaxel; Doxorubicin; Gemcitabine; Ifosfamide; Neo(adjuvant) chemotherapy; Soft tissue sarcoma

PMID:
26066736
DOI:
10.1016/j.ejca.2015.05.010
[Indexed for MEDLINE]

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