Published in:
Open Access 01-12-2015 | Research
A phase II trial to assess the activity of gemcitabine and docetaxel as first line chemotherapy treatment in patients with unresectable leiomyosarcoma
Published in: Clinical Sarcoma Research | Issue 1/2015
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Background
Gemcitabine and docetaxel have been shown to be active in pre-treated relapsed leiomyosarcoma. This study investigated the combination as first line treatment in patients with unresectable locally advanced/metastatic leiomyosarcoma.
Methods
Patients received gemcitabine 900 mg/m2 days 1 and 8, and docetaxel 100 mg/m2 day 8, administered 3-weekly for up to 8 cycles, with GCSF support on days 9–15. Patients who had received previous radiotherapy were treated at 75% dose. Patients were evaluated for response by RECIST 1.0 after cycles 2, 4, 6 and 8, and 3-monthly after completing treatment.
Results
Forty-four patients were evaluable for response. Eligible patients had histologically proven leiomyosarcoma of the uterus (54.5%) or other sites (45.5%). Thirty-nine patients (84.4%) had metastatic disease, and 5 (15.6%) had locally advanced disease. Six patients (13.6%) had grade 1 disease, and 23 (75%) had grade 2/3 disease. All patients had demonstrated disease progression prior to trial entry. Responses were as follows: partial response 11 (25.0%), stable disease (confirmed) 16 (36.6%), stable disease (unconfirmed) 7 (15.9%), progressive disease 10 (22.7%). Median progression-free survival and overall survival were 7.1 months (95% CI 5.7–8.3) and 17.9 months (95% CI 10.6–25.2), respectively. Progression free rates at 3 and 6 months were 70.5% (95% CI 56.7–84.2%) and 59.1% (95% CI 44.3–73.9%).
Conclusions
This study demonstrates gemcitabine and docetaxel to be active in locally advanced/metastatic leiomyosarcoma in the first line setting. Further investigation comparing with current standard therapies for leiomyosarcoma is warranted.