Low-dose gemcitabine doxorubicin and docetaxel combination in patients with advanced/unresectable/metastatic sarcoma who failed prior chemotherapy: Updated analysis.

Authors

null

Vivek Narasimhan

Sarcoma Oncology Center, Santa Monica, CA

Vivek Narasimhan , James Hu , Kamalesh Kumar Sankhala , Doris V. Quon , Lawrence Menendez , Lita Fernandez , Victoria S Chua , Sant P. Chawla

Organizations

Sarcoma Oncology Center, Santa Monica, CA, USC Norris Comprehensive Cancer Center, Los Angeles, CA

Research Funding

No funding sources reported

Background: Gemcitabine with Docetaxel is active in soft tissue sarcoma. Doxorubicin is a standard agent for sarcoma with proven efficacy. The combination of Gemcitabine, Docetaxel and Doxorubicin has been studied, and is well tolerated and active in breast cancer and non-small cell lung cancer. This study assesses the safety profile and efficacy of Gemcitabine, Doxorubicin, and Docetaxel regimen in patients with advanced, metastatic and/or unresectable sarcoma. Methods: 31 patients with advanced unresectable/metastatic sarcomas who progressed through standard chemotherapy were enrolled with consent. Patients were treated with Gemcitabine 400 mg/m2, Doxorubicin 20 mg/m2, and Docetaxel 20 mg/m2 on days 1 and 8 of a 21 day cycle. Disease was assessed with RECIST 1.1 and median Progression Free Survival(PFS) and Response rates(RR) were calculated. Toxicity evaluation was done using NCI CTCAE 4.2. Results: All subjects had advanced metastatic disease and were treated with a median of 2 prior regimens(range1-6). The sarcoma subtypes were Leiomyosarcoma(29%), Dedifferentiated Liposarcoma(13%), Myxoid Liposarcoma(13%), Angiosarcoma(6%), Synovial Sarcoma(6%), Pleiomorphic Undifferentiated Sarcoma(6%) and other(27%). 31% patients were treated with prior Gemcitabine and Taxotere and 67% with prior Anthracycline. The median age was 53(range25-72). 31 patients were enrolled and 26 were evaluable for response. A partial response was observed in one patient and stable disease in 24 patients with a median PFS of 3.5 months. Grade 3 or 4 cytopenias were observed in 45% of patients(7neutropenia, 3Anemia, and 5thrombocytopenia). One patient was taken off study due to toxicity and no significant grade 3 or 4 non-hematologic toxicities were seen. Conclusions: The combination of Gemcitabine, Doxorubicin and Docetaxel is well tolerated with manageable toxicity profile. Though response rates were low, this heavily pretreated population demonstrated durable stable disease even when rechallenged with prior used agents. The role of this low dose combination is not well defined but should be considered as an option in the appropriate setting.

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Sarcoma

Track

Sarcoma

Sub Track

Soft Tissue Tumors

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 10599)

DOI

10.1200/jco.2014.32.15_suppl.10599

Abstract #

10599

Poster Bd #

306

Abstract Disclosures