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Phase II study of weekly docetaxel and fixed dose rate gemcitabine in patients with previously treated advanced soft tissue and bone sarcoma

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Abstract

Purpose

The purpose of this prospective multicenter phase II study was to evaluate the efficacy and toxicity of weekly docetaxel and fixed dose rate gemcitabine in patients with previously treated advanced soft tissue and bone sarcoma.

Methods

Patients with advanced soft tissue or bone sarcoma, previously treated with ifosfamide and anthracycline-based chemotherapies, were treated with docetaxel (35 mg/m2 over 60 min) and gemcitabine (1,000 mg/m2 over 100 min) on days 1 and 8 of every 3-week cycle.

Results

From September 2008 to August 2010, 30 patients were enrolled; 24 (80.0%) were men and median patient age was 45 years (range 17–70 years). The patients received a total of 136 cycles of therapy (median 4 cycles per patient; range 1–15 cycles). Of these 30 patients, none achieved complete response (CR) and 5 achieved a partial response (PR), making the overall response rate 16.7% (95% CI, 2.5–30.8%). Twelve patients had stable disease (SD), resulting in tumor control (CR or PR or SD) in 17 of 30 patients (56.7%). Median progression-free survival was 2.5 months (range 0.8–15.3 months), and median overall survival was 8.4 months (range 1.4–22.3 months). Grade 3 or 4 neutropenia, thrombocytopenia, and anemia were observed in 17 (56.7%), 13 (43.4%), and 4 (13.3%) patients, respectively. None of these patients, however, had febrile neutropenia or bleeding events, and all non-hematologic toxicities were manageable.

Conclusions

The combination of weekly docetaxel and fixed dose rate gemcitabine was tolerable and may be an active regimen in patients with previously treated advanced sarcoma.

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Acknowledgments

This study was supported by sanofi-aventis Korea and Chong Kun Dang Pharm with the sample (Docetaxel and Gemcitabine) supply.

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Authors and Affiliations

  1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 388-1 Pungnap-Dong Songpa-Gu, Seoul, 138-736, Korea

    Eun Mi Lee & Jin-Hee Ahn

  2. Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea

    Sun Young Rha

  3. Division of Hematology and Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

    Jeeyun Lee

  4. Division of Hematology and Oncology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea

    Kyong Hwa Park

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  1. Eun Mi Lee
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Correspondence to Jin-Hee Ahn.

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Lee, E.M., Rha, S.Y., Lee, J. et al. Phase II study of weekly docetaxel and fixed dose rate gemcitabine in patients with previously treated advanced soft tissue and bone sarcoma. Cancer Chemother Pharmacol 69, 635–642 (2012). https://doi.org/10.1007/s00280-011-1742-5

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