Cancer Res Treat.  2018 Jan;50(1):175-182. 10.4143/crt.2016.535.

Gemcitabine and Docetaxel Combination for Advanced Soft Tissue Sarcoma: A Nationwide Retrospective Study

Affiliations
  • 1Department of Pharmaceutical Management, Health Insurance Review & Assessment, Wonju, Korea.
  • 2College of Pharmacy, Health, Social & Clinical Pharmacy, Chung-Ang University, Seoul, Korea. dongsuh75@gmail.com
  • 3Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 4Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 5Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
  • 6Division of Oncology/Hematology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea. yhk0215@korea.ac.kr
  • 7Cancer Deliberation Committee, Health Insurance Review & Assessment Service, Wonju, Korea.
  • 8Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.

Abstract

PURPOSE
This nationwide retrospective study was conducted to evaluate the efficacy and safety of combined gemcitabine and docetaxel (GD) as an off-label therapy for advanced soft tissue sarcoma, which has limited treatment options owing to its rare occurrence.
MATERIALS AND METHODS
A total of 228 patients received GD therapy for advanced soft tissue sarcoma from 2009 to 2014 in Korea. We retrospectively reviewed the clinical medical records and claims data of these patients.
RESULTS
A total of 218 patients in 20 medical centers were included in the final analysis (median age, 50.0 years). The objective response rate was 15.1% (34/218, in the leiomyosarcoma subgroup; 26.3%). The median overall survival and progression-free survival were 10.3 months (95% confidence interval [CI], 8.4 to 12.2) and 3.3 months (95% CI, 2.8 to 4.7), respectively. The treatment was discontinued in 7.8% of patients owing to adverse events; however, there was no adverse event-related death. Neutropenia (35.7%) and anemia (15.1%) were the most frequent grade 3/4 toxicities. Univariate analysis for identifying the predictors of the progression-free survival period revealed that patients aged ≤ 50 years had a hazard ratio of 1.388 (95% CI, 1.027 to 1.875; p < 0.05) relative to those aged > 50 years, and the group with leiomyosarcoma had a hazard ratio of 0.693 (95% CI, 0.493 to 0.975; p < 0.05) relative to the group with other histopathological subtypes.
CONCLUSION
GD therapy was tolerable and effective for Korean patients with soft tissue sarcoma. In conclusion, for patients with advanced soft tissue sarcoma, especially leiomyosarcoma, GD therapy could be an important therapeutic option.

Keyword

Advanced soft tissue sarcoma; Gemcitabine; Docetaxel; Off-label use; Retrospective study

MeSH Terms

Anemia
Disease-Free Survival
Humans
Korea
Leiomyosarcoma
Medical Records
Neutropenia
Off-Label Use
Retrospective Studies*
Sarcoma*
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