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Dose-dense biweekly docetaxel combined with 5-fluorouracil as first-line treatment in advanced gastric cancer: a phase II trial

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Abstract

This study evaluated the efficacy, safety and impact on quality of life (QoL) of a dose-dense biweekly regimen of docetaxel and 5-fluorouracil in first-line treatment of advanced gastric cancer (AGC). Eligible patients received docetaxel 60 mg/m2 and 5-fluorouracil (400 mg/m2 bolus followed by 2,400 mg/m2 46-h infusion), fortnightly. Prophylactic use of G-CSF was adopted in all patients. The primary end point was response rate (RR). Secondary end points were progression-free survival (PFS), overall survival (OS), toxicity and QoL. Thirty-nine patients with a median age of 55 (28–80) were included. The RR was 51.3 %. Median PFS and OS were 6.7 and 14.0 months, respectively. The most common adverse events (all grades) were anemia (34, 87.2 %), fatigue (29, 74.4 %), neutropenia (26, 66.7 %), nail change (19, 48.7 %) and liver dysfunction (15, 38.5 %). In QoL analysis, improvements were obtained in seven scales, whereas drops were seen in three scales. Common Grade 3/4 toxicities included anemia (28.2 %), liver dysfunction (7.7 %) and fatigue (7.7 %). This novel regimen is a promising option for AGC, showing high RR, improvement on QoL and acceptable toxicity.

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Acknowledgments

This trial is an investigator initiated study. It is supported by National Key Clinical Discipline. The authors are grateful to all the staff in Department of Medical Oncology of the Sixth Affiliated Hospital of Sun Yat-sen University, for their contribution to this study.

Conflict of interest

All the authors declare they have no conflict of interest.

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    Authors and Affiliations

    1. Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, 26 Yuancun Erheng Road, Guangzhou, 510655, China

      Jian Xiao & Yanhong Deng

    2. Department of Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, 26 Yuancun Erheng Road, Guangzhou, 510655, China

      Yonghe Chen, Lei Wang, Donglin Ren, Jianping Wang, Junsheng Peng & Ping Lan

    3. Centre for Quantitative Medicine, Duke-NUS Graduate Medical School, National University of Singapore, 20 College Road Academia, Singapore, 169856, Singapore

      Wenyun Li

    4. Department of Radiology, The Sixth Affiliated Hospital, Sun Yat-sen University, 26 Yuancun Erheng Road, Guangzhou, 510655, China

      Jiaying Gong & Zhiyang Zhou

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    1. Jian Xiao
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    Correspondence to Junsheng Peng or Ping Lan.

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    Jian Xiao, Yonghe Chen, and Wenyun Li have contributed equally to this work.

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    Xiao, J., Chen, Y., Li, W. et al. Dose-dense biweekly docetaxel combined with 5-fluorouracil as first-line treatment in advanced gastric cancer: a phase II trial. Med Oncol 32, 38 (2015). https://doi.org/10.1007/s12032-014-0334-8

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    • DOI: https://doi.org/10.1007/s12032-014-0334-8

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