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A randomized phase II study of weekly docetaxel/cisplatin versus weekly docetaxel/oxaliplatin as first-line therapy for patients with advanced gastric cancer

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Abstract

Background

Docetaxel, in combination with cisplatin or oxaliplatin, has demonstrated efficacy in advanced gastric cancer (AGC). This randomized, non-comparative phase II trial evaluated two weekly docetaxel-based regimens to determine which is the most promising in terms of efficacy and safety as a front-line therapy in AGC.

Methods

Chemotherapy-naïve patients with measurable unresectable and/or metastatic gastric adenocarcinoma were randomly assigned to receive docetaxel (35 mg/m2) weekly on days 1 and 8 of a 21-day cycle plus either cisplatin (60 mg/m2 on day 1) (wDP) or oxaliplatin (120 mg/m2 on day 1) (wDO).

Results

Of the 77 randomly assigned patients, 76 patients (38 per arm) received one of the study treatments. Overall, response rate (ORR) was 37 % for wDP and 41 % for wDO. Median progression-free survival (PFS) was 4.9 and 4.4 months for wDP and wDO, respectively, and median overall survival (OS) was 9.7 and 12.3 months, respectively. Exploratory analyses showed no significant difference between wDP and wDO in terms of ORR (P = 0.707), PFS (P = 0.324), or OS (P = 0.581). The main grade 3 or 4 toxicity in the wDP and wDO groups was neutropenia (47 % in both groups). wDO was less associated with nausea (66 vs. 82 %) and vomiting (39 vs. 63 %), but more associated with peripheral neuropathy (68 vs. 39 %) than wDP. Rates of overall grade 3 or 4 adverse events were similar (wDP 66 vs. wDO 68 %).

Conclusions

wDP and wDO were found to be equally active and tolerable as front-line treatments in AGC.

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Acknowledgments

This study was supported by a grant from Gachon University Gil Hospital. Study drug (oxaliplatin, Eloxatin®) was kindly provided by Sanofi-Aventis.

Conflict of interest

The authors have no vested interest of any kind in the materials or services referred to in this article.

Author information

Authors and Affiliations

  1. Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Hospital, 1198, Guwol-dong, Namdong-gu, Incheon, 405-706, Republic of Korea

    Young Saing Kim, Sun Jin Sym, Inkeun Park, Junshik Hong, Hee Kyung Ahn, Jinny Park, Eun Kyung Cho, Jae Hoon Lee & Dong Bok Shin

  2. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Se Hoon Park

  3. Department of General Surgery, Gachon University Gil Hospital, Incheon, Republic of Korea

    Woon Ki Lee & Min Chung

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  1. Young Saing Kim
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  2. Sun Jin Sym
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  4. Inkeun Park
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Corresponding author

Correspondence to Dong Bok Shin.

Additional information

Y. S. Kim and S. J. Sym have equally contributed to this work.

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Kim, Y.S., Sym, S.J., Park, S.H. et al. A randomized phase II study of weekly docetaxel/cisplatin versus weekly docetaxel/oxaliplatin as first-line therapy for patients with advanced gastric cancer. Cancer Chemother Pharmacol 73, 163–169 (2014). https://doi.org/10.1007/s00280-013-2334-3

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  • DOI: https://doi.org/10.1007/s00280-013-2334-3

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