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Randomized Controlled Trial
. 2020 Mar 1;21(3):727-732.
doi: 10.31557/APJCP.2020.21.3.727.

The Efficacy and Safety of Modified Docetaxel, Cisplatin, and 5-Fluorouracil Vs. Epirubicin, Oxaliplatin, and Capecitabine Regimen in the Advanced Gastric Cancer: A Randomized Controlled Clinical Trial

Ahmad Ahmadzadeh  1 , Seyed Saeid Seyedian  2 , Armita Valizadeh  3 , Mahin Soleimani  4 , Pedram Nazari  5 , Hossein Hamidi  4
Affiliations
Randomized Controlled Trial

The Efficacy and Safety of Modified Docetaxel, Cisplatin, and 5-Fluorouracil Vs. Epirubicin, Oxaliplatin, and Capecitabine Regimen in the Advanced Gastric Cancer: A Randomized Controlled Clinical Trial

Ahmad Ahmadzadeh et al. Asian Pac J Cancer Prev. .

Abstract

Introduction: One of the major challenges of advanced gastric cancer treatment is the lack of a standard regimen for patients. However, several clinical trials have shown that modified docetaxel, cisplatin, and 5-fluorouracil (m-DCF) and epirubicin, oxaliplatin, and capecitabine (EOX) regimens are superior to other regimens.

Methods: This randomized, single-center clinical trial was performed on 40 patients with advanced gastric cancer. The first group received the m-DCF regimen as follows: docetaxel (40 mg/m2) on the first day; cisplatin (40 mg/m2) on the first and second days; and 5-fluorouracil (400 mg/m2) from the first to fourth day. The second group received the EOX regimen, including epirubicin (50 mg/m2) and oxaliplatin (130 mg/m2) i.v on the first day and capecitabine at a twice-daily dose of 625 mg/m2 p.o for 21 days. Treatment was applied every three weeks for a total of eight cycles in both groups. In each group, the overall and progression-free survival rates and toxicity were assessed.

Results: A total of 40 patients were enrolled in this study (21 samples in the m-DCF group and 19 samples in the EOX group), 62.5% of whom were male. The median survival rate was 14.00 (95% CI: 11.82-16.18) months in the m-DCF group and 15.00 (95% CI: 9.56-20.43) months in the EOX group; however, differences between the groups were not significant. The progression-free survival rate was higher in the EOX group, although there was no significant difference between the two groups. Also, there was no significant difference regarding the side effects (e.g., toxicity) or need for supportive care between the groups.

Conclusion: It seems that both m-DCF and EOX regimens are similar in terms of survival and toxicity and are recommended as first-line treatment for advanced gastric cancer with respect to the patient's status.

Keywords: EOX; Efficacy; Gastric cancer; m-DCF; safety.

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Figures

Figure 1
Figure 1
CONSORT Flow Diagram of Trial
Figure 2
Figure 2
Kaplan–Meier Estimates of Ooverall Survival
Figure 3
Figure 3
Kaplan–Meier Estimates of Progression-free Survival
See this image and copyright information in PMC

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