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Clinical Trial
. 2021 Aug 20;27(4):219-224.
doi: 10.5761/atcs.oa.20-00294. Epub 2021 Jan 6.

Randomized Phase II Study to Comparing Docetaxel/Nedaplatin versus Docetaxel for 5-Fluorouracil/Cisplatin Resistant Esophageal Squamous Cell Carcinoma

Satoshi Yajima  1 , Takashi Suzuki  1 , Tatsuki Nanami  1 , Yoko Oshima  1 , Yoshinori Kikuchi  2 , Kimihiko Funahashi  1 , Hideaki Shimada  1   3
Affiliations
Clinical Trial

Randomized Phase II Study to Comparing Docetaxel/Nedaplatin versus Docetaxel for 5-Fluorouracil/Cisplatin Resistant Esophageal Squamous Cell Carcinoma

Satoshi Yajima et al. Ann Thorac Cardiovasc Surg. .

Abstract

Purpose: To compare efficacy and safety of dual docetaxel/nedaplatin treatment versus docetaxel alone as second-line chemotherapy for advanced esophageal cancer.

Methods: In all, 36 patients with metastatic and/or recurrent esophagus squamous cell carcinoma resistant to first-line chemotherapy (fluorouracil/cisplatin) were recruited from 2011 to 2018 and randomized into two groups. Treatment response and survival were compared between the docetaxel/nedaplatin (60/80 mg/m2/day) group and docetaxel (70 mg/m2/day) group. Treatment was repeated every 3 weeks until tumor progression. Patients were followed up until March 2019 or death.

Results: The frequency of Grade 3 or higher adverse events in the docetaxel/nedaplatin group (58.8%) was higher compared with the docetaxel group (26.3%) (P = 0.090). We found a treatment response rate of 52.9% and 36.8% and a median survival of 8.9 and 7.0 months in the docetaxel/nedaplatin-treated and docetaxel-treated group, respectively (P = 0.544).

Conclusion: No significant survival advantage was found for docetaxel/nedaplatin-treated patients, although there was an increased frequency of high-grade adverse events compared to docetaxel-treated patients. Because of the limited cohort size, a Phase III study based on our findings is not warranted to assess the clinical impact of docetaxel/nedaplatin treatment. This trial is registered with the University Hospital Medical Information Network (UMIN 000005877).

Keywords: Phase II study; docetaxel; esophageal squamous cell carcinoma; nedaplatin; second-line treatment.

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Figures

Fig. 1
Fig. 1. Design study and cluster randomization of patients with metastatic and/or recurrent esophageal squamous cell carcinoma to two second-line chemotherapy groups, a docetaxel plus nedaplatin group and a docetaxel group.
Fig. 2
Fig. 2. Patient survival after treatment with docetaxel and nedaplatin or docetaxel alone.
See this image and copyright information in PMC

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