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

• Published in: Annals of Thoracic and Cardiovascular Surgery 2021, Vol.27(4), pp.219-224
• Main Authors: Yajima, Satoshi, Suzuki, Takashi, Nanami, Tatsuki, Oshima, Yoko, Kikuchi, Yoshinori, Funahashi, Kimihiko, Shimada, Hideaki
• Format: Article
• Language: English
• Subjects: Cisplatin - pharmacology; docetaxel; Docetaxel - adverse effects; Docetaxel - therapeutic use; Drug Resistance; Drug Therapy, Combination - adverse effects; Esophageal Neoplasms - drug therapy; esophageal squamous cell carcinoma; Esophageal Squamous Cell Carcinoma - drug therapy; Fluorouracil - pharmacology; Humans; nedaplatin; Organoplatinum Compounds - adverse effects; Organoplatinum Compounds - therapeutic use; Original; Phase II study; second-line treatment; Treatment Outcome
• ISSN: 1341-1098; 2186-1005
• DOI: 10.5761/atcs.oa.20-00294

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).