Phase II Trial of 5-Fluorouracil, Docetaxel, and Nedaplatin (UDON) Combination Therapy for Recurrent or Metastatic Esophageal Cancer
Mené sur 23 patients atteints d'un cancer de l'œsophage de stade métastatique ou récidivant, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse, de la survie globale et de la survie sans progression, et la toxicité d'un traitement combinant 5-fluorouracile, docétaxel et nédaplatine
Background : A phase II study was performed to evaluate the efficacy and safety of 5‐fluorouracil (5‐FU), docetaxel, and nedaplatin (UDON) combination therapy for untreated recurrent or metastatic esophageal cancer. Methods : Patients received intravenous nedaplatin (90 mg/m2) on day 1, docetaxel (35 mg/m2) on days 1 and 15, and 5‐fluorouracil (800 mg/m2) on days 1–5 of a 4‐week cycle. The primary endpoint was response rate, with secondary endpoints including overall survival (OS), progression-free survival (PFS), dysphagia score, and adverse events. Results : Between March 2015 and July 2017, 23 patients were enrolled. Of 22 evaluable patients, 16 and 4 individuals experienced a partial response and stable disease, respectively, yielding a response rate of 72.7% (95% confidence interval [CI], 49.8%–89.3%) and disease control rate of 90.9% (95% CI, 70.8%–98.9%). Median OS and PFS were 11.2 months (95% CI, 9.1 months to not reached) and 6.0 months (95% CI, 2.5–10.6 months), respectively. Eleven (64.7%) of the 17 patients with a primary lesion showed amelioration of dysphagia after treatment. Frequent adverse events of grade 3 or 4 included neutropenia (87.0%) and leukopenia (39.1%). Febrile neutropenia was observed in two patients (8.7%). Conclusion : This phase II study demonstrated promising antitumor activity and good tolerability of UDON.