Abstract
Abstract Background In Japan, pre-operative5-FU and cisplatin (CDDP) (FP) combination therapy has been the standard neoadjuvant chemotherapy (NAC) for advanced resectable esophageal cancer (EC), whereas the efficacy of docetaxel (DTX)-containing triplet regimen, FP plus DTX has been reported (Yamasaki M, et al, Ann Oncol 2017). However, for frail patients, such as patients with old age, chronic renal failure, poor performance status, severe commodities or malnutrition, high dose CDDP is not generally recommended in terms of toxicity. We have been developing non-CDDP-containing triplet regimen, 5-FU, DTX, and nedaplatin (NED) (UDON) on a phase I/II trial basis. This retrospective study aimed to investigate the safety and efficacy of NAC with UDON combination for advanced EC. Methods Eleven patients with advanced resectable EC who were unsuitable for the administration of high dose CDDP were enrolled in this study. Patients received two cycles of NAC with UDON (5-FU, 640 or 800 mg/m2, day1–5, DTX, 28 or 35 mg/m2, day1 and 15 and NED, 72 or 90 mg/m2, day1, q28) followed by esophagectomy. Primary endpoint was response rate and secondary endpoint was adverse event (AE). Results The median age was 73 years (range: 58–80) with eight patients being aged 70 or older. ECOG PS was 1/2: 7/4. The main location of the tumor was Ce/Ut/Mt/Lt/Ae: 1/1/7/1/1 and cStage was IIA/IIB/IIIA/IIIB/IIIC/IV: 2/2/4/0/2/1. The RR (CR + PR) was 82% (CR/PR/SD/PD: 1/8/2/0). The pathological response was grade 0/1a/1b/2/3: 2/3/3/2/1. Major grade 3 or 4 adverse events included neutropenia (27%), febrile neutropenia (27%), diarrhea (18%), enteritis (9%) and hyponatremia (27%). The postoperative morbidity included recurrent nerve palsy (36%), aspiration (27%), pneumonia (18%), anastomotic leakage (9%) and delirium (36%). There was no treatment-related death and no reoperation. Conclusion NAC with UDON for advanced resectable EC unsuitable for the administration of high dose CDDP might be feasible and effective. We are planning a phase II clinical study based on the present results. Disclosure All authors have declared no conflicts of interest.
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