Phase II Trial of 5-Fluorouracil, Docetaxel, and Nedaplatin (UDON) Combination Therapy for Recurrent or Metastatic Esophageal Cancer.
Journal
The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837
Informations de publication
Date de publication:
02 2019
02 2019
Historique:
received:
13
08
2018
accepted:
24
09
2018
pubmed:
27
10
2018
medline:
21
3
2020
entrez:
27
10
2018
Statut:
ppublish
Résumé
The 5-fluorouracil, docetaxel, and nedaplatin (UDON) regimen was well tolerated and showed promising antitumor activity in terms of both objective response rate and survival for patients with advanced or recurrent esophageal squamous cell carcinoma in the first-line setting.UDON may be an optimal treatment option for patients with advanced esophageal cancer who are unfit for docetaxel, cisplatin, and 5-fluorouracil regimens.The high response rate as well as the rapid and marked tumor shrinkage associated with UDON suggest that further evaluation of this regimen in the neoadjuvant setting is warranted. 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. Patients received intravenous nedaplatin (90 mg/m 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%). This phase II study demonstrated promising antitumor activity and good tolerability of UDON.
Sections du résumé
LESSONS LEARNED
The 5-fluorouracil, docetaxel, and nedaplatin (UDON) regimen was well tolerated and showed promising antitumor activity in terms of both objective response rate and survival for patients with advanced or recurrent esophageal squamous cell carcinoma in the first-line setting.UDON may be an optimal treatment option for patients with advanced esophageal cancer who are unfit for docetaxel, cisplatin, and 5-fluorouracil regimens.The high response rate as well as the rapid and marked tumor shrinkage associated with UDON suggest that further evaluation of this regimen in the neoadjuvant setting is warranted.
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/m
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.
Identifiants
pubmed: 30361422
pii: theoncologist.2018-0653
doi: 10.1634/theoncologist.2018-0653
pmc: PMC6369940
doi:
Substances chimiques
Antineoplastic Agents
0
Organoplatinum Compounds
0
Docetaxel
15H5577CQD
nedaplatin
8UQ3W6JXAN
Fluorouracil
U3P01618RT
Banques de données
UMIN-CTR
['UMIN000017685']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
163-e76Informations de copyright
© AlphaMed Press; the data published online to support this summary are the property of the authors.
Références
Cancer Chemother Pharmacol. 1989;23(4):243-6
pubmed: 2647312
Oncotarget. 2017 May 17;8(46):80286-80294
pubmed: 29113302
Anticancer Res. 1989 Jul-Aug;9(4):1083-8
pubmed: 2817790
Jpn J Clin Oncol. 1992 Jun;22(3):172-6
pubmed: 1518165
Cancer. 2010 Mar 15;116(6):1446-53
pubmed: 20108336
Cancer Chemother Pharmacol. 1992;31(3):187-92
pubmed: 1334448
J Clin Oncol. 2006 May 10;24(14):2137-50
pubmed: 16682732
Anticancer Res. 2011 Feb;31(2):633-8
pubmed: 21378349
Jpn J Cancer Res. 1990 Feb;81(2):196-200
pubmed: 2110134
Br J Cancer. 2010 Feb 2;102(3):475-81
pubmed: 20068567
Cancer Control. 1999 Jan;6(1):64-72
pubmed: 10758536
Anticancer Res. 2012 Apr;32(4):1403-8
pubmed: 22493377
Cancer Chemother Pharmacol. 2015 Aug;76(2):279-85
pubmed: 26050210
Cancer Sci. 2014 Sep;105(9):1189-95
pubmed: 25041052
Ann Gastroenterol Surg. 2018 May 28;2(4):253-265
pubmed: 30003188
Cancer Chemother Pharmacol. 1990;26(6):393-6
pubmed: 2171794
Dig Dis Sci. 1998 Oct;43(10):2255-60
pubmed: 9790462
J Thorac Oncol. 2010 Jan;5(1):122-8
pubmed: 19898259
Arq Gastroenterol. 2010 Oct-Dec;47(4):348-53
pubmed: 21225144
Oncology. 2011;80(5-6):307-13
pubmed: 21778771
Dis Esophagus. 2017 Feb 1;30(2):1-7
pubmed: 26725778
JAMA. 1999 May 5;281(17):1623-7
pubmed: 10235156
Lancet Oncol. 2018 Apr;19(4):461-473
pubmed: 29501366