A Phase II Study of Capecitabine/Oxaliplatin With Concurrent Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Anal Canal.
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Anus Neoplasms
/ pathology
Capecitabine
/ administration & dosage
Carcinoma, Squamous Cell
/ pathology
Chemoradiotherapy
/ mortality
Feasibility Studies
Female
Follow-Up Studies
Humans
Male
Middle Aged
Oxaliplatin
/ administration & dosage
Prognosis
Prospective Studies
Survival Rate
Anal cancer
Combined modality therapy
Objective response
Radiation therapy
Time to treatment failure
Journal
Clinical colorectal cancer
ISSN: 1938-0674
Titre abrégé: Clin Colorectal Cancer
Pays: United States
ID NLM: 101120693
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
25
05
2019
revised:
21
06
2019
accepted:
25
06
2019
pubmed:
28
7
2019
medline:
24
7
2020
entrez:
28
7
2019
Statut:
ppublish
Résumé
Squamous cell carcinoma of the anal canal (SCCA) presents a rising incidence in the United States. Standard of care for locally advanced disease is comprised of infusional 5-fluorouracil with mitomycin C or cisplatin concurrent with radiation therapy (RT). We designed this trial to evaluate the efficacy and safety of a more convenient regimen composed of capecitabine and oxaliplatin. This was a single-arm, phase II trial, with treatment-naive stage II to IIIB (TX,1-4NxM0) SCCA patients. The regimen was composed of capecitabine (825 mg/m Twenty patients were enrolled. Seven patients of group 1 (63%) developed Grade 3 toxicity, which reduced to 22% in Group 2. No Grade 4 toxicities were noted. The median RT dose was 55 Gy. CR occurred in 100% of the 19 patients evaluable for response at 12 to 14 weeks. After a median follow-up of 47.6 months, 2 patients had local recurrence and 1 had distant recurrence. Three-year TTF was 90.0%, with similar rates between groups 1 and 2 (respectively, 90.9% vs. 88.8%, P = .984). Three-year CFS was 90.0%. The median OS has not been reached. The XELOX-XRT regimen is safe, with promising efficacy, and should be explored in larger trials for the treatment of locally advanced SCCA.
Identifiants
pubmed: 31350201
pii: S1533-0028(19)30212-9
doi: 10.1016/j.clcc.2019.06.003
pii:
doi:
Substances chimiques
Oxaliplatin
04ZR38536J
Capecitabine
6804DJ8Z9U
Banques de données
ClinicalTrials.gov
['NCT00093379']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
301-306Informations de copyright
Copyright © 2019. Published by Elsevier Inc.