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Planned Safety Analysis of the ACTS-CC 02 Trial: A Randomized Phase III Trial of S-1 With Oxaliplatin Versus Tegafur and Uracil With Leucovorin as Adjuvant Chemotherapy for High-Risk Stage III Colon Cancer.
- Source :
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Clinical colorectal cancer [Clin Colorectal Cancer] 2018 Jun; Vol. 17 (2), pp. e153-e161. Date of Electronic Publication: 2017 Nov 01. - Publication Year :
- 2018
-
Abstract
- Background: This trial was designed to verify the superiority of 6 months of postoperative adjuvant chemotherapy with SOX (S-1 with oxaliplatin) with UFT (tegafur and uracil) with LV (leucovorin) in terms of disease-free survival in patients with high-risk stage III colon cancer. We report the results of a planned safety analysis.<br />Patients and Methods: Patients who underwent curative resection for high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries) were randomly assigned to receive either UFT/LV (300-600 mg/d UFT with 75 mg/d LV on days 1-28, every 35 days, for 5 cycles) or SOX (100 mg/m <superscript>2</superscript> of oxaliplatin on day 1 with 80-120 mg/d S-1 on days 1-14, every 21 days, for 8 cycles). Treatment status and safety were evaluated.<br />Results: A total of 966 patients were enrolled, and 932 patients were included in safety analyses. The planned 6-month protocol treatment was received by 76.9% of the patients in the UFT/LV group and 65.8% of those in the SOX group. The overall incidence of any Grade adverse events (AEs) were 91.3% in the UFT/LV group and 98.7% in the SOX group, and those of Grade ≥ 3 AEs were 16.1% and 36.1%, respectively. As for Grade ≥ 3 AEs, leukopenia, neutropenia, thrombocytopenia, and sensory neuropathy were more common in the SOX group. The incidence of Grade ≥ 3 sensory peripheral neuropathy was 4.6% in the SOX group.<br />Conclusion: The completion rate of adjuvant SOX and its incidence of AEs were acceptable in patients with colon cancer.<br /> (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Colorectal Neoplasms mortality
Disease-Free Survival
Drug Combinations
Female
Humans
Leucovorin administration & dosage
Leucovorin adverse effects
Male
Middle Aged
Neoplasm Staging
Oxaliplatin administration & dosage
Oxaliplatin adverse effects
Oxonic Acid administration & dosage
Oxonic Acid adverse effects
Tegafur administration & dosage
Tegafur adverse effects
Uracil administration & dosage
Uracil adverse effects
Antineoplastic Combined Chemotherapy Protocols adverse effects
Chemotherapy, Adjuvant adverse effects
Chemotherapy, Adjuvant methods
Colorectal Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1938-0674
- Volume :
- 17
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Clinical colorectal cancer
- Publication Type :
- Academic Journal
- Accession number :
- 29249584
- Full Text :
- https://doi.org/10.1016/j.clcc.2017.10.015