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.

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.

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/m2 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.

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.

CONCLUSION:

The completion rate of adjuvant SOX and its incidence of AEs were acceptable in patients with colon cancer.

• Authors: Tetsuya Kusumoto, Eiji Sunami, Mitsuyoshi Ota, Kazuhiro Yoshida, Yoshiyuki Sakamoto, Naohiro Tomita, Atsuyuki Maeda, Izumi Mochizuki, Michio Okabe, Katsuyuki Kunieda, Junichiro Yamauchi, Michio Itabashi, Kenjiro Kotake, Keiichi Takahashi, Hideo Baba, Narikazu Boku, Keisuke Aiba, Megumi Ishiguro, Satoshi Morita, Kenichi Sugihara
• Journal: Clinical colorectal cancer (Clin Colorectal Cancer) Vol. 17 Issue 2 Pg. e153-e161 (06 2018) ISSN: 1938-0674 [Electronic] United States
• PMID: 29249584 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Drug Combinations
• Oxaliplatin
• S 1 (combination)
• Tegafur
• Uracil
• Oxonic Acid
• Leucovorin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Chemotherapy, Adjuvant (adverse effects, methods)
• Colorectal Neoplasms (drug therapy, mortality)
• Disease-Free Survival
• Drug Combinations
• Female
• Humans
• Leucovorin (administration & dosage, adverse effects)
• Male
• Middle Aged
• Neoplasm Staging
• Oxaliplatin (administration & dosage, adverse effects)
• Oxonic Acid (administration & dosage, adverse effects)
• Tegafur (administration & dosage, adverse effects)
• Uracil (administration & dosage, adverse effects)