Abstract 94P
Background
FOLFOX and CAPOX are standard adjuvant chemotherapy for resected stage III colon cancer. MOSAIC and XELOXA trials were performed outside of Japan, thus, we conducted a phase II study (NORTH/HGCSG1003) to assess the efficacy and safety of FOLFOX as adjuvant chemotherapy for Japanese patients(pts) with resected stage III colon cancer (UMIN ID: 000004590).
Methods
This phase II study enrolled patients with resected stage III colon cancer. Patients received 12 cycles of FOLFOX4 or mFOLFOX6. Sample size was determined to be 243 pts. Primary endpoint was disease-free survival (DFS). We assumed an expected 3-year DFS rate of 81.2% in this study. Secondary endpoints included overall survival (OS) and safety. In this meeting, we present for the 5-year OS rate.
Results
From Sep 2010 to Mar 2013, 273 pts were enrolled at 28 institutions. Full analysis included 265 patients who received FOLFOX. Patients characteristics were as follows: median age; 65(33-84), Male/female; 131/134, PS 0/1; 258/7, stage IIIA/IIIB/IIIC; 37/197/31, colon/rectosigmoid: 214/51. The most common grade 3-4 adverse events were neutrophil count decreased (48.1%), peripheral sensory neuropathy (6.4%), platelet count decreased (2.3%), and allergic reaction (1.5%). The median number of cycles of FOLFOX was 12, and the completion treatment rate was 80.4%. There was no treatment-related death. The 3-year/5-year DFS rate was 76.0%(95%C.I. 70.3- 80.7)/70.6%(95%C.I. 64.7-75.7). The 3-year/5-year 0S rate was 95.8%(95%C.I. 92.5- 97.7)/88.1%(95%C.I. 83.5-91.5).
Conclusions
In Japanese patients with resected stage III colon cancer, FOLFOX is a well-tolerable regimen as adjuvant chemotherapy. In this trial, the 3-year DFS rate of primary endpoint was not meet the expectation. However, the 3-year DFS and 5-year OS rate in this trial were similar to several pivotal trials.
Clinical trial identification
UMIN ID: 000004590.
Editorial acknowledgement
Legal entity responsible for the study
Non-Political Organization: Hokkaido Gastrointestinal Cancer Study Group.
Funding
Non-Political Organization: Hokkaido Gastrointestinal Cancer Study Group.
Disclosure
S. Yuki: Honoraria (self): Yakult Honsha Co. Ltd. All other authors have declared no conflicts of interest.
Resources from the same session
465P - A phase IIIb open-label study of afatinib in EGFR TKI-naïve patients (pts) with EGFR mutation-positive (EGFRm+) NSCLC: Exploratory biomarker analysis
Presenter: Jie Wang
Session: Poster display session
Resources:
Abstract
470P - Prognostic significance of serum biomarkers in small cell lung cancer: A meta-analysis and systematic review
Presenter: Rogelio Velasco
Session: Poster display session
Resources:
Abstract
471P - Chemotherapy in advanced thymic malignancies
Presenter: Ankur Varshney
Session: Poster display session
Resources:
Abstract
466P - Cancer immunotherapy efficacy and patients’ age: A systematic review and meta-analysis
Presenter: Yu Jiang
Session: Poster display session
Resources:
Abstract
506P - Efficacy and safety of pegvorhyaluronidase alfa (PEGPH20; PVHA) and pembrolizumab (pembro) combination therapy in patients (Pts) with stage III/IV non-small cell lung cancer (NSCLC)
Presenter: Jeffrey Ward
Session: Poster display session
Resources:
Abstract
480P - Safety and efficacy of dacomitinib for EGFR+ NSCLC in the subgroup of Asian patients from ARCHER 1050
Presenter: Tony S.K. Mok
Session: Poster display session
Resources:
Abstract
503P - Activity of afatinib in patients (pts) with NSCLC harboring uncommon EGFR mutations: Pooled analysis of three large phase IIIB trials
Presenter: Antonio Passaro
Session: Poster display session
Resources:
Abstract
488P - Randomized trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer (PEARL trial)
Presenter: Kei Kusaka
Session: Poster display session
Resources:
Abstract
495P - Tracking of activating EGFR mutations predicts progression-free survival in advanced EGFR-mutated NSCLC patients treated with osimertinib
Presenter: Anna Buder
Session: Poster display session
Resources:
Abstract
520P - A phase II study to evaluate abscopal effect by palliative radiation therapy in nivolumab treatment for pretreated non-small cell lung cancer (HANSHIN 0116)
Presenter: Akito Hata
Session: Poster display session
Resources:
Abstract