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
329P - High-level expression of HDAC10 is associated with PD-L1 expression and poor prognosis in patients with non-small cell lung cancer receiving pulmonectomy
Presenter: Xiaomei Liu
Session: Poster display session
Resources:
Abstract
331P - A retrospective analysis of immune checkpoint therapy in patients with non-small cell lung cancer: Focus on thyroid disorder
Presenter: Sawana Ono
Session: Poster display session
Resources:
Abstract
332P - Analyse the association between adverse events (AEs) and survival in patients treated with immune checkpoint inhibitors (ICIs)
Presenter: Chi-yuan Cheng
Session: Poster display session
Resources:
Abstract
333P - Study of searching on efficacy of immune checkpoint inhibitor for the non-small cell lung cancer using FDG-PET/CT and thallium SPECT
Presenter: KAYOKO Kibata
Session: Poster display session
Resources:
Abstract
334P - Incidence and characteristic of adrenal insufficiency due to immune checkpoint inhibitors therapy
Presenter: Daisuke Etoh
Session: Poster display session
Resources:
Abstract
335P - PD-L1 profile of nasopharyngeal cancer patients in Indonesia
Presenter: Handoko Handoko
Session: Poster display session
Resources:
Abstract
336P - Pembrolizumab plus chemotherapy versus pembrolizumab monotherapy for PD-L1-positive advanced non-small cell lung cancer in the real world
Presenter: Jun Sugisaka
Session: Poster display session
Resources:
Abstract
337P - Neutrophil-to-Lymphocyte ratio as a predictive factor for hyperprogressive disease in NSCLC patients treated with immune checkpoint inhibitor
Presenter: Ryo Takahashi
Session: Poster display session
Resources:
Abstract
338P - A new insight into tumour immune-evasion: Crosstalk between cancer stem cells and T regulatory cells
Presenter: Abhishek Dutta
Session: Poster display session
Resources:
Abstract
339TiP - PACIFIC-5: Phase III study of durvalumab after either concurrent or sequential chemoradiotherapy (CRT) in patients with stage III NSCLC
Presenter: Yi-Long Wu
Session: Poster display session
Resources:
Abstract