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
206P - Population-based validation of the risk stratification among prostate cancer patients
Presenter: Mu Xie
Session: Poster display session
Resources:
Abstract
211P - Adjuvant axitinib in Asian vs non-Asian patients with metastatic renal cell carcinoma (mRCC): ATLAS trial subgroup analysis
Presenter: Chi Fai Ng
Session: Poster display session
Resources:
Abstract
212P - Immunotherapy with nivolumab in metastatic renal cell carcinoma patients in India: Bringing a change in clinical practice
Presenter: Amit Rauthan
Session: Poster display session
Resources:
Abstract
213P - An observational retrospective real-world study of sarcomatoid renal cell carcinoma (sRCC) patients in an Asian cancer centre
Presenter: Ravindran Kanesvaran
Session: Poster display session
Resources:
Abstract
214P - Targeting epithelial-mesenchymal transition (EMT), novel strategy to delay resistance or re-sensitize renal cancer to Sunitinib
Presenter: Revati Sharma
Session: Poster display session
Resources:
Abstract
215P - Radiologic and pathologic tumour size variation in localized renal cell carcinoma and its implications
Presenter: Shanky Singh
Session: Poster display session
Resources:
Abstract
216P - Partial versus radical nephrectomy: 10- year long-term survival among patients with Wilms tumour
Presenter: Mira Mostafa
Session: Poster display session
Resources:
Abstract
217P - Neutrophil-to-lymphocyte ratio is a useful biomarker for predicting worse clinical outcome in chemo-resistant urothelial carcinoma patients treated with pembrolizumab
Presenter: Koichiro Ogihara
Session: Poster display session
Resources:
Abstract
219P - Long-term outcomes of bladder preservation in muscle-invasive bladder cancer patients
Presenter: Amanda Dania Satiti
Session: Poster display session
Resources:
Abstract
220P - An outcome analysis of robotassisted radical nephroureterectomy with extended template lymphadenectomy for upper tract urothelial carcinoma
Presenter: Ashwin Tamhankar
Session: Poster display session
Resources:
Abstract