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
314P - An EGF motif of Del1 inhibits efficient angiogenesis and suppresses tumour growth in vivo
Presenter: Hisataka Kitano
Session: Poster display session
Resources:
Abstract
315P - Inhibition of JAK1 sensitizes human head and neck cancer cells to cetuximab
Presenter: James Bonner
Session: Poster display session
Resources:
Abstract
316TiP - Neoadjuvant and adjuvant pembrolizumab (pembro) plus standard of care (SOC) in patients (pts) with resectable locally advanced (LA) head and neck squamous cell carcinoma (HNSCC): The phase III KEYNOTE-689 study
Presenter: Ezra Cohen
Session: Poster display session
Resources:
Abstract
322P - Three-year overall survival update from the PACIFIC trial
Presenter: Yi-Long Wu
Session: Poster display session
Resources:
Abstract
323P - Novel tumour mutation score versus tumour mutation burden in predicting survival after immunotherapy in pan-cancer from MSK-IMPACT cohort
Presenter: Yuan Li
Session: Poster display session
Resources:
Abstract
324P - A novel anti-PD-1 antibody HLX10 study led to the initiation of combination immunotherapy
Presenter: Tsu Yi Chao
Session: Poster display session
Resources:
Abstract
325P - Association between immune-related adverse events and efficacy of immune checkpoint inhibitors in patients with advanced hepatocellular carcinoma
Presenter: Lawrence Wong
Session: Poster display session
Resources:
Abstract
326P - Autologous V gamma 9 V delta 2 T cell therapy to target Epstein Barr Virus (EBV)-related malignancies
Presenter: Esdy Rozali
Session: Poster display session
Resources:
Abstract
327P - Neoantigen profile of hepatocellular carcinoma reveals its correlation with tumour progression and clonal evolution
Presenter: Xiaolong Liu
Session: Poster display session
Resources:
Abstract
328P - A retrospective analysis of patients with non-small cell lung cancer who developed drug-induced lung disorder by immune checkpoint inhibitors
Presenter: Fumiko Hayashi
Session: Poster display session
Resources:
Abstract