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
238P - Laparoscopic cytoreduction in low disease burden, advanced-stage ovarian cancers: Experience from a tertiary cancer center
Presenter: Vikas Gupta
Session: Poster display session
Resources:
Abstract
239P - Impact of counseling on patient reported sexual adjustment following chemoradiation and brachytherapy for cervical cancer
Presenter: Vibhay Pareek
Session: Poster display session
Resources:
Abstract
240P - Morbidity and mortality of cervical cancer in the Republic of Kazakhstan
Presenter: Almagul Zhabagina
Session: Poster display session
Resources:
Abstract
241P - Impact of genomic alterations and HPV genotypes on clinical outcomes of Japanese patients with locally advanced cervical cancer
Presenter: Ikumi Kuno
Session: Poster display session
Resources:
Abstract
242P - Impact of combined interstitial and intracavitary brachytherapy in locally advanced cervical cancer: A survival and toxicity profile assessment
Presenter: Vibhay Pareek
Session: Poster display session
Resources:
Abstract
243P - Cervical cancer screening in sub-urban area of Banten and factor associated with uptake of screening
Presenter: Prio Wibisono
Session: Poster display session
Resources:
Abstract
245P - Factors influencing adherence to cryotherapy following positive VIA result as cervical cancer prevention in Temanggung, Central Java, Indonesia
Presenter: Herindita Puspitaningtyas
Session: Poster display session
Resources:
Abstract
246P - The main of reasons of advanced stage cervical cancer in Uzbekistan
Presenter: Zakhirova Nargiza
Session: Poster display session
Resources:
Abstract
247P - Role of ADC values in assessing response after chemoradiotherapy in cervix cancer and in identifying residual disease
Presenter: Venkata Pradeep Babu Koyyala
Session: Poster display session
Resources:
Abstract
248P - Retrospective review of metastatic carcinoma of cervix from a tertiary cancer institute of south India
Presenter: Arkoprovo Halder
Session: Poster display session
Resources:
Abstract