210P - Survival outcomes after toxicity-related dose modification of 5-fluorouracil, leucovorin and oxalipatin (FOLFOX) in stage III, resected colorectal...

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Anticancer Agents
Colon and Rectal Cancer
Rectal Cancer
Presenter Francis Ha
Citation Annals of Oncology (2016) 27 (suppl_9): ix53-ix67. 10.1093/annonc/mdw581
Authors F.J. Ha, G. Aksakal, G. Chong
  • Department Of Medical Oncology, Olivia Newton-John Cancer Research Institute, Austin Hospital, 3084 - Melbourne/AU



FOLFOX is a standard adjuvant chemotherapy regimen in resected stage III colorectal cancer (CRC). Despite established efficacy, toxicity is common and patients often require dose reduction or cessation. The effect of such dose modifications on long-term disease-free survival (DFS) and overall survival (OS) is not known.


We retrospectively assessed outcomes in all patients with stage III, node-positive, resected CRC diagnosed between January 2005-December 2009 and who received FOLFOX6 adjuvant chemotherapy at a major tertiary hospital. Baseline characteristics, treatment details, toxicity and outcome data were collected from hospital records. Outcome measures included OS, DFS and toxicity. The study was approved by the local institutional review board.


41 eligible patients were identified. Median age was 57 years (IQR 52-67), 49% were female and most patients were ECOG functional status 0-1. Seventy percent completed the intended 12 cycles of FOLFOX. After a median follow-up of 6.3 years (IQR 4.9-7.9), five-year DFS and OS were 73% (95% CI [56-84%]) and 83% (95% CI [65-92%]), respectively. Any-grade toxicities were as follows: gastrointestinal upset, 70%; nausea/vomiting, 66%; mucositis, 68%; peripheral neuropathy, 98%; and dyspnoea, 24%. No cases of febrile neutropenia were reported. Subsequent to toxicity, 73% had dose reduction or cessation of oxalipatin (median no. of cycles before cessation, 10) and 34% had dose cessation of bolus 5-FU (median no. of cycles before cessation, 5). No significant difference in 5-year DFS or OS was found between patients with usual dosing regimen and those with early reduction/cessation of oxalipatin, bolus 5-FU or both.


FOLFOX-associated toxicity is very common in stage III CRC patients, in particular peripheral neuropathy. Despite many patients undergoing subsequent dose limitations, no significant difference in long-term DFS or OS is apparent. Certain dose modifications in FOLFOX, including early cessation of bolus 5-FU and reduction of oxalipatin, reduces the risk of worsening toxicity without compromising long-term efficacy.

Clinical trial indentification

Legal entity responsible for the study

Olivia Newton-John Cancer Research Institute




All authors have declared no conflicts of interest.