Tumori
Gastrointestinali Dott. Domenico Corsi
UOC Oncologia
Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
Practice changing in gi cancer in 2017
• Stage III colon cancer 3 vs 6 (IDEA)
• A new regimen in Gastric and
Gastroesofageal Cancer (FLOT)
A missed opportunity
• Despite its large size and prospective design, IDEA provides no direct evidence on the efficacy of CAPOX compared with that of FOLFOX.
Patients could have been randomized to CAPOX vs.
FOLFOX in addition to being randomized to 3 vs. 6 mos.
• No analysis of IDEA is ideal !
• the “ITT” analysis is biased in favor of non-inferiority
• “per protocol” analyses are also biased because of patient exclusion
Patients could have been randomized between stopping vs. continuing (vs. reducing) treatment at 3 months.
3 yr DFS Comparison by risk group and Regimen
3 yr DFS Comparison by risk group and Regimen
3 yr DFS Comparison by risk group and Regimen
3 yr DFS Comparison by risk group and Regimen
Pts’ attitude : FIGHTERS vs FATALISTS
Considering the toxicities and inconveniencies suffered, what % of cure rate would you be willing to sacrifice for a shorter
treatment duration (3 mo) ? N= 45
Potential reduction in cure rate % responders Definition of attitude
1-2% 30% fighter
2-4% 30% fatalist
>4 % 30% fatalist
Sobrero , ESMO WGICC Barcelona 2017. Europacolon.
Clinical decision making in stage III colon cancer
1. FATALIST : always 3 months of CAPOX,
even high risk
2. FIGHTERS:
low risk (T1-3 N1 ): always 3 months of CAPOX high risk N2: usually 3 months CAPOX high risk T4: always 6 months CAPOX (Discuss toxicity and low
cost effettiveness)
For pts treated with FOLFOX (unfit for CAPOX/
medical choice) 6 months treatment added extra benefit in terms of DFS
low risk (T1-3 N1 ): 3 months of CAPOX high risk N2: 3 months CAPOX
high risk T4: 6 months CAPOX
Are there unasweered questions
• Is 3 months CapOx non inferior to 6 months FOLFOX?
– But I don’t think any funder will support this trial.
• How do borderline fit patients fare in the trials?
- Pts with eGFR 50-80 ml/min? increased capecitabine toxicity?
- Older patients with high risk disease?
• How does MSI status affect the outcome?
• How can we identify stage 3 patients who need NO adjuvant chemotherapy?
• How can we improve on oxaliplatin based adjuvant chemotherapy?
• Is there more effective therapy for T4 disease?
30 m 18 m
50 m 35 m
