Table 1

Randomised studies comparing adjuvant systemic chemotherapy versus surgery alone after curative resection of colorectal cancer liver metastases

Author
(study)
ArmChemo regimenTOTNCountry
(N centres)
ADJ begin from surgeryFollow -upStatistical aim
(randomisation ratio)
Primary outcome
(secondary outcome)
Enrolment
(phase)
Saiura et al 16 Surgery+UFT/LV
Surgery alone
((Tegafur 300 mg/m2/day+leucovorin 75 mg/m2/day) three times per day, D1–28, q5 wks) ×518090
90
Japan
(11)
Within 8 wks6 years15% increase in 3-year RFS (from 30% to 45%) two-sided 95% CI, power 75%, 180 patients needed
(1:1)
3-year RFS
(OS, RFS liver, RFS other organs, toxicity)
Completed
01.2004–12.2010
(phase III)
Langer et al 19
(ENG)
Surgery +
5-FU/FA
Surgery alone
(L-leucovorin 100/m2, 5-FU 370/m2 bolus D1–5/q28) ×612962
67
Canada and Europe
(67)
Within 8 wksNA15% increase in 5-year survival (from 30% to 45%) two-sided 95% CI power 90%, 418 patients needed (1:1)OS
(DFS)
Stopped: slow accrual
2.1994–1.1998
(phase III)
Portier et al 21
(FFCD)
Surgery +
5-FU/FA
Surgery alone
(DL-leucovorin 200/m2, 5-FU 400/m2 bolus D1–5/q28)×617386
87
France, Belgium and Switzerland
(47)
2–5 wks87 months20% increase in 2-year DFS (from 20% to 40%) two-sided, 95% CI power 90%, 200 patients and 134 events needed
(1:1)
DFS at 2 years
(OS, toxicity)
Stopped: slow accrual
12.1991–12.2001
(phase III)
Lopez-Ladron et al 13 Surgery+CT
Surgery alone
Not reported3828
10
Spain
(3)
NA15 monthsNA, study underpowered
(3:1)
OSCompleted
(phase II)
Kanemitsu et al 14
(JCOG0603)
Surgery+mFOLFOX
Surgery alone
(Oxaliplatin 85 mg/m2, +
L-leucovorin 200/m2,+5-FU 400/m2 bolus,+5-FU 2400 mg/m2 CI over 48 hours) q14×12
Still recruitingJapan
(38)
6–10 wksNA12% increase in 5-year DFS (from 25% to 37%), one-sided, 95% CI power 80%, 300 patients, 150 per arm, and 233 events needed
(1:1)
DFS
(OS, toxicity)
Still recruiting
-analyses planned in 2024 (phases II and III)
  • ADJ, adjuvant; DFS, disease-free survival; RFS, relapse-free survival, DL, dextro-levogyre; ENG, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada, Gruppo Italiano di Valutazione Interventi in Oncologia; FFCD, Federation Francophone de Cancerologie Digestive; 5-FU, fluorouracil; JCOG, Japan Clinical Oncology Group; LV, leucovorin; OS, overall survival; TOT, total; UFT, uracil–tegafur