Hannah Kalvin, MSPH
Research Biostatistician
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Andrea Cercek, MD
Attending
MEMORIAL SLOAN KETTERING CANCER CENTER
New York, New York, United States
Louise C. Connell, MB BCh BAO
Attending
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Lily V. Saadat, MD
Assistant Attending Surgeon
MEMORIAL SLOAN KETTERING CANCER CENTER
New York, New York, United States
Vinod Balachandran, MD
Assistant Attending Surgeon
MEMORIAL SLOAN KETTERING CANCER CENTER
New York, New York, United States
Jeffrey A. Drebin, MD, PhD
Chair of Surgery
MEMORIAL SLOAN KETTERING CANCER CENTER
New York, New York, United States
T. Peter Kingham, MD
Professor
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Alice C. Wei, MD (she/her/hers)
Attending Surgeon
MEMORIAL SLOAN KETTERING CANCER CENTER
New York, New York, United States
Kevin C. Soares, MD
Assistant Attending Surgeon
MEMORIAL SLOAN KETTERING CANCER CENTER
New York, New York, United States
William R. Jarnagin, MD
Chief of Hepatopancreatobiliary Surgery
MEMORIAL SLOAN KETTERING CANCER CENTER
New York, New York, United States
Mithat Gonen, PhD
Chief of Epidemiology and Biostatistics
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Nancy E. Kemeny, MD
Attending
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Michael I. D’Angelica, MD
Enid A. Haupt Endowed Chair in Surgery, Professor
Hepatopancreatobiliary Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, United States
Remo Alessandris, MD
Research Fellow
Memorial Sloan Kettering Cancer Center
New York, New York, United States
A total of 156 patients were treated on trial and randomized to receive adjuvant HAI with floxuridine plus systemic fluorouracil (n=74) or systemic fluorouracil alone (n=82). The median follow-up was 26 years (95% CI: 19-29) for the entire cohort. The cumulative incidence of hepatic recurrence at 5 and 10 years was 27% (95% CI: 17–38) and 30% (95% CI: 20–41) in the HAI group, versus 52% (95% CI: 40–62) and 53% (95% CI: 41–64) in the systemic group (p=0.002). The cumulative incidence of recurrence (any site) at 5 and 10 years was 58% (95% CI: 46–68) and 62% (95% CI: 50–72) in the HAI group, versus 63% (95% CI: 52–73) and 70% (95% CI: 58–78) in the systemic group (p=0.2). Median OS was 5.7 years (95% CI: 4.4-12) in the HAI group and 4.9 years (95% CI: 3.5-7.1) in the systemic therapy. The cumulative incidence of disease-specific death at 5, 10, and 15 years was 39% (95% CI: 28–50), 55% (95% CI: 43–66), and 55% (95% CI: 43–66) in the HAI group, versus 50% (95% CI: 39–60), 63% (95% CI: 52–73), and 66% (95% CI: 55–76) in the systemic group (p=0.14).
Conclusions: Adjuvant HAI in combination with systemic chemotherapy offer long-term durable hepatic disease control after resection of CRLM. Although differences in disease-specific death were not statistically significant, this was an underpowered study for long-term survival outcomes; nevertheless, the effect size and direction of the association support a potential oncologic benefit and justify renewed investigation of HAI in contemporary randomized trials.