Intera Oncology

Clinical Evidence For HAI Therapy for Colorectal Cancer Liver Metastases

HAI Therapy for Unresectable CRLM

Hepatic Arterial Infusion in Combination with Modern Systemic Chemotherapy is Associated with Improved Survival Compared with Modern Systemic Chemotherapy Alone in Patients with Isolated Unresectable Colorectal Liver Metastases: A Case–Control Study (Ann Surg Oncol. – July, 2016)

Mashaal Dhir MD, Heather L. Jones MPA-C, Yongli Shuai MS, Amber K. Clifford MPA-C, Samantha Perkins MPA-C, Jennifer Steve BS, Melissa E. Hogg MD, M. Haroon A. Choudry MD, James F. Pingpank MD, Matthew P. Holtzman MD, Herbert J. Zeh III MD, Nathan Bahary MD, PhD, David L. Bartlett MD & Amer H. Zureikat MD

In a study at University of Pittsburgh Medical Center, patients with unresectable liver metastases who received HAI therapy with the the Intera 3000 HAI Pump with floxuridine and systemic chemotherapy had a median overall survival rate of 32.8 months. Patients treated with systemic chemotherapy alone had a median survival of 15.3 months. Hepatic Artery Infusion as 2nd line doubled survival in unresectable CRLM, whether or not conversion was achieved.

Prospective phase II trial of combination hepatic artery infusion and systemic chemotherapy for unresectable colorectal liver metastases: Long term results and curative potential (J Surg Oncol – November 22, 2017)

Linda M. Pak MD, Nancy E. Kemeny MD, Marinela Capanu PhD, Joanne F. Chou MPH, Taryn Boucher BA, Andrea Cercek MD, Vinod P. Balachandran MD, T. Peter Kingham MD, Peter J. Allen MD, Ronald P. DeMatteo MD, William R. Jarnagin MD, Michael I. D'Angelica MD

For unresectable CRLM patients, Hepatic Artery Infusion resulted in high response rates in chemo-naive and previously treated patients (86% and 67% respectively).
Overall response rate was 73%.
Patients in this study had high disease burden and the majority underwent previous chemotherapy treatment, yet more than half (52%) converted to resection using combination HAI and systemic chemotherapy.
Patients who converted to resection after treatment with combination of HAI and systemic therapy had 5-year OS of 62%, which is comparable to that of patients who are initially resectable, and higher than that of patients treated with systemic chemotherapy alone.

HAI Therapy for Adjuvant Applications in CRLM

Hepatic Arterial Infusion of Chemotherapy after Resection of Hepatic Metastases from Colorectal Cancer (New England Journal of Medicine. - 1999)

Nancy Kemeny, M.D., Ying Huang, Ph.D., Alfred M. Cohen, M.D., Weiji Shi, M.S., John A. Conti, M.D., Murray F. Brennan, M.D., Joseph R. Bertino, M.D., Alan D.M. Turnbull, M.D., Deidre Sullivan, B.A., Jennifer Stockman, B.A., Leslie H. Blumgart, M.D., and Yuman Fong, M.D.

This RCT demonstrated that HAI as an adjuvant therapy after liver resection for CRLM resulted in significantly improved survival and hepatic progression free survival at 2 years.

Perioperative Hepatic Arterial Infusion Pump Chemotherapy Is Associated With Longer Survival After Resection of Colorectal Liver Metastases: A Propensity Score Analysis (J Clin Oncol. – April, 2017)

Bas Groot Koerkamp, Eran Sadot, Nancy E. Kemeny, Mithat Gönen, Julie N. Leal, Peter J. Allen, Andrea Cercek, Ronald P. DeMatteo, T. Peter Kingham, William R. Jarnagin, and Michael I.

Median OS was almost 2 years longer for patients receiving HAI plus systemic chemotherapy after CRLM resection compared to those receiving systemic chemo alone, even though patients in the HAI cohort had advanced disease.
After CRLM resection, median OS was significantly improved for patient treated with HAI + modern systemic chemo vs modern systemic chemo alone (67 vs. 47 months, respectively(p<0.001)).
Adjuvant HAI therapy after CRLM resection improved 10-Year overall survival by 60%.