Downstaging disease in patients with hepatocellular carcinoma outside of Milan criteria: strategies using drug-eluting bead chemoembolization.
OBJECTIVE
To assess downstaging rates in patients with United Network for Organ Sharing stage T3N0M0 hepatocellular carcinoma (HCC) treated with doxorubicin-eluting bead transarterial chemoembolization to meet Milan criteria for transplantation.


METHODS
A single-center retrospective review of 239 patients treated with doxorubicin-eluting bead (DEB) chemoembolization between September 2008 and December 2011 was undertaken. Baseline and follow-up computed tomography or magnetic resonance imaging was assessed for response based on the longest enhancing axial dimension of each tumor (ie, modified Response Evaluation Criteria In Solid Tumors measurements), and medical records were reviewed. Fisher exact tests and exact logistic regression were used to test the association of patient and disease characteristics with downstaging.


RESULTS
After exclusions, 22 patients remained in the analysis, 17 of whom (77%) had their HCC downstaged to meet Milan criteria. Among those whose disease was downstaged, seven underwent transplantation, one remained listed for transplantation, six had disease progression beyond Milan criteria, two underwent conventional transarterial chemoembolization, and one underwent radiofrequency ablation. The seven patients who received transplants were still living, but recurrent HCC developed in two. Baseline age (P = .25), Model for End-stage Liver Disease score (P = .77), and α-fetoprotein (AFP) level (P = 1.00) were similar between patients with and without downstaged HCC. No associations were observed between the odds of downstaging and sex (P = .21), Child-Pugh class (P = .14), Child-Pugh class controlling for baseline tumor multiplicity (P = .15), Eastern Cooperative Oncology Group performance status (P = 1.00), tumor burden (P = .31), multiple tumors (P = .31), or hepatitis C virus infection (P = 1.00). Fifteen patients who did not receive transplants were alive at 1 year, with two progression-free. Baseline AFP levels differed between those who survived 1 year and those who did not (P = .02), but did not differ by progression-free survival status (P = .62).


CONCLUSIONS
T3N0M0 HCC treatment with DEB chemoembolization has a high likelihood (77%) of downstaging the disease to meet Milan criteria.
Department of Radiology, University of Colorado Hospital, Aurora. Electronic address: keepergreen@gmail.com.
Tyler J
TJ
Green
Paul J
PJ
Rochon
Samuel
S
Chang
Charles E
CE
Ray
Helena
H
Winston
Robert
R
Ruef
Sarah M
SM
Kreidler
Deborah H
DH
Glueck
Benjamin C
BC
Shulman
Anthony C
AC
Brown
Janette
J
Durham
D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000000981:diagnostic imaging / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D017115:Catheter Ablation; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D003120:Colorado; D018450:Disease Progression; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000097:blood / Q000000981:diagnostic imaging / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D016031:Liver Transplantation / Q000009:adverse effects / Q000401:mortality; D016015:Logistic Models; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D016017:Odds Ratio; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D000509:alpha-Fetoproteins / Q000378:metabolism
C097353:AFP protein, human; D000903:Antibiotics, Antineoplastic; D000509:alpha-Fetoproteins; D004317:Doxorubicin
AFP; CI; DEB; ECOG; Eastern Cooperative Oncology Group; HCC; UCSF; UNOS; United Network for Organ Sharing; University of California, San Francisco; confidence interval; doxorubicin-eluting bead; hepatocellular carcinoma; mRECIST; modified Response Evaluation Criteria In Solid Tumors; α- fetoprotein