Chemoocclusion vs chemoperfusion for treatment of advanced hepatocellular carcinoma: a randomised trial.
OBJECTIVE
Transarterial chemoembolization (TACE) can be associated with considerable toxicity and treatment-associated mortality. Transient transarterial chemoocclusion (TACO) using degradable starch microspheres (DSM) has been proposed as a potentially safer alternative while maintaining anti-tumour efficiency. In a randomised phase II trial TACO was compared to transarterial chemoperfusion without DSM (TACP).


METHODS
Seventy-four patients with advanced HCC were randomised to two treatment arms: (i) TACO (600-1200 mg DSM) and (ii) TACP. In both arms regional chemotherapy consisted of cisplatin (100 mg/m2) and doxorubicin (60 mg/m2). Both arms were corresponding in terms of age, gender, liver performance state, and tumour-stage. A maximum of six treatment cycles was applied in monthly intervals. Follow-up was performed in terms of tumour response, time to progression, survival and quality of life.


RESULTS
Tumour response rates did not differ significantly between the two treatment arms, however, there was a tendency towards higher response rates in the TACO arm (TACO vs TACP): partial response: 26 vs 9%, stable disease: 41 vs 55%, progressive disease: 33 vs 36%. Time to tumour progression (32 vs 27 weeks), and overall survival (60 vs 69 weeks) were not significantly different. Grade 4 adverse events were rare in both arms and treatment-associated mortality was not observed. In addition, there was no significant difference in terms of quality of life under therapy (EORTC).


CONCLUSIONS
TACO with DSM did not improve response or survival significantly compared to TACP in advanced non-resectable HCC.
Kirchhoff
T D
TD
Department of Diagnostic Radiology, Hannover Medical School, OE 8220, D-30625 Hannover, and Department of Radiology, University Hospital, Bonn, Germany. kirchhoff.timm@mh-hannover.de
Rudolph
K L
KL
Layer
G
G
Chavan
A
A
Greten
T F
TF
Rosenthal
H
H
Kubicka
S
S
Galanski
M
M
Manns
M P
MP
Schild
H
H
Gallkowski
U
U
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D018450:Disease Progression; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D013213:Starch / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome; D047368:Tumor Burden / Q000187:drug effects
C083286:degradable starch microspheres; D004317:Doxorubicin; D013213:Starch; D002945:Cisplatin