Thalidomide for treating metastatic hepatocellular carcinoma: a pilot study.
BACKGROUND
Thalidomide has been reported to have antitumor activity for treating metastatic hepatocellular carcinoma (HCC). We evaluated the safety and efficacy of using thalidomide for treating selected patients with unresectable or metastatic HCC, and their disease was refractory to systemic chemotherapy.


METHODS
Eight patients with measurable and metastatic HCC that had progressed with prior systemic chemotherapy and who desired further active therapy were enrolled in this study. Thalidomide was given orally at bedtime and it was started at 200 mg/day with no further dose escalation. The response was measured at 2-month intervals.


RESULTS
The median age was 44 years (range: 34-52 years) and all the patients had received doxorubicin-based systemic chemotherapy prior to their enrollment. Each patient received thalidomide for a median of 152 days (range: 5-422 days). One partial response was observed (12.5%, 95% CI; 0-42%) along with 4 cases of stable diseases. The most commonly encountered toxicity was somnolence; grade 3 somnolence was noted for one patient, which led to treatment discontinuation. Skin rash was observed in one responding patient.


CONCLUSIONS
The results indicate that thalidomide may feasibly offer disease stabilization to metastatic HCC patients. Further dose escalation of thalidomide, or its combination with other chemotherapeutic agents, may be of interest and this should be investigated for treating patients with metastatic HCC.
Han
Sang Hoon
SH
Department of Internal Medicine, Gachon Medical School Gil Medical Center, Incheon, Korea.
Park
Se Hoon
SH
Kim
Jung Ho
JH
Lee
Jong Jun
JJ
Kwon
So Young
SY
Kwon
Oh Sang
OS
Kim
Sun Suk
SS
Kim
Ju Hyun
JH
Kim
Keon Kug
KK
Park
Yeon Ho
YH
Lee
Jeong Nam
JN
Nam
Eunmi
E
Bang
Soo-Mee
SM
Cho
Eun Kyung
EK
Shin
Dong Bok
DB
Lee
Jae Hoon
JH
D000328:Adult; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012189:Retrospective Studies; D013792:Thalidomide / Q000627:therapeutic use*; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D013792:Thalidomide