A phase II study of oxaliplatin in combination with doxorubicin as first-line systemic chemotherapy in patients with inoperable hepatocellular carcinoma.
OBJECTIVE
We designed a phase II trial of the combination with oxaliplatin and doxorubicin for patients with unresectable HCC to evaluate the overall response rate (ORR) and the toxicity.


METHODS
Forty patients with inoperable, systemic chemotherapy naive HCC were enrolled. Finally, 32 patients received oxaliplatin (130 mg/m(2)) and doxorubicin (60 mg/m(2)) every 3 weeks.


RESULTS
Eighty-two treatment cycles were administered (median 2 cycles, range 1-6). There was no treatment-related mortality. The ORR was 15.6% (95% CI, 3.3-28.7) with five partial responses. The median overall survival and median overall progression free survival were 31 weeks (95% CI, 22-40 weeks) and 12 weeks (95% CI, 5-19 weeks). Nausea and peripheral neuropathy were most frequent non-hematologic toxicities (nausea, n = 15; peripheral neuropathy, n = 10). The most frequent grade 3-4 hematologic adverse event was neutropenia (14 of 82 cycles) including three cases of febrile neutropenia.


CONCLUSIONS
The combination of oxaliplatin and doxorubicin showed modest activity and a tolerable toxicity profile in advanced HCC patients.
Uhm
Ji Eun
JE
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul, 135-710, South Korea.
Park
Joon Oh
JO
Lee
Jeeyun
J
Park
Young Suk
YS
Park
Se Hoon
SH
Yoo
Byung Chul
BC
Paik
Seung Woon
SW
Koh
Kwang Cheol
KC
Kang
Won Ki
WK
Lim
Ho Yeong
HY
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D004317:Doxorubicin