Clinical, serologic, and immunologic effects of human leukocyte interferon in HBsAg-positive primary hepatocellular carcinoma

Nair, Prem V.; Tong, Myron J.; Kempf, Raymond A.; Co, Ruth L.; Lee, Shou‐Dong; Venturi, Cheryl L.

doi:10.1002/1097-0142(19850901)56:5<1018::aid-cncr2820560507>3.0.co;2-v

Cited by 23 publications

(10 citation statements)

References 25 publications

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“…(If we include the three patients switched over from doxorubicin to rIFN, then 24.5% of patients had tumour regression, with 11.3% having over 50% regression.) The lack of regression in the two studies published using IFN in HCC may be due to the smaller size of patient samples and/or the lower dosages used in both studies (Nair et al, 1985;Sachs et al, 1985).…”

Section: Patient Survivalsupporting

confidence: 77%

“…rIFN is reported to be of use in vitro (Dunk et al, 1986), but was of no use in two uncontrolled trials in human HCC (Nair et al, 1985;Sach et al, 1985). It is therefore essential to compare its effect with a standard agent for the treatment of HCC.…”

Section: Discussionmentioning

confidence: 99%

“…The large doses of rIFN chosen in both regimes in this trial were justified by the in vitro finding that decrease in 3H-thymidine uptake by PLC/PRF/5 cells was dose-dependent (Dunk et al, 1986). This is further confirmed by the ineffectiveness of the two previous trials in human HCC using lower dosages of IFN (Nair et al, 1985;Sacs et al, 1985). Determination of the optimal dosage of rIFN for inducing tumour regression in human HCC will require a study on a much larger scale than the present trial.…”

Section: Patient Survivalmentioning

confidence: 99%

“…Doxorubicin (adriamycin) is the only therapeutic agent generally accepted to be of some use in its treatment (Olweny et al, 1980;Chlebowski et al, 1984). Unfortunately, in the only prospective randomised trial of doxorubicin versus no antitumour therapy in HCC, it was shown that though doxorubicin prolonged the median survival of 3 weeks, it was associated with fatal toxicity in 25% of patients (Lai et al, 1988).…”

mentioning

confidence: 99%

“…This study also showed slowing in tumour growth in athymic mice treated with IFN. For human HCC, two studies had been published using M2 IFN, one with five patients (four Asians) (Nair et al, 1985) and one with 16 South Africans (Sachs et al, 1985). No regression was reported.…”

mentioning

confidence: 99%

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Recombinant α2 interferon is superior to doxorubicin for inoperable hepatocellular carcinoma: a prospective randomised trial

Lai

Wu²,

Lok³

et al. 1989

Br J Cancer

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Summary In a prospective trial of 75 Chinese patients with histologically proven inoperable hepatocellular carcinoma (HCC), 25 patients were randomised to receive doxorubicin 60-75 mg m2 intravenously once every 3 weeks, 25 to receive recombinant M2 interferon (rIFN) (Roferon) 9-18 x 106 IU m-2 intramuscularly (i.m.) daily and 25 to receive rIFN 25-50 x 106 IU m-2 i.m. three times weekly. Patients were switched to the other drug if: (a) there was progressive disease after 12 weeks, (b) unacceptable toxicity developed and (c) they had received a total of 500 mg m2 of doxorubicin. Six patients had switching over of therapy, three on doxorubicin and three on rIFN. In the remaining 69 patients on single drug therapy, the median survival rate of patients on doxorubicin and rIFN was 4.8 and 8.3 weeks respectively (P = ns.). rIFN induced tumour regression of 25-50% in 12% of patients and of over 50% in 10% of patients. When compared with doxorubicin, rIFN was associated with more tumour regression (P = 0.00199) and less progressive tumours (P= 0.00017). It caused less prolonged and less severe marrow suppression (P= 0.01217), and had significantly less fatal complications than doxorubicin (P = 0.01383). Doxorubicin caused fatal complications due to cardiotoxicity and neutropenia in 25% of patients. rIFN was associated with fatal complications due to dementia and renal failure in 3.8% of patients. In the treatment of inoperable HCC, rIFN is superior to doxorubicin in causing more tumour regression, less serious marrow suppression and less fatal complications.

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Section: Patient Survivalsupporting

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Section: Patient Survivalmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Recombinant α2 interferon is superior to doxorubicin for inoperable hepatocellular carcinoma: a prospective randomised trial

Lai

Wu²,

Lok³

et al. 1989

Br J Cancer

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A phase II study of mitoxantrone combined with beta-interferon in unresectable hepatocellular carcinoma

Colleoni

Buzzoni

Bajetta

et al. 1993

Cancer

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Background. Chemoimmunotherapy is being evaluated in the most common gastrointestinal tumors, but little data are available on hepatocellular carcinoma (HCC). Considering the encouraging objective response rates and the absence of important side effects obtained with mitoxantrone in HCC, we tested the activity and feasibility of a schedule combining beta‐interferon (β‐IFN) and mitoxantrone. Methods. Forty patients (ECOG Performance Status 0‐1) with unresectable HCC received mitoxantrone (12 mg/m2 intravenously every 3 weeks) plus β‐IFN (3 × 106 U on days 1, 2, and 3; 6 × 106 U from day 4 to day 60; and then 6 × 106 U three times a week for 10 months). Results. Thirty‐eight patients were evaluable for response and toxicity with a median of four administered cycles (range, 2–10 cycles). Nine patients achieved a partial response (23%) (95% confidence interval, 11–40%) with a median duration of response of 4 months. In 15 cases, the disease was stable for at least 2 months; 14 patients had disease progression. The median survival time of the group as a whole was 8 months. Patients who were alpha‐fetoprotein positive had a median survival time of 7 months; those who were alpha‐fetoprotein negative had a median survival time of 9 months. The most common side effects were hematologic (World Health Organization Grade 3, 15 patients; Grade 4, 3 patients). Mild or moderate flulike syndrome was present in 50% of treated patients, whereas 10 patients experienced mild or moderate nausea. Conclusions. The schedule was active on advanced tumors with high alpha‐fetoprotein values, and side effects were manageable. However, the addition of β‐IFN did not seem to improve significantly the response rate in HCC.

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Combined intraarterial 5‐fluorouracil and subcutaneous interferon‐α therapy for advanced hepatocellular carcinoma with tumor thrombi in the major portal branches

Sakon

Nagano

Dono

et al. 2002

Cancer

205

218

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BACKGROUNDThe prognosis of hepatocellular carcinoma (HCC) invading into the major branches of the portal vein (Vp3) is extremely poor.METHODSEleven consecutive patients with HCC and Vp3 were treated with 2–6 cycles of a “basic” combination therapy consisting of continuous arterial infusion of 5‐fluorouracil (450–500 mg/day, for the initial 2 weeks) and subcutaneous injection of interferon‐α (5 million international units, 3 times/week, 4 weeks). In the first 3 patients, methotrexate (90 mg/day 1 of every week), cisplatin (10 mg/day), and leucovorin (30 mg/days 2 and 3 of every week) also were administered for the initial 2 weeks (“full” regimen).RESULTSIn 8 (73%) of 11 patients, an objective response (complete response [CR] or partial response [PR]) was observed with marked regression of tumor and decrease in tumor markers. The use of the full regimen was associated with objective response in all patients; instead, they developed thrombocytopenia or leukopenia. In the subsequent 8 patients with basic regimen, 5 patients showed CR (2 cases) or PR (3 cases; objective response rate, 63%), and leukopenia was observed only in 1 patient.CONCLUSIONSSimple combination therapy with subcutaneous interferon‐α and intraarterial 5‐fluorouracil therefore is a promising treatment modality for intractable HCC with Vp3. Cancer 2002;94:435–42. © 2002 American Cancer Society.

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Clinical, serologic, and immunologic effects of human leukocyte interferon in HBsAg-positive primary hepatocellular carcinoma

Cited by 23 publications

References 25 publications

Recombinant α2 interferon is superior to doxorubicin for inoperable hepatocellular carcinoma: a prospective randomised trial

Recombinant α2 interferon is superior to doxorubicin for inoperable hepatocellular carcinoma: a prospective randomised trial

A phase II study of mitoxantrone combined with beta-interferon in unresectable hepatocellular carcinoma

Combined intraarterial 5‐fluorouracil and subcutaneous interferon‐α therapy for advanced hepatocellular carcinoma with tumor thrombi in the major portal branches

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