Evaluation of antiandrogen therapy in unresectable hepatocellular carcinoma : results of a European Organization for Research and Treatment of Cancer multicentric double-blind trial
PURPOSE: The aim of the study was to evaluate the efficacy of antiandrogen therapy on overall survival and response in unresectable hepatocellular carcinoma (HCC).
PATIENTS AND METHODS: A total of 244 patients with unresectable HCC were included in this multicentric double-blind trial. According to a two-by-two factorial design, patients were randomly assigned to receive one of the following treatments: pure antiandrogen plus placebo (A+P group, 60 patients); luteinizing hormone-releasing hormone (LHRH) agonist plus placebo (LHRH+P group, 62 patients); pure antiandrogen plus LHRH agonist (A+LHRH group, 62 patients); or placebo plus placebo (P+P group, 60 patients). Pure antiandrogen consisted of Anandron (Roussel-Uclaf Laboratory, Romainville, France) administered orally (300 mg daily for 1 month, then 150 mg daily). LHRH consisted of goseriline acetate (3.6 mg) or triptoreline (3.75 mg) administered monthly by subcutaneous injection. Treatment was given until death. Response was evaluated every 8 weeks according to World Health Organization (WHO) criteria.
RESULTS: Six patients were considered ineligible. One patient had a complete response (A+P arm) and three had a partial response (two in the LHRH+P arm and one in the A+LHRH arm). An overall log-rank test did not demonstrate any significant difference in survival among the four arms. Taking the factorial design into account, comparison of survival showed no significant difference between Anandron-containing regimens and others, or between LHRH-containing regimens and others. No serious side effects occurred for any regimen.
CONCLUSION: This controlled study shows clearly the lack of efficacy of androgen treatment in unresectable HCC.
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
1998 |
|---|---|
| Erschienen: |
1998 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
|---|---|
| Enthalten in: |
Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 16(1998), 2 vom: 28. Feb., Seite 411-7 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Grimaldi, C [VerfasserIn] |
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| Anmerkungen: |
Date Completed 02.03.1998 Date Revised 01.12.2018 published: Print Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM094122083 |
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| 100 | 1 | |a Grimaldi, C |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluation of antiandrogen therapy in unresectable hepatocellular carcinoma |b results of a European Organization for Research and Treatment of Cancer multicentric double-blind trial |
| 264 | 1 | |c 1998 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
| 338 | |a Band |b nc |2 rdacarrier | ||
| 500 | |a Date Completed 02.03.1998 | ||
| 500 | |a Date Revised 01.12.2018 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: The aim of the study was to evaluate the efficacy of antiandrogen therapy on overall survival and response in unresectable hepatocellular carcinoma (HCC) | ||
| 520 | |a PATIENTS AND METHODS: A total of 244 patients with unresectable HCC were included in this multicentric double-blind trial. According to a two-by-two factorial design, patients were randomly assigned to receive one of the following treatments: pure antiandrogen plus placebo (A+P group, 60 patients); luteinizing hormone-releasing hormone (LHRH) agonist plus placebo (LHRH+P group, 62 patients); pure antiandrogen plus LHRH agonist (A+LHRH group, 62 patients); or placebo plus placebo (P+P group, 60 patients). Pure antiandrogen consisted of Anandron (Roussel-Uclaf Laboratory, Romainville, France) administered orally (300 mg daily for 1 month, then 150 mg daily). LHRH consisted of goseriline acetate (3.6 mg) or triptoreline (3.75 mg) administered monthly by subcutaneous injection. Treatment was given until death. Response was evaluated every 8 weeks according to World Health Organization (WHO) criteria | ||
| 520 | |a RESULTS: Six patients were considered ineligible. One patient had a complete response (A+P arm) and three had a partial response (two in the LHRH+P arm and one in the A+LHRH arm). An overall log-rank test did not demonstrate any significant difference in survival among the four arms. Taking the factorial design into account, comparison of survival showed no significant difference between Anandron-containing regimens and others, or between LHRH-containing regimens and others. No serious side effects occurred for any regimen | ||
| 520 | |a CONCLUSION: This controlled study shows clearly the lack of efficacy of androgen treatment in unresectable HCC | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, U.S. Gov't, P.H.S. | |
| 650 | 7 | |a Androgen Antagonists |2 NLM | |
| 650 | 7 | |a Antineoplastic Agents |2 NLM | |
| 650 | 7 | |a Imidazoles |2 NLM | |
| 650 | 7 | |a Imidazolidines |2 NLM | |
| 650 | 7 | |a Triptorelin Pamoate |2 NLM | |
| 650 | 7 | |a 08AN7WA2G0 |2 NLM | |
| 650 | 7 | |a Goserelin |2 NLM | |
| 650 | 7 | |a 0F65R8P09N |2 NLM | |
| 650 | 7 | |a Gonadotropin-Releasing Hormone |2 NLM | |
| 650 | 7 | |a 33515-09-2 |2 NLM | |
| 650 | 7 | |a nilutamide |2 NLM | |
| 650 | 7 | |a 51G6I8B902 |2 NLM | |
| 700 | 1 | |a Bleiberg, H |e verfasserin |4 aut | |
| 700 | 1 | |a Gay, F |e verfasserin |4 aut | |
| 700 | 1 | |a Messner, M |e verfasserin |4 aut | |
| 700 | 1 | |a Rougier, P |e verfasserin |4 aut | |
| 700 | 1 | |a Kok, T C |e verfasserin |4 aut | |
| 700 | 1 | |a Cirera, L |e verfasserin |4 aut | |
| 700 | 1 | |a Cervantes, A |e verfasserin |4 aut | |
| 700 | 1 | |a De Greve, J |e verfasserin |4 aut | |
| 700 | 1 | |a Paillot, B |e verfasserin |4 aut | |
| 700 | 1 | |a Buset, M |e verfasserin |4 aut | |
| 700 | 1 | |a Nitti, D |e verfasserin |4 aut | |
| 700 | 1 | |a Sahmoud, T |e verfasserin |4 aut | |
| 700 | 1 | |a Duez, N |e verfasserin |4 aut | |
| 700 | 1 | |a Wils, J |e verfasserin |4 aut | |
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