Luteinizing hormone-releasing hormone agonist triptorelin in combination with cytotoxic chemotherapy in patients with advanced ovarian carcinoma: A prospective double blind randomized trial

Günter Emons, Olaf Ortmann, Hanns Martin Teichert, Horst Fassl, Udo Löhrs, Stig Kullander, Antti Kauppila, Daniel Ayalon, Andrew V Schally, Friedhelm Oberheuser

Research output: Contribution to journalArticle

66 Citations (Scopus)

Abstract

BACKGROUND. Several lines of evidence suggest that the proliferation of ovarian carcinoma might be stimulated by gonadotrophins. A number of Phase I/Phase II clinical trials have reported that the suppression of endogenous luteinizing hormone and follicle-stimulating hormone secretion by luteinizing hormone-releasing hormone (LHRH) analogs induced objective remissions and/or disease stabilization in 10-30% of patients with advanced refractory ovarian carcinoma. The current study was performed to evaluate whether the addition of LHRH agonist treatment to standard platinum-based chemotherapy could prolong survival of patients with surgically treated Stage III or IV epithelial ovarian carcinoma. METHODS. One hundred and thirty-five patients with Stage III or IV epithelial ovarian carcinoma participated in this prospective randomized double blind trial. After cytoreductive surgery, 69 patients received monthly injections of a depot preparation of the LHRH agonist [D-Trp6] LHRH (triptorelin, 3.75 mg) and 66 patients received placebo until their deaths or termination of the trial, respectively. All patients were treated with a standard platinum-based chemotherapy, and, if necessary, with second- or third-line cytotoxic regimens. RESULTS. Endogenous gonadotrophins were reliably suppressed in patients treated with triptorelin. However, their progression free and overall survival were not significantly different from that of patients receiving placebo injections (statistical power > 80% for a difference between both groups of ≤20%). CONCLUSIONS. The results of this trial suggest that the suppression of endogenous gonadotrophins by conventional doses of an LHRH agonist produces no relevant beneficial effects in patients with advanced ovarian carcinoma who receive standard surgical cytoreduction and cytotoxic chemotherapy.

Original languageEnglish
Pages (from-to)1452-1460
Number of pages9
JournalCancer
Volume78
Issue number7
DOIs
StatePublished - Oct 1 1996
Externally publishedYes

Fingerprint

Triptorelin Pamoate
Gonadotropin-Releasing Hormone
Carcinoma
Drug Therapy
Gonadotropins
Platinum
Placebos
Delayed-Action Preparations
Phase II Clinical Trials
Injections
Follicle Stimulating Hormone
Luteinizing Hormone
Disease-Free Survival

Keywords

  • cytoreductive surgery
  • cytotoxic chemotherapy
  • luteinizing hormone-releasing hormone agonist
  • ovarian cancer
  • suppression of gonadotrophins

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Luteinizing hormone-releasing hormone agonist triptorelin in combination with cytotoxic chemotherapy in patients with advanced ovarian carcinoma : A prospective double blind randomized trial. / Emons, Günter; Ortmann, Olaf; Teichert, Hanns Martin; Fassl, Horst; Löhrs, Udo; Kullander, Stig; Kauppila, Antti; Ayalon, Daniel; Schally, Andrew V; Oberheuser, Friedhelm.

In: Cancer, Vol. 78, No. 7, 01.10.1996, p. 1452-1460.

Research output: Contribution to journalArticle

Emons, Günter ; Ortmann, Olaf ; Teichert, Hanns Martin ; Fassl, Horst ; Löhrs, Udo ; Kullander, Stig ; Kauppila, Antti ; Ayalon, Daniel ; Schally, Andrew V ; Oberheuser, Friedhelm. / Luteinizing hormone-releasing hormone agonist triptorelin in combination with cytotoxic chemotherapy in patients with advanced ovarian carcinoma : A prospective double blind randomized trial. In: Cancer. 1996 ; Vol. 78, No. 7. pp. 1452-1460.
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abstract = "BACKGROUND. Several lines of evidence suggest that the proliferation of ovarian carcinoma might be stimulated by gonadotrophins. A number of Phase I/Phase II clinical trials have reported that the suppression of endogenous luteinizing hormone and follicle-stimulating hormone secretion by luteinizing hormone-releasing hormone (LHRH) analogs induced objective remissions and/or disease stabilization in 10-30{\%} of patients with advanced refractory ovarian carcinoma. The current study was performed to evaluate whether the addition of LHRH agonist treatment to standard platinum-based chemotherapy could prolong survival of patients with surgically treated Stage III or IV epithelial ovarian carcinoma. METHODS. One hundred and thirty-five patients with Stage III or IV epithelial ovarian carcinoma participated in this prospective randomized double blind trial. After cytoreductive surgery, 69 patients received monthly injections of a depot preparation of the LHRH agonist [D-Trp6] LHRH (triptorelin, 3.75 mg) and 66 patients received placebo until their deaths or termination of the trial, respectively. All patients were treated with a standard platinum-based chemotherapy, and, if necessary, with second- or third-line cytotoxic regimens. RESULTS. Endogenous gonadotrophins were reliably suppressed in patients treated with triptorelin. However, their progression free and overall survival were not significantly different from that of patients receiving placebo injections (statistical power > 80{\%} for a difference between both groups of ≤20{\%}). CONCLUSIONS. The results of this trial suggest that the suppression of endogenous gonadotrophins by conventional doses of an LHRH agonist produces no relevant beneficial effects in patients with advanced ovarian carcinoma who receive standard surgical cytoreduction and cytotoxic chemotherapy.",
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T1 - Luteinizing hormone-releasing hormone agonist triptorelin in combination with cytotoxic chemotherapy in patients with advanced ovarian carcinoma

T2 - A prospective double blind randomized trial

AU - Emons, Günter

AU - Ortmann, Olaf

AU - Teichert, Hanns Martin

AU - Fassl, Horst

AU - Löhrs, Udo

AU - Kullander, Stig

AU - Kauppila, Antti

AU - Ayalon, Daniel

AU - Schally, Andrew V

AU - Oberheuser, Friedhelm

PY - 1996/10/1

Y1 - 1996/10/1

N2 - BACKGROUND. Several lines of evidence suggest that the proliferation of ovarian carcinoma might be stimulated by gonadotrophins. A number of Phase I/Phase II clinical trials have reported that the suppression of endogenous luteinizing hormone and follicle-stimulating hormone secretion by luteinizing hormone-releasing hormone (LHRH) analogs induced objective remissions and/or disease stabilization in 10-30% of patients with advanced refractory ovarian carcinoma. The current study was performed to evaluate whether the addition of LHRH agonist treatment to standard platinum-based chemotherapy could prolong survival of patients with surgically treated Stage III or IV epithelial ovarian carcinoma. METHODS. One hundred and thirty-five patients with Stage III or IV epithelial ovarian carcinoma participated in this prospective randomized double blind trial. After cytoreductive surgery, 69 patients received monthly injections of a depot preparation of the LHRH agonist [D-Trp6] LHRH (triptorelin, 3.75 mg) and 66 patients received placebo until their deaths or termination of the trial, respectively. All patients were treated with a standard platinum-based chemotherapy, and, if necessary, with second- or third-line cytotoxic regimens. RESULTS. Endogenous gonadotrophins were reliably suppressed in patients treated with triptorelin. However, their progression free and overall survival were not significantly different from that of patients receiving placebo injections (statistical power > 80% for a difference between both groups of ≤20%). CONCLUSIONS. The results of this trial suggest that the suppression of endogenous gonadotrophins by conventional doses of an LHRH agonist produces no relevant beneficial effects in patients with advanced ovarian carcinoma who receive standard surgical cytoreduction and cytotoxic chemotherapy.

AB - BACKGROUND. Several lines of evidence suggest that the proliferation of ovarian carcinoma might be stimulated by gonadotrophins. A number of Phase I/Phase II clinical trials have reported that the suppression of endogenous luteinizing hormone and follicle-stimulating hormone secretion by luteinizing hormone-releasing hormone (LHRH) analogs induced objective remissions and/or disease stabilization in 10-30% of patients with advanced refractory ovarian carcinoma. The current study was performed to evaluate whether the addition of LHRH agonist treatment to standard platinum-based chemotherapy could prolong survival of patients with surgically treated Stage III or IV epithelial ovarian carcinoma. METHODS. One hundred and thirty-five patients with Stage III or IV epithelial ovarian carcinoma participated in this prospective randomized double blind trial. After cytoreductive surgery, 69 patients received monthly injections of a depot preparation of the LHRH agonist [D-Trp6] LHRH (triptorelin, 3.75 mg) and 66 patients received placebo until their deaths or termination of the trial, respectively. All patients were treated with a standard platinum-based chemotherapy, and, if necessary, with second- or third-line cytotoxic regimens. RESULTS. Endogenous gonadotrophins were reliably suppressed in patients treated with triptorelin. However, their progression free and overall survival were not significantly different from that of patients receiving placebo injections (statistical power > 80% for a difference between both groups of ≤20%). CONCLUSIONS. The results of this trial suggest that the suppression of endogenous gonadotrophins by conventional doses of an LHRH agonist produces no relevant beneficial effects in patients with advanced ovarian carcinoma who receive standard surgical cytoreduction and cytotoxic chemotherapy.

KW - cytoreductive surgery

KW - cytotoxic chemotherapy

KW - luteinizing hormone-releasing hormone agonist

KW - ovarian cancer

KW - suppression of gonadotrophins

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