Phase II trial of tamoxifen and goserelin in recurrent epithelial ovarian cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/76839
Title:
Phase II trial of tamoxifen and goserelin in recurrent epithelial ovarian cancer.
Authors:
Hasan, Jurjees; Ton, Nhuan C; Mullamitha, Saifee A; Clamp, Andrew R; McNeilly, A; Marshall, E; Jayson, Gordon C ( 0000-0002-8515-8944 )
Abstract:
Endocrine therapy is a recognised option in the treatment of chemo-resistant ovarian cancer. We conducted a nonrandomised phase II evaluation of combination endocrine therapy with tamoxifen and goserelin in patients with advanced ovarian cancer that had recurred following chemotherapy. In total, 26 patients entered the study, of which 17 had platinum-resistant disease. The median age was 63 years and enrolled patients had received a median of three chemotherapy regimens prior to trial entry. Patients were given oral tamoxifen 20 mg twice daily on a continuous basis and subcutaneous goserelin 3.6 mg once a month until disease progression. Using the definition of endocrine response that included patients with stable disease (SD) of 6 months or greater, the overall response rate (clinical benefit rate) was 50%. This included one complete response (CR) (3.8%), two partial responses (PR) (7.7%) and 10 patients with SD (38.5%). The median progression-free interval (PFI) was 4 months (95% CI 2.4-9.6) while the median overall survival (OS) was 13.6 months (95% CI 5.5-30.6). Four patients received treatment for more than 2 years (range 1-31) and one of them is still on treatment. In none of the four patients was there any evidence of recurrent or cumulative treatment related toxicity. Treatment-limiting toxicity was not seen in any of the study population. Endocrine data demonstrated a marked suppression of luteinising hormone (LH) and follicle-stimulating hormone (FSH) to less than 4% of baseline values. No consistent correlation could be established between LH/FSH suppression and tumour response. Likewise no relationship was observed between Inhibin A/B and pro-alpha C levels and tumour response. Inhibin is unlikely to be a useful surrogate marker for response in locally advanced or metastatic ovarian cancer. Combination endocrine therapy with tamoxifen and goserelin is an active regimen in platinum-resistant ovarian cancer patients. Hormonal therapy is advantageous in its relative lack of toxicity, ease of administration and tolerability, thus making it suitable for patients with heavily pretreated disease, compromised bone marrow function and other comorbid conditions that contraindicate cytotoxic therapy as well as in patients with indolent disease.
Affiliation:
Cancer Research UK, Department Medical Oncology, Christie Hospital, Wilmslow Road, Withington, Manchester M20 4BX, UK. jurjees.hasan@christie-tr.nwest.nhs.uk
Citation:
Phase II trial of tamoxifen and goserelin in recurrent epithelial ovarian cancer. 2005, 93 (6):647-51 Br. J. Cancer
Journal:
British Journal of Cancer
Issue Date:
19-Sep-2005
URI:
http://hdl.handle.net/10541/76839
DOI:
10.1038/sj.bjc.6602752
PubMed ID:
16222310
Type:
Article
Language:
en
ISSN:
0007-0920
Appears in Collections:
All Christie Publications ; All Paterson Institute for Cancer Research

Full metadata record

DC FieldValue Language
dc.contributor.authorHasan, Jurjees-
dc.contributor.authorTon, Nhuan C-
dc.contributor.authorMullamitha, Saifee A-
dc.contributor.authorClamp, Andrew R-
dc.contributor.authorMcNeilly, A-
dc.contributor.authorMarshall, E-
dc.contributor.authorJayson, Gordon C-
dc.date.accessioned2009-08-10T17:23:45Z-
dc.date.available2009-08-10T17:23:45Z-
dc.date.issued2005-09-19-
dc.identifier.citationPhase II trial of tamoxifen and goserelin in recurrent epithelial ovarian cancer. 2005, 93 (6):647-51 Br. J. Canceren
dc.identifier.issn0007-0920-
dc.identifier.pmid16222310-
dc.identifier.doi10.1038/sj.bjc.6602752-
dc.identifier.urihttp://hdl.handle.net/10541/76839-
dc.description.abstractEndocrine therapy is a recognised option in the treatment of chemo-resistant ovarian cancer. We conducted a nonrandomised phase II evaluation of combination endocrine therapy with tamoxifen and goserelin in patients with advanced ovarian cancer that had recurred following chemotherapy. In total, 26 patients entered the study, of which 17 had platinum-resistant disease. The median age was 63 years and enrolled patients had received a median of three chemotherapy regimens prior to trial entry. Patients were given oral tamoxifen 20 mg twice daily on a continuous basis and subcutaneous goserelin 3.6 mg once a month until disease progression. Using the definition of endocrine response that included patients with stable disease (SD) of 6 months or greater, the overall response rate (clinical benefit rate) was 50%. This included one complete response (CR) (3.8%), two partial responses (PR) (7.7%) and 10 patients with SD (38.5%). The median progression-free interval (PFI) was 4 months (95% CI 2.4-9.6) while the median overall survival (OS) was 13.6 months (95% CI 5.5-30.6). Four patients received treatment for more than 2 years (range 1-31) and one of them is still on treatment. In none of the four patients was there any evidence of recurrent or cumulative treatment related toxicity. Treatment-limiting toxicity was not seen in any of the study population. Endocrine data demonstrated a marked suppression of luteinising hormone (LH) and follicle-stimulating hormone (FSH) to less than 4% of baseline values. No consistent correlation could be established between LH/FSH suppression and tumour response. Likewise no relationship was observed between Inhibin A/B and pro-alpha C levels and tumour response. Inhibin is unlikely to be a useful surrogate marker for response in locally advanced or metastatic ovarian cancer. Combination endocrine therapy with tamoxifen and goserelin is an active regimen in platinum-resistant ovarian cancer patients. Hormonal therapy is advantageous in its relative lack of toxicity, ease of administration and tolerability, thus making it suitable for patients with heavily pretreated disease, compromised bone marrow function and other comorbid conditions that contraindicate cytotoxic therapy as well as in patients with indolent disease.en
dc.language.isoenen
dc.subjectCancer Recurrenceen
dc.subjectOvarian Canceren
dc.subjectGlandular and Epithelial Canceren
dc.subject.meshAged-
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols-
dc.subject.meshCystadenocarcinoma, Serous-
dc.subject.meshDisease-Free Survival-
dc.subject.meshDrug Resistance, Neoplasm-
dc.subject.meshFemale-
dc.subject.meshGoserelin-
dc.subject.meshHumans-
dc.subject.meshMaximum Tolerated Dose-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasm Recurrence, Local-
dc.subject.meshNeoplasms, Glandular and Epithelial-
dc.subject.meshOvarian Neoplasms-
dc.subject.meshSalvage Therapy-
dc.subject.meshSurvival Rate-
dc.subject.meshTamoxifen-
dc.titlePhase II trial of tamoxifen and goserelin in recurrent epithelial ovarian cancer.en
dc.typeArticleen
dc.contributor.departmentCancer Research UK, Department Medical Oncology, Christie Hospital, Wilmslow Road, Withington, Manchester M20 4BX, UK. jurjees.hasan@christie-tr.nwest.nhs.uken
dc.identifier.journalBritish Journal of Canceren

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