5011 ZORO: Prospective randomized multicenter-study to prevent chemotherapy induced ovarian failure with the GnRH-Agonist Goserelin in young hormone insensitive breast cancer patients receiving anthracycline containing (neo-) adjuvant chemotherapy (GBG 37)

Gerber, Bernhard; Minckwitz, Gϋnter von; Stehle, H.; Felderbaum, R.; Maass, Nicolaì; Fischer, Dennis; Sommer, H.; Conrad, Bettina; Mehta, Keyur; Loibl, S.

doi:10.1016/s1359-6349(09)70903-6

Cited by 13 publications

(8 citation statements)

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“…Two women, one in each arm, became pregnant. 23,24 Preliminary data from the OPTION (Ovarian Protection Trial In Estrogen Negative) trial were presented at the 46th Annual Meeting of ASCO. This trial tested the effects of goserelin during chemotherapy in 227 premenopausal patients with breast cancer.…”

Section: Gnrh Agonist Triptorelin For Preservation Of Ovarian Functionmentioning

confidence: 99%

Randomized Trial Using Gonadotropin-Releasing Hormone Agonist Triptorelin for the Preservation of Ovarian Function During (Neo)Adjuvant Chemotherapy for Breast Cancer

Münster

Moore

Ismail‐Khan

et al. 2012

JCO

208

131

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A B S T R A C T PurposeChemotherapy-induced amenorrhea is a serious concern for women undergoing cancer therapy. This prospective randomized trial evaluated the use of gonadotropin-releasing hormone (GnRH) analog triptorelin to preserve ovarian function in women treated with chemotherapy for early-stage breast cancer. Patients and MethodsPremenopausal women age 44 years or younger were randomly assigned to receive either triptorelin or no triptorelin during (neo)adjuvant chemotherapy and were further stratified by age (Ͻ 35, 35 to 39, Ͼ 39 years), estrogen receptor status, and chemotherapy regimen. Objectives included the resumption of menses and serial monitoring of follicle-stimulating hormone (FSH) and inhibin A and B levels. ResultsTargeted for 124 patients with a planned 5-year follow-up, the trial was stopped for futility after 49 patients were enrolled (median age, 39 years; range, 21 to 43 years); 47 patients were treated according to assigned groups with four cycles of adriamycin plus cyclophosphamide alone or followed by four cycles of paclitaxel or six cycles of fluorouracil, epirubicin, and cyclophosphamide. Menstruation resumed in 19 (90%) of 21 patients in the control group and in 23 (88%) of 26 in the triptorelin group (P ϭ .36). Menses returned after a median of 5.8 months (range, 1 to 19 months) after completion of chemotherapy in the triptorelin versus 5.0 months (range, 0 to 28 months) in the control arm (P ϭ .58). Two patients (age 26 and 35 years at random assignment) in the control group had spontaneous pregnancies with term deliveries. FSH and inhibin B levels correlated with menstrual status. ConclusionWhen stratified for age, estrogen receptor status, and treatment regimen, amenorrhea rates on triptorelin were comparable to those seen in the control group.

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Section: Gnrh Agonist Triptorelin For Preservation Of Ovarian Functionmentioning

confidence: 99%

Randomized Trial Using Gonadotropin-Releasing Hormone Agonist Triptorelin for the Preservation of Ovarian Function During (Neo)Adjuvant Chemotherapy for Breast Cancer

Münster

Moore

Ismail‐Khan

et al. 2012

JCO

208

131

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“…Recently, as an ovarian protection strategy during chemotherapy, premenopausal women with early breast carcinoma have received a gonadotropin-releasing hormone (GRH) analogue in addition to adjuvant therapy. A prospective, randomized multicenter study reported that goserelin concurrent with chemotherapy produced no significant difference in menstruation compared with chemotherapy alone [26]. It is unclear whether GRH analogues may preserve ovarian function during chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

Incidence of chemotherapy-induced amenorrhea in premenopausal patients with breast cancer following adjuvant anthracycline and taxane

et al. 2011

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“…Women who received chemotherapy prior to puberty enter the menopause significantlyearlierascomparedtountreatedwomen [9,10]. Whether the administration of a GnRH-a offers sufficient protectionofovarianfunctionremainscontroversial:whereas the ZORO trial in patients with breast cancer [11] and the study of Behringer et al [12] in lymphoma patients did not find ovarian protection, other studies [13][14][15] and the metaanalysis of Clowse et al [16] showed a protective effect. Sonmezer and Oktay [17] and Beck-Fruchter et al [18] summarised the inconsistent current data on GnRH ovarian protection.Asaconsequence,GnRH-ashouldnotbeusedas theonlymethodoffertilitypreservation.…”

Section: Complications and Delay Of Systemic Treatment Caused By Fertmentioning

confidence: 99%

Fertility Preservation in Young Female Lymphoma Patients: Review of Available Options and Initial Experiences with Their Implementation in Clinical Routine

Lawrenz

Fehm²,

Neunhoeffer³

et al. 2011

Onkologie

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Background: High cure rates in women suffering from Hodgkin’s disease or aggressive non-Hodgkin’s lymphoma are often achieved at the cost of impaired ovarian function or infertility. Different strategies can be offered to protect fertility. Early experiences with the implementation of a specialised fertility preservation clinic are analysed with the aim to assess the need for and acceptance of the clinic, as well as the delay of treatment caused by the different approaches. Available options are reviewed. Patients and Methods: Data on underlying malignancy and fertility preservation measures in women of childbearing age treated for aggressive lymphoma and Hodgkin’s disease with curative intent between November 2006 and January 2010 were retrospectively analysed. Results: Among 111 female lymphoma patients, 30 were eligible for counselling. Nineteen accepted the offer. The main reason for declining was completed family planning. Eight further patients were referred from elsewhere. Of the counselled patients, 96% decided to pursue at least 1 protective strategy, 39% chose an invasive procedure (cryopreservation of ovarian tissue or oocyte aspiration following hormonal stimulation). These procedures deferred the start of systemic treatment within the expected range, no undue delays were observed. Conclusions: Female lymphoma patients have a large demand for counselling about measures to protect fertility. In a proper setting, counselling and intervention can be offered without undue delays menacing the chance for cure.

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5011 ZORO: Prospective randomized multicenter-study to prevent chemotherapy induced ovarian failure with the GnRH-Agonist Goserelin in young hormone insensitive breast cancer patients receiving anthracycline containing (neo-) adjuvant chemotherapy (GBG 37)

Cited by 13 publications

References 0 publications

Randomized Trial Using Gonadotropin-Releasing Hormone Agonist Triptorelin for the Preservation of Ovarian Function During (Neo)Adjuvant Chemotherapy for Breast Cancer

Randomized Trial Using Gonadotropin-Releasing Hormone Agonist Triptorelin for the Preservation of Ovarian Function During (Neo)Adjuvant Chemotherapy for Breast Cancer

Incidence of chemotherapy-induced amenorrhea in premenopausal patients with breast cancer following adjuvant anthracycline and taxane

Fertility Preservation in Young Female Lymphoma Patients: Review of Available Options and Initial Experiences with Their Implementation in Clinical Routine

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