Trial reportJournal of the National Cancer Institute2022
Long-Term Outcomes With Pharmacological Ovarian Suppression During Chemotherapy in Premenopausal Early Breast Cancer Patients.
Trial report in Journal of the National Cancer Institute, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Interventions for fertility preservation in women with cancer undergoing chemotherapy.The Cochrane database of systematic reviews · 2025Pooled it
- Very young age stratification and development of a multiple-imputation Cox nomogram for disease-free survival in breast cancer women aged ≤40 years.The oncologist · 2026Article
- The roles of RNA-binding proteins in ovarian aging.Journal of assisted reproduction and genetics · 2026Review
- Validation of PREDICT tool v2.2 in patients with early-stage breast cancer enrolled in the GIM and MIG trials.ESMO open · 2026Article
- Fertility preservation practices and gastrointestinal oncologist in Europe: a pan-European study.The oncologist · 2025Article
- Risk Assessment and Fertility Counseling for Hereditary Gynecological Cancer Syndromes.Cancer medicine · 2025Review
- Current Endocrine Therapy in Hormone-Receptor-Positive Breast Cancer: From Tumor Biology to the Rationale for Therapeutic Tunning.Medicina (Kaunas, Lithuania) · 2025Review
- [Impact of concurrent use of goserelin on the efficacy of neoadjuvant chemotherapy in young breast cancer patients].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2025Article
- Clinical practice guideline for female fertility preservation.Frontiers in medicine · 2025Article
- Early breast cancer in youngTherapeutic advances in medical oncology · 2025Review
- Impact of Molecular Profiling on Therapy Management in Breast Cancer.Journal of clinical medicine · 2024Review
- Ovarian Suppression: Early Menopause and Late Effects.Current treatment options in oncology · 2024Review
- Intermediate clinical endpoints in early-stage breast cancer: an analysis of individual patient data from the Gruppo Italiano Mammella and Mammella Intergruppo trials.EClinicalMedicine · 2024Article
- Selection of appropriate biomarkers to monitor effectiveness of ovarian function suppression in pre-menopausal patients with ER+ breast cancer.NPJ breast cancer · 2024Review
- Fertility and Pregnancy-Related Issues in YoungBreast cancer : basic and clinical research · 2024Review
- Pharmacological methods for ovarian function and fertility preservation in women with cancer: A literature review.Oncology research · 2024Review
- Article
- Gonadotropin-Releasing Hormone Agonists during Gonadal Chemotherapy for the Effect on Pregnancy Outcome and Ovarian Function in Premenopausal Patients with Breast Cancer: A Systematic Review and Meta-Analysis.Breast care (Basel, Switzerland) · 2023Article
- The Future of Breast Cancer Research in the Survivorship Field.Oncology and therapy · 2023Review
- Chemotherapy impairs ovarian function through excessive ROS-induced ferroptosis.Cell death & disease · 2023Article
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough use of gonadotropin-releasing hormone agonist (GnRHa) during chemotherapy is an established strategy to protect ovarian function in premenopausal breast cancer patients, no long-term safety data are available, raising some concerns in women with hormone receptor-positive disease. There are controversial data on its fertility preservation potential.
methodsThe Prevention of Menopause Induced by Chemotherapy: a Study in Early Breast Cancer Patients-Gruppo Italiano Mammella 6 (PROMISE-GIM6) trial is a multicenter, randomized, open-label, phase III superiority trial conducted at 16 Italian centers from October 2003 to January 2008. Eligible patients were randomly assigned to (neo)adjuvant chemotherapy alone (control arm) or combined with the GnRHa triptorelin (GnRHa arm). The primary planned endpoint was incidence of chemotherapy-induced premature ovarian insufficiency. Post hoc endpoints were disease-free survival (DFS), overall survival (OS), and post-treatment pregnancies. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated.
resultsOf 281 randomly assigned patients, 80.4% had hormone receptor-positive breast cancer. Median follow-up was 12.4 years (interquartile range = 11.3-13.2 years). No differences in 12-year DFS (65.7% [95% CI = 57.0% to 73.1%] in the GnRHa arm vs 69.2% [95% CI = 60.3% to 76.5%] in the control arm; HR = 1.16, 95% CI = 0.76 to 1.77) or in 12-year OS (81.2% [95% CI = 73.6% to 86.8%] in the GnRHa arm vs 81.3% [95% CI = 73.1% to 87.2%] in the control arm; HR = 1.17, 95% CI = 0.67 to 2.03) were observed. In patients with hormone receptor-positive disease, the hazard ratio was 1.02 (95% CI = 0.63 to 1.63) for DFS and 1.12 (95% CI = 0.59 to 2.11) for OS. In the GnRHa and control arms, 9 and 4 patients had a posttreatment pregnancy, respectively (HR = 2.14, 95% CI = 0.66 to 6.92).
conclusionsFinal analysis of the PROMISE-GIM6 trial provides reassuring results on the safety of GnRHa use during chemotherapy as a strategy to preserve ovarian function in premenopausal patients with early breast cancer, including those with hormone receptor-positive disease.
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