Twenty-Year Benefit From Adjuvant Goserelin and Tamoxifen in Premenopausal Patients With Breast Cancer in a Controlled Randomized Clinical Trial.

Johansson A, Dar H, van 't Veer LJ, Tobin NP, Perez-Tenorio G, Nordenskjöld A, Johansson U, Hartman J, Skoog L, Yau C, Benz CC, Esserman LJ and 4 more

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Stål O, Nordenskjöld B, Fornander T, Lindström LS

Journal of clinical oncology : official journal of the American Society of Clinical Oncology21 Jul 2022Cited by 30 (Europe PMC)

PMID35862873PMCIDPMC9746735DOI10.1200/jco.21.02844PepBankPUB-35862873

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Summary

PurposeTo assess the long-term (20-year) endocrine therapy benefit in premenopausal patients with breast cancer.MethodsSecondary analysis of the Stockholm trial (STO-5, 1990-1997) randomly assigning 924 premenopausal patients to 2 years of goserelin (3.6 mg subcutaneously once every 28 days), tamoxifen (40 mg orally once daily), combined goserelin and tamoxifen, or no adjuvant endocrine therapy (control) is performed. Random assignment was stratified by lymph node status; lymph node-positive patients (n = 459) were allocated to standard chemotherapy (cyclophosphamide, methotrexate, and fluorouracil). Primary tumor immunohistochemistry (n = 731) and gene expression profiling (n = 586) were conducted in 2020. The 70-gene signature identified genomic low-risk and high-risk patients. Kaplan-Meier analysis, multivariable Cox proportional hazard regression, and multivariable time-varying flexible parametric modeling assessed the long-term distant recurrence-free interval (DRFI). Swedish high-quality registries allowed a complete follow-up of 20 years.ResultsIn estrogen receptor-positive patients (n = 584, median age 47 years), goserelin, tamoxifen, and the combination significantly improved long-term distant recurrence-free interval compared with control (multivariable hazard ratio [HR], 0.49; 95% CI, 0.32 to 0.75, HR, 0.57; 95% CI, 0.38 to 0.87, and HR, 0.63; 95% CI, 0.42 to 0.94, respectively). Significant goserelin-tamoxifen interaction was observed (P = .016). Genomic low-risk patients (n = 305) significantly benefitted from tamoxifen (HR, 0.24; 95% CI, 0.10 to 0.60), and genomic high-risk patients (n = 158) from goserelin (HR, 0.24; 95% CI, 0.10 to 0.54). Increased risk from the addition of tamoxifen to goserelin was seen in genomic high-risk patients (HR, 3.36; 95% CI, 1.39 to 8.07). Moreover, long-lasting 20-year tamoxifen benefit was seen in genomic low-risk patients, whereas genomic high-risk patients had early goserelin benefit.ConclusionThis study shows 20-year benefit from 2 years of adjuvant endocrine therapy in estrogen receptor-positive premenopausal patients and suggests differential treatment benefit on the basis of tumor genomic characteristics. Combined goserelin and tamoxifen therapy showed no benefit over single treatment. Long-term follow-up to assess treatment benefit is critical.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanRandomized controlled trialEfficacy outcome
In estrogen receptor-positive premenopausal breast cancer, goserelin improved long-term distant recurrence-free interval versus control, with hazard ratio 0.49.
In plain wordsIn premenopausal breast cancer, goserelin improved the interval without distant recurrence compared with no endocrine therapy.
Peptide
Goserelin
Outcome
IncreaseLong-term distant recurrence-free interval
Study
n: not reported in source
Comparator
No adjuvant endocrine therapy
Outcome group
Tumor growth · Cancer
Studied dose
3.6 mg once every 28 days · subcutaneous · 2 yearsAs given in this study (human).
Measurements
Hazard ratio
0.49
95% CI 0.32-0.75; goserelin versus control
Source sentences
Summary
In estrogen receptor-positive patients (n = 584, median age 47 years), goserelin, tamoxifen, and the combination significantly improved long-term distant recurrence-free interval compared with control (multivariable hazard ratio [HR], 0.49; 95% CI, 0.32 to 0.75, HR, 0.57; 95% CI, 0.38 to 0.87, and HR, 0.63; 95% CI, 0.42 to 0.94, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
Secondary analysis of the Stockholm trial (STO-5, 1990-1997) randomly assigning 924 premenopausal patients to 2 years of goserelin (3.6 mg subcutaneously once every 28 days), tamoxifen (40 mg orally once daily), combined goserelin and tamoxifen, or no adjuvant endocrine therapy (control) is performed.
Show in the study text Report a problemFND-3586287301
02HumanRandomized controlled trialEfficacy outcome
In genomic high-risk premenopausal breast cancer, goserelin improved distant recurrence-free interval versus control, with hazard ratio 0.24.
In plain wordsIn genomic high-risk premenopausal breast cancer, goserelin improved the interval without distant recurrence compared with no endocrine therapy.
Peptide
Goserelin
Outcome
IncreaseGenomic high-risk distant recurrence-free interval
Study
n: not reported in source
Comparator
No adjuvant endocrine therapy
Outcome group
Tumor growth · Cancer
Studied dose
3.6 mg once every 28 days · subcutaneous · 2 yearsAs given in this study (human).
Measurements
Hazard ratio
0.24
95% CI 0.10-0.54; genomic high-risk goserelin versus control
Source sentences
Summary
Genomic low-risk patients (n = 305) significantly benefitted from tamoxifen (HR, 0.24; 95% CI, 0.10 to 0.60), and genomic high-risk patients (n = 158) from goserelin (HR, 0.24; 95% CI, 0.10 to 0.54).
1 context sentence(design, population, supporting numbers)
Summary · context
Secondary analysis of the Stockholm trial (STO-5, 1990-1997) randomly assigning 924 premenopausal patients to 2 years of goserelin (3.6 mg subcutaneously once every 28 days), tamoxifen (40 mg orally once daily), combined goserelin and tamoxifen, or no adjuvant endocrine therapy (control) is performed.
Show in the study text Report a problemFND-3586287302
03HumanRandomized controlled trialEfficacy outcome
In genomic high-risk premenopausal breast cancer, goserelin showed early benefit compared with control.
In plain wordsIn genomic high-risk premenopausal breast cancer, goserelin showed early benefit compared with no endocrine therapy.
Peptide
Goserelin
Outcome
IncreaseTiming of genomic high-risk benefit
Study
n: not reported in source
Comparator
No adjuvant endocrine therapy
Outcome group
Tumor growth · Cancer
Studied dose
3.6 mg once every 28 days · subcutaneous · 2 yearsAs given in this study (human).
Source sentences
Summary
Moreover, long-lasting 20-year tamoxifen benefit was seen in genomic low-risk patients, whereas genomic high-risk patients had early goserelin benefit.
2 context sentences(design, population, supporting numbers)
Summary · context
Genomic low-risk patients (n = 305) significantly benefitted from tamoxifen (HR, 0.24; 95% CI, 0.10 to 0.60), and genomic high-risk patients (n = 158) from goserelin (HR, 0.24; 95% CI, 0.10 to 0.54).
Summary · context
Secondary analysis of the Stockholm trial (STO-5, 1990-1997) randomly assigning 924 premenopausal patients to 2 years of goserelin (3.6 mg subcutaneously once every 28 days), tamoxifen (40 mg orally once daily), combined goserelin and tamoxifen, or no adjuvant endocrine therapy (control) is performed.
Show in the study text Report a problemFND-3586287303

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Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

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