---
title: "Menopausal Hormone Therapy and Primary Liver Cancer Risk: Long-Term WHI Randomized Trial Follow-up"
id: "british-journal-of-cancer-0-menopausal-hormone-therapy-and-primary-liver-cancer-long-term-follow-up-of-the"
canonical_url: "https://medichelpline.com/clinical-feed/british-journal-of-cancer-0-menopausal-hormone-therapy-and-primary-liver-cancer-long-term-follow-up-of-the"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "British Journal of Cancer"
source_url: "https://www.nature.com/articles/s41416-026-03621-9"
published_at: "2026-09-16T12:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Menopausal Hormone Therapy and Primary Liver Cancer Risk: Long-Term WHI Randomized Trial Follow-up
## Provenance & Clinical Metadata
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- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** British Journal of Cancer
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41416-026-03621-9)
- **Published At:** 2026-09-16T12:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The Women’s Health Initiative (WHI) conducted two randomized, double-blind, placebo-controlled trials testing menopausal hormone therapy: conjugated equine estrogen (CEE) alone in women with prior hysterectomy and CEE plus medroxyprogesterone acetate (MPA) in women with a uterus. The present analysis examined long-term incidence and mortality from primary **liver cancer** among randomized participants. - Trial enrollment included 16,608 postmenopausal women with a uterus randomized to **CEE plus MPA** (0.625 mg CEE daily + 2.5 mg MPA daily) versus placebo, and 10,739 women with hysterectomy randomized to **CEE-alone** (0.625 mg daily) versus placebo. Randomization, blinding, and adherence measures followed standardized WHI protocols. - Follow-up extended to December 31, 2023, with nearly 24 years of cumulative observation and centralized adjudication of incident cancers and cause-specific mortality using medical record review and National Death Index queries. Outcomes were analyzed by intention-to-treat using stratified Cox models and log-rank tests. - Across both trials there were 74 incident primary liver cancers over follow-up. For the CEE-alone trial there were 11 cancers in the active arm versus 15 in placebo (HR 0.75; 95% CI, 0.34–1.63). For the CEE plus MPA trial there were 30 cancers in the active arm versus 18 in placebo (HR 1.63; 95% CI, 0.91–2.92). - Liver cancer mortality in the CEE plus MPA trial showed 27 deaths in the active arm versus 22 in placebo (HR 1.18; 95% CI, 0.67–2.07). Overall, neither regimen produced a statistically significant effect on liver cancer incidence or mortality in the entire trial populations. - Subgroup analyses in the CEE plus MPA trial suggested potential heterogeneity: more liver cancers were observed among women randomized at ages 50–59 (10 vs 0 cancers; P-trend 0.01) and among prior oral contraceptive users (HR 4.30; 95% CI, 1.46–12.72; P-interaction 0.01). These subgroup findings are hypothesis-generating and were limited by small event counts. - The CEE plus MPA trial was stopped early in 2002 (after 5.6 years) and the CEE-alone trial in 2004 (after 7.2 years) for reasons unrelated to liver cancer. The present liver cancer analyses were not protocol-specified and event counts were limited, prompting cautious interpretation. - Overall conclusion: no clear influence of menopausal hormone therapy on primary liver cancer incidence or mortality in the full trial cohorts, though a possible increased risk in selected subgroups merits further study. - Trial registration: clinicaltrials.gov Identifier NCT00000611. Additional methodological and analytic details are reported in the WHI publications; some trial-result details beyond the provided report were not included in the source.
## Clinical Analysis & Structured Key Points
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[nature](https://www.nature.com/) 2. [british journal of cancer](https://www.nature.com/bjc) 3. [articles](https://www.nature.com/bjc/articles?type=article) 4. article Menopausal hormone therapy and primary liver cancer: long-term follow-up of the women’s health initiative randomized trials [ Download PDF ](https://www.nature.com/articles/s41416-026-03621-9.pdf) [ Download PDF ](https://www.nature.com/articles/s41416-026-03621-9.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 16 September 2026 Clinical Study # Menopausal hormone therapy and primary liver cancer: long-term follow-up of the women’s health initiative randomized trials * [Margaret S. Pichardo](https://www.nature.com/articles/s41416-026-03621-9#auth-Margaret_S_-Pichardo-Aff1) [ORCID: orcid.org/0000-0002-9132-4400](https://orcid.org/0000-0002-9132-4400)[1](https://www.nature.com/articles/s41416-026-03621-9#Aff1), * [Aaron K. Aragaki](https://www.nature.com/articles/s41416-026-03621-9#auth-Aaron_K_-Aragaki-Aff2) [ORCID: orcid.org/0000-0001-5075-6437](https://orcid.org/0000-0001-5075-6437)[2](https://www.nature.com/articles/s41416-026-03621-9#Aff2), * [JoAnn E. Manson](https://www.nature.com/articles/s41416-026-03621-9#auth-JoAnn_E_-Manson-Aff3)[3](https://www.nature.com/articles/s41416-026-03621-9#Aff3), * [Kathy Pan](https://www.nature.com/articles/s41416-026-03621-9#auth-Kathy-Pan-Aff4) [ORCID: orcid.org/0000-0003-3546-2566](https://orcid.org/0000-0003-3546-2566)[4](https://www.nature.com/articles/s41416-026-03621-9#Aff4), * [Su Yon Jung](https://www.nature.com/articles/s41416-026-03621-9#auth-Su_Yon-Jung-Aff5) [ORCID: orcid.org/0000-0002-0513-1830](https://orcid.org/0000-0002-0513-1830)[5](https://www.nature.com/articles/s41416-026-03621-9#Aff5), * [Thomas E. Rohan](https://www.nature.com/articles/s41416-026-03621-9#auth-Thomas_E_-Rohan-Aff6)[6](https://www.nature.com/articles/s41416-026-03621-9#Aff6), * [Reed Mszar](https://www.nature.com/articles/s41416-026-03621-9#auth-Reed-Mszar-Aff7)[7](https://www.nature.com/articles/s41416-026-03621-9#Aff7) & * … * [Rowan T. Chlebowski](https://www.nature.com/articles/s41416-026-03621-9#auth-Rowan_T_-Chlebowski-Aff8)[8](https://www.nature.com/articles/s41416-026-03621-9#Aff8) Show authors [_British Journal of Cancer_](https://www.nature.com/bjc) (2026) [Cite this article](https://www.nature.com/articles/s41416-026-03621-9#citeas) [ Save article ](https://www.nature.com/articles/s41416-026-03621-9/save-research?_csrf=5sw8yu-A4HnVAvnjsKs-JZbgrVAogd8h) [ View saved research ](https://www.nature.com/saved-research) ## Abstract ### Background: Long-term results on liver cancer incidence and mortality are reported from two Women’s Health Initiative randomized trials evaluating menopausal hormone therapy. ### Methods: 16,608 postmenopausal women with a uterus were randomized to conjugated equine estrogen (CEE) 0.625 mg/d plus medroxyprogesterone acetate (MPA) 2.5 mg/d or placebo and 10,739 women with hysterectomy were randomized to 0.625 mg/d of CEE-alone or placebo. ### Results: After nearly 24 years follow-up and 74 incident liver cancers, neither CEE-alone nor CEE plus MPA influenced liver cancer development (CEE-alone vs placebo (11 vs 15 cancers; hazard ratio [HR] 0.75; 95% CI, 0.34-1.63; CEE plus MPA vs placebo (30 vs 18 cancers; HR 1.63; 95% CI, 0.91-2.92). CEE plus MPA did not significantly influence liver cancer mortality: 27 vs 22 deaths (HR 1.18; 95% CI, 0.67-2.07). In subgroup analyses, CEE plus MPA vs placebo was associated with more liver cancers among women aged 50-59 years (10 vs 0 cancers (P-trend 0.01) and prior oral contraceptive users (HR 4.30, 95% CI, 1.46-12.72; P-interaction 0.01). ### Conclusions: These findings indicate no overall influence of menopausal hormone therapy on liver cancer incidence or mortality although a possible increased risk with CEE plus MPA in select subgroups warrants further investigation. ### Trial Registration clinicaltrials.gov Identifier: NCT00000611 ### Explore related subjects Discover the latest articles and news in related subjects. * [Cancer prevention](https://www.nature.com/subjects/cancer-prevention) * [Hepatocellular carcinoma](https://www.nature.com/subjects/hepatocellular-carcinoma) * [Risk factors](https://www.nature.com/subjects/risk-factors) ## Background There are significant gender differences in the incidence and outcome of liver cancer [[1](https://www.nature.com/articles/s41416-026-03621-9#ref-CR1 "Makarova-Rusher OV, Altekruse SF, McNeel TS, Ulahannan S, Duffy AG, Graubard BI, et al. Population attributable fractions of risk factors for hepatocellular carcinoma in the United States. Cancer. 2016;122:1757–65.")]. Compared with men, the incidence and mortality of liver cancer in women are substantially lower with 14,020 new cases in women versus 28,220 in men in 2025 [[2](https://www.nature.com/articles/s41416-026-03621-9#ref-CR2 "Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA: A Cancer J Clin. 2025;75:10–45.")]. Notably, the gap narrows after menopause, suggesting a role for hormonal or reproductive factors [[3](https://www.nature.com/articles/s41416-026-03621-9#ref-CR3 "Shimizu I, Ito S. Protection of estrogens against the progression of chronic liver disease. Hepatol Res. 2007;37:239–47.")]. For over two decades, alterations in estrogen signaling pathways have been postulated to influence the occurrence and development of hepatocellular carcinoma [[3](https://www.nature.com/articles/s41416-026-03621-9#ref-CR3 "Shimizu I, Ito S. Protection of estrogens against the progression of chronic liver disease. Hepatol Res. 2007;37:239–47."),[4](https://www.nature.com/articles/s41416-026-03621-9#ref-CR4 "Villa E, Grottola A, Colantoni A, De Maria N, Buttafoco P, Ferretti I, et al. Hepatocellular carcinoma: role of estrogen receptors in the liver. Ann NY Acad Sci. 2002;963:37–45."),[5](https://www.nature.com/articles/s41416-026-03621-9#ref-CR5 "Zhong GC, Liu Y, Chen N, Hao FB, Wang K, Cheng JH, et al. Reproductive factors, menopausal hormone therapies and primary liver cancer risk: a systematic review and dose-response meta-analysis of observational studies. Hum Reprod Update. 2016;23:126–38.")]. However, observational study evidence on estrogen exposure and hepatocellular carcinoma risk is inconsistent. In the US Liver Cancer Pooling Project among 799,500 women with 203 hepatocellular carcinomas, bilateral oophorectomy and menopausal hormone therapy were associated with higher liver cancer risk (hazard ratio [HR], 1.35; 95% CI, 1.01–1.81), though the latter attenuated after adjusting for oophorectomy [[6](https://www.nature.com/articles/s41416-026-03621-9#ref-CR6 "McGlynn KA, Sahasrabuddhe VV, Campbell PT, Graubard BI, Chen J, Schwartz LM, et al. Reproductive factors, exogenous hormone use and risk of hepatocellular carcinoma among US women: results from the Liver Cancer Pooling Project. Br J Cancer. 2015;112:1266–72.")]. A meta-analysis of 1795 cases reported higher risk with oophorectomy, but lower risk with menopausal hormone therapy (RR, 0.60; 95% CI, 0.37–0.96) [[5](https://www.nature.com/articles/s41416-026-03621-9#ref-CR5 "Zhong GC, Liu Y, Chen N, Hao FB, Wang K, Cheng JH, et al. Reproductive factors, menopausal hormone therapies and primary liver cancer risk: a systematic review and dose-response meta-analysis of observational studies. Hum Reprod Update. 2016;23:126–38.")]. Thus, the influence of menopausal hormone therapy on liver cancer is uncertain. To our knowledge, no randomized trials have reported on this question, a gap which is addressed here. ## Methods The Women’s Health Initiative (WHI, Clinical Trial# NCT00000611) included two randomized, double-blind, placebo-controlled hormone therapy trials conducted in 40 U.S. clinical centers from 1993 to 1998 to evaluate menopausal hormone therapy. The design and conduct of the trials have been described previously [[7](https://www.nature.com/articles/s41416-026-03621-9#ref-CR7 "Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288:321–33."),[8](https://www.nature.com/articles/s41416-026-03621-9#ref-CR8 "Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women’s Health Initiative randomized controlled trial. JAMA. 2004;291:1701–12."),[9](https://www.nature.com/articles/s41416-026-03621-9#ref-CR9 "Prentice RL, Pettinger M, Anderson GL. Statistical issues arising in the Women’s Health Initiative. Biometrics. 2005;61:899–911. discussion –41.")]. Details of the public’s involvement in the design and conduct of the WHI trial can be found here [[10](https://www.nature.com/articles/s41416-026-03621-9#ref-CR10 "Rossouw JE, Finnegan LP, Harlan WR, Pinn VW, Clifford C, McGowan JA. The evolution of the Women’s Health Initiative: perspectives from the NIH. J Am Med Womens Assoc \(1972\). 1995;50:50–5.")]. For both trials, the primary protocol-defined monitoring outcome for benefit with coronary heart disease and the primary monitoring outcome for harm was breast cancer. Thus, breast cancer incidence was a primary study outcome [[11](https://www.nature.com/articles/s41416-026-03621-9#ref-CR11 "Chlebowski RT, Anderson GL, Aragaki AK, Manson JE, Stefanick ML, Pan K, et al. Association of menopausal hormone therapy with breast cancer incidence and mortality during long-term follow-up of the women’s health initiative randomized clinical trials. JAMA 2020;324.")]. Secondary outcomes included hip fractures, stroke, venous thromboembolism, and mortality across both trials. The CEE plus MPA trial additionally included colorectal and endometrial cancers as secondary outcomes. Trial eligibility included postmenopausal women aged 50–79 years who provided written informed consent. Major exclusions included prior breast cancer, anticipated survival < 3 years, other invasive cancer within 10 years. The sample sizes were chosen to provide approximately 80% power to detect effects on the primary outcomes; the present secondary analysis used all randomized participants [[12](https://www.nature.com/articles/s41416-026-03621-9#ref-CR12 "The Women’s Health Initiative Study Group. Design of the Women’s Health Initiative clinical trial and observational study. Control Clin Trials. 1998;19:61–109.")]. Postmenopausal women with a uterus (_n_ = 16,608) were randomized to conjugated equine estrogen (CEE) 0.625 mg/d plus medroxyprogesterone acetate (MPA) 2.5 mg/d or placebo; women with hysterectomy (n = 10,739) were randomized to CEE-alone or placebo. Treatment assignment (1:1 allocation) was performed through a centralized database function that verified eligibility and assigned participants using a randomized permuted-block algorithm stratified by clinical center, age group, and hysterectomy status, with randomly varying block sizes. Before randomization, hormone therapy participants completed a placebo run-in period; adherence of less than 80% was considered inadequate. The intervention was self-administered as once daily oral tablets, hormone therapy or matching placebo, with temporal holds for safety if mammography screening was overdue. After randomization, adherence was assessed by pill counts at follow-up visits. Blinding was maintained using matching active and placebo tablets, with all participants taking 1 tablet daily; unblinding was permitted only when necessary for safety. Participants continued usual care with their own physicians augmented with protocolized specified annual mammography and clinical exams applied uniformly across arm [[7](https://www.nature.com/articles/s41416-026-03621-9#ref-CR7 "Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002;288:321–33."), [8](https://www.nature.com/articles/s41416-026-03621-9#ref-CR8 "Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, et al. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women’s Health Initiative randomized controlled trial. JAMA. 2004;291:1701–12.")]. Adverse events were prospectively monitored throughout follow-up, including vaginal bleeding, endometrial abnormalities, venous thromboembolism, breast cancer, and other serious adverse experiences, with regular review by the Data and Safety Monitoring Board. The CEE plus MPA trial was stopped early in 2002 after 5.6 years because overall risks were judged to outweigh benefits. The CEE-alone trial was stopped early in 2004 after 7.2 years because of increased stroke risk and no clear coronary heart disease benefit. Clinical outcome ascertainment was monthly through 2005 with subsequent updates annually. Follow-up beyond the protocol-specified end date for incidence required written re-consent. All incident cancers, including liver cancers, were confirmed by central medical record review by reviewers blinded to randomization assignment. Participants’ own physicians directed liver cancer therapy. Deaths and cause of death were verified by central medical record or death certificate review while serial National Death Index queries through 2023 provide near complete (98%) information on mortality and cause of death independent of re-consent status [[13](https://www.nature.com/articles/s41416-026-03621-9#ref-CR13 "Rich-Edwards JW, Corsano KA, Stampfer MJ. Test of the national death index and equifax nationwide death search. Am J Epidemiol. 1994;140:1016–9.")]. The current liver cancer analyses were not protocol-specified. Outcomes included incidence of and mortality from primary liver cancer, analyzed separately by trial group. Analyses followed the intention-to-treat principle. Follow-up time continued until December 31, 2023, first cancer, death, or loss to follow-up. Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (CIs), with baseline hazard functions stratified by age group, dietary modification trial randomization, and study period. Two-sided stratified log-rank tests were used to test for differences between the intervention and control groups, with P ≤ 0.05 considered statistically significant. Temporal patterns were assessed using Kaplan-Meier curves with cumulative HRs (95% CIs) under proportional hazards assumptions [[14](https://www.nature.com/articles/s41416-026-03621-9#ref-CR14 "Hernan MA. The hazards of hazard ratios. Epidemiology. 2010;21:13–5.")]. Given the limited number of events, subgroup analyses were restricted to the CEE plus MPA trial and, where appropriate, supplemented with sensitivity analyses to aid interpretation [[15](https://www.nature.com/articles/s41416-026-03621-9#ref-CR15 "VanderWeele TJ, Knol MJ. Interpretation of subgroup analyses in randomized trials: heterogeneity versus secondary interventions. Ann Intern Med. 2011;154:680–3.")]. For interpretative purposes, an overall HR for liver cancer was computed across the two HT trials using an inverse-variance weighted average of the trial-specific log-HRs, analogous to a fixed-effect meta-analysis. Analyses were conducted using SAS version 9.4 and R version 4.4. Statistical code used to estimate the primary results is available from the corresponding author upon reasonable request. ## Results For each trial, randomization group characteristics were generally well balanced at baseline (Table [1](https://www.nature.com/articles/s41416-026-03621-9#Tab1)), although bilateral oophorectomy was less common in CEE-alone vs placebo group women (39.5% vs. 42%, P = 0.01). Trial cohorts differed, with the CEE-alone trial including women with higher prevalence of ob
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