Outcomes of haploidentical hematopoietic stem cell transplantation in adults aged 60 and over: a systematic review and meta-analysis

Background: Haploidentical hematopoietic stem cell transplantation (HSCT) has become a viable option for older adults with hematologic malignancies lacking matched donors. However, outcomes in patients aged ≥60 years vary widely, with reported 2-year overall survival (OS) ranging from 15% to 74%. This systematic review and meta-analysis aimed to estimate pooled survival outcomes and identify factors contributing to outcome heterogeneity in older recipients of haploidentical HSCT.

Methods: A comprehensive systematic literature search was conducted across PubMed, Google Scholar, and Cochrane databases from inception to April 30, 2025, following PRISMA guidelines. Studies enrolling adults aged ≥60 years undergoing haploidentical HSCT with reported OS, non-relapse mortality (NRM), or relapse incidence at 1-, 2-, or 3-years were included. Meta-analyses were performed using DerSimonian-Laird random-effects models. A composite “High-Impact Trio” risk score was developed based on the prevalence of active/refractory disease, high-risk cytogenetics, and impaired performance status to explore heterogeneity through subgroup analyses and meta-regression.

Results: Sixteen studies (18 cohorts; 1,268 patients) were analyzed. Pooled survival estimates were: 1-year OS 62% (95% CI, 56–68%), 2-year OS 53% (95% CI, 46–60%), and 3-year OS 45% (95% CI, 38–52%). Three-year NRM and relapse incidence were 28% (95% CI, 23–34%) and 32% (95% CI, 25–40%), respectively. Significant heterogeneity was observed (I² = 71–82%); the risk score explained 39–60% of between-study variability and correlated with OS and NRM (P<0.05).

Conclusion: Haploidentical HSCT offers competitive survival outcomes in selected older patients, though prognosis remains strongly influenced by baseline risk factors.

Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD420251013617.

1 Introduction

The increasing prevalence of myeloid malignancies in older adults, particularly AML and MDS, poses a major therapeutic challenge (1). In most older adults with high-risk disease, allogeneic HSCT will be the only therapeutic modality that can offer cure potential (2). Reduced-intensity conditioning (RIC) regimens have expanded access for older adults and with careful selection, HSCT is now recommended in international guidelines (3).

Donor availability remains a major barrier. Only 13-51% of patients have a matched sibling donor (MSD) (4). Matched unrelated donor (MUD) searches are slow for rapidly progressive disease (5) and consistently disadvantage minority patients, whose match rates are far lower than the 29-78% observed in Caucasians (6, 7).

Haploidentical (half-matched) HSCT offers near-universal donor access by using readily available family members (5). High-dose post-transplant cyclophosphamide (PTCy) enables this platform by limiting graft failure and GVHD (8). When MSDs are absent, clinicians choose between haploidentical and MUD grafts. In adults aged 50–75 years with AML in remission, a CIBMTR analysis showed young MUD donors (18–40 years) achieved higher overall survival and lower relapse than haplo-HSCT with PTCy, while non-relapse mortality was similar (9).

Reported haploidentical outcomes in patients ≥60 years vary markedly. Physiologic reserve, comorbidities, and competing risks between relapse and non-relapse mortality (NRM) shape post-transplant trajectories (10, 11). Retrospective series have described 2-year overall survival (OS) spanning 15%-74% and 2-year NRM from 9 to 44% (12–15).

Most evidence derives from single-center or registry analyses with heterogeneous patient selection, conditioning, and GVHD prophylaxis (1). In the absence of prospective trials, a rigorous synthesis of observational data is needed. We therefore conducted a systematic review and meta-analysis to derive pooled estimates for 1-, 2-, and 3-year OS, NRM, and relapse in patients aged ≥60 years receiving haploidentical HSCT, and to identify study-level factors driving heterogeneity.

2 Materials and methods

2.1 Study selection and data extraction

A comprehensive systematic literature search following PRISMA guidelines was conducted across PubMed, Google Scholar, and Cochrane databases from inception to April 30, 2025. The protocol was registered in PROSPERO (CRD420251013617). Detailed database-specific search strategies, including all keywords and Boolean operators, are provided in the Supplementary Materials.

Studies were eligible if they enrolled adults aged ≥60 years undergoing haploidentical HSCT and reported OS, NRM, or relapse at 1, 2, or 3 years, either numerically or via extractable Kaplan-Meier curves. Full-text articles in English were eligible; for studies with multiple donor types, separate haploidentical data were required. Exclusion criteria were: lack of a distinct subgroup aged ≥60 years, enrollment <10 patients, insufficient outcome data, or publication as conference abstracts or gray literature.

Two investigators (MMK and IAC) independently screened titles and abstracts, followed by full-text review. Inter-rater agreement was high; only 2 studies required discussion, both resolved by consensus. Although Cohen’s kappa was not calculated, minimal discordance reflects the use of pre-specified criteria. All full-text articles were available through institutional or open-access platforms; authors were not contacted. The study selection process is illustrated in Figure 1. Study characteristics are summarized in Supplementary eTable 1.

Figure 1

Figure 1. PRISMA flow diagram of study selection process.

2.2 Data extraction and quality assessment

Two reviewers independently extracted data on study characteristics (publication year, country, sample size), patient demographics (age, sex, diagnosis, disease status, performance status, comorbidity indices, cytogenetic risk), transplant details (conditioning regimen, graft-versus-host disease prophylaxis), and outcomes (OS, NRM, relapse at 1, 2, and 3 years). When outcomes were reported only graphically, data were digitized from Kaplan-Meier curves using validated software (webplotdigitizer). Discrepancies were resolved by consensus, with third-investigator consultation (RK) when necessary.

Study quality was assessed using a 5-item reporting checklist evaluating the completeness of reporting for disease status, performance status, comorbidity index, GVHD prophylaxis, and cytogenetic risk (Supplementary eTable 2). Items were scored 0/1 to yield totals from 0 to 5, which were categorized as higher or lower quality relative to the median. Scores informed sensitivity analyses but did not determine inclusion. Given that all studies were non-randomized cohorts, risk of bias was assessed with ROBINS-I across seven domains (confounding, selection, intervention classification, deviations, missing data, outcome measurement, reporting), with overall ratings driven by the most concerning domain (16).

2.3 Statistical analysis

We used DerSimonian-Laird random-effects models with logit-transformed proportions to pool OS, NRM, and relapse at each time point, presenting back-transformed estimates with 95% CIs. Heterogeneity was quantified using I² and Q statistics, and publication bias assessed with Egger’s test and funnel plots (e Figure 2). We conducted analyses in R.

Figure 2

Figure 2. Forest plots of overall survival after haploidentical hematopoietic stem cell transplantation in patients ≥60 years. (A) 1-year, (B) 2-year, and (C) 3-year overall survival. Boxes represent pooled proportions; error bars represent 95% confidence intervals. Diamonds represent pooled estimates.

To explain heterogeneity, we created a study-level “High-Impact Trio” risk score (range 0-3) incorporating disease burden (active/refractory status), genomic risk (adverse cytogenetics), and functional reserve (performance status). These domains capture tumor burden, disease biology, and physiologic tolerance in older adults (17–19). Active/refractory disease was defined as not in remission at transplant. High-risk cytogenetics was extracted as reported by each study. Impaired performance status was defined as KPS <90% or ECOG ≥1. Performance status is a critical factor in determining transplant eligibility and outcomes in older adults with hematologic malignancies (20).

Each cohort received one point if the prevalence of active disease, high-risk cytogenetics, or impaired performance status exceeded the median across studies (≥30%, ≥24%, and ≥36%, respectively), yielding scores from 0-3 (distribution shown in Supplementary eTable 3).

Subgroup analyses used random-effects models to compare outcomes by disease classification (myeloid- vs lymphoid-dominant) and by risk score. The risk score was dichotomized into low risk (scores 0-1, representing 0–1 risk factors present) and high risk (scores 2-3, representing ≥2 risk factors present) to enhance clinical utility and statistical interpretability. For each subgroup we calculated pooled OS, NRM, and relapse at 1/2/3 years using the same logit transformation approach. Random-effects meta-regression evaluated the association between the continuous risk score and logit-transformed outcomes, reporting the proportion of heterogeneity (R²) explained by the covariate.

To address potential patient overlap among studies utilizing the EBMT registry database (Santoro 2018, Maffini 2023, Maffini 2024), we performed a sensitivity analysis excluding Santoro 2018 (n=250). Potential overlap was minimal given mutually exclusive disease criteria between the Maffini studies (CR1 only vs. active/refractory only) and non-overlapping age distributions (Santoro median 65 years, 15% aged ≥70 vs. 100% aged ≥70 in both Maffini studies).

3 Results

3.1 Study characteristics

Sixteen studies contributed 18 cohorts (Kasamon, and Duléry each provided two distinct cohorts), encompassing 1,268 patients aged ≥60 years (range 22–250 per study). All studies were retrospective. The median 5-item reporting score was 4 (range 2-5), with 16 of 18 cohorts classified as higher quality. Disease status and GVHD prophylaxis were reported in 94.4% of cohorts, comorbidity indices in 77.8%, cytogenetic risk in 83.3%, and baseline performance status in 66.7% (details in Supplementary eTable 2).

Median age was 68 years (range 63-72) with 62.7% male. Myeloid diagnoses (AML/MDS/MPN) comprised 87.3% of patients, and all studies included AML (mean 67.3%; range 25-100%). At transplant, 72% were in complete remission, 28% had active disease, 26.7% had high-risk cytogenetics, and 35% had impaired performance status (KPS <90% or ECOG ≥1).

Sixteen cohorts (n=1,105) reported conditioning distributions. Conventional RIC backbones accounted for 50.9% of patients, non-myeloablative fludarabine/cyclophosphamide + 2 Gy TBI regimens for 31.6%, and myeloablative approaches for 14.4%, the latter largely within registry datasets that mixed donor types. Thiotepa/busulfan/fludarabine platforms predominated in Duléry et al., while the two-step approach of Bi et al. combined 14% MAC with 86% RIC.

PTCy-based GVHD prophylaxis was used in 16 of 18 cohorts (88.9%). The most common dosing was 50 mg/kg on days +3/+4 (100 mg/kg total) across 10 cohorts. One Duléry cohort used reduced-dose PTCy (80 mg/kg total). Bi et al. administered cyclophosphamide pre-transplant in their two-step platform, and Cho et al. used ATG/tacrolimus/methotrexate instead of PTCy. Registry datasets (Santoro, Maffini, Yamasaki) reported partial PTCy uptake without specific doses. PTCy was typically paired with tacrolimus or cyclosporine plus mycophenolate. Detailed study and patient characteristics, conditioning regimens, and PTCy dosing information for each cohort are provided in Supplementary eTable 1.

3.2 Meta-analysis

Table 1, Figures 2–4 summarize pooled outcomes: OS at 1/2/3 years was 62% (95% CI, 56-68%), 53% (95% CI, 46-60%), and 45% (95% CI, 38-52%); corresponding NRM estimates were 22% (95% CI, 17-27%), 26% (95% CI, 21-31%), and 28% (95% CI, 23-34%); relapse rates were 21% (95% CI, 16-26%), 25% (95% CI, 20-30%), and 32% (95% CI, 25-40%). Substantial heterogeneity was present across outcomes (all P<.001): I² values for OS were 81%, 82%, and 81% at 1/2/3 years; for NRM, 71%, 73%, and 74%; and for relapse, 80%, 76%, and 82%.

Figure 3

Figure 3. Forest plots of non-relapse mortality after haploidentical hematopoietic stem cell transplantation in patients ≥60 years. (A) 1-year, (B) 2-year, and (C) 3-year non-relapse mortality. Boxes represent pooled proportions; error bars represent 95% confidence intervals. Diamonds represent pooled estimates.

Figure 4

Figure 4. Forest plots of relapse incidence after haploidentical hematopoietic stem cell transplantation in patients ≥60 years. (A) 1-year, (B) 2-year, and (C) 3-year relapse incidence. Boxes represent pooled proportions; error bars represent 95% confidence intervals. Diamonds represent pooled estimates.

Table 1

Table 1. Pooled clinical outcomes in haploidentical HSCT for patients ≥60 years.

3.3 Subgroup analysis and meta-regression

Subgroup analysis by risk score demonstrated strong discrimination between low-risk (scores 0-1) and high-risk (scores 2-3) patients (Table 2). At 1 year, low-risk patients had significantly higher OS (68.9%, 95% CI 63.7-73.7) compared to high-risk patients (50.6%, 95% CI 35.5-65.6, p<0.001). Similar patterns were observed for NRM (low 18.9% vs high 32.4%, p<0.001) and relapse (low 18.4% vs high 26.5%, p=0.170). Outcome separation persisted at 2 years (OS: 59.8% vs 41.5%, p<0.001; NRM: 22.3% vs 36.2%, p<0.001) and 3 years (OS: 53.8% vs 33.1%, p<0.001; NRM: 23.2% vs 40.1%, p<0.001). Disease type (myeloid vs lymphoid predominance) did not significantly influence outcomes at any timepoint (all p>0.05).

Table 2

Table 2. Subgroup analysis of clinical outcomes after haploidentical HSCT for patients ≥60 years.

Meta-regression (Table 3; e Figure 1) confirmed the risk score was associated with poorer OS (adjusted β at 1/2/3 years: −0.080, −0.081, −0.095; all P≤.002) and higher NRM (adjusted β at 1/2/3 years: 0.054, 0.055, 0.069; all P≤.03), explaining 39%-60% of between-study heterogeneity. Associations with relapse were not significant.

Table 3

Table 3. Univariable meta-regression of risk score on clinical outcomes.

Sensitivity analysis excluding Santoro 2018 (n=250) to address potential EBMT registry overlap demonstrated consistency across all outcomes. For 2-year OS, the pooled estimate was 53.7% (95% CI 46.5-60.9) compared to 52.8% (95% CI 45.9-59.6) in the primary analysis (absolute difference 0.9%). Similar consistency was observed for all outcomes, with absolute differences ≤1.1% and overlapping confidence intervals (Supplementary eTable 5).

3.4 Risk of bias and publication bias

ROBINS-I ratings (e Figures 3, 4) were Critical in 2 of 16 studies, Serious in 7, and Moderate in 6, driven primarily by confounding (Serious/Critical in 56%). Missing data, outcome measurement, and selective reporting were generally Moderate or better, reflecting the limitations of retrospective cohorts. Funnel plots did not reveal major asymmetry for OS, NRM, or relapse, and neither Egger’s nor Begg’s tests showed statistically significant evidence of publication bias (e Figure 2).

Sensitivity analyses excluding studies with higher risk of bias demonstrated consistency with the primary findings (Supplementary eTable 4). When restricted to studies with Moderate risk of bias (k=7 for most outcomes), pooled 1-year OS was 57.8% (95% CI 48.0-67.4) compared to 62.1% (95% CI 55.5-68.5) in the primary analysis. Similarly, 2-year OS was 47.1% (95% CI 36.0-58.4) versus 52.8% (95% CI 45.9-59.7). All confidence intervals overlapped substantially, indicating no statistically significant differences. Similar patterns were observed for NRM and relapse across all timepoints, confirming that study quality heterogeneity did not materially affect our conclusions.

4 Discussion

Our analysis of 18 cohorts (1,268 patients aged ≥60 years) establishes contemporary benchmarks for haploidentical HSCT outcomes in older adults. The pooled 3-year OS of 45% and substantial between-study heterogeneity highlight both the feasibility and challenges of this approach. A study-level “High-Impact Trio” risk score accounted for much of this variability, linking lower scores to superior OS and lower NRM.

Our pooled survival estimates are consistent with outcomes reported for older adults undergoing MUD transplants. For example, the BMT CTN 1102 trial showed a 3-year OS of 48% for older patients with MDS in the donor arm (21). Recent CIBMTR data through 2023 also report similar figures (22). Comparative evidence remains mixed. Some studies suggest younger MUD donors may reduce relapse and improve OS (23). A recent PTCy-based series found haploidentical HSCT associated with inferior OS and higher NRM compared to MUD-HSCT (24). In contrast, a meta-analysis of 17 studies reported broadly comparable OS, PFS, NRM, and relapse between haplo- and MUD-HSCT, with lower rates of grade II–IV acute and chronic GVHD after haploidentical grafts (25). Despite ongoing debate about survival differences, haploidentical HSCT offers a key clinical advantage: near-universal and immediate donor availability. This avoids delays and ethnic disparities in MUD searches, enabling timely transplantation for patients with rapidly progressing disease (23).

Published outcomes for older adults receiving haploidentical HSCT vary widely, with reported 2-year OS ranging from 15% to 74% (12, 13). These differences reflect selection bias and center-specific practices. For instance, the Australasian registry reported a 2-year OS of 74% in a select AML/MDS cohort, while a single-center U.S. study observed only 15% in patients over 55 (12, 13). A Beijing series noted a 3-year OS of 74% in patients aged 55–65 in first remission (26). By pooling data across diverse international cohorts, our meta-analysis mitigates these biases. The resulting 2-year OS of 53% offers a more robust and generalizable benchmark, providing clinicians with a realistic reference point for prognosis and future study design. These benchmarks can inform shared decision-making with older patients considering haploidentical HSCT, particularly when alternative donors are unavailable or search times are prohibitive.

The near-equal 3-year incidences of relapse (32%) and NRM (28%) illustrate the competing risks older adults face after haploidentical HSCT, with deaths divided almost evenly between disease control and treatment toxicity (27). Optimizing outcomes therefore requires balanced strategies that preserve anti-leukemic intensity while minimizing regimen-related harm.

Conditioning practices likely influence outcomes. Only 14% of patients received myeloablative regimens. In contrast, 51% underwent conventional RIC and 32% received non-myeloablative conditioning, so our benchmarks largely reflect reduced-toxicity strategies. PTCy dosing was remarkably uniform (50 mg/kg ×2 in 10 cohorts), and this limited variation prevented analysis of dose–response relationships. Preliminary reports suggest that reduced-dose PTCy (80 mg/kg) may improve hematologic recovery and lessen hemorrhagic cystitis in older recipients (28). Current data are insufficient to determine whether this approach reduces NRM without compromising disease control; further prospective studies are needed.

A key contribution of this work is the ‘High-Impact Trio’ risk score, which demonstrated clear outcome separation between low-risk and high-risk patients (1-year OS 68.9% vs 50.6%, p<0.001) and explained up to 60% of between-study heterogeneity in meta-regression. These findings suggest that baseline disease burden, biology, and performance status account for much of the variability in reported haploidentical outcomes. Notably, these components are routinely assessed using established tools (disease status at transplant, ELN 2022 or IPSS-R for cytogenetics, KPS/ECOG for performance), making the risk score readily applicable in clinical practice once validated.

Although ROBINS-I ratings highlighted confounding as the predominant limitation, sensitivity analyses excluding higher-risk studies yielded similar estimates, supporting the robustness of our conclusions. Nevertheless, the risk score is derived from study-level data and is susceptible to ecological fallacy; prospective validation with individual patient data will be required before clinical application.

4.1 Limitations

Our synthesis is constrained by the retrospective nature of included studies, which introduces selection bias and reporting variability that cannot be fully adjusted at the study level. Granular disease-specific subgroup analyses (AML, MDS, MPN, lymphoid) were not feasible because many reports combined diagnoses or used inconsistent taxonomies, which would have produced underpowered and misclassified strata. Second, reporting heterogeneity prevented the use of an ECOG ≥2 threshold for impaired performance status. Most studies used binary KPS <90% cutoffs or grouped KPS 70-80% together, precluding isolation of a strictly defined ECOG ≥2 subgroup. We therefore defined impaired performance status as KPS <90% or ECOG ≥1, which our meta-regression confirmed was significantly associated with non-relapse mortality (p<0.01). Finally, even after accounting for the risk score, residual heterogeneity likely reflects clinical variables that were inconsistently reported—such as conditioning nuances, supportive care practices, and center-level approaches—that future prospective datasets should capture.

Data availability statement

The datasets presented in this study can be found in online repositories. The names of the repository/repositories and accession number(s) can be found in the article/Supplementary Material.

Author contributions

MK: Visualization, Conceptualization, Writing – review & editing, Formal Analysis, Methodology, Data curation, Writing – original draft. IC: Writing – original draft, Data curation, Methodology. AB: Writing – review & editing. RK: Writing – review & editing, Supervision.

Funding

The author(s) declared that financial support was not received for this work and/or its publication.

Conflict of interest

The authors declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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The author(s) declared that generative AI was not used in the creation of this manuscript.

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Supplementary material

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/frhem.2025.1759405/full#supplementary-material

Abbreviations

AML, Acute Myeloid Leukemia; CI, Confidence Interval; ECOG, Eastern Cooperative Oncology Group Performance Status; GVHD, Graft-versus-Host Disease; HCT-CI, Hematopoietic Cell Transplantation-Comorbidity Index; HSCT, Hematopoietic Stem Cell Transplantation; KPS, Karnofsky Performance Status; MDS, Myelodysplastic Syndromes; MSD, Matched Sibling Donor; MUD, Matched Unrelated Donor; NRM, Non-Relapse Mortality; OS, Overall Survival; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PTCy, Post-Transplant Cyclophosphamide; RIC, Reduced-Intensity Conditioning.

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