ArticleWorld journal of surgical oncology2026
Oncologic outcomes after poly-4-hydroxybutyrate scaffold in post-mastectomy breast reconstruction: a retrospective, multi-center cohort study.
Article in World journal of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundPoly-4-hydroxybutyrate (P4HB) scaffolds are increasingly used in post-mastectomy implant-based breast reconstruction. Clinical adoption has outpaced evidence regarding oncologic outcomes and recurrence detection in reconstructed breasts.
methodsWe conducted a real-world cohort study via the Guardian Research Network database (2016-2023). Female patients with breast cancer undergoing mastectomy and reconstruction were identified; 269 P4HB cases were compared with 269 stratified, randomly sampled non-P4HB controls. Primary endpoints were LRR and LRRFS; secondary endpoints included disease-specific and overall survival. Cumulative incidence functions accounted for competing risk of non-breast cancer death. Administrative censoring at 3 years (as well as time aligned cohorts) was used to mitigate temporal imbalance.
resultsOver a median follow-up of 2.2 years in P4HB and 5.5 years in controls, LRR was uncommon (4/269 (1.5%) vs. 6/269 (2.2%)). The 3-year cumulative incidence of LRR was 1.6% in both groups. Disease-specific mortality was rare (0.7% vs. 2.6%). No early signal of differences in locoregional recurrence was observed between groups within the observed follow‑up period.
conclusionsIn this real-world, multi-center analysis, no detectable signal of increased locoregional recurrence was observed between cohorts. These findings do not establish evidence of oncologic equivalence, but rather an absence of a detectable early signal of increased risk within the observed follow-up. Larger, time-aligned datasets with plane-stratified surveillance and analyses are warranted to further evaluate oncologic outcomes given the comparator cohort included a greater proportion of earlier-era reconstructions than the P4HB cohort, reflecting more recent clinical adoption of P4HB.
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