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Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer : a multicentre pooled analysis of 5161 patients
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I-SPY 2 TRIAL Consortium (Including:
). (2022) Residual cancer burden after neoadjuvant chemotherapy and long-term survival outcomes in breast cancer : a multicentre pooled analysis of 5161 patients. Lancet Oncology, 23 (1). pp. 149-160. doi:10.1016/S1470-2045(21)00589-1 ISSN 1470-2045.
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Official URL: https://doi.org/10.1016/S1470-2045(21)00589-1
Abstract
Background
Previous studies have independently validated the prognostic relevance of residual cancer burden (RCB) after neoadjuvant chemotherapy. We used results from several independent cohorts in a pooled patient-level analysis to evaluate the relationship of RCB with long-term prognosis across different phenotypic subtypes of breast cancer, to assess generalisability in a broad range of practice settings.
Methods
In this pooled analysis, 12 institutes and trials in Europe and the USA were identified by personal communications with site investigators. We obtained participant-level RCB results, and data on clinical and pathological stage, tumour subtype and grade, and treatment and follow-up in November, 2019, from patients (aged ≥18 years) with primary stage I–III breast cancer treated with neoadjuvant chemotherapy followed by surgery. We assessed the association between the continuous RCB score and the primary study outcome, event-free survival, using mixed-effects Cox models with the incorporation of random RCB and cohort effects to account for between-study heterogeneity, and stratification to account for differences in baseline hazard across cancer subtypes defined by hormone receptor status and HER2 status. The association was further evaluated within each breast cancer subtype in multivariable analyses incorporating random RCB and cohort effects and adjustments for age and pretreatment clinical T category, nodal status, and tumour grade. Kaplan-Meier estimates of event-free survival at 3, 5, and 10 years were computed for each RCB class within each subtype.
Findings
We analysed participant-level data from 5161 patients treated with neoadjuvant chemotherapy between Sept 12, 1994, and Feb 11, 2019. Median age was 49 years (IQR 20–80). 1164 event-free survival events occurred during follow-up (median follow-up 56 months [IQR 0–186]). RCB score was prognostic within each breast cancer subtype, with higher RCB score significantly associated with worse event-free survival. The univariable hazard ratio (HR) associated with one unit increase in RCB ranged from 1·55 (95% CI 1·41–1·71) for hormone receptor-positive, HER2-negative patients to 2·16 (1·79–2·61) for the hormone receptor-negative, HER2-positive group (with or without HER2-targeted therapy; p<0·0001 for all subtypes). RCB score remained prognostic for event-free survival in multivariable models adjusted for age, grade, T category, and nodal status at baseline: the adjusted HR ranged from 1·52 (1·36–1·69) in the hormone receptor-positive, HER2-negative group to 2·09 (1·73–2·53) in the hormone receptor-negative, HER2-positive group (p<0·0001 for all subtypes).
Interpretation
RCB score and class were independently prognostic in all subtypes of breast cancer, and generalisable to multiple practice settings. Although variability in hormone receptor subtype definitions and treatment across patients are likely to affect prognostic performance, the association we observed between RCB and a patient's residual risk suggests that prospective evaluation of RCB could be considered to become part of standard pathology reporting after neoadjuvant therapy.
| Item Type: | Journal Article | |||||||||||||||||||||
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| Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) | |||||||||||||||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | |||||||||||||||||||||
| Library of Congress Subject Headings (LCSH): | Breast -- Cancer -- Research, Breast -- Cancer -- Treatment, Breast -- Diseases -- Treatment, Breast -- Cancer -- Adjuvant treatment -- Analysis | |||||||||||||||||||||
| Journal or Publication Title: | Lancet Oncology | |||||||||||||||||||||
| Publisher: | Elsevier Science BV | |||||||||||||||||||||
| ISSN: | 1470-2045 | |||||||||||||||||||||
| Official Date: | January 2022 | |||||||||||||||||||||
| Dates: |
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| Volume: | 23 | |||||||||||||||||||||
| Number: | 1 | |||||||||||||||||||||
| Page Range: | pp. 149-160 | |||||||||||||||||||||
| DOI: | 10.1016/S1470-2045(21)00589-1 | |||||||||||||||||||||
| Status: | Peer Reviewed | |||||||||||||||||||||
| Publication Status: | Published | |||||||||||||||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||||||||||||||
| Date of first compliant deposit: | 25 November 2021 | |||||||||||||||||||||
| Date of first compliant Open Access: | 17 December 2021 | |||||||||||||||||||||
| RIOXX Funder/Project Grant: |
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