Association of Pathologic Complete Response to Neoadjuvant Therapy in HER2-Positive Breast Cancer With Long-Term Outcomes

Broglio, Kristine; Quintana, Melanie; Foster, Margaret; Olinger, Melissa; McGlothlin, Anna; Berry, Scott M.; Boileau, Jean François; Brezden-Masley, Christine; Chia, Stephen; Dent, Susan; Gelmon, Karen A.; Paterson, Alexander; Rayson, Daniel; Berry, Donald A.

doi:10.1001/jamaoncol.2015.6113

Cited by 277 publications

(214 citation statements)

References 58 publications

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“…In all patients, this analysis suggested that patients who achieved pCR However, the analysis was unable to demonstrate a relationship between the effect of treatment on pCR (estimated using an odds ratio) and the effect of treatment on EFS and OS (estimated using a hazard ratio) at the study level. These findings are generally consistent with other similar studies [11,12]. The ERG accepts that there is evidence at the patient-level that a pCR responder is associated with a lower risk of EFS and OS.…”

Section: Limitations Of the Rctssupporting

confidence: 91%

Pertuzumab for the Neoadjuvant Treatment of Early-Stage HER2-Positive Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2017

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As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence The probabilistic incremental cost-effectiveness ratio (ICER) was estimated to be £20,104 per quality-adjusted life-year (QALY) gained for pertuzumab alongside trastuzumab and docetaxel compared with trastuzumab and docetaxel, which was revised to £21,869 per QALY gained following the clarification process. The ERG corrected an error in the digitisation of the survivor functions and modified the clinically inappropriate assumption that recurrence is zero after 7 years. The ERG's probabilistic base case was £23,962 per QALY gained. During the appraisal, to mitigate the uncertainties associated with the evidence, the company offered a patient access scheme (PAS), which led to the NICE Appraisal Committee recommending pertuzumab in this patient group, subject to the company providing the agreed discount in the PAS. Key points for decision makers Neoadjuvant pertuzumab in combination with trastuzumab and chemotherapy provides a statistically significant advantage in terms of pathological complete response rates compared with trastuzumab and chemotherapy for treating HER2-positive breast cancer which is either locally advanced, inflammatory, or early stage (at a high-risk of recurrence).  The safety of pertuzumab has been demonstrated. Given the patient access scheme proposed by the company, neoadjuvant pertuzumab is considered to be a cost-effective use of NHS resources.

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Section: Limitations Of the Rctssupporting

confidence: 91%

Pertuzumab for the Neoadjuvant Treatment of Early-Stage HER2-Positive Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

et al. 2017

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“…Finally, we obtained data for leukemia-free survival (LFS), overall survival (OS), and cumulative incidence of relapse (CIR) and non-relapse mortality (NRM) from the date of HCT. We used a hierarchical approach 14 to compare outcomes of MRD pos and MRD neg subjects: (i) when available, we used observed hazard ratios (HRs) and confidence intervals (CIs); (ii) when Kaplan-Meier curves were provided, we used Enguage Digitizer version 4.1 to calculate HRs and CIs based on an established algorithm, 15 and (iii) for articles providing survival data at single time points, we estimated HRs based on exponential decay.…”

Section: Methodsmentioning

confidence: 99%

Minimal residual disease prior to allogeneic hematopoietic cell transplantation in acute myeloid leukemia: a meta-analysis

et al. 2017

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Minimal residual disease prior to allogeneic hematopoietic cell transplantation has been associated with increased risk of relapse and death in patients with acute myeloid leukemia, but detection methodologies and results vary widely. We performed a systematic review and meta-analysis evaluating the prognostic role of minimal residual disease detected by polymerase chain reaction or multiparametric flow cytometry before transplant. We identified 19 articles published between January 2005 and June 2016 and extracted hazard ratios for leukemia-free survival, overall survival, and cumulative incidences of relapse and non-relapse mortality. Pre-transplant minimal residual disease was associated with worse leukemia-free survival (hazard ratio=2.76 [1.90–4.00]), overall survival (hazard ratio=2.36 [1.73–3.22]), and cumulative incidence of relapse (hazard ratio=3.65 [2.53–5.27]), but not non-relapse mortality (hazard ratio=1.12 [0.81–1.55]). These associations held regardless of detection method, conditioning intensity, and patient age. Adverse cytogenetics was not an independent risk factor for death or relapse. There was more heterogeneity among studies using flow cytometry-based than WT1 polymerase chain reaction-based detection (I2=75.1% vs. <0.1% for leukemia-free survival, 67.8% vs. <0.1% for overall survival, and 22.1% vs. <0.1% for cumulative incidence of relapse). These results demonstrate a strong relationship between pre-transplant minimal residual disease and post-transplant relapse and survival. Outcome heterogeneity among studies using flow-based methods may underscore site-specific methodological differences or differences in test performance and interpretation.

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“…The reported rates of trastuzumab use were also slightly higher than published rates, although many patients were unsure and likely did not receive trastuzumab 18 . Also, women with her2-positive disease might be more likely to receive chemotherapy and might therefore have been overrepresented in this sample of patients 19 .…”

Section: Discussionmentioning

confidence: 99%

Perceptions of Vascular Access for Intravenous Systemic Therapy and Risk Factors for Lymphedema in Early-Stage Breast Cancer—A Patient Survey

et al. 2018

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Association of Pathologic Complete Response to Neoadjuvant Therapy in HER2-Positive Breast Cancer With Long-Term Outcomes

Cited by 277 publications

References 58 publications

Pertuzumab for the Neoadjuvant Treatment of Early-Stage HER2-Positive Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Pertuzumab for the Neoadjuvant Treatment of Early-Stage HER2-Positive Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Minimal residual disease prior to allogeneic hematopoietic cell transplantation in acute myeloid leukemia: a meta-analysis

Perceptions of Vascular Access for Intravenous Systemic Therapy and Risk Factors for Lymphedema in Early-Stage Breast Cancer—A Patient Survey

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