Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial

Bonnefoi, Hervé; Litière, Saskia; Piccart, Martine; MacGrogan, Gaëtan; Fumoleau, P.; Brain, Étienne; Petit, Thierry; Rouanet, Philippe; Jassem, Jacek; Moldovan, Cosmin; Bodmer, Alexandre; Zaman, Khalil; Čufer, Tanja; Campone, Mario; Luporsi, É.; Malmström, Per; Werutsky, Gustavo; Bogaerts, Jan; Bergh, Jonas; Cameron, David

doi:10.1093/annonc/mdu118

Cited by 167 publications

(127 citation statements)

References 18 publications

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“…In contrast, luminal A carcinoma that presents higher ER and lower Ki67 showed very low pCR rate [17,21,[49][50][51]. The clinical meanings of results for cCR in luminal tumor were different from TN and HER2 carcinomas.…”

Section: Discussionmentioning

confidence: 90%

Predictors of Pathological Complete Response in Women with Clinical Complete Response to Neoadjuvant Chemotherapy in Breast Carcinoma

et al. 2018

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Objective: There is insufficient information on predictors of pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast carcinoma that also presented clinical complete response (cCR) evaluated in breast, axilla and breast and axilla. Methods: This retrospective study included 310 women with breast carcinoma who received NAC from 1/1/13 to 12/31/15 with follow-up until 8/31/16. The factors analyzed to predict pCR and cCR were menopausal status, Ki67, estrogen receptor, histologic grade, molecular subtype, tumor size, axilla status, and stage. Results: The cCR/pCR rates were 53.2/16.5% (breast), 76.3/36.8% (axilla) and 50.6/13.9% (breast and axilla). Molecular subtype and HER2-positive were independent predictors to confirm pCR in women with cCR, mainly triple negative (TN) in breast (OR 22.81, 95% CI 7.13–72.96) and breast and axilla (OR 36.06, 95% CI 8.77–148.26), but not in axilla. Ki67 ≥50% expression was predictor of cCR in breast (OR 2.00, 95% CI 1.31–3.06) and breast and axilla (OR 1.67, 95% CI 1.10–1.45). Conclusion: TN subtype and HER2-positive were the main independent predictors of pCR in women who also had cCR to NAC in breast and breast and axilla, but none was predictor in axilla. The Ki67 ≥50% was the independent predictor of cCR in breast and breast and axilla.

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Section: Discussionmentioning

confidence: 90%

Predictors of Pathological Complete Response in Women with Clinical Complete Response to Neoadjuvant Chemotherapy in Breast Carcinoma

et al. 2018

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“…RDA identified substantially more chemotherapy non-responders (20 %) compared to clinical assessment (5 %). Given that pCR has been shown to be an independent predictive factor of increased survival after neoadjuvant chemotherapy, irrespective of breast cancer subtype [27], the Food and Drug Administration USA has conditionally approved the use of pCR as a drug response biomarker for accelerated drug approval. MA.22 patients without a pCR who exhibited a zone 3 level of tumor RNA disruption had a DFS benefit from chemotherapy equivalent to pCR recipients, including those with HR?…”

Section: Discussionmentioning

confidence: 99%

Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy

Parissenti

Guo

Pritzker³

et al. 2015

Breast Cancer Res Treat

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In a prior substudy of the CAN-NCIC-MA.22 clinical trial (ClinicalTrials.gov identifier NCT00066443), we observed that neoadjuvant chemotherapy reduced tumor RNA integrity in breast cancer patients, a phenomenon we term "RNA disruption." The purpose of the current study was to assess in the full patient cohort the relationship between mid-treatment tumor RNA disruption and both pCR post-treatment and, subsequently, disease-free survival (DFS) up to 108 months post-treatment. To meet these objectives, we developed the RNA disruption assay (RDA) to quantify RNA disruption and stratify it into 3 response zones of clinical importance. Zone 1 is a level of RNA disruption inadequate for pathologic complete response (pCR); Zone 2 is an intermediate level, while Zone 3 has high RNA disruption. The same RNA disruption cut points developed for pCR response were then utilized for DFS. Tumor RDA identified >fourfold more chemotherapy non-responders than did clinical response by calipers. pCR responders were clustered in RDA Zone 3, irrespective of tumor subtype. DFS was about 2-fold greater for patients with tumors in Zone 3 compared to Zone 1 patients. Kaplan-Meier survival curves corroborated these findings that high tumor RNA disruption was associated with increased DFS. DFS values for patients in zone 3 that did not achieve a pCR were similar to that of pCR recipients across tumor subtypes, including patients with hormone receptor positive tumors that seldom achieve a pCR. RDA appears superior to pCR as a chemotherapy response biomarker, supporting the prospect of its use in response-guided chemotherapy.

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“…Breast cancer is a heterogeneous disease with at least five subtypes according to the PAM50 classification, each with distinct biology and clinical outcome (13)(14)(15). The frequency and prognostic impact of pathological complete response are known to vary between PAM50 subtypes (16)(17)(18)(19). Subtype-specific responses to bevacizumab have not yet been systematically studied.…”

Section: Introductionmentioning

confidence: 99%

The Longitudinal Transcriptional Response to Neoadjuvant Chemotherapy with and without Bevacizumab in Breast Cancer

Silwal-Pandit

Nord

Gythfeldt

et al. 2017

Clinical Cancer Research

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Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial

Cited by 167 publications

References 18 publications

Predictors of Pathological Complete Response in Women with Clinical Complete Response to Neoadjuvant Chemotherapy in Breast Carcinoma

Predictors of Pathological Complete Response in Women with Clinical Complete Response to Neoadjuvant Chemotherapy in Breast Carcinoma

Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy

The Longitudinal Transcriptional Response to Neoadjuvant Chemotherapy with and without Bevacizumab in Breast Cancer

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