Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer

Prowell, Tatiana M.; Pazdur, Richard

doi:10.1056/nejmp1205737

Cited by 309 publications

(205 citation statements)

References 22 publications

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“…Recent findings have shed light on this prognostic relationship, which seems to apply especially to patients with HER21, triple-negative (ER2/PR2/ HER22), or high-risk ER1 tumors [28,29]. In fact, regarding drug approval, the Food and Drug Administration has adopted pCR in these patient subgroups as a surrogate marker of longterm treatment efficacy [30]. Thus, a Ki67 index .50% may be predictive of high pCR rates of postneoadjuvant chemotherapy (especially in the ER2/HER22 and ER2/HER21 population).This cutpoint may potentially identify a subpopulation of breast cancer patients with a favorable long-term prognosis after achieving pCR with primary chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

Alba

Lluch²,

Ribelles

et al. 2016

The Oncologist

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Background. In the neoadjuvant setting, changes in the proliferation marker Ki67 are associated with primary endocrine treatment efficacy, but its value as a predictor of response to chemotherapy is still controversial. Patients and Methods. We analyzed 262 patients with centralized basal Ki67 immunohistochemical evaluation derived from 4 GEICAM (Spanish Breast Cancer Group) clinicaltrialsofneoadjuvant chemotherapy for breast cancer. The objective was to identify the optimal threshold for Ki67 using the receiver-operating characteristic curve method to maximize its predictive value for chemotherapy benefit. We also evaluated the predictive role of the defined Ki67 cutoffs for molecular subtypes defined by estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2). Results. A basal Ki67 cutpoint of 50% predicted pathological complete response (pCR). Patients with Ki67 .50% achieved a

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Section: Discussionmentioning

confidence: 99%

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

Alba

Lluch²,

Ribelles

et al. 2016

The Oncologist

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“…The last finding provides one more use for NACT: that of allowing investigators to examine efficacy of new chemotherapeutic regimens, as well as the modulation of biomarkers from initial biopsy to definitive surgery in order to gain approval for new treatments. This is particularly useful for aggressive subtypes of breast cancer, such as TNBC, and this modality has been adopted from regulatory agencies for providing accelerated approval for new drugs since studies based on adjuvant chemotherapy take much more time to be completed [23] .…”

Section: The Rationale Of Neoadjuvant Chemotherapy (Nact)mentioning

confidence: 99%

The recent progress of neoadjuvant chemotherapy in triple negative breast cancer: A short review

Liontos

Karageorgopoulou²,

Michalaki³

et al. 2015

JST

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Triple negative breast cancer (TNBC) encompasses tumors that do not express either the estrogen receptor (ER) or the progesterone receptor (PR) and also do not overexpress the Human Epidermal growth factor Receptor 2 (HER2). This is a heterogenous group of tumors that significantly overlaps with both basal-like tumors and BRCA1/BRCA2 mutationassociated tumors. TNBC is highly aggressive in nature and exhibits worse prognosis than the other subtypes of breast cancer, despite its increased chemosensitivity. Neoadjuvant chemotherapy (NACT) is a treatment option regularly incorporated in clinical practice to improve subsequent surgical management. In parallel, allows rating of the pathological compete response (pCR) which is associated with the prognosis of these patients and evaluates the efficacy of the applied treatment as well. Platinum-based regimens and novel targeted therapies have shown some benefit in TNBC, though an unmet need for improved therapeutic strategies in this patient population still remains. In this review, the latest progresses in NACT in TNBC are discussed, along with the improved understanding of molecular targets and useful biomarkers in this group of patients.

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“…"It's close to 100%. " Encouragingly, the FDA declared in mid-2012 that it would consider accelerated approval for breast-cancer drugs that can eliminate detectable tumour tissue without surgery 4 , based in part on data from trials such as I-SPY 2. In September 2013, the agency issued its first such approval for the neoadjuvant use of pertuzumab, which Roche markets as Perjeta.…”

Section: Open Armsmentioning

confidence: 99%

Clinical trials: More trials, fewer tribulations

Eisenstein¹

2014

Nature

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Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer

Cited by 309 publications

References 22 publications

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

The recent progress of neoadjuvant chemotherapy in triple negative breast cancer: A short review

Clinical trials: More trials, fewer tribulations

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