Frequent Pathologic Complete Responses in Aggressive Stages II to III Breast Cancers With Every-4-Week Carboplatin and Weekly Paclitaxel With or Without Trastuzumab: A Brown University Oncology Group Study

Sikov, William M.; Dizon, Don S.; Strenger, Rochelle; Legare, Robert D.; Theall, Kathy Puyana; Graves, Theresa A.; Gass, Jennifer; Kennedy, T. A.; Fenton, Mary Anne

doi:10.1200/jco.2008.21.4163

Cited by 100 publications

(67 citation statements)

References 49 publications

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“…Neoadjuvant trastuzumab plus chemotherapy demonstrated a significant increase in pCR rates (15.7% vs. 31.7%; P < 0.001). pCR rates with neoadjuvant trastuzumab and anthracycline-free regimens in other studies range from 11% to 76% 22,24,25,[30][31][32][33][34][35] .…”

Section: Discussionmentioning

confidence: 99%

“…Several trials have examined the potential benefits of concurrent trastuzumab in combination with anthracycline-based 11,12,[18][19][20][21] or non-anthracycline-based neoadjuvant therapy [22][23][24][25][26][27][28][29] in HER2-positive breast cancer, with reported pCR rates of up to 76% 30 . In this retrospective non-randomized study, we showed that while TCH is active, trastuzumab combined with a taxane and then with an anthracycline (PH-FECH) shows higher pCR rate.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy of neoadjuvant therapy with trastuzumab concurrent with anthracycline- and nonanthracycline-based regimens for HER2-positive breast cancer.

Bayraktar¹,

González-Angulo²,

Lei³

et al. 2011

JCO

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Efficacy of neoadjuvant therapy with trastuzumab concurrent with anthracycline- and nonanthracycline-based regimens for HER2-positive breast cancer.

Bayraktar¹,

González-Angulo²,

Lei³

et al. 2011

JCO

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“…For example, gene-expression profiling of breast cancer in the early 2000s suggested that TNBC shares molecular features with basallike BRCA-1 tumors, and TNBC is likely to be sensitive to DNA cross-linking agents such as cisplatin (15). Subsequently, various small neoadjuvant trials testing cisplatin observed a high path CR rate with platinum therapy suggesting it merits further evaluation (16,17 (19)(20)(21). In contrast, the phase III neoadjuvant trastuzumab trial, NOAH, enrolled 334 patients and successfully demonstrated that neoadjuvant trastuzumab in combination with chemotherapy resulted in a significantly higher path CR rate (43% vs. 23%, P ¼ 0.002) than chemotherapy alone (22).…”

Section: Rationale For Drug Development In the Neoadjuvant Settingmentioning

confidence: 99%

Neoadjuvant Therapy as a Platform for Drug Development and Approval in Breast Cancer

Bardia

Baselga

2013

Clinical Cancer Research

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The traditional drug development process in breast cancer based on large phase III studies has serious limitations and needs a major overhaul. Searching for new approaches, the testing of novel agents in the preoperative (neoadjuvant) setting approach offers a potentially rapid and efficient strategy for drug development utilizing pathologic complete response (path CR), a surrogate marker for survival, as the primary endpoint. In addition, neoadjuvant studies allow the assessment of drug effects on the target (pharmacodynamic response) and the development of predictive biomarkers of response. Molecular profiling of the residual tumor in the surgical specimen may also provide insights into actionable mechanisms of resistance. Recognizing the potential of neoadjuvant trials for drug development, the U.S. Food and Drug Administration (FDA) recently announced consideration of neoadjuvant trials for accelerated drug approval in early breast cancer, particularly for tumors with high risk of recurrence and unfavorable prognosis, and provided accelerated approval to neoadjuvant pertuzumab in September 2013. The FDA has emphasized that while improvement in path CR could be utilized for "accelerated" approval, improvement in survival will still need to be demonstrated for "regular" approval. Key considerations in conduct of such neoadjuvant drug development trials include (i) study design such as utilization of biomarker stratified design to evaluate a biomarker that could enrich response, (ii) definition of path CR, (iii) distribution of factors that influence path CR between the treatment arms, (iv) prespecified plan for follow-up to obtain data on survival, and (v) safety as it involves a patient population with curable disease. In the years to come, we anticipate an increase in the number of neoadjuvant trials testing novel therapies that hopefully will open a new path in bringing efficacious new therapies to patients with breast cancer.

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“…Most importantly, BRCA1 hypermethylation proves to be a predictor of longer time to relapse and improved OS in ovarian cancer patients undergoing chemotherapy with cisplatin [39] . Under this perspective single agent cisplatin NACT resulted in pCR in 21% of patients with TNBC [40] , while carboplatin and taxane combinations resulted in even greater response rates [41,42] . Despite taxane-and anthracycline-based regimens remain the mainstay for TNBC neoadjuvant treatment, these encouraging results indicate that carboplatin-taxane regimens could be a very efficacious non-anthracycline containing combination.…”

Section: Neoadjuvant Chemotherapy In Tnbcmentioning

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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Frequent Pathologic Complete Responses in Aggressive Stages II to III Breast Cancers With Every-4-Week Carboplatin and Weekly Paclitaxel With or Without Trastuzumab: A Brown University Oncology Group Study

Cited by 100 publications

References 49 publications

Efficacy of neoadjuvant therapy with trastuzumab concurrent with anthracycline- and nonanthracycline-based regimens for HER2-positive breast cancer.

Efficacy of neoadjuvant therapy with trastuzumab concurrent with anthracycline- and nonanthracycline-based regimens for HER2-positive breast cancer.

Neoadjuvant Therapy as a Platform for Drug Development and Approval in Breast Cancer

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

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