Is It Important to Adapt Neoadjuvant Chemotherapy to the Visible Clinical Response? An Open Randomized Phase II Study Comparing Response-Guided and Standard Treatments in HER2-Negative Operable Breast Cancer

Wang-Lopez, Q.; Mouret-Reynier, Marie-Ange; Savoye, Aude-Marie; Abrial, Catherine; Kwiatkowski, Fabrice; Garbar, Christian; Dubray‐Longeras, Pascale; Eymard, Jean‐Christophe; Lebouedec, Guillaume; Van-Praagh, Isabelle; Penault‐Llorca, Frédérique; Chollet, Philippe; Curé, Hervé

doi:10.1634/theoncologist.2014-0400

Cited by 5 publications

(6 citation statements)

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“…Tumors with estrogen receptor (ER) and/or progesterone receptor (PgR) expression ≥10% by immunohistochemistry (IHC) or positive by reverse transcription polymerase chain reaction (RT-PCR) were considered HR+. For subset designation, the decision to use ≥10% by IHC as a definition of HR positivity is a method consistent with other similar studies (6,7,9). Tumors with HER2 expression of 3+ by IHC or 2+ by IHC with positive gene amplification by fluorescence in situ hybridization (FISH) were considered HER2+.…”

Section: Methodsmentioning

confidence: 96%

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Breast Cancer Subtype Influences the Accuracy of Predicting Pathologic Response by Imaging and Clinical Breast Exam After Neoadjuvant Chemotherapy

Waldrep

Avery

Rose

et al. 2016

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Abstract. Background/Aim: Clinical response evaluation after neoadjuvant chemotherapy (NACT) for breast cancer could include various imaging methods, as well as clinical breast exam (CBE).Neoadjuvant chemotherapy (NACT) for early breast cancer is equivalent to adjuvant chemotherapy in terms of disease-free survival and overall survival (1). The major difference between NACT and adjuvant chemotherapy is the ability to directly observe the treatment effect on the tumor. Clinical response can be assessed throughout the administration of NACT, while pathologic response is revealed upon breast surgery after completion of NACT. A pathologic complete response (pCR) after NACT, defined as no residual invasive breast cancer, translates into an improved long-term prognosis (2, 3).The use of NACT also provides the opportunity to explore the potential value of response-guided therapy for early nonresponders (4-6). An improvement in disease-free survival for hormone receptor (HR)-positive breast cancer using a response-guided NACT regimen has been reported previously (4). On the other end of the spectrum, it could hypothetically be beneficial to identify early responders, who may have reached a complete remission after a shorter duration of therapy than planned. For these patients, completing NACT to the planned number of cycles could be unnecessary and potentially detrimental in terms of toxicity and cost.Routine clinical breast exam (CBE), as well as imaging modalities, such as mammography (MG), ultrasound (US) and magnetic resonance imaging (MRI), have been used to assess clinical response in an attempt to predict pathological response. A meta-analysis revealed that MRI most accurately predicts the amount of residual pathologic disease in nonsubtyped early breast cancer patients when compared to CBE, MG and US (7). Yet, there have been conflicting reports on whether MRI typically underestimates or overestimates the amount of residual disease after NACT (8,9). The routine use of MRI in clinical practice may at times be challenged by a patient's pre-existing conditions, technical feasibility and 5389

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Section: Methodsmentioning

confidence: 96%

“…The use of NACT also provides the opportunity to explore the potential value of response-guided therapy for early nonresponders (4)(5)(6). An improvement in disease-free survival for hormone receptor (HR)-positive breast cancer using a response-guided NACT regimen has been reported previously (4).…”

mentioning

confidence: 96%

Breast Cancer Subtype Influences the Accuracy of Predicting Pathologic Response by Imaging and Clinical Breast Exam After Neoadjuvant Chemotherapy

Waldrep

Avery

Rose

et al. 2016

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“…In a trial conducted by Wang-Lopez et al [ 37 ], a number of 264 previously untreated stage II–III operable patients with breast cancer were randomized to three cycles of 5-fluorouracil-epirubicin-cyclophosphamide combination (FEC), followed by three cycles of docetaxel, or to receive response-guided treatment. In the response-guided arm, the first evaluation occurred after two or four additional cycles of FEC.…”

Section: Adapted Strategies In Natmentioning

confidence: 99%

Recent Advances in the Neoadjuvant Treatment of Breast Cancer

Rubovszky

Horváth

2017

J Breast Cancer

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In the last few decades, neoadjuvant therapy for breast cancer has gained considerable therapeutic importance. Despite extensive clinical investigations, it has not yet been clarified whether neoadjuvant therapy would result in improved survival in comparison with the standard adjuvant setting in any subgroups of patients with breast cancer. Chemotherapy is especially effective in the treatment of endocrine insensitive tumors, and such ther-apeutic benefit can be assumed for patients with triple-negative, or hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-positive breast cancer. However, dose escalation, modification of the therapeutic regimens according to early tumor response, as well as the optimal sequence of administration are still matters of debate. There is a current debate between clinical experts regarding the concomitant and sequential administration of carboplatin and capecitabine, respectively, as part of the standard neoadjuvant treatment, as well as the use of bevacizumab, as part of the preoperative treatment. In case of HER2 positive tumors, an anti-HER2 agent can be administered as part of the preoperative treatment, and according to preliminary clinical data, dual HER2 blockade can also be reasonable. Further, chemotherapy-free regimens can be justified in highly endocrine sensitive tumors, while immune modulating agents may also gain particular importance in the case of certain subtypes of breast cancer. Several small-molecule targeted therapies are under clinical investigation and are expected to provide new neoadjuvant treatment options. However, novel, more predictive biomarkers are required for further evaluation of the neoadjuvant therapies, as well as the effect of novel targeted agents intended to be incorporated into neoadjuvant therapy.

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“…Previous randomized controlled trials (RCTs) have failed to illustrate a signi cant difference in survival outcomes between using the same chemotherapy regimen in neoadjuvant and adjuvant settings [1,2].…”

Section: Introductionmentioning

confidence: 99%

A phase III study of HR-positive/HER2-negative and lymph node-positive breast cancer non- responsive to primary chemotherapy: a randomized clinical trial

Yang

Fan

et al. 2022

Preprint

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Background: We evaluated the use of pathological response-guided non-cross-resistant adjuvant chemotherapy in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-)/lymph node-positive (LN+) breast cancer who were non-responsive to primary chemotherapy. Methods: A multi-center, open-label, randomized, controlled phase III trial was conducted. Patients with HR+/HER2−/LN+ breast cancer and non-responsive to four cycles of neoadjuvant chemotherapy (Miller and Payne grade (G) 1 to G3 or any Miller and Payne grade but with residual positive lymph nodes in surgical specimens) were randomly assigned to receive four cycles of non-cross-resistant regimen plus endocrine therapy, or endocrine therapy alone. Patients with Miller and Payne G4 or G5 and LN− status were assigned to the observation group. Distant disease-free survival was the primary endpoint. Results: Of the 433 patients enrolled between October 2010 and September 2018, 391 were non-responsive to treatment, and the final intention-to-treat analysis comprised 379 patients (chemotherapy plus endocrine therapy group, n=187; endocrine therapy-alone group, n=192). Forty patients responsive to neoadjuvant chemotherapy were assigned to the observation group. After a median follow-up period of 72.4 months, the 5-year distant disease-free survival was 92% (95% confidence interval [CI], 88–96%) and 90% (95% CI, 86–94%) in the chemotherapy plus endocrine therapy and endocrine therapy-alone groups, respectively (hazard ratio 0.79, 95% CI 0.45‒1.37; P=0.401). There was no significant difference between any of the prespecified subgroups. Compared to these two randomized groups, the observation group showed a trend towards better distant disease-free survival (P=0.107). Conclusions: For patients non-responsive to neoadjuvant chemotherapy, adjuvant non-cross-resistant chemotherapy did not significantly improve distant disease-free survival compared to endocrine therapy alone. Trial registration: The trial was registered on November 25, 2009, at ClinicalTrials.gov, and the registration number was NCT01019616. https://clinicaltrials.gov/ct2/show/NCT01019616?term=alternative+non-cross-resistant&draw=2&rank=1

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Is It Important to Adapt Neoadjuvant Chemotherapy to the Visible Clinical Response? An Open Randomized Phase II Study Comparing Response-Guided and Standard Treatments in HER2-Negative Operable Breast Cancer

Cited by 5 publications

References 0 publications

Breast Cancer Subtype Influences the Accuracy of Predicting Pathologic Response by Imaging and Clinical Breast Exam After Neoadjuvant Chemotherapy

Breast Cancer Subtype Influences the Accuracy of Predicting Pathologic Response by Imaging and Clinical Breast Exam After Neoadjuvant Chemotherapy

Recent Advances in the Neoadjuvant Treatment of Breast Cancer

A phase III study of HR-positive/HER2-negative and lymph node-positive breast cancer non- responsive to primary chemotherapy: a randomized clinical trial

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