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12th Annual School of Breast Oncology®

12th Annual School of Breast Oncology®


Resources

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PER Pulse™ Recap
Three PER Pulse™ Recaps presenting key topics from the 12th Annual School of Breast Oncology®, which was held on November 6 - 8, 2014. 




PER Pulse™ Recap

PER Pulse™ Recap



1 of 3
PER Pulse™ Recap
12th Annual School of Breast Oncology®

The 12th Annual School of Breast Oncology® provided specialized education for oncologists focusing on the treatment of breast cancer. This interactive, curriculum-based program allowed leading clinical investigators to review implications of the latest data relevant to breast cancer biology, diagnostics, prevention, and treatment. This recap, which is the first of 3 PER Pulse™ Recaps summarizing highlights of the program, covers select presentations about biologic subtypes of breast cancer, predictive biomarker testing, and sentinel lymph node (SLN) biopsy and axillary dissection. Highlights included:
  • Biologic Subtypes and Prognostic Factors. Dr Claudine Isaacs reviewed gene expression profiles used to classify patients into distinct breast cancer subtypes. She also commented on the implications of the existing and emerging data supporting the utility of these assays in informing treatment decisions. According to Dr Isaacs, currently available data are strongest for the 21-gene recurrence score (RS), which divides patients into low-, intermediate-, and high-risk groups. This tool was validated using tumor blocks from patients with estrogen receptor (ER)-positive, lymph node (LN)-negative breast cancer who participated in the NSABP B-14 study. A high RS was associated with an approximate 30% 10-year risk of distant recurrence, whereas the risk was only about 7% in low-risk patients. Importantly, patients with a high RS, but not a low RS, benefited from receiving chemotherapy in addition to adjuvant tamoxifen, suggesting that only high-risk patients should receive chemotherapy. Thus, the 21-gene RS has the capacity to predict the benefit of chemotherapy for low- or high-risk patients. Its utility in intermediate-risk patients remains less clear, and the ongoing Intergroup TAILORx trial is currently exploring this issue. The predictive benefit of the RS also remains unclear for ER-positive, LN-positive disease. In the SWOG 8814 trial, the RS divided patients into risk groups, but the low-risk group still had a 40% risk of recurrence when given endocrine therapy without chemotherapy. Therefore, there is a lack of consensus in the field as to how to treat these patients—with or without chemotherapy. The SWOG 1007 RxPONDER trial is under way to investigate this matter.

    Several other gene expression profiles are available, but trials remain ongoing that will determine their therapeutic predictability. Using the Rotterdam Study 70-gene recurrence assay, high-risk patients seemed to benefit from chemotherapy, whereas those with a low risk did not, in a retrospective analysis. These findings are currently being confirmed in the prospective MINDACT trial of LN-negative patients. As another example, the PAM50 gene assay divides patients into the breast cancer intrinsic subtypes and forms a prognosis based on these subtypes. The final example is the Breast Cancer IndexSM (BCI), which consists of 2 independently developed gene expression biomarkers. In a head-to-head analysis, the BCI was a better predictor of late recurrence than the RS or IHC4. These findings indicate that the BCI can potentially help select patients who may benefit from receiving more than 5 years of adjuvant therapy. Indeed, the MA.17 trial showed that patients with a low BCI did not benefit from 5 extra years of endocrine therapy, whereas those with a high BCI did.
     
  • Predictive Biomarker Testing. Given that breast cancer treatment decisions are based on HER2 and hormone receptor (HR) status, Dr Elizabeth Hammond emphasized the importance of being familiar with the most recent ASCO/CAP guidelines for predictive biomarker testing.

    HER2 testing guidelines were updated in 2013. The most important revisions pertained to tissue handling, with surgeons/pathologists now being advised to avoid delaying fixation to preserve the fidelity of receptor expression, to use neutral-buffered formalin (NBF) fixation (as it was used when optimizing most available assays), and to complete fixation within 12 to 24 hours. To obtain tissues, the guidelines recommend using core biopsies and performing confirmatory testing on resection specimens when necessary. In addition, clinicians should test every metastatic site for HER2 expression, given the potential for interlesional heterogeneity. Another notable recommendation was to report HER2 results as positive, negative, or equivocal (ie, needing additional testing), based on expression thresholds.

    The ER/progesterone receptor (PR) guideline algorithm was updated in 2011 and divided patients into HR-positive (>1% of cells staining) and HR-negative groups. Unlike HER2 testing, HR status can be only positive or negative (not equivocal), according to the guidelines. Also recommended was incorporating adequate internal controls into testing protocols to differentiate normal and aberrant breast ER expression.

    Other noteworthy recommendations included surveying an entire biopsy specimen for biomarkers to account for intratumoral heterogeneity and using clinical judgment upon receiving biomarker testing results. If the pathology results seem to contrast with the patient's clinical picture, there should be a discussion between the oncologist and pathologist as to why the discordance exists.
     
  • SLN Biopsy and Axillary Lymph Node Dissection (ALND). Dr Henry Kuerer discussed SLN biopsy, which revolutionized the surgical management of early breast cancer. Although the procedure still has risks, side effects are less common than with ALND, and the procedures have similar efficacy. As demonstrated in the NSABP B-32 and ACOSOG Z0011 trials, SLN biopsy was noninferior to ALND, with respect to preventing recurrence, for patients with node-negative disease. Although the clinical relevance of ACOSOG Z0011 has been called into question due to the overall good prognosis of the patient population and the high rates of adjuvant radiation and systemic therapy, the trial reported that locoregional recurrences occurred in about 4% of patients with ALND and 3% of patients with SLN biopsy. Furthermore, disease-free survival and overall survival were not significantly different between treatment arms. Thus, the more invasive ALND may be withheld for most node-negative patients.

    Despite these findings, Dr Kuerer and his colleagues at MD Anderson do recommend ALND when there is a positive SLN, after mastectomy, for patients who received partial-breast radiotherapy, and for those who received neoadjuvant chemotherapy. However, for patients who are currently receiving neoadjuvant treatment, these recommendations may soon change. Because neoadjuvant therapy is so effective, it may not be necessary to perform an SLN biopsy in all patients. This point is supported by the fact that many patients who receive chemotherapy or HER2-targeted therapy (for HER2-positive patients) convert from being ALN-positive to ALN-negative after systemic treatment. This hypothesis is being tested in the ongoing Alliance A11202 and NSABP B-51/RTOG1304 clinical trials.

    In an effort to optimize ALND, Dr Kuerer and colleagues have developed a technique called targeted axillary dissection, in which they perform an ultrasound-guided fine-needle aspiration (FNA) to identify nodal metastases. Once identified, they place a metallic clip on the node that remains throughout the duration of neoadjuvant therapy. At surgery, they remove the LN with known disease (ie, with clip) and LNs most likely to harbor disease, instead of all axillary LNs.


2 of 3
PER Pulse Recap
12th Annual School of Breast Oncology®

The 12th Annual School of Breast Oncology® provided specialized education for oncologists focusing on the treatment of breast cancer. This interactive, curriculum-based program enabled leading clinical investigators to review implications of the latest data relevant to breast cancer biology, diagnostics, prevention, and treatment. This recap, which is the second of 3 PER Pulse™ Recaps summarizing highlights of the program, covers select presentations about adjuvant chemotherapy and endocrine therapy for premenopausal and postmenopausal patients. Highlights included:

  • Adjuvant chemotherapy. Dr Joyce O’Shaughnessy discussed the role of adjuvant chemotherapy in patients with early breast cancer. In this setting, outcomes have dramatically improved over the years. Some examples include the optimization of anthracyclines, which improve survival in both ER-positive and ER-poor breast cancer, but the benefits are potentially confined to HER2-positive disease. As another example, the use of taxanes has been optimized, with dose-dense and weekly paclitaxel having been shown to prolong survival regardless of ER or HER2 status. Overall, Dr O’Shaughnessy recommended prescribing the most effective adjuvant chemotherapy for biologically aggressive disease regardless of age, with AC/T (doxorubicin plus cyclophosphamide, and then paclitaxel) remaining the standard of care.

  • Adjuvant endocrine therapy. In 2 separate presentations, Dr Joyce O'Shaughnessy and Dr William Gradishar discussed adjuvant endocrine therapy in premenopausal and postmenopausal women, respectively. Although North American guidelines do not currently recommend adding ovarian suppression to endocrine therapy for premenopausal women, findings from the SOFT trial,1 reported a month after Dr O’Shaughnessy’s presentation, provided evidence that ovarian suppression can help reduce the risk of recurrence in high-risk patients who receive chemotherapy.1 For both premenopausal and postmenopausal patients with early breast cancer, the optimal type and duration of adjuvant endocrine therapy continues to be investigated. For women with lymph node-positive and -negative breast cancer, clinical evidence currently supports administering endocrine therapy for 10 years, consisting either of tamoxifen or tamoxifen followed by an aromatase inhibitor (AI). Managing postmenopausal women is not as straightforward and may be dictated by tolerability. These women may receive either tamoxifen, an AI, or one of these first and then the other for up to 10 years of total therapy.

Reference
  • Francis PA, Regan MM, Fleming GF, et al. Randomized comparison of adjuvant tamoxifen (T) plus ovarian function suppression (OFS) versus tamoxifen in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): analysis of the SOFT trial. Presented at: the 2014 San Antonio Breast Cancer Symposium; December 9-13, 2014; San Antonio, TX. Abstract S3-08.



3 of 3
PER Pulse Recap
12th Annual School of Breast Oncology®

The 12th Annual School of Breast Oncology® provided specialized education for oncologists focusing on the treatment of breast cancer. This interactive, curriculum-based program allowed leading clinical investigators to review implications of the latest data relevant to breast cancer biology, diagnostics, prevention, and treatment. This recap, which is the final of 3 PER Pulse™ Recaps summarizing highlights of the program, covers select presentations about hormone-independent and -dependent metastatic breast cancer (MBC) and HER2-positive MBC.

Highlights included:

  • Hormone-independent MBC. In her presentation, Dr. Anne Moore focused on patients with triple-negative and endocrine-refractory MBC, for whom overall survival (OS) is short, with few therapeutic options available. According to ASCO guidelines, these patients should receive sequential single-agent chemotherapy, or for rapidly advancing disease, combination chemotherapy. Although ASCO does not list a preferred agent, eribulin significantly extended OS compared with physician's choice chemotherapy in the EMBRACE study, suggesting that it may be an optimal first-line option. Given the lack of identified mechanisms to target in these patients, ongoing clinical trials investigating agents targeting PARP, HSP90, growth factor receptors, and other pathways may expand the current treatment armamentarium for this type of MBC.
  • Hormone-dependent MBC. Although endocrine therapies (ETs) remain a mainstay of hormone receptor (HR)–positive disease, Dr. Ruth O'Regan discussed recent clinical trials that also support the use of targeted therapies. In the first-line setting, positive clinical trials of palbociclib, a cyclin-dependent kinase (CDK) inhibitor, support its use along with ET. Dasatinib and entinostat, which both inhibit Src, also have demonstrated good clinical activity in newly diagnosed patients. For patients with endocrine resistance, restoring sensitivity to ET may be accomplished by inhibiting the mTOR/PI3K pathway with everolimus. Early clinical trials in the post-everolimus setting suggest that further mTOR/PI3K inhibition may be effective in restoring endocrine sensitivity, as well.
  • HER2-positive MBC. Since trastuzumab become available and increased the OS of patients with HER2-positive MBC, the field has continued to advance. Dr. William Gradishar discussed these advancements, starting with the development of lapatinib, and then pertuzumab and T-DM1. Based on results from the CLEOPATRA clinical trial showing unprecedented increases in OS when pertuzumab was added to docetaxel and trastuzumab, this regimen has become the first-line standard of care for patients with HER2-positive MBC. In previously treated patients, T-DM1 has demonstrated efficacy in the TH3RESA and EMILIA trials and is currently under investigation in the first-line setting, as well. In addition, everolimus and neratinib, are currently being examined for their potential utility in patients who acquire resistance to HER2-targeted therapies.

To learn about the other breast cancer topics discussed at the 12th Annual School of Breast Oncology®, visit www.gotoper.com for the full proceedings.


Physicians' Education Resource®, LLC is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

This activity is not approved for AMA PRA Category 1 Credit™.

Supported by educational grants from Celgene Corporation, EISAI, Genentech, and Novartis Oncology.
 







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