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Journal of Clinical Oncology | 2014

Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline

Sharon H. Giordano; Sarah Temin; Jeffrey J. Kirshner; Sarat Chandarlapaty; Jennie R. Crews; Nancy E. Davidson; Francisco J. Esteva; Ana M. Gonzalez-Angulo; Ian E. Krop; Jennifer Levinson; Nan Lin; Shanu Modi; Debra A. Patt; Edith A. Perez; Jane Perlmutter; Naren Ramakrishna

PURPOSE To provide evidence-based recommendations to practicing oncologists and others on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. METHODS The American Society of Clinical Oncology convened a panel of medical oncology, radiation oncology, guideline implementation, and advocacy experts and conducted a systematic literature review from January 2009 to October 2012. Outcomes of interest included overall survival, progression-free survival (PFS), and adverse events. RESULTS A total of 16 trials met the systematic review criteria. The CLEOPATRA trial found survival and PFS benefits for docetaxel, trastuzumab, and pertuzumab in first-line treatment, and the EMILIA trial found survival and PFS benefits for trastuzumab emtansine (T-DM1) in second-line treatment. T-DM1 also showed a third-line PFS benefit. One trial reported on duration of HER2-targeted therapy, and three others reported on endocrine therapy for patients with HER-positive advanced breast cancer. RECOMMENDATIONS HER2-targeted therapy is recommended for patients with HER2-positive advanced breast cancer, except for those with clinical congestive heart failure or significantly compromised left ventricular ejection fraction, who should be evaluated on a case-by-case basis. Trastuzumab, pertuzumab, and taxane for first-line treatment and T-DM1 for second-line treatment are recommended. In the third-line setting, clinicians should offer other HER2-targeted therapy combinations or T-DM1 (if not previously administered) and may offer pertuzumab, if the patient has not previously received it. Optimal duration of chemotherapy is at least 4 to 6 months or until maximum response, depending on toxicity and in the absence of progression. HER2-targeted therapy can continue until time of progression or unacceptable toxicities. For patients with HER2-positive and estrogen receptor-positive/progesterone receptor-positive breast cancer, clinicians may recommend either standard first-line therapy or, for selected patients, endocrine therapy plus HER2-targeted therapy or endocrine therapy alone.


Journal of Clinical Oncology | 2014

Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: American Society of Clinical Oncology Clinical Practice Guideline

Naren Ramakrishna; Sarah Temin; Sarat Chandarlapaty; Jennie R. Crews; Nancy E. Davidson; Francisco J. Esteva; Sharon H. Giordano; Ana M. Gonzalez-Angulo; Jeffrey J. Kirshner; Ian E. Krop; Jennifer Levinson; Shanu Modi; Debra A. Patt; Edith A. Perez; Jane Perlmutter; Nan Lin

PURPOSE To provide formal expert consensus-based recommendations to practicing oncologists and others on the management of brain metastases for patients with human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. METHODS The American Society of Clinical Oncology (ASCO) convened a panel of medical oncology, radiation oncology, guideline implementation, and advocacy experts and conducted a systematic review of the literature. When that failed to yield sufficiently strong quality evidence, the Expert Panel undertook a formal expert consensus-based process to produce these recommendations. ASCO used a modified Delphi process. The panel members drafted recommendations, and a group of other experts joined them for two rounds of formal ratings of the recommendations. RESULTS No studies or existing guidelines met the systematic review criteria; therefore, ASCO conducted a formal expert consensus-based process. RECOMMENDATIONS Patients with brain metastases should receive appropriate local therapy and systemic therapy, if indicated. Local therapies include surgery, whole-brain radiotherapy, and stereotactic radiosurgery. Treatments depend on factors such as patient prognosis, presence of symptoms, resectability, number and size of metastases, prior therapy, and whether metastases are diffuse. Other options include systemic therapy, best supportive care, enrollment onto a clinical trial, and/or palliative care. Clinicians should not perform routine magnetic resonance imaging (MRI) to screen for brain metastases, but rather should have a low threshold for MRI of the brain because of the high incidence of brain metastases among patients with HER2-positive advanced breast cancer.


BJUI | 2013

Primary treatments for clinically localised prostate cancer: a comprehensive lifetime cost-utility analysis.

Matthew R. Cooperberg; Naren Ramakrishna; Steven B. Duff; Kathleen Hughes; Sara Sadownik; Joseph A. Smith; Ashutosh Tewari

Multiple treatment alternatives exist for localised prostate cancer, with few high‐quality studies directly comparing their comparative effectiveness and costs. The present study is the most comprehensive cost‐effectiveness analysis to date for localised prostate cancer, conducted with a lifetime horizon and accounting for survival, health‐related quality‐of‐life, and cost impact of secondary treatments and other downstream events, as well as primary treatment choices. The analysis found minor differences, generally slightly favouring surgical methods, in quality‐adjusted life years across treatment options. However, radiation therapy (RT) was consistently more expensive than surgery, and some alternatives, e.g. intensity‐modulated RT for low‐risk disease, were dominated – that is, both more expensive and less effective than competing alternatives.


Radiation Oncology | 2012

Physician self-reported treatment of brain metastases according to patients’ clinical and demographic factors and physician practice setting

Marie-Adele S Kress; Naren Ramakrishna; Solomon B. Makgoeng; Keith R Unger; Arnold L. Potosky

BackgroundLimited data guide radiotherapy choices for patients with brain metastases. This survey aimed to identify patient, physician, and practice setting variables associated with reported preferences for different treatment techniques.Method277 members of the American Society for Radiation Oncology (6% of surveyed physicians) completed a survey regarding treatment preferences for 21 hypothetical patients with brain metastases. Treatment choices included combinations of whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS), and surgery. Vignettes varied histology, extracranial disease status, Karnofsky Performance Status (KPS), presence of neurologic deficits, lesion size and number. Multivariate generalized estimating equation regression models were used to estimate odds ratios.ResultsFor a hypothetical patient with 3 lesions or 8 lesions, 21% and 91% of physicians, respectively, chose WBRT alone, compared with 1% selecting WBRT alone for a patient with 1 lesion. 51% chose WBRT alone for a patient with active extracranial disease or KPS=50%. 40% chose SRS alone for an 80 year-old patient with 1 lesion, compared to 29% for a 55 year-old patient. Multivariate modeling detailed factors associated with SRS use, including availability of SRS within one’s practice (OR 2.22, 95% CI 1.46-3.37).ConclusionsPoor prognostic factors, such as advanced age, poor performance status, or active extracranial disease, correspond with an increase in physicians’ reported preference for using WBRT. When controlling for clinical factors, equipment access was independently associated with choice of SRS. The large variability in preferences suggests that more information about the relative harms and benefits of these options is needed to guide decision-making.


Journal of Clinical Oncology | 2018

Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Clinical Practice Guideline Update

Sharon H. Giordano; Sarah Temin; Sarat Chandarlapaty; Jennie R. Crews; Francisco J. Esteva; Jeffrey J. Kirshner; Ian E. Krop; Jennifer Levinson; Nan Lin; Shanu Modi; Debra A. Patt; Jane Perlmutter; Naren Ramakrishna; Nancy E. Davidson

Purpose To update evidence-based guideline recommendations for practicing oncologists and others on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer to 2018. Methods An Expert Panel conducted a targeted systematic literature review (for both systemic treatment and CNS metastases) and identified 622 articles. Outcomes of interest included overall survival, progression-free survival, and adverse events. Results Of the 622 publications identified and reviewed, no additional evidence was identified that would warrant a change to the 2014 recommendations. Recommendations HER2-targeted therapy is recommended for patients with HER2-positive advanced breast cancer, except for those with clinical congestive heart failure or significantly compromised left ventricular ejection fraction, who should be evaluated on a case-by-case basis. Trastuzumab, pertuzumab, and taxane for first-line treatment and trastuzumab emtansine for second-line treatment are recommended. In the third-line setting, clinicians should offer other HER2-targeted therapy combinations or trastuzumab emtansine (if not previously administered) and may offer pertuzumab if the patient has not previously received it. Optimal duration of chemotherapy is at least 4 to 6 months or until maximum response, depending on toxicity and in the absence of progression. HER2-targeted therapy can continue until time of progression or unacceptable toxicities. For patients with HER2-positive and estrogen receptor-positive/progesterone receptor-positive breast cancer, clinicians may recommend either standard first-line therapy or, for selected patients, endocrine therapy plus HER2-targeted therapy or endocrine therapy alone. Additional information is available at www.asco.org/breast-cancer-guidelines .


Journal of Clinical Oncology | 2018

Recommendations on Disease Management for Patients With Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer and Brain Metastases: ASCO Clinical Practice Guideline Update

Naren Ramakrishna; Sarah Temin; Sarat Chandarlapaty; Jennie R. Crews; Nancy E. Davidson; Francisco J. Esteva; Sharon H. Giordano; Jeffrey J. Kirshner; Ian E. Krop; Jennifer Levinson; Shanu Modi; Debra A. Patt; Jane Perlmutter; Nan Lin

Purpose To update the formal expert consensus-based guideline recommendations for practicing oncologists and others on the management of brain metastases for patients with human epidermal growth factor receptor 2-positive advanced breast cancer to 2018. Methods An Expert Panel conducted a targeted systematic literature review (for both systemic treatment and CNS metastases) and identified 622 articles. Outcomes of interest included overall survival, progression-free survival, and adverse events. In 2014, the American Society of Clinical Oncology (ASCO) convened a panel of medical oncology, radiation oncology, guideline implementation, and advocacy experts, and conducted a systematic review of the literature. When that failed to yield sufficiently strong quality evidence, the Expert Panel undertook a formal expert consensus-based process to produce these recommendations. ASCO used a modified Delphi process. The panel members drafted recommendations, and a group of other experts joined them for two rounds of formal ratings of the recommendations. Results Of the 622 publications identified and reviewed, no additional evidence was identified that would warrant a change to the 2014 recommendations. Recommendations Patients with brain metastases should receive appropriate local therapy and systemic therapy, if indicated. Local therapies include surgery, whole-brain radiotherapy, and stereotactic radiosurgery. Treatments depend on factors such as patient prognosis, presence of symptoms, resectability, number and size of metastases, prior therapy, and whether metastases are diffuse. Other options include systemic therapy, best supportive care, enrollment in a clinical trial, and/or palliative care. Clinicians should not perform routine magnetic resonance imaging to screen for brain metastases, but rather should have a low threshold for magnetic resonance imaging of the brain because of the high incidence of brain metastases among patients with HER2-positive advanced breast cancer. Additional information is available at www.asco.org/breast-cancer-guidelines .


Archive | 2011

Management of Brain Metastases

Naren Ramakrishna

Brain metastases are among the most feared complications of cancer. Improved systemic therapy has resulted in improved survival for patients with metastatic cancer and a rise in incidence of brain metastases, often as a sole site of failure. In this setting, both the efficacy and toxicity of brain metastasis treatment are of even greater importance. While treatment paradigms remain controversial, recent survival and neurocognitive outcomes data have led to a greater emphasis on stereotactic radiosurgery (SRS), and a diminished use of whole-brain radiotherapy both in the initial and recurrent setting. SRS has also proven to be a viable alternative to surgical resection among select patients. As the number of patients and the number of lesions and sessions per patient increases, the comfort and logistics of treatment are of increasing importance. The emergence of image-guided frameless radiosurgery has provided a robust technique for safe and effective treatment of brain metastases with improved patient comfort and treatment logistics.


Breast Cancer Research and Treatment | 2013

A phase I study of lapatinib with whole brain radiotherapy in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancer brain metastases.

Nan Lin; Rachel A. Freedman; Naren Ramakrishna; Jerry Younger; Anna Maria Storniolo; Jennifer R. Bellon; Steven E. Come; Rebecca Gelman; Gordon J. Harris; Mark A. Henderson; Shannon M. MacDonald; Anand Mahadevan; Emily Eisenberg; Jennifer A. Ligibel; Erica L. Mayer; Beverly Moy; April F. Eichler


Journal of Clinical Oncology | 2010

Phase I study of lapatinib (L) in combination with whole-brain radiation therapy (WBRT) in patients (pts) with brain metastases from HER2-positive breast cancer.

Nan Lin; Naren Ramakrishna; W. J. Younger; Anna Maria Storniolo; Steven E. Come; Rebecca Gelman; E. Eisenberg


Journal of Breath Research | 2013

Detection of volatile biomarkers of therapeutic radiation in breath

Michael R. Phillips; Richard Byrnes; Renee N. Cataneo; Anirudh Chaturvedi; Peter D. Kaplan; Mark Libardoni; Vivek Mehta; Mayur Mundada; Urvish Patel; Naren Ramakrishna; Peter B. Schiff; Xiang Zhang

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Sarah Temin

American Society of Clinical Oncology

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Sarat Chandarlapaty

Memorial Sloan Kettering Cancer Center

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Shanu Modi

Memorial Sloan Kettering Cancer Center

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Sharon H. Giordano

University of Texas MD Anderson Cancer Center

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