المؤلفون: Friedman, Claire F., D'Souza, Anishka, Bello Roufai, Diana, Tinker, Anna V., de Miguel, Maria, Gambardella, Valentina, Goldman, Jonathan, Loi, Sherene, Melisko, Michelle E., Oaknin, Ana, Spanggaard, Iben, Shapiro, Geoffrey I., ElNaggar, Adam C., Panni, Stefano, Ravichandran, Vignesh, Frazier, Aimee L., DiPrimeo, Daniel, Eli, Lisa D., Solit, David B.

المساهمون: Cycle for Survival, Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Puma Biotechnology Inc

المصدر: Gynecologic Oncology ; volume 181, page 162-169 ; ISSN 0090-8258

مصطلحات موضوعية: Obstetrics and Gynecology, Oncology

الإتاحة: https://doi.org/10.1016/j.ygyno.2023.12.004Test
https://api.elsevier.com/content/article/PII:S0090825823016013?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S0090825823016013?httpAccept=text/plainTest

المؤلفون: Gumusay, Ozge, Huppert, Laura A., Magbanua, Mark Jesus M., Wabl, Chiara A., Assefa, Michael, Chien, Amy Jo, Melisko, Michelle E., Majure, Melanie C., Moasser, Mark, Park, John, Rugo, Hope S.

المساهمون: Eisai Incorporated

المصدر: Breast Cancer Research and Treatment ; volume 203, issue 2, page 197-204 ; ISSN 0167-6806 1573-7217

مصطلحات موضوعية: Cancer Research, Oncology

الوصف: Purpose We hypothesized that eribulin combined with cyclophosphamide (EC) would be an effective combination with tolerable toxicity for the treatment of advanced breast cancer (ABC). Methods Patients with histologically confirmed metastatic or unresectable ABC with any number of prior lines of therapy were eligible to enroll. In the dose escalation cohort, dose level 0 was defined as eribulin 1.1 mg/m 2 and cyclophosphamide 600 mg/m 2 , and dose level 1 was defined as eribulin 1.4 mg/m 2 and cyclophosphamide 600 mg/m 2 . Eribulin was given on days 1 and 8 and cyclophosphamide on day 1 of a 21-day cycle. In the dose expansion cohort, enrollment was expanded at dose level 1. The primary objective was clinical benefit rate (CBR), and secondary objectives were response rate (RR), duration of response (DOR), progression-free survival (PFS), and safety. Results No dose-limiting toxicities were identified in the dose escalation cohort (n = 6). In the dose expansion cohort, an additional 38 patients were enrolled for a total of 44 patients, including 31 patients (70.4%) with hormone receptor-positive (HR +)/HER2- disease, 12 patients (27.3%) with triple-negative breast cancer (TNBC), and 1 patient (2.3%) with HR + /HER2 + disease. Patients had a median age of 56 years (range 33–82 years), 1 prior line of hormone therapy (range 0–6), and 2 prior lines of chemotherapy (range 0–7). CBR was 79.5% (35/44; 7 partial response, 28 stable disease) and the median DOR was 16.4 weeks (range 13.8–21.1 weeks). Median PFS was 16.4 weeks (95% CI: 13.8–21.1 weeks). The most common grade 3/4 adverse event was neutropenia (47.7%, n = 21). Fourteen of 26 patients (53.8%) with circulating tumor cell (CTC) data were CTC-positive ( $$\ge$$ ≥ 5 CTC/7.5 mL) at baseline. Median PFS was shorter in patients who were CTC-positive vs. negative (13.1 vs 30.6 weeks, p = 0.011). Conclusion In heavily pretreated patients with ABC, treatment with EC resulted in an encouraging CBR of 79.5% and PFS of 16.4 weeks, which compares favorably to ...

الإتاحة: https://doi.org/10.1007/s10549-023-07073-0Test

المؤلفون: Abel, Mary Kathryn, Melisko, Michelle E., Rugo, Hope S., Chien, A. Jo, Diaz, Italia, Levine, Julia K., Griffin, Ann, McGuire, Joseph, Esserman, Laura J., Borno, Hala T., Mukhtar, Rita A.

المصدر: npj Breast Cancer ; volume 7, issue 1 ; ISSN 2374-4677

مصطلحات موضوعية: Pharmacology (medical), Radiology, Nuclear Medicine and imaging, Oncology

الوصف: Enrollment in metastatic breast cancer trials usually requires measurable lesions, but patients with invasive lobular carcinoma (ILC) tend to form diffuse disease. We found that the proportion of patients with metastatic ILC enrolled in clinical trials at our institution was significantly lower than that of patients with invasive ductal carcinoma (IDC). Possible links between requiring measurable disease and decreased enrollment of ILC patients require further study to ensure equitable trial access.

الإتاحة: https://doi.org/10.1038/s41523-021-00348-zTest
https://www.nature.com/articles/s41523-021-00348-z.pdfTest
https://www.nature.com/articles/s41523-021-00348-zTest

المؤلفون: Heath, Courtney Lawhn, Esserman, Laura J., Flavell, Robert R., Melisko, Michelle E.

المصدر: Journal of the National Comprehensive Cancer Network ; volume 19, issue 8, page xxx-xxxii ; ISSN 1540-1405 1540-1413

مصطلحات موضوعية: Oncology

الإتاحة: https://doi.org/10.6004/jnccn.2021.7080Test
https://jnccn.org/view/journals/jnccn/19/8/article-pxxx_2.xmlTest
https://jnccn.org/downloadpdf/journals/jnccn/19/8/article-pxxx_2.xmlTest

المؤلفون: Melisko, Michelle E., Goldman, Mindy, Rugo, Hope S.

المصدر: Journal of Cancer Survivorship: Research and Practice. 4(3)

مصطلحات موضوعية: Medicine & Public Health, Primary Care Medicine, Quality of Life Research, Health Informatics, Health Promotion and Disease Prevention, Oncology, Public Health/Gesundheitswesen, Breast cancer, Estrogen, Libido, Sexual dysfunction, Testosterone, Vaginal dryness

الوصف: As the number of breast cancer survivors increases, the long term consequences of breast cancer treatment are gaining attention. Sexual dysfunction is a common complaint amongst breast cancer survivors, and there are few evidence based recommendations and even fewer well designed clinical trials to establish what treatments are safe or effective in this patient population.We conducted a PubMed search for articles published between 1995–2009 containing the terms breast cancer, sexual dysfunction, libido, vaginal dryness, testosterone, and vaginal estrogen. We initially reviewed articles focusing exclusively on sexual issues in breast cancer patients. Given the paucity of clinical trials addressing sexual issues in breast cancer patients, we also included studies evaluating both hormone and non-hormone based interventions for sexual dysfunction in post-menopausal women in general.Among breast cancer survivors, vaginal dryness and loss of libido represent some of the most challenging long term side effects of breast cancer treatment. In the general post-menopausal population, topical preparations of estrogens and testosterone both appear to improve sexual function; however there are conflicting reports about the efficacy and safety of these interventions in women with a history of breast cancer, and further research is warranted.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/3905k9c0Test

المؤلفون: Huppert, Laura A., Walker, Zak, Li, Moming, Kim, Mi-Ok, Callan, Jennifer, Brandman, Danielle, Majure, Melanie, Melisko, Michelle E., Rugo, Hope S., Behr, Spencer, Chien, A. Jo

المصدر: Breast Cancer Research and Treatment ; volume 197, issue 1, page 137-148 ; ISSN 0167-6806 1573-7217

مصطلحات موضوعية: Cancer Research, Oncology

الإتاحة: https://doi.org/10.1007/s10549-022-06771-5Test

المؤلفون: Ganz, Patricia A., Hahn, Erin E., Petersen, Laura, Melisko, Michelle E., Pierce, John P., Von Friederichs-Fitzwater, Marlene, Lane, Karen T., Hiatt, Robert A.

المصدر: Clinical Breast Cancer ; volume 16, issue 5, page 356-363 ; ISSN 1526-8209

مصطلحات موضوعية: Cancer Research, Oncology

الإتاحة: https://doi.org/10.1016/j.clbc.2016.05.003Test
https://api.elsevier.com/content/article/PII:S1526820916300994?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1526820916300994?httpAccept=text/plainTest

المؤلفون: I-SPY2 Trial Consortium, Yee, Douglas, DeMichele, Angela M, Yau, Christina, Isaacs, Claudine, Symmans, W Fraser, Albain, Kathy S, Chen, Yunn-Yi, Krings, Gregor, Wei, Shi, Harada, Shuko, Datnow, Brian, Fadare, Oluwole, Klein, Molly, Pambuccian, Stefan, Chen, Beiyun, Adamson, Kathi, Sams, Sharon, Mhawech-Fauceglia, Paulette, Magliocco, Anthony, Feldman, Mike, Rendi, Mara, Sattar, Husain, Zeck, Jay, Ocal, Idris T, Tawfik, Ossama, LeBeau, Lauren Grasso, Sahoo, Sunati, Vinh, Tuyethoa, Chien, A Jo, Forero-Torres, Andres, Stringer-Reasor, Erica, Wallace, Anne M, Pusztai, Lajos, Boughey, Judy C, Ellis, Erin D, Elias, Anthony D, Lu, Janice, Lang, Julie E, Han, Hyo S, Clark, Amy S, Nanda, Rita, Northfelt, Donald W, Khan, Qamar J, Viscusi, Rebecca K, Euhus, David M, Edmiston, Kirsten K, Chui, Stephen Y, Kemmer, Kathleen, Park, John W, Liu, Minetta C, Olopade, Olufunmilayo, Leyland-Jones, Brian, Tripathy, Debasish, Moulder, Stacy L, Rugo, Hope S, Schwab, Richard, Lo, Shelly, Helsten, Teresa, Beckwith, Heather, Haugen, Patricia, Hylton, Nola M, Van't Veer, Laura J, Perlmutter, Jane, Melisko, Michelle E, Wilson, Amy, Peterson, Garry, Asare, Adam L, Buxton, Meredith B, Paoloni, Melissa, Clennell, Julia L, Hirst, Gillian L, Singhrao, Ruby, Steeg, Katherine, Matthews, Jeffrey B, Asare, Smita M, Sanil, Ashish, Berry, Scott M, Esserman, Laura J, Berry, Donald A

المصدر: Articles, Abstracts, and Reports

مصطلحات موضوعية: Oncology, Pathology

الوصف: Importance: Pathologic complete response (pCR) is a known prognostic biomarker for long-term outcomes. The I-SPY2 trial evaluated if the strength of this clinical association persists in the context of a phase 2 neoadjuvant platform trial. Objective: To evaluate the association of pCR with event-free survival (EFS) and pCR with distant recurrence-free survival (DRFS) in subpopulations of women with high-risk operable breast cancer treated with standard therapy or one of several novel agents. Design, Setting, and Participants: Multicenter platform trial of women with operable clinical stage 2 or 3 breast cancer with no prior surgery or systemic therapy for breast cancer; primary tumors were 2.5 cm or larger. Women with tumors that were ERBB2 negative/hormone receptor (HR) positive with low 70-gene assay score were excluded. Participants were adaptively randomized to one of several different investigational regimens or control therapy within molecular subtypes from March 2010 through 2016. The analysis included participants with follow-up data available as of February 26, 2019. Interventions: Standard-of-care neoadjuvant therapy consisting of taxane treatment with or without (as control) one of several investigational agents or combinations followed by doxorubicin and cyclophosphamide. Main Outcomes and Measures: Pathologic complete response and 3-year EFS and DRFS. Results: Of the 950 participants (median [range] age, 49 [23-77] years), 330 (34.7%) achieved pCR. Three-year EFS and DRFS for patients who achieved pCR were both 95%. Hazard ratios for pCR vs non-pCR were 0.19 for EFS (95% CI, 0.12-0.31) and 0.21 for DRFS (95% CI, 0.13-0.34) and were similar across molecular subtypes, varying from 0.14 to 0.18 for EFS and 0.10 to 0.20 for DRFS. Conclusions and Relevance: The 3-year outcomes from the I-SPY2 trial show that, regardless of subtype and/or treatment regimen, including 9 novel therapeutic combinations, achieving pCR after neoadjuvant therapy implies approximately an 80% reduction in recurrence rate. The ...

العلاقة: https://digitalcommons.psjhealth.org/publications/3361Test; https://pubmed.ncbi.nlm.nih.gov/32701140Test

الإتاحة: https://digitalcommons.psjhealth.org/publications/3361Test
https://pubmed.ncbi.nlm.nih.gov/32701140Test

المؤلفون: Freedman, Rachel A., Gelman, Rebecca S., Agar, Nathalie Y.R., Santagata, Sandro, Randall, Elizabeth C., Gimenez-Cassina Lopez, Begoña, Connolly, Roisin M., Dunn, Ian F., Van Poznak, Catherine H., Anders, Carey K., Melisko, Michelle E., Silvestri, Kelly, Cotter, Christine M., Componeschi, Kathryn P., Marte, Juan M., Moy, Beverly, Blackwell, Kimberly L., Puhalla, Shannon L., Ibrahim, Nuhad, Moynihan, Timothy J., Nangia, Julie, Tung, Nadine, Burns, Robyn, Rimawi, Mothaffar F., Krop, Ian E., Wolff, Antonio C., Winer, Eric P., Lin, Nancy U.

المساهمون: Puma Biotechnology, Eisai, Novartis, Nektar, Lilly, Merck, Merrimack, Genentech, Macrogenics, Bayer, Paxman Coolers Ltd, Pfizer, GSK, Kadmon, Array BioPharma, American Cancer Society, Breast Cancer Research Foundation, Harvard Cancer Center, National Institutes of Health, Dana-Farber Cancer Institute PLGA

المصدر: Clinical Breast Cancer ; volume 20, issue 2, page 145-151.e2 ; ISSN 1526-8209

مصطلحات موضوعية: Cancer Research, Oncology

الإتاحة: https://doi.org/10.1016/j.clbc.2019.07.011Test
https://api.elsevier.com/content/article/PII:S1526820919306573?httpAccept=text/xmlTest
https://api.elsevier.com/content/article/PII:S1526820919306573?httpAccept=text/plainTest

المؤلفون: Chien, A Jo, Tripathy, Debasish, Albain, Kathy S, Symmans, W Fraser, Rugo, Hope S, Melisko, Michelle E, Wallace, Anne M, Schwab, Richard, Helsten, Teresa, Forero-Torres, Andres, Stringer-Reasor, Erica, Ellis, Erin D, Kaplan, Henry G, Nanda, Rita, Jaskowiak, Nora, Murthy, Rashmi, Godellas, Constantine, Boughey, Judy C, Elias, Anthony D, Haley, Barbara B, Kemmer, Kathleen, Isaacs, Claudine, Clark, Amy S, Lang, Julie E, Lu, Janice, Korde, Larissa, Edmiston, Kirsten K, Northfelt, Donald W, Viscusi, Rebecca K, Yee, Douglas, Perlmutter, Jane, Hylton, Nola M, Van't Veer, Laura J, DeMichele, Angela, Wilson, Amy, Peterson, Garry, Buxton, Meredith B, Paoloni, Melissa, Clennell, Julia, Berry, Scott, Matthews, Jeffrey B, Steeg, Katherine, Singhrao, Ruby, Hirst, Gillian L, Sanil, Ashish, Yau, Christina, Asare, Smita M, Berry, Donald A, Esserman, Laura J

المصدر: Articles, Abstracts, and Reports

مصطلحات موضوعية: Oncology

الوصف: PURPOSE: The phosphatidylinositol 3-kinase/Akt/mammalian target of rapamycin is a key pathway of survival and therapeutic resistance in breast cancer. We evaluated the pan-Akt inhibitor MK-2206 in combination with standard therapy in patients with high-risk early-stage breast cancer. PATIENTS AND METHODS: I-SPY 2 is a multicenter, phase II, open-label, adaptively randomized neoadjuvant platform trial that screens experimental therapies and efficiently identifies potential predictive biomarker signatures. Patients are categorized by human epidermal growth factor receptor 2 (HER2), hormone receptor (HR), and MammaPrint statuses in a 2 × 2 × 2 layout. Patients within each of these 8 biomarker subtypes are adaptively randomly assigned to one of several experimental therapies, including MK-2206, or control. Therapies are evaluated for 10 biomarker signatures, each of which is a combination of these subtypes. The primary end point is pathologic complete response (pCR). A therapy graduates with one or more of these signatures if and when it has an 85% Bayesian predictive probability of success in a hypothetical phase III trial, adjusting for biomarker covariates. Patients in the current report received standard taxane- and anthracycline-based neoadjuvant therapy without (control) or with oral MK-2206 135 mg/week. RESULTS: MK-2206 graduated with 94 patients and 57 concurrently randomly assigned controls in 3 graduation signatures: HR-negative/HER2-positive, HR-negative, and HER2-positive. Respective Bayesian mean covariate-adjusted pCR rates and percentage probability that MK-2206 is superior to control were 0.48:0.29 (97%), 0.62:0.36 (99%), and 0.46:0.26 (94%). In exploratory analyses, MK-2206 evinced a numerical improvement in event-free survival in its graduating signatures. The most significant grade 3-4 toxicity was rash (14% maculopapular, 8.6% acneiform). CONCLUSION: The Akt inhibitor MK-2206 combined with standard neoadjuvant therapy resulted in higher estimated pCR rates in HR-negative and HER2-positive breast ...

العلاقة: https://digitalcommons.psjhealth.org/publications/2881Test; https://www.ncbi.nlm.nih.gov/pubmed/32031889Test

الإتاحة: https://digitalcommons.psjhealth.org/publications/2881Test
https://www.ncbi.nlm.nih.gov/pubmed/32031889Test