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Phase II trial of nivolumab with chemotherapy as neoadjuvant treatment in inflammatory breast cancer. [Meeting Abstract]

Kwa, Maryann J.; Tray, Nancy; Esteva, Francisco J.; Novik, Yelena; Speyer, James L.; Oratz, Ruth; Meyers, Marleen Iva; Muggia, Franco; Ty, Victor; Troxel, Andrea; Schneider, Robert; Adams, Sylvia
ISSN: 0732-183x
CID: 5197792

Serial immunological parameters in a phase II trial of exemestane and low-dose oral cyclophosphamide in advanced hormone receptor-positive breast cancer

Kwa, Maryann; Li, Xiaochun; Novik, Yelena; Oratz, Ruth; Jhaveri, Komal; Wu, Jennifer; Gu, Ping; Meyers, Marleen; Muggia, Franco; Speyer, James; Iwano, Alyssa; Bonakdar, Maryam; Kozhaya, Lina; Tavukcuoglu, Ece; Budan, Bahar; Raad, Roy; Goldberg, Judith D; Unutmaz, Derya; Adams, Sylvia
BACKGROUND AND PURPOSE: Resistance to endocrine therapies in hormone receptor (HR)-positive breast cancer is a significant challenge. Prior studies have shown that low-dose oral cyclophosphamide can transiently deplete regulatory T cells (Tregs) and improve anti-tumor immunity. We investigated the combination of exemestane with cyclophosphamide in patients with advanced HR-positive breast cancer and assessed changes in circulating immune cell subsets. METHODS: This was a single-arm phase II trial of exemestane with cyclophosphamide in patients with metastatic HR-positive/HER2-negative breast cancer who had progressed on prior endocrine therapy ( NCT01963481). Primary endpoint was progression-free survival (PFS) at 3 months (RECIST 1.1). Secondary objectives included median PFS, objective response rate, duration of response, and safety. Circulating Tregs (FOXP3+Helios+) and other immune cell subsets were monitored during treatment and compared with healthy controls. RESULTS: Twenty-three patients were enrolled. Treatment was well tolerated, without grade 4/5 toxicities. Objective responses were seen in 6/23 patients (26.1%; 95% CI 10.2-48.4%) and were durable (median 11.6 months). Three-month PFS rate was 50.1% (95% CI 33.0-76.0%); median PFS was 4.23 months (95% CI 2.8-11.7). No treatment-related decrease in Tregs was observed. However, elevated baseline levels of Naive Tregs [greater than 2.5 (the median of the naive Tregs)] were associated with relative risk of disease progression or death [hazard ratio 11.46 (95% CI 2.32-56.5)]. In addition, the baseline levels of Naive Tregs (adj-p = 0.04), Memory Tregs (adj-p = 0.003), CD4 + Central Memory T cells (adj-p = 0.0004), PD-1 + CD4 + Central Memory T cells (adj-p = 0.008), and PD-1 + CD4 + Effector Memory T cells (adj-p = 0.009) were significantly greater in the patients than in the healthy controls; the baseline levels of %CD4 + Naive T cells (adj-p = 0.0004) were significantly lower in patients compared with healthy controls (n = 40). CONCLUSION: Treg depletion was not observed with low-dose cyclophosphamide when assessed by the specific marker FOXP3 + Helios +; however, baseline naive Tregs were associated with 3-month PFS. Exemestane/cyclophosphamide combination had favorable safety profile with evidence of clinical activity in heavily pretreated patients.
PMID: 29124456
ISSN: 1573-7217
CID: 2772912

Phase II trial of pembrolizumab in combination with nab-paclitaxel in patients with metastatic HER2-negative breast cancer [Meeting Abstract]

Kwa, Maryann J.; Iwano, Alyssa; Esteva, Francisco J.; Novik, Yelena; Speyer, James L.; Oratz, Ruth; Meyers, Marleen Iva; Axelrod, Deborah M.; Hogan, Rebecca; Mendoza, Sandra; Goldberg, Judith D.; Muggia, Franco; Adams, Sylvia
ISSN: 0732-183x
CID: 3726432


Seidman, Carly J; Finger, Paul T; Silverman, Joshua S; Oratz, Ruth
PURPOSE: To report a case of neovascular and angle closure glaucoma secondary to breast cancer metastatic to the iris that was successfully treated with injections of intravitreal bevacizumab (Avastin) 1.25 mg/0.05 mL. METHODS: Case report. PATIENTS: A 47-year-old woman with metastatic breast cancer presented to The New York Eye Cancer Center with left ocular pain, photosensitivity, vision loss, and multiple iris nodules. Her intraocular pressure was uncontrolled. Gonioscopy revealed neovascularization of the iris and angle; no choroidal neovascularization was noted. Ultrasound biomicroscopy demonstrated tumor invasion of iris stroma with marked anterior uveal thickening and narrowed angles. RESULTS: Three monthly injections of intravitreal bevacizumab resulted in nearly complete resolution of iris neovascularization, reduction of intraocular pressure, and control of tumor (although a small amount of residual tumor remained). CONCLUSION: Intravitreal anti-vascular endothelial growth factor therapy for breast cancer metastatic to the iris with secondary neovascular glaucoma provided good local control for a limited follow-up period, because the patient died because of systemic complications of her disease.
PMID: 26862924
ISSN: 1937-1578
CID: 2044842

Phase II trial of exemestane with immunomodulatory oral cyclophosphamide in metastatic hormone receptor (HR)-positive breast cancer: Prolonged progression-free survival (PFS) in patients with distinct T regulatory cell (Treg) profile [Meeting Abstract]

Kwa, M; Novik, Y; Oratz, R; Jhaveri, K; Wu, J; Gu, P; Meyers, M; Muggia, F; Bonakdar, M; Abidoglu, C; Kozhaya, L; Li, X; Joseph, B; Iwano, A; Friedman, K; Goldberg, JD; Unutmaz, D; Adams, S
ISSN: 1538-7445
CID: 2411072

A Phase I-II Study of Adjuvant Concurrent Carboplatin and Accelerated Radiation Therapy for Triple Negative Breast Cancer: Updated Results [Meeting Abstract]

Golden, EB; Chhabra, AM; Fenton-Kerimian, MB; Novik, Y; Oratz, R; Speyer, J; Formenti, SC
ISSN: 1879-355x
CID: 2097822

Clinical Trial Evidence of the Antitumor Activity of Topical Imiquimod for Breast Cancer Skin Metastases [Letter]

Adams, Sylvia; Novik, Yelena; Oratz, Ruth; Axelrod, Deborah; Speyer, James; Tiersten, Amy; Goldberg, Judith D; Bhardwaj, Nina; Unutmaz, Derya; Demaria, Sandra; Formenti, Silvia
PMID: 25092780
ISSN: 0732-183x
CID: 1105352

Cancer Risk Assessment Using Genetic Panel Testing: Considerations for Clinical Application

Hiraki, Susan; Rinella, Erica S; Schnabel, Freya; Oratz, Ruth; Ostrer, Harry
With the completion of the Human Genome Project and the development of high throughput technologies, such as next-generation sequencing, the use of multiplex genetic testing, in which multiple genes are sequenced simultaneously to test for one or more conditions, is growing rapidly. Reflecting underlying heterogeneity where a broad range of genes confer risks for one or more cancers, the development of genetic cancer panels to assess these risks represents just one example of how multiplex testing is being applied clinically. There are a number of issues and challenges to consider when conducting genetic testing for cancer risk assessment, and these issues become exceedingly more complex when moving from the traditional single-gene approach to panel testing. Here, we address the practical considerations for clinical use of panel testing for breast, ovarian, and colon cancers, including the benefits, limitations and challenges, genetic counseling issues, and management guidelines.
PMID: 24599651
ISSN: 1059-7700
CID: 958122

Novel Combination of Toll-Like Receptor (TLR)-7 Agonist Imiquimod and Local Radiation Therapy in the Treatment of Metastatic Breast Cancer Involving the Skin or Chest Wall [Meeting Abstract]

Vatner, R. ; Demaria, S. ; Fenton-Kerimian, M. ; Novik, Y. ; Oratz, R. ; Tiersten, A. ; Goldberg, J. D. ; Adams, S. ; Formenti, S.
ISSN: 0360-3016
CID: 657332

Novel combination of toll-like receptor (TLR)-7 agonist imiquimod and local radiotherapy in the treatment of breast cancer chest wall recurrences or skin metastases [Meeting Abstract]

Janosky, Maxwell Dale; Demaria, Sandra; Novik, Yelena; Oratz, Ruth; Tiersten, Amy; Goldberg, Judith D; Wang, Ena; Marincola, Francesco; Formenti, Silvia; Adams, Sylvia
ISSN: 1527-7755
CID: 1675612