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Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: MAINTAIN Trial

Kalinsky, Kevin; Accordino, Melissa K; Chiuzan, Codruta; Mundi, Prabhjot S; Sakach, Elizabeth; Sathe, Claire; Ahn, Heejoon; Trivedi, Meghna S; Novik, Yelena; Tiersten, Amy; Raptis, George; Baer, Lea N; Oh, Sun Y; Zelnak, Amelia B; Wisinski, Kari B; Andreopoulou, Eleni; Gradishar, William J; Stringer-Reasor, Erica; Reid, Sonya A; O'Dea, Anne; O'Regan, Ruth; Crew, Katherine D; Hershman, Dawn L
PURPOSE/OBJECTIVE:Cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with endocrine therapy (ET) improves progression-free survival (PFS) and overall survival (OS) in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Although preclinical and clinical data demonstrate a benefit in changing ET and continuing a CDK4/6i at progression, no randomized prospective trials have evaluated this approach. METHODS:In this investigator-initiated, phase II, double-blind placebo-controlled trial in patients with HR+/HER2- MBC whose cancer progressed during ET and CDK4/6i, participants switched ET (fulvestrant or exemestane) from ET used pre-random assignment and randomly assigned 1:1 to the CDK4/6i ribociclib versus placebo. PFS was the primary end point, defined as time from random assignment to disease progression or death. Assuming a median PFS of 3.8 months with placebo, we had 80% power to detect a hazard ratio (HR) of 0.58 (corresponding to a median PFS of at least 6.5 months with ribociclib) with 120 patients randomly assigned using a one-sided log-rank test and significance level set at 2.5%. RESULTS:= .006. At 6 and 12 months, the PFS rate was 41.2% and 24.6% with ribociclib, respectively, compared with 23.9% and 7.4% with placebo. CONCLUSION/CONCLUSIONS:In this randomized trial, there was a significant PFS benefit for patients with HR+/HER2- MBC who switched ET and received ribociclib compared with placebo after previous CDK4/6i and different ET.
PMID: 37207300
ISSN: 1527-7755
CID: 5508142

Impact of the COVID-19 Pandemic on Cancer Care and Quality of Life for Patients With Breast and Gynecologic Malignancies: A Single-Center Survey-Based Study

Berger, Natalie F; Zimmerman, Brittney S; Seidman, Danielle; Cascetta, Krystal P; Moshier, Erin; Nezolosky, Michelle; Trlica, Kara; Ryncarz, Alisa; Keeton, Caitlin; Tiersten, Amy
This study evaluated the mental health and cancer treatment-related impact of the first wave of the COVID-19 pandemic on patients with breast and gynecologic cancers. An 18-question survey was administered in June 2020 at a New York City-based cancer center to assess the quality of life (QOL) and overall health (OH) during both the pandemic time period from March 1, 2020, through June 30, 2020, and the pre-pandemic period (prior to March 1, 2020). Survey questions were answered on a 5-point Likert scale and a 7-point EORTC QLQ-C30 QOL scale. Differences in mean QOL and OH scores were evaluated using a paired t-test. QOL and OH were significantly worsened by the pandemic, with significant increases in anxiety, depression, and mood swings.
PMCID:8850998
PMID: 35187223
ISSN: 2374-3735
CID: 5505412

Association of Insulin Resistance and Higher Oncotype DXâ„¢ Recurrence Score

Gordon, Nicole T; Alberty-Oller, Jaime J; Fei, Kezhen; Greco, Giampaolo; Gallagher, Emily J; LeRoith, Derek; Feldman, Sheldon M; Killilea, Bridgid; Boolbol, Susan K; Choi, Lydia; Friedman, Neil; Pilewskie, Melissa; Port, Elisa; Tiersten, Amy; Bickell, Nina A
BACKGROUND:Black women with breast cancer have a worse overall survival compared with White women; however, no difference in Oncotype DX™ (ODX) recurrence scores has been observed to explain this health disparity. Black women are also disproportionately affected by insulin resistance. We evaluated whether insulin resistance is associated with a higher ODX recurrence score and whether there is a difference between White and Black women to explain disparate clinical outcomes. METHODS:A subgroup analysis of patients in a multi-institutional cross-sectional study evaluating differences in insulin resistance between White and Black women was performed. Women diagnosed with a new hormone receptor-positive, HER2/neu-negative breast cancer with an ODX recurrence score were identified. Fasting blood glucose and insulin measurements were used to calculate the homeostatic model assessment of insulin resistance (HOMA-IR) score, a method for assessing insulin resistance, and compared against ODX scores. RESULTS:, p < 0.0001), higher HOMA-IR score (2.4 vs. 1.4, p = 0.004), and more high-grade tumors (30% vs. 16%, p = 0.01). There was a direct positive association with an increasing ODX score and HOMA-IR (p = 0.014). On subset analysis, this relationship was seen in White women (p = 0.005), but not in Black women (p = 0.55). CONCLUSION/CONCLUSIONS:In women with newly diagnosed breast cancer, increasing insulin resistance is associated with a higher recurrence score; however, this association was not present in Black women. This lack of association may be due to the small number of Black women in the cohort, or possibly a reflection of a different biological disease process of the patient's tumor.
PMID: 33813671
ISSN: 1534-4681
CID: 4838772

Prognostic Factors and Survival Outcomes among Patients with Breast Cancer and Brain Metastases at Diagnosis: A National Cancer Database Analysis

Zimmerman, Brittney S; Seidman, Danielle; Cascetta, Krystal P; Ru, Meng; Moshier, Erin; Tiersten, Amy
INTRODUCTION/BACKGROUND:The aim of this study was to assess for clinicopathologic and socioeconomic features that predict improved survival for patients with advanced breast cancer with synchronous brain metastases at diagnosis. METHODS:We utilized the National Cancer Database (NCDB) to identify all patients with brain metastases present at diagnosis, with adequate information on receptor status (ER, PR, Her2), clinical T stage of cT1-4, clinical M1, with 3,943 patients available for analysis. The association between brain metastases patterns and patient/disease variables was examined by robust Poisson regression model. Cox proportional hazards model was used to quantify the associations between overall survival (OS) and these variables. RESULTS:In univariable analysis, OS was significantly associated with the number of sites of metastases (p < 0.0001). Patients with 2 or more additional extracranial sites of metastases had significantly worse OS (median 8.8 months, 95% confidence interval [CI] 7.8, 9.9) than patients with brain metastases only (median OS 10.6 months, 95% CI 9.4, 12.9) or brain metastases plus one other extracranial site of metastases (median OS 13.1 months, 95% CI 11.8, 14.4). Risk factors which predicted poor prognosis included triple-negative disease, high comorbidity score, poorly differentiated tumors, invasive lobular histology, multi-organ involvement of metastases, and government or lack of insurance. Factors which improve survival include younger age and Hispanic race. DISCUSSION/CONCLUSION/CONCLUSIONS:Using a large NCDB, we identified various factors associated with prognosis for patients with brain metastases at the time of breast cancer diagnosis. Insurance status and related socioeconomic challenges provide potential areas for improvement in care for these patients. This information may help stratify patients into prognostic categories at the time of diagnosis to improve treatment plans.
PMID: 33652435
ISSN: 1423-0232
CID: 5505392

Patient Perception of Telehealth Services for Breast and Gynecologic Oncology Care during the COVID-19 Pandemic: A Single Center Survey-based Study

Zimmerman, Brittney S; Seidman, Danielle; Berger, Natalie; Cascetta, Krystal P; Nezolosky, Michelle; Trlica, Kara; Ryncarz, Alisa; Keeton, Caitlin; Moshier, Erin; Tiersten, Amy
Prior to the coronavirus disease 2019 (COVID-19) pandemic, telehealth was rarely utilized for oncologic care in metropolitan areas. Our large New York City based outpatient breast/gynecologic cancer clinic administered an 18-question survey to patients from March to June 2020, to assess the perceptions of the utility of telehealth medicine. Of the 622 patients, 215 (35%) completed the survey, and of the 215 respondents, 74 (35%) had participated in a telehealth visit. We evaluated the use of telehealth services using the validated Service User Technology Acceptability Questionnaire. Sixty-eight patients (92%) reported that telehealth services saved them time, 54 (73%) reported telehealth increased access to care, and 58 (82%) reported telehealth improved their health. Overall, 67 (92%) of patients expressed satisfaction with the use of telehealth services for oncologic care during the COVID-19 pandemic. Telehealth services should be carefully adopted as an addition to in-person clinical care of patients with cancer.
PMCID:7604367
PMID: 33154829
ISSN: 1738-6756
CID: 4673482

Phase I and pharmacokinetic study of veliparib, a PARP inhibitor, and pegylated liposomal doxorubicin (PLD) in recurrent gynecologic cancer and triple negative breast cancer with long-term follow-up

Pothuri, Bhavana; Brodsky, Allison L; Sparano, Joseph A; Blank, Stephanie V; Kim, Mimi; Hershman, Dawn L; Tiersten, Amy; Kiesel, Brian F; Beumer, Jan H; Liebes, Leonard; Muggia, Franco
OBJECTIVE:Poly(ADP-ribosyl) polymerases (PARPs) are nuclear enzymes with roles in DNA damage recognition and repair. PARP1 inhibition enhances the effects of DNA-damaging agents like doxorubicin. We sought to determine the recommended phase two dose (RP2D) of veliparib with pegylated liposomal doxorubicin (PLD) in breast and recurrent gynecologic cancer patients. METHODS:on day 1 of a 28-day cycle. Dose escalation proceeded in two strata: A (prior PLD exposure) and B (no prior PLD exposure). Patients underwent limited pharmacokinetic (PK) sampling; an expansion PK cohort was added. RESULTS:44 patients with recurrent ovarian or triple negative breast cancer were enrolled. Median age 56 years; 23 patients BRCA mutation carriers; median prior regimens four. Patients received a median of four cycles of veliparib/PLD. Grade 3/4 toxicities were observed in 10% of patients. Antitumor activity was observed in both sporadic and BRCA-deficient cancers. Two BRCA mutation carriers had complete responses. Two BRCA patients developed oral squamous cell cancers after completing this regimen. PLD exposure was observed to be higher when veliparib doses were > 200 mg BID. CONCLUSIONS:PLD on day 1 of a 28-day cycle. Anti-tumor activity was seen in both strata. However, given development of long-term squamous cell cancers and the PK interaction observed, efforts should focus on other targeted combinations to improve efficacy.
PMID: 32055930
ISSN: 1432-0843
CID: 4304612

Molecular Imaging of Apoptosis in Cancer Therapy-Related Cardiac Dysfunction Before LVEF Reduction [Letter]

Nakahara, Takehiro; Petrov, Artiom; Tanimoto, Takashi; Chaudhry, Farhan; Narula, Navneet; Seshan, Surya V; Mattis, Jeffrey A; Pak, Koon Yan; Sahni, Gagan; Bhardwaj, Aarti; Sengupta, Partho P; Tiersten, Amy; Strauss, H William; Narula, Jagat
PMID: 29454766
ISSN: 1876-7591
CID: 3146812

A multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab and pertuzumab in HR-positive, Her2-positive metastatic breast cancer [Meeting Abstract]

Cascetta, Krystal P.; Poulikakos, Poulikos; Shapiro, Charles; Fasano, Julie; Bhardwaj, Aarti; Irie, Hanna; Goel, Anupama; Klein, Paula; Adams, Sylvia; Kalinsky, Kevin; Vahdat, Linda; Ru, Meng; Tiersten, Amy
ISI:000425489400061
ISSN: 0008-5472
CID: 2978552

`Tc-99m-Duramycin imaging detects cancer therapy related cardiac dysfunction before onset of ventricular dysfunction. [Meeting Abstract]

Nakahara, Takehiro; Petrov, Artiom; Tanimoto, Takashi; Haider, Nezam; Narula, Navneet; Chaudhry, Farhan; Mattis, Jeffrey; Gray, Brian; Pak, Koon; Sahni, Gagan; Tiersten, Amy; Bhardwaj, Aarti; Sengupta, Partho; Dweck, Marc; Strauss, H. William; Narula, Jagat
ISI:000404949902185
ISSN: 0161-5505
CID: 3151872

A randomized phase II trial of fulvestrant with or without ribociclib after progression on aromatase inhibition plus cyclin-dependent kinase 4/6 inhibition in patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer [Meeting Abstract]

Mundi, PS; Codruta, C; Accordino, MK; Sparano, J; Andreopoulou, E; Vadhat, LT; Tiersten, A; Esteva, F; O'Regan, R; Jain, S; Mayer, I; Forero, A; Crew, KD; Hershman, DL; Kalinsky, KM
ISI:000397999000086
ISSN: 1538-7445
CID: 2529362