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Outcomes of Breast Cancer Patients Treated with Chemotherapy, Biologic Therapy, Endocrine Therapy, or Active Surveillance During the COVID-19 Pandemic

Marks, Douglas K; Budhathoki, Nibash; Kucharczyk, John; Fa'ak, Faisal; D'Abreo, Nina; Kwa, Maryann; Plasilova, Magdalena; Dhage, Shubhada; Soe, Phyu Phyu; Becker, Daniel; Hindenburg, Alexander; Lee, Johanna; Winner, Megan; Okpara, Chinyere; Daly, Alison; Shah, Darshi; Ramdhanny, Angela; Meyers, Marleen; Oratz, Ruth; Speyer, James; Novik, Yelena; Schnabel, Freya; Jones, Simon A; Adams, Sylvia
PURPOSE:Provide real-world data regarding the risk for SARS-CoV-2 infection and mortality in breast cancer (BC) patients on active cancer treatment. METHODS:Clinical data were abstracted from the 3778 BC patients seen at a multisite cancer center in New York between February 1, 2020 and May 1, 2020, including patient demographics, tumor histology, cancer treatment, and SARS-CoV-2 testing results. Incidence of SARS-CoV-2 infection by treatment type (chemotherapy [CT] vs endocrine and/or HER2 directed therapy [E/H]) was compared by Inverse Probability of Treatment Weighting. In those diagnosed with SARS-CoV-2 infection, Mann-Whitney test was used to a assess risk factors for severe disease and mortality. RESULTS:Three thousand sixty-two patients met study inclusion criteria with 641 patients tested for SARS-COV-2 by RT-PCR or serology. Overall, 64 patients (2.1%) were diagnosed with SARS-CoV-2 infection by either serology, RT-PCR, or documented clinical diagnosis. Comparing matched patients who received chemotherapy (n = 379) with those who received non-cytotoxic therapies (n = 2343) the incidence of SARS-CoV-2 did not differ between treatment groups (weighted risk; 3.5% CT vs 2.7% E/H, P = .523). Twenty-seven patients (0.9%) expired over follow-up, with 10 deaths attributed to SARS-CoV-2 infection. Chemotherapy was not associated with increased risk for death following SARS-CoV-2 infection (weighted risk; 0.7% CT vs 0.1% E/H, P = .246). Advanced disease (stage IV), age, BMI, and Charlson's Comorbidity Index score were associated with increased mortality following SARS-CoV-2 infection (P ≤ .05). CONCLUSION:BC treatment, including chemotherapy, can be safely administered in the context of enhanced infectious precautions, and should not be withheld particularly when given for curative intent.
PMID: 35641208
ISSN: 1549-490x
CID: 5235912

Heterogeneity of posttraumatic stress, depression, and fear of cancer recurrence in breast cancer survivors: a latent class analysis

Malgaroli, Matteo; Szuhany, Kristin L; Riley, Gabriella; Miron, Carly D; Park, Jae Hyung; Rosenthal, Jane; Chachoua, Abraham; Meyers, Marleen; Simon, Naomi M
PURPOSE/OBJECTIVE:Breast cancer survivors may demonstrate elevated psychological distress, which can also hinder adherence to survivorship care plans. Our goal was to study heterogeneity of behavioral health and functioning in breast cancer survivors, and identify both risk and protective factors to improve targets for wellness interventions. METHODS:Breast cancer survivors (n = 187) consented to complete self-reported psychological measures and to access their medical records. Latent class analysis (LCA) was used to classify heterogeneous subpopulations based on levels of depression, post-traumatic stress, fear of cancer recurrence, cancer-related pain, and fatigue. Multinomial logistic regression and auxiliary analysis in a 3-step modeling conditional approach was used to identify characteristics of the group based on demographics, treatment history and characteristics, and current medication prescriptions. RESULTS:Three subpopulations of breast cancer survivors were identified from the LCA: a modal Resilient group (48.2%, n = 90), a Moderate Symptoms group (34%, n = 65), and an Elevated Symptoms group (n = 17%, n = 32) with clinically-relevant impairment. Results from the logistic regression indicated that individuals in the Elevated Symptoms group were less likely to have a family history of breast cancer; they were more likely to be closer to time of diagnosis and younger, have received chemotherapy and psychotropic prescriptions, and have higher BMI. Survivors in the Elevated Symptoms group were also less likely to be prescribed estrogen inhibitors than the Moderate Symptoms group. CONCLUSIONS:This study identified subgroups of breast cancer survivors based on behavioral, psychological, and treatment-related characteristics, with implications for targeted monitoring and survivorship care plans. IMPLICATIONS FOR CANCER SURVIVORS/CONCLUSIONS:Results showed the majority of cancer survivors were resilient, with minimal psychological distress. Results also suggest the importance of paying special attention to younger patients getting chemotherapy, especially those without a family history of breast cancer.
PMID: 35224684
ISSN: 1932-2267
CID: 5174072

Barriers and engagement in breast cancer survivorship wellness activities

Szuhany, Kristin L; Malgaroli, Matteo; Riley, Gabriella; Miron, Carly D; Suzuki, Rebecca; Park, Jae Hyung; Rosenthal, Jane; Chachoua, Abraham; Meyers, Marleen; Simon, Naomi M
PURPOSE/OBJECTIVE:Breast cancer survivors may be at risk for increased rates of emotional distress and poorer quality of life. Survivorship care plans (SCPs) promoting wellness activities may support well-being; however, survivors may not receive or engage in their SCPs. This study aimed to assess receipt and participation in SCP activities as well as barriers to engagement amongst breast cancer survivors. METHODS:Breast cancer survivors (n = 187; 99% female, Mean age = 57.7) consented and completed self-reported assessments of SCP recommendations, engagement and interest in wellness activities, and potential barriers to engagement. RESULTS:A minority of participants recalled receiving an SCP (21%). The most physician recommended (62%) and completed (53%) activity was exercise. Interest in adding other wellness activities to the SCP was high, with reported interest levels of approximately 50% for several activities (e.g., mind body, nutrition, psychotherapy interventions). Fully half reported that having a physician-designed plan would influence participation in activities. The most common reported barriers to SCP activity engagement were lack of time (82%), work/school (65%), and lack of information (65%). CONCLUSION/CONCLUSIONS:Few survivors recalled receiving a formal SCP, and lack of information about wellness activities was a commonly reported barrier to participation. Interest in wellness activities was generally high and may indicate the need for more formal prescription or motivation enhancement techniques to promote SCP engagement. There may be a clinical need to emphasize SCP recommendations to enhance recall and increase engagement in wellness activities that may reduce psychological distress and improve quality of life.
PMID: 34095986
ISSN: 1573-7217
CID: 4899592

"Bridge" Neoadjuvant Endocrine Therapy for Early Stage Breast Cancer Patients During COVID-19 at an Academic Hospital in NYC: Lessons Learned and Future Directions

Feinberg, Joshua; Cen, Cindy; Schnabel, Freya; Adams, Sylvia; Plasilova, Magdalena; Yeh, Janet; Meyers, Marleen; Speyer, James; Belenkov, Elliot; Kwa, Maryann; Novik, Yelena; Katz, Elena; Guth, Amber Azniv
ORIGINAL:0015541
ISSN: 2578-9503
CID: 5192472

Nutrition Literacy among Cancer Survivors: Feasibility Results from the Healthy Eating and Living Against Breast Cancer (HEAL-BCa) Study: a Pilot Randomized Controlled Trial

Parekh, Niyati; Jiang, Jieying; Buchan, Marissa; Meyers, Marleen; Gibbs, Heather; Krebs, Paul
Knowledge of nutrition among breast cancer patients is insufficient, despite their motivation to seek valid information about healthy food choices. This study examines the feasibility of nutrition education workshops for cancer survivors, to inform the design of a multi-center intervention. Fifty-nine female English-speaking breast cancer patients, who had completed treatment, were enrolled. Participants were randomized to the intervention or control group. The intervention group attended six nutrition education sessions, and the control group received brochures. Measurements were done at baseline and 3-month follow-up and included the Assessment Instrument for Breast Cancer (NLit-BCa), fruit/vegetable and general health literacy screeners. Height and weight were measured. Changes in nutrition literacy, health literacy, and food intake from baseline to follow-up (within-group change) were calculated for both groups (effect sizes were reported as Cohen's d). Participants were mostly white, with a mean age of 58 years, BMI of 31.6 kg/m2, and had college degrees. Follow-up rates were high (89% = control and 77% = intervention group). At baseline, participants scored high for most NLit-BCa assessment components except food portions in both groups. At the 3-month follow-up, effect sizes (d) on the NLit-BCa ranged from -0.5 to 0.16. The study met its recruitment goals within 6 months. Focus groups indicated that (a) attending six sessions was acceptable, (b) patients found social/emotional support, (c) improvements should include information for special diets and booster sessions. This pilot study suggests that the intervention was acceptable and that scaling up of this intervention is feasible and could provide benefit to breast cancer survivors.
PMID: 28624990
ISSN: 1543-0154
CID: 2604122

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 (ClinicalTrials.gov: 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

Vinorelbine/cisplatin therapy of locally advanced and metastatic breast cancer: an active regimen [Meeting Abstract]

Hochster H; Wasserheit C; Siddiqui N; Sorich J; Downey A; Wernz J; Oratz R; Meyers M; Moskovits T; Speyer J
Single agent activity of vinorelbine in previously untreated breast cancer and its predictable toxicity make it ideal for combination with cisplatin, a drug we found to be very active in combination with paclitaxel (J Clin Oncol; 14:1993, 1996), but with a high rate of neurotoxicity limiting duration of therapy. Eligibility included: histologically proven locally advanced or metastatic measurable breast cancer, ECOG performance status (PS) of 2 or less, adequate organ function. Cisplatin was given at a dose of 75 mg/m2 on day 1, with vinorelbine 30 mg/m2 days 1 and 8 of a 21 day cycle; day 8 vinorelbine dose was modified for neutropenia and thrombocytopenia. 24 patients (pts) entered the study, of whom 23 were eligible and 1 too early for response evaluation. 20 pts were treated as first line therapy for advanced disease (10 locally advanced and 10 metastatic). 3 pts were treated as second-line therapy for metastatic disease. Median age was 49 (range 32-67), median ECOG PS = 0. Nine pts had prior adjuvant chemotherapy and 8 pts had prior RT. A total of 91 cycles of chemotherapy were given with a median of 3 per pt. Hematological toxicity included leukopenia gr 3 = 4 pts, gr 4 = 2; neutropenia gr 3 = 4, gr 4 = 7 pts; no gr 3 or 4 thrombocytopenia. Non-heme toxicity included: N/V gr 2 = 6 pts, gr 3 = 1; neuropathy gr 1 = 10; gr 2 = 2; renal gr 2 = 1 pt. Responses seen included 2 CRs and 6 PRs (of 9 evaluable) locally advanced, 1 CR and 5 PRs (of 10) in metastatic disease, and 1 CR + 1 PR (of 3) second line therapy. Overall response rate was 73% (4 CR + 12 PR + 4 SD = 18% CR and 55% PR) of 22 evaluable pts. These data suggest that combined vinorelbine/cisplatin therapy is highly active in locally advanced and metastatic breast cancer without the high incidence of dose-limiting neurotoxicity seen in our prior paclitaxel/cisplatin trial. Accrual is continuing to improve the 95% confidence interval. (C) American Society of Clinical Oncology 1997
ORIGINAL:0014207
ISSN: 0736-7589
CID: 6028

Phase II trial of paclitaxel and cisplatin (DDP) in women with metastatic breast cancer [Meeting Abstract]

Wasserheit C; Alter R; Speyer J; Hochster H; Oratz R; Wernz J; Chachoua A; Meyers M; Sorich J; Downey A; et al
We report the results of an ongoing Phase II study of paclitaxel (Taxol) and DDP in women with metastatic breast cancer. Paclitaxel is administered at 200 mg/m2 iv 24 hr infusion on d1, bolus DDP at 75 mg/m2 d2; G-CSF 5 mcg/kg SQ qd d3 until WBC recovery, with premedications of dexamethasone, cimetidine, and diphenhydramine. Eligibility criteria are: age greater than 18, ECOG PS less than or equal to 2, measurable/evaluable disease, adequate BM, liver, and renal functions, no prior paclitaxel or DDP, and informed consent. Pts may have received adjuvant (adj) therapy (Rx) greater than 1 yr prior to enrollment and less than or equal to 1 prior chemotherapy (CT) regimen for metastatic disease. 27 pts are enrolled on study. Pt characteristics: median age 50 (range 25-69), stage IV 23, stage IIIB, prior adj CT 18, CT 2, hormone 9. Disease sites include lung 13, bone 11, soft tissue 12, lymph node 11, and liver 3 (19 pts have greater than or equal to 2 sites). 27 pts received 111 cycles, median of 5 cycles/pt. Of 21 evaluable pts, there were 2 CR, 9 PR, 9 SD, and 1 PD (overall response rate 52%) [1 pt was non-evaluable (toxic death in cycle 1); 5 pts are too early]. The median duration of response is 3+ months (range 1-12+ months). 16/27 pts (59%; (33/111 cycles)) had grade 4 neutropenia. 17 pts had grade greater than or equal to 2 fatigue (WHO). 9/27 (33%; 12 cycles) required RBC Tx. 8 pts went off study because of cumulative neuropathy. Other off study reasons: 5 PD, 1 toxic death (sepsis), anaphylaxis to DDP-1, and 2 pts went to surgery. Conclusion: Paclitaxel/DDP is an active regimen as first line therapy for metastatic breast cancer, but acute myelosuppression and cumulative neurotoxicity are limiting. (C) American Society of Clinical Oncology 1997
ORIGINAL:0014195
ISSN: 0736-7589
CID: 6017

Topotecan 21-day continuous infusion: excellent tolerance of a novel schedule [Meeting Abstract]

Hochster H; Speyer J; Oratz R; Meyers M; Wemz J; Chachoua A; Raphael B; Lee R; Sorich J; Taubes B; et al
Topotecan (TPT), a semi-synthetic, water soluble analog of camptothecin (CPT), acts by topoisomerase-1 inhibition. Previous studies with CPT analogs in human xenograft-bearing mice show that prolonged depot administration at nontoxic doses were curative (Giovanella et al, Science, 246:1046, 1989). We treated 33 patients (pts) (16 F, 17 M) with prolonged continuous infusion using ambulatory CADD pumps delivering 7 cc/day (d) with cassette changes every 3 d. Cohorts of 4-6 pts began at a dose of 0.2 mg/m2/day x 7 days with escalation to 10, 14, 17, and 21 days q 28 d. Further escalations were 0.3, 0.4, and 0.53 mg/m2/d x 21 d q 28 d. Disease sites included colon ca (13), NSCLC (4), sarcoma (3), gastric (3), ovarian (3), pancreatic (2); H and N, breast, renal, melanoma, anal (each 1). Median age was 63 (range 29 -79) yr; PS 1 (0-2); prior chemo = 33 (med 2 regimens); prior RT=10. A total of 72 cycles (med 2, range 1-6) were given for a total of 1090 pt-days of infusion. One infectious complication was seen (Mediport-pocket), 4 pts required transfusion; one pt with 3 prior chemo regimens and pelvic RT developed gr 4 leukopenia and thrombocytopenia at the 0.4 mg/m2 x 21 d level. No other hematologic toxicity has been observed. Nonhematologic toxicity included fatigue only. Steady state plasma conc for the active lactone form of TPT at 0.4 mg/m2/d was 1.4 +/- 0.29 ng/ml (N=3) and 4.4 +/- 0.99 (N=3) at the 0.53 level. Best responses were 1 PR (NSCLC), 1 mixed response (breast), 11 stable, 15 progression and 5 too early. TPT administration by this schedule is feasible and safe; we continue to accrue. Dose-limiting heme toxicity has not yet been reached, yet dose intensity (2.8 mg/m2/wk) exceeds that achieved using the recommended Phase II 1.5 mg/m2/d x5 schedule (1.9 mg/m2/wk). Once an MTD is reached, Phase III trials comparing this schedule to the daily x5 bolus schedule will be warranted. (C) American Society of Clinical Oncology 1997
ORIGINAL:0014197
ISSN: 0736-7589
CID: 6015

Pharmacokinetics of the cardioprotector ADR-529 (ICRF-187) in escalating doses combined with fixed-dose doxorubicin

Hochster H; Liebes L; Wadler S; Oratz R; Wernz JC; Meyers M; Green M; Blum RH; Speyer JL
BACKGROUND: Although doxorubicin is an anticancer agent with a wide spectrum of activity, therapy with this anthracycline must often be discontinued at a time of benefit to the patient because of the drug's cumulative cardiotoxicity. ICRF-187 (ADR-529, dexrazoxane) is a bisdioxopiperazine compound that protects against cardiac toxicity induced by doxorubicin. PURPOSE: Our objectives in this study were to determine the maximum tolerated dose of ADR-529 (which uses a different vehicle than ICRF-187) when given with a fixed doxorubicin dose and to determine whether ADR-529 alters doxorubicin pharmacokinetics. METHODS: Twenty-five patients were treated with doxorubicin (60 mg/m2) preceded by administration of ADR-529 in escalating dosages (i.e., 60, 300, 600, 750, and 900 mg/m2) to groups of three to nine patients. ADR-529 was administered over a 15-minute period beginning 30 minutes before doxorubicin treatment; the protocol was repeated every 3 weeks. Blood was sampled frequently for drug levels, which were determined by high-pressure liquid chromatography with fluorescence (doxorubicin) and electrochemical detection (ADR-529). RESULTS: Dose-limiting neutropenia occurred in four of six previously treated patients at an ADR-529 dose of 600 mg/m2; the dose ratio of ADR-529 to doxorubicin was 10:1. For three additional patients with better Eastern Cooperative Oncology Group performance status and a maximum of one prior chemotherapy regimen, 600 mg/m2 was tolerated, but grade 3 or 4 neutropenia occurred in four of six patients who received an ADR-529 dose of 900 mg/m2 and in three of four patients at a dose of 750 mg/m2. Doxorubicin's estimated terminal half-life was 39.5 +/- 18.3 (mean +/- SD) hours; the area under the curve for plasma concentration of drug x time (AUC) was 1.74 +/- 0.40 (micrograms/microL) x hour. Total-body clearance was 598 +/- 142 microL/m2 per minute (N = 20), and it did not vary with ADR-529 dose. Estimated distribution and elimination phase half-lives for plasma ADR-529 were 0.46 +/- 0.30 hours and 4.16 +/- 2.94 hours, respectively. Total-body clearance was 111 +/- 87 microL/m2 per minute (N = 18); AUC was linear (r2 = .92), and the clearance rate was constant (r2 = .18) from 60 to 900 mg/m2. CONCLUSIONS: Myelotoxicity was dose limiting for ADR-529 at 600-750 mg/m2 when given with a fixed dose of doxorubicin at 60 mg/m2 (dose ratios of ADR-529 to doxorubicin ranged from 10:1 to 12.5:1). When used in combination, ADR-529 did not perturb doxorubicin's distribution, metabolism, or excretion; therefore, other mechanisms of cardioprotection must be involved. IMPLICATIONS: We recommend that an ADR-529 dose of 600 mg/m2 be given with single-agent doxorubicin at a dose of 60 mg/m2 in future studies
PMID: 1433357
ISSN: 0027-8874
CID: 57431