Impact of patient characteristics on compliance to adjuvant chemotherapy in hormone receptor negative breast cancer: A single institution experience.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19568-e19568
Author(s):  
Alaa Abdelhalim Ahmed ◽  
Nuttapong Ngamphaiboon ◽  
Ellen Kossoff ◽  
Alison Meagher ◽  
Kristopher Attwood ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Hormone Receptor ◽  
Cox Regression ◽  
Performance Status ◽  
P Value ◽  
Hematologic Toxicity ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Co Morbidity

e19568 Background: Adherence to adjuvant chemotherapy (ACT) has been implicated in poor outcomes in early breast cancer (BC). We investigated factors that may contribute to non-compliance (NC) in hormone receptor (HR) negative BC. Methods: 310 HR- patients (pts) who received adjuvant chemotherapy (ACT) at Roswell Park Cancer Institute (RPCI) between 2002 and 2008 were eligible for this retrospective analysis. Patients were categorized as Compliant or Non Compliant (NC). Compliance was subdivided into adequate Tx (AT) and inadequate Tx due to Toxicity (ITT). NC was discontinuation or delays in ACT for reasons other than toxicities. The 3 groups were compared based on baseline characteristics, treatment-related toxicities, and survival. Fisher’s exact, logistic regression, Cox regression, and log-rank tests were used to analyze the data. A significant p value was assigned at ≤ 0.05. Results: 192 pts were included, with a median age of 55 (range 27-86), and median follow up of 4.9 yrs. NC was observed in 19 (10%) pts, ITT in 47 (24%), and AT in 126 (66%). ITT and NC pts were more likely to have a higher Charlson co-morbidity index (CCI) (p=.019), ECOG performance status (p=.048), more hospital stays (p=<.001) and more heme/non-heme toxicities (p=<.001). Comparing NC/ITT/AT groups; 63/94/100 % completed ≥ half of planned Tx (p=<.001), 22/41/5 % had hematologic toxicity (p=<.001). The groups did not differ by trastuzumab use. There were no statistically significant differences in OS and DFS among the 3 groups. Conclusions: Predictors of non-compliance among HR- breast cancer patients receiving ACT include co-morbidities, and performance status. Clinicians should be aware that this group of pts are likely to have problems completing adjuvant chemotherapy and should be proactive about managing toxicities.

Poor prognostic factors of post-CNS recurrence survival in breast cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 2097-2097
Author(s):  
Carlos Castaneda Altamirano ◽  
Henry Leonidas Gomez ◽  
Joseph A. Pinto ◽  
Luis Jesus Schwarz ◽  
C. E. Vigil ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Brain Metastases ◽  
Cancer Patients ◽  
Cox Regression ◽  
Histological Grade ◽  
Performance Status ◽  
Prognostic Scores ◽  
Breast Cancer Patients ◽  
Class Iii ◽  
Ecog Performance Status

2097 Background: Survival after the onset of metastases in the central nervous system is very short. However, some variables could indicate subsets of worse prognosis. Our aim was to determine the value of clinicopathological characteristics and prognostic scores in the post-SNC recurrence survival. Methods: We evaluated a retrospective cohort of 2597 breast cancer patients treated at the Instituto Nacional de Enfermedades Neoplasicas (Lima-Peru) between 2000-2005. Clinicopathological data was retrieved, RPA and GPA brain metastases prognostic scores were constructed and phenotypes were categorized according to the IHC expression in [HR+,HER2-], [Any HR, HER2+] and Triple Negative. Survival was calculated according to the Kaplan Meier methodology and cases were stratified by variables evaluated. The log-rank or Breslow tests were used when appropriate and multivariate analysis was done by the cox regression. A P<0.05 was considered statistically significant. Results: One hundred and fifty seven cases developed CNS metastasis, from which 23 developed leptomeningeal metastases. The post recurrence CNS survival was 0.405 years. There were not differences according to phenotype (P=0.102), histological grade (P=0.647), number of brain metastases (P=0.695) and metastases volume (P=0.155). We found statistic differences in regard to leptomeningeal carcinomatosis (present, 0.249ys vs absent 0.436ys; P=0.033); CSF infiltration (present, 0.115ys vs absent, 1.044ys; P=0.022); status of primary tumor (controlled, 0.501ys vs uncontrolled, 0.263ys; P<0.001); ECOG performance status (<2, 0.504ys vs ≥2, 0.288ys; P=0.030); and time from BC diagnosis to SNC metastases (<8 moths, 0.115 vs ≥8 months, 0.425ys; P=0.023). Cox regression identifies to CSF infiltration as statistically significant (HR=9.77; P=0.025). In regard to Prognostic scores, we found differences when cases were stratified according to RPA score (Class I, 0.564ys vs Class II, 0.455ys vs Class III, 0.288ys; P=0.049) and GPA score (0-1, 0.26ys vs 1.5-3, 0.455ys vs 3.5-5, 0,564; 0.048). Conclusions: RPA and GPA scores are more accurate to identify poor survival subsets in this group of patients than other tumor features (phenotype or histology).

Thromboembolic events in breast cancer patients: A large series.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9589-9589 ◽  
Author(s):  
Danilo Souza Reboucas ◽  
Luiz Claudio Santos Thuler ◽  
Maria Eduarda Ferro Costa ◽  
Alvaro Henrique Ingles Garces ◽  
Luciana Carla Martins de Aquino ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Cox Regression ◽  
Performance Status ◽  
Univariate Analysis ◽  
Multivariate Logistic Regression Model ◽  
Control Group ◽  
Thromboembolic Events ◽  
Breast Cancer Patients ◽  
Ecog Performance Status

9589 Background: Breast cancer is frequently associated with thromboembolic events (TEE). TEE may result in significant morbidity, a substantial economic burden and they represent a leading cause of death. Methods: We conducted a case-control study to analyze patients’ baseline and treatment characteristics in predicting TEE occurrence as well as the prognosis of breast cancer patients with thromboembolic events. We identified all breast cancer patients with a TEE at INCA (Brazilian National Cancer Institute), between January 2007 and December 2011. The control group consisted of breast cancer patients that had a doppler ultrasound with normal findings during the same period. Variables found to be significant (P <0.10) by univariate analysis were subsequently entered into a multivariate logistic regression model. We used Kaplan-Meier and Cox regression for survival analysis. Results: Overall, 225 patients that developed TEE were compared to 225 matched controls. The majority of events were deep vein thrombosis of the lower extremity (78.7%) and unilateral (94.2%). Most TEE occurred within the first 3 years after the diagnosis of cancer (66.2%), with the highest incidence observed in the initial 6 months. Factors associated with the development of TEE were: age above 50 years (OR 1.85, 95% CI: 1.16 to 2.95), ECOG performance status (PS) equal to or above 3 (OR 2.01, CI 95%: 1.24 to 3.26) and the presence of a central venous catheter (CVC) (OR 2.56, 95% CI: 1.42 to 4.62). The occurrence of TEE led to systemic treatment changes (44.9%) and, most importantly, it was associated with decreased survival (HR = 1.34, 95% CI: 1.01 to 1.77, p = 0.041). Conclusions: This large retrospective analysis of TEE in breast cancer patients confirms that most events occur early in the treatment course. The incidence of TEE was associated with patients’ age, PS, and the presence of CVC. Prospective studies are needed to evaluate outpatient thromboprophylaxis for selected groups of patients.

Effect of Age on Heart Rate Variability Analysis in Breast Cancer Patients

2020 ◽  
pp. 141-167
Author(s):  
Reema Shyamsunder Shukla ◽  
Yogender Aggarwal ◽  
Rakesh Kumar Sinha ◽  
Shreeniwas S. Raut
Keyword(s):  
Breast Cancer ◽  
Standard Deviation ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Age Groups ◽  
Heart Rate Variability Analysis ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Poincaré Plot ◽  
Index Ratio

Breast Cancer (BC) is the leading cause of death in women, worldwide. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of BC can be studied using HRV measures. The main purpose of this chapter is to give an insight to clinicians via HRV measures with respect to age to make them understand the PS of patients. Data from 114 BC patients was segregated into two age groups, G1 (20 to 40 years) and G2 (41 to 75 years). The 5-minute electrocardiogram of the subjects was taken and HRV measures were extracted. One-way ANOVA with Posthoc Tukeys' HSD test was done. Triangular Index, Ratio of standard deviation of poincare plot perpendicular to the line of identity to the standard deviation along line of identity, Detrended Fluctuation Analysis descriptors, Approximate Entropy, Sample Entropy and Correlation Dimension significantly decreased from ECOG0 to 4 and from G1 to G2. The sympathetic activity increased with vagal withdrawal as age advanced.

scholarly journals Assessment of cardiotoxicity in hormone positive postmenopausal breast cancer patients receiving aromatase inhibitors

2019 ◽  
Vol 9 (1) ◽  
pp. 11
Author(s):  
Reham M. Faheim ◽  
Eman A. El-Shaarawy ◽  
Dina A. Salem ◽  
Rehab G. Shaaban
Keyword(s):  
Breast Cancer ◽  
Blood Pressure ◽  
Lipid Profile ◽  
Cancer Patients ◽  
Aromatase Inhibitors ◽  
Hormone Receptor ◽  
Postmenopausal Breast Cancer ◽  
P Value ◽  
Breast Cancer Patients ◽  
Hormone Receptor Positive

Background: Aromatase inhibitors (AIs) represent an effective endocrine treatment for hormone receptor-positive postmenopausal breast cancer patients with early stage or metastatic disease.Objective: Assessment of Cardiotoxicity in Hormone positive Postmenopausal Breast Cancer Patients receiving AIs (upfront orswitch therapy).Methods: This cross sectional study included 123 postmenopausal breast cancer patients presented to the Clinical Oncology Department, Ain Shams University (Cairo, Egypt) in the interval from August 2016 to June 2017 with hormone receptor positive receiving Aromatase Inhibitors, To assess cardiotoxicity in these patients, they were subjected to blood pressure and lipid profile measurement, electrocardiography (ECG), and electrocardiography (ECHO) and classified into patients had Nolvadex then A.I (arm 1) and others had upfront A.I (arm 2).Results: The age of patients ranged from 41 years to 85 years with mean age of 61 years. Seventy one patients (57.7%) showed cardiotoxicity as assessed by ECHO. They showed significant correlation with rising age above 62 years, IHD, history of HTN and DM (p value: .001, .001, .017 and 0.035 respectively). However, correlation between cardiotoxity and blood pressure changes, lipid profile changes and ECG findings and ECHO changes in switch therapy and upfront A.I were not statistically significant (p value = .275, .116, .081 and .761 respectively).Conclusion: Assessment of cardiotoxicity in hormone positive postmenopausal breast cancer patients receiving Aromatase Inhibitors showed evidence of cardiotoxicity in half the patients (57.7%) as detected by ECHO only. They showed statistically non significant correlations either recievied switch therapy or upfront A.I.

Assessment of Hematologic and Non-Hematologic Toxicity in Older Cancer Patients Receiving Systemic Chemotherapy: Results from a Prospective Nationwide Registry.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3131-3131
Author(s):  
Naeem Tahir ◽  
Jerome H. Goldschmidt ◽  
Eva Culakova ◽  
Marek S. Poniewierski ◽  
Debra A. Wolff ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Multivariate Analysis ◽  
Cancer Patients ◽  
Performance Status ◽  
Univariate Analysis ◽  
Hematologic Toxicity ◽  
Breast Cancer Patients ◽  
Nationwide Registry ◽  
Older Cancer Patients ◽  
Grade Iii

Abstract Introduction: Although 60% of all malignancies occur in patients ≥65, this population is poorly represented in cancer clinical trials. While fit elderly patients appear to tolerate chemotherapy as well as younger individuals, less is known about chemotherapy tolerance in older cancer patients with poor performance status or co-morbidities. The purpose of this study was to examine the impact of patient and disease characteristics on the reported toxicities of cancer chemotherapy. Methods: This study represents part of a prospective, nationwide registry based at 137 randomly selected practice sites throughout the US. The major malignancies considered were cancers of the breast (33%), colon (10%), lung (19%) and ovary (7%) along with malignant lymphoma (8%). To date, 3422 patients have been registered of which 2719 are available for analysis including 1083 patients age ≥65 (40%). Primary outcome measures were: relative dose intensity (RDI) compared to standard doses, anemia (Hgb &lt;10), neutropenia (neutrophils &lt;1000) and non-hematologic toxicities pertinent to older adults including stomatitis, diarrhea, anorexia, dehydration and weight loss. Univariate and multivariate logistic regression analysis was performed to compare the difference between the 65–74 and ≥75 age groups. Results: Complete data were available on 927 patients ≥65 years of age. Among breast cancer patients, increasing age (&lt;65, 65–74, ≥75) was associated with progressively less Grade III/IV neutropenia (62%, 51% and 41%), respectively (p=0.006). This corresponds to patients receiving progressively less RDI (93.4%, 91.3%, 89.8%; P=.025) with 17%, 19% and 25% receiving RDI &lt;85%, respectively. Most of the reduced RDI was planned in patients ≥75 years compared with less than half in younger patients (P=.035). Non-breast cancer patients experienced no significant difference in rates of Grade III/IV neutropenia by age. Increasing age was associated with progressively more anemia (27%, 34%, and 44%) respectively (p&lt;0.0001) among non-breast cancer patients but not among those with breast cancer. Despite a trend, no significant increase in non-hematologic toxicities was observed with increasing age in breast cancer or non-breast cancer patients. Factors significantly associated with Grade III/IV neutropenia in univariate analysis included baseline ANC &lt;3000, BSA&lt;2.0, female gender and anthracycline containing regimens. In multivariate analysis, after adjusting for tumor type and performance status the following were significant predictors of Grade III/IV neutropenia: BSA&lt;2.0 (OR=1.5 p=0.04), Baseline ANC&lt;3000 (OR=2.0 p=0.001) and anthracycline containing regimen (OR=3.5 p&lt;0.0001). Factors associated with non-hematologic toxicity in univariate analysis included colon cancer (p&lt;0.0001), Charlson Co-morbidity Index (CCI) ≥ 3 (p=0.068), ECOG performance status ≥2 (p=0.05), and 5-Fluorouracil containing regimens (p&lt;0.0001) while in multivariate analysis, only the CCI maintained a trend towards increased non-hematologic toxicity (p=0.069). Conclusions: While anemia increases with age in non-breast cancer patients, neutropenia decreases with increasing age in breast cancer patients, most likely as a result of age-related reductions in RDI.

Association of polymorphic drug metabolizing enzymes (DME) with outcomes in breast cancer patients treated on the ECOG 2190/Intergroup 0121 (E2190/Int0121) study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 596-596
Author(s):  
P. P. Gor ◽  
R. J. Gray ◽  
M. Horn ◽  
T. R. Rebbeck ◽  
P. A. Gimotty ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Stem Cell ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Cox Regression ◽  
Disease Free Survival ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Breast Cancer Patients ◽  
Stem Cell Rescue

596 Background: Disparate outcomes of breast cancer patients after adjuvant chemotherapy may be influenced by variation in drug metabolism due to genetic polymorphisms in DME. Cyclophosphamide and thiotepa require activation by cytochrome P450 (CYP) and detoxification by glutathione-S-transferase, two highly polymorphic enzymes. We hypothesized that variants in CYP3A4(*1B), GSTM1 and GSTT1 would impact survival outcomes after adjuvant chemotherapy, with effects potentially modulated by chemotherapy dose. Methods: We performed a retrospective cohort study of patients enrolled on E2190/Int0121, a randomized trial of cyclophosphamide (C), doxorubicin (A), and fluorouracil (F) versus CAF + high dose chemotherapy (HDC) using cyclophosphamide and thiotepa followed by stem cell rescue; disease-free survival (DFS) and overall survival (OS) were equivalent in the clinical trial. PCR-based methods were used to genotype hematologic stem cells. Hazard ratios for genotypes were obtained using Cox regression. Results: Stem cell samples and clinical data from August 1, 1991 through August 1, 2005 were available for 347/540 of patients enrolled; 151 patients on CAF and 196 on CAF + HDC arms, respectively. Median follow-up was 9.8 years. See table . CYP3A4*1B allele carriers had significantly poorer DFS (HR 1.84) in the combined cohort and CAF arm (HR 1.87), but not in the HDC arm; OS was not significant by CYP3A4 genotype. GSTM1 null homozygotes in the combined cohort and HDC arm had significantly better DFS (HR 0.70 and 0.66, respectively) and OS (HR 0.67 and 0.57, respectively), but not in the CAF arm. GSTT1 null homozygotes had significantly worse DFS (HR 2.3) and OS (2.02) in the CAF arm, but not in the HDC arm or combined cohort. Conclusions: In the overall E2190/Int0121 cohort, polymorphisms in activating (CYP3A4*1B) and inactivating (GSTM1) DME significantly impact DFS and OS. The detrimental effect of GSTT1 in the CAF arm appears to be ameliorated by HDC. [Table: see text] No significant financial relationships to disclose.

scholarly journals Eribulin Mesylate in Treated Metastatic Breast Cancer Patients: A Retrospective Study of Tumor Response and Adverse Effects

2021 ◽  
Vol 6 (2) ◽  
pp. 37-44
Author(s):  
Bindu SM ◽  
PL Rema ◽  
Praveen Jacob Ninan
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Retrospective Study ◽  
Tumor Response ◽  
Performance Status ◽  
Metastatic Breast ◽  
Complete Response ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Eribulin Mesylate

Introduction: Breast cancer is the most common cancer, majority of patients present in advanced stage and 30% develop distant metastasis. Metastatic Breast Cancer (MBC) is not curable and treatment aims at prolongation of life with good palliation. There is no standard treatment, though the usual first and second lines of chemotherapy include anthracyclines and taxanes. The third line chemo drugs available are gemcitabine, capecitabine, vinorelbine and eribulinmesylate Materials and Methods: This is a retrospective study of MBC patients pretreated with anthracyclines and taxanes and then received 4 cycles of eribulin during the period March 2015-2017 in Medical College, Alappuzha and aims at studying the tumor response and drug toxicities. The tumor response is studied using CR-complete response, PR- partial response, PD-progressive disease and SD-stable disease. Results: There were a total of 18 patients, majority of whom were below 50 years. ECOG performance status of 0-1 was found in 83.3% and 77.8% were receptor positive. No patient had CR, 66.7% of patients had PR, 22.2% had PD and 11.1% had SD. 61.1% of patients who had a PR had good performance status.55.6% of patients who were ERPR positive had a PR and 44.4% patients who were Her2neu positive had a PR. Most common toxicities detected were alopecia (83.3%), neutropenia (72.2%), fatigue (72.2%) and neurotoxicity (55.6%). Conclusion: Eribulin mesylate is a drug having good response with tolerable toxicities and can be considered in our population. Keywords: Metastatic breast cancer, eribulin mesylate, capecitabine.

scholarly journals Photobiomodulation Therapy Prevents Dysgeusia Chemotherapy-Induced in Breast Cancer Women Treated with Doxorubicin Plus Cyclophosphamide: A Triple-Blinded, Randomized, Placebo-Controlled Clinical Trial

2021 ◽  
Author(s):  
Malta Cássia Emanuella Nóbrega ◽  
Anna Clara Aragão Matos Carlos ◽  
Manuele Carine Maciel de Alencar ◽  
Eveline Fernandes Alves e Silva ◽  
Victor Bruno Caitano Nogueira ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Placebo Group ◽  
Cancer Patients ◽  
Performance Status ◽  
Test Group ◽  
Controlled Clinical Trial ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Chi Square

Abstract Purpose To evaluate the effectiveness of photobiomodulation (PBMT) in preventing dysgeusia in breast cancer patients treated with doxorubicin-cyclophosphamide (AC). Methods This is a phase II, randomized, triple-blind, placebo-controlled clinical trial involving 112 breast cancer patients treated with AC. The patients were divided equally into two groups: a test group treated with 2 J red laser and 3 J infrared laser on 21 points that were symmetrically distributed on the tongue on day 0 of four cycles of AC, and an equal placebo group treated with simulated PBMT to blind the patient, evaluator, and statistician. The clinicopathological and sociodemographic data, results of the hematological tests, taste test, and subjective taste analysis, and the QoL, ECOG performance status, body mass index, and other side effects were recorded. The data were analyzed using ANOVA-RM/Bonferroni, Friedman/Dunn, and chi-square/Fisher's exact tests. Results PBMT patients showed less objective and subjective taste loss (p < 0.05). On the other hand, the placebo group showed a higher ECOG status (p = 0.037) and more significant weight loss (p < 0.001) after four cycles of AC. The QoL was significantly higherin the PBMT group (p < 0.05) at all assessment periods, and PBMT treatment also reduced the incidence of cachexia (p = 0.020), anorexia (p < 0.001), diarrhea (p = 0.040), oral mucositis (p = 0.020), and vomiting (p = 0.008). Conclusion PBMT reduced the taste loss and improved the overall health status and QoL of patients with breast cancer treated with AC. Trial registration : Brazilian Clinical Trials Registry (www.ensaiosclinicos.gov.br) approval numberRBR-9qnm34y, registered on 01/05/2021

Safety of long-term administration of capecitabine in metastatic breast cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10755-10755
Author(s):  
M. Lomas ◽  
J. Salvador ◽  
M. Ruiz ◽  
J. L. Bayo
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Performance Status ◽  
Metastatic Breast ◽  
Term Treatment ◽  
Breast Cancer Patients ◽  
Ecog Performance Status ◽  
Long Term Treatment

10755 Background: To evaluate the effectiveness and tolerability of long -term treatment with capecitabine in metastatic breast cancer patients. Capecitabine (C) has been administered offering clinical benefit to women with metastatic breast cancer (MBC) (ORR: 42%). The aim of this trial was to evaluate the efficacy and tolerance of capecitbine in long-term treatment, administered as first, second and third line treatment in MBC. Methods: Patients ≥ 18 years old with MBC, ECOG performance status (PS) ≤2, HER-2 neu negative, non-chemotherapy naive were included in this prospective, multicentre, non-randomized. To date, twenty-two ambulatory patients were evaluable for toxicity and response. Median age 59.2 years (37–81). All of patients had previously received adjuvant treatment. Hormonal therapy were allowed as clinically required. They received three weekly cycles of oral capecitabine 1000–1250 mg/m2 twice daily, days 1–14, followed one week rest until progression or relapse. Results: The overall response rate (ORR) is including PR, CR, and EE 78%. The median treatment duration was 14 months, median range (3–32). Median progression-free and overall survival have not yet been reached. The most common grade ½ (NCIC CTC) treatment related adverse events were /23, hand foot syndrome 4/23, diarrea 1/23. Conclusions: These preliminary data confirm that the treatment with capecitabine (C) is an effective and well tolerated regiment in metastatic breast cancer patients. No significant financial relationships to disclose.

Randomized trial to assess bone mineral density (BMD) effects of zoledronic acid (ZA) in postmenopausal women (PmW) with breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19558-19558 ◽  
Author(s):  
A. Tevaarwerk ◽  
J. A. Stewart ◽  
R. Love ◽  
N. C. Binkley ◽  
S. Black ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Performance Status ◽  
Study Endpoint ◽  
Breast Cancer Patients ◽  
Mineral Density ◽  
Ecog Performance Status ◽  
Cancer Relapse ◽  
Femur Neck ◽  
Clinically Significant

19558 Introduction: Osteoporotic fracture represents a major source of morbidity in PmW. Breast cancer patients can be at additional risk because of treatment related estrogen deprivation. The favorable effects of bisphosphonates in osteoporosis and potential reduction of metastases warrant evaluation of ZA in PmW at high risk for breast cancer relapse. We assessed whether ZA 4 mg IV every 12 weeks x 4 doses was associated with an increase in BMD. Secondary objectives included defining ZA’s toxicity profile in this setting, and assessing for differences in overall cancer relapse. Methods: PmW with node positive or stage III breast cancer diagnosed less than 5 years earlier were randomized to ZA or observation. BMD was assessed by dual energy xray absorptiometry (DXA) for all subjects at 0 and 12 months. A toxicity evaluation was performed pre- and post-treatment for patients receiving ZA. Study endpoint occurred when subjects completed the DXAs, had disease progression or declined further treatment. We calculated change in BMD between 0 and 12 months at the L1–4 spine and femur neck. Results: 66 women have enrolled since 2000; 49 women have completed DXAs at 0 and 12 months (observation 23, ZA 26). Median age was 52 (range 40–81 yr), median ECOG performance status was 0 (range 0–1), and most women received concurrent tamoxifen (observation 74%, ZA 61%). Over 12 months, L1–4 spine BMD decreased in the observation arm (-0.006 ± 0.034 g/cm2) and increased in the ZA arm (p<0.001; 0.050 ± 0.042 g/cm2). No significant BMD change occurred at the femur neck. Only three grade 3 events occurred (2 arthralgia, 1 myalgia). Side effects were mild and transient, but as frequent as 87% following dose 1. The most common side effects were fatigue, myalgia and arthralgia. No clinically significant changes in creatinine or calcium occurred. Osteonecrosis of the jaw was not observed. Of the 66 women enrolled, 7 have relapsed (observation 4, ZA 3) but time since diagnosis is less than 10 years for most patients. Conclusions: ZA administered every 12 weeks for 4 doses leads to a statistically and clinically significant change in BMD at the lumbar spine. Toxicity was mild but common. There are as yet no significant differences in cancer relapse. No significant financial relationships to disclose.

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