Understanding the symptom experience of breast cancer outpatients: The validity and utility of the M.D. Anderson Symptom Inventory (MDASI).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9106-9106
Author(s):  
Tito R. Mendoza ◽  
Fengmin Zhao ◽  
Charles S. Cleeland ◽  
Lynne I. Wagner ◽  
Linda J. Patrick-Miller ◽  
...  

9106 Background: Breast cancer and its treatments can produce multiple symptoms that cause distress and impair function. The MDASI, a patient-reported outcome measure of symptoms (sxs) and functional interference has been validated in general oncology and has the potential to inform symptom experience and guide treatment specific to breast cancer patients (pts). Methods: The Eastern Cooperative Oncology Group (ECOG) conducted the Symptom Outcomes and Practice Patterns (SOAPP) study at academic and community medical oncology clinics and included pts with breast cancer of all stages and phases of care. At baseline and 4 weeks, pts completed the MDASI. Symptom experiences and psychometric properties of the MDASI in breast cancer pts (n = 1544) were analyzed. Results: The median age was 58 years, and the race/ethnicity included 11% black and 8% hispanic. 5% had ECOG performance status (PS) ≥2. The 5 most prevalent moderate/severe sxs reported at baseline were fatigue (31%), disturbed sleep (27%), drowsiness (21%), hair loss (22%) and dry mouth (19%); moderate/severe skin rash (6%) and vomiting (4%) were the least prevalent. At follow-up, about 1/3 of patients had moderate/severe fatigue and 19% had moderate/severe pain and distress. Internal consistency and test-retest reliability were good, with Cronbach alphas of ≥0.85 and intraclass correlations of ≥0.76 for all subscales. Among those whose PS was stable or improving, the change scores in sx severity improved most for sleep disturbance, numbness/tingling, and difficulty remembering things. Significantly higher scores and moderately large effects for the severity scale were reported by pts with poorer PS (ES=.61) and those with local/regional/metastatic disease (ES=.67). Results were similar for the interference scale. Pts whose quality of life (QOL) declined showed greater increase in severity (1.1 vs .07, p<.001) from baseline to follow-up than pts whose QOL was unchanged, demonstrating sensitivity to change. Conclusions: Breast cancer pts have significant sx burden despite well-preserved PS. The MDASI is a valid, reliable, and sensitive sx assessment method for research and patient care in breast cancer outpatients.

Author(s):  
Reema Shyamsunder Shukla ◽  
Yogender Aggarwal ◽  
Rakesh Kumar Sinha ◽  
Shreeniwas S. Raut

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.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13064-e13064
Author(s):  
Shaoyan Lin ◽  
Hongnan Mo ◽  
Yiqun Li ◽  
Xiuwen Guan ◽  
Yimeng Chen ◽  
...  

e13064 Background: The prognosis of patients with advanced breast cancer (ABC) varied according to different prognostic factors. This study aimed to establish a nomogram to predict the overall survival (OS) of ABC patients in China. Methods: Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC patients with complete relevant information were included in this study, which were further randomized 3:1 and divided into training ( n = 1706) and validation ( n = 557) cohorts. The nomogram was built based on independent predictors identified by univariate and multivariate analyses. Harrell′s concordance index (C-index) and calibration plots were used to assessed the discriminatory and predictive capacities of the nomogram. Results: With a median OS of 45.4 months, the 2-year and 3-year OS rates of ABC patients were 75.2% and 60.2%, respectively. Univariate and multivariate analyses found that age, Eastern Cooperative Oncology Group (ECOG) performance status, T-stage, N-stage, tumor subtype, the presence of distant lymph node (DLN)/liver/brain metastasis, local therapy, efficacy of first-line therapy and metastatic-free interval (MFI) were significantly associated with OS (all P < 0.05). These variables were incorporated into a nomogram to predict the 2-year and 3-year OS of ABC patients. The C-indexes of the nomogram were 0.700 (95% confidence interval [CI]: 0.683-0.717) and 0.686 (95% CI: 0.652-0.719) for the training and the validation sets, respectively. The calibration curves revealed satisfactory agreement between actual survival and nomogram prediction in both the internal and external validations. The nomogram was able to stratify patients into different risk groups. Conclusions: We developed and validated a nomogram that might serve as an efficient tool to provide individual prediction for ABC patients and guide the physicians to make personalized treatment decisions for individual ABC patients.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jeeyeon Lee ◽  
Jin Hyang Jung ◽  
Wan Wook Kim ◽  
Byeongju Kang ◽  
Jungmin Woo ◽  
...  

Abstract Purpose The incidence of depression and anxiety is higher in patients with breast cancer than in the general population. We evaluated the degree of depression and anxiety and investigated the changes in patients with breast cancer during the treatment period and short-term follow-up period. Methods Overall, 137 patients with breast cancer were evaluated using the Patient Health Questionnaire 9-item depression scale (PHQ-9) and Generalized Anxiety Disorder scale (GAD-7). The scales were developed as a web-based electronic patient-reported outcome measure, and serial results were assessed before the operation, after the operation, in the post-treatment period, and in the 6-month follow-up period after surgery. Results The degree of depression and anxiety increased during treatment and decreased at 6-month follow-up, even if there were no statistical differences among the four periods (PHQ-9: p = 0.128; GAD-7: p = 0.786). However, daily fatigue (PHQ-9 Q4) and insomnia (PHQ-9 Q3) were the most serious problems encountered during treatment and at 6-month follow-up, respectively. In the GAD-7, worrying too much (Q3) consistently showed the highest scores during the treatment and follow-up periods. Of the patients, 7 (5.11%) and 11 (8.03%) patients had a worsened state of depression and anxiety, respectively, after treatment compared with before treatment. Conclusion Most factors associated with depression and anxiety improved after treatment. However, factors such as insomnia and worrying too much still disturbed patients with breast cancer, even at 6-month follow-up. Therefore, serial assessment of depression and anxiety is necessary for such patients.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3521-3521 ◽  
Author(s):  
Heinz-Josef Lenz ◽  
Sara Lonardi ◽  
Vittorina Zagonel ◽  
Eric Van Cutsem ◽  
M. Luisa Limon ◽  
...  

3521 Background: In the phase 2 CheckMate 142 trial, NIVO + low-dose IPI provided robust and durable clinical benefit and was well tolerated as 1L therapy for MSI-H/dMMR mCRC (Lenz et al. Ann Oncol 2018;29:LBA18). Longer follow-up data will be presented. Methods: Patients with MSI-H/dMMR mCRC and no prior treatment for metastatic disease received NIVO 3 mg/kg every 2 weeks + low-dose IPI 1 mg/kg every 6 weeks until disease progression or discontinuation. The primary endpoint was investigator-assessed objective response rate (ORR). Results: For all 45 patients (median follow-up was 13.8 months), ORR was 60% (95% CI 44.3–74.3). Responses were consistent with the overall population across subgroups including age, Eastern Cooperative Oncology Group (ECOG) performance status, prior adjuvant/neoadjuvant therapy, and mutation status (Table). Seven patients (16%) had grade 3–4 treatment-related adverse events (TRAEs); 3 (7%) had any grade TRAEs leading to discontinuation. Updated response, survival, and safety data after a longer follow-up (median 19.9 months) will be presented. Conclusions: NIVO + low-dose IPI demonstrated robust and durable clinical benefit and was well tolerated. Evaluated subgroups had responses consistent with the overall population. NIVO + low-dose IPI may represent a new 1L treatment option for patients with MSI-H/dMMR mCRC. Clinical trial information: NCT02060188. [Table: see text]


2021 ◽  
Vol 6 (2) ◽  
pp. 37-44
Author(s):  
Bindu SM ◽  
PL Rema ◽  
Praveen Jacob Ninan

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.


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 ◽  
...  

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


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10755-10755
Author(s):  
M. Lomas ◽  
J. Salvador ◽  
M. Ruiz ◽  
J. L. Bayo

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.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19558-19558 ◽  
Author(s):  
A. Tevaarwerk ◽  
J. A. Stewart ◽  
R. Love ◽  
N. C. Binkley ◽  
S. Black ◽  
...  

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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