The prevalence and pattern of chemotherapy-induced peripheral neuropathy (CIPN) among women with breast cancer receiving care in a large community oncology practice.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 80-80
Author(s):  
Natalie Brooke Simon ◽  
Michael A. Danso ◽  
Thomas Alberico ◽  
Ethan M. Basch ◽  
Antonia Vickery Bennett

80 Background: CIPN is a common side effect of taxane-based chemotherapy agents. This study examined the prevalence, severity, and risk factors of CIPN and its impact on quality of life (QOL) among women treated for breast cancer in a large U.S. community oncology practice. Methods: In this cross-sectional survey study, women previously treated with taxane-based chemotherapy for early stage breast cancer completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), breast cancer module (QLQ-BR23) and CIPN module (QLQ-CIPN20). Each subscale is scored 0-100 where higher scores indicate better function or greater symptom severity. Clinical data were abstracted from the medical record. Bivariate analyses were conducted to test pre- specified hypotheses. Results: 126 women with mean age 56.7 years (SD = 11.8) were stage I-II (79.4%) or stage III (20.6%) at the time of the survey; 65.1% were White and 27.8% were Black or African American. 73.0% of women reported they had CIPN. The mean time since last taxane chemotherapy cycle was 144.9 weeks (SD = 112.9). The mean (SD) score of QLQ-C30 global health status/QOL was 77.0 (20.3) and physical function was 85.7 (17.1). QLQ-CIPN20 mean scores for the sensory, motor, and autonomic subscales were 18.9 (23.1), 18.6 (18.7), and 17.1 (21.8), respectively. Presence of CIPN was associated with patient referral and visitation to a neurologist or pain specialist (p < 0.05). CIPN symptom severity was negatively correlated with global health status/QOL and physical and role functioning (range of r= -0.46 to -0.72). Further, it was not associated with age, body mass index, diabetes, or cumulative taxane dosage, but was greater for Black or African American patients versus White patients (e.g., sensory: 28.6 vs 14.5, p < 0.002). CIPN sensory impairment was marginally greater for patients treated with paclitaxel compared to docetaxel (23.3 vs 15.6, p < 0.06). Conclusions: CIPN was prevalent in this community oncology practice and significantly impacts function and QOL. These data highlight the importance of developing methods to mitigate CIPN.

2015 ◽  
Vol 87 (4) ◽  
Author(s):  
Andrzej Nowicki ◽  
Bernardeta Licznerska ◽  
Piotr Rhone

AbstractSelection of the treatment method in breast cancer patients and its consequences may affect their quality of life through somatic, psychical, and social factors.The aim of the study was early evaluation of the quality of life of women after mastectomy vs. breast conserving surgery.Material and methods. The study included 100 women aged 31 to 79 years (mean: 57) who underwent surgery due to breast cancer (amputation: 52; breast conserving surgery: 48 women) at the Cancer Centre in Bydgoszcz in 2014. The QLQ C-30 and QLQ BR-23 questionnaires were used to evaluate the quality of life of the patients 3 months after surgery.Results. In the Global Health Status/QoL domain, the mean score for women after amputation and breast conserving surgery was 49 and 53, respectively; for Physical Functioning, the scores were 70 and 75, and for Role Functioning, 62 and 68, respectively. For Cognitive Functioning, the mean score was 74 and 73; for Emotional Functioning - 62 and 68, and for Social Functioning 64 and 60, respectively. The difference in the arm symptoms domain was significant at 46 and 33 points, respectively (p = 0.004). The patients treated with breast conserving surgery had a better body image than women after amputation - the mean score was 52 and 66, respectively (p = 0.01).Conclusions. With respect to Global Health Status/QoL and Physical Functioning, the quality of life of women in the early postoperative period was similar in women after breast amputation and those who underwent breast conserving surgery. Patients treated with breast conserving surgery had a better score for body image, while those who underwent amputation more often suffered from arm symptoms, such as pain, oedema, and problems with raising of the limb.


2020 ◽  
Vol 26 (6) ◽  
pp. 1421-1428
Author(s):  
Ebrahim Salehifar ◽  
Ghasem Janbabaei ◽  
Abbas Alipour ◽  
Nasim Tabrizi ◽  
Razieh Avan

Purpose Taxane-induced peripheral neuropathy (TIPN) is a common and bothersome toxicity. This study aimed to determine the incidence and severity of TIPN in patients with breast cancer and to investigate the relationship between TIPN and quality of life. Methods A total of 82 breast cancer patients with TIPN symptoms were included in this study. The criteria of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03) and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) were used to evaluate grading of sensory neuropathy and quality of life, respectively. Analysis of the data was done by IBM SPSS statistics version 23. Results A total of 346 patients received taxane-based chemotherapy and 82 patients (23.7%) experience TIPN. The mean (SD) global health status/quality of life, physical functioning, role functioning, and pain subscales were 60.63 (5.26), 80.64 (9.05), 81.77 (10.41), and 43.88 (11.27), respectively. There were significant negative correlations between global health status/quality of life, physical functioning, and role functioning subscales with the grade of neuropathy (r = −0.33, −0.80, and −0.61, respectively) and positive correlation between pain subscale and the grade of neuropathy (r = 0.70). Conclusion This study shows a clear association between TIPN and worsened quality of life. These findings emphasize on detecting and management of TIPN in an effort to improve the quality of life of breast cancer patients.


2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Sang S. Pak ◽  
Matthew J. Miller ◽  
Victor A. Cheuy

Abstract Background Although evidence-based guidelines for physical therapy for patients with chronic low back pain (cLBP) are available, selecting patient-reported outcome measures to capture complexity of health status and quality of life remains a challenge. PROMIS-10 Global Health (GH) may be used to screen for impactful health risks and enable patient-centered care. The purpose of this study was to investigate the interrelationships between PROMIS-10 GH scores and patient demographics, health status, and healthcare utilization in patients with cLBP who received physical therapy. Methods A retrospective review of de-identified electronic health records of patients with cLBP was performed. Data were collected for 328 patients seen from 2017 to 2020 in three physical therapy clinics. Patients were grouped into HIGH and LOW initial assessment scores on the PROMIS-10 Global Physical Health (PH) and Global Mental Health (MH) measures. Outcomes of interest were patient demographics, health status, and healthcare utilization. Mann–Whitney U and chi-square tests were used to determine differences between groups, and binary logistic regression was used to calculate odds ratios (OR) to determine predictors of PH-LOW and MH-LOW group assignments. Results The PH-LOW and MH-LOW groups contained larger proportions of patients who were African American, non-Hispanic, and non-commercially insured compared to PH-HIGH and MH-HIGH groups (p < .05). The PH-LOW and MH-LOW groups also had a higher Charlson comorbidity index (CCI), higher rates of diabetes and depression, and more appointment cancellations or no-shows (p < .05). African American race (OR 2.54), other race (2.01), having Medi-Cal insurance (OR 3.37), and higher CCI scores (OR 1.55) increased the likelihood of being in the PH-LOW group. African American race (OR 3.54), having Medi-Cal insurance (OR 2.19), depression (OR 3.15), kidney disease (OR 2.66), and chronic obstructive pulmonary disease (OR 1.92) all increased the likeihood of being in the MH-LOW group. Conclusions Our study identified groups of patients with cLBP who are more likely to have lower PH and MH scores. PROMIS-10 GH provides an opportunity to capture and identify quality of life and global health risks in patients with cLBP. Using PROMIS-10 in physical therapy practice could help identify psychosocial factors and quality of life in the population with cLBP.


Nutrients ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 136
Author(s):  
Concetta Montagnese ◽  
Giuseppe Porciello ◽  
Sara Vitale ◽  
Elvira Palumbo ◽  
Anna Crispo ◽  
...  

Healthy lifestyles are associated with better health-related quality of life (HRQoL), favorable prognosis and lower mortality in breast cancer (BC) survivors. We investigated changes in HRQoL after a 12-month lifestyle modification program in 227 BC survivors participating in DEDiCa trial (Mediterranean diet, exercise, vitamin D). HRQoL was evaluated through validated questionnaires: EQ-5D-3L, EORTC-QLQ-C30 and EORTC QLQ-BR23. Baseline changes were tested using analysis of variance. Multiple regression analyses were performed to assess treatment effects on HRQoL. Increases were observed in global health status (p < 0.001), physical (p = 0.003), role (p = 0.002) and social functioning (p < 0.001), body image (p < 0.001), future perspective (p < 0.001), well-being (p = 0.001), and reductions in fatigue (p < 0.001), nausea and vomiting (p = 0.015), dyspnea (p = 0.001), constipation (p = 0.049), financial problems (p = 0.012), sexual functioning (p = 0.025), systematic therapy side effects (p < 0.001) and breast symptoms (p = 0.004). Multiple regression analyses found inverse associations between changes in BMI and global health status (p = 0.048) and between serum 25(OH)D levels and breast symptoms (p = 0.002). A healthy lifestyle treatment of traditional Mediterranean diet and exercise may impact positively on HRQoL in BC survivors possibly through reductions in body weight while vitamin D sufficiency may improve BC-related symptoms. These findings are relevant to BC survivors whose lower HRQoL negatively affects treatment compliance and disease outcomes.


2020 ◽  
Vol 41 ◽  
Author(s):  
Eunice de Oliveira Lacerda Lima ◽  
Marcelle Miranda da Silva

ABSTRACT Objectives: To identify the main affected domains of quality of life of hospitalized women with locally advanced or metastatic breast cancer; and to analyze the association between the level of quality of life and stage of cancer. Method: This was a cross-sectional quantitative, study conducted in Rio de Janeiro, Brazil, between March and July 2017. Interviews were performed with 199 women. The researchers administered the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, with analysis using the Statistical Package for the Social Sciences software and the Kruskal-Wallis test. Results: Mean global health status was 32.04. On the functional scales, cognitive functioning scored the highest (60.47), while role functioning scored the lowest (12.48). Fatigue presented the highest mean (69.57). The scores for global health status and the functional scales (with the exception of the social functioning) decreased as staging progressed. Conclusion: The stage of cancer affects the quality of life of the studied sample of women.


2019 ◽  
Vol 3 (1) ◽  
Author(s):  
A. Barnadas ◽  
◽  
M. Muñoz ◽  
M. Margelí ◽  
J. I. Chacón ◽  
...  

Abstract Background Bone metastasis (BM) is the most common site of disease in metastatic breast cancer (MBC) patients. BM impacts health-related quality of life (HRQoL). We tested prospectively the psychometric properties of the Bone Metastasis Quality of Life (BOMET-QoL-10) measure on MBC patients with BM. Methods Patients completed the BOMET-QoL-10 questionnaire, the Visual Analogue Scale (VAS) for pain, and a self-perceived health status item at baseline and at follow-up visits. We performed psychometric tests and calculated the effect size of specific BM treatment on patients´ HRQoL. Results Almost 70% of the 172 patients reported symptoms, 23.3% experienced irruptive pain, and over half were receiving chemotherapy. BOMET-QoL-10 proved to be a quick assessment tool performing well in readability and completion time (about 10 min) with 0–1.2% of missing/invalid data. Although BOMET-QoL-10 scores remained fairly stable during study visits, differences were observed for patient subgroups (e.g., with or without skeletal-related events or adverse effects). Scores were significantly correlated with physician-reported patient status, patient-reported pain, symptoms, and perceived health status. BOMET-QoL-10 scores also varied prospectively according to changes in pain intensity. Conclusions BOMET-QoL-10 performed well as a brief, easy-to-administer, useful, and sensitive HRQoL measure for potential use for clinical practice with MBC patients. Trial registration NCT03847220. Retrospectively registered on clinicaltrials.gov (February the 20th 2019).


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4097-4097
Author(s):  
Juan W. Valle ◽  
Antoine Hollebecque ◽  
Junji Furuse ◽  
Lipika Goyal ◽  
Funda Meric-Bernstam ◽  
...  

4097 Background: In FOENIX-CCA2 (NCT02052778), a pivotal phase 2 study among iCCA patients (pts) with FGFR2 fusions/rearrangements, the highly selective, irreversible FGFR1–4 inhibitor futibatinib demonstrated a confirmed objective response rate of 41.7%, with a 9.7-month median duration of response. Adverse events were manageable with dosing modifications that did not adversely impact on response. We report outcomes for the preplanned analysis of Patient-Reported Outcomes (PROs) during futibatinib treatment as a secondary objective of FOENIX-CCA2. Methods: Pts enrolled in FOENIX-CCA2 had locally advanced/metastatic unresectable iCCA with FGFR2 fusions/rearrangements, ≥1 prior line of therapy (including gemcitabine/cisplatin) and ECOG PS 0-1. Pts received oral futibatinib 20 mg continuous QD dosing per 21-day cycle. PRO measures included EORTC-QLQ-C30 (1 global health, 5 functional, 9 symptom scales), EQ-5D-3L, and EQ visual analogue scale (VAS). PROs were collected at screening, cycles 2 and 4, every 3 cycles thereafter, and end of treatment. PRO data were evaluated up to cycle 13, the last visit before data were missing for >50% of the PRO population (PRO primary assessment time point). Results: 92/103 (89.3%) pts enrolled had PRO completion data at baseline and a minimum of 1 follow-up assessment (median age 58 y, 56.5% female), with 48 pts having PRO data at cycle 13. At baseline, mean (SD) EORTC QLQ-C30 global health status score was 70.1 (19.4) and EQ VAS score 71.7 (20.3). Mean EORTC QLQ-C30 global health status scores were maintained from baseline to cycle 13, corresponding to 9.0 months on treatment, with no clinically meaningful (≥10-point) changes in individual functional measures (Table). EORTC QLQ-C30 scores across individual symptom measures were also stable from baseline through cycle 13; only constipation showed an average of 10.0-point worsening at only cycle 4. Mean EQ VAS scores were sustained from baseline to cycle 13 (mean change ranging -1.8 to +4.8 across cycles), with values maintained within the population norm range from across 20 countries. Conclusions: Quality of life data from the phase 2 FOENIX-CCA2 trial show that physical, cognitive and emotional functioning, and overall health status were maintained among pts with advanced iCCA receiving futibatinib. Clinical trial information: NCT02052778. [Table: see text]


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3491-3491 ◽  
Author(s):  
Alexey Danilov ◽  
Habte A Yimer ◽  
Michael Boxer ◽  
John M Burke ◽  
Sunil Babu ◽  
...  

Introduction: Longitudinal changes in health-related quality of life (HRQoL) are important in patients with chronic lymphocytic leukemia (CLL). GIBB (NCT02320487) is an open-label, single-arm phase II study of obinutuzumab (GA101; G) in combination with bendamustine (G-Benda) in patients with previously untreated CLL. A previous report from the GIBB study demonstrated an investigator-assessed objective response rate of 89.2%, a complete response rate of 49.0%, and no unexpected safety signals with G-Benda (Sharman et al. J Clin Oncol 2017). Here we report the final HRQoL data over 3 years from the GIBB study. Methods: Enrolled patients received G-Benda by intravenous infusion over six 28-day cycles: G 100mg on Day (D)1, 900mg on D2, and 1000mg on D8 and D15 of Cycle (C)1, then 1000mg on D1 of C2-6; benda 90mg/m2 on D2-3 of C1, and on D1-2 of C2-6. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) includes a global health status measure, 5 functional scales (physical, emotional, cognitive, social, and role functioning), 8 symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea), and an item on financial difficulties (Aaronson et al. J Natl Cancer Inst 1993). The EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) is a 16-item module, specific to CLL, containing 4 multi-item scales (fatigue, treatment side effects, disease symptoms, and infection) and 2 single items (social activities and future health worries). Both questionnaires were completed by patients on C1D1 (baseline), C3D1, and C6D1, at the end of induction (EOI) treatment (defined as +28 days from C6D1 or early treatment termination visit), at the response visit (defined as 2-3 months after the EOI treatment for all patients who received study treatment and had not experienced disease progression), and every 3 months thereafter at follow-up visits for up to 2 years. In total, there were 14 timepoints where data were collected. HRQoL scores were linear transformed to a 0-100-point scale. Mean baseline scores and mean score changes from baseline at each visit were evaluated. A threshold of ≥10-point change in score represents a clinically meaningful difference. For symptoms, negative change scores from baseline reflect an improvement in symptom burden. For global health status and functioning, positive change scores from baseline reflect improvements. Results: The trial enrolled 102 patients. Median age was 61 years and 68.4% of patients were male. Ninety-eight patients (96%) completed a questionnaire at baseline and at least 1 other questionnaire during a follow-up visit. Questionnaire completion rates at 14 time points ranged from 96% at baseline to 66% at 27 months follow-up (Table 1). According to the EORTC QLQ-C30 (Figure 1), improvements were observed for global health status at all follow-up visits, and clinically meaningful improvements were observed at the response visit, 3 months follow-up, and 27 months follow-up. Clinically meaningful improvements in role functioning were observed at EOI and persisted throughout the 27-month follow-up. For fatigue, clinically meaningful improvements were observed at every visit starting from the end of treatment (EOT) visit. Improvements were also observed for insomnia with mean reductions from baseline ≥10 points at various time points during follow-up. There was no worsening in other patient-reported symptoms or functional status over time. Similarly, with the EORTC QLQ-CLL16 (Figure 2), clinically meaningful improvements in symptoms were observed for fatigue, disease symptoms, and future health worries during treatment, at the EOT and/or throughout the follow-up. The largest improvement was observed for fatigue (-24.7) at the 24-month follow-up and future health worries (-25.4) at the 27-month follow-up. Conclusions: We previously reported that G-Benda is an effective regimen for first-line treatment of CLL with no unexpected safety signals. The HRQoL data from the GIBB trial suggest that G-Benda treatment consistently improved patient HRQoL over time. Several clinically meaningful improvements were observed in HRQoL, including global health status, functioning, symptoms, and future health worries. Disclosures Danilov: AstraZeneca: Consultancy, Research Funding; Genentech: Consultancy, Research Funding; TG Therapeutics: Consultancy; MEI: Research Funding; Bristol-Meyers Squibb: Research Funding; Verastem Oncology: Consultancy, Other: Travel Reimbursement , Research Funding; Takeda Oncology: Research Funding; Genentech: Consultancy, Research Funding; Bristol-Meyers Squibb: Research Funding; Takeda Oncology: Research Funding; Aptose Biosciences: Research Funding; Aptose Biosciences: Research Funding; Janssen: Consultancy; Pharmacyclics: Consultancy; Bayer Oncology: Consultancy, Research Funding; Celgene: Consultancy; Pharmacyclics: Consultancy; Janssen: Consultancy; Curis: Consultancy; Seattle Genetics: Consultancy; Verastem Oncology: Consultancy, Other: Travel Reimbursement , Research Funding; Gilead Sciences: Consultancy, Research Funding; Bayer Oncology: Consultancy, Research Funding; Curis: Consultancy; Seattle Genetics: Consultancy; MEI: Research Funding; TG Therapeutics: Consultancy; Celgene: Consultancy; Gilead Sciences: Consultancy, Research Funding; AstraZeneca: Consultancy, Research Funding; Abbvie: Consultancy; Abbvie: Consultancy. Yimer:AstraZeneca: Speakers Bureau; Janssen: Speakers Bureau; Seattle Genetics: Honoraria; Celgene: Honoraria; Clovis Oncology: Equity Ownership; Puma Biotechnology: Equity Ownership; Amgen: Consultancy. Boxer:Gerson Lerman: Consultancy; Best Doctors: Consultancy; Takeda: Honoraria, Speakers Bureau; AbbVie: Honoraria, Speakers Bureau. Burke:Celgene: Consultancy; Gilead: Consultancy; Roche/Genentech: Consultancy. Babu:Genentech: Research Funding. Li:Genentech: Employment; Roche: Equity Ownership. Mun:Genentech: Employment, Equity Ownership. Trask:Genentech: Employment, Equity Ownership. Masaquel:Roche: Equity Ownership; Genentech: Employment. Sharman:Acerta: Consultancy, Honoraria, Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Research Funding; Genentech: Consultancy, Honoraria, Research Funding; TG Therapeutics: Consultancy, Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria, Research Funding. OffLabel Disclosure: GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia; in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen


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