Quality of Life in Cancer Patients Undergoing Anticoagulant Treatment for Venous Thromboembolism: The Quavitec Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 880-880
Author(s):  
Dominique Farge ◽  
Nicolas Falvo ◽  
Matthieu Resche-Rigon ◽  
Toufek Berremili ◽  
Francis Couturaud ◽  
...  

Abstract Introduction: Treatment and prevention of VTE is crucial, yet anticoagulation is under-prescribed in cancer patients. The recommended treatment for established VTE in cancer patients is low molecular weight heparin (LMWH) once daily for at least 3 months, and termination or continuation of treatment after 3-6 months is still based on individual evaluation of the benefit-risk ratio, tolerability, drug availability, patient preference, and cancer. Despite important concerns about long-term patient tolerance for LMWH treatment (after 10 days) and its side effects, no study has analyzed the overall impact of LMWH on quality-of-life (QoL) in cancer patients. Methods: In this prospective, longitudinal, multicenter study, consecutive eligible adult cancer patients (>18 years), diagnosed with either deep vein thrombosis or a pulmonary embolism (PE), were recruited at participating centers between February 2011 and 2012. Patients were asked to answer three questionnaires administered at time of VTE diagnosis (M0), and 3 (M3) and 6 (M6) months after start of anticoagulant treatment: 1) the Medical Outcome Study 36-item Short-Form Health Survey (MOS SF-36) for generic Health-Related Quality of Life (HRQoL), 2) the European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire, and 3) the Venous Insufficiency Epidemiological and Economic Study (VEINES)-QOL questionnaire. Results (median[iqr], Wilcoxon Signed Rank Test): At M0, 400 cancer patients (51.5% female) were included, 60.4% with metastatic disease and 67.0% on chemotherapy. The choice of anticoagulant was made by the attending physician. 88.75% of patients received LMWH, 5.5% a vitamin K antagonist, 1.5% unfractionated heparin, and 3.75% a direct oral anticoagulant. Throughout the study, 18.9% of patients on LMWH reported at least one side effect with injection (number of reports: pain, 26 (7.3%); ecchymosis, 57(16.1%); pruritis, 2(0.6%); nodules, 28 (7.9%)). Mortality rate was 24.73%, with 79 deaths attributable to cancer progression and 3 to VTE. At M3, patients on LMWH showed a significant increase of 3.9 [5.7-14 ] points in the MOS SF-36 global HRQoL score (p=0.0007) and 8.3 [-8.3;17] points in the EORTC global Health status/QoL survey (p=0.0001). The veinsQoL score decreased by 2 [-5.2-4] points (p=0.022). Logistic regression analysis identified predictive factors common to both MOS SF-36 and EORTC: ECOG scores (MOS SF-36, p=0.050; EORTC, p=0.006) and whether patients were ambulatory as opposed to bedridden (MOS SF-36, p=0.001; EORTC, p=0.019). Cancer surgery (p=0.005), presence of central venous catheter (CVC) (p=0.018) or PE (p=0.029), and absence of chemotherapy (p=0.017), or acute infection (p=0.048) were also positive predictors of cancer-related QoL in the EORTC survey. No predictive factors were identified for veinsQoL. At M6, patients on LMWH showed sustained point increases of 5.5 [-5.6; 22] in the MOS SF-36 global HRQoL score (p<0.0001) and 8.3 [-8.3;33] in the EORTC global Health status/QoL score (p<0.0001), with no change in VeinsQoL. Logistic regression identified the pattern of change in QoL in the first three months of anticoagulation as a strong predictor of QoL scores at the M6 follow-up (MOS SF-36, p<0.0001; EORTC, p<0.0001; veinesQoL, p<0.0001). Tumor histology (p=0.005), CVC (p=0.024), absence of acute infection (p=0.034), and being ambulatory as opposed to bedridden (p=0.045), were additional predictive factors in the MOS SF-36. There was no change in the MOS SF-36 global HRQoL score between 3 and 6 months, but there was significant improvement in the sub-dimensions of general health (1.9 pts, p=0.057) and vitality (3.7 pts; p=0.016). The improved global health status/QoL score in the EORTC was also maintained between 3 and 6 months, with a significant 4.7 point reduction in the fatigue symptom subscale (p=0.016). No change was observed in the VeinsQoL. Painful side effects of LMWH treatment did not predict diminished QoL in the logistic regression analysis. Cancer progression was a negative predictor of MOS SF-36 global HRQoL in these patients (p=0.051). Conclusion: In cancer patients with established VTE who survive to 3 and 6 month follow-ups under recommended anticoagulant treatment, QoL increases despite long term treatment with LMWH. This analysis is the first to show that LMWH treatment from 3 to 6 months does not diminish QoL in cancer patients diagnosed with VTE. Disclosures No relevant conflicts of interest to declare.

Author(s):  
Maria Lavdaniti ◽  
Styliani Michalopoulou ◽  
Dimitra-Anna Owens ◽  
Eugenia Vlachou ◽  
Kyriakos Kazakos

Background and objective: Cancer and diabetes are two highly prevalent diseases worldwide and influence the quality of life. The study aimed to compare the quality of life in patients diagnosed with cancer and diabetes with those without diabetes undergoing chemotherapy and to investigate the responsible factors. Method: A convenience sample of 101 participants that had cancer and diabetes type 2 and 99 had cancer without diabetes, were used. Results: Patients with comorbid diabetes were divided based on their diabetes duration and whether they had glycemic control or not. Diabetic cancer patients without glycemic control had lower scores in global health status in physical and emotional functioning compared to diabetic cancer patients with glycemic control and patients without diabetes (p < .05). After adjusting for demographic characteristics, the differences between the group with diabetes and without glycemic control and the other two groups on global health status were statistically significant (p < .05). Patients with over 7 years of diabetes had a statistically significantly lower emotional functioning than the no diabetes group and lower global health status score that both of the other groups (p < .05). After adjusting for clinical and demographic characteristics, only the difference between the ≥ 7 years diabetes duration group and the no diabetes groups remained significant. Conclusion: The presence of diabetes in cancer patients underwent chemotherapy seems to negatively influence certain domains of quality of life and this seems to be affected by the duration of diabetes and whether glycemic control has been achieved.


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 697-697
Author(s):  
Dae Young Zang ◽  
Hyun Ae Jung ◽  
Boram Han ◽  
Jung Hoon Kim ◽  
Dae Ro Choi ◽  
...  

697 Background: Early detection of cancer and improved treatment have led to higher survival rates and an increasing number of long-term survivors in oncology practice. But there are few longitudinal Quality of Life (QoL) studies in patients who experienced cancer surgery. To investigate the longitudinal change in QoL of elderly gastrointestinal cancer patients, we designed prospective study for QoL in resected gastrointestinal cancer patients. Methods: A prospective longitudinal cohort study was designed. Patients from Hallym, Ajou, and Samsung medical center in South Korea were enrolled consecutively from February to September of 2012. Patients over 55 years old who received curative resection due to gastrointestinal cancer were included. They were given questionnaires every 6 months since then, and we’ve been using EORTC QLQ C-30 as quality of life scale. We selected patients using propensity score matching(PSM). The mean scores of the patients completing the interview at the 3 time points were compared using mixed model. Results: A total of 353 patients with gastrointestinal cancer were interviewed at baseline. We dichotomized patients into 2 groups ( < 70 years old vs. > = 70 years old). There were significant difference in ECOG performance status between 2 groups. After balancing with PSM, we selected 272 patients. Overall QoL did not show significant difference between 2 groups at baseline interview. After repeated interview, the score of global health status, physical functioning, and pain showed significantly higher in younger group ( < 70 years old). But other items didn't show significant difference.Especially patients in both group felt financial difficulty increased. Conclusions: Although the elderly gastrointestinal cancer patients showed lower score in global health status, physical function, they preserved relatively well in other functional status after curative surgery. Most patients felt increased financial burden.


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]


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.


2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Maike Jörling ◽  
Sandra Rutzner ◽  
Markus Hecht ◽  
Rainer Fietkau ◽  
Luitpold V. Distel

Objectives. Baseline health-related quality of life (HRQoL) scores predict survival, which has already been demonstrated in various studies. However, we were interested in whether changes in baseline scores during treatment are also significant predictors of survival. Methods and Materials. We analysed the data of 400 consecutive cancer patients receiving radiochemotherapy. Leading diagnoses were head and neck cancer (34.5%), rectal cancer (24.5%), and lung cancer (13%). HRQoL was studied at baseline, six weeks after therapy and after each completed year after the start of therapy until drop out of the study using the EORTC QLQ-C30 questionnaire. The change score was calculated as the baseline score subtracted from the score after therapy. Statistics included Kaplan-Meier estimates and Cox regression. Results. High global health status (p=0.005) and low pain scores (p=0.040) at baseline were related to favourable overall survival. Change scores of role functioning (p=0.027), global health status (p<0.018), and pain (p<0.001) were predictive of overall survival. Pain was the superior predictor of survival (p=0.001) among all variables and QoL scores studied by multivariate analysis. A deterioration in pain was associated with a 2.8 times higher chance of survival (HR 0.36). Conclusions. Deterioration of HRQoL baseline pain score by cancer treatment is a favourable and superior prognostic factor for survival.


2015 ◽  
Vol 2 (2) ◽  
pp. 96-97

Hintergrund: Fortschritte in der Krebstherapie haben zur Verlängerung der Überlebenszeit geführt. Dennoch beeinträchtigen Tumorsymptome und Nebenwirkungen immer noch die körperliche Aktivität und Lebensqualität (LQ). Patienten und Methoden: Wir führten eine anonyme Umfrage unter Krebspatienten durch, die sich zu der Zeit einer Chemotherapie unterzogen. Dabei verwendeten wir standardisierte Fragebögen: den Freiburger Fragebogen zur körperlichen Aktivität und den EORTC-Fragebogen QLQ-C30 (EORTC = European Organisation for Research and Treatment of Cancer). Zwei wichtige Fragen wurden untersucht: Gibt es Unterschiede 1) hinsichtlich der körperlichen Aktivität und LQ von Patienten, die nicht glauben, dass Sport ihre LQ verbessern könnte, und solchen, die dies glauben (Gruppe A vs. B), und 2) hinsichtlich der LQ von Patienten mit einer Gesamtaktivität (GA) von <18 MET-h/Woche (MET = metabolisches Äquivalent) und solchen mit einer GA von ≥18 MET-h/Woche (Gruppe C vs. D)? Ergebnisse: 276 von 400 Fragebögen wurden ausgefüllt. Die Gruppen A und B wurden in Bezug auf die Merkmale zu Studienbeginn ausbalanciert. Gruppe A litt signifikant häufiger unter Müdigkeit und Schmerzen; in Gruppe B waren höhere Werte für den allgemeinen Gesundheitsstatus (global health status; GHS) und die GA zu verzeichnen. Die Gruppen C und D unterschieden sich in Geschlechterverteilung, Alter und Bildungsgrad. Gruppe D wies signifikant höhere GHS-Werte auf; Gruppe C litt stärker unter Müdigkeit, Schmerzen und Appetitlosigkeit. Schlussfolgerung: Körperliche Aktivität korreliert bei Krebspatienten unter einer Chemotherapie mit einer höheren LQ. Übersetzung aus Kripp M, et al: Does physical activity improve quality of life in cancer patients undergoing chemotherapy? Oncol Res Treat 2015;38:230-236 (DOI: 10.1159/000381734)


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1989-1989
Author(s):  
Liesbeth C. de Wreede ◽  
Maggie Watson ◽  
Donald Milligan ◽  
Mauricette Michallet ◽  
Peter Dreger ◽  
...  

Abstract Abstract 1989 Objective: High-dose therapy (HDT) and ASCT is the standard of care in a variety of hematologic malignancies. Whereas for some indications a survival advantage for HDT and ASCT has been demonstrated, a benefit only in terms of better progression-free survival has been shown for CLL. Because of this the quality of life (QoL) deserves particular attention. QoL assessment was a major focus of a randomized controlled EBMT-Intergroup trial on the value of HDT compared to observation in first or second remission of CLL (Michallet, Blood, 2011). Methods: 222 patients were enrolled into the study and allocated to either ASCT or observation. In the transplant arm, 72% received HDT and ASCT (for those median time from randomization to transplant was 3.01 months); in the observation arm 9% received ASCT. QoL was assessed with the EORTC QLQ C30 version 3.0, a questionnaire that has to be filled in by the patients. The answers to the questions yielded 15 scores, each on a scale from 0 to 100. The scores represent 15 domains: global health status/QoL, 5 functional scales (100 representing perfect health) and 9 symptom scales (0 representing no complaints). QoL forms had to be completed at randomization and at months 4, 8, 12, and 24. Data on 56%, 53%, 54%, 61%, and 50% of the baseline patients are available for the respective periods. Missing forms were not systematically related to baseline variables or relapse. The numbers of drop out due to death at 2 years were 5 patients in the HDT arm and 4 patients in the control arm. All QoL outcomes were analyzed with mixed models according to the intent to treat principle. Time (as factor), age, gender, treatment arm and the interaction of time and treatment arm were modelled as fixed effects, whereas individual random effects were added for the intercept. Results: The mean values for global health status/QoL, physical functioning, role functioning and social functioning over time for the transplant and the observation group are shown in Figure 1. Global health status/QoL at 4 months (estimated effect from the multivariate model −7.15, p=0.034) was significantly inferior in the transplant cohort compared to the control group. At 8 months the estimated effect of HDT on global health status/QoL was −3.06 (p=0.36). This difference further diminished over the first year (estimate at 1 year −0.53, p=0.87). QoL did not decrease independently from the treatment during the first 2 years. The same global pattern of change over time was observed for physical functioning, role functioning and social functioning; however, the treatment impact was still significant at 8 months for physical functioning (-6.58; p=0.025) and social functioning (-11.18; p=0.014). No significant covariate effects could be delineated for either of these scales apart from age having a beneficial effect on social functioning. Conclusions: Quality of life is affected multi-dimensionally in the first year after high-dose therapy and autologous stem cell support. The negative impact of HDT on QoL has disappeared after two years. Patients should be informed that HDT followed by ASCT impairs quality of life in the first year after transplantation. Disclosures: No relevant conflicts of interest to declare.


2021 ◽  
Vol 37 (8) ◽  
Author(s):  
Daniela Pena Moreira ◽  
Giovana Paula Rezende Simino ◽  
Ilka Afonso Reis ◽  
Marcos Antonio da Cunha Santos ◽  
Mariangela Leal Cherchiglia

This study aims to evaluate changes in quality of life of cancer patients at the beginning of the first and the second cycle of chemotherapy (CT) in hospitals in Belo Horizonte, Minas Gerais State, Brazil. Longitudinal, prospective, descriptive study with a quantitative approach. We enrolled 230 patients, from a broader cohort, diagnosed with the five most frequent types of cancer (breast, colorectal, cervical, lung, and head and neck), aged 18 years or older, who were initiating CT for the first time. quality of life was assessed with the EORTC QLQ-C30 version 3, applied at the beginning of the first and second chemotherapy cycle. The paired Wilcoxon test was used to identify differences in quality of life between the two time points. A multivariate linear regression analysis was performed using the bootstrap method to investigate potential predictors of global health Status/quality of life. There was a significant increase in patients’ emotional function scores (p < 0.001) as well as symptom scores for pain (p = 0.026), diarrhea (p = 0.018), and nausea/vomiting (p < 0.001) after initiation of CT. Widowhood was associated with improvements in the global health Status/quality of life (p = 0.028), whereas the presence of cervical cancer (p = 0.034) and being underweight (p = 0.033) were related to poorer global health status/quality of life scores. CT has detrimental effects on patients’ physical health but, on the other hand, it leads to improvements in the emotional domain. Patients’ individual characteristics at the beginning of CT are associated with changes in their quality of life. Our study could help identify these characteristics.


2020 ◽  
Vol 50 (9) ◽  
pp. 990-998
Author(s):  
Shigeko Umezaki ◽  
Yusuke Shinoda ◽  
Akitake Mukasa ◽  
Shota Tanaka ◽  
Shunsaku Takayanagi ◽  
...  

Abstract Objective The factors associated with health-related quality of life in patients with glioma remain unclear; particularly, the impact of symptoms on quality of life has not been studied comprehensively. This study aims to document the quality of life of patients with glioma and clarify the impact of symptoms. Methods In this cross-sectional study, participants were recruited from patients at The University of Tokyo Hospital and from patients who were registered at the Japan Brain Tumor Alliance. We included adult patients with World Health Organization grade II–IV glioma and excluded those with disturbances of consciousness or aphasia. We used the European Organization for Research and Treatment of Cancer QLQ-C30 and BN20 to evaluate quality of life and the symptoms. Multiple regression analyses were performed to investigate the impact of symptoms on European Organization for Research and Treatment of Cancer global health status and QLQ-C30 social functioning. In addition, we performed univariate subgroup analyses classified by World Health Organization grade and history of chemotherapy. Results This study included 76 patients. Seven symptoms occurred in more than 50% of the patients: fatigue, future uncertainty, drowsiness, communication deficit, financial difficulties, motor dysfunction and weakness of legs. Multiple regression analyses showed that insomnia affected their global health status, and appetite loss, financial difficulties and motor dysfunction were significantly related to their social functioning. In subgroup analysis, the number of symptom subscales that were significantly related to global health status and social functioning was larger in World Health Organization grade II patients compared with grade III/IV patients. Conclusions In addition to neurological deficits, symptoms were associated with poor quality of life in patients with glioma. This study provided the basis on further investigation of usefulness of symptom evaluation on quality of life improvement.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19118-e19118
Author(s):  
Vikram Gota ◽  
Krunal Vasant Kavathiya ◽  
Damodaran S E ◽  
Amit Joshi ◽  
Vanita Noronha ◽  
...  

e19118 Background: Pemetrexed in combination with cisplatin or carboplatin is commonly recommended for the first-line treatment of patients with locally advanced or metastatic NSCLC of adenocarcinoma histology. The present study explores the safety and the impact of this doublet on the quality of life in adult Indian NSCLC patients. Methods: Patients were enrolled from a single tertiary care cancer hospital in India. Patients were administered pemetrexed 500 mg/m2, cisplatin 75 mg/m2or carboplatin AUC 5 every 3 weekly. All patients received standard folate and Vitamin B12 supplementation. Premedication included dexamethasone, granisetron and ranitidine. Quality of Life (QoL) data was collected at baseline and at completion of 3 cycles using EORTC QLQ-C30 (version 3) and QLQ- LC13 questionnaires. Toxicity was graded using CTCAE v. 4.03. Results: Twenty seven patients were enrolled on the study since July 2012.Twenty received carboplatin and seven received cisplatin. Mean age of the participants was 54.7 years (SD=9.58) with stage (IV=25; III A/B=2) and ECOG performance status (0=1; 1=17; and 2=9). Pemetrexed–platinum doublet caused significant improvement in Global Health Status and dyspnea score at 3 cycles compared to baseline (Table). The treatment also caused marked improvement in the physical function, emotional function, cognitive function and insomnia scales, although not statistically significant (Table). No significant difference compared to baseline was observed for other parameters. Grade 3/4 toxicities include anemia (3), neutropenia (3), hyponatremia (6), vomiting), diarrhea, and dyspnea (1 each). Conclusions: Pemetrexed-platinum doublet was well tolerated and markedly improved the global health status and dyspnoea at the end of three cycles. A higher incidence of hyponatreemia was observed in our cohort that needs to be investigated further. [Table: see text]


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