PS01.122: LONG-TERM QUALITY OF LIFE IN PATIENTS AFTER MCKEOWN VERSUS IVOR LEWIS ESOPHAGECTOMY

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 84-84
Author(s):  
Egle Jezerskyte ◽  
Suzanne Gisbertz ◽  
Mark I Van Berge Henegouwen ◽  
Luca Saadeh ◽  
Marco Scarpa
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Cognitive Functioning ◽  
Ivor Lewis ◽  
Physical Role ◽  
Eortc Qlq

Abstract Background Treatment of distal esophageal and gastroesophageal junction (GEJ) cancers is challenging. The therapy for these cancers mainly consist of (neo)adjuvant chemo(radio)therapy and surgery. There are different surgical approaches possible for these patients: transthoracic esophagectomy with a cervical anastomosis (McKeown) or an intrathoracic anastomosis (Ivor Lewis). However, there is no evidence which is the preferred approach in terms of oncology, morbidity and quality of life. The aim of this study was to investigate the difference in the long-term quality of life in patients undergoing McKeown (McK) versus Ivor Lewis (IL) esophagectomy in a tertiary referral center. Methods Consecutive patients after either McK or IL for distal oesophagus, GEJ or proximal gastric carcinoma were asked to fill in EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires to evaluate quality of life during the period of January 2014 – December 2017. EORTC QLQ-INFO25 quality of life questionnaire was used to evaluate information needs of patients in both groups. All answers with a long follow up (> 1 year) after surgery were analysed. Results In the McK group 62 and in the IL group 110 patients were included. Median follow up was 3 years for McK and 2 years for IL. Median age was 62,4 years. Cognitive functioning was significantly better in the IL group (P = 0.038). Complaints of dyspnoe (P = 0.004) and dysphagia (P = 0.028) were significantly higher in the McK group. Patients after IL had significantly less trouble with eating with others (P = 0.003), trouble with taste (P = 0.032), chocking when swallowing (P = 0.022) and trouble with talking (P = 0.038). There was no significant difference in global health status or physical, role, social or emotional functioning. Furthermore there was no difference in symptoms of nausea, fatigue, pain, discomfort or information scores between McK and IL groups. Conclusion After a follow up of > 1 year no differences in global health status or physical, role, social or emotional functioning scales between McK and IL esophagectomy were found. However, significant differences in some symptom scales and cognitive functioning were observed in favor of IL. These findings should be taken into consideration when deciding between a McK and IL esophagectomy in patients where both procedures are feasible. Disclosure All authors have declared no conflicts of interest.

OS09.7.A Quality of life outcomes in patients with incidental and operated meningiomas: the QUALMS study

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii12-ii13
Author(s):  
S M Keshwara ◽  
A I Islim ◽  
C P Millward ◽  
C S Gillespie ◽  
G E Richardson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Global Health ◽  
Cognitive Functioning ◽  
Emotional Health ◽  
Health Score ◽  
Sf 36 ◽  
Eortc Qlq

Abstract BACKGROUND Long-term Health-Related Quality of Life (HRQoL) is an important measure of patient wellbeing. There is a paucity of studies evaluating HRQoL in meningioma patients. MATERIAL AND METHODS Cross-sectional study of adult patients with an incidental or symptomatic intracranial meningioma. Patients with less than 5 years of follow-up, a history of craniospinal radiation or neurofibromatosis type 2 were excluded. HRQoL was evaluated with SF-36, EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Outcome determinants were evaluated using a multi-variable linear regression analysis, adjusted for patient, tumour and treatment characteristics, and duration of follow-up. RESULTS 699 patients were invited to participate and 246 responded: 118 (48%) had an incidental meningioma. Mean age at diagnosis was 56.8 years (SD=13) and 81% were female. Median time from diagnosis to completion of questionnaire was 8.5 years (IQR 6.8–11.5). During follow-up, 158 patients (64.2%) had at least one operation for their meningioma and 47 patients (19.1%) had radiotherapy. Of those operated, 126 (79.7%) had WHO grade 1 and 24 (15.2%) had grade 2 meningiomas. Compared to normative population values, meningioma patients reported a worse SF-36 general health score (mean 61.9 vs 56.5, P=0.003) but a similar QLQ-C30 global health score (mean 62.3 vs 65.8, P=0.039), worse SF-36 and QLQ-C30 physical functioning scores (mean 74.1 vs 64.6, P<0.001 and mean 81.8 vs 76.5, P=0.007) and similar SF-36 and QLQ-C30 emotional health scores (mean 72.2 vs 70.9, P=0.367 and mean 71.0 vs 71.9, P=0.960). QLQ-C30 cognitive functioning was worse (mean 80.5 vs 71.4, P<0.001). Compared to the meningioma literature, QLQ-BN20 seizure burden was similar (mean 2.0 vs 1.6, P=0.760). A worse performance status at diagnosis was associated with an inferior QLQ-C30 global health score (β-coefficient=-4.9 [95% CI -9.1-(-)0.6] P=0.024). Number of surgeries was significantly associated with a worse QLQ-C30 cognitive functioning score (β-coefficient=-7.0 [95% CI -13.2-(-)0.9], P=0.025). Anti-epileptic drug use was associated with a significantly worse QLQ-C30 emotional health score (β-coefficient=-10.9 [95% CI -21.7-(-)0.01], P=0.050). CONCLUSION Meningioma patients have long-term HRQoL impairments affecting their physical and cognitive functions. An understanding that multiple surgeries affects cognitive function, and the need for anti-epileptic drugs equate to poorer emotional health, could help target appropriate therapies and support in the future.

P13 DIFFERENCE IN LONG-TERM QUALITY OF LIFE BETWEEN MCKEOWN AND IVOR LEWIS ESOPHAGECTOMY

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
E Jezerskyte ◽  
L M Saadeh ◽  
E R C Hagens ◽  
M A G Sprangers ◽  
L Noteboom ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy ◽  
Significant Difference ◽  
Cardia Carcinoma ◽  
Eortc Qlq ◽  
Mckeown Esophagectomy

Abstract Aim The purpose of this study was to investigate the difference in long-term health-related quality of life (HR-QoL) between McKeown and Ivor Lewis esophagectomy in a tertiary referral center. Background & Methods The therapy of esophageal cancers consist of (neo)adjuvant chemo(radio)therapy and surgery. Often different surgical approaches are possible such as transthoracic esophagectomy with a cervical anastomosis (McKeown) or an intrathoracic anastomosis (Ivor Lewis). Evidence is scarce on whether either of these approaches is better in terms of survival, perioperative morbidity, pathology results and quality of life. Patients with mid-, distal esophageal, gastroesophageal (GEJ) or cardia carcinoma who have undergone a McKeown or an Ivor lewis esophagectomy in the period of 2003 – 2018 were included in this study. EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires were handed out during the outpatient clinic visits and a follow-up of at least one year was ensured. Problems with eating, reflux and nausea and vomiting were chosen as primary HR-QoL domain endpoints while the remaining HR-QoL domains, postoperative complications and pathology results were observed as secondary endpoints. Correction for confounders age and gender was performed. Results 147 patients were included in the McKeown group and 120 in the Ivor Lewis group. Mean age was 63.5 years and median follow-up was three years (range 12-137 months). No significant difference was found in problems with eating, reflux and nausea and vomiting. Significantly more problems with eating with others were found in McKeown group (β=10.435, 95% CI 4.474 – 16.395) and anastomotic leakage was significantly more common after McKeown esophagectomy (p=0.004). No significant difference was found in Clavien Dindo classification. During Ivor Lewis esophagectomy significantly more lymph nodes were resected (p<0.001). Number of lymph node metastases and R0 resection rate did not differ between groups. Conclusion No major differences in long-term HR-QoL were found in patients with mid-, distal esophageal, GEJ or cardia carcinoma following McKeown or Ivor Lewis esophagectomy. Problems with eating with others and anastomotic leakages were more common after McKeown esophagectomy, however, Clavien Dindo classification and radicality of surgery were similar between the two groups. Results of this study could assist the patient during the decision-making process prior to the surgery.

scholarly journals Long-Term Quality of Life After Total Gastrectomy Versus Ivor Lewis Esophagectomy

2019 ◽  
Vol 44 (3) ◽  
pp. 838-848 ◽  
Author(s):  
E. Jezerskyte ◽  
L. M. Saadeh ◽  
E. R. C. Hagens ◽  
M. A. G. Sprangers ◽  
L. Noteboom ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postoperative Complications ◽  
Lymph Nodes ◽  
Total Gastrectomy ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy ◽  
Eortc Qlq

Abstract Background There is scarce evidence on whether a total gastrectomy or an Ivor Lewis esophagectomy is preferred for gastroesophageal junction (GEJ) cancers regarding effects on morbidity, pathology, survival and health-related quality of life (HR-QoL). The aim of this study was to investigate the difference in long-term HR-QoL in patients undergoing total gastrectomy versus Ivor Lewis esophagectomy in a tertiary referral center. Methods Patients with a follow-up of >1 year after a total gastrectomy or an Ivor Lewis esophagectomy for GEJ/cardia carcinoma completed the EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires. ‘Problems with eating,’ ‘reflux,’ and ‘nausea and vomiting’ were the primary HR-QoL endpoints. The secondary endpoints were the remaining HR-QoL domains, postoperative complications and pathology results. Results Thirty patients after gastrectomy and 71 after esophagectomy were included. Mean age was 63 years. Median follow-up was 2 years (range 12–84 months). Patients after gastrectomy reported less ‘choking when swallowing’ and ‘coughing’ (β = − 5.952, 95% CI − 9.437 to − 2.466; β = − 13.084, 95% CI − 18.525 to − 7.643). More lymph nodes were resected in esophagectomy group (p = 0.008). No difference was found in number of positive lymph nodes, R0 resection or postoperative complications. Conclusions After a follow-up of >1 year ‘choking when swallowing’ and ‘coughing’ were less common after a total gastrectomy. No differences were found in postoperative complications or radicality of surgery. Based on this study, no general preference can be given to either of the procedures for GEJ cancer. These results support shared decision making when a choice between the two treatment options is possible.

FOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangements.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4097-4097
Author(s):  
Juan W. Valle ◽  
Antoine Hollebecque ◽  
Junji Furuse ◽  
Lipika Goyal ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Global Health Status ◽  
Phase 2 ◽  
Life Data ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Eq Vas

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]

scholarly journals Improvements in Health-Related Quality of Life and Symptoms in Patients with Previously Untreated Chronic Lymphocytic Leukemia: Final Results from the Phase II GIBB Study of the Combination of Obinutuzumab and Bendamustine

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3491-3491 ◽  
Author(s):  
Alexey Danilov ◽  
Habte A Yimer ◽  
Michael Boxer ◽  
John M Burke ◽  
Sunil Babu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Chronic Lymphocytic Leukemia ◽  
Global Health ◽  
Research Funding ◽  
Lymphocytic Leukemia ◽  
Future Health ◽  
Equity Ownership

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

P12 LONG-TERM QUALITY OF LIFE AFTER TOTAL GASTRECTOMY VERSUS IVOR LEWIS ESOPHAGECTOMY

2019 ◽  
Vol 32 (Supplement_2) ◽  
Author(s):  
E Jezerskyte ◽  
L M Saadeh ◽  
E R C Hagens ◽  
M A G Sprangers ◽  
L Noteboom ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Postoperative Complications ◽  
Total Gastrectomy ◽  
Nausea And Vomiting ◽  
Ivor Lewis ◽  
Ivor Lewis Esophagectomy ◽  
Significant Difference

Abstract Aim The aim of this study was to investigate the difference in long-term health-related quality of life in patients undergoing total gastrectomy versus Ivor Lewis esophagectomy in a tertiary referral center. Background & Methods Surgical treatment for gastroesophageal junction (GEJ) cancers is challenging. Both a total gastrectomy and an esophagectomy can be performed. Which of the two should be preferred is unknown given the scarce evidence regarding effects on surgical morbidity, pathology, long-term survival and health-related quality of life (HR-QoL). From 2014 to 2018, patients with a follow-up of > 1 year after either a total gastrectomy or an Ivor Lewis esophagectomy for GEJ or cardia carcinoma completed the EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires. Problems with eating, reflux and nausea and vomiting were chosen as the primary HR-QoL endpoints. The secondary endpoints were the remaining HR-QoL domains, postoperative complications and pathology results. Multivariable linear regression was applied taking confounders age, gender, ASA classification and neoadjuvant therapy into account. Results 30 patients after gastrectomy and 71 after Ivor Lewis esophagectomy with a mean age of 63 years were included. Median follow-up was two years (range 12-84 months). Patients after total gastrectomy reported significantly less choking when swallowing and coughing (β=-5.952, 95% CI -9.437 – -2.466; β=-13.084, 95% CI -18.525 – -7.643). Problems with eating, reflux and nausea and vomiting were not significantly different between the two groups. No significant difference was found in postoperative complications or Clavien-Dindo grade. Significantly more lymph nodes were resected in esophagectomy group (p=0.008). No difference in number of positive lymph nodes or R0 resection was found. Conclusion After a follow-up of > 1 year choking when swallowing and coughing were less common after total gastrectomy. No significant difference was found in problems with eating, reflux or nausea and vomiting nor in postoperative complications or radicality of surgery. Based on this study no general preference can be given to either of the procedures for GEJ cancer. Patients may be informed about the HR-QoL domains that are likely to be affected by the different surgical procedures, which in turn may support shared decision making when a choice between the two treatment options is possible.

Quality of life after preoperative radio-/chemotherapy in locally advanced breast cancer patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12083-e12083 ◽  
Author(s):  
Christiane Matuschek ◽  
Carolin Nestle-Kraemling ◽  
Sylvia Wollandt ◽  
Vanessa Speer ◽  
Edwin Boelke ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Preoperative Radiotherapy ◽  
External Beam Radiation ◽  
Beam Radiation ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

e12083 Background: Preoperative radiotherapy and chemoradiotherapy (PRT/PCRT) represents an increasingly used clinical strategy in different tumor sites. However, concerns regarding a possible unfavorable influence on the clinical outcome still exist. The aim of the current study was to examine the long-term global health status in our series of LABC patients treated with PRT/PCRT followed by breast-conserving surgery (BCS) or mastectomy (ME). Methods: Of the 315 patients treated with PRT/PCRT in the years 1991 and 1999, 203 patients were still alive at long-term follow up of mean 17.7 years (range 14-21). Thirty-seven patients were lost to follow up and 58 patients refused to be contacted, which resulted in 107 patients (64 patients after BCS and 43 after mastectomy) being available and willing to undergo further clinical assessment. PRT/PCRT consisted of external beam radiation therapy (EBRT) with 50 Gy (5 × 2 Gy/week) to the breast and the supra-/ infraclavicular lymph nodes combined with a consecutive electron boost or (in case of BCS) a 10-Gy interstitial brachytherapy boost with Ir-192 prior to EBRT. Overall, chemotherapy was administered either prior to RT or concomitantly in the majority of patients. Quality of life (QoL) was assessed by EORTC QLQ-C30 questionnaires for overall QoL and EORTC QLQ-BR23 for breast-specific QoL. Results are reported using functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and symptom-related items (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). The results were compared to a published reference cohort of n=2028 healthy adults (16-92 years), including n=1139 women (age 16-92 years). EORTC QLQ-C30 functional scales were also analyzed between different subgroups including an age-matched analysis with a two sided paired t-test. Results: In comparison with this healthy control group of 1139 women, we did not detect any significant differences for the functional scales measured by physical function, emotional well-being, cognitive, and social function as well as the symptom scales: fatigue, nausea, vomiting, pain, diarrhea and financial difficulties for both groups. However, significant inferior scores were found in the present study group regarding obstipation (p=0.013), loss of appetite (0.038), sleeping disorder (p=0.01) and dyspnoe (p=0.01). Conclusions: Taken together, retrospective as well as prospective data underline the feasibility of preoperative radiotherapy in breast cancer.

scholarly journals Quality-of-Life Outcomes in Patients with Relapsed or Refractory Multiple Myeloma Treated with Elotuzumab Plus Lenalidomide/Dexamethasone or Lenalidomide/Dexamethasone: Final Analysis of the Phase 3 ELOQUENT-2 Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2190-2190 ◽  
Author(s):  
David Cella ◽  
Jan McKendrick ◽  
Harrison Davis ◽  
Ravi Vij ◽  
Clara Chen
Keyword(s):  
Quality Of Life ◽  
Global Health ◽  
Research Funding ◽  
Final Analysis ◽  
Pain Severity ◽  
Global Health Status ◽  
Treatment Groups ◽  
Eortc Qlq

Introduction: The development of numerous novel therapies for the treatment of relapsed or refractory multiple myeloma (MM) has resulted in improved response rates and durable responses that prolong survival. Assessment of health-related quality of life (HRQoL) has therefore become increasingly important as HRQoL decreases with increasing lines of therapy (LoTs) (Despiégel et al. Clin Lymphoma Myeloma Leuk 2019). In the phase 3 ELOQUENT-2 study (NCT01239797), elotuzumab (E) plus lenalidomide/dexamethasone (Ld) showed a 30% reduction in the risk of progression/death versus Ld in patients with relapsed or refractory MM and 1-3 prior LoTs (median follow-up: 24.5 months; Lonial et al. N Engl J Med 2015). The initial analysis of patient-reported outcomes (PROs) from ELOQUENT-2 at a 3-year extended follow-up showed that the improvement in efficacy observed with ELd was achieved without a detriment to HRQoL (Cella et al. Ann Hematol 2018). Here we present the final analysis of PRO data from ELOQUENT-2. Methods: In ELOQUENT-2, patients with relapsed or refractory MM and 1-3 prior LoTs were randomized 1:1 to receive ELd or Ld in 28-day cycles until disease progression, unacceptable toxicity, or withdrawal of consent. The Brief Pain Inventory-Short Form (BPI-SF; pain severity, pain interference, and worst pain), the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 questionnaire (QLQ-C30; prespecified key domains were physical function, fatigue, global health status/QoL, and pain), and the myeloma-specific module (QLQ-MY20; includes assessment of symptoms and treatment side effects) were administered at baseline (BL), on Day 1 of each treatment cycle, and at the end of treatment/study withdrawal. All randomized patients with ≥1 post-BL assessment were included in each PRO analysis. Overall mean change from BL was compared between treatment groups based on a mixed-effect model for repeated measures; statistical tests for the overall population only included treatment cycles with >30 patients in each treatment group. A paired t-test was used to compare scores at each cycle with BL; an unpaired t-test compared mean values between treatment groups. BPI-SF scores range from 0-10 with lower scores representing better pain outcomes. EORTC QLQ-C30 scores range from 0-100 with higher scores representing better physical functioning and global health status/QoL, and worse fatigue and pain; EORTC QLQ-MY20 scores range from 0-100 with higher scores representing worse symptoms and problems. Results: In total, 646 patients were treated with ELd (n=321) or Ld (n=325); 319 and 311 patients had ≥1 post-BL assessment and were included in the PRO analysis, respectively (minimum follow-up: 70.6 months). BL BPI-SF mean scores for ELd versus Ld were low across all domains: pain severity (2.6 vs 2.9), pain interference (2.5 vs 2.8), and worst pain (3.6 vs 3.8). Scores for all BPI-SF domains remained stable over the course of the study (eg, pain severity: Figure A). ELd-treated patients with BL moderate/severe pain severity (score of ≥5) had significantly lower mean pain severity scores versus Ld-treated patients in Cycles 1-5. A higher proportion of clinical responders (complete or partial response per European Group for Blood and Marrow Transplantation criteria) versus non-responders had a sustained reduction in pain score across all BPI-SF domains: pain severity (18% vs 6%), pain interference (15% vs 6%), and worst pain (30% vs 13%); the difference in time to sustained improvement was not statistically significant between the clinical responders and non-responders for any pain endpoint. For both treatment groups, there was no clinically meaningful change (≥10 points) from BL scores at any cycle (>30 patients) across all key domains for EORTC QLQ-C30 (eg, global health status/QoL: Figure B) and QLQ-MY20. Conclusions: This final analysis of PROs in ELOQUENT-2 confirms that the efficacy benefits observed with addition of elotuzumab to Ld in patients with relapsed or refractory MM treated with 1-3 prior LoTs were achieved without negatively affecting HRQoL compared with Ld. Study support: BMS. Medical writing: Kenny Tran, Caudex, funded by BMS. Disclosures Cella: FACIT.org: Equity Ownership. McKendrick:PRMA Consulting Ltd.: Employment, Other: I am employed by PRMA Consulting Ltd who provide consulting services to a number of pharmaceutical companies. Davis:PRMA Consulting Ltd.: Employment, Other: I am employed by PRMA Consulting Ltd who provide consulting services to a number of pharmaceutical companies.. Vij:Sanofi: Honoraria; Karyopharm: Honoraria; Janssen: Honoraria; Genentech: Honoraria; Celgene: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Takeda: Honoraria, Research Funding. Chen:Bristol-Myers Squibb: Employment.

scholarly journals Real-World Health-Related Quality of Life in Patients with Diffuse Large B-Cell Lymphoma: Comparisons with Reference Populations and By Line of Therapy

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4111-4111
Author(s):  
Qiufei Ma ◽  
Abigail Bailey ◽  
Neil Milloy ◽  
Jake Butcher ◽  
Ruben G.W Quek ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Reference Values ◽  
Real World ◽  
Role Functioning ◽  
Functional Scores ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Abstract Introduction: Diffuse large B-cell lymphoma (DLBCL) is the most common type of aggressive non-Hodgkin's lymphoma (NHL) constituting 30-58% of all NHL (Tilly et al, 2015; Thieblemont et al, 2020). Treatment can include intensive multiagent chemotherapy and other novel therapies which carries risk for toxicities. Despite this, we lack data comprehensively depicting the quality of life of real-world patients with DLBCL, particularly in the modern era with novel therapies. Therefore, we aimed to compare Quality of Life (QoL) to reference populations and assess real-world DLBCL patients across multiple countries and lines of therapy. Methods: Real-world data were drawn from the Adelphi DLBCL Disease Specific Programme™ (DSP), a point-in-time survey of hematologists, hemato-oncologists, oncologists and their patients with DLBCL conducted in France (FR), Germany (DE), Italy (IT), Spain (SP), the United Kingdom (UK) and the United States of America (US) between Jan-May 2021. Patients were asked to voluntarily complete a patient self-completion form (PSC) capturing demographics and QoL data through the use of patient-reported outcome instruments: the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L), EQ-5D-5L Visual Analogue Scale and Work Productivity and Activity Impairment questionnaire. Bivariate analysis was conducted to compare all cancer and NHL-specific reference values from the EORTC QLQ-C30 manual (Scott et al, 2008) to DLBCL DSP data, and to review QoL across lines of therapy, defined as first line and second line (1L+2L) and third line and above (3L+). Statistical significance level was set at p&lt;.05. If functional scores were lower, when compared to reference values, within the DSP, this was indicative of a worse QoL in patients with DLBCL. For symptomatic scores the opposite was true; should the DSP value be higher, this was indicative of a worse QoL in patients with DLBCL. Results: Data analysis was conducted on 441 patients with DLBCL who completed a PSC (FR: n=80, DE: n=150, IT: n=54, SP: n=43, UK: n=34, US: n=80); at data collection, mean (standard deviation) age was 64.6 (12.39) years, 36% of patients were female, 19% working full- or part-time and 80% were relapsed/refractory, 29% were 3L+. 8%, 24%, 28% and 40% were at Ann Arbor disease stage I, II, III and IV respectively at the time of data collection. When comparing DLBCL DSP values to EORTC QLQ-C30 all cancer reference values for functional scores (Table 1), global health status, physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning were significantly worse than all cancer reference values. In terms of symptoms, DSP values for fatigue, nausea and vomiting, dyspnea, appetite loss and diarrhea were significantly worse than all cancer reference values (Table 2). Results were mixed when comparing with EORTC QLQ-C30 NHL-specific reference values (Table 1) for functional scores; global health status was significantly worse for the DLBCL DSP population, whilst role functioning, cognitive functioning and social functioning were significantly better than NHL reference values. Significantly worse symptom scores were observed in the DLBCL DSP population (Table 2) for nausea and vomiting, pain, dyspnea and diarrhea when compared with the reference values. Functioning scores were significantly worse in 3L+ patients vs 1L+2L for global health status, physical functioning, role functioning, cognitive functioning and social functioning (Table 3). Fatigue, dyspnea and diarrhea symptomatic scores were significantly worse in 3L+ vs 1L+2L patients. Symptom burden was high across all lines of therapy (Table 4). Conclusion: Real-world patients with DLBCL demonstrated significantly worse QoL when compared with a general cancer reference population with respect to all functional scores, as well as fatigue, nausea and vomiting, dyspnea, appetite loss and diarrhea, underscoring the high symptom burden experienced by patients with DLBCL. Patients with DLBCL on 3L+ had significantly worse QoL than those on earlier lines of therapy with respect to global health status, physical functioning, role functioning, cognitive functioning and social functioning, fatigue, dyspnea and diarrhea indicating an unmet need in novel treatment options to help improve QoL in later lines. Figure 1 Figure 1. Disclosures Ma: Regeneron Pharmaceuticals Inc.: Current Employment, Current holder of individual stocks in a privately-held company. Quek: Regeneron Pharmaceuticals Inc.: Current Employment, Current holder of individual stocks in a privately-held company.

Smartphone app as a follow-up tool after cardiac rehabilitation: Single-arm feasibility study (Preprint)

2018 ◽  
Author(s):  
Pernille Lunde ◽  
Birgitta Blakstad Nilsson ◽  
Astrid Bergland ◽  
Asta Bye
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Cardiac Rehabilitation ◽  
Potential Effect ◽  
Goal Achievement ◽  
Recruitment Rate ◽  
Floor Effect

BACKGROUND Long-term maintenance of preventive activities is fundamental for achieving improved outcomes of cardiac rehabilitation (CR). Despite this, it is shown to be a major challenge for many patients to follow recommendations and thereby adhere to a heart-friendly lifestyle. Smartphone applications (apps) have been emphasized as potential tools to promote preventive activities after attendance in a CR program. Before commencing a trial to assess the potential effect of using an app for long-term adherence to preventive activities after attendance in CR, a study to assess the feasibility of the intervention is warranted. OBJECTIVE To assess the feasibility of an intervention where an app is used as a tool enabling individualized and monitored follow-up for patients after attendance in a CR program. METHODS Experimental, pre-post single arm trial, lasting for 12 weeks. All patients received access to an app aimed to guide people to change or to maintain a heart friendly lifestyle. During the study period, they got weekly, individualized follow-up through the app, based on their own goalsetting. Feasibility outcome assessed were adherence to the intervention, recruitment rate, resource requirements and efficacy regarding capability to detect a difference on quality of life (QoL), health status and perceived goal achievement as well as evaluating ceiling and floor effect in these outcomes. Criteria’s for success were preset to be able to evaluate whether the intervention were feasible in a potential future RCT. RESULTS All 14 patients included in the study used the app to promote preventive activities throughout the study. Satisfaction with the technology were high and the patients found the technology based follow-up intervention both useful and motivational. In total, 71% of the patients completed CR were eligible for a potential RCT as well as for the present study. Ceiling effect was achieved in more than 50% of the patients in questionnaires evaluating quality of life (SF-36 and COOP/WONCA) and health status (EQ-5D). Overall self-rated health status (EQ VAS) and perceived goal achievement were found to be able to detect a difference through the study. CONCLUSIONS Individual follow-up intervention through an app after attendance in CR is feasible. All patients used the app for preventive activities and found the follow-up intervention through an app as both useful and motivating for adherence to a heart-friendly lifestyle. Several points of guidance from the patients in the current study has been taken along and have contributed to the final design of the RCT now in the field.

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