Health-related quality of life in stage III melanoma patients treated with neoadjuvant ipilimumab and nivolumab followed by index lymph node excision only, compared to therapeutic lymph node dissection: First results of the PRADO trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10064-10064
Author(s):  
Noëlle Milena Jane Van den Heuvel ◽  
Irene L.M. Reijers ◽  
Elisa A. Rozeman ◽  
Judith M. Versluis ◽  
Katarzyna Józwiak ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lymph Node ◽  
Stage Iii ◽  
Health Related Quality ◽  
Related Quality ◽  
First Results ◽  
Health Related ◽  
Melanoma Patients ◽  
Stage Iii Melanoma

10064 Background: Neoadjuvant ipilimumab and nivolumab induces high pathologic response rates of 74-78% (OpACIN and OpACIN-neo trial), thus the role of Therapeutic Lymph Node Dissections (TLND) in patients with major pathologic responses (MPR: pathological (near) complete response) is now unclear. In the PRADO trial, TLND was omitted in patients with MPR in their index lymph node ((ILN), the largest LN marked prior to neoadjuvant therapy). We sought to determine if less extensive surgery is associated with better Health Related Quality of Life (HRQoL). These are the first results of the comparison of HRQoL between patients undergoing a TLND or less extensive ILN excision. Methods: HRQoL was assessed with the European Organisation for Research and Treatment of Cancer QoL questionnaire-C30 (QLQ-C30). A generalized estimation equation was used to assess the difference in HRQoL outcomes between patients who underwent TLND (pathological non- and partial-responders, pNR/pPR) versus those who did not (pathological (near)complete responders, pNCR/pCR). Differences were adjusted for age, gender and follow-up (FU, in weeks), but not for pathological responses (pNR, pPR, pNCR & pCR). Differences in QLQ-C30 scores were classified as clinically important according to published guidelines. Results: A total of 49 patients from the PRADO study had reached at least 24 weeks FU, and were included in the first explorative analysis. The median age of this study population was 58 years (range, 22-84). Questionnaire completion rates were high: 94% at baseline, 100%, 90%, 88% at week 6, 12 and 24, respectively. Sixteen (33%) patients underwent TLND versus 33 (67%) who had ILN excision only. Over a FU period of 24 weeks, patients who underwent TLND scored significantly lower on global (68 vs 78, adjusted difference (diff) = -9.53, p = .005), physical (84 vs 94 diff = -11.1, p = < .001), emotional (69 vs 83, diff = -11.7, p = .001), role (70 vs 85, diff = -13, p = .004), and social functioning (81 vs 91, diff = -8.9, p = .016) and had a higher symptom burden of fatigue (35 vs 23, diff = 11.1, p = .004), insomnia (38 vs 18, diff = 16.6, p = .002) and financial impact (12 vs 4, diff = 7.9, p = .027) than patients undergoing ILN excision only. These differences were indicated as clinically relevant. Conclusions: First results from PRADO suggest that reducing the extent of surgery following neoadjuvant immunotherapy might result in better HRQoL of high-risk stage III melanoma patients. Clinical trial information: NCT02977052.

scholarly journals Health-related quality of life analysis in stage III melanoma patients treated with adjuvant dendritic cell therapy

2018 ◽  
Vol 21 (6) ◽  
pp. 774-780 ◽  
Author(s):  
M. Bloemendal ◽  
M. J. A. Rietveld ◽  
W. W. van Willigen ◽  
W. R. Gerritsen ◽  
C. G. Figdor ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Dendritic Cell ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Melanoma Patients ◽  
Life Analysis ◽  
Stage Iii Melanoma ◽  
Dendritic Cell Therapy

Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group

2009 ◽  
Vol 27 (18) ◽  
pp. 2916-2923 ◽  
Author(s):  
Andrew Bottomley ◽  
Corneel Coens ◽  
Stefan Suciu ◽  
Mario Santinami ◽  
Willem Kruit ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adjuvant Therapy ◽  
Phase Iii ◽  
Stage Iii ◽  
Health Related Quality ◽  
European Organisation ◽  
Related Quality ◽  
Health Related ◽  
Stage Iii Melanoma

PurposeInterferon (IFN) -based adjuvant therapy in melanoma is associated with significant side effects, which necessitates evaluation of health-related quality of life (HRQOL). Our trial examined the HRQOL effects of adjuvant pegylated IFN-α-2b (PEG-IFN-α-2b) versus observation in patients with stage III melanoma.MethodsA total of 1,256 patients with stage III melanoma were randomly assigned after full lymphadenectomy to receive either observation (n = 629) or PEG-IFN-α-2b (n = 627): induction 6 μg/kg/wk for 8 weeks then maintenance 3 μg/kg/wk for an intended total duration of 5 years. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL.ResultsAt 3.8 years of median follow-up, for the primary end point, recurrence-free survival (RFS), risk was reduced by 18% (hazard rate = 0.82; P = .01) in the PEG-IFN-α-2b arm compared with observation. Significant and clinically meaningful differences occurred with the PEG-IFN-α-2b treatment arm compared with the observation group, showing decreased global HRQOL at month 3 (−11.6 points; 99% CI, −8.2 to −15.0) and year 2 (−10.5 points; 99% CI, −6.6 to −14.4). Many of the other scales showed statistically significant differences between scores when comparing the two arms. From a clinical point of view, important differences were found for five scales: two functioning scales (social and role functioning) and three symptom scales (appetite loss, fatigue, and dyspnea), with the PEG-IFN-α-2b arm being most impaired.ConclusionPEG-IFN-α-2b leads to a significant and sustained improvement in RFS. There is an expected negative effect on global HRQOL and selected symptoms when patients undergo PEG-IFN-α-2b treatment.

scholarly journals Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment

2012 ◽  
Vol 10 (1) ◽  
pp. 66 ◽  
Author(s):  
Dennis A Revicki ◽  
Alfons JM van den Eertwegh ◽  
Paul Lorigan ◽  
Celeste Lebbe ◽  
Gerald Linette ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Stage Iii ◽  
Health Related Quality ◽  
Life Outcomes ◽  
Quality Of Life Outcomes ◽  
Unresectable Stage ◽  
Related Quality ◽  
Health Related ◽  
Melanoma Patients

scholarly journals Pelvic organ prolapse surgery and health-related quality of life: a follow-up study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tadesse Belayneh ◽  
Abebaw Gebeyehu ◽  
Mulat Adefris ◽  
Guri Rortveit ◽  
Janne Lillelid Gjerde ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pelvic Organ Prolapse ◽  
Pelvic Organ ◽  
Prolapse Surgery ◽  
Stage Iii ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Abstract Background Symptomatic prolapse impairs quality of life. Health-related quality of life (HRQoL) is considered an important outcome of pelvic organ prolapse (POP) surgery. However, it is rarely reported, and measures are inadequately used. Thus, studies reporting patient-reported surgical outcomes in low-income contexts are needed. This study aims to evaluate the effect of prolapse surgery on patient HRQoL and determine the predictive factors for change in HRQoL. Methods A total of 215 patients who had prolapse stage III or IV were enrolled. Patients underwent vaginal native tissue repair, and their HRQoL was evaluated at baseline, 3 and 6 months postoperatively. Effect of surgery on subjective outcomes were measured using validated Prolapse Quality of Life (P-QoL-20), Prolapse Symptom Score (POP-SS), Body Image in Prolapse (BIPOP), Patient Health Questionnaire (PHQ-9), and Patient Global Index of Improvement (PGI-I) tools. A linear mixed-effect model was used to compare pre- and postoperative P-QoL scores and investigate potential predictors of the changes in P-QoL scores. Results In total, 193 (89.7%) patients were eligible for analysis at 3 months, and 185 (86.0%) at 6 months. Participant’s mean age was 49.3 ± 9.4 years. The majority of patients had prolapse stage III (81.9%) and underwent vaginal hysterectomy (55.3%). All domains of P-QoL improved significantly after surgery. Altogether more than 72% of patients reported clinically meaningful improvement in condition-specific quality of life measured with P-QoL-20 at 6 months. An improvement in POP-SS, BIPOP, and the PHQ-9 scores were also observed during both follow-up assessments. At 6 months after surgery, only 2.7% of patients reported the presence of bulge symptoms. A total of 97.8% of patients had reported improvement in comparison to the preoperative state, according to PGI-I. The change in P-QoL score after surgery was associated with the change in POP-SS, PHQ, BIPOP scores and marital status (p < 0.001). However, age, type of surgery, and prolapse stage were not associated with the improvement of P-QoL scores. Conclusions Surgical repair for prolapse effectively improves patient’s HRQoL, and patient satisfaction is high. The result could be useful for patient counselling on the expected HRQoL outcomes of surgical treatment. Surgical service should be accessible for patients suffering from POP to improve HRQoL.

scholarly journals Unemployment and Health-Related Quality of Life in Melanoma Patients During the COVID-19 Pandemic

2021 ◽  
Vol 9 ◽  
Author(s):  
Yeye Guo ◽  
Minxue Shen ◽  
Xu Zhang ◽  
Yi Xiao ◽  
Shuang Zhao ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Family Members ◽  
Chinese Patients ◽  
Health Related Quality ◽  
Income Loss ◽  
Online Questionnaire ◽  
Related Quality ◽  
Health Related ◽  
Melanoma Patients

The outbreak of coronavirus disease-2019 (COVID-19) ineluctably caused social distancing and unemployment, which may bring additional health risks for patients with cancer. To investigate the association of the pandemic-related impacts with the health-related quality of life (HRQoL) among patients with melanoma during the COVID-19 pandemic, we conducted a cross-sectional study among Chinese patients with melanoma. A self-administered online questionnaire was distributed to melanoma patients through social media. Demographic and clinical data, and pandemic-related impacts (unemployment and income loss) were collected. HRQoL was determined by the Functional Assessment of Cancer Therapy-General (FACT-G) and its disease-specific module (the melanoma subscale, MS). A total of 135 patients with melanoma completed the study. The mean age of the patients was 55.8 ± 14.2 years, 48.1% (65/135) were male, and 17.04% (34/135) were unemployed since the epidemic. Unemployment of the patients and their family members and income loss were significantly associated with a lower FACT-G score, while the MS score was associated with the unemployment of the patients' family members. Our findings suggested that unemployment is associated with impaired HRQoL in melanoma patients during the COVID-19 epidemic.

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