Favorable Quality Of Life Research Articles

A post-hoc analysis of risk factors for poor quality of life after surgical treatment of spondylodiscitis

Patient-reported outcome measures for quality of life (QoL) like the Oswestry-Disability-Index (ODI) are useful for a quick, comprehensive and comparable evaluation of spondylodiscitis treatment. While it is known that even after successful surgical treatment, the QoL of spondylodiscitis patients remains below that of the general population, risk factors for a poor outcome have not been described so far. We did a retrospective post-hoc analysis of 130 surgically treated spondylodiscitis patients from 2008 to 2022. Biographical, clinical und QoL data were prospectively collected before (T0) and one year (T1) after surgery. The primary outcome was QoL at T1. Patients were grouped according to their ODI score at T1 (Group 1: ODI < 35, favorable QoL; Group 2: ODI ≥ 35, poor QoL) and analyzed for risk factors present at T0. Poor QoL at T1 occurred in 51 patients (39%). Multivariate analysis identified a higher preoperative leg pain (odds ratio: 1.2) and the presence of a malignant disease (odds ratio: 1.9) as independent preoperative risk factors for a poor QoL at T1. Spondylodiscitis patients with malignancy and/or preoperative leg pain may be at increased risk for poor QoL after surgical treatment. These results can be used to individualize patient information and provide a better assessment of prognosis before surgery.

Active aging, autonomy, and mental health among older adults with chronic illness - focus on optimism

Abstract Background In the active aging framework, the focus has shifted to the quality of life of the elderly, where autonomy plays an important role. Chronic illnesses often lead to autonomy limitations, impacting activities of daily living (ADL) and increasing the risk of depression. Fostering an optimistic outlook can mitigate depression’s severity and promote healthy aging. Methods The data is from a cross-sectional survey in Hungary (n = 832). 60,1% of the sample had at least one chronic illness. Measurements included the EQ-5D-5L, Mental Health Continuum-SF, Life Orientation Test, and the Geriatric Depression Scale. Results We found worse mental health (p = 0,024), lower levels of optimistic outlook (p = 0,002), and higher levels of depression (p &amp;lt; 0,001) among those who reported ADL limitations. ADL limitations (ß = -0,27, p &amp;lt; 0,001) showed the strongest association with perceived health status, followed by mobility (ß = -0,22, p &amp;lt;; 0,001) and self-care (ß =-0,14, p &amp;lt; 0,001). Considering mental health, only ADL limitations (ß = -0,15, p &amp;lt; 0,001) were a significant predictor from the above-mentioned dimensions. Additional analysis showed that depression affected mental health both directly (effect = -1,90, p &amp;lt; 0,001) and indirectly, mediated by an optimistic outlook (effect = -0,88). Conclusions 1. Limitations in autonomy were negatively linked to perceived health status and mental health. 2. The optimistic orientation toward life can mediate the association between depression and mental health among the elderly with chronic conditions. 3. The Implications of the results could enlighten the necessity of preventive initiatives on autonomy preservation and enhance an optimistic outlook to maintain healthy aging and a favorable quality of life. Key messages • Preventive interventions focusing on health-preserving behaviors could be designed for specific groups with a higher risk of ADL limitations in the future. • Optimism could mediate depression’s impact on the mental health of the elderly with chronic illnesses, suggesting that interventions should target enhancing optimism for improving active aging.

Impact of rehabilitation with dental implants on the quality of life of patients undergoing maxillofacial reconstruction: a systematic review.

Maxillofacial reconstruction with dental implants in microvascular tissue flaps aims to improve mastication. However, the quality of life (QoL) impact of this intervention is yet to be determined. This systematic review assessed the QoL impact of maxillofacial reconstruction with implant-supported teeth compared to no dental rehabilitation, removable dentures, and obturator (modified denture). Additionally, we examined instruments applied to measure QoL in maxillofacial reconstruction. Databases Ovid Medline and Embase, Scopus, Web of Science and Handle on QoL were searched. Cohort, case-control and randomized controlled trials (RCT) were narratively synthesized for QoL captured through validated instruments. Study methodological quality was assessed using Cochrane Risk of Bias 2 and Risk of Bias in Non-randomized studies of Exposure. Instruments underwent COSMIN content validity analysis. Of a total of 2735 studies screened, the three included studies (two cohort and one RCT) showed improved QoL with maxillofacial reconstruction compared to obturator and no dental rehabilitation. However, these studies have high risk of bias due to confounding. None of the instruments achieved a sufficient relevance rating for maxillofacial reconstruction, having been designed for other target populations and there is no evidence on their content validity for this population, but the EORTC QLQ30 H&N35 satisfied more COSMIN criteria than the UW-QOL and OHIP-14. Although studies showed favourable QoL with maxillofacial reconstruction involving dental implants, these have high risk of bias and further studies are needed to establish the impact. Existing QoL instruments lack content validity and tailored instruments are needed for QoL evaluation in maxillofacial reconstruction.

Outcomes after laser enucleation of the prostate with and without significant storage symptoms.

To test for differences in recovery of lower urinary tract symptoms (LUTS) between patients with storage-positive vs -negative symptoms after laser enucleation of the prostate (LEP). Consecutive storage-positive (severe storage symptoms, International Prostate Symptom Score [IPSS] storage subscore >8) vs storage-negative patients treated with LEP (November 2017-September 2022) within our tertiary-care database were identified. Mixed linear models tested for changes in IPSS and quality of life (QoL) at 1, 3 and 12 months after LEP. Multiple linear regression models tested for LUTS and QoL recovery risk factors at 1, 3 and 12 months. Of 291 study patients, 180 (62%) had storage-positive symptoms. There were no differences between storage-positive and -negative patients in mean adjusted total IPSS, IPSS-storage, IPSS-voiding and QoL at 12 months after LEP. In multiple linear regression models, storage-positive status was identified as a risk factor for higher IPSS at 1 month (β coefficient 2.98, P = 0.004) and 3 months (β coefficient 2.24, P = 0.04), as well as for more unfavourable QoL at 1 month (βcoefficient 0.74, P = 0.006) and 3 months (β coefficient 0.73, P = 0.004) after LEP. Conversely, at 12 months there were no differences between storage-positive vs -negative patients. Storage-positive patients appear to experience similar long-term benefits from LEP compared to storage-negative patients. However, significant storage symptoms are associated with higher total IPSS and less favourable QoL at 1 and 3 months after LEP. These findings advocate for the consideration of LEP also in storage-positive cases with the need for thorough patient education especially in the initial post-LEP period.

Evaluation of quality of root canal therapy performed by predoctoral students on endodontic outcome and quality of life of patients

AbstractThis study evaluated the technical quality (TQ) of root canal therapy (RCT) performed by predoctoral students and its impact on endodontic outcome (EO) and patients' quality of life (QoL). The TQ of RCT done by predoctoral students was evaluated and follow‐up visits were conducted to determine the clinical, radiographic outcome of RCT and patients' QoL. Frequency distribution, multiple regression, independent‐samples t test and one‐way anova were performed. A total of 226 teeth of 164 patients were clinically and radiographically examined. A satisfactory TQ was observed in 130 (57.5%), successful clinical outcomes in 155 (68.6%), successful radiographical outcomes in 206 (91%) and overall successful EO in 150 teeth (66.4%) with 80% of patients reporting a favourable QoL. A significant positive correlation was noted between EO and QoL (p = 0.002) with no significant correlation in between TQ‐RCT and EO (p = 0.07) and TQ‐RCT and QoL (p = 0.316). Successful EO had a positive impact on patients' QoL.

Predictive Model for Estimating the Risk of Epilepsy After Aneurysmal Subarachnoid Hemorrhage: The RISE Score.

The occurrence of seizures after aneurysmal subarachnoid hemorrhage (aSAH) is associated with a poorer functional and cognitive prognosis and less favorable quality of life. It would be of value to promptly identify patients at risk of epilepsy to optimize follow-up protocols and design preventive strategies. Our aim was to develop a predictive score to help stratify epilepsy risk in patients with aSAH. This is a retrospective, longitudinal study of all adults with aSAH admitted to our center (2012-2021). We collected demographic data, clinical and radiologic variables, data on early-onset seizures (EOSs), and data on development of epilepsy. Exclusion criteria were previous structural brain lesion, epilepsy, and ≤7 days' follow-up. Multiple Cox regression was used to evaluate factors independently associated with unprovoked remote seizures (i.e., epilepsy). The best fitting regression model was used to develop a predictive score. Performance was evaluated in an external validation cohort of 308 patients using receiver-operating characteristic curve analysis. From an initial database of 743 patients, 419 met the inclusion criteria and were included in the analysis. The mean age was 60 ± 14 years, 269 patients (64%) were women, and 50 (11.9%) developed epilepsy within a median follow-up of 4.2 years. Premorbid modified Rankin Score (mRS) (hazard ratio [HR] 4.74 [1.8-12.4], p = 0.001), VASOGRADE score (HR 2.45 [1.4-4.2], p = 0.001), surgical treatment (HR 2.77 [1.6-4.9], p = 0.001), and presence of EOSs (HR 1.84 [1.0-3.4], p = 0.05) were independently associated with epilepsy. The proposed scale, designated RISE, scores 1 point for premorbid mRS ≥ 2 (R), VASOGRADE-Yellow (I, Ischemia), surgical intervention (S), and history of EOSs (E) and 2 points for VASOGRADE-Red. RISE stratifies patients into 3 groups: low (0-1), moderate (2-3), and high (4-5) risk (2.9%, 20.8%, and 75.7% developed epilepsy, respectively). On validation in a cohort from a different tertiary care center (N = 308), the new scale yielded a similar risk distribution and good predictive power for epilepsy within 5 years after aSAH (area under the curve [AUC] 0.82; 95% CI 0.74-0.90). The RISE scale is a robust predictor of post-SAH epilepsy with immediate clinical applicability. In addition to facilitating personalized diagnosis and treatment, RISE may be of value for exploring future antiepileptogenesis strategies.

Long-term survival outcomes and quality of life of image-guided proton therapy for operable stage I non-small cell lung cancer: A phase 2 study

Background and purposeThis study evaluated long-term efficacy, safety, and changes in quality of life (QOL) of patients after image-guided proton therapy (IGPT) for operable stage I non-small cell lung cancer (NSCLC). Materials and methodsThis single-institutional prospective phase 2 study enrolled patients with operable histologically confirmed stage IA or IB NSCLC (7th edition of UICC). The prescribed dose was 66 Gy relative biological effectiveness equivalents (GyRBE) in 10 fractions for peripheral lesions, or 72.6 GyRBE in 22 fractions for central lesions. The primary endpoint was the 3-year overall survival (OS). The secondary endpoints included disease control, toxicity, and changes in QOL score. ResultsWe enrolled 43 patients (median age: 68 years; range, 47–79 years) between July 2013 to January 2021, of whom 41 (95 %) had peripheral lesions and 27 (63 %) were stage IA. OS, local control, and progression-free survival rates were 95 % (95 % CI: 83–99), 95 % (82–99), and 86 % (72–94), respectively, at 3 years, and 83 % (66–92), 95 % (82–99), and 77 % (60–88), respectively, at 7 years. Four patients (9 %) developed grade 2, and one patient (2 %) developed grade 3 radiation pneumonitis. No other grade 3 or higher adverse events were observed. In the QOL analysis, global QOL remained favorable; however, approximately 40 % of patients reported dyspnea at 3 and 24 months. ConclusionOur findings suggest that IGPT provides effective disease control and survival in operable stage I NSCLC, particularly for peripheral lesions. Moreover, toxicity associated with IGPT was minimal, and patients reported favorable QOL.

Social determinants of health rather than race impact health-related quality of life in 10-year-old children born extremely preterm.

Reducing healthcare disparities among children is extremely important given the potential impact of these disparities on long-term health-related quality of life (HRQL). Race and parental socioeconomic status (SES) are associated with child HRQL, but these associations have not been studied in infants born extremely preterm (EP), a population at increased risk for physical, cognitive, and psychosocial impairments. Achieving health equity for infants born EP across their life course requires identifying the impact of racism and SES on HRQL. We aimed to evaluate the association between self-reported maternal race, SES factors, and HRQL among 10-year-old children born EP. Participants were identified from an ongoing multicenter prospective longitudinal study of Extremely Low Gestational Age Newborns (ELGAN Study), born between 2002 and 2004, and evaluated at 10 years of age using the Pediatric quality of life (QoL) Inventory completed by their parent or guardian, assessing physical, emotional, social, school, and total (composite) QoL domains. Multivariable regression models were used to evaluate the relationship between QoL scores and self-identified maternal race, adjusting for SES factors (education level, marital status, and public insurance). Of 1,198 study participants who were alive at 10 years of age, 863 (72.0%) were evaluated at 10 years of age. Differences in mean 10-year QoL scores across racial groups were observed and were significant on univariate analysis. However, these associations attenuated when adjusted for the marital status, public insurance status, and education status of mothers. A comparison of children with English as the primary language spoken at home vs. any other language revealed a significant difference only in school QoL, in which non-English language was associated with more favorable school QoL scores. Among 10-year-old children born EP, differences in parent-reported QoL were associated with maternal SES factors but not with race. Our results suggest that interventions designed to improve the SES of mothers may enhance the QoL of children born EP. Furthermore, these results underscore that race is a social construct, rather than a biological variable, as we work toward greater equity in care provision.

An 18-month meditation training selectively improves psychological well-being in older adults: A secondary analysis of a randomised controlled trial.

As the world population is ageing, it is vital to understand how older adults can maintain and deepen their psychological well-being as they are confronted with the unique challenges of ageing in a complex world. Theoretical work has highlighted the promising role of intentional mental training such as meditation practice for enhancing human flourishing. However, meditation-based randomised controlled trials in older adults are lacking. We aimed to investigate the effects of meditation training on psychological well-being in older adults. This study presents a secondary analysis of the Age-Well trial (ClinicalTrials.gov: NCT02977819), which randomised 137 healthy older adults (age range: 65 to 84 years) to an 18-month meditation training, an active comparator (English language training), or a passive control. Well-being was measured at baseline, mid-intervention, and 18-month post-randomisation using the Psychological Well-being Scale (PWBS), the World Health Organisation's Quality of Life (QoL) Assessment psychological subscale, and composite scores reflecting the meditation-based well-being dimensions of awareness, connection, insight, and a global score comprising the average of these meditation-based dimensions. The 18-month meditation training was superior to English training on changes in the global score (0.54 [95% CI: 0.26, 0.82], p = 0.0002) and the subscales of awareness, connection, insight, and superior to no-intervention only on changes in the global score (0.54 [95% CI: 0.26, 0.82], p = 0.0002) and awareness. Between-group differences in psychological QoL in favour of meditation did not remain significant after adjusting for multiple comparisons. There were no between-group differences in PWBS total score. Within the meditation group, psychological QoL, awareness, insight, and the global score increased significantly from baseline to 18-month post-randomisation. The longest randomised meditation training conducted to date enhanced a global composite score reflecting the meditation-based well-being dimensions of awareness, connection, and insight in older adults. Future research is needed to delineate the cognitive, affective, and behavioural factors that predict responsiveness to meditation and thus help refine the development of tailored meditation training.

Oncological Outcomes, Long-Term Toxicities, Quality of Life and Sexual Health after Pencil-Beam Scanning Proton Therapy in Patients with Low-Grade Glioma.

To assess oncological outcomes, toxicities, quality of life (QoL) and sexual health (SH) of low-grade glioma (LGG) patients treated with pencil-beam scanning proton therapy (PBS-PT). We retrospectively analyzed 89 patients with LGG (Neurofibromatosis type 1; n = 4 (4.5%) patients) treated with PBS-PT (median dose 54 Gy (RBE)) from 1999 to 2022 at our institution. QoL was prospectively assessed during PBS-PT and yearly during follow-up from 2015 to 2023, while a cross-sectional exploration of SH was conducted in 2023. Most LGGs (n = 58; 65.2%) were CNS WHO grade 2 and approximately half (n = 43; 48.3%) were located in the vicinity of the visual apparatus/thalamus. After a median follow-up of 50.2 months, 24 (27%) patients presented with treatment failures and most of these (n = 17/24; 70.8%) were salvaged. The 4-year overall survival was 89.1%. Only 2 (2.2%) and 1 (1.1%) patients presented with CTCAE grade 4 and 3 late radiation-induced toxicity, respectively. No grade 5 late adverse event was observed. The global health as a domain of QoL remained stable and comparable to the reference values during PBS-PT and for six years thereafter. Sexual satisfaction was comparable to the normative population. LGG patients treated with PBS-PT achieved excellent long-term survival and tumor control, with exceptionally low rates of high-grade late toxicity, and favorable QoL and SH.

Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer (UK TACT2; CRUK/05/19): quality of life results from a multicentre, phase 3, open-label, randomised, controlled trial

Adjuvant chemotherapy for patients with early breast cancer improves outcomes but its toxicity affects patients' quality of life (QOL). The UK TACT2 trial investigated whether accelerated epirubicin improves time to recurrence and if oral capecitabine is non-inferior to cyclophosphamide, methotrexate, and fluorouracil (CMF) for efficacy with less toxicity. Results showed no benefit for accelerated epirubicin and capecitabine was non-inferior. As part of the QOL substudy, we aimed to assess the effect of chemotherapies on psychological distress, physical symptoms, and functional domains. TACT2 was a multicentre, phase 3, open-label, parallel-group, randomised, controlled trial done in 129 UK centres. Participants were aged 18 years or older with histologically confirmed node-positive or high-risk node-negative invasive primary breast cancer, who had undergone complete excision, and due to receive adjuvant chemotherapy. Patients were randomly assigned (1:1:1:1) to four cycles of 100 mg/m2 epirubicin either every 3 weeks (standard epirubicin) or every 2 weeks with 6 mg pegfilgrastim on day 2 of each cycle (accelerated epirubicin), followed by four 4-week cycles of either CMF (600 mg/m2 cyclophosphamide intravenously on days 1 and 8 or 100 mg/m2 orally on days 1-14; 40 mg/m2 methotrexate intravenously on days 1 and 8; and 600 mg/m2 fluorouracil intravenously on days 1 and 8 of each cycle) or four 3-week cycles of 2500 mg/m2 capecitabine (1250 mg/m2 given twice daily on days 1-14 of each cycle). The randomisation schedule was computer generated in random permuted blocks, stratified by centre, number of nodes involved (none vs 1-3 vs ≥4), age (≤50 years vs >50 years), and planned endocrine treatment (yes vs no). QOL was one of the secondary outcomes and is reported here. All patients from a subset of 44 centres were invited to complete QOL questionnaires (Hospital Anxiety and Depression Scale [HADS] and European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire 30-item core module [QLQ-C30] and Quality of Life Questionnaire breast module [QLQ-BR23]) at baseline, end of standard or accelerated epirubicin, end of CMF or capecitabine, and at 12 and 24 months after randomisation. The QOL substudy prespecified two coprimary QOL outcomes assessed in the intention-to-treat population: overall QOL (reported elsewhere) and HADS total score. Prespecified secondary QOL outcomes were EORTC QLQ-C30 subscales of physical function, role function, and fatigue and EORTC QLQ-BR23 subscales of sexual function and systemic therapy side-effects. This trial is registered with ISRCTN, ISRCTN68068041, and ClinicalTrials.gov, NCT00301925. From Dec 16, 2005, to Dec 5, 2008, 4391 patients (20 [0·5%] of whom were male) were enrolled in TACT2; 1281 (85·8%) of 1493 eligible patients were included in the QOL substudy. Eight (0·6%) participants in the QOL substudy were male and 1273 (99·4%) were female. Median follow-up was 85·6 months (IQR 80·6-95·9). Analysis was performed on the complete QOL dataset (as of Sept 15, 2011) when all participants had passed the 24-month timepoint. Prerandomisation questionnaires were completed by 1172 (91·5%) patients and 1179 (92·0%) completed at least one postrandomisation questionnaire. End-of-treatment HADS depression score (p=0·0048) and HADS total change score (p=0·0093) were worse for CMF versus capecitabine. Accelerated epirubicin led to worse physical function (p=0·0065), role function (p<0·0001), fatigue (p=0·0002), and systemic side-effects (p=0·0001), but not sexual function (p=0·36), compared with standard epirubicin during treatment, but the effect did not persist. Worse physical function (p=0·0048), sexual function (p=0·0053), fatigue (p<0·0001), and systemic side-effects (p<0·0001), but not role functioning (p=0·013), were seen for CMF versus capecitabine at end of treatment; these differences persisted at 12 months and 24 months. Accelerated epirubicin was associated with worse QOL than was standard epirubicin but only during treatment. These findings will help patients and clinicians make an informed choice about accelerated chemotherapy. CMF had worse QOL effects than did capecitabine, which were persistent for 24 months. The favourable capecitabine QOL compared with CMF supports its use as an adjuvant option after neoadjuvant chemotherapy in patients with triple-negative breast cancer. Cancer Research UK, Amgen, Pfizer, and Roche.

Predictors of quality of life and mental health in breast cancer survivors in Northern Iran

Background and purposeThe global incidence of breast cancer is the highest among all cancers and is the primary reason for cancer-related fatalities. Our study aimed to assess the predictors of quality of life (QOL) and mental health in breast cancer survivors in Northern Iran.MethodsThis cross-sectional study was done on 96 female breast cancer survivors between the ages of 20 and 65 and was based on convenience samples. We gathered information through demographic and fertility data, a QOL survey, and the Hospital Anxiety and Depression Scale (HADS). A significance level of P < 0.05 was set for the analysis.ResultsIn this study, results showed that 11.5% of women had the optimal quality of life, 31.3% favorable quality of life, and 57.3% undesirable quality of life. The average HADS score was 20.14 ± 3.07, with anxiety scores of 10.21 ± 2.31 and depression scores of 9.93 ± 1.64. On multiple linear regression, marital relationship and the number of children were predictors of quality of life (β=-17.624, p = 0.023 and β=-7.427, p = 0.016, respectively), as well as the husband’s education and having no history of other cancers in the woman, were the most important predictors of HADS (β = 0.763, p = 0.039 and β=-0.528, p = 0.016, respectively).ConclusionIt is crucial to provide exceptional care to breast cancer patients during treatment and post-recovery. Emotional and psychological support is a fundamental requirement for their well-being.

Safety, tolerability, and quality of life (QoL) of single-agent plinabulin (Plin) for the prevention of docetaxel (Doc) chemotherapy (chemo)-induced neutropenia (CIN) in non-small cell lung cancer (NSCLC) patients (pts) from two randomized trials.

e21168 Background: Plin, is a novel, non-G-CSF, small molecule agent with comparable CIN-preventive effects vs pegfilgrastim. In contrast to pegfilgrastim, Plin is given on the same day of chemo (30 mins after chemo), and does not cause bone pain, nor thrombopenia. In the two randomized controlled (placebo (Plac)/no treatment) cancer trials, Phase (Ph) 2 Study 101 and Ph3 Study 103, single-agent (SA) Plin reduced estimated Doc-induced mean duration of severe neutropenia by &gt; 1 Day vs Plac. We conducted a post hoc analysis of safety, tolerability, and QoL in NSCLC pts from these trials. Methods: NSCLC pts in 2nd/3rd line, with at least 1 NCCN FN risk factor, were randomized to Doc (75 mg/m2) + Plin (n = 116; at the CIN dose of 20 mg/m2 or its pharmacokinetic equivalent), or Doc + Plac (n = 296) in trials 101 (NCT00630110) and 103 (NCT02504489). Doc was given on day (D) 1, and Plin was given twice per cycle, on D1 and D8 (Plin D1 and D8 dosing is supratherapeutic for CIN but facilitated a more robust safety/tolerability evaluation [the CIN Plin dose is D1 only]). Safety blood draws and AE collection on D1 and D8; tolerability; and QoL (pre-dose and D8) were evaluated over 4 cycles. All pts received dexamethasone premedication. QoL scores were obtained in study 103 only, with Plin (n = 80) and Plac (n = 234), by validated questionnaires (EORTC QLQ C30, to evaluate global health status/QoL; the combined symptom scales/items, and the lung cancer-specific QoL questionnaire QLQ-LC13). Results: QoL scores over 4 cycles between Plin and Plac were similar, indicating Plin was well-tolerated. Grade (Gr) 3/4 AEs of interest for Plin (+Doc) and Plac (+Doc) are summarized in the table. With Plin, AE frequency of diarrhea was slightly higher (5.2% vs 1%; 1 Gr4 case with Plin), but was manageable, and so was hypertension (11.2% vs 1.7%; all Gr3 cases) vs Plac. Hypertension occurred around the time of infusion and was short-lasting (~2-4 hours) and typically self-limiting. Plin had less AEs of neutropenia (16.4% vs 50.3%) and leukopenia (15.5% vs 38.5%) vs Plac. Conclusions: Plin is an effective agent for CIN, has a favorable safety, tolerability, and QoL profile, and has the advantage of dosing on the same day of chemo. Clinical trial information: NCT02504489 . [Table: see text]

Prospective quality of life outcomes for human papillomavirus associated oropharynx cancer patients after surgery alone

PurposeTo evaluate changes in patient-reported quality of life (QOL) to inform treatment decisions for human papillomavirus-associated oropharynx squamous cell carcinoma (HPV + OPSCC). Materials and methodsPatients with American Joint Committee on Cancer (AJCC) 8th edition cT0-T3 and cN0-N3 HPV + OPSCC treated with transoral robotic surgery to the primary site with neck dissection completed questionnaires prior to surgery and at three-months and one-year post-operatively. Questionnaires included four validated instruments: the University of Washington Quality of Life Questionnaire (UW-QOL), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Head and Neck Module (HN35), and the Neck Dissection Impairment Index (NDII). ResultsForty-eight patients filled out pretreatment and three-month questionnaires. 37 patients filled out one-year questionnaires. With the UW-QOL, at three-months, patients reported a statistically significant and clinically meaningful decreased mean score for appearance that resolved at one-year (presurgery: 92.4, 3-month: 81.0, p < 0.001; one year: 86.5). At three months and one-year, significant and clinically meaningful decreased mean taste scores persisted (presurgery: 98.0; three-months: 76.3, one-year: 80.3; all p < 0.001). With the EORTC QLQ-C30 and HN35, at one-year, only mean scores for sense of taste or smell (one-year: 13.1; p < 0.001) did not return to baseline. With the NDII, patients returned to functions comparable to baseline in all domains. ConclusionPost-treatment quality of life is high for HPV+ OPSCC patients treated with surgery alone. Mild taste and possibly smell dysfunction may continue in some patients. With careful selection, surgery alone for HPV + OPSCC offers favorable QOL outcomes. Lay summaryPatients with HPV+ associated oropharynx cancer treated with surgery alone completed quality of life questionnaires before and after surgery. Quality of life remained high for most patients, with a subset of patients experiencing mild taste dysfunction one-year after surgery.

Mediterranean Diet Adherence Is Associated with Favorable Health-Related Quality of Life, Physical Activity, and Sleep Quality in a Community-Dwelling Greek Older Population.

The Mediterranean diet (MD) is a beneficial dietary pattern with strong antioxidant and anti-inflammatory properties that can promote mental and physical human health. This study aims to assess the impact of MD adherence on health-related quality of life, physical activity levels, and sleep quality in a representative Greek elderly population. This is a cross-sectional study. A total of 3254 persons ≥65 years from 14 different Greek regions, urban, rural and islands participated in this study, of which 48.4% were female and 51.6% were male. Health-Related Quality of Life (HRQOL) was evaluated utilizing a short form healthy survey, physical activity was determined by the International Physical Activity Questionnaire (IPAQ), sleep quality was assessed utilizing the Pittsburgh Sleep Quality Index (PSQI) and MD adherence was assessed via the Mediterranean Diet Score (MedDietScore). Moderate adherence to the MD and an increased prevalence of poor quality of life, low physical activity levels and inadequate sleep quality among the elderly population were recorded. High MD adherence was independently associated with better quality of life (OR: 2.31, 95% CI: 2.06-2.68, p = 0.0008), higher physical activity (OR: 1.89, 95% CI: 1.47-2.35, p = 0.0141) and adequate sleep quality (OR: 2.11, 95%: 1.79-2.44, p = 0.0018), female sex (OR: 1.36, 95% CI: 1.02-1.68, p = 0.0032) and living with others (OR: 1.24, 95% CI: 0.81-1.76, p = 0.0375), after adjustment for potential confounding factors. In unadjusted analysis, participants' age (p < 0.0001), anthropometric characteristics (p < 0.005), educational (p = 0.0026) and financial status (p = 0.0005) and smoking habits (p = 0.0031) were also identified as indicators of MD adherence; however, their impact on MD adherence was considerably attenuated after adjusting for confounding factors (p > 0.05). High MD adherence was correlated with favorable quality of life, higher levels of physical activity, and a more adequate sleep quality score. Strategies and public health policies that facilitate MD adherence and physical activity in older adults may improve sleep and quality of life, impacting overall wellbeing in this age group.

Systematic literature review of quality-of-life questionnaires in Waldenström macroglobulinaemia-need for a disease-specific tool.

Systematic literature review of quality-of-life questionnaires in Waldenström macroglobulinaemia-need for a disease-specific tool.

Implantable Cardioverter-Defibrillators in Poland Compared with other European Countries from the Patient’s Perspective: Insights from the EHRA Patient Survey

The aim of this study was to compare differences between Polish ICD recipients and ICD recipients from other European countries in terms of quality of life, information provision before ICD implantation, and end-of-life issues. This is a sub-analysis of the "Living with an ICD" patient survey (25-item questionnaire) organized by the European Heart Rhythm Association between 12 April 2021 and 5 July 2021 in ten European countries. There were 410 (22.7%) patients from Poland and 1399 (77.3%) from other European countries. A total of 51.0% of Polish patients reported improvement in their quality of life compared with 44.3% in other countries (p = 0.041). Remote monitoring was three times more often utilized in other countries than in Poland (66.8% vs. 21.0%, p < 0.001). While 78.1% of Poles felt well informed before ICD implantation compared with 69.6% of subjects from other countries (p = 0.001), they were less familiar with the ICD deactivation process than others (38.9% vs. 52.5%, p < 0.001). Despite the less frequent use of remote monitoring and gaps in end-of-life issues, Polish ICD recipients reported more favorable quality of life and a higher level of information received before device placement than patients in other European countries.

Abstract PD16-04: To monitor or not to monitor? MRI monitoring of neoadjuvant chemotherapy effect and its benefit on breast cancer patients’ pathological complete response rate

Abstract Introduction: Neoadjuvant chemotherapy (NACT) represents an essential tool for the treatment of selected breast cancer patients aimed to reduce the tumor size for a more conservative resection and to gain early information about the sensitivity to applied treatment. An effective early response assessment helps both to change the therapeutic strategy for patients nonresponding to the treatment used and to avoid the toxicity related to ineffective treatment. We assumed that changing the chemotherapy regimen might avoid the residual cancer burden (RCB) III outcome and lead to the highest possible rate of pathological complete response (pCR) achieved. We examined the benefit of MRI as a preferred method for interim response assessment to NACT with a primary focus on the relation between the pattern of responses to NACT within the MRI- monitored and non-monitored patients and the pattern of final outcomes on the RCB scale. Methods We present a real-life data-based retrospective analysis of 124 female patients with locally advanced breast carcinoma. All patients received NACT (anthracycline-based regimen followed by taxane-based regimen/early switch to taxanes after the 2nd cycle in nonresponders, and antiHER2 therapy if indicated) prior to surgery (mastectomy/breast-conserving surgery, sentinel lymph node biopsy/axillary dissection). Postoperative histopathological analysis of tumor specimens categorised 120 patients according to the RCB scale 0 – III. Four patients had surgery ex muros and were lost to follow-up. Patients were divided into two cohorts. Group A covered monitored patients with pre-treatment MRI and follow-up MRI after the 2nd cycle of NACT. If no response was detected, another follow-up MRI was indicated after the 2nd cycle of a new treatment. Group B comprised patients with no/incomplete MRI monitoring and patients without the change of therapy even though no response was detected by MRI after the 2nd cycle of NACT. Association between categorical variables was tested using chi-square tests. Statistical analysis was performed using StatsDirect® 3.3.5 (StatsDirect Ltd., Cheshire, UK). The data analysis was supported by a grant from the Cultural and Educational Grant Agency of the Ministry of Education, Science, Research, and Sport of the Slovak Republic (KEGA 041UK-4/2020). Results MRI-monitored patients had two times the odds of being RBC 0 (OR = 2.02, P = 0.122) and almost three times the odds of being RCB 0 or RCB I (OR = 2.83, P = 0.0206) than patients with no monitoring. Changing the NACT after the 2nd cycle in the cohort of monitored patients with no response to initial therapy was significantly associated with better outcomes on the RCB scale (P = 0.0042). This result was confirmed by comparing the pattern of results in patients with no response within the group of incompletely monitored patients with known MRI results after the 2nd cycle (P = 0.0257). Changing the ineffective NACT after the 2nd cycle significantly increased the proportion of RCB 0-I by 23.4%, confirming the benefit of response monitoring by MRI. Conclusion Breast cancer constitutes a heterogeneity of tumor subtypes and it is acknowledged that their behaviour during NACT is highly variable and often unpredictable. MRI represents an effective tool for the assessment of tumor response to applied NACT. To achieve the most clinically meaningful impact of the selected treatment it is critical to monitor the tumor response within the first 3 cycles. Our data clearly confirmed that clinical decisions related to the detection of early response or no response (resulting in the change of NACT) lead to better treatment outcomes and less toxicity. The rate of pCR defines the applied treatment efficacy. Every single patient with results different from RCB III has a better prognosis, reduced need for further expensive treatment and also a more favourable quality of life. These key facts need to be carefully considered when discussing the cost and benefits of MRI monitoring. Citation Format: Lucia Vanovcanova, Iveta Waszulikova, Bibiana Vertakova Krakovska. To monitor or not to monitor? MRI monitoring of neoadjuvant chemotherapy effect and its benefit on breast cancer patients’ pathological complete response rate [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD16-04.

Double-tract reconstruction is superior to esophagogastrostomy in controlling reflux esophagitis and enhancing quality of life after proximal gastrectomy: Results from a prospective randomized controlled clinical trial in China.

The aim of this study was to prospectively compare double-tract reconstruction (DTR) and esophagogastrostomy (EG) after proximal gastrectomy (PG) regarding the incidence of reflux esophagitis, quality of life (QOL), nutritional status and surgical safety. This study was a randomized controlled trial. Patients eligible for PG were enrolled and randomly assigned to the EG group and DTR group. The characteristics of patients, parameters for surgical safety, incidence of reflux esophagitis, nutrition status and QOL were collected and compared between the two groups. Univariate analysis and multivariate analysis were performed to determine the significant factors affecting the incidence of reflux esophagitis after PG. Thirty-seven patients of the EG group and 36 patients of the DTR group were enrolled. The incidence of reflux esophagitis was significantly lower in the DTR group than in the EG group (8.3% vs. 32.4%, P=0.019). The DTR group demonstrated a more favorable QOL than the EG group after PG. The nutritional status was balanced within the EG group and the DTR group. The operation time was longer in the DTR group than in the EG group (191 min vs. 221 min, P=0.001), while surgical safety was similar in the two groups. Our research demonstrated that DTR is superior to EG after PG in terms of the incidence of reflux esophagitis and provides a more satisfactory QOL without increasing surgical complications or sacrificing nutritional status.

Novel Data Analytics Identify Predictors of Quality-of-Life Trajectories in Patients with AML or High-Risk Myeloid Neoplasms

Background: Acute myeloid leukemia (AML) remains fatal in most patients (pts) with a 5-year survival probability of approximately 30% (less than 10% in pts aged 65 or older). Beyond survival, quality of life (QOL) can be significantly impaired by both disease and treatment-related factors. There is an urgent need to both characterize and identify factors predictive of QOL trajectories. Leveraging prospective data from 503 pts enrolled on an observational clinical trial, we implemented a novel statistical approach using non-supervised longitudinal clustering and ordinal logistic regression. We successfully identified: i) distinct QOL trajectories, ii) baseline factors independently associated with QOL trajectories. Methods: We analyzed data from pts with AML (90%) or high-risk myelodysplastic, myeloproliferative syndrome, or myelofibrosis (10%) enrolled on an observational clinical trial (NCT01929408) between 2013 and 2017 at 13 centers. QOL questionnaires were collected at the time of enrollment and approximately at months 1, 3, 6, 9, 12, 18, and 24 after study enrollment. Pts with a least six longitudinal data points available for QOL were included (n=503). Missing QOL data were imputed using linear interpolation. QOL was evaluated using the visual analog scale of the EQ5D (0, worst imaginable health state; 100, best imaginable health state). Deceased pts were considered to have a QOL of 0. Disease risk was assessed using the ELN 2017 criteria. Comorbidities and frailty were measured using the hematopoietic cell transplant comorbidity index (HCT-CI) and the NIH Toolbox 4-Meter Walk Gait Speed Test, respectively. QOL trajectories were clustered using non-supervised k-means based on Euclidian distances (TimeSeriesKMeans function of the tslearn library). Optimal cluster number was determined using the silhouette plot approach. Multivariable ordinal logistic regression was applied to predict QOL trajectories as a function of baseline variables using the rms R package. All analyses were done in Python (3.5) or R (4.0.2). Results: Six distinct QOL trajectories could be clustered and ordered from very good (n=109, 22%), good (n=76, 15%), intermediate 1 (n=49, 10%), intermediate 2 (n=86, 17%), poor (n=88, 17%), and very poor (n=95, 19%), as shown in the Figure. Comparisons of extreme clusters showed that pts in the very good QOL trajectory group were at baseline significantly younger (median age, 60 versus 66, respectively, p<0.001), had fewer comorbidities (median HCT-CI, 2 versus 4, respectively, p<0.001), less adverse AML cytogenetic/molecular risk (26% versus 48%, respectively, p=0.004), and were less frail (median walking speed, 0.89 versus 0.69m/s, p=0.009) compared to those in the very poor QOL trajectory group. A higher proportion of very good QOL pts received intensive chemotherapy (91% versus 62%, p<0.001) followed by consolidative allo-HCT (68% versus 11%, p<0.001) after achieving complete response/complete response with incomplete hematologic recovery (94% versus 40%, p<0.001). Multivariable modeling including baseline variables showed that older age (OR per 1-year increase, 1.34; 95%CI, 1.09-1.66; p=0.006), higher HCT-CI (OR per 1-unit increase, 1.66; 95%CI, 1.27-2.16; p<0.001), and frailty (OR per m/s increase, 0.8; 95%CI, 1.09-1.66; p=0.06) were associated with worse QOL trajectories. Favorable disease risk (favorable versus adverse: OR, 0.45; 95%CI, 0.28-0.71; p<0.001) and intensive therapy (OR, 0.54; 95%CI, 0.36-0.83; p=0.004) were independently associated with more favorable QOL trajectories. Conclusion: Unsupervised k-means clustering identified groups of pts with distinct QOL trajectories. Multivariable ordinal regression identified age, HCT-CI, disease risk and treatment intensity as independently associated with QOL trajectories. Favorable QOL trajectories were more likely to be achieved in younger, non-comorbid pts with favorable disease risk and receiving intensive therapy. Intensive therapy was independently associated with more favorable QOL trajectories even in older pts and in those with higher comorbidity burden. Probabilities of achieving the most favorable QOL trajectory in pts aged ≥60 after intensive therapy were <40% (<25% in case of adverse disease risk), indicating a critically unmet need to improve outcomes in older pts with high-risk myeloid neoplasms. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal