Patient-reported Quality Of Life Research Articles

Quality of life improvement after radiotherapy for bone metastases assessed using real-world data: a secondary analysis of a Nationwide Multicenter Cohort Study.

Single-center studies or randomized controlled trials have evaluated the impact of radiotherapy for bone metastases on quality of life (QOL). We investigated the real-world impact of radiotherapy for bone metastases on QOL using nationwide multicenter cohort data. We conducted a prospective observational study at 26 centers in Japan. Of 333 patients who received radiotherapy for bone metastases between December 2020 and March 2021, 232 (70%) were enrolled in the study. Patient-reported QOL was evaluated at enrollment and at two- and six-month follow-up using the European Organization for Research and Treatment of Cancer (EORTC) QOL Questionnaire Core 15-Palliative and the EORTC QOL Questionnaire Bone Metastases module (QLQ-BM22). Possible predictors (patient-, tumor -, and treatment-related factors) of QOL improvement were screened using logistic regression models. QOL scores showed significant improvement at two-month follow-up in seven (global health status/QOL, emotional functioning, pain, insomnia, painful sites, pain characteristics and functional interference) of the 14 scales. Of these seven scales, mean improvement ≥ the minimal clinically important difference (defined by a change of 10 or more on the 0 to 100 scale) was seen in four scales (pain, insomnia, pain characteristics and functional interference). We did not find any predictors of QOL improvement in the functional interference scale of QLQ-BM22. Radiotherapy for bone metastases performed in daily practice is effective in improving some scales of QOL.

Stereotactic Radiotherapy Plus Nivolumab in Patients with Locally Advanced Pancreatic Cancer: Results from Phase 1/2 Clinical CA209-9KH Trial.

The dismal prognosis of pancreatic ductal adenocarcinoma (PDAC) highlights the urgent need for novel therapeutic strategies. Immune checkpoint inhibitors (ICIs) seem to be ineffective in most PDAC studies. Therefore, we conducted an open-label, multicenter phase 1/2 study (CA209-9KH) to evaluate the safety of stereotactic radiotherapy (SRT) and sequential ICI therapy in PDAC, as well as to validate the efficacy of this regimen as a potential activator of antitumor immunity. Patients aged ≥ 18years with unresectable non-metastatic PDAC following four FOLFIRINOX induction cycles were included. Treatment comprised SRT (4 × 8Gy) and sequential nivolumab administration until disease progression or unacceptable toxicity. The primary endpoints were safety and toxicity assessment. Secondary endpoints included progression-free survival (PFS), overall survival (OS), biomarker evaluation, and quality of life (QoL) analysis. Twenty-two patients were screened, with 15 enrolled. Eleven (median) nivolumab cycles were administered. SRT demonstrated low and clinically nonsignificant toxicity, whereas nivolumab toxicity aligned with prior safety profiles, without grade 4-5 events observed. Three patients discontinued therapy owing to toxicity. Median PFS and OS were 8.1 and 13.0months, respectively, with 12-month PFS and OS rates of 0% and 66.7%, respectively, and a 24-month OS rate of 8.9%. Biomarker levels correlated with clinical or radiological disease control. Patient-reported QoL remained acceptable, deteriorating with disease progression. SRT and nivolumab therapy exhibited manageable toxicity profiles consistent with previous findings; however, long-term treatment responses were not achieved with this regimen in locally advanced PDAC. Another strategy to trigger antitumor immunity in PDAC needs to be sought. EudraCT: 2017-003404-52; ClinicalTrials.gov: NCT04098432.

What Is the Optimal Strategy for Pouch Salvage at Time of Redo Ileal-Pouch Anal Anastomosis? Pouch Repair with Reanastomosis vs Pouch Excision with Neopouch.

The long-term risk of pouch failure after restorative proctocolectomy with ileal-pouch anal anastomosis (IPAA) range from 5% to 15%. Salvage surgery for failing IPAA may be achieved by disconnecting the IPAA and either repairing and reusing the existing pouch (REP) or constructing a neopouch (NEO). We aimed to evaluate whether there are differences in long-term functional pouch survival and functional outcomes between the REP group and the NEO group. We hypothesized that patients undergoing REP have higher long-term pouch survival rates compared with patients who require NEO pouch construction. Our prospectively maintained Pouch Registry was queried for patients who underwent a pouch salvage surgery with either pouch REP or NEO from 1988 to 2020. Patients who underwent pouch repair without disconnection from the anus were excluded. The primary endpoint was long-term pouch survival after redo pouch surgery. Secondary outcomes were patient-reported quality of life and pouch function. Of 653 patients undergoing redo IPAA, 462 met inclusion criteria of transabdominal redo surgery with pouch reconnection: 243 (52.6%) had REP and 219 (47.4%) had NEO. Median age was 39 years and 59% were women. Median time between index and redo IPAA was 34 months for REP vs 54 months for NEO (p = 0.002). The 5-year pouch survival after redo IPAA was similar between REP (79.5%) and NEO (76.8%) groups (p = 0.4). Fewer patients in the REP group reported nighttime pad use (51.4% vs 68.2%, p = 0.04). Pouch survival and functional outcomes after salvage surgery for failing ileoanal pouch was similar regardless of pouch salvage procedure. When performing redo pouch surgery, surgeons should not hesitate to construct a new pouch if indicated.

Identifying Frailty and Its Risk Factors in Pediatric Patients with Fontan Physiology.

Frailty is a clinical syndrome common in adults with chronic disease with resultant vulnerability to adverse health outcomes. Little is known about frailty in pediatric patients, including those with single-ventricle heart disease. This study aimed to examine the prevalence of frailty and its associated risk factors in patients with Fontan circulation. A single-center, prospective cohort study assessed frailty in patients (10-21years old) after Fontan palliation. Slowness, weakness, exhaustion, shrinkage, and diminished physical activity were evaluated and scored using a modified Fried frailty assessment comprised of validated pediatric tests. Providers estimated subjects' degree of frailty. Patient-reported quality of life (QOL) was assessed. Of 54 participants (median age 15.3years, 61% male), 18 (33%) were identified as frail, while 26 (48%) were pre-frail. Patients frequently exhibited frailty in the domains of slowness (93%), weakness (41%), and diminished physical activity (39%). There was poor correlation between frailty scores and provider estimates of frailty (Kappa = 0.11). Frail subjects had lower PedsQL physical functioning scores (mean 62.8 ± SD 18.5 in Frail vs. 75.7 ± 16.0 in No/pre-Frail; p = 0.01). Factors associated with frailty included protein-losing enteropathy (p = 0.03) and at least one hospitalization in the last year (p = 0.047). One-third of pediatric patients after Fontan palliation were frail which was associated with lower physical functioning and higher healthcare utilization. Providers poorly recognized frailty. These findings highlight the need for improved screening and support for an at-risk population where frailty is not easily identified.

Disparities in neighborhood deprivation and patient reported quality of life relating to post-operative sequelae after radical cystectomy.

141 Background: Readmissions following radical cystectomy(RC) remain high despite prehabilitation and enhanced recovery after surgery (ERAS) care. Recently, studies have shown the correlation between socioeconomic neighborhood deprivation (ND) and post-operative quality of life (QoL) in oncologic surgeries. We sought to examine the impact of preoperative QoL and ND with postoperative sequela following RC. Methods: This was a prospective IRB approved study of patients undergoing RC for bladder cancer from 2021 to 2023. QoL was assessed with the FACT-Bl-Cys survey. Clinicopathologic, complication, and readmission data were collected up to 90 days, as well as distance from the hospital and 4 zip-code based Indices (1-100 index scores representing socioeconomic deprivation). FACT-BL-Cys and indices scores were correlated with outcomes of interest. Pairwise Spearman correlation was done between indices and QoL Instruments. A multivariable analysis (MVA) identified the factors that influence complications and readmissions. Results: The cohort consisted of 56 patients, mostly men (n=40, 71%). Median age was 69, most had organ-confined disease (≤(y)pT2N0M0, n =45, 80%) and underwent neoadjuvant chemotherapy (n=32, 57%). 75% underwent a continent diversion (neobladder n=38, 68% or continent cutaneous diversion n=4, 7%). Median follow-up time was 10.1 months (range 3.7 - 16.7 months). No correlation was observed between 30/90-day complications or readmissions with FACT-BL-Cys. Healthy Places Index (HPI) correlated with overall QoL and subscores. On MVA, correlation was seen between Social Deprivation Index (SDI) and 90-day readmissions (p=0.03, OR=0.97, 95%CI= 0.94-0.99). Conclusions: Patient-reported QoL aligns with diverse socioeconomic strata, as per deprivation indices, which in turn correlate with readmissions. Further studies are needed to understand the relationship between patient reported QoL and ND with postoperative outcomes. Correlation between zip code-based deprivation indexes and quality of life scores. Well Being Scores Distance to Hospital HPI DCI SDI Physical 0.35 (p=0.01) 0.28 (p=0.05) -0.22 (p=0.11) -0.15 (p=0.27) Social 0.00 (p= 0.97) 0.10 (p=0.46) -0.11 (p=0.40) -0.10 (p=0.49) Emotional -0.07 (p=0.62) -0.18 (p=0.21) 0.19 (p=0.15) 0.22 (p=0.11) Functional 0.28 (p=0.04) 0.36 (p=0.01 ) -0.26 (p=0.05) -0.16 (p=0.24) BL-CYS 0.13 (p=0.36) 0.23 (p=0.10) -0.11 (p=0.42) -0.04 (p=0.79) TOI (PWB+FWB+BL-CYS) 0.26 (p=0.06) 0.34 (p=0.01) -0.22 (p=0.10) -0.13 (p=0.33) FACT-BL-CYS Total Score 0.19 (p=0.16) 0.31 (p=0.03) -0.20 (p=0.13) -0.11 (p=0.42) HPI: Healthy Places Index, DCI: Distressed Communities Index, SDI: Social Deprivation Index, ADI: Area Deprivation Index.

The Surprise Question in Hemodialysis, Frailty, Nutrition, Patient-reported Quality of Life, and All-Cause Mortality: The Osaka Dialysis Complication Study (ODCS)

Rationale & ObjectiveA response “no” (SQ-No) to the surprise question (SQ) of whether a clinician would be surprised if a dialysis patient died in the next 6 months is associated with a higher risk of all-cause death. It is uncertain what domains are intuitively assessed with SQ. We hypothesized that SQ would be assessing the patient’s frailty, malnutrition, or patient-perceived health-related quality of life in a cohort of patients on maintenance hemodialysis. Study DesignCohort study Setting & ParticipantsA multi-center study including 994 patients on maintenance hemodialysis in Japan Predictors1) SQ answered by nurses, 2) frailty by modified Cardiovascular Health Study criteria, 3) malnutrition as evaluated by Geriatric Nutritional Risk Index (GNRI), and 4) patient-perceived health-related quality of life examined by the 36 Item Short-Form Health Survey (SF-36) physical component summary (PCS). OutcomesAll-cause mortality Analytical ApproachCox proportional hazard models ResultsMedian age and dialysis vintage were 66 and 5.9 years, respectively, and 35.8% were female, and 39.6% had diabetic kidney disease. The prevalence of SQ-No and frailty was 19.7% and 45.9%. Medians GNRI and SF-36 PCS were 96.3 and 36.9, respectively. During follow-up for 5 years, 247 patients died. Each of SQ-No, being frail, a low GNRI, and a low SF-36 PCS was a significant predictor of a higher risk for mortality independent of potential confounders. SQ-No remained a significant predictor after further adjustment for frailty or GNRI, but SQ-No was no longer significant when adjusted for SF-36 PCS. LimitationsWe did not assess the agreement of responses to SQ between different raters. ConclusionsPredictive ability of SQ was closely related to SF-36 PCS in hemodialysis patients. SQ by nurses appears to assess the physical domain of patient-perceived health-related quality of life rather than objectively assessed frailty or malnutrition.

Longitudinal changes in patient-reported outcomes (PROs) among early phase clinical trial (EP-CT) participants.

243 Background: Little research has explored associations of longitudinal changes in PROs and clinical outcomes among EP-CT participants. We sought to describe changes in PROs over the first month of EP-CT participation and examine associations of changes with clinical outcomes. Methods: We prospectively enrolled adults participating in EP-CTs at Massachusetts General Hospital from 04/2021-01/2023. We assessed quality of life (QOL) (Functional Assessment of Cancer Therapy-General, with subdomains: physical wellbeing [PWB], emotional wellbeing [EWB], social wellbeing [SWB], functional wellbeing [FWB]); hope (Herth Hope Index); symptom burden (Edmonton Symptom Assessment System); and financial wellbeing (Comprehensive Score for Financial Toxicity) at time of EP-CT enrollment and one month later (1-month). We used descriptive statistics and regression models to describe 1-month changes in PROs and explore associations of patient-reported QOL, hope, symptom burden, and financial wellbeing with patient factors (age, diagnosis, performance status) and clinical outcomes (time on trial [TOT], treatment response, ED visits, hospitalizations, and survival). Results: Of 205 enrolled patients, 159 (77.9%) had baseline and 1-month data evaluable for analysis (median age: 63.0 [range 33.0 – 88.6], 59.8% female, 93.6% metastatic cancer, ECOG 0= 46.2% and ECOG 1=53.8%). Most common cancer types were gastrointestinal (31.5%) and breast (22.0%). There was no significant change from baseline to 1-month in mean QOL (75.2 to 76.2), hope (27.1 to 26.7), ESAS total symptom burden (20.4 to 20.9), ESAS physical symptoms (13.3 to 13.7), and financial wellbeing (28.5 to 28.0). There was no significant change in overall QOL and in each subdomain with the exception of EWB (16.2 to 17.0, p<.001). Older age was associated with increased hope (B=1.29, p=.008) and increased QOL (B=3.02, p=0.024). Increasing EWB at 1-month was associated with longer TOT (HR=0.93, p=.011). Increased symptom burden at 1-month was associated with greater risk of ED visits (HR=1.04, p=.005) and hospitalizations (HR=1.03, p=.012). Improving financial wellbeing at 1-month was associated with lower risk of hospitalization (HR=0.96, p=.046). We found no other significant associations of 1-month changes in PROs with treatment response or survival. Conclusions: We described changes in PROs from baseline to 1-month and identified factors associated with these changes. Despite the rigors and intensity associated with EP-CT initiation, most PROs did not worsen, with significantly improved EWB after 1-month of participation. Results demonstrate changes in physical symptoms predicted for greater risk of ED visits and hospitalizations. Future studies should build upon this work and measure PROs throughout trial participation to identify factors associated with changes and guide intervention development.

Prospective Assessment of Quality of Life and Patient-Reported Toxicities Over the First Year After Chimeric Antigen Receptor T-Cell Therapy

Chimeric antigen receptor (CAR) T-cell therapy has transformed survival outcomes in patients with relapsed and refractory large B-cell lymphoma (LBCL), but it is associated with a variety of side effects. This study examined changes in patient-reported quality of life (QoL) and toxicities, as well as risk factors for worse QoL and toxicities, in the first year after treatment. Patients with LBCL completed questionnaires assessing QoL and toxicity severity before infusion, and 90, 180, and 360 days after infusion. Mixed models were used to examine changes in QoL and toxicities over time, and clinical moderators of change in QoL and toxicities. Patients reported improvements in physical functioning and fatigue in the year after treatment (P values <.01), but there were no changes in pain, anxiety, or depression over time. Patients with active disease at day 90 reported more physical dysfunction at all postinfusion timepoints (Ps ≤ .01) compared to patients who responded to treatment. Similarly, patients with active disease at day 90 reported worsening depression over time, such that at day 360, depressive symptoms were worse for patients with active disease than patients without active disease (P = .02). Patients treated with 4+ lines of prior therapy reported worsening pain and anxiety over time, such that at day 360, both pain and anxiety were significantly worse for patients previously treated with 4 of more lines of therapy than patients treated with fewer lines of therapy (Ps ≤ .01). Regarding toxicities, patients reported decreasing overall toxicity burden up to day 180, with subsequent worsening at day 360 (P = .02). Most patients reported at least one or two grade 2 toxicities at each timepoint. Patients demonstrated unchanging or improved QoL after treatment with CAR T-cell therapy, but active disease and greater prior lines of therapy were associated with worse QoL outcomes over time. Toxicity severity also improved during the first 6 months post-treatment, but worsened thereafter, particularly among patients with active disease after treatment.

Elective complex ventral hernia repair in contaminated fields: A propensity score–matched analysis of long-term quality of life and outcomes between different prostheses

BackgroundRandomized studies have endorsed nonabsorbable prosthetics for contaminated ventral hernia surgery, yet the broader applicability and impact on patient-reported outcomes are still questioned. Here, we evaluated the long-term outcomes of elective contaminated ventral hernia repairs (based on Centers of Disease Control and Prevention [CDC] wound classification) using real-world data from a multicenter US cohort, focusing on quality of life and postoperative pain. MethodsThe Abdominal Core Health Quality Collaborative database was queried for patients undergoing elective contaminated (CDC class II–IV) ventral hernia repair (2013–2023). After propensity matching, we compared long-term differences in patient-reported quality of life and pain scores (by HerQLes and PROMIS questionnaires) among those who underwent repair with nonabsorbable, absorbable synthetic, and biologic mesh. ResultsA total of 1,073 patients were included, of whom 920 (86%), 56 (5%), and 97 (9%) underwent repair with nonabsorbable, absorbable synthetic, and biologic mesh, respectively. Among them, the median age was 62 years (interquartile range [IQR] 53–70), and 523 (49%) were male. The median length and width of the defect were 20 cm (IQR 12–25) and 13 cm (IQR 8–16), respectively. A transversus abdominis release was performed in 716 patients (67% of all cases). In most cases, the mesh was positioned in the retro-rectus (85%) and/or the preperitoneal space (45%). Before and after propensity matching (n = 185), the change from baseline in HerQLes and PROMIS scores at 6 months and at 1, 3, 5, and 6 years was comparable between different types of mesh. Lastly, there were no differences in readmission, surgical site infection, or surgical site occurrence at 30 days. Recurrence at 1 year was also comparable among groups. ConclusionIn the long term, there were no differences in quality of life or pain scores with nonabsorbable, absorbable synthetic, or biologic mesh for elective ventral hernia repair in contaminated fields.

The Effectiveness of Facial Neuromuscular Retraining on Patients with Facial Nerve Dysfunction: A Mental Health and Quality of Life Analysis.

Background: Facial muscle dysfunction can have drastic psychosocial effects. Objectives: To evaluate the impacts of customized neuromuscular retraining on mental health, quality of life (QoL), facial muscle function, and synkinesis. Methods: Thirty patients with facial nerve dysfunction completed a course of neuromuscular retraining. Patients' mental health, QoL, facial muscle function, and synkinesis were evaluated using Patient Health Questionnaire (PHQ-9), Facial Clinimetric Evaluation (FaCE) scale, electronic, clinician-graded facial function scale (eFACE), and Synkinesis Assessment Questionnaire (SAQ) at the initial and final visits. Scores were compared before and after treatment. Results: Patients (n = 30) included had a mean age of 59.4 ± 13.4 years (range 32.3-82.8) and were mostly female (22/30, 73.3%). The most common etiology was Iatrogenic facial nerve paralysis (11/20, 36.7%). Most patients had postfacial paralysis synkinesis (15/30, 50%), while 10 had complete flaccid paralysis. The median house-Brackmann score was 2 (range 1-6). The mean duration of facial palsy was 39.5 ± 106.9 (range 1-576 months). The duration of follow-up after the initial treatment session was 5.5 months, including 10 sessions. After neuromuscular retraining median PHQ-9 scores improved from 5 (range 0-25) to 3 (range 0-20) (p = 0.002). Mean FaCE PROM scores increased from 47.7 ± 11.5 to 56.5 ± 8.8 (p = 0.001). The mean eFACE score increased from 55.8 ± 15.1 to 71.7 ± 13.6 (p < 0.001). Median SAQ score was lower at the final visit (34.6 ± 13.4) compared to the initial visit (47.7 ± 17.8; p < 0.001). Conclusion: Customized neuromuscular retraining may improve patient-reported mental health, QoL, and facial muscle function and reduce synkinesis in facial nerve dysfunction.

Effect of Residual Stone Fragments on Patient-Reported Quality of Life after Endoscopic Kidney Stone Surgery

Effect of Residual Stone Fragments on Patient-Reported Quality of Life after Endoscopic Kidney Stone Surgery

Impact of Diet Modifications on Body Weight, Body Composition, Treatment Outcomes, and Quality of Life During Primary Treatment for Breast Cancer: A Systematic Review.

Breast cancer is a significant public health challenge, with 290 000 new cases annually and significant healthcare costs. Treatment advancements have led to improvements in survival, but common adverse effects include weight gain, fatigue, nausea, and taste changes, decreasing quality of life. This review aims to assess the impact of diet and lifestyle interventions during primary treatment for breast cancer and their effects on body weight, body composition, treatment-related adverse outcomes, and patient-reported quality of life. A search of PubMed, CINAHL, and EMBASE conducted through May 10, 2023, identified 31 publications describing 27 interventions including diet or diet plus exercise. The Cochrane Risk of Bias tool assessed the quality of publications. The findings suggest that whole foods, aerobic and strength-training exercises, and intermittent fasting during treatment may improve body weight and composition, treatment-related outcomes, and quality of life. Limitations include variation in study duration, small sample sizes, and limited sociodemographic data. Improvements seen with increased diet quality and reduced caloric intake, with or without exercise, challenge current standard-of-care recommendations during treatment for breast cancer. While there is a need for additional research, healthcare teams can confidently promote healthy diets and exercise during primary treatment for breast cancer to manage weight and improve treatment-related side effects and quality of life. PROSPERO registration no. 42023425613.

Natural disease course of chronic visceral acid sphingomyelinase deficiency in adults: A first step toward treatment criteria.

Acid sphingomyelinase deficiency (ASMD) is an ultra-rare lysosomal storage disease with a broad spectrum of manifestations ranging from severe neuropathic forms to attenuated, chronic visceral forms. Manifestations of the chronic visceral subtype are variable and encompass different degrees of hepatosplenomegaly, pulmonary disease and dyslipidemia. The aim of this study was to provide insights into the natural course of adult patients with the chronic visceral subtype. Based on these insights, we proposed tentative criteria for initiation and follow-up of enzyme replacement therapy (ERT). The data of 23 adult patients were collected in a prospective study. Clinical, genetic and demographic data, plasma measurements, abdominal imaging, pulmonary imaging, pulmonary function tests and quality of life questionnaires were collected. Stability of disease based on several clinical, biochemical and radiological markers (i.e., spleen volume, platelet levels, liver volume, alanine aminotransferase [ALT] levels, diffusion capacity of the lungs for carbon monoxide [DLCO] chitotriosidase activity and lysosphingomyelin [LSM]) was assessed. Cardiovascular risk was estimated based on sex, age, smoking, systolic blood pressure and lipid profile. Quality of life was evaluated with the 36-Item Short Form Health Survey and the Health Assessment Questionnaire. Median follow-up was 6.1 years (range 1.3-19.5 years). The most common manifestations were splenomegaly (100%), decreased high-density lipoprotein cholesterol (HDL-C) plasma levels (83%), (signs of) steatosis measured with transient elastography (82%), thrombocytopenia (64%), hepatomegaly (52%) and decreased diffusion capacity (45%). The majority of markers remained stable during follow-up. Twelve patients showed progression of disease: four for spleen volume, two for liver volume, three for DLCO, seven for chitotriosidase activity and three for LSM. One patient showed progression of disease based on four markers, although this patient did not report any problems at the last visit. Cardiovascular risk was estimated and was increased in half of the patients older than 40 years. Patient-reported quality of life did not differ from the general population, but differences in median 36-Item Short Form Health Survey (SF-36) scores of patients with severe pulmonary involvement and those of patients without pulmonary involvement were observed. Tentative criteria for initiation and effect of therapy were proposed. In conclusion, the chronic visceral subtype of ASMD showed a predominantly stable disease course in this cohort. We propose that ERT should be initiated on an individual basis and only in case of progression or symptomatic disease. Collection and analysis of real world data are necessary to refine start, stop and follow-up criteria in the future.

Unveiling hidden outcomes in malignant gastric outlet obstruction research - insights from a "Pancreas 2000" review.

Malignant gastric outlet obstruction (mGOO) is a major condition affecting patients with periampullary tumors, including pancreatic cancer. The current treatment options include surgical gastroenterostomy, endoscopic stenting and more recently EUS-guided gastroenterostomy. Most studies comparing the outcomes of the three procedures focus on technical success, clinical success and safety. Several "occult" outcomes relevant to the patient's viewpoints and perspective may ultimately impact on cancer-related and overall survival, such as body mass composition, nutritional biomarkers, chemotherapy tolerance and patient-reported quality of life. The aim of this review is to provide an overview of potential key outcomes that should be explored in future comparative research around mGOO treatment options.

Quality of Life Outcomes in Breast Cancer Patients Receiving Chemotherapy With or Without Radiation Therapy

PurposeUnderstanding quality of life (QOL) implications of individual components of breast cancer treatment is important as systemic therapies continue to improve oncologic outcomes. We hypothesized that adjuvant radiation therapy does not significantly impact QOL domains in breast cancer patients undergoing chemotherapy. MethodsData was drawn from three prospective studies in women with localized breast cancer being treated with chemotherapy from March 2014 to December 2019. Patient-reported measures were collected at baseline (pretreatment) and post-treatment using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) measure, which consists of 5 subscales. Changes in mean QOL scores in patients who received radiotherapy were compared to those who did not using a one-sided noninferiority method. Statistical significance was determined below 0.05 to meet noninferiority. ResultsIn a sample of 175 patients, 131 were treated with radiation and 44 had no radiation. The sample consisted mostly of stage I-II breast cancer (78%) with hormone receptor positive (59%) disease, receiving either neoadjuvant (36%) or adjuvant chemotherapy (64%). Mean change in QOL for the group treated with radiation compared to no radiation was noninferior with respect to Physical Well-Being (P = .0027), Social/Family Well-Being (P = .0002), Emotional Well-Being (P = .0203), FACIT-Fatigue Subscale (P = .0072), and the Total FACIT-F score (P = .0005); however, mean change in QOL did not meet noninferiority for Functional Well-Being (P = .0594). ConclusionPatient-reported QOL from baseline to post-treatment, using the Total FACIT-F score, was noninferior in patients treated with versus without radiation therapy. This finding, in addition to individualized QOL subscales, provides important information in the informed decision-making process when discussing the effects of locoregional radiation on QOL in localized breast cancer patients treated with chemotherapy.

Mastectomy Incision Choice in Ptotic Patients Undergoing Immediate Implant-Based Reconstruction: A Comparison of Wise-Pattern and Oblique-Elliptical Incisions.

Breast ptosis presents challenges for implant-based reconstruction due to the large skin envelope. Skin-reducing mastectomy reduces the envelope but must consider many other factors including complications. Limited data exist on incision impact on outcomes. We compare oblique-elliptical and Wise-pattern incisions on complications and patient-reported quality of life in immediate implant-based reconstruction.A retrospective review of patients who underwent immediate implant-based skin-reducing mastectomy at a single institution from 2015 to 2021 was done and was divided into two cohorts: wise and oblique incisions. Demographics, complications, and patient-reported outcomes (BREAST-Q) were compared. Descriptive, t test, and chi-square test analyses, followed by adjusted linear and logistic regression models, were performed to compare complication rates and BREAST-Q scores.Eighty-nine patient breasts were analyzed, 39 (43.8%) in the oblique (OI) and 50 (56.2%) in the wise (WI) cohort. No differences in demographics or preoperative comorbidities between groups were found. The oblique incision patients had significantly more mean total complications (OI 1.46 vs WI 0.88; P = 0.048), as well as increased incidence of explantation (OI 15 vs WI 3; P = 0.003) and cellulitis (OI 14 vs WI 3; P = 0.020) compared to wise group. Linear regression analysis revealed that incision choice was a significant predictor of complication rate (β = -1.06, 95% CI [-1.63--0.50], P = <0.001). Logistic regression analysis showed that incision was a significant predictor of specific complications such as explantation (odds ratio = 0.10, 95% CI [0.02-0.52], P = 0.006) and cellulitis (odds ratio = 0.16, 95% CI [0.03-0.73], P = 0.018), with decreased risk of choosing wise incision. There was no difference in BREAST-Q results.Ptotic patients with oblique incision are associated with higher rates of postoperative complications compared to wise incisions.These findings suggest that incision choice is an important factor in postoperative complication development and emphasizes the need for further investigation and discussion with patients during preoperative planning.

Association between Cognitive Function and Physical Function, Frailty, and Quality of Life in Older Breast Cancer Survivors.

Older cancer survivors in general are at greater risk for cancer-related cognitive impairment (CRCI), yet few studies have explored its association with health outcomes. This study examined the association between subjective and objective measures of cognitive function and physical function, frailty, and quality of life (QoL) among older breast cancer survivors. Older breast cancer survivors who reported cognitive concerns completed surveys on patient-reported cognitive function, physical function, frailty, and QoL as well as objective tests of visuospatial working memory and sustained attention. Data were analyzed using descriptive statistics and separate linear regression models. A total of 219 female breast cancer survivors completed the study. Perceived cognitive abilities were associated with better physical function, frailty, and QoL (p ≤ 0.001) while cognitive concerns were negatively related with these metrics (p ≤ 0.001). Poorer visuospatial working memory and sustained attention were linked to increased frailty (p ≤ 0.001-0.01), whereas poorer sustained attention was associated with poorer physical function (p < 0.01). Older breast cancer survivors with perceived cognitive impairment and poorer cognitive performance reported poorer physical functioning, increased frailty, and poorer QoL. These findings underscore the importance of assessing cognitive concerns and their associated outcomes in older breast cancer survivors.

A prospective cohort study on stereotactic radiotherapy in the management of dural recurrence of olfactory neuroblastoma.

Treatment for dural recurrence of olfactory neuroblastoma (ONB) is not standardized. We assess the outcomes of stereotactic body radiotherapy (SBRT) in this population. ONB patients with dural recurrences treated between 2013 and 2022 on a prospective registry were included. Tumor control, survival, and patient-reported quality of life were analyzed. Fourteen patients with 32 dural lesions were evaluated. Time to dural recurrence was 58.3 months. Thirty lesions (94%) were treated with SBRT to a median dose of 27 Gy in three fractions. Two patients (3 of 32 lesions; 9%) developed in-field radiographic progression, five patients (38%) experienced progression in non-contiguous dura. Two-year local control was 85% (95% CI: 51-96%). There were no >grade 3 acute toxicities and 1 case of late grade 3 brain radionecrosis. In this largest study of SBRT reirradiation for ONB dural recurrence to date, high local control rates with minimal toxicity were attainable.

Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP): study protocol for a multicenter, randomized, adaptive allocation clinical trial to identify the optimal duration of induced hypothermia for neuroprotection in comatose, adult survivors of after out-of-hospital cardiac arrest

BackgroundCardiac arrest is a common and devastating emergency of both the heart and brain. More than 380,000 patients suffer out-of-hospital cardiac arrest annually in the USA. Induced cooling of comatose patients markedly improved neurological and functional outcomes in pivotal randomized clinical trials, but the optimal duration of therapeutic hypothermia has not yet been established.MethodsThis study is a multi-center randomized, response-adaptive, duration (dose) finding, comparative effectiveness clinical trial with blinded outcome assessment. We investigate two populations of adult comatose survivors of cardiac arrest to ascertain the shortest duration of cooling that provides the maximum treatment effect. The design is based on a statistical model of response as defined by the primary endpoint, a weighted 90-day mRS (modified Rankin Scale, a measure of neurologic disability), across the treatment arms. Subjects will initially be equally randomized between 12, 24, and 48 h of therapeutic cooling. After the first 200 subjects have been randomized, additional treatment arms between 12 and 48 h will be opened and patients will be allocated, within each initial cardiac rhythm type (shockable or non-shockable), by response adaptive randomization. As the trial continues, shorter and longer duration arms may be opened. A maximum sample size of 1800 subjects is proposed. Secondary objectives are to characterize: the overall safety and adverse events associated with duration of cooling, the effect on neuropsychological outcomes, and the effect on patient-reported quality of life measures.DiscussionIn vitro and in vivo studies have shown the neuroprotective effects of therapeutic hypothermia for cardiac arrest. We hypothesize that longer durations of cooling may improve either the proportion of patients that attain a good neurological recovery or may result in better recovery among the proportion already categorized as having a good outcome. If the treatment effect of cooling is increasing across duration, for at least some set of durations, then this provides evidence of the efficacy of cooling itself versus normothermia, even in the absence of a normothermia control arm, confirming previous RCTs for OHCA survivors of shockable rhythms and provides the first prospective controlled evidence of efficacy in those without initial shockable rhythms.Trial registrationClinicalTrials.gov NCT04217551. Registered on 30 December 2019.

Longitudinal Quality-of-Life Outcomes of Skull Base Chondrosarcoma Patients following Surgical Resection

Abstract Objective Owing to the rarity of skull base chondrosarcomas (CS), much of its natural history and long-term impact on patient quality of life (QoL) are not well studied. This novel study demonstrates QoL among CS patients following radical treatment constituting surgery and postoperative radiotherapy over 2 decades. Study Design Retrospective review and prospective data collection to obtain patient demographic, tumor characteristics, clinical symptoms, and patient-reported QoL outcomes using the 36-Item Short Form Health Survey (SF-36). Setting/Participants Patients diagnosed with CS who underwent radical intent surgical resection by the senior author and adjuvant early postoperative proton beam therapy. Results Twenty-eight skull base CS patients were identified, with 19 patients completing full treatment course. Mean long-term follow-up was 148.9 months. Diplopia symptom resolution was high. No significant deterioration in SF-36 Physical Health Component (PHC) and Mental Health Component (MHC) scores was observed at postoperative and long-term follow-up. General health was stable initially but deteriorated in long term (Δ −18.88, minimal clinically important difference [MCID]: 9.86, p = 0.04). Compared with age-matched Canadian control patients, CS patients reported similar PHC scores at baseline and follow-up. CS patients reported lower MHC scores (45.8 vs. 50.9, p = 0.13) preoperatively, which persisted at follow-up decreasing by 1.9 (43.9 vs. 53.7, p = 0.03); this difference, however, did not reach MCID threshold of Δ 5.9. Conclusion We present the longest follow-up data on CS demonstrating stable long-term QoL with aggressive surgery. Tumor control was high and preoperative tumor size did not affect long-term QoL. Preoperative QoL was lower among CS compared with Canadian normative data. Postoperatively, only the decline in physical functioning QoL scores exceeded MCID. At long-term follow-up, the decline in physical functioning, social functioning, and general health exceeded MCID. Overall, QoL among CS patients remained lower at long-term follow-up despite absence of tumor progression and resolution of symptoms.