Performance Status Assessment Research Articles

Palliative and end-of-life care for the older adult with cancer.

Despite established benefits of palliative care in the oncology population, it remains an underutilized resource particularly among older adults. The illness trajectory and needs of an older adult with cancer are unique. The purpose of this paper is to review the current literature on providing comprehensive palliative and end-of-life care for the older adult with cancer. Though the difficulties of applying traditional palliative care principles in the older patients with cancer have been discussed, this review reveals a clear gap in the literature in discussing the provision of comprehensive palliative and end-of-life care in this population. Very few articles have been published in this domain with even fewer published within the past 18 months. As such, this article reviews key aspects of palliative and geriatric medicine that need to be considered and integrated in order to provide comprehensive palliative care to the older adult with cancer. This includes a discussion of proper pain and symptoms assessment, performance status assessment, advance care planning, and end-of-life care while considering the nuances of geriatric syndromes.

Immunotherapy in patients with non-small cell lung cancer with ECOG PS 2.

Immunotherapy is a new and very promising method of anti-cancer treatment. Unfortunately, not every patient can benefit from this treatment. The Polish drug program determines the selection of patients based on PD-L1 expression and the performance status assessed with the use of Eastern Cooperative Oncology Group Performance Status (ECOG PS) score. Patients with ECOG PS 2 represent a significant proportion of the cancer population, one which is overlooked in most clinical trials of immunotherapy. Often, a reduced performance status is the only factor that excludes the patient from treatment with immunotherapy. Choosing the optimal method of treatment in patients with a worse general condition and with multiple diseases may be a significant problem for the doctor. Assessment of performance status may be a particular problem because not every patient has a worse PS score for the same reasons. In this study, we analyse the results of treatment of patients with a poorer performance status to date, and we present tools that improve the precise assessment of the degree of the performance status, which may enable more patients to access novel lung cancer treatments.

Assessment of Functional Status and Quality of Life of Elderly Patients Undergoing Radiotherapy and Radiotherapy Combined with Chemotherapy - A Cross-Sectional Study.

BackgroundAging is associated with various diseases, a plethora of which are oncological. Selected treatment methods influence the performance status and the adaptability to changing circumstances.ObjectiveThe aim of the study was to assess the functional status, quality of life, and adaptation to disease of elderly patients who underwent only radiotherapy or chemotherapy combined with radiotherapy.Patients and MethodsThe cross-sectional study was conducted in a sample of 76 patients diagnosed with cancer, over 60 years of age (mean 69.3/SD 6.8) who were hospitalized in the Radiotherapy Department at the Ludwik Rydygier Hospital in Krakow. Standardized research tools were: Functional Assessment of Chronic Illness Therapy (FACIT-F), Mental Adjustment to Cancer Scale (Mini-MAC), Lawton Instrumental Activity of Daily Living (IADL), Yesavage Geriatric Depression Scale (GDS), an assessment scale of the post radiation reaction devised by Eastern Cooperative Oncology Group (ECOG).ResultsMost (n=37) patients were treated with a combination of radiotherapy and chemotherapy (48.6%), whereas 21 patients underwent only radiotherapy (27.6%). More than half of the respondents were male (68.4%, n = 52), whereas 24 (31.6%) were female. The assessment of the participants’ performance status yielded results indicating an average level of all domains. Men performed better in terms of physical condition compared to a group of women (p=0.010). Women experienced fatigue more frequently than men (p=0.012). Patients who had received radiation therapy combined with chemotherapy achieved on average better results in functional well-being (FWB) than the patients who had undergone radiotherapy only (p=0.046). Depression had a significant impact on all spheres of functioning (p<0.001) except social/family well-being.ConclusionThe results pointed to the essential elements that should be taken into consideration in relation to treatment planning and providing care. Particular attention should be paid to women who suffered from depression and negative adaptation strategies that directly affect their functioning.

Current opportunities of comprehensive therapy for bone metastases from thyroid cancer

Background. Approximately 10 % of patients with well-differentiated thyroid cancer (WDTC) develop distant metastases. Of them, only 23 % have bone metastases. Complications associated with metastatic lesion in the skeleton significantly affect overall condition of patients and their quality of life. Surgery and pharmacotherapy are highly traumatic and toxic. Bisphosphonates are stable structural analogues of pyrophosphate that inhibit osteoclast activity, thereby reducing bone resorption, which increases the time to development of bone complications, improves patient’s quality of life, and reduces pain.The study objective is to assess performance status and pain severity in WDTC patients with distant bone metastases after bisphosphonate therapy.Materials and methods. We analyzed clinical experience in using bisphosphonates in WDTC patients treated in P.A. Herzen Moscow Oncology Research Institute between 2016 and 2020. This study included 41 patients with WDTC and bone metastases of various locations. Pain severity was evaluated using a 5-point verbal scale; performance status was evaluated using the Eastern Cooperative Oncology Group scale.Results. We observed an improvement in patients’ performance status (from score 2 to 0 according to the Eastern Cooperative Oncology Group scale) in response to therapy. We also found a decrease in pain intensity (from score 4 to 1.5).Conclusion. The inclusion of bisphosphonates into the treatment scheme for WDTC patients with bone metastases can reduce pain intensity and improve performance status.

Comparison of the prognostic value of must, ECOG-PS, systemic inflammatory response and ct derived body composition analysis in patients with advanced lung cancer .

Rationale: Assessment of malnutrition, performance status and systemic inflammation are routine aspects of clinical assessment in patients with advanced cancer. There is increasing evidence that body composition measurements from routine staging CT also have prognostic value. To date the relative prognostic value of Malnutrition Universal Screening Tool (MUST)1, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), modified Glasgow Prognostic score (mGPS)2 and CT derived body composition analysis in patients with advanced lung cancer has not been examined.

177Lu]Lu-DOTA-ZOL bone pain palliation in patients with skeletal metastases from various cancers: efficacy and safety results

Background[177Lu]Lu-DOTA-ZOL has shown promising results from the dosimetry and preclinical aspects, but data on its role in the clinical efficacy are limited. The objective of this study is to evaluate the efficacy and safety of [177Lu]Lu-DOTA-ZOL as a bone pain palliation agent in patients experiencing pain due to skeletal metastases from various cancers.MethodsIn total, 40 patients experiencing bone pain due to skeletal metastases were enrolled in this study. The patients were treated with a mean cumulative dose of 2.1 ± 0.6 GBq (1.3–2.7 GBq) [177Lu]Lu-DOTA-ZOL in a median follow-up duration of 10 months (IQR 8–14 months). The primary outcome endpoint was response assessment according to the visual analogue score (VAS). Secondary endpoints included analgesic score (AS), global pain assessment score, Eastern Cooperative Oncology Group Assessment performance status (ECOG), Karnofsky performance status, overall survival, and safety assessment by the National Cancer Institute’s Common Toxicity Criteria V5.0.ResultsIn total, 40 patients (15 males and 25 females) with a mean age of 46.6 ± 15.08 years (range 24–78 years) were treated with either 1 (N = 15) or 2 (N = 25) cycles of [177Lu]Lu-DOTA-ZOL. According to the VAS response assessment criteria, complete, partial, and minimal responses were observed in 11 (27.5%), 20 (50%), and 5 patients (12.5%), respectively with an overall response rate of 90%. Global pain assessment criteria revealed complete, partial, minimal, and no response in 2 (5%), 25 (62.5%), 9 (22.5%), and 4 (10%) patients, respectively. Twenty-eight patients died and the estimated median overall survival was 13 months (95% CI 10–14 months). A significant improvement was observed in the VAS, AS, and ECOG status when compared to baseline. None of the patients experienced grade III/IV haematological, kidney, or hepatotoxicity due to [177Lu]Lu-DOTA-ZOL therapy.Conclusion[177Lu]Lu-DOTA-ZOL shows promising results and is an effective radiopharmaceutical in the treatment of bone pain due to skeletal metastases from various cancers.

Racial disparities in performance status among cancer patients at a community oncology practice.

132 Background: Performance status is used to characterize patient ability to tolerate chemotherapy and as a selection criterion for clinical research. Poor performance status can exclude patients from clinical trial participation. Further, African American cancer patients are underrepresented in cancer clinical trials. The study purpose was to document performance status at the initial patient visit to a community oncology practice and to explore racial disparities between White and Black patients. Methods: This study used a retrospective, observational design with ePRO collected via the Patient Care Monitor™ (PCM). All study data were collected as part of routine clinical care at a community oncology practice during 1/2019–11/2019. An Eastern Cooperative Oncology Group (ECOG) score was automatically calculated after patients at an initial clinic visit completed a 1-item question that assessed performance status via e-tablet. Results: 6,613 patients completed the PCM survey (mean age 59; 33% male/67% female; 55.4% White, 38% Black). Cancer type was known for a subset of patients (22% breast, 9% hematologic, 4% lung, 5% colorectal, 3% prostate, 11% other types). The average ECOG score for the total sample was 0.97. 50% indicated they were able to complete their normal daily activities without any restriction; 26.9% were able to complete their normal daily activities and some light work. In contrast, 10.3% indicated they could take care of themselves, but could not work and are in bed/chair less than half the day. 10.3% could take care of themselves sometimes but could not work and are in bed/chair more than half the day. 4.5% indicated they could not take care of themselves and were in bed/chair almost always. When assessing racial differences between those self-identifying as White or Black/African American, average ECOG score was higher in Black patients [Mean(SD) = 1.03(1.24)] when compared to White patients [Mean(SD) = 0.93(1.14)] (p = 0.003). We observed a higher percentage of Black patients reported not being able to take care of themselves (51.9% Black v. 41.0% White). In contrast, a higher percentage of White patients reported being able to complete all daily activities without restriction (38.3% Black v. 54.5% White). Conclusions: This study shows significant racial disparities in performance status among patients seen at a community oncology practice with Black patients exhibiting significant worse performance status than White patients. These findings have implications for disparities in treatment outcomes and racially biased access to clinic trials.

Use of Wearable Activity Tracker in Patients With Cancer Undergoing Chemotherapy: Toward Evaluating Risk of Unplanned Health Care Encounters.

PURPOSEUnplanned health care encounters (UHEs) such as emergency room visits can occur commonly during cancer chemotherapy treatments. Patients at an increased risk of UHEs are typically identified by clinicians using performance status (PS) assessments based on a descriptive scale, such as the Eastern Cooperative Oncology Group (ECOG) scale. Such assessments can be bias prone, resulting in PS score disagreements between assessors. We therefore propose to evaluate PS using physical activity measurements (eg, energy expenditure) from wearable activity trackers. Specifically, we examined the feasibility of using a wristband (band) and a smartphone app for PS assessments.METHODSWe conducted an observational study on a cohort of patients with solid tumor receiving highly emetogenic chemotherapy. Patients were instructed to wear the band for a 60-day activity-tracking period. During clinic visits, we obtained ECOG scores assessed by physicians, coordinators, and patients themselves. UHEs occurring during the activity-tracking period plus a 90-day follow-up period were later compiled. We defined our primary outcome as the percentage of patients adherent to band-wear ≥ 80% of 10 am to 8 pm for ≥ 80% of the activity-tracking period. In an exploratory analysis, we computed hourly metabolic equivalent of task (MET) and counted 10 am to 8 pm hours with > 1.5 METs as nonsedentary physical activity hours.RESULTSForty-one patients completed the study (56.1% female; 61.0% age 40-60 years); 68% were adherent to band-wear. ECOG score disagreement between assessors ranged from 35.3% to 50.0%. In our exploratory analysis, lower average METs and nonsedentary hours, but not higher ECOG scores, were associated with higher 150-day UHEs.CONCLUSIONThe use of a wearable activity tracker is generally feasible in a similar population of patients with cancer. A larger randomized controlled trial should be conducted to confirm the association between lower nonsedentary hours and higher UHEs.

Comparison of the prognostic value of MUST, ECOG-PS, mGPS and CT derived body composition analysis in patients with advanced lung cancer

Assessment of malnutrition, performance status and systemic inflammation are routine aspects of clinical assessment in patients with advanced cancer. There is increasing evidence that body composition measurements from routine staging CT also have prognostic value. To date the relative prognostic value of Malnutrition Universal Screening Tool (MUST), Eastern Cooperative Oncology Group Performance Status (ECOG-PS), modified Glasgow Prognostic score (mGPS) and CT derived body composition analysis in patients with advanced lung cancer has not been examined. The aim of the present study was to examine this relationship. Clinicopathological characteristics including MUST, ECOG-PS, mGPS and body composition data were collected pre-radiotherapy from a prospectively maintained database of patients with advanced lung cancer (n=643). Using the MUST score, patients were classified into low (MUST=0, n=189), medium (MUST=1, n=341) and high (MUST≥2, n=113) malnutrition risk and their relationship to systemic inflammatory response (SIR) and body composition with clinical outcomes were examined using univariate and multivariate analyses. Primary outcome of the study was overall survival. Compared with the patients at low nutrition risk (MUST=0), patients at moderate to high risk (MUST 1-≥2) had poorer ECOG-PS>1 (p<0.01), elevated modified frailty index (mFI) (p<0.001), elevated mGPS (p<0.001), lower skeletal muscle index (SMI, p<0.01) but not lower skeletal muscle density (SMD, p=0.115). MUST was an important prognostic marker of 12 months overall survival (p=0.001). On multivariate analysis, higher MUST (HR 1.16, 95% CI 1.03-1.31, p<0.05), ECOG-PS>1 (HR 1.23, 95% CI 1.10-1.39, p<0.001), elevated mGPS (HR 1.20, 95% CI 1.09-1.33, p<0.001) were independently associated with overall survival. A large proportion of patients (71%) with advanced lung cancer were at moderate to high nutrition risk. Higher malnutrition risk and elevated inflammatory status were independently associated with poor overall survival. MUST, ECOG-PS and mGPS all had independent prognostic value and may form an important prognostic framework in treatment decision making and resource utilization.

603TiP Phase II, open-label study of erdafitinib in adult and adolescent patients (pts) with advanced solid tumours harboring fibroblast growth factor receptor (FGFR) gene alterations

The pan-FGFR tyrosine kinase inhibitor erdafitinib is approved by the US Food and Drug Administration for adults with locally advanced or metastatic urothelial carcinoma and susceptible FGFR3/2 alterations who have progressed during or after ≥ 1 line of platinum-containing chemotherapy. FGFR alterations are potential oncogenic drivers that have been reported in many solid tumours in adult and pediatric pts. Because of limited response to standard of care options in patients failing systemic therapy, there is strong rationale to assess the safety and efficacy of erdafitinib in adolescent and adult pts with advanced solid tumours and FGFR alterations. This phase II open-label study (RAGNAR/42756493CAN2002; NCT04083976) will include pts aged ≥ 12 years with histologically confirmed unresectable locally advanced or metastatic solid tumours (except urothelial) harboring predefined FGFR mutations or fusions. Eligibility screening includes molecular screening for FGFR alterations by central or local next-generation sequencing assays and other clinical criteria. Pts will enroll into either a broad panel cohort (BPC) of target FGFR alterations or an exploratory cohort (EC) for FGFR alterations not meeting BPC criteria. ∼280 pts (BPC, n = 240; EC, n = 40) will be enrolled. The primary efficacy end point is overall response rate (ORR) per Independent Review Committee. Secondary end points include investigator-assessed ORR, duration of response, disease control rate, progression-free survival, overall survival, safety, pharmacokinetics, and health-related quality of life. Safety assessments include adverse events, vital signs, electrocardiograms, physical examinations, laboratory tests, performance status assessment, growth assessments in adolescents, and ophthalmologic examination. Starting in December 2019, pts will be enrolled at ∼158 sites in 15 countries. Results of this study will provide efficacy and safety data for erdafitinib across multiple solid tumours with FGFR alterations and evaluate potential benefit of targeting underlying altered biology of FGFR irrespective of tumour histology in adult and adolescent pts. NCT04083976. Writing assistance was provided by Sally Hassan, PhD, of Parexel, and was funded by Janssen Global Services, LLC. Janssen Research & Development, LLC.

Retrospective Evaluation of the Use of Pembrolizumab in Malignant Mesothelioma in a Real-World Australian Population

IntroductionWe investigated the efficacy and toxicity of pembrolizumab in patients with mesothelioma from a real-world Australian population. We aimed to determine clinical factors and predictive biomarkers that could help select patients who are likely to benefit from pembrolizumab. MethodPatients with mesothelioma who were treated with pembrolizumab as part of the Insurance and Care New South Wales compensation scheme were included. Clinical information was collected retrospectively. Tumor biomarkers such as programmed death-ligand 1 (PD-L1), BAP1, and CD3-positive (CD3+) tumor-infiltrating lymphocytes (TILs) were examined using archival formalin-fixed paraffin-embedded tumor samples. ResultsA total of 98 patients were included with a median age of 70 years (range, 46–91 y); 92% were men; 76% had epithelioid subtype; 21% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0. Pembrolizumab was used as second-line or subsequent-line treatment in 94 patients and as first-line treatment in four patients. The overall response rate was 18%, and the disease control rate was 56%. The median progression-free survival (PFS) was 4.8 months (95% confidence interval: 3.6–6.2), and the median overall survival (OS) was 9.5 months (95% confidence interval: 6.6–13.7). Immune-related adverse events occurred in 27% of patients, of which nine (9%) were of grade 3 or higher. In the multivariable analysis, factors independently associated with longer PFS included baseline ECOG status of 0 (median PFS: 12 mo versus 4 mo, p < 0.01) and PD-L1 tumor proportion score of greater than or equal to 1% (median PFS: 6 mo versus 4 mo, p < 0.01). Baseline platelet count of less than or equal to 400 × 109/liter was independently associated with longer PFS and OS (median PFS: 6 mo versus 2 mo, p = 0.05; median OS: 10 mo versus 4 mo, p = 0.01), whereas lack of pretreatment dexamethasone was independently associated with OS but not PFS (median OS: 10 mo versus 3 mo, p = 0.01). The odds of response were higher for patients with baseline ECOG status of 0 (p = 0.02) and with greater than or equal to 5% CD3+ TILs in the tumor (p < 0.01). PD-L1 expression, BAP1 loss, and CD3+ TILs in the stroma were not significantly associated with the overall response rate. ConclusionsImmunotherapy is a reasonable treatment option for patients with mesothelioma. Our results are comparable to other clinical trials investigating pembrolizumab in mesothelioma in terms of response. Good performance status assessment remains the most robust predictor for patient outcomes. CD3+ TILs in the tumor may help select patients that are likely to respond to pembrolizumab, whereas factors such as PD-L1 expression, baseline platelet count, and lack of pretreatment dexamethasone may help predict survival outcomes from pembrolizumab treatment.

Telemedicine During the COVID-19 Pandemic: Impact on Care for Rare Cancers

PURPOSEMany patients with cancer, often those with rare cancers such as sarcomas, travel long distances to access expert care. The COVID-19 pandemic necessitated widespread changes in delivery of cancer care, including rapid adoption of telemedicine-based care. We aimed to evaluate the impact of telemedicine on patients, clinicians, and care delivery at the Royal Marsden Hospital (RMH) Sarcoma Unit during the pandemic.METHODSData were extracted from patient records for all planned outpatient appointments at the RMH Sarcoma Unit from March 23 to April 24, 2020. Patients and clinicians completed separate questionnaires to understand their experiences.RESULTSOf 379 planned face-to-face appointments, 283 (75%) were converted to telemedicine. Face-to-face appointments remained for patients who needed urgent start of therapy or performance status assessment. Patients lived on average > 1.5 hours from RMH. Patient satisfaction (n = 108) with telemedicine was high (mean, 9/10), and only 48% (n = 52/108) would not want to hear bad news using telemedicine. Clinicians found telemedicine efficient, with no associated increased workload, compared with face-to-face appointments. Clinicians indicated lack of physical examination did not often affect care provision when using telemedicine. Most clinicians (n = 17; 94%) believed telemedicine use was practice changing; congruently, 80% (n = 86/108) of patients desired some telemedicine as part of their future care, citing reduced cost and travel time.CONCLUSIONTelemedicine can revolutionize delivery of cancer care, particularly for patients with rare cancers who often live far away from expert centers. Our study demonstrates important patient and clinician benefits; assessment of longer-term impact on patient outcomes and health care systems is needed.

Continuous monitoring of mobility performance trajectory in patients receiving chemotherapy.

e14104 Background: Accurate performance status (PS) assessment is important for chemotherapy decisions, but current tools such as the Eastern Cooperative Oncology Group (ECOG) PS assessment are subjective, static, and prone to inter-observer and recall biases. Continuous patient monitoring technology can enhance PS assessment by providing an objective and dynamic measurement of mobility performance (MP), defined as mobility in real-life situations. This study examined the feasibility of a pendant sensor to continuously track MP during a 4-week period of chemotherapy. Methods: Patients on chemotherapy were recruited from a single center. Patients were asked to continuously wear a water-resistant pendant sensor (PAMSys, Biosensics, USA) for 4-weeks during the day and night. Patients completed psychosocial surveys (cognitive, depression, and fatigue) and a technology acceptance survey measured on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Chart review was completed for demographics, medical history, and baseline ECOG PS. Using a validated algorithm, postures (lying and sitting postures: LSP) and walking parameters (cadence, longest walking bout, total steps per day) were extracted from the pendant. We also calculated percent change from baseline activity to the lowest activity level during the 4-week period. To determine clinically meaningful digital biomarkers, we compared these MP measures between two groups: ECOG 0 or ECOG ≥1. Results: Fifteen patients (median age 68), with either a solid (n = 14) or hematologic (n = 1) malignancy, stages II-IV, with ECOG 0 (n = 7) and ECOG ≥1 (n = 8) were evaluated. Baseline psychosocial parameters were not significantly different. ECOG ≥1 tend to have poorer baseline walking compared to ECOG 0 with the largest effect size observed for cadence (79.2 ± 10.0 vs 73.3±3.7, Cohen’s d effect size d = 0.78). The percentage of MP decline was higher in ECOG 0 compared to ECOG ≥1 (89.0±22.9% vs 79.9±34.5%). None of the observed trends reached statistical significance. Patients reported that the pendant was comfortable to wear (4.9±0.30) and did not interfere with activities (4.9±0.25). Conclusions: This study showed the feasibility of a pendant sensor to continuously monitor MP and its trajectory during chemotherapy. Results suggest continuous MP monitoring may provide objective information to enhance PS assessment. Larger studies are needed to confirm statistical significance of digital MP metrics and its potential effect on clinical decisions such as dose reduction, rehabilitation, and palliative care.

Clinical significance of primary debulking surgery and neoadjuvant chemotherapy-interval debulking surgery in advanced ovarian cancer.

Primary debulking surgery followed by platinum-based chemotherapy remains the standard treatment of patients with stage III-IV epithelial ovarian cancer. Neoadjuvant chemotherapy is an alternative treatment regimen that can be considered in selected patients. Complete cytoreduction, both through primary debulking surgery and interval debulking surgery, has a major positive effect on survival and should be the goal, even if this requires extensive surgery. When thorough assessment of tumor spread and performance status of the patient indicates that complete primary cytoreduction is not feasible without unacceptable morbidity, then alternative therapeutic strategies, such as neoadjuvant chemotherapy, must be considered. Such patients can be offered the option of interval debulking surgery after checking their response to neoadjuvant chemotherapy and resolution of the initial obstacles for primary debulking surgery (i.e. complete response of irresectable disease and improvement of the performance status). Current evidence suggests that a selected group of patients with International Federation of Gynecology and Obstetrics stage III-IV ovarian cancer will benefit from NAC-IDS. Research is ongoing to identify patients who might derive the greatest benefit from neoadjuvant chemotherapy followed by interval debulking surgery, instead of primary debulking surgery, on the basis of radiological, genetic, pathological, and immunological variables. In this review, we discuss current knowledge about the clinical significance of primary debulking surgery and neoadjuvant chemotherapy in advanced ovarian cancer and discuss unanswered questions in the field.

Haplo Allogeneic Hematopoietic Stem Cell Transplantation in Patients of 65 Years or Older: A Monocenter Analysis

Advanced hematologic malignancies have a higher incidence in older patients and very often lack effective treatments. Allo-HSCT represents the only potential curative option for most of hematologic malignancies. However, 2 main limitations limited this development for a long period of time in older patients. High rates of fatal non-relapse morbidities have been progressively decreased using reduced toxicity conditioning approaches. This allowed pushing up the age limit of patients considered for transplant. The search for a donor has been also a high limitation in older population, due to the lower incidence of matched sibling donors in this population. The development of allo-HSCT from a familial Haplo donor after a reduced intensity (RIC) or non-myeloablative conditioning (NMAC) has allowed for the recent development of allo-HSCT in older population. Here we analyzed a cohort of 111 consecutive patients aged of 65 years or older transplanted from a haplo donor in a single institution from 2013 to 2018. During this period of time, the search for a one-mismatch haplotype donor (Haplo) has been progressively introduced in our program, the upper limit age for transplant progressively increased and more advanced diseases. Patient characteristics: Median age: 69,3 (65-78) years; Male patients: 64%; Acute leukemia (AL): 34%; Myelodysplastic/myeloproliferative syndromes (MDS/MPS): 45%; Chronic Leukemia: 2%; Lymphoma: 18%; others: 3%. High or very high risk disease index (DRI): 44%. Donor characteristics: median age: 39,2 (22-68); Male gender: 61%; sibling donor: 17%; offspring donor: 83%. Non Myeloablative/ Reduced toxicity conditioning: 51%/49%; All patients received PTCY. PT Immunosuppression included CSA and MMF. Median follow-up: 20 (3-78) months; ANC recovery in 96%: 19 (10-44) days; untransfused platelet recovery above 20 in 75%: 17 (7-56) days. In evaluable patients for aGVHD: No: 59%; Grade 1: 7%; Grade 2: 16%; Grade 3: 11%; Grade 4: 5%; 85% patients were evaluable for cGVHD: No: 62%; limited: 13%; Moderate/severe:25%; 32 patients (25%) patients died from non-relapse mortality at a median of 116 days (13-1373); 16 patients relapsed/progressed at a median of 5,6 (1-63) months. Two year overall and disease-free survivals are respectively of 58% (95% CI: 6.35-7.04) and 54% (95% CI: 7.17-7.55). the only predictive factor was disease risk. Overall these data show that allo haplo HSCT is a valid option in older patients with high-risk malignancies. To improve results we performed from 2015 in patients older than 65 years systematic and combined evaluation of comorbidities score, performance status and geriatric assessment (instrumental activity of daily living (AIDL); vulnerability assessment) that will be presented in the meeting for this population.

Inter-rater reliability in performance status assessment among healthcare professionals: an updated systematic review and meta-analysis.

Survival prediction for patients with incurable malignancies is invaluable information during end-of-life discussions, as it helps the healthcare team to appropriately recommend treatment options and consider hospice enrolment. Assessment of performance status may differ between different healthcare professionals (HCPs), which could have implications in predicting prognosis. The aim of this systematic review and meta-analysis is to update a prior systematic review with recent articles, as well as conduct a meta-analysis to quantitatively compare performance status scores. A literature search was carried out in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials, from the earliest date until the first week of August 2019. Studies were included if they reported on (1) Karnofsky Performance Status (KPS), Eastern Cooperative Oncology Group (ECOG) Performance Status, and/or Palliative Performance Scale (PPS) and (2) assessment of performance status by multiple HCPs for the same patient sets. The concordance statistics (Kappa, Krippendorff's alpha, Kendall correlation, Spearman rank correlation, Pearson correlation) were extracted into a summary table for narrative review, and Pearson correlation coefficients were calculated for each study and meta-analyzed with a random effects analysis model. Analyses were conducted using Comprehensive Meta-Analysis (Version 3) by Biostat. Fourteen articles were included, with a cumulative sample size of 2808 patients. The Pearson correlation coefficient was 0.787 (95% CI: 0.661, 0.870) for KPS, 0.749 (95% CI: 0.716, 0.779) for PPS, and 0.705 (95% CI: 0.536, 0.819) for ECOG. Four studies compared different tools head-to-head; KPS was favored in three studies. The quality of evidence was moderate, as determined by the GRADE tool. The meta-analysis's Pearson correlation coefficient ranged from 0.705 to 0.787; there is notable correlation of performance status scores, with no one tool statistically superior to others. KPS is, however, descriptively better and favored in head-to-head trials. Future studies could now examine the accuracy of KPS assessment in prognostication and focus on model-building around KPS.

Fried Frailty Phenotype Predicts Mortality for Newly Diagnosed Older Patients with Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Fried Frailty Phenotype Predicts Mortality for Newly Diagnosed Older Patients with Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Allogeneic Hematopoietic Stem Cell Transplantation in Patients of 65 Years or Older: A Monocenter Analysis on 252 Patients

Advanced hematologic malignancies in older patients are unmet medical needs due to increased incidence in the aging population and the lack of effective treatment. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) represents the only potential curative option for most of hematologic malignancies. However, two main limitations limited this development for a long period of time. High rates of fatal non-relapse morbidities have been progressively addressed using reduced toxicity conditioning approaches and pushing up the age limit of patients considered for transplant. The search for a donor has been also a high limitation in older population, due to the lower incidence of matched sibling donors in this population. The development of allo-HSCT from a familial haplo mismatch donor (Haplo donor) after a reduced intensity (RIC) or non-myeloablative conditioning (NMAC) has allowed for the recent development of allo-HSCT in older population. Here we analyzed a cohort of 252 consecutive patients aged of 65 years or older treated in a single institution. Patients were selected on the following parameters: age of 65 or older on the day of transplant, first allogeneic transplant, no unrelated cord blood HSCT, hematologic malignancies, transplant between 01/01/2004 and 31/12/2018. During this period of time, the search for a one-mismatch haplotype donor (Haplo) has been introduced, the upper limit age for transplant progressively increased, more advanced diseases were considered and patients have gradually benefit from improvement in transplant care. Patient characteristics: Median age: 67,9 (65-77) years; Male patients: 61 %; CMV Positive (70%); Acute leukemia (AL): 43%; Myelodysplastic/myeloproliferative syndromes (MDS/MPS): 35%; Chronic Leukemia: 5%; Lymphoma: 11%; Plasma cell disorders (PCD): 6%. Complete remission (CR) or Chronic phase: 155 (62%) (of whom 81 CR1 AL) Donor characteristics: median age: 62,45 (19-77); Male patients: 63 %; Matched sibling donor (MSD) (24%): 60: Unrelated donor: 75 (29%); Haplo Donor: 118 (47%). Transplant characteristics: % patients per period of time: year range: 2004-2010: 12% (Median age: 67; % Haplo D: 0; No CR/CP: 23%); 2011-2015: 40% (Median age: 68; % Haplo D: 35%; No CR/CP: 39%); 2016-2018: 48% (Median age: 69; % Haplo D: 69%; No CR/CP: 42%); PBSC: 97%; Non Myeloablative/ Reduced toxicity conditioning: 35%/65%; All patients received Post-Transplant (PostT) CSA; PT Cyclophosphamide: 49%; Pre-Transplant ATG: 47%. Median follow-up: 17 (3-112) months; ANC recovery in 96%: 19 (10-44) days; untransfused platelet recovery above 20 in 75%: 17 (7-56) days. In evaluable patients for aGVHD: No: 58%; Grade 1: 13%; Grade 2: 14%; Grade 3: 10%; Grade 4: 4%; 85% patients were evaluable for cGVHD: No: 68%; limited: 17%; extensive:16%; 64 patients (25%) patients died from non-relapse mortality at a median of 122 days (13-3934): 2004-2010: 10/30 (33%); 2011-2015: 36/101 (25%); 2016-2018: 28/121 (23%); 53 patients relapsed/progressed at a median of 252 (30-2764) days. Three year overall and disease-free survivals are respectively of 56% (95% CI: 6.35-7.04) and 47% (95% CI: 7.17-7.55) without any difference according to age or donor type but with an impact of disease status (EFS: CR/CP 51% (95% CI: 8.7-9.5) vs others 38% ((95% CI: 11.9-12.0)) Overall these data show that allo HSCT is a valid option in older patients with high-risk malignancies. They show also that over a long period of time patient typology (more advanced diseases, older patients) and transplant practice (lower number of MSD) show a regular evolution making transplant realization more challenging. This field needs specific approach taking into account comorbidities, performance status and geriatric evaluation, to adapt treatment to every given patient. In this perspective we performed from 2015 in patients older than 65 years systematic and combined evaluation of comorbidities score, performance status and geriatric assessment (instrumental activity of daily living (AIDL); vulnerability assessment). Disclosures Chabannon: Sanofi SA: Other: research support, speaker's fees, hospitalities; Gilead: Other: speaker's fees, hospitalities; Novartis: Other: speaker's fees; Celgene: Other: speaker's fees; Terumo BCT: Other: speaker's fees; Miltenyi Biotech: Other: research support; Fresenius Kabi: Other: research support; EBMT: Other: Working Party Chair, Board member. Vey:Janssen: Honoraria; Novartis: Consultancy, Honoraria. Blaise:Jazz Pharmaceuticals: Honoraria; Sanofi: Honoraria; Pierre Fabre medicaments: Honoraria; Molmed: Consultancy, Honoraria.

Reliability and validity of the Arabic translation of the palliative performance scale.

The aim of this study was to translate the Palliative Performance Scale (PPSv2) into Arabic and to test the reliability and validity of the PPS Arabic translation (PPS-Arabic). The PPSv2 was translated into Modern Standard Arabic using a forward-backward method. Inter-rater and intra-rater reliabilities were tested in a pilot study that included 20 patients. The validation study included 150 cancer patients. Patients were divided according to their treatment plan into three groups (in-remission, palliative chemotherapy, and best supportive care) to perform hypothesis-testing construct validity. Validity was further evaluated by correlating PPS-Arabic with the Karnofsky Performance Scale (KPS), the Eastern Cooperative Oncology Group (ECOG) scale, and Physical Functioning (PF2) and Role Functioning (RF2) scales of the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30). The intraclass correlation coefficients for the intra-rater and inter-rater reliability were 0.935 (95% CI: 0.88-0.965; p < 0.001) and 0.965 (95% CI: 0.934-0.981; p < 0.001), respectively. The PPS-Arabic internal consistency Cronbach's alpha was 0.986. The average PPS-Arabic score differed significantly (p < 0.001) between the three groups of patients being 89 for in-remission, 58 for palliative chemotherapy, and 38 for best supportive care. The PPS-Arabic score correlated significantly (p < 0.001) with the KPS, ECOG performance scale, and the EORTC QLQ-C30 PF2 and RF2 scales. The PPS-Arabic is a reliable and valid tool for the assessment of performance status of cancer patients.

Patient reported outcomes can improve performance status assessment: a pilot study

BackgroundPatient performance status is routinely used in oncology to estimate physical functioning, an important factor in clinical treatment decisions and eligibility for clinical trials. However, validity and reliability data for ratings of performance status have not been optimal. This study recruited oncology patients who were about to begin emetogenic palliative or adjuvant chemotherapy for treatment of solid tumors. We employed actigraphy as the gold standard for physical activity level. Correspondences between actigraphy and oncologists’ and patients’ ratings of performance status were examined and compared with the correspondences of actigraphy and several patient reported outcomes (PROs). The study was designed to determine feasibility of the measurement approaches and if PROs can improve the accuracy of assessment of performance status.MethodsOncologists and patients made performance status ratings at visit 1. Patients wore an actigraph and entered weekly PROs on a smartphone app. Data for days 1–14 after visit 1 were analyzed. Chart reviews were conducted to tabulate all unexpected medical events across days 1–150.ResultsNeither oncologist nor patient ratings of performance status predicted steps/hour (actigraphy). The PROMIS® Physical Function PRO (average of Days 1, 7, 14) was associated with steps/hour at high (for men) and moderate (for women) levels; the PROMIS® Fatigue PRO predicted steps for men, but not for women. Unexpected medical events occurred in 57% of patients. Only body weight in female patients predicted events; oncologist and patient performance status ratings, steps/hour, and other PROs did not.ConclusionsPROMIS® Physical Function and Fatigue PROs show good correspondence with steps/hour making them easy, useful tools for oncologists to improve their assessment of performance status, especially for male patients. Female patients had lower levels of steps/hour than males and lower correlations among the predictors, suggesting the need for further work to improve performance status assessment in women. Assessment of pre-morbid sedentary behavior alongside current Physical Functioning and Fatigue PROs may allow for a more valid determination of disease-related activity level and performance status.