DREAMM-1 Patient perspectives from the first-in-human study of single-agent belantamab mafodotin for relapsed and refractory multiple myeloma (RRMM).

e20531 Background: Patient-reported outcomes in RRMM remain poor, particularly for those refractory to immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies, and there is an increased risk of cumulative toxicities in these patients. Single-agent belantamab mafodotin (GSK2857916), a first-in-class, B-cell maturation antigen–binding immunoconjugate, has demonstrated deep and durable responses with a manageable safety profile in heavily pretreated patients with RRMM (DREAMM-1, NCT02064387). Here, we present patient-reported clinical benefit/tolerability of belantamab mafodotin evaluated by trial-embedded end-of-treatment (EOT) and follow-up interviews. Methods: DREAMM-1 study design and results have been reported ( Blood Cancer J 2019). Patients in the Part 2 expansion phase were administered single-agent belantamab mafodotin 3.4 mg/kg IV once every 3 weeks for 16 cycles and invited to participate in interviews at EOT and 6-month follow-up. Patients discussed symptoms, treatment-related adverse events (AEs), treatment burden, and overall treatment satisfaction, rated 0–10 (0 = not severe to 10 = most severe/0 = not at all satisfied to 10 = extremely satisfied). Results: A total of 17/35 patients (9 female [53%]) were interviewed; 4/17 patients completed both interviews. Most patients (94%; 16/17) achieved a partial response or better. At EOT, patients reported an improvement from the worst point in symptoms of bone pain (mean change in score from 6.4 to 4.0) and fatigue (8.0 to 5.5). The most commonly reported treatment-related AE was blurred vision (76%; 13/17). Among those reporting this AE, 62% (8/13) reported resolution or steady improvement in vision after EOT; with a reduction in severity rating from 7.3 at worst to 5.3 at EOT for this event. Most patients (93%; 13/14) never considered stopping treatment owing to AEs, including ocular events. Overall treatment satisfaction was high (mean score 7.9; median 9.0). Conclusions: Despite small sample sizes, trial-embedded interviews provide valuable insight into patient experience with belantamab mafodotin. Patients treated with single-agent belantamab mafodotin reported high treatment satisfaction and improvements in symptoms. Visual symptoms were frequent but manageable, and improved or resolved after treatment. Funding: GlaxoSmithKline (117159). Drug linker technology licensed from Seattle Genetics; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa. Clinical trial information: NCT02064387.

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Lower perception of pharmacological treatment increases risk of non-adherence to medication

European Journal of Preventive Cardiology ◽

10.1093/eurjpc/zwab061.258 ◽

2021 ◽

Vol 28 (Supplement_1) ◽

Author(s):

CB Graversen ◽

JB Valentin ◽

ML Larsen ◽

S Riahi ◽

T Holmberg ◽

...

Keyword(s):

Pharmacological Treatment ◽

Poisson Regression ◽

Drug Class ◽

Angiotensin Receptor Blockers ◽

Adverse Outcomes ◽

Adherence To Medication ◽

Increased Risk ◽

Patient Reported ◽

High Level

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): The Danish Heart Foundation Background A large proportion of patients fail to reach optimal adherence to medication following incident ischemic heart disease (IHD) despite amble evidence of the beneficial effect of medication. Non-adherence to medication increases risk of disease-related adverse outcomes but none has explored how perception about pharmacological treatment detail on non-adherence using register-based follow-up data. Purpose To investigate the association between patients’ perception of pharmacological treatment and risk of non-initiation and non-adherence to medication in a population with incident IHD. Methods This cohort study followed 871 patients until 365 days after incident IHD. The study combined patient-reported survey data on perception about pharmacological treatment (categorised by ‘To a high level’, ‘To some level’, and ‘To a lesser level’) with register-based data on reimbursed prescription of cardiovascular medication (antithrombotics, statins, ACE-inhibitors/angiotensin receptor blockers, and β-blockers). Non-initiation was defined as no pick-up of medication in the first 180 days following incident IHD and analysed by Poisson regression. Two different measures evaluated non-adherence in patients initiating treatment: 1) proportion of days covered (PDC) analysed by Poisson regression, and 2) risk of discontinuation analysed by Cox proportional hazard regression. All analyses were adjusted for confounding variables (age, sex, ethnicity, income, educational level, civil status, occupation, charlson comorbidity index, supportive relatives, and individual consultation in medication) identified by directed acyclic graph and obtained from national registers and the survey. Item non-response was handled by multiple imputation and item consistency was evaluated by McDonalds omega. Results Lower perceptions about pharmacological treatment was associated with increased risk of non-initiation and non-adherence to medication irrespectively of drug class and adherence measure in the multiple adjusted analyses (please see figure illustrating results on antithrombotics). A dose-response relationship was observed both at 180- and 365-days of follow-up, but the steepest decline in adherence differed when comparing the two adherence measures (results not shown). Moderate internal consistency was found for the summed measure of perception (McDonalds omega = 0.67). Conclusion Lower perception of pharmacological treatment was associated with subsequent non-initiation and non-adherence to medication, irrespectively of measurement method and drug class. Abstract Figure. Figre: Multiple adjusted analyses

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Twenty-Year Outcomes After Anterior Cruciate Ligament Reconstruction: A Systematic Review of Prospectively Collected Data

The American Journal of Sports Medicine ◽

10.1177/03635465211027302 ◽

2021 ◽

pp. 036354652110273

Author(s):

Joshua S. Everhart ◽

Sercan Yalcin ◽

Kurt P. Spindler

Keyword(s):

Systematic Review ◽

Anterior Cruciate Ligament ◽

Acl Reconstruction ◽

Cruciate Ligament ◽

Knee Function ◽

Increased Risk ◽

Patient Reported ◽

The Mean ◽

Anterior Cruciate

Background: Several long-term (≥20 years) follow-up studies after anterior cruciate ligament (ACL) reconstruction have been published in recent years, allowing for a systematic evaluation of outcomes. Purpose: To summarize outcomes at ≥20 years after ACL reconstruction and identify patient and surgical factors that affect these results. Study Design: Systematic review; Level of evidence, 4. Methods: Prospective studies of primary ACL reconstructions with hamstring or bone–patellar tendon—bone (BTB) autograft via an arthroscopic or a mini-open technique and with a mean follow-up of ≥20 years were identified. When possible, the mean scores for each outcome measure were calculated. Factors identified in individual studies as predictive of outcomes were described. Results: Five studies met the inclusion and exclusion criteria with a total of 2012 patients. The pooled mean follow-up for patient-reported outcome measures was 44.2% (range, 29.6%-92.7%) and in-person evaluation was 33.2% (range, 29.6%-48.9%). Four studies (n = 584) reported graft tears at a mean rate of 11.8% (range, 2%-18.5%) and 4 studies (n = 773) reported a contralateral ACL injury rate of 12.2% (range, 5.8%-30%). Repeat non-ACL arthroscopic surgery (4 studies; n = 177) to the ipsilateral knee occurred in 10.4% (range, 9.5%-18.3%) and knee arthroplasty (1 study; n = 217) in 5%. The pooled mean of the International Knee Documentation Committee subjective knee function (IKDC) score was 79.1 (SD, 21.8 [3 studies; n = 644]). In 2 studies (n?= 221), 57.5% of patients continued to participate in strenuous activities. The IKDC-objective score was normal or nearly normal in 82.3% (n = 496; 3 studies), with low rates of clinically significant residual laxity. Moderate-severe radiographic osteoarthritis (OA) (IKDC grade C or D) was present in 25.9% of patients (n = 605; 3 studies). Medial meniscectomy is associated with increased risk of radiographic OA. Radiographic OA severity is associated with worse patient-reported knee function, but the association with knee pain is unclear. Conclusion: Currently available prospective evidence for ACL reconstruction with hamstring or BTB autograft provides several insights into outcomes at 20 years. The rates of follow-up at 20 years range from 30% to 93%. IKDC-objective scores were normal or nearly normal in 82% and the mean IKDC-subjective score was 79 points.

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Smoking Is Associated with Anterior Ankle Impingement After Isolated Autologous Matrix-Induced Chondrogenesis for Osteochondral Lesions of the Talus

Cartilage ◽

10.1177/1947603520959405 ◽

2020 ◽

pp. 194760352095940

Author(s):

Arnd F. Viehöfer ◽

Fabio Casari ◽

Felix W.A. Waibel ◽

Silvan Beeler ◽

Florian B. Imhoff ◽

...

Keyword(s):

Clinical Outcome ◽

Pearson Correlation ◽

Osteochondral Lesions ◽

Duration Of Symptoms ◽

Ankle Impingement ◽

Increased Risk ◽

Patient Reported ◽

Specific Factors ◽

Anterior Ankle Impingement

Objective To determine potential predictive associations between patient-/lesion-specific factors, clinical outcome and anterior ankle impingement in patients that underwent isolated autologous matrix-induced chondrogenesis (AMIC) for an osteochondral lesion of the talus (OLT). Design Thirty-five patients with a mean age of 34.7 ± 15 years who underwent isolated cartilage repair with AMIC for OLTs were evaluated at a mean follow-up of 4.5 ± 1.9 years. Patients completed AOFAS (American Orthopaedic Foot and Ankle Society) scores at final follow-up, as well as Tegner scores at final follow-up and retrospectively for preinjury and presurgery time points. Pearson correlation and multivariate regression models were used to distinguish associations between patient-/lesion-specific factors, the need for subsequent surgery due to anterior ankle impingement and patient-reported outcomes. Results At final follow-up, AOFAS and Tegner scores averaged 92.6 ± 8.3 and 5.1 ± 1.8, respectively. Both body mass index (BMI) and duration of symptoms were independent predictors for postoperative AOFAS and Δ preinjury to postsurgery Tegner with positive smoking status showing a trend toward worse AOFAS scores, but this did not reach statistical significance ( P = 0.054). Nine patients (25.7%) required subsequent surgery due to anterior ankle impingement. Smoking was the only factor that showed significant correlation with postoperative anterior ankle impingement with an odds ratio of 10.61 when adjusted for BMI and duration of symptoms (95% CI, 1.04-108.57; P = 0.047). Conclusion In particular, patients with normal BMI and chronic symptoms benefit from AMIC for the treatment of OLTs. Conversely, smoking cessation should be considered before AMIC due to the increased risk of subsequent surgery and possibly worse clinical outcome seen in active smokers.

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Twenty-Two-Year Outcome of Cartilage Repair Surgery by Perichondrium Transplantation

Cartilage ◽

10.1177/1947603520958146 ◽

2020 ◽

pp. 194760352095814 ◽

Cited By ~ 1

Author(s):

Maarten P. F. Janssen ◽

Esther G. M. van der Linden ◽

Tim A. E. J. Boymans ◽

Tim J. M. Welting ◽

Lodewijk W. van Rhijn ◽

...

Keyword(s):

Cartilage Repair ◽

Revision Surgery ◽

Treatment Success ◽

Patient Characteristics ◽

Long Term Outcome ◽

Major Revision ◽

Increased Risk ◽

Patient Reported ◽

Ikdc Score

Objective The main purpose of the present study was to assess the risk for major revision surgery after perichondrium transplantation (PT) at a minimum of 22 years postoperatively and to evaluate the influence of patient characteristics. Design Primary outcome was treatment success or failure. Failure of PT was defined as revision surgery in which the transplant was removed, such as (unicondylar) knee arthroplasty or patellectomy. The functioning of nonfailed patients was evaluated using the International Knee Documentation Committee (IKDC) score. In addition, the influence of patient characteristics was evaluated. Results Ninety knees in 88 patients, aged 16 to 55 years with symptomatic cartilage defects, were treated by PT. Eighty knees in 78 patients were eligible for analysis and 10 patients were lost to follow-up. Twenty-eight knees in 26 patients had undergone major revision surgery. Previous surgery and a longer time of symptoms prior to PT were significantly associated with an increased risk for failure of cartilage repair. Functioning of the remaining 52 patients and influence of patient characteristics was analyzed using their IKDC score. Their median IKDC score was 39.08, but a relatively young age at transplantation was associated with a higher IKDC score. Conclusions This 22-year follow-up study of PT, with objective outcome parameters next to patient-reported outcome measurements in a unique group of patients, shows that overall 66% was without major revision surgery and patient characteristics also influence long-term outcome of cartilage repair surgery.

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Treatment with Fludarabine and Rituximab Produces Extended Overall Survival (OS) and Progression-Free Survival (PFS) in Chronic Lymphocytic Leukemia (CLL) without Increased Risk of Second Malignancy: Long-Term Follow up of CALGB Study 9712.

Blood ◽

10.1182/blood.v114.22.539.539 ◽

2009 ◽

Vol 114 (22) ◽

pp. 539-539 ◽

Cited By ~ 5

Author(s):

Jennifer A Woyach ◽

Amy S Ruppert ◽

Nyla A. Heerema ◽

Bercedis Peterson ◽

John G. Gribben ◽

...

Keyword(s):

Single Agent ◽

Progression Free Survival ◽

Large Cell ◽

Lymphocytic Leukemia ◽

Published Data ◽

Increased Risk ◽

Long Term Follow Up ◽

Sequential Group

Abstract Abstract 539 Introduction: The addition of rituximab to fludarabine-based regimens in CLL has been shown to produce high response rates with extended remissions. The long-term follow-up of these regimens with respect to progression, survival, and development of secondary malignancies has been limited. Patients and Methods: We report the long-term follow up of the chemoimmunotherapy trial CALGB 9712 (Blood 2003;101:6-14). This trial randomized 104 untreated, symptomatic patients to receive either 6 monthly cycles of fludarabine plus rituximab (FR) followed 2 months later by 4 weekly doses of rituximab (concurrent arm) or 6 monthly cycles of single agent fludarabine followed by rituximab consolidation using 4 weekly doses (sequential arm). With a median follow up of 92 months (range: 60-107), we analyzed the updated CALGB database and flow sheets submitted by treating physicians. Results: The overall response rate (ORR) was 84% (95% CI: 77%-91%), with a 90% ORR in the concurrent group (95% CI: 82%-98%) and a 77% ORR in the sequential group (95% CI: 66%-89%). Complete response (CR) was seen in 38% of patients (95% CI: 30%-45%), and partial response (PR) in 46% (95% CI: 38%-54%). The median OS was 85 months (95% CI: 71-95), with 71% of patients alive at 5 years (95% CI: 61%-79%). The median PFS was 37 months (95% CI: 27-45), with 27% progression-free at 5 years (95% CI: 19%-36%). With long-term follow up, the estimated median OS and PFS for the concurrent group were 84 months (95% CI: 57-100) and 32 months (95% CI: 23-55), respectively; the median OS and PFS for the sequential group were 91 months (95% CI: 71-110) and 40 months (95% CI: 23-50), respectively. Patients with del(17p13.1)/del(11q22.3)(18 patients) and unmutated IgVH(43 patients) continue to have an inferior OS (P=0.01 and P=0.04, respectively) and PFS (P=0.03 and P=0.04, respectively) compared to those without these abnormalities. We next assessed the frequency of therapy-related myeloid neoplasms (t-MN) and other cancers occurring after this chemoimmunotherapy regimen. No patient has developed MDS or AML prior to relapse. One patient (1%) developed t-MDS following relapse and receipt of FCR 41 months after completing trial therapy; t-MDS was diagnosed 9 months later. Richter's transformation was noted in three (3%) of the CALGB 9712 patients with large cell (n=2) or Hodgkin lymphoma (n=1). Second malignancies have included localized basal cell or squamous cell skin cancer in 12 (12%) patients whereas 11 (11%) have developed other epithelial malignancies including 4 GI, 3 lung, 3 melanomas, and 1 prostate cancer. Conclusions: Long-term follow up of patients enrolled on CALGB 9712 demonstrates extended OS and PFS with fludarabine plus rituximab, given either concurrently or sequentially, with an estimated 17%(95% CI: 9%-27%) of responders still in remission 8 years later. Looking at other published data, patients treated with FR administered concurrently or sequentially do not appear to have an increased risk of t-MN or second cancers. These long-term data reaffirm that FR is one of several acceptable frontline treatments for symptomatic patients with CLL. Disclosures: Morrison: Genentech: Speakers Bureau.

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Efficacy of Once-Weekly Bortezomib with Daratumumab for Patients with Relapsed or Refractory Multiple Myeloma

Blood ◽

10.1182/blood-2018-99-111908 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 1958-1958

Author(s):

Natalia Gut ◽

Filiz Yucebay ◽

Jessica Dempsey ◽

Junan Li ◽

Don M. Benson

Keyword(s):

Multiple Myeloma ◽

Peripheral Neuropathy ◽

Hematologic Malignancy ◽

Small Sample Size ◽

Single Agent ◽

Proteasome Inhibitors ◽

Progression Free Survival ◽

Small Sample ◽

Weekly Schedule ◽

Refractory Multiple Myeloma

Abstract Background Multiple Myeloma (MM) is an essentially incurable hematologic malignancy with the goals of therapy being disease control, improved quality of life, and prolonged survival.1,2 Despite improved survival with proteasome inhibitors and immunomodulatory agents, outcomes for patients with refractory disease, resistant to these classes of therapy, are poor. Daratumumab, an anti-CD38 antibody, is a commonly utilized therapy for relapsed/refractory multiple myeloma (RRMM) as a single agent based on the SIRIUS study which resulted in adequate response and acceptable safety profiles.3,4 Currently, it is approved in various combinations including with bortezomib. The approval of daratumumab in combination with bortezomib days 1, 4, 8, and 11 of a 21-day cycle was based on the CASTOR study which resulted in high response rates and acceptable safety profiles.5With the addition of bortezomib, additional toxicities in this RRMM setting may be a concern.6 Previous studies of bortezomib in RRMM patients have demonstrated that once-weekly bortezomib is equally as efficacious and better tolerated than the standard twice-weekly schedule, with a lower incidence of peripheral neuropathy and myelosuppression.8,9 However, there are currently no published reports of combining once-weekly bortezomib with daratumumab for patients with RRMM. Methods The present study sought to evaluate the progression-free survival (PFS) of daratumumab administered with once-weekly bortezomib for patients with RRMM. Secondary objectives included evaluation of overall survival (OS), overall response rate (ORR), time to response (TTR), and toxicity of once-weekly bortezomib with daratumumab. Eighteen patients were identified in an Institutional Review Board (IRB)-approved retrospective review of our institutional experience with daratumumab and once-weekly bortezomib. The median age of patients was 65 years (range 47 - 76, Table 1). Ten patients (55.6%) had three or more prior lines of therapy. Twelve patients (66.7%) had previous autologous stem cell transplantation. Sixteen patients (88.9%) had prior proteasome inhibitor (PI) therapy. Thirteen patients (72.2%) had disease refractory to their last line of therapy. Results The median PFS was 3.5 months. Median OS was not reached and TTR were undetermined due to the small sample size. The ORR was 33.3%, with 6 out of 18 patients experiencing an objective partial response or better (Table 2). Of those that responded, 4 patients (66.7%) remained on therapy at the time of data collection.The side effect profile was more tolerable, with less thrombocytopenia (27.8% all grade) and peripheral neuropathy (33.3% all grade) than previously reported (Table 3). Conclusions Daratumumab monotherapy was approved in heavily pretreated RRMM based on the SIRIUS trial showing promising efficacy and a favorable safety profile.4 The median PFS was 3.7 months compared to our PFS of 3.5 months. The combination of daratumumab with bortezomib administered twice weekly was approved based results from the CASTOR trial showing superiority of daratumumab in combination with bortezomib and dexamethasone over bortezomib and dexamethasone.5 As depicted in Table 2, our ORR of 33.3% is similar to the ORR of 29.2% in the SIRIUS trial, however differs greatly from 82.9% in the CASTOR trial. While the present work is retrospective and hypothesis-generating, our results suggest that further prospective inquiry is necessary to determine the additional efficacy of adding once-weekly bortezomib to daratumumab. Disclosures Dempsey: Heron Therapeutics: Honoraria; TESARO: Honoraria.

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Failures, Reoperations, and Improvement in Knee Symptoms Following Matrix-Assisted Autologous Chondrocyte Transplantation: A Meta-Analysis of Prospective Comparative Trials

Cartilage ◽

10.1177/1947603519870861 ◽

2019 ◽

pp. 194760351987086 ◽

Cited By ~ 5

Author(s):

Joshua S. Everhart ◽

Eric X. Jiang ◽

Sarah G. Poland ◽

Amy Du ◽

David C. Flanigan

Keyword(s):

Meta Analysis ◽

Weight Bearing ◽

Patient Reported Outcome ◽

Pain Scores ◽

Randomized Studies ◽

Increased Risk ◽

Patient Reported ◽

Outcome Scores ◽

Autologous Chondrocyte

Objective Though multiple high-level comparative studies have been performed for matrix-assisted autologous chondrocyte transplantation (MACT), quantitative reviews synthesizing best-available clinical evidence on the topic are lacking. Design A meta-analysis was performed of prospective randomized or nonrandomized comparative studies utilizing MACT. A total of 13 studies reporting 13 prospective trials (9 randomized, 5 nonrandomized) were included (658 total study participants at weighted mean 3.1 years follow-up, range 1-7.5 years). Results Reporting and methodological quality was moderate according to mean Coleman (59.4 SD 7.6), Delphi (3.0 SD 2.1), and MINORS (Methodological Index For Non-Randomized Studies) scores (20.2 SD 1.6). There was no evidence of small study or reporting bias. Effect sizes were not correlated with reporting quality, financial conflict of interest, sample size, year of publication, or length of follow-up ( P > 0.05). Compared to microfracture, MACT had greater improvement in International Knee Documentation Committee (IKDC)-subjective and Knee Injury and Osteoarthritis Outcome Pain Subscale Score (KOOS)-pain scores in randomized studies ( P < 0.05). Accelerated weight-bearing protocols (6 or 8 weeks) resulted in greater improvements in IKDC-subjective and KOOS-pain scores than standard protocols (8 or 11 weeks) for MACT in randomized studies ( P < 0.05) with insufficient nonrandomized studies for pooled analysis. Conclusions Compared to microfracture, MACT has no increased risk of clinical failure and superior improvement in patient-reported outcome scores. Compared to MACT with standardized postoperative weight-bearing protocols, accelerated weight-bearing protocols have no increased risk of clinical failure and show superior improvement in patient-reported outcome scores. There is limited evidence regarding MACT compared to first-generation autologous chondrocyte implantation, mosaicplasty, and mesenchymal stem cell therapy without compelling differences in outcomes.

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Patient-reported outcomes (PROs) with ibrutinib-rituximab in Waldenström macroglobulinemia (WM): Results from iNNOVATE.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.8018 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 8018-8018

Author(s):

Alessandra Tedeschi ◽

Meletios A. Dimopoulos ◽

Judith Trotman ◽

Ramón Garcia-Sanz ◽

David MacDonald ◽

...

Keyword(s):

Pearson Correlation ◽

Single Agent ◽

Correlation Coefficients ◽

Subscale Score ◽

Trade Mark ◽

Meaningful Improvement ◽

Patient Reported ◽

Clinical Trial Information

8018 Background: Anemia and fatigue can impair quality of life in patients (pts) with WM. Ibrutinib (ibr) as single agent or in combination with RTX is FDA-approved for WM. In pts with RTX-refractory WM, single-agent ibr induced meaningful improvements in PROs (Trotman, EHA 2017). In iNNOVATE, ibr-RTX (IR) produced higher rates of sustained hemoglobin improvement and meaningful improvements in PROs versus placebo-RTX (R; Dimopoulos NEJM 2018). Here, we report detailed PRO analyses from iNNOVATE. Methods: Pts with symptomatic WM requiring therapy were randomized to daily 420 mg oral ibr or placebo, both with RTX (375 mg/m2/week IV at weeks 1–4 and 17–20). PRO measures included FACIT-Fatigue (FACIT-F), FACT-An total score (TS) and anemia subscale score (AS), and EQ-5D-5L (EuroQol Research Foundation. EQ-5D is a trade mark of the EuroQol Research Foundation) visual analog scale (VAS), and utility score (US). Results: For 150 randomized pts (n=75/arm), most common reasons for initiating therapy were fatigue (61%), constitutional symptoms (32%), and anemia (32%). Baseline PRO scores were comparable in both arms. At a median follow-up of 26.5 mo, numerically more pts showed clinically meaningful improvement in FACIT-F, TS, and AS with IR than R (Table). Median time to PRO improvement was short (1-2 mo) in both arms. At week 25, the Pearson correlation coefficients were 0.28, 0.29, and 0.26 for changes in hemoglobin levels vs changes in FACIT-F, TS and AS, respectively, in the IR arm; no meaningful correlations were observed on R. The correlation coefficients were -0.32, -0.33, -0.35 and -0.26 for changes in IgM levels vs changes in FACIT-F, TS, AS, and EQ-VAS, respectively, for IR and 0.29 and 0.35 vs FACIT-F and TS for R. Conclusions: Clinical response and improvements in anemia with IR are consistent with more pts showing clinically meaningful improvement in PROs versus R. Changes in IgM correlate with improvements in PROs. Clinical trial information: NCT02165397. [Table: see text]

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Abstract 078: Implications of Patient-Reported Treatment Satisfaction for Discontinuation of Rivaroxaban versus Warfarin in ROCKET-AF

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.10.suppl_3.078 ◽

2017 ◽

Vol 10 (suppl_3) ◽

Author(s):

Fatima Rodriguez ◽

Leo Ungar ◽

Anne Hellkamp ◽

Richard C Becker ◽

Scott D Berkowitz ◽

...

Keyword(s):

Treatment Satisfaction ◽

Patient Reported Outcomes ◽

Study Drug ◽

Drug Discontinuation ◽

Women Patients ◽

Double Blind ◽

Loss To Follow Up ◽

Patient Reported ◽

Study Drug Discontinuation

Background: Patient-reported outcomes and satisfaction are important in both trials and clinical practice and may be associated with treatment adherence. Methods: ROCKET-AF was a randomized, double-blind trial of rivaroxaban versus warfarin for prevention of thromboembolism in patients with atrial fibrillation. In a substudy, we compared treatment satisfaction scores: Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM II). Patient-driven discontinuation included stopping study drugs due to withdrawal of consent, non-compliance, or loss to follow-up. Rates of discontinuation were calculated for participants above and below the median scores for each scale. Results: Of 14,264 patients in ROCKET AF, 1,181 (8.3%; median age 75 years; 34% women) patients completed both the ACTS and TSQM II questionnaires 4 weeks after starting the study drug. Over a median follow-up of 1.6 years, 450 premature study drug discontinuations occurred, 116 (26%) patient-driven. Patients less satisfied with treatment by the ACTS Benefits and Burdens and TSQM II scales had higher rates of study drug discontinuation ( Table ). Conclusions: Patient-reported satisfaction was lower in patients with study drug discontinuation, suggesting that collecting patient-reported outcomes early in clinical trials may guide interventions that improve adherence and clinical outcomes.

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QOLP-20. A FEASIBILITY STUDY UTILIZING MINDFULNESS MEDITATION DURING CONCOMITANT CHEMORADIATION IN MALIGNANT GLIOMA PATIENTS: HEALTH-REPORTED QUALITY OF LIFE (HRQOL) RESULTS

Neuro-Oncology ◽

10.1093/neuonc/noaa215.745 ◽

2020 ◽

Vol 22 (Supplement_2) ◽

pp. ii179-ii179

Author(s):

Dina Randazzo ◽

Evan Buckley ◽

James Herndon ◽

Nicole Cort ◽

Mary Affronti ◽

...

Keyword(s):

Quality Of Life ◽

Malignant Glioma ◽

Mindfulness Meditation ◽

Malignant Gliomas ◽

Well Being ◽

Small Sample ◽

Coping Skill ◽

Patient Reported

Abstract BACKGROUND Primary brain tumor patients experience high levels of distress due to their diagnosis and treatment leading to changes in their health-related quality of life (HRQoL). Even with the standard treatment of 6 weeks of radiation with concurrent temozolomide for malignant gliomas, the prognosis remains poor. We sought to provide a new intervention and coping skill for our patients during chemoradiation to alleviate some of their stress and anxiety. Mindfulness meditation is a mind-body therapy used in many other cancer groups which can alleviate stress and improve fatigue, cognition, and sleep. METHODS 15 newly diagnosed malignant glioma subjects started 1-hour weekly phone mindfulness sessions during the 6 weeks of chemoradiation. They completed an in-person mindfulness session and interview upon return to the clinic with a final follow up survey 2 months later. Patient reported outcomes questionnaires were collected at each time point. RESULTS 0/15 subjects completed their post-chemo/in-person visit, and 9 completed their final follow-up surveys 2 months later. Scores for perceived cognition, fatigue, sleep, anxiety, spiritual-well being and mindfulness improved over these time points. Completed HRQoL patient-reported outcome questionnaires with positive trends noted from the mean (SD) post-chemo/in-person visit change from baseline and the follow-up change from baseline were: FACT-Cog perceived Cognitive Impairments subscale 4.11(13.55), 9.14(16.77); FACT-G total -5.48(16.02), 7.02(13.44); FACT-Br total -3.15(24.76), 13.17(23.37); FACIT-F -5(7.68), 0(7.92); and the FACIT-Sp12 -1.38(7.6), 2.17(4.88). Trail making Part A completion times from baseline to follow up decreased over time in 8/9 subjects and 7/9 subjects in Part B. Per the final follow up survey, 7/9 subjects continued their meditation practices after the training sessions and subjectively noted benefits with their stress and anxiety. Conclusion: Despite this small sample size, this mindfulness meditation intervention did positively impact patient-report outcomes of HRQoL in this patient population, thereby larger randomized studies are warranted.

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