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Patient-reported physical functioning predicts the success of hematopoietic cell transplantation (BMT CTN 0902).

ABSTRACT: In hematopoietic cell transplantation (HCT), current risk adjustment strategies are based on clinical and disease-related variables. Although patient-reported outcomes (PROs) predict mortality in multiple cancers, they have been less well studied within HCT. Improvements in risk adjustment strategies in HCT would inform patient selection, patient counseling, and quality reporting. The objective of the current study was to determine whether pre-HCT PROs, in particular physical health, predict survival among patients undergoing autologous or allogeneic transplantation.In this secondary analysis, the authors studied pre-HCT PROs that were reported by 336 allogeneic and 310 autologous HCT recipients enrolled in the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0902 protocol, a study with broad representation of patients who underwent transplantation in the United States.Among allogeneic HCT recipients, the pre-HCT Medical Outcomes Study Short Form-36 Health Survey (SF-36) physical component summary (PCS) scale independently predicted overall mortality (hazards ratio, 1.40 per 10-point decrease; P<.001) and performed at least as well as currently used, non-PRO risk indices. Survival probability estimates at 1 year for the first, second, third, and fourth quartiles of the baseline PCS were 50%, 65%, 75%, and 83%, respectively. Early post-HCT decreases in PCS were associated with higher overall and treatment-related mortality. When adjusted for patient variables included in the US Stem Cell Therapeutic Outcomes Database model for transplant center-specific reporting, the SF-36 PCS retained independent prognostic value.PROs have the potential to improve prognostication in HCT. The authors recommend the routine collection of PROs before HCT, and consideration of the incorporation of PROs into risk adjustment for quality reporting.

SUBMITTER: Wood WA

PROVIDER: S-EPMC4707096 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Patient-reported physical functioning predicts the success of hematopoietic cell transplantation (BMT CTN 0902).

Wood William A WA Le-Rademacher Jennifer J Syrjala Karen L KL Jim Heather H Jacobsen Paul B PB Knight Jennifer M JM Abidi Muneer H MH Wingard John R JR Majhail Navneet S NS Geller Nancy L NL Rizzo J Douglas JD Fei Mingwei M Wu Juan J Horowitz Mary M MM Lee Stephanie J SJ

Cancer 20151006 1

<h4>Background</h4>In hematopoietic cell transplantation (HCT), current risk adjustment strategies are based on clinical and disease-related variables. Although patient-reported outcomes (PROs) predict mortality in multiple cancers, they have been less well studied within HCT. Improvements in risk adjustment strategies in HCT would inform patient selection, patient counseling, and quality reporting. The objective of the current study was to determine whether pre-HCT PROs, in particular physical ...[more]

PMID: 26439325

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Project description:BackgroundRoutine monitoring of cancer-related distress is recognized as essential to quality care and mandated by a major accrediting organization. However, to the authors' knowledge, few cancer-specific measures have been developed to date to assess the multiple cancer-related factors contributing to this distress. In the current study, the authors examined the psychometric properties of the Cancer and Treatment Distress (CTXD) measure over time in hematopoietic cell transplantation (HCT) recipients.MethodsAs a secondary analysis of a multicenter randomized controlled clinical trial, adult patients undergoing autologous or allogeneic HCT completed patient-reported outcomes including the CTXD and the Medical Outcomes Study Short Form-36 (SF-36) before transplantation and 100 days and 180 days after HCT.ResultsAcross 21 transplantation centers, a total of 701 patients consented, underwent transplantation, and were included in the current analyses, 645 of whom were alive at 100 days and 618 of whom were alive at 180 days. Internal consistency reliability was found to be strong for the overall CTXD at the 3 time points: Cronbach alphas (α) were .94, .95, and .95, respectively. Subscale reliability met hypothesized levels of an α>.70 across time, with the lowest reliability noted for the Identity subscale at 180 days (α = .77). Correlations with the SF-36 Mental Health subscale were higher than with the Physical Functioning subscale at each time point, thereby supporting convergent and discriminant validity. Strong correlations of the pretransplantation CTXD with the posttransplantation CTXD and SF-36 Mental Health subscale supported predictive validity.ConclusionsThe CTXD is reliable and valid as a measure of cancer distress both before and after HCT. It may be a useful tool for measuring dimensions of distress and for defining those patients requiring treatment for distress during and after transplantation. Cancer 2017;123:1416-1423. © 2016 American Cancer Society.

Project description:Hematopoietic cell transplantation (HCT) is associated with impaired physical and psychological functioning for some long-term survivors. A risk prediction model would help clinicians estimate their patients' physical and psychological functioning after HCT and determine when to refer to added supportive care when appropriate. The purpose of the present study was to develop risk prediction models for physical and psychological functioning in HCT survivors. This was a secondary analysis of data from a randomized controlled trial (NCT00799461) that included 3- to 10-year HCT survivors. Risk predictions for physical and psychological functioning were developed by using backward logistic regression. The models were internally validated using bootstrapping techniques. Regression coefficients were converted into easy-to-use risk scores. Finally, the sensitivity, specificity, and positive and negative predictive values of the total risk score were calculated. The analyses included 489 survivors, with a mean age of 45.6 (SD, 12.4) years; 47% were female and with a mean of 6.1 years (SD, 2.0) after transplantation. Younger age, higher body mass index (BMI), no or part-time work, more comorbid diseases, autologous transplantation, and chronic graft-versus-host disease predicted impaired physical functioning. Female gender, younger age, higher BMI, not living with a partner, autologous transplantation, and chronic graft-versus-host disease predicted impaired psychological functioning. Although both models had predictive value for long-term functioning, diagnostic accuracy was moderate. For the physical functioning receiver operating characteristic, area under the curve (AUC) after internal validation was .74 with sensitivity 51.9 and specificity 82.8 at the optimal cut-off. For psychological functioning, AUC after internal validation was .69 with sensitivity 83.3 and specificity 42.9 at the optimal cut-off. We conclude that it is possible to predict long-term physical and psychological functioning with readily accessible, mostly pretransplantation predictors. The accuracy of the risk prediction models can be improved for use in clinical practice, potentially by adding pretransplantation patient-reported functioning and comorbidities.

Project description:BACKGROUND:Autologous haemopoietic stem-cell transplantation (HSCT) improves survival in patients with multiple myeloma, but disease progression remains an issue. Allogeneic HSCT might reduce disease progression, but can be associated with high treatment-related mortality. Thus, we aimed to assess effectiveness of allogeneic HSCT with non-myeloablative conditioning after autologous HSCT compared with tandem autologous HSCT. METHODS:In our phase 3 biological assignment trial, we enrolled patients with multiple myeloma attending 37 transplant centres in the USA. Patients (<70 years old) with adequate organ function who had completed at least three cycles of systemic antimyeloma therapy within the past 10 months were eligible for inclusion. We assigned patients to receive an autologous HSCT followed by an allogeneic HSCT (auto-allo group) or tandem autologous HSCTs (auto-auto group) on the basis of the availability of an HLA-matched sibling donor. Patients in the auto-auto group subsequently underwent a random allocation (1:1) to maintenance therapy (thalidomide plus dexamethasone) or observation. To avoid enrolment bias, we classified patients as standard risk or high risk on the basis of cytogenetics and ?2-microglobulin concentrations. We used the Kaplan-Meier method to estimate differences in 3-year progression-free survival (PFS; primary endpoint) between patients with standard-risk disease in the auto-allo group and the best results from the auto-auto group (maintenance, observation, or pooled). This study is registered with ClinicalTrials.gov, number NCT00075829. FINDINGS:Between Dec 17, 2003, and March 30, 2007, we enrolled 710 patients, of whom 625 had standard-risk disease and received an autologous HSCT. 156 (83%) of 189 patients with standard-risk disease in the auto-allo group and 366 (84%) of 436 in the auto-auto group received a second transplant. 219 patients in the auto-auto group were randomly assigned to observation and 217 to receive maintenance treatment, of whom 168 (77%) completed this treatment. PFS and overall survival did not differ between maintenance and observation groups and pooled data were used. Kaplan-Meier estimates of 3-year PFS were 43% (95% CI 36-51) in the auto-allo group and 46% (42-51) in the auto-auto group (p=0·671); overall survival also did not differ at 3 years (77% [95% CI 72-84] vs 80% [77-84]; p=0·191). Within 3 years, 87 (46%) of 189 patients in the auto-allo group had grade 3-5 adverse events as did 185 (42%) of 436 patients in the auto-auto group. The adverse events that differed most between groups were hyperbilirubinaemia (21 [11%] patients in the auto-allo group vs 14 [3%] in the auto-auto group) and peripheral neuropathy (11 [6%] in the auto-allo group vs 52 [12%] in the auto-auto group). INTERPRETATION:Non-myeloablative allogeneic HSCT after autologous HSCT is not more effective than tandem autologous HSCT for patients with standard-risk multiple myeloma. Further enhancement of the graft versus myeloma effect and reduction in transplant-related mortality are needed to improve the allogeneic HSCT approach. FUNDING:US National Heart, Lung, and Blood Institute and the National Cancer Institute.

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Patient-reported physical functioning predicts the success of hematopoietic cell transplantation (BMT CTN 0902).

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Patient-reported physical functioning predicts the success of hematopoietic cell transplantation (BMT CTN 0902).

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