Dataset Information

Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience.

ABSTRACT: Patients with urothelial cell carcinoma (UCC) often have comorbidities, which cause trouble for the completion of oncological treatment, and little is known about their quality of life (QoL). The aim of the present study was to obtain and describe patient-reported outcomes (PRO) and QoL data from UCC patients in the treatment for locally advanced muscle-invasive or metastatic UCC. A total of 79 patients with UCC completed four questionnaires (EORTC QLQ-C30, QLQ-BLM30, HADS, and select PRO-CTCAE™ questions) once weekly during their treatment. From those, 26 patients (33%) underwent neoadjuvant treatment for local disease while 53 patients (67%) were treated for metastatic disease. Of all patients, 54% did not complete the planned treatment due to progression, nephrotoxicity, death, or intolerable symptoms during treatment. The five most prevalent PRO-CTCAE grade ≥ 2 symptoms were frequent urination (37%), fatigue (35%), pain (31%), dry mouth (23%), and swelling of the arms or legs (23%). The baseline mean overall QoL was 61 (±SD 24) for all patients (neoadjuvant (73, ±SD 19) and metastatic (54, ±SD 24)) and remained stable over the course of treatment for both groups. A stable overall QoL was observed for the patients in this study. More than half of the patients did not, however, complete the planned treatment. Further supportive care is warranted for bladder cancer patients.

SUBMITTER: Taarnhoj GA

PROVIDER: S-EPMC8123186 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:Selection of specific patient-reported outcomes (PROs) for cancer patients requires careful consideration to the purpose and population at aim. Here we report the process of choosing which items to include in a bladder cancer population in chemo- or immunotherapy based on the Patient-Reported Outcomes Version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE). METHODS:Initial PRO-CTCAE symptoms were chosen through 1) medical record audit 2) patient interviews 3) summary of product characteristics from European Medicines Agency and Food and Drug Administration for the applied chemotherapies, and 4) toxicity reporting from Phase 2 and 3 trials for immunotherapies applied in patients with urothelial cancer. The selected questions were applied in a prospective cohort of 78 bladder cancer patients receiving chemo- or immunotherapy at Rigshospitalet and Herlev Hospital, Denmark. Symptoms tested in this population were selected for the final module if they appeared in ?3 of the following groupings a) the most prevalent PRO-CTCAE symptoms grade???2 overall during treatment b) the PRO-CTCAE symptoms reported in conjunction with hospital admissions or mentioned in focus group interviews discussing which symptoms were prevalent in this patient group with specialized c) nurses or d) physicians. The authors also included symptoms in the final module if they were present in two of the above groups and defined as actionable by clinicians. RESULTS:From the initial selection of PRO-CTCAE symptoms, a total of 45 PRO-CTCAE symptoms explored by 84 PRO-CTCAE questions were retrieved. Through the second selection process based on the described criteria, the study group agreed on 15 PRO-CTCAE symptoms explored by 30 PRO-CTCAE items to be appropriate and relevant for the bladder population during medical oncological treatment. CONCLUSIONS:The selection of disease specific PROs in a bladder cancer population was feasible. The process revealed several steps of selection needed in order to reach a final module for clinical application.

Project description:BackgroundOne fourth of the adult population in Europe suffer from respiratory allergy. Subcutaneous-allergen-specific-immunotherapy (SCIT) has long-term disease modifying effect on disease specific Health-Related Quality of Life (HRQoL). The purpose of this study was to assess the effect of SCIT on alternative disease outcomes in patients with grass-pollen and/or house dust mite induced allergic rhino-conjunctivitis and/or an asthma diagnosis. Focus was on expressing outcomes in terms of generic quality of life (Quality-Adjusted-Life-Years (QALY)) and reductions in sick days.MethodsThe study was a multi-centre study with prospective follow-up. 248 patients were initiated on SCIT. The disease specific Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ) and two generic (HRQoL) instruments 15D and EQ-5D were used at baseline and at follow-up. The outcome measures included change in; disease severity, RQLQ-scores, number of days with symptoms- and number of sick days per year and finally changes in generic HRQoL and thus, QALY. Disease severity was assessed by specialist doctors; severity of rhino-conjunctivitis was classified according to the Allergic Rhinitis and its Impact on Asthma (ARIA) and asthma severity according to the Global Initiative for Asthma (GINA guideline). The remaining outcome measures were assessed by the patients in questionnaires at baseline and at follow-up. An intension to treat approach was applied. For missing items imputation of sample mean base-line values or follow-up values were used after specified criteria. The effect of SCIT on rhino-conjunctivitis and/or asthma diagnoses was analysed at follow-up using three logistic regression models.ResultsThe disease severity showed significantly improved disease control. Mean RQLQ-score was reduced from 3.02 at baseline to 2.00 at follow-up. Average annual days with symptoms were reduced from 189 to 145 days whilst annual sick days were reduced from 3.7 to 1.2 days. The 15D-score increased from 0.83 to 0.86 and the EQ-5D-score from 0.70 to 0.77, which indicated an annual gain per patient of 0.03-0.06 QALY.ConclusionsAllergic patients suffering from rhino-conjunctivitis alone or rhino-conjunctivitis and asthma experience significantly increased HRQoL and they gain 0.03-0.06 QALY, when treated with SCIT for one year.Trial registrationThe study was registered at ClinicalTrials.gov with the identifier: NCT01486498.

Dataset Information

Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets