Are changes in patient-reported outcomes prognostic for diffuse large B-Cell lymphoma survival? Results from the GOYA trial.

In this hypothesis-generating analysis, we examined whether longitudinal changes in patient-reported outcomes (PROs), such as symptoms, over time would be prognostic for progression-free survival (PFS) and overall survival (OS) in patients with diffuse large B-cell lymphoma (DLBCL) who were newly treated with obinutuzumab (G) in combination with CHOP (G-CHOP) or rituximab (R) with CHOP (R-CHOP), in the GOYA Phase 3 trial (NCT01287741). Our results show that from the study baseline to cycle 3 day 1, every 1-point increase (worsening) in fever symptoms was associated with a 41% higher risk of death (hazard ratio [HR], 1.41; P = 0.

Psychometrics of patient-reported bother from side effects of treatment single-items in industry-sponsored oncology trials.

Background: Improvements in cancer treatment have increased the number of cancer survivors, but also increased the long-term and late effects from cancer therapy. Patient reported "side effect bother" could be used to measure the burden of treatment, and the risk for negative outcomes such as dose reduction, treatment delay or discontinuation. The current study addresses the psychometric properties of a single item, determines what represents a "meaningful change", and evaluates the correlation to safety endpoints and functioning.

Patient-reported outcomes provide prognostic information for survival in patients with diffuse large B-cell lymphoma: Analysis of 1239 patients from the GOYA study.

Purpose: We investigated the prognostic value of pretreatment patient-reported outcomes (PROs) in patients with diffuse large B-cell lymphoma (DLBCL) receiving obinutuzumab/rituximab plus chemotherapy in the GOYA phase III study.

Methods: Patients completed the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) and the Functional assessment of chronic illness therapy-Lymphoma (FACT-Lym) lymphoma subscale (LYMS) during the study. PRO scales with high prognostic value were identified through Cox regression analyses of overall survival (OS) and progression-free survival (PFS).

Improvements in Health-related Quality of Life and Symptoms in Patients With Previously Untreated Chronic Lymphocytic Leukemia: Final Results From the Phase II GIBB Study of the Combination of Obinutuzumab and Bendamustine.

Background: We evaluated health-related quality of life (HRQoL) in patients with chronic lymphocytic leukemia (CLL) receiving first-line chemoimmunotherapy in the GIBB single-arm, Phase II study of obinutuzumab plus bendamustine (BG).

Materials And Methods: Patients received six 28-day cycles of BG and were followed for up to 27 months. HRQoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) and EORTC QLQ Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) questionnaires.

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials.

As new cancer treatment regimens demonstrate increased potential to improve patients' survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment's tolerability.

Health-related quality of life and symptoms in patients with rituximab-refractory indolent non-Hodgkin lymphoma treated in the phase III GADOLIN study with obinutuzumab plus bendamustine versus bendamustine alone.

We present health-related quality of life (HRQoL) data from GADOLIN, comparing bendamustine (B) alone or combined with obinutuzumab (G-B) in rituximab-refractory indolent non-Hodgkin lymphoma patients. The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) questionnaire was administered on day 1 of cycles 1, 3, and 5 during treatment, at end of induction (EOI), bi-monthly for 2 years during maintenance/follow-up, and annually during extended follow-up until progression/death. Time to first ≥6-point worsening from baseline in the FACT-Lym trial outcome index (TOI) was estimated.

Randomized controlled trials in relapsed/refractory follicular lymphoma: a systematic review and meta-analysis.

This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity.

Randomized controlled trials in relapsed/refractory chronic lymphocytic leukemia: a systematic review and meta-analysis.

This systematic literature review with meta-analysis was conducted on the clinical efficacy and safety of interventions used in the treatment of chronic lymphocytic leukemia (CLL). We systematically searched databases (PubMed, Cochrane Library, and Embase; 1997 to August 2, 2012), conference abstracts, bibliographic reference lists, recent reviews, and Clinicaltrials.gov.

Clinical efficacy and safety in relapsed/refractory mantle cell lymphoma: a systematic literature review.

A systematic literature review was performed to collect and review information on the clinical efficacy and safety of treatments for relapsed/refractory (R/R) mantle cell lymphoma (MCL), with a meta-analysis, if possible. PubMed, Embase, and the Cochrane Library were searched for studies published in English from January 1, 1997, to August 2, 2012. Conference proceedings, bibliographic reference lists of included articles, recent reviews, and ClinicalTrials.

Clinical efficacy and safety in relapsed/refractory diffuse large B-cell lymphoma: a systematic literature review.

This systematic literature review was designed to assess information on the clinical efficacy and safety of interventions used in the treatment of refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL) and to perform a meta-analysis if possible. We searched databases (PubMed, EMBASE, and Cochrane Library for articles from 1997 to August 2, 2012 reported in English), conference abstracts, bibliographic reference lists, and the ClinicalTrials.gov database for phase II to IV studies with results.

Health-related quality of life in chronic myeloid leukemia.

The increased survival associated with treatments for CML emphasize the importance of understanding the HRQOL of newly diagnosed and previously treated CML patients with all phases of disease. Functional Assessment of Cancer Therapy-Leukemia results from a phase 3 and a phase 2 trial are reported for over 900 1st, 2nd, 3rd line CP, AP, and BP patients. Physical Well-being and Leukemia symptoms were worse for patients in later lines of therapy.

Patterns and prognostic indicators of response to CML treatment in a multi-country medical record review study.

We conducted a review of patient medical records to assess treatment response patterns and prognostic indicators of response among chronic myeloid leukemia (CML) patients in the United States, the United Kingdom, Germany, and Japan. All 1,063 patients selected met the following inclusion criteria: aged 18 or older and in chronic phase at the time of diagnosis, Philadelphia chromosome and/or BCR-ABL positive, received first-line treatment with imatinib, and not enrolled in a randomized clinical trial during the period of retrospective review. Multivariable logistic regression models were used to evaluate prognostic indicators of complete hematological response (CHR), complete cytogenetic response (CCyR), and complete or major molecular response (C/MMR).

Patient characteristics and treatment patterns in chronic myeloid leukemia: evidence from a multi-country retrospective medical record chart review study.

We conducted a retrospective medical record review of 1,063 patients to examine patient characteristics and treatment patterns among adults with Philadelphia chromosome and/or BCR-ABL-positive chronic-phase chronic myeloid leukemia in the USA, UK, Germany, and Japan. Patients who were included received first-line treatment with imatinib between 1 January 2005 and 31 December 2009 and were not enrolled in a randomized clinical trial between first-line treatment initiation and end of recorded follow-up. The average age was 55 years; 60% were male.

Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their family caregivers.

Background: Few intervention programs assist patients and their family caregivers to manage advanced cancer and maintain their quality of life (QOL). This study examined (i) whether patient-caregiver dyads (i.e.

Health-related quality of life of bosutinib (SKI-606) in imatinib-resistant or imatinib-intolerant chronic phase chronic myeloid leukemia.

Understanding the impact of second-line tyrosine kinase inhibitor therapy on the health-related quality of life (HRQOL) of imatinib (IM)-resistant and IM-intolerant chronic phase chronic myeloid leukemia (CP CML) patients is important given the increased survival that comes with therapy. As part of a bosutinib single-arm phase 2 trial, 200 IM-resistant and 88 IM-intolerant CP CML patients' HRQOL was assessed prior to and throughout treatment with the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). Little HRQOL impairment was demonstrated at baseline.

Baseline patient-reported kidney cancer-specific symptoms as an indicator for median survival in sorafenib-refractory metastatic renal cell carcinoma.

Introduction: The goal of the study was to determine the relationship of baseline Functional Assessment of Cancer Therapy-Kidney Cancer Symptom Index (FKSI) scores with median progression-free survival (mPFS) and median overall survival (mOS) after treatment with axitinib in patients with sorafenib-refractory metastatic renal cell carcinoma.

Methods: As part of a multicenter, open-label, phase II study, patients (N = 62) reported symptoms at baseline using the FKSI, with higher scores indicating less severe symptoms. A Weibull (fully parametric) model was fit to time-to-event data to establish the relationship of baseline FKSI score with mPFS and mOS.

Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study.

Background: Axitinib is a potent, selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3. A randomised phase 2 trial of gemcitabine with or without axitinib in advanced pancreatic cancer suggested increased overall survival in axitinib-treated patients. On the basis of these results, we aimed to assess the effect of treatment with gemcitabine plus axitinib on overall survival in a phase 3 trial.

Does recall period have an effect on cancer patients' ratings of the severity of multiple symptoms?

Context: Choosing an appropriate recall period for symptom assessment in a clinical trial is dependent on the design and purpose of the trial.

Objective: To examine the effects of recall on symptom severity ratings by comparing ratings made using 24-hour and seven-day recall periods of the MD Anderson Symptom Inventory (MDASI).

Methods: Forty-two patients in their third to eighth week of chemoradiation rated their symptoms using the MDASI on two separate occasions (T1 and T2), one week apart.

Validation and application of a module of the M. D. Anderson Symptom Inventory for measuring multiple symptoms in patients with gastrointestinal cancer (the MDASI-GI).

Background: The M. D. Anderson Symptom Inventory (MDASI) was developed as a brief yet comprehensive tool to assess patient-reported symptom severity and interference in patients with cancer.

Psychological distress in patients with pancreatic cancer--an understudied group.

Background: Pancreatic cancer is the fourth leading cause of cancer-related death in the United States, unsuccessful in significantly improving 5-year survival. A diagnosis of pancreatic cancer may be associated with increased psychological distress, yet remarkably little is known about the degree of psychological distress experienced by these patients at the time of diagnosis and treatment.

Method: In a cross-sectional study, 304 patients with pancreatic cancer and 7749 patients with other cancer diagnoses completed the Brief Symptom Inventory (BSI) or the Brief Symptom Inventory-Shortened Version (BSI-18) and the Problem Common Checklist (PCL) during outpatient registration.

Other paradigms: health-related quality of life as a measure in cancer treatment: its importance and relevance.

During the past 2 decades, there have been advances in the definition, measurement, and application in clinical trials and practice of health-related quality of life (HRQOL). In addition, the importance of bringing the patient's voice to medical decision making has been increasing. However, there remains some question as to the importance of the HRQOL construct in cancer treatment.

Phase II study of axitinib in sorafenib-refractory metastatic renal cell carcinoma.

Purpose: To investigate the efficacy and safety of axitinib, an oral, potent, and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3 in patients with metastatic renal cell carcinoma (mRCC) refractory to prior therapies that included, but were not limited to, sorafenib.

Patients And Methods: In this multicenter, open-label, phase II study, patients with sorafenib-refractory mRCC received a starting dose of axitinib 5 mg orally twice daily. A one-arm, single-stage design was used to estimate the primary end point of objective response rate (ORR), defined by RECIST (Response Evaluation Criteria in Solid Tumors).

A patient-based utility measure of health for clinical trials of cancer therapy based on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire.

Background: The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) is a widely used quality-of-life measure in oncology. The ability to translate QLQ-C30 responses into utility scores would further expand its use in medical decision-making. The aims of this study were to: 1) map QLQ-C30 responses onto patient time trade-off utility scores; and 2) compare a multiattribute approach to a global evaluation approach to modeling utility scores.

Future perspectives on the treatment issues associated with cancer and aging.

For many older individuals, the decision to undergo treatment for cancer is viewed as a tradeoff between loss of function and extension of life: a decision that often is complicated by concomitant issues such as comorbid medical conditions, frailty, functional declines, family dynamics, and social and psychological issues. This poses several challenges and affords opportunities for healthcare professionals conducting research with older cancer patients who are undergoing treatment. The current article presents a summary of a roundtable discussion of the issues that face older individuals with cancer during the treatment phase of a cancer diagnosis.