Health-related quality of life data from a phase 3, international, randomized, open-label, multicenter study in patients with previously treated mantle cell lymphoma treated with ibrutinib versus temsirolimus

Heß, Georg; Rule, Simon; Jurczak, Wojciech; Silva, Rodrigo Santucci; Rusconi, Chiara; Caballero, Dolores; João, Cristina; Witzens-Harig, Mathias; Bence‐Bruckler, Isabelle; Cho, Seok-Goo; Zhou, Wangda; Goldberg, Jenna D.; Trambitas, Cristina; Enny, Christopher; Vermeulen, Jessica; Traina, Shana; Chiou, Chiun–Fang; Diels, Joris; Dreyling, Martin

doi:10.1080/10428194.2017.1326034

Cited by 16 publications

(27 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Patients who died were considered missing rather than being given a utility value of 0. Any differences in sample size with earlier studies reporting results from the RAY trial [13,18] are due to the fact that our analyses were performed only on patients with available PRO data.…”

Section: Discussionmentioning

confidence: 98%

See 1 more Smart Citation

Testing the validity and responsiveness of a new cancer-specific health utility measure (FACT-8D) in relapsed/refractory mantle cell lymphoma, and comparison to EQ-5D-5L

Herdman

Kerr

Pavesi

et al. 2020

J Patient Rep Outcomes

View full text Add to dashboard Cite

Background: The FACT-8D is a new cancer-specific, preference-based measure (PBM) of health, derived from the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The FACT-8D's measurement properties have not been tested to date. We assessed it's validity and responsiveness in relapsed/refractory mantle cell lymphoma (RR MCL) and compared the results to the EQ-5D-5L. Methods: Blinded analysis of pooled data from a phase 3 clinical trial. FACT-8D baseline and follow-up data (weeks 4, 7, 16, 31) were scored using Australian preference weights, the first available value-set. Convergent validity was assessed by estimating baseline correlations with the FACT-Lym total score, Trial Outcome Index (TOI), FACT-Lym lymphoma-specific sub-scale (LymS), EQ-5D Visual Analog Scale (VAS), and haemoglobin (HgB). Relevant clinical variables were used to categorise patients to test known groups' validity and responsiveness was investigated using data from baseline (n = 250) and week 31 (n = 130). Results were compared with EQ-5D-5L, scored using the UK 3L crosswalk and the 5L England value-sets. Results: The FACT-8D showed good convergent validity and responsiveness; baseline Pearson correlation coefficients between FACT-8D Index scores and other PRO measures were moderate to very strong (range: 0.49 for the EQ-VAS to 0.79 for FACT TOI) and the size of the change in FACT-8D Index scores at week 31 differed significantly (p < 0.005) between patients categorised as improved, worsened or stable using the FACT-Lym total score, LymS, and HgB. However, when assessing known groups' validity, FACT-8D failed to discriminate between patients categorised by health status on four of the seven variables analysed. Overall, FACT-8D and EQ-5D-5L performed similarly, although EQ-5D-5L showed better known groups' validity.

show abstract

Section: Discussionmentioning

confidence: 98%

“…Instruments were administered at the beginning of clinic visits prior to any procedures or physician interventions. The main PRO methods and results are presented in Hess et al [18].…”

Section: Patient Reported Outcomesmentioning

confidence: 99%

Testing the validity and responsiveness of a new cancer-specific health utility measure (FACT-8D) in relapsed/refractory mantle cell lymphoma, and comparison to EQ-5D-5L

Herdman

Kerr

Pavesi

et al. 2020

J Patient Rep Outcomes

View full text Add to dashboard Cite

show abstract

“…In a single-arm phase 2 study of ibrutinib plus rituximab for high-risk CLL, patients showed significant improvements in global health status, functioning, and symptom scales on the EORTC-QLQ-C30 at 12 months [42]. In the phase 3 RAY (MCL3001) trial of patients with relapsed/refractory mantle cell lymphoma, ibrutinib monotherapy was associated with improved Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) subscale and total scores, as well as EQ-5D-5L utility and EQ-5D VAS scores, compared with temsirolimus [43].…”

Section: Discussionmentioning

confidence: 99%

Improvement of fatigue, physical functioning, and well-being among patients with severe impairment at baseline receiving ibrutinib in combination with bendamustine and rituximab for relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma in the HELIOS study

Cramer

Fraser

Santucci-Silva³

et al. 2018

Leukemia & Lymphoma

Self Cite

View full text Add to dashboard Cite

Health-related quality of life (HRQoL) is an important endpoint, especially in clinical trials for malignancies with a long course of disease, such as chronic lymphocytic leukemia (CLL). Patient-reported outcomes were examined in the randomized, double-blind, placebo-controlled HELIOS study to assess the impact of treatment with the Bruton's tyrosine kinase inhibitor ibrutinib, added to bendamustine plus rituximab (BR) background therapy. Measures included FACIT-Fatigue, EORTC QLQ-C30, QLQ-CLL16, and EQ-5D-5L. Of 578 patients enrolled, 540 (93%) provided FACIT-Fatigue responses at baseline. Most had only a moderate degree of impairment at baseline; mean values did not appear to change over time in either treatment arm, suggesting that adding ibrutinib to BR did not impact health-related quality of life. However, post-hoc analyses showed that subgroups of patients with the worst fatigue, physical functional status, and well-being at baseline had greater improvements in these outcomes with ibrutinib plus BR treatment versus placebo.

show abstract

“…Armstrong et al reported that adalimumab treatment resulted in a statistically significant and clinically relevant reduction in disease severity that was associated with QoL improvement in patients with psoriasis compared with placebo [ 30 ]. Hess et al reported that patients with mantle cell lymphoma achieving a partial or better clinical response showed an improvement in FACT-Lym total scores [ 31 ]. Similarly, our results reflect that effective TKI treatment leads to an improvement in physical and mental health in patients with CML, suggesting that TKI therapy responses within 1 year can possibly predict both future treatment outcomes and physical and mental well-being of patients with CML-CP.…”

Section: Discussionmentioning

confidence: 99%

Achieving optimal response at 12 months is associated with a better health-related quality of life in patients with chronic myeloid leukemia: a prospective, longitudinal, single center study

et al. 2018

View full text Add to dashboard Cite

BackgroundTo assess the relationship between responses within 1 year and health-related quality of life (HRQoL) outcomes by exploring profiles of patients with CML-CP who were treated with front-line imatinib or nilotinib.MethodsA prospective, longitudinal, single-center study was conducted to assess the response to treatment with imatinib or nilotinib and the HRQoL profile of patients who were newly diagnosed with CML in chronic phase enrolled in the ENESTchina study.ResultsFifty-nine patients were randomized to receive imatinib (n = 31) or nilotinib (n = 28). With a median follow-up of 5 years, there was no difference in HRQoL profile observed between patients receiving imatinib and nilotinib. Achieving optimal response at 12 months was associated with better role limitations due to physical health problems (RP; P = 0.0019) and emotional problems (RE; P = 0.0110) and was the sole factor associated with significantly improving physical component summary over time (PCS; P = 0.0160). Achieving optimal response at 6 months had high probability of better physical functioning (PF; P = 0.0674), better social functioning (SF; P = 0.0571), and reduced role limitations due to emotional problems (RE; P = 0.0916). In addition, factors including age < 40 years, female gender, and higher level of education were also associated with better HRQoL subscale scores. However, optimal response at 3 months had no impact on HRQoL profile. The proportions of patients with failure-free survival and PFS at 5 years were significantly higher among patients who achieved optimal response at 3, 6, or 12 months than among those who did not achieve optimal response (warning or failure), and the OS rate at 5 years was significantly higher among those who achieved optimal response at 12 months. In a multivariate analysis, treatment received (nilotinib vs imatinib) was identified as an independent factor for the achievement of optimal response at both 6 months (OR, 3.9; 95% CI, 1.0–14.9) and 12 months (OR, 5.6; 95% CI, 1.7–17.9).ConclusionsAchieving optimal response at 12 months was not only associated with longer OS and reduced treatment failure rates and disease progression but also better HRQoL in newly diagnosed patients with CML-CP receiving front-line tyrosine kinase inhibitor treatment.Trial registrationChinese Clinical Trial Registry (http://www.chictr.org.cn): ChiCTR-OCH-11001699.

show abstract

Health-related quality of life data from a phase 3, international, randomized, open-label, multicenter study in patients with previously treated mantle cell lymphoma treated with ibrutinib versus temsirolimus

Cited by 16 publications

References 17 publications

Testing the validity and responsiveness of a new cancer-specific health utility measure (FACT-8D) in relapsed/refractory mantle cell lymphoma, and comparison to EQ-5D-5L

Testing the validity and responsiveness of a new cancer-specific health utility measure (FACT-8D) in relapsed/refractory mantle cell lymphoma, and comparison to EQ-5D-5L

Improvement of fatigue, physical functioning, and well-being among patients with severe impairment at baseline receiving ibrutinib in combination with bendamustine and rituximab for relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma in the HELIOS study

Achieving optimal response at 12 months is associated with a better health-related quality of life in patients with chronic myeloid leukemia: a prospective, longitudinal, single center study

Contact Info

Product

Resources

About