Differences in Quality of Life Between Bendamustine-Rituximab and R-CHOP/R-CVP in Patients With Previously Untreated Advanced Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Burke, John M.; Jagt, Richard H. C. Van Der; Kahl, Brad S.; Wood, Peter; Hawkins, Tim E.; MacDonald, David; Hertzberg, Mark; Simpson, David; Craig, Michael; Kolibaba, Kathryn S.; Issa, Samar; Munteanu, Mihaela; Victor, Timothy W.; Flinn, Ian W.

doi:10.1016/j.clml.2016.01.001

Cited by 17 publications

(11 citation statements)

References 17 publications

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“…Studies evaluated : Twelve studies of recently approved drugs for indolent non-Hodgkin’s, relapsed/refractory setting of non-DLBCL and Hodgkin’s lymphoma were evaluated (table 5). 46–62…”

Section: Resultsmentioning

confidence: 99%

“…Scorability : In one of the studies,46 PFS/EFS gains could not be graded because the PFS of the control arm was very long, the median PFS was not reached and only interim gains were reported. The BRIGHT study could not be scored because form 2 c makes no provision for scoring of non-inferiority studies based on response rates 49 50. The remaining 10 studies were published with endpoints and data applicable to the ESMO-MCBS v1.1 and were all evaluable.…”

Section: Resultsmentioning

confidence: 99%

“…This evaluation of the behaviour of the ESMO-MCBS v1.1 in the grading of 80 studies across the full spectrum of HMs has demonstrated that the ESMO-MCBS v1.1 is widely applicable for the overwhelming majority of analysed studies (90% scoreable studies) and that the generated scores were generally adjudicated by clinical experts to reasonably accord with their evaluation of the magnitude of clinical benefit. In 5 of the 80 studies (6%), the ESMO-MCBS could not be applied at all21 27 46 49 50 78 and in 3 more studies (4%), it could not be applied to one of the evaluable parameters 68 76 77. In the evaluation of imatinib in CML,36–38 it generated scores that were considered to under-represent the true value of the intervention in the opinion of experts in the evaluated diseases.…”

Section: Discussionmentioning

confidence: 99%

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EHA evaluation of the ESMO—Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for haematological malignancies

et al. 2020

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ObjectiveValue frameworks in oncology have not been validated for the assessment of treatments in haematological malignancies, but to avoid overlaps and duplications it appears reasonable to build up experience on existing value frameworks, such as the European Society for Medical Oncology—Magnitude of Clinical Benefit Scale (ESMO-MCBS).MethodsHere we present the results of the first feasibility testing of the ESMO-MCBS v1.1 for haematological malignancies based on the grading of 80 contemporary studies for acute leukaemia, chronic leukaemia, lymphoma, myeloma and myelodysplastic syndromes. The aims were (1) to evaluate the scorability of data, (2) to evaluate the reasonableness of the generated grades for clinical benefit using the current version and (3) to identify shortcomings in the ESMO-MCBS v1.1 that require amendments to improve the efficacy and validity of the scale in grading new treatments in the management of haematological malignancies.ResultsIn general, the ESMO-MCBS v1.1 was found to be widely applicable to studies in haematological malignancies, generating scores that were judged as reasonable by European Hematology Association (EHA) experts. A small number of studies could either not be graded or were not appropriately graded. The reasons, related to the differences between haematological and solid tumour malignancies, are identified and described.ConclusionsBased on the findings of this study, ESMO and EHA are committed to develop a version of the ESMO-MCBS that is validated for haematological malignancies. This development process will incorporate all of the usual stringencies for accountability of reasonableness that have characterised the development of the ESMO-MCBS including field testing, statistical modelling, evaluation for reasonableness and openness to appeal and revision. Applying such a scale will support future public policy decision-making regarding the value of new treatments for haematological malignancies and will provide insights that could be helpful in the design of future clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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EHA evaluation of the ESMO—Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for haematological malignancies

et al. 2020

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“…The impact of CINV appeared to be transient with HRQoL returning to levels similar to the general reference population. The EORTC QLQ-C30 nausea/vomiting subscale score (a specific scale within the EORTC QLQ-C30 addressing the impact of nausea/vomiting on patient HRQoL) indicated that this event was the least burdensome of all symptoms assessed by this measure (fatigue, pain, and nausea/ vomiting); although scores do increase (worsen) during treatment, the overall humanistic impact remained low [47,48,50]. Data from other measures corroborated the low humanistic burden associated with CINV, especially when compared to other AEs of interest [27].…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Exploring the burden of short-term CHOP chemotherapy adverse events in post-transplant lymphoproliferative disease: a comprehensive literature review in lymphoma patients

Watson

Barlev

Worrall³

et al. 2020

Journal of Drug Assessment

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Purpose: CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) is a treatment for post-transplant lymphoproliferative disease (PTLD) following solid organ transplant after failing rituximab, an aggressive and potentially fatal lymphoma. This study explores the humanistic and economic burden of CHOP-associated adverse events (AEs) in PTLD patients. Since PTLD is rare, searches included lymphoproliferative disease with lymphoma patients. Design: This comprehensive literature review used the PRISMA protocol, pre-specifying the search strategy and criteria. CHOP-associated short-term AEs with an incidence of >4% were sourced from published literature and cancer websites to inform the search strategy. PubMed and EMBASE searches were used to identify humanistic and economic burden studies. Results: PubMed and EMBASE searches identified 3,946 citations with 27 lymphoma studies included. Studies were methodologically heterogeneous. Febrile neutropenia (FN) was the AE most encountered, followed by chemotherapy-induced (CI) anemia (A), infection, CI-nausea and vomiting, thrombocytopenia, and CI-peripheral neuropathy (PN). FN and infections were associated with significant disutility, increased hospitalization, and extended length of stay. Infections and CIPN significantly impacted the utility of patients and CIA-related fatigue showed reductions in quality of life. Many patients continue to have quality of life deficits continued even after AEs were treated.

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“…At the time of writing this review, no data on PFS and OS in the BRIGHT study were available. Interestingly, B-R regimen was better tolerated than CHOP-R or CVP-R as measured by quality of life (QoL) questionnares ( 19 ). Patients reported improved outcomes on many scales such as cognitive, physical, social and emotional functioning, indicating major QoL improvement in patients receiving B-R.…”

Section: Bendamustine As First Line Therapy In Nhl: the End Of Chop-rmentioning

confidence: 99%

Bendamustine: an Old Drug in the New Era for Patients with Non-Hodgkin Lymphomas and Chronic Lymphocytic Leukemia

Patekar

Milunović

Jakobac

et al. 2018

ACC

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SUMMARY – The aim of this review is to present data on bendamustine, a non-cross resistant alkylating agent, alone or in combination for treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Bendamustine is currently approved for rituximab-resistant indolent NHL and CLL in patients not fit for conventional chemotherapy. Recent studies have shown superiority of bendamustine combination with rituximab (B-R) in first line treatment of indolent NHLs and mantle cell lymphoma, suggesting a shift of the standard of care in this setting. B-R regimen has also shown efficacy in relapsed setting suggesting the possible treatment option for patients failing conventional chemotherapy. In rituximab-resistant NHL, the recent GADOLIN study exploring the addition of obinutuzumab to bendamustine has yielded impressive result changing the standard of care in this hard-to-treat population. Concerning CLL, despite inferiority to the standard of care in young fit patients, as defined in CLL10 study, B-R has yielded a more beneficial toxicity profile and its use in first line treatment should be decided individually. In relapsed setting, the addition of ibrutinib to B-R has shown superior results compared to B-R alone, possibly changing the paradigm of treatment of relapsed CLL. In conclusion, bendamustine as a single agent or in combinations has shown activity with acceptable toxic profile in the treatment of patients with indolent NHLs or CLL without del(17p) mutation.

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Differences in Quality of Life Between Bendamustine-Rituximab and R-CHOP/R-CVP in Patients With Previously Untreated Advanced Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Abstract: Compared with patients treated with standard therapy, patients treated with BR reported better quality of life in several areas.

Cited by 17 publications

References 17 publications

EHA evaluation of the ESMO—Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for haematological malignancies

EHA evaluation of the ESMO—Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1) for haematological malignancies

Exploring the burden of short-term CHOP chemotherapy adverse events in post-transplant lymphoproliferative disease: a comprehensive literature review in lymphoma patients

Bendamustine: an Old Drug in the New Era for Patients with Non-Hodgkin Lymphomas and Chronic Lymphocytic Leukemia

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