Correcetions to “A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)”

Cherny, Nathan I.; Sullivan, Richard; Dafni, Urania; Kerst, J. Martijn; Sobrero, A.; Zielinski, C.; Vries, Elisabeth G.E. de; Piccart, Martine

doi:10.1093/annonc/mdw258

Cited by 55 publications

(29 citation statements)

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“…Meanwhile, and most importantly, the regulatory agencies should be able to undertake some recommended actions to negotiate fair prices 48. Moreover, the definition of validated approaches to stratify the magnitude of clinical benefit49 along with payment-by-result strategies are urgently required to guarantee the sustainability on national health systems.…”

Section: Advantages and Disadvantages Of Finite Duration Vs Continuoumentioning

confidence: 99%

Relapsed/Refractory Chronic Lymphocytic Leukemia: Chemoimmunotherapy, Treatment Until Progression With Mechanism-Driven Agents or Finite-Duration Therapy?

Cuneo

Foà

2019

Mediterr J Hematol Infect Dis

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Treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) has dramatically improved thanks to the development of mechanism-driven agents including drugs that inhibit kinases in the BCR pathway or BCL2. The treating physician has now the opportunity to decide i) which patient can be still offered chemoimmunotherapy as salvage treatment, ii) which patient is a candidate to receiving at relapse continuous treatment with ibrutinib, idelalisib and rituximab or venetoclax and iii) which patient may benefit from a fixed-duration treatment using the BCL2 antagonist venetoclax in association with rituximab. Ibrutinib is the most actively investigated drug in R/R CLL and data at a 7-year follow-up were reported, showing durable efficacy and favorable efficacy profile. The patients with cardiac disease, hypertension and on anticoagulant therapy are not ideal candidates for continuous therapy with this agent. Idelalisib and rituximab was tested in patients with unfavorable characteristics including cytopenias. The short follow-up and treatment emergent adverse events limit its role to patients unlikely to get a benefit with other agents. Venetoclax and rituximab is the only effective chemo-free approach for the treatment of R/R with a fixed duration (up to 24 months) schedule capable of inducing deep responses in the majority of cases with a reassuring safety profile. While a deep knowledge of the growing body of scientific evidence is required to inform and guide the appropriate treatment choice and management, physicians cannot disregard the growing problem of sustainability

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Section: Advantages and Disadvantages Of Finite Duration Vs Continuoumentioning

confidence: 99%

Relapsed/Refractory Chronic Lymphocytic Leukemia: Chemoimmunotherapy, Treatment Until Progression With Mechanism-Driven Agents or Finite-Duration Therapy?

Cuneo

Foà

2019

Mediterr J Hematol Infect Dis

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“…All guidelines have the highest recommendation grade and evidence level (based on ≥1 large randomized clinical trial). In 2015, ESMO developed a dynamic tool to stratify the magnitude of clinical benefits for anti-cancer therapies that assess the magnitude of drug–clinical benefits balanced against cost (ESMO-MCBS) [ 25 ]. Evaluating 80 drugs currently used in oncology, radium-223 has been identified with the highest score and currently it is the only prostate cancer drug to achieve this [ 25 ].…”

Section: Radium 223mentioning

confidence: 99%

Targeted α Therapies for the Treatment of Bone Metastases

Zustovich¹,

Barsanti

2017

IJMS

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The skeleton is the target tissue for many types of tumors, and, recently, the survival of patients with prostate cancer metastasis has been increased using α-emitting drugs known as targeted α therapies. The use of α-radiopharmaceuticals in medicine was hypothesized at the beginning of the nineteenth century after the observation that α-radionuclides were associated with high cell-killing energy and low tissue penetration in healthy tissues. In the prostate cancer (PC) scenario, current research suggests that this class of radiopharmaceuticals has limited toxicity, and that the mechanism of action does not overlap with pre-existing drugs, allowing us to extend therapeutic armaments and address medical oncology towards personalized and precision medicine. Ongoing studies may extend these benefits also to bone metastases deriving from other neoplasms. The aim of this review is to summarize the current research on targeted α therapies and try to identify the right patient to be treated in the right time in order to integrate in these medications in the every-day clinical practice.

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“…With promoting the use of high-value drugs, a number of organizations, including the American Society of Clinical Oncology (ASCO) (Schnipper et al, 2015;Schnipper et al, 2016), European Society for Medical Oncology (ESMO) (Cherny et al, 2015;Cherny et al, 2017), and National Comprehensive Cancer Network (NCCN) (National Comprehensive Cancer Network, ) have developed frameworks to assess antineoplastic agents either quantitatively or qualitatively, involving stakeholders (e.g., physicians, patients, and healthcare insurers). However, there is no a universally accepted framework and unfortunately no value assessment frameworks in developing countries, e.g.…”

Section: Introductionmentioning

confidence: 99%

Development of the First Value Assessment Index System for Off-Label Use of Antineoplastic Agents in China: A Delphi Study

Jiang

Zeng

et al. 2020

Front. Pharmacol.

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Objective: To develop the first value assessment index system for off-label use of antineoplastic agents in China. Methods: A modified two-round Delphi method was employed to establish consensus within a field to reach agreement via a questionnaire or doing interview among a multidisciplinary panel of experts by collecting their feedback to inform the next round, exchanging their individual knowledge, experience, and opinions anonymously, and resolving uncertainties. Results: Expert's positive coefficient was 94.74% in the first round and 100.00% in the second round. In the first round, expert's authority coefficient for a majority of 61 indicators was ≥ 0.80 (85.2%, ranging from 0.70 to 0.89, mean=0.84) and coefficient of variation for all the 61 indicators was ≥ 22% (ranging from 11.67% to 21.74%, mean=17.4%). In two rounds, the mean expert's authority coefficient raised to 0.85 (ranging from 0.75 to 0.90), and coefficient of variation for all indicators was < 20% (ranging from 10.49% to 19.71%, mean=15.97%). The P-values of Kendall's W test were all < 0.001 for each round. At the end of two rounds, W-value for concordance was 0.395 (c 2 =347.494, P<0.0001). The final value assessment index system comprised of eight domains, 21 subdomains, and 56 indicators. The weight and combination weight of each domain were 0.4211 for therapeutic value, 0.1678 for source and type of evidence, 0.0961 for public feedback/ comments, 0.0894 for novelty in drug discovery, 0.0689 for grading of evidence recommendation, 0.0578 for consistency of evidence results, 0.0561 for disease burden, and 0.0428 for ratio of composition/integration. Conclusion: Use of Delphi method to develop the proposed value assessment index system was found scientific and credible. This value assessment index system is highly appropriate for off-label use of antineoplastic agents in China.

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Correcetions to “A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)”

Cited by 55 publications

References 0 publications

Relapsed/Refractory Chronic Lymphocytic Leukemia: Chemoimmunotherapy, Treatment Until Progression With Mechanism-Driven Agents or Finite-Duration Therapy?

Relapsed/Refractory Chronic Lymphocytic Leukemia: Chemoimmunotherapy, Treatment Until Progression With Mechanism-Driven Agents or Finite-Duration Therapy?

Targeted α Therapies for the Treatment of Bone Metastases

Development of the First Value Assessment Index System for Off-Label Use of Antineoplastic Agents in China: A Delphi Study

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