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Skipping a step: what happened to the design of randomized clinical trials in chronic lymphocytic leukaemia
L. Smolej
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, práce podpořená grantem, přehledy
Odkazy
PubMed
33216352
DOI
10.1111/bjh.17215
Knihovny.cz E-zdroje
- MeSH
- adenin analogy a deriváty terapeutické užití MeSH
- bicyklické sloučeniny heterocyklické terapeutické užití MeSH
- chronická lymfatická leukemie farmakoterapie MeSH
- lidé MeSH
- piperidiny terapeutické užití MeSH
- protokoly antitumorózní kombinované chemoterapie terapeutické užití MeSH
- randomizované kontrolované studie jako téma * MeSH
- rituximab terapeutické užití MeSH
- sulfonamidy terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
Clinical research of chronic lymphocytic leukaemia (CLL) has been advancing at an unprecedented pace. Several randomized studies in the current era of oral targeted agents seem to have skipped one step and proceeded directly to combinations with antibodies, omitting the testing of novel-agent monotherapy. Thus, the ibrutinib + rituximab combination was used as the experimental arm in a major trial for untreated fit patients while two other trials subsequently showed that addition of rituximab to ibrutinib does not produce any meaningful benefit. Similarly, two large trials omitted venetoclax monotherapy and proceeded directly to venetoclax + rituximab or obinutuzumab versus chemoimmunotherapy. While such trials are undoubtedly cheaper, quicker and easier to manage, they leave the CLL community with uncertainty regarding the real role of the monoclonal antibody components. Thus, we are left with regimens which are undoubtedly effective, but might actually be unnecessarily toxic and expensive. The solution to this problem is simple: future randomized trials should be carefully designed in a 'step by step' fashion which would provide the CLL community with simple yet robust answers regarding efficacy of novel regimens so that these can be introduced to practice following the best principles of evidence-based medicine.
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- $a Clinical research of chronic lymphocytic leukaemia (CLL) has been advancing at an unprecedented pace. Several randomized studies in the current era of oral targeted agents seem to have skipped one step and proceeded directly to combinations with antibodies, omitting the testing of novel-agent monotherapy. Thus, the ibrutinib + rituximab combination was used as the experimental arm in a major trial for untreated fit patients while two other trials subsequently showed that addition of rituximab to ibrutinib does not produce any meaningful benefit. Similarly, two large trials omitted venetoclax monotherapy and proceeded directly to venetoclax + rituximab or obinutuzumab versus chemoimmunotherapy. While such trials are undoubtedly cheaper, quicker and easier to manage, they leave the CLL community with uncertainty regarding the real role of the monoclonal antibody components. Thus, we are left with regimens which are undoubtedly effective, but might actually be unnecessarily toxic and expensive. The solution to this problem is simple: future randomized trials should be carefully designed in a 'step by step' fashion which would provide the CLL community with simple yet robust answers regarding efficacy of novel regimens so that these can be introduced to practice following the best principles of evidence-based medicine.
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