Redefining efficacy and safety endpoints for chronic lymphocytic leukemia in the era of targeted therapy

Molica, Stefano

doi:10.1080/17474086.2023.2271170

Cited by 5 publications

(2 citation statements)

References 31 publications

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“…In contrast, a statistically significant shorter OS at 5 years relative to the AGMGP persists for CLL patients treated with FCR-based CIT. Given the imperative to maximize therapeutic benefits while minimizing long-term side effects, our results provide additional evidence that TAs outperform FCR in terms not only for PFS but also OS [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

Impact of Targeted Agents on Survival of Chronic Lymphocytic Leukemia Patients Fit for Fludarabine, Cyclophosphamide, and Rituximab (FCR) Relative to Age- and Sex-Matched Population

Molica,

Shanafelt,

Allsup

et al. 2024

Cancers

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To assess the impact of first-line treatment with targeted agents (TAs) or fludarabine, cyclophosphamide, and rituximab (FCR)-based chemo-immunotherapy (CIT) on overall survival (OS) compared to age- and sex-matched individuals in the general population, we conducted an aggregated analysis of phase 3 clinical trials, including the two FLAIR sub-studies, ECOG1912, and CLL13 trials. The restricted mean survival time (RMST), an alternative measure in outcome analyses capturing OS changes over the entire history of the disease, was used to minimize biases associated with the short follow-up time of trials. Patients treated with TAs demonstrated a higher 5-year RMST (58.1 months; 95% CI: 57.4 to 58.8) compared to those treated with CIT (5-year RMST, 56.9 months; 95% CI: 56.7–58.2). Furthermore, the OS comparison of treatment groups with the AGMGP suggests that TAs may mitigate the impact of CLL on OS during the first five years post-treatment initiation. In summary, the 5-year RMST difference was −0.4 months (95% CI: −0.8 to 0.2; p = 0.10) when comparing CLL patients treated with TAs to the Italian age- and gender-matched general population (AGMGP). A similar trend was observed when CLL patients treated with TAs were compared to the US AGMGP (5-year RMST difference, 0.3 months; 95% CI: −0.1 to 0.9; p = 0.12). In contrast, CLL patients treated with FCR exhibited sustained OS differences when compared to both the Italian cohort (5-year RMST difference: −1.6 months; 95% CI: −2.4 to −0.9; p < 0.0001) and the US AGMGP cohort (5-year RMST difference: −0.9 months; 95% CI: −1.7 to −0.2; p = 0.015). Although these results support TAs as the preferred first-line treatment for younger CLL patients, it is crucial to acknowledge that variations in patient selection criteria and clinical profiles across clinical trials necessitate a cautious interpretation of these findings that should be viewed as directional and hypothesis-generating. A longer follow-up is needed to assess the survival improvement of younger CLL patients treated with TAs relative to the AGMGP.

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Section: Discussionmentioning

confidence: 99%

Impact of Targeted Agents on Survival of Chronic Lymphocytic Leukemia Patients Fit for Fludarabine, Cyclophosphamide, and Rituximab (FCR) Relative to Age- and Sex-Matched Population

Molica,

Shanafelt,

Allsup

et al. 2024

Cancers

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Targeted therapies have improved outcome for patients with chronic lymphocytic leukemia (CLL), offering the potential for long-term disease control and the promise of a normal lifespan for many patients. 1,2

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confidence: 99%

Impact of targeted agents on survival of chronic lymphocytic leukemia patients age >65 relative to age‐ and sex‐matched population

Molica,

Shanafelt,

Allsup

et al. 2023

American J Hematol

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Fixed-duration therapy comes of age in CLL: long-term results of MURANO and CLL14 trials

Molica,

Allsup

2023

Expert Review of Anticancer Therapy

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Redefining efficacy and safety endpoints for chronic lymphocytic leukemia in the era of targeted therapy

Cited by 5 publications

References 31 publications

Impact of Targeted Agents on Survival of Chronic Lymphocytic Leukemia Patients Fit for Fludarabine, Cyclophosphamide, and Rituximab (FCR) Relative to Age- and Sex-Matched Population

Impact of Targeted Agents on Survival of Chronic Lymphocytic Leukemia Patients Fit for Fludarabine, Cyclophosphamide, and Rituximab (FCR) Relative to Age- and Sex-Matched Population

Impact of targeted agents on survival of chronic lymphocytic leukemia patients age >65 relative to age‐ and sex‐matched population

Fixed-duration therapy comes of age in CLL: long-term results of MURANO and CLL14 trials

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