Purpose <p>Real-world evidence studies provide valuable information on clinical multi-kinase inhibitor (MKI) treatment approaches. Reported real-world (rw) progression-free-survival (rwPFS) and overall-survival (rwOS), and prognostic factors show considerable variability. We aimed to characterise clinicopathological features and identify prognostic factors of rwPFS and rwOS in patients with unresectable or metastatic radioactive iodine-refractory differentiated thyroid carcinoma (RAI-R DTC) treated with MKIs as part of routine clinical care across three medical centres in southeastern Spain.</p> Methods <p>Multicentre retrospective observational study based on real-world data. We analysed rwPFS, rwOS, objective response rate (ORR), disease control rate (DCR), adverse events (AEs) and adjusted risk factors. Statistical analysis comprised descriptive statistics, Kaplan–Meier curves, log-rank tests and multivariable Cox regression.</p> Results <p>Cohort of 58 patients. Median age at DTC diagnosis was 62.0&#xa0;years, at metastasis diagnosis 67&#xa0;years, and 55.2% were female. First-line MKIs comprised mostly sorafenib 55.2%, and lenvatinib 34.5%. Median follow-up was 37.13 (0.49–165.82)&#xa0;months. Median rwPFS and rwOS were 32.66 and 55.66&#xa0;months, respectively. ORR, DCR and AEs grade (3–4) rate were 41.2%, 88.2%, and 25.9%, respectively. Age ≥ 67&#xa0;years at metastasis diagnosis, AEs grade (3–4), and objective response were independent factors significantly associated with improved rwPFS whereas neutrophil-to-lymphocyte ratio (NLR) ≥ 3.5 was independently associated with shorter rwPFS and, in adjusted analysis, with shorter rwOS.</p> Conclusion <p>NLR ≥ 3.5 was independently associated with poorer rwPFS and, in adjusted analysis, with poorer rwOS, representing a low-cost candidate marker with potential utility to guide MKI therapy and patient selection that warrants prospective validation.</p>

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Real-world experience of clinicopathological features and survival predictors in radioactive iodine-refractory differentiated thyroid cancer treated with multi-kinase inhibitors: a multicentre study from southeastern Spain

  • Carlos Ayala-de Miguel,
  • Miguel Ángel Berciano-Guerrero,
  • Manuel Chaves-Conde,
  • Pablo Ayala-de Miguel

摘要

Purpose

Real-world evidence studies provide valuable information on clinical multi-kinase inhibitor (MKI) treatment approaches. Reported real-world (rw) progression-free-survival (rwPFS) and overall-survival (rwOS), and prognostic factors show considerable variability. We aimed to characterise clinicopathological features and identify prognostic factors of rwPFS and rwOS in patients with unresectable or metastatic radioactive iodine-refractory differentiated thyroid carcinoma (RAI-R DTC) treated with MKIs as part of routine clinical care across three medical centres in southeastern Spain.

Methods

Multicentre retrospective observational study based on real-world data. We analysed rwPFS, rwOS, objective response rate (ORR), disease control rate (DCR), adverse events (AEs) and adjusted risk factors. Statistical analysis comprised descriptive statistics, Kaplan–Meier curves, log-rank tests and multivariable Cox regression.

Results

Cohort of 58 patients. Median age at DTC diagnosis was 62.0 years, at metastasis diagnosis 67 years, and 55.2% were female. First-line MKIs comprised mostly sorafenib 55.2%, and lenvatinib 34.5%. Median follow-up was 37.13 (0.49–165.82) months. Median rwPFS and rwOS were 32.66 and 55.66 months, respectively. ORR, DCR and AEs grade (3–4) rate were 41.2%, 88.2%, and 25.9%, respectively. Age ≥ 67 years at metastasis diagnosis, AEs grade (3–4), and objective response were independent factors significantly associated with improved rwPFS whereas neutrophil-to-lymphocyte ratio (NLR) ≥ 3.5 was independently associated with shorter rwPFS and, in adjusted analysis, with shorter rwOS.

Conclusion

NLR ≥ 3.5 was independently associated with poorer rwPFS and, in adjusted analysis, with poorer rwOS, representing a low-cost candidate marker with potential utility to guide MKI therapy and patient selection that warrants prospective validation.