Valentina Giai MD, PhD, Tiziana Rosso MSc, PhD, Fausto Castagnetti MD, PhD, Patrizia Pregno MD, Massimiliano Bonifacio MD, PhD, Isabella Capodanno MD, Mario Tiribelli MD, PhD, Fabio Stagno MD, PhD, Giovanni Caocci MD, PhD, Antonella Gozzini MD, Luigiana Luciano MD, Sara Galimberti MD, PhD, Monica Bocchia MD, PhD, Andrea Patriarca MD, Giuseppe Lanzarone MD, Bruno Martino MD, Anna Guella MD, Anna Rita Scortechini MD, Carmen Fava MD, PhD, Claudio Fozza MD, PhD, Simona Sica MD, PhD, Nicola Di Renzo MD, Pellegrino Musto MD, PhD, Domenico Pastore MD, PhD, Alessandro Maggi MD, Michele Pizzuti MD, Lorella Maria Antonia Melillo MD, Angelo Michele Carella MD, PhD, Giuseppe Tarantini MD, Anna Mele MD, Elisabetta Calistri MD, Maria Rosaria Coppi MD, Fabio Saccona MSc, Emilia Scalzulli MD, Beatrice Battaglio MD, Miriam Iezza MD, Cinzia Bitetti MD, Roberto Freilone MD, Gianantonio Rosti MD, Francesco Albano MD, PhD, Fabrizio Pane MD, PhD, Giorgina Specchia MD, PhD, Giovannino Ciccone MD, PhD, Giuseppe Saglio MD, PhD, Massimo Breccia MD
{"title":"现实世界中基线风险和一线治疗的慢性髓性白血病结局：来自意大利网络/CML校园的数据","authors":"Valentina Giai MD, PhD, Tiziana Rosso MSc, PhD, Fausto Castagnetti MD, PhD, Patrizia Pregno MD, Massimiliano Bonifacio MD, PhD, Isabella Capodanno MD, Mario Tiribelli MD, PhD, Fabio Stagno MD, PhD, Giovanni Caocci MD, PhD, Antonella Gozzini MD, Luigiana Luciano MD, Sara Galimberti MD, PhD, Monica Bocchia MD, PhD, Andrea Patriarca MD, Giuseppe Lanzarone MD, Bruno Martino MD, Anna Guella MD, Anna Rita Scortechini MD, Carmen Fava MD, PhD, Claudio Fozza MD, PhD, Simona Sica MD, PhD, Nicola Di Renzo MD, Pellegrino Musto MD, PhD, Domenico Pastore MD, PhD, Alessandro Maggi MD, Michele Pizzuti MD, Lorella Maria Antonia Melillo MD, Angelo Michele Carella MD, PhD, Giuseppe Tarantini MD, Anna Mele MD, Elisabetta Calistri MD, Maria Rosaria Coppi MD, Fabio Saccona MSc, Emilia Scalzulli MD, Beatrice Battaglio MD, Miriam Iezza MD, Cinzia Bitetti MD, Roberto Freilone MD, Gianantonio Rosti MD, Francesco Albano MD, PhD, Fabrizio Pane MD, PhD, Giorgina Specchia MD, PhD, Giovannino Ciccone MD, PhD, Giuseppe Saglio MD, PhD, Massimo Breccia MD","doi":"10.1002/cncr.35963","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Improved outcome has been reported in chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) in sponsored trials.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This is a multicenter prospective cohort study of consecutive patients with newly diagnosed chronic phase CML from 19 regions in Italy. Baseline treatments and prognostic factors on time to first optimal molecular response (≥ molecular response 3, MR3), time to disease progression, time to death from CML, and overall survival (OS) were analyzed using multivariable Fine and Gray models.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>The authors included 1433 CML patients: 49% (median age, 70 years) treated with frontline imatinib (IMA), and 51% treated with second-generation TKIs (2G-TKIs; median age, 52 years). EUTOS long-term survival (ELTS) was low in 68.1% of 2G-TKIs patients, compared to 50.4% of IMA patients. Faster molecular responses were observed with 2G-TKIs within the first 6 months and maintained thereafter (subhazard ratio [sHR], 1.31; 95% confidence interval [CI], 1.15–1.50). Female gender and low ELTS risk had faster time of response. Achieving major molecular response (MMR or MR3) was associated with reduced risk of progression at 6 and 12 months. Overall, 41 patients progressed without differences between IMA and 2G-TKIs. Intermediate and high risk ELTS showed higher risk of progression and death from CML. Twenty-two CML-related deaths (16.5%) occurred mostly in the first 2 years from diagnosis, higher in 2G-TKIs patients (sHR, 1.75; 95% CI, 0.52–5.87). OS at 5 years was 88% with no clear differences between IMA and 2G-TKIs treatment after adjustment for potential confounders.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>The study confirms faster responses with 2G-TKIs compared to IMA but similar clinical outcomes and a strong prognostic effect of ELTS.</p>\n </section>\n </div>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 13","pages":""},"PeriodicalIF":6.1000,"publicationDate":"2025-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cncr.35963","citationCount":"0","resultStr":"{\"title\":\"Chronic myeloid leukemia outcomes according to baseline risk and first-line treatment in real-world settings: Data from the Italian Network/CML Campus\",\"authors\":\"Valentina Giai MD, PhD, Tiziana Rosso MSc, PhD, Fausto Castagnetti MD, PhD, Patrizia Pregno MD, Massimiliano Bonifacio MD, PhD, Isabella Capodanno MD, Mario Tiribelli MD, PhD, Fabio Stagno MD, PhD, Giovanni Caocci MD, PhD, Antonella Gozzini MD, Luigiana Luciano MD, Sara Galimberti MD, PhD, Monica Bocchia MD, PhD, Andrea Patriarca MD, Giuseppe Lanzarone MD, Bruno Martino MD, Anna Guella MD, Anna Rita Scortechini MD, Carmen Fava MD, PhD, Claudio Fozza MD, PhD, Simona Sica MD, PhD, Nicola Di Renzo MD, Pellegrino Musto MD, PhD, Domenico Pastore MD, PhD, Alessandro Maggi MD, Michele Pizzuti MD, Lorella Maria Antonia Melillo MD, Angelo Michele Carella MD, PhD, Giuseppe Tarantini MD, Anna Mele MD, Elisabetta Calistri MD, Maria Rosaria Coppi MD, Fabio Saccona MSc, Emilia Scalzulli MD, Beatrice Battaglio MD, Miriam Iezza MD, Cinzia Bitetti MD, Roberto Freilone MD, Gianantonio Rosti MD, Francesco Albano MD, PhD, Fabrizio Pane MD, PhD, Giorgina Specchia MD, PhD, Giovannino Ciccone MD, PhD, Giuseppe Saglio MD, PhD, Massimo Breccia MD\",\"doi\":\"10.1002/cncr.35963\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Improved outcome has been reported in chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) in sponsored trials.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>This is a multicenter prospective cohort study of consecutive patients with newly diagnosed chronic phase CML from 19 regions in Italy. Baseline treatments and prognostic factors on time to first optimal molecular response (≥ molecular response 3, MR3), time to disease progression, time to death from CML, and overall survival (OS) were analyzed using multivariable Fine and Gray models.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>The authors included 1433 CML patients: 49% (median age, 70 years) treated with frontline imatinib (IMA), and 51% treated with second-generation TKIs (2G-TKIs; median age, 52 years). EUTOS long-term survival (ELTS) was low in 68.1% of 2G-TKIs patients, compared to 50.4% of IMA patients. Faster molecular responses were observed with 2G-TKIs within the first 6 months and maintained thereafter (subhazard ratio [sHR], 1.31; 95% confidence interval [CI], 1.15–1.50). Female gender and low ELTS risk had faster time of response. Achieving major molecular response (MMR or MR3) was associated with reduced risk of progression at 6 and 12 months. Overall, 41 patients progressed without differences between IMA and 2G-TKIs. Intermediate and high risk ELTS showed higher risk of progression and death from CML. Twenty-two CML-related deaths (16.5%) occurred mostly in the first 2 years from diagnosis, higher in 2G-TKIs patients (sHR, 1.75; 95% CI, 0.52–5.87). OS at 5 years was 88% with no clear differences between IMA and 2G-TKIs treatment after adjustment for potential confounders.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>The study confirms faster responses with 2G-TKIs compared to IMA but similar clinical outcomes and a strong prognostic effect of ELTS.</p>\\n </section>\\n </div>\",\"PeriodicalId\":138,\"journal\":{\"name\":\"Cancer\",\"volume\":\"131 13\",\"pages\":\"\"},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2025-06-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cncr.35963\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/cncr.35963\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/cncr.35963","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Chronic myeloid leukemia outcomes according to baseline risk and first-line treatment in real-world settings: Data from the Italian Network/CML Campus
Background
Improved outcome has been reported in chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs) in sponsored trials.
Methods
This is a multicenter prospective cohort study of consecutive patients with newly diagnosed chronic phase CML from 19 regions in Italy. Baseline treatments and prognostic factors on time to first optimal molecular response (≥ molecular response 3, MR3), time to disease progression, time to death from CML, and overall survival (OS) were analyzed using multivariable Fine and Gray models.
Results
The authors included 1433 CML patients: 49% (median age, 70 years) treated with frontline imatinib (IMA), and 51% treated with second-generation TKIs (2G-TKIs; median age, 52 years). EUTOS long-term survival (ELTS) was low in 68.1% of 2G-TKIs patients, compared to 50.4% of IMA patients. Faster molecular responses were observed with 2G-TKIs within the first 6 months and maintained thereafter (subhazard ratio [sHR], 1.31; 95% confidence interval [CI], 1.15–1.50). Female gender and low ELTS risk had faster time of response. Achieving major molecular response (MMR or MR3) was associated with reduced risk of progression at 6 and 12 months. Overall, 41 patients progressed without differences between IMA and 2G-TKIs. Intermediate and high risk ELTS showed higher risk of progression and death from CML. Twenty-two CML-related deaths (16.5%) occurred mostly in the first 2 years from diagnosis, higher in 2G-TKIs patients (sHR, 1.75; 95% CI, 0.52–5.87). OS at 5 years was 88% with no clear differences between IMA and 2G-TKIs treatment after adjustment for potential confounders.
Conclusions
The study confirms faster responses with 2G-TKIs compared to IMA but similar clinical outcomes and a strong prognostic effect of ELTS.
期刊介绍：
The CANCER site is a full-text, electronic implementation of CANCER, an Interdisciplinary International Journal of the American Cancer Society, and CANCER CYTOPATHOLOGY, a Journal of the American Cancer Society.
CANCER publishes interdisciplinary oncologic information according to, but not limited to, the following disease sites and disciplines: blood/bone marrow; breast disease; endocrine disorders; epidemiology; gastrointestinal tract; genitourinary disease; gynecologic oncology; head and neck disease; hepatobiliary tract; integrated medicine; lung disease; medical oncology; neuro-oncology; pathology radiation oncology; translational research
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