Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World
The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients. Herein, we report updated survival data, post-progression managemen...
Gespeichert in:
| Veröffentlicht in: | The oncologist (Dayton, Ohio) Ohio), 2024-07, Vol.29 (7), p.596-608 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 608 |
|---|---|
| container_issue | 7 |
| container_start_page | 596 |
| container_title | The oncologist (Dayton, Ohio) |
| container_volume | 29 |
| creator | Pasello, Giulia Lorenzi, Martina Scattolin, Daniela Del Conte, Alessandro Cecere, Fabiana Pavan, Alberto Macerelli, Marianna Polo, Valentina Pilotto, Sara Santarpia, Mariacarmela Cumerlato, Enrico Da Ros, Valentina Targato, Giada Bortolami, Alberto Bonanno, Laura Ferro, Alessandra Dal Maso, Alessandro Frega, Stefano Guarneri, Valentina |
| description | The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients.
Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib.
Overall, 189 Caucasian patients receiving first-line osimertinib were included. After a follow-up of 20.7 months, 74(39.2%) patients discontinued osimertinib, median time-to-treatment discontinuation (mTTD) was 27.9 months, overall survival 36.8 months. At progression, tissue biopsy was performed in 29 (56.9%), liquid biopsy in 15 (29.4%) and both in 7 (13.7%) cases. The most frequent resistant mechanism was MET amplification (N = 14, 29.8%). At data cutoff, 13 (6.9%) patients were continuing osimertinib beyond progression; 52 (67.5%) received second-line treatment; no further treatments were administered in 25 (32.5%) cases. Thirty-three (63.4%) patients received chemotherapy, 12(23.1%) TKIs combination. Cost-effectiveness analysis showed a total cost per patient based on RW mTTD of 98,957.34€, 21,726.28€ and 19,637.83€ for osimertinib, erlotinib and gefitinib, respectively. The incremental cost-effectiveness ratio (ICER)/month for osimertinib was 359,806.0€/life-year-gained (LYG) and 197,789.77€/LYG compared to erlotinib and gefitinib. For osimertinib, the BI-gap between RW-TTD and theoretical-TTD was 16,501.0€ per patient.
This updated analysis confirms the effectiveness of osimertinib in RW. Although the ICER of osimertinib seems not cost-effective, additional costs for the management of disease progression to old generation TKIs were not considered in this study. The BI-gap suggests RW mTTD as a more reliable measure for expense estimation. |
| doi_str_mv | 10.1093/oncolo/oyae043 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11224988</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A804865845</galeid><sourcerecordid>A804865845</sourcerecordid><originalsourceid>FETCH-LOGICAL-c343t-3c23ef255173b5c3119e7a0b4a971a301e9cc122cf57e3f09505625d237de86a3</originalsourceid><addsrcrecordid>eNptkk1r3DAQhk1paT7aa49F0EsPcSJZ1trqpWyXJA1ssiFNSW9iVh47Kra0leSF_U39k9Wy29BCEEgjzTMvM-LNsneMnjIq-Zmz2vXuzG0AaclfZIdMlDIvJf3xMsW05nnFhDzIjkL4SWkKefE6O-C1KGhVisPs9yKYAX001iyJseQWokEbA3kw8ZHce4Q4pHt-A2aN5Pzy4i6_HiPYSG6czcMAfU9mmLb5aDsyA6vRfyKLNfpt5tvo12YN_Qm5dSHmK-86jyEYZ8k1WOhwq03ANuTL2HQYydWwAh3J1EK_CSZsO7pD6PMH5_vmTfaqhT7g2_15nH2_OL-ffc3ni8ur2XSea17ymHNdcGwLIVjFl0JzxiRWQJclyIoBpwyl1qwodCsq5C2VgopJIZqCVw3WE-DH2eed7mpcDtjo1GOaRq28GcBvlAOj_s9Y86g6t1YsqZayrpPCx72Cd79GDFENJuj0TWDRjUEVsiopnYhKJvTDDu2gR2Vs65Kk3uJqWtOynoi6FIk6fYZKq8HBaGexNen9uQLtXQge26f2GVVb56idc9TeOang_b9DP-F_rcL_AOlww1Q</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2974006579</pqid></control><display><type>article</type><title>Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World</title><source>Oxford Journals Open Access Collection</source><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Pasello, Giulia ; Lorenzi, Martina ; Scattolin, Daniela ; Del Conte, Alessandro ; Cecere, Fabiana ; Pavan, Alberto ; Macerelli, Marianna ; Polo, Valentina ; Pilotto, Sara ; Santarpia, Mariacarmela ; Cumerlato, Enrico ; Da Ros, Valentina ; Targato, Giada ; Bortolami, Alberto ; Bonanno, Laura ; Ferro, Alessandra ; Dal Maso, Alessandro ; Frega, Stefano ; Guarneri, Valentina</creator><creatorcontrib>Pasello, Giulia ; Lorenzi, Martina ; Scattolin, Daniela ; Del Conte, Alessandro ; Cecere, Fabiana ; Pavan, Alberto ; Macerelli, Marianna ; Polo, Valentina ; Pilotto, Sara ; Santarpia, Mariacarmela ; Cumerlato, Enrico ; Da Ros, Valentina ; Targato, Giada ; Bortolami, Alberto ; Bonanno, Laura ; Ferro, Alessandra ; Dal Maso, Alessandro ; Frega, Stefano ; Guarneri, Valentina</creatorcontrib><description>The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients.
Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib.
Overall, 189 Caucasian patients receiving first-line osimertinib were included. After a follow-up of 20.7 months, 74(39.2%) patients discontinued osimertinib, median time-to-treatment discontinuation (mTTD) was 27.9 months, overall survival 36.8 months. At progression, tissue biopsy was performed in 29 (56.9%), liquid biopsy in 15 (29.4%) and both in 7 (13.7%) cases. The most frequent resistant mechanism was MET amplification (N = 14, 29.8%). At data cutoff, 13 (6.9%) patients were continuing osimertinib beyond progression; 52 (67.5%) received second-line treatment; no further treatments were administered in 25 (32.5%) cases. Thirty-three (63.4%) patients received chemotherapy, 12(23.1%) TKIs combination. Cost-effectiveness analysis showed a total cost per patient based on RW mTTD of 98,957.34€, 21,726.28€ and 19,637.83€ for osimertinib, erlotinib and gefitinib, respectively. The incremental cost-effectiveness ratio (ICER)/month for osimertinib was 359,806.0€/life-year-gained (LYG) and 197,789.77€/LYG compared to erlotinib and gefitinib. For osimertinib, the BI-gap between RW-TTD and theoretical-TTD was 16,501.0€ per patient.
This updated analysis confirms the effectiveness of osimertinib in RW. Although the ICER of osimertinib seems not cost-effective, additional costs for the management of disease progression to old generation TKIs were not considered in this study. The BI-gap suggests RW mTTD as a more reliable measure for expense estimation.</description><identifier>ISSN: 1083-7159</identifier><identifier>ISSN: 1549-490X</identifier><identifier>EISSN: 1549-490X</identifier><identifier>DOI: 10.1093/oncolo/oyae043</identifier><identifier>PMID: 38520745</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Acrylamides - economics ; Acrylamides - pharmacology ; Acrylamides - therapeutic use ; Adult ; Aged ; Aged, 80 and over ; Aniline Compounds - economics ; Aniline Compounds - therapeutic use ; Antineoplastic Agents - economics ; Antineoplastic Agents - therapeutic use ; Cancer ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - economics ; Carcinoma, Non-Small-Cell Lung - genetics ; Carcinoma, Non-Small-Cell Lung - mortality ; Carcinoma, Non-Small-Cell Lung - pathology ; Care and treatment ; Cell receptors ; Cost-Benefit Analysis ; Disease Progression ; Drug therapy ; ErbB Receptors - genetics ; Erlotinib Hydrochloride - economics ; Erlotinib Hydrochloride - therapeutic use ; Female ; Gefitinib - economics ; Gefitinib - therapeutic use ; Health aspects ; Humans ; Indoles ; Lung Cancer ; Lung cancer, Non-small cell ; Lung Neoplasms - drug therapy ; Lung Neoplasms - economics ; Lung Neoplasms - genetics ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Male ; Medical care, Cost of ; Middle Aged ; Mutation ; Pharmacology, Experimental ; Physiological aspects ; Prognosis ; Prospective Studies ; Pyrimidines</subject><ispartof>The oncologist (Dayton, Ohio), 2024-07, Vol.29 (7), p.596-608</ispartof><rights>The Author(s) 2024. Published by Oxford University Press.</rights><rights>COPYRIGHT 2024 Oxford University Press</rights><rights>The Author(s) 2024. Published by Oxford University Press. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0003-4874-0422 ; 0000-0002-1163-3765 ; 0000-0002-2375-8397 ; 0000-0003-2229-4874 ; 0000-0003-3743-717X ; 0000-0002-2998-5072 ; 0000-0001-5218-4970 ; 0000-0002-8741-6038</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11224988/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11224988/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38520745$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pasello, Giulia</creatorcontrib><creatorcontrib>Lorenzi, Martina</creatorcontrib><creatorcontrib>Scattolin, Daniela</creatorcontrib><creatorcontrib>Del Conte, Alessandro</creatorcontrib><creatorcontrib>Cecere, Fabiana</creatorcontrib><creatorcontrib>Pavan, Alberto</creatorcontrib><creatorcontrib>Macerelli, Marianna</creatorcontrib><creatorcontrib>Polo, Valentina</creatorcontrib><creatorcontrib>Pilotto, Sara</creatorcontrib><creatorcontrib>Santarpia, Mariacarmela</creatorcontrib><creatorcontrib>Cumerlato, Enrico</creatorcontrib><creatorcontrib>Da Ros, Valentina</creatorcontrib><creatorcontrib>Targato, Giada</creatorcontrib><creatorcontrib>Bortolami, Alberto</creatorcontrib><creatorcontrib>Bonanno, Laura</creatorcontrib><creatorcontrib>Ferro, Alessandra</creatorcontrib><creatorcontrib>Dal Maso, Alessandro</creatorcontrib><creatorcontrib>Frega, Stefano</creatorcontrib><creatorcontrib>Guarneri, Valentina</creatorcontrib><title>Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World</title><title>The oncologist (Dayton, Ohio)</title><addtitle>Oncologist</addtitle><description>The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients.
Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib.
Overall, 189 Caucasian patients receiving first-line osimertinib were included. After a follow-up of 20.7 months, 74(39.2%) patients discontinued osimertinib, median time-to-treatment discontinuation (mTTD) was 27.9 months, overall survival 36.8 months. At progression, tissue biopsy was performed in 29 (56.9%), liquid biopsy in 15 (29.4%) and both in 7 (13.7%) cases. The most frequent resistant mechanism was MET amplification (N = 14, 29.8%). At data cutoff, 13 (6.9%) patients were continuing osimertinib beyond progression; 52 (67.5%) received second-line treatment; no further treatments were administered in 25 (32.5%) cases. Thirty-three (63.4%) patients received chemotherapy, 12(23.1%) TKIs combination. Cost-effectiveness analysis showed a total cost per patient based on RW mTTD of 98,957.34€, 21,726.28€ and 19,637.83€ for osimertinib, erlotinib and gefitinib, respectively. The incremental cost-effectiveness ratio (ICER)/month for osimertinib was 359,806.0€/life-year-gained (LYG) and 197,789.77€/LYG compared to erlotinib and gefitinib. For osimertinib, the BI-gap between RW-TTD and theoretical-TTD was 16,501.0€ per patient.
This updated analysis confirms the effectiveness of osimertinib in RW. Although the ICER of osimertinib seems not cost-effective, additional costs for the management of disease progression to old generation TKIs were not considered in this study. The BI-gap suggests RW mTTD as a more reliable measure for expense estimation.</description><subject>Acrylamides - economics</subject><subject>Acrylamides - pharmacology</subject><subject>Acrylamides - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aniline Compounds - economics</subject><subject>Aniline Compounds - therapeutic use</subject><subject>Antineoplastic Agents - economics</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Cancer</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - economics</subject><subject>Carcinoma, Non-Small-Cell Lung - genetics</subject><subject>Carcinoma, Non-Small-Cell Lung - mortality</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Care and treatment</subject><subject>Cell receptors</subject><subject>Cost-Benefit Analysis</subject><subject>Disease Progression</subject><subject>Drug therapy</subject><subject>ErbB Receptors - genetics</subject><subject>Erlotinib Hydrochloride - economics</subject><subject>Erlotinib Hydrochloride - therapeutic use</subject><subject>Female</subject><subject>Gefitinib - economics</subject><subject>Gefitinib - therapeutic use</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Indoles</subject><subject>Lung Cancer</subject><subject>Lung cancer, Non-small cell</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - economics</subject><subject>Lung Neoplasms - genetics</subject><subject>Lung Neoplasms - mortality</subject><subject>Lung Neoplasms - pathology</subject><subject>Male</subject><subject>Medical care, Cost of</subject><subject>Middle Aged</subject><subject>Mutation</subject><subject>Pharmacology, Experimental</subject><subject>Physiological aspects</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Pyrimidines</subject><issn>1083-7159</issn><issn>1549-490X</issn><issn>1549-490X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNptkk1r3DAQhk1paT7aa49F0EsPcSJZ1trqpWyXJA1ssiFNSW9iVh47Kra0leSF_U39k9Wy29BCEEgjzTMvM-LNsneMnjIq-Zmz2vXuzG0AaclfZIdMlDIvJf3xMsW05nnFhDzIjkL4SWkKefE6O-C1KGhVisPs9yKYAX001iyJseQWokEbA3kw8ZHce4Q4pHt-A2aN5Pzy4i6_HiPYSG6czcMAfU9mmLb5aDsyA6vRfyKLNfpt5tvo12YN_Qm5dSHmK-86jyEYZ8k1WOhwq03ANuTL2HQYydWwAh3J1EK_CSZsO7pD6PMH5_vmTfaqhT7g2_15nH2_OL-ffc3ni8ur2XSea17ymHNdcGwLIVjFl0JzxiRWQJclyIoBpwyl1qwodCsq5C2VgopJIZqCVw3WE-DH2eed7mpcDtjo1GOaRq28GcBvlAOj_s9Y86g6t1YsqZayrpPCx72Cd79GDFENJuj0TWDRjUEVsiopnYhKJvTDDu2gR2Vs65Kk3uJqWtOynoi6FIk6fYZKq8HBaGexNen9uQLtXQge26f2GVVb56idc9TeOang_b9DP-F_rcL_AOlww1Q</recordid><startdate>20240705</startdate><enddate>20240705</enddate><creator>Pasello, Giulia</creator><creator>Lorenzi, Martina</creator><creator>Scattolin, Daniela</creator><creator>Del Conte, Alessandro</creator><creator>Cecere, Fabiana</creator><creator>Pavan, Alberto</creator><creator>Macerelli, Marianna</creator><creator>Polo, Valentina</creator><creator>Pilotto, Sara</creator><creator>Santarpia, Mariacarmela</creator><creator>Cumerlato, Enrico</creator><creator>Da Ros, Valentina</creator><creator>Targato, Giada</creator><creator>Bortolami, Alberto</creator><creator>Bonanno, Laura</creator><creator>Ferro, Alessandra</creator><creator>Dal Maso, Alessandro</creator><creator>Frega, Stefano</creator><creator>Guarneri, Valentina</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-4874-0422</orcidid><orcidid>https://orcid.org/0000-0002-1163-3765</orcidid><orcidid>https://orcid.org/0000-0002-2375-8397</orcidid><orcidid>https://orcid.org/0000-0003-2229-4874</orcidid><orcidid>https://orcid.org/0000-0003-3743-717X</orcidid><orcidid>https://orcid.org/0000-0002-2998-5072</orcidid><orcidid>https://orcid.org/0000-0001-5218-4970</orcidid><orcidid>https://orcid.org/0000-0002-8741-6038</orcidid></search><sort><creationdate>20240705</creationdate><title>Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World</title><author>Pasello, Giulia ; Lorenzi, Martina ; Scattolin, Daniela ; Del Conte, Alessandro ; Cecere, Fabiana ; Pavan, Alberto ; Macerelli, Marianna ; Polo, Valentina ; Pilotto, Sara ; Santarpia, Mariacarmela ; Cumerlato, Enrico ; Da Ros, Valentina ; Targato, Giada ; Bortolami, Alberto ; Bonanno, Laura ; Ferro, Alessandra ; Dal Maso, Alessandro ; Frega, Stefano ; Guarneri, Valentina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c343t-3c23ef255173b5c3119e7a0b4a971a301e9cc122cf57e3f09505625d237de86a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Acrylamides - economics</topic><topic>Acrylamides - pharmacology</topic><topic>Acrylamides - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Aniline Compounds - economics</topic><topic>Aniline Compounds - therapeutic use</topic><topic>Antineoplastic Agents - economics</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Cancer</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - economics</topic><topic>Carcinoma, Non-Small-Cell Lung - genetics</topic><topic>Carcinoma, Non-Small-Cell Lung - mortality</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Care and treatment</topic><topic>Cell receptors</topic><topic>Cost-Benefit Analysis</topic><topic>Disease Progression</topic><topic>Drug therapy</topic><topic>ErbB Receptors - genetics</topic><topic>Erlotinib Hydrochloride - economics</topic><topic>Erlotinib Hydrochloride - therapeutic use</topic><topic>Female</topic><topic>Gefitinib - economics</topic><topic>Gefitinib - therapeutic use</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Indoles</topic><topic>Lung Cancer</topic><topic>Lung cancer, Non-small cell</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - economics</topic><topic>Lung Neoplasms - genetics</topic><topic>Lung Neoplasms - mortality</topic><topic>Lung Neoplasms - pathology</topic><topic>Male</topic><topic>Medical care, Cost of</topic><topic>Middle Aged</topic><topic>Mutation</topic><topic>Pharmacology, Experimental</topic><topic>Physiological aspects</topic><topic>Prognosis</topic><topic>Prospective Studies</topic><topic>Pyrimidines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pasello, Giulia</creatorcontrib><creatorcontrib>Lorenzi, Martina</creatorcontrib><creatorcontrib>Scattolin, Daniela</creatorcontrib><creatorcontrib>Del Conte, Alessandro</creatorcontrib><creatorcontrib>Cecere, Fabiana</creatorcontrib><creatorcontrib>Pavan, Alberto</creatorcontrib><creatorcontrib>Macerelli, Marianna</creatorcontrib><creatorcontrib>Polo, Valentina</creatorcontrib><creatorcontrib>Pilotto, Sara</creatorcontrib><creatorcontrib>Santarpia, Mariacarmela</creatorcontrib><creatorcontrib>Cumerlato, Enrico</creatorcontrib><creatorcontrib>Da Ros, Valentina</creatorcontrib><creatorcontrib>Targato, Giada</creatorcontrib><creatorcontrib>Bortolami, Alberto</creatorcontrib><creatorcontrib>Bonanno, Laura</creatorcontrib><creatorcontrib>Ferro, Alessandra</creatorcontrib><creatorcontrib>Dal Maso, Alessandro</creatorcontrib><creatorcontrib>Frega, Stefano</creatorcontrib><creatorcontrib>Guarneri, Valentina</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The oncologist (Dayton, Ohio)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pasello, Giulia</au><au>Lorenzi, Martina</au><au>Scattolin, Daniela</au><au>Del Conte, Alessandro</au><au>Cecere, Fabiana</au><au>Pavan, Alberto</au><au>Macerelli, Marianna</au><au>Polo, Valentina</au><au>Pilotto, Sara</au><au>Santarpia, Mariacarmela</au><au>Cumerlato, Enrico</au><au>Da Ros, Valentina</au><au>Targato, Giada</au><au>Bortolami, Alberto</au><au>Bonanno, Laura</au><au>Ferro, Alessandra</au><au>Dal Maso, Alessandro</au><au>Frega, Stefano</au><au>Guarneri, Valentina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World</atitle><jtitle>The oncologist (Dayton, Ohio)</jtitle><addtitle>Oncologist</addtitle><date>2024-07-05</date><risdate>2024</risdate><volume>29</volume><issue>7</issue><spage>596</spage><epage>608</epage><pages>596-608</pages><issn>1083-7159</issn><issn>1549-490X</issn><eissn>1549-490X</eissn><abstract>The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients.
Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib.
Overall, 189 Caucasian patients receiving first-line osimertinib were included. After a follow-up of 20.7 months, 74(39.2%) patients discontinued osimertinib, median time-to-treatment discontinuation (mTTD) was 27.9 months, overall survival 36.8 months. At progression, tissue biopsy was performed in 29 (56.9%), liquid biopsy in 15 (29.4%) and both in 7 (13.7%) cases. The most frequent resistant mechanism was MET amplification (N = 14, 29.8%). At data cutoff, 13 (6.9%) patients were continuing osimertinib beyond progression; 52 (67.5%) received second-line treatment; no further treatments were administered in 25 (32.5%) cases. Thirty-three (63.4%) patients received chemotherapy, 12(23.1%) TKIs combination. Cost-effectiveness analysis showed a total cost per patient based on RW mTTD of 98,957.34€, 21,726.28€ and 19,637.83€ for osimertinib, erlotinib and gefitinib, respectively. The incremental cost-effectiveness ratio (ICER)/month for osimertinib was 359,806.0€/life-year-gained (LYG) and 197,789.77€/LYG compared to erlotinib and gefitinib. For osimertinib, the BI-gap between RW-TTD and theoretical-TTD was 16,501.0€ per patient.
This updated analysis confirms the effectiveness of osimertinib in RW. Although the ICER of osimertinib seems not cost-effective, additional costs for the management of disease progression to old generation TKIs were not considered in this study. The BI-gap suggests RW mTTD as a more reliable measure for expense estimation.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>38520745</pmid><doi>10.1093/oncolo/oyae043</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0003-4874-0422</orcidid><orcidid>https://orcid.org/0000-0002-1163-3765</orcidid><orcidid>https://orcid.org/0000-0002-2375-8397</orcidid><orcidid>https://orcid.org/0000-0003-2229-4874</orcidid><orcidid>https://orcid.org/0000-0003-3743-717X</orcidid><orcidid>https://orcid.org/0000-0002-2998-5072</orcidid><orcidid>https://orcid.org/0000-0001-5218-4970</orcidid><orcidid>https://orcid.org/0000-0002-8741-6038</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1083-7159 |
| ispartof | The oncologist (Dayton, Ohio), 2024-07, Vol.29 (7), p.596-608 |
| issn | 1083-7159 1549-490X 1549-490X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11224988 |
| source | Oxford Journals Open Access Collection; MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Acrylamides - economics Acrylamides - pharmacology Acrylamides - therapeutic use Adult Aged Aged, 80 and over Aniline Compounds - economics Aniline Compounds - therapeutic use Antineoplastic Agents - economics Antineoplastic Agents - therapeutic use Cancer Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - economics Carcinoma, Non-Small-Cell Lung - genetics Carcinoma, Non-Small-Cell Lung - mortality Carcinoma, Non-Small-Cell Lung - pathology Care and treatment Cell receptors Cost-Benefit Analysis Disease Progression Drug therapy ErbB Receptors - genetics Erlotinib Hydrochloride - economics Erlotinib Hydrochloride - therapeutic use Female Gefitinib - economics Gefitinib - therapeutic use Health aspects Humans Indoles Lung Cancer Lung cancer, Non-small cell Lung Neoplasms - drug therapy Lung Neoplasms - economics Lung Neoplasms - genetics Lung Neoplasms - mortality Lung Neoplasms - pathology Male Medical care, Cost of Middle Aged Mutation Pharmacology, Experimental Physiological aspects Prognosis Prospective Studies Pyrimidines |
| title | Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-27T14%3A05%3A32IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Osimertinib%20in%20Patients%20With%20Treatment-Naive%20EGFR-Mutant%20Non-small%20Cell%20Lung%20Cancer:%20Overall%20Survival,%20Post-progression%20Management%20and%20Budget%20Impact%20Analysis%20in%20Real-World&rft.jtitle=The%20oncologist%20(Dayton,%20Ohio)&rft.au=Pasello,%20Giulia&rft.date=2024-07-05&rft.volume=29&rft.issue=7&rft.spage=596&rft.epage=608&rft.pages=596-608&rft.issn=1083-7159&rft.eissn=1549-490X&rft_id=info:doi/10.1093/oncolo/oyae043&rft_dat=%3Cgale_pubme%3EA804865845%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2974006579&rft_id=info:pmid/38520745&rft_galeid=A804865845&rfr_iscdi=true |