Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database
Avelumab has been approved worldwide for treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. This study evaluated outcomes in patients with mMCC in France who received avelumab as second-line or later (2L+) treatment in routine clinical practice. This retrospecti...
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| Veröffentlicht in: | European journal of cancer (1990) 2024-09, Vol.209, p.114261, Article 114261 |
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| creator | Mortier, Laurent Blom, Astrid van Hille, Benoît Samimi, Mahtab Luciani, Laura Cahuzac, Capucine Robert, Caroline Quereux, Gaelle Maubec, Eve Miotti, Hakima Maillard, Cathy Aubin, François Lenormand, Cédric Solbes, Marie-Noëlle Joly, Pascal Kachaner, Isabelle Lebbé, Céleste Dutriaux, Caroline Saiag, Philippe |
| description | Avelumab has been approved worldwide for treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. This study evaluated outcomes in patients with mMCC in France who received avelumab as second-line or later (2L+) treatment in routine clinical practice.
This retrospective, noninterventional study evaluated all patients diagnosed with mMCC using two databases: CARADERM (French national database of rare dermatological cancers) and SNDS (national healthcare database), identified via probabilistic linkage. Eligible patients initiated avelumab as 2L+ treatment between August 2016 and December 2019 and were followed for 24 months. The primary endpoint was overall survival (OS) at 24 months.
Overall, 180 patients who received 2L+ avelumab were identified (112 from CARADERM, 68 after SNDS linkage). Median age at diagnosis was 74.0 years and 177 (98.3 %) had received chemotherapy alone as first-line treatment. Median follow-up was 13.1 months. Median OS from start of avelumab was 14.6 months (95 % CI, 9.9–21.3) in the overall population, 15.9 months (95 % CI, 8.6–28.3) in CARADERM patients, and 13.3 months (95 % CI, 6.7–19.1) in non-CARADERM patients. OS rates at 12 and 24 months were 53.8 % (95 % CI, 46.2 %−60.8 %) and 40.5 % (95 % CI, 33.2 %−47.6 %), respectively. In evaluable patients (CARADERM database), median progression-free survival was 3.6 months (95 % CI, 2.7–7.5) and the objective response rate was 55.3 % (95 % CI, 45.3–65.4), including complete response in 31.9 %.
Real-world outcomes with 2L+ avelumab treatment for mMCC are consistent with clinical trial findings, supporting the recommendation of avelumab as a standard of care.
•This study examined patients with metastatic Merkel cell carcinoma in France.•180 patients who received second-line or later avelumab treatment were identified.•Median overall survival was 14.6 months and 24-month overall survival was 40.5 %.•Objective response rate was 55.3 % including complete response in 31.9 %.•Findings support the use of avelumab treatment for patients with this disease. |
| doi_str_mv | 10.1016/j.ejca.2024.114261 |
| format | Article |
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This retrospective, noninterventional study evaluated all patients diagnosed with mMCC using two databases: CARADERM (French national database of rare dermatological cancers) and SNDS (national healthcare database), identified via probabilistic linkage. Eligible patients initiated avelumab as 2L+ treatment between August 2016 and December 2019 and were followed for 24 months. The primary endpoint was overall survival (OS) at 24 months.
Overall, 180 patients who received 2L+ avelumab were identified (112 from CARADERM, 68 after SNDS linkage). Median age at diagnosis was 74.0 years and 177 (98.3 %) had received chemotherapy alone as first-line treatment. Median follow-up was 13.1 months. Median OS from start of avelumab was 14.6 months (95 % CI, 9.9–21.3) in the overall population, 15.9 months (95 % CI, 8.6–28.3) in CARADERM patients, and 13.3 months (95 % CI, 6.7–19.1) in non-CARADERM patients. OS rates at 12 and 24 months were 53.8 % (95 % CI, 46.2 %−60.8 %) and 40.5 % (95 % CI, 33.2 %−47.6 %), respectively. In evaluable patients (CARADERM database), median progression-free survival was 3.6 months (95 % CI, 2.7–7.5) and the objective response rate was 55.3 % (95 % CI, 45.3–65.4), including complete response in 31.9 %.
Real-world outcomes with 2L+ avelumab treatment for mMCC are consistent with clinical trial findings, supporting the recommendation of avelumab as a standard of care.
•This study examined patients with metastatic Merkel cell carcinoma in France.•180 patients who received second-line or later avelumab treatment were identified.•Median overall survival was 14.6 months and 24-month overall survival was 40.5 %.•Objective response rate was 55.3 % including complete response in 31.9 %.•Findings support the use of avelumab treatment for patients with this disease.</description><identifier>ISSN: 0959-8049</identifier><identifier>ISSN: 1879-0852</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2024.114261</identifier><identifier>PMID: 39128185</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Avelumab ; CARADERM ; Immunotherapy ; Metastatic Merkel cell carcinoma ; Overall survival ; Progression-free survival ; Second line ; SNDS</subject><ispartof>European journal of cancer (1990), 2024-09, Vol.209, p.114261, Article 114261</ispartof><rights>2024 The Authors</rights><rights>Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c237t-bc2830e8331748d5846818ffc146b2ede0f88b82bdb3c0f6df4495f9d6af3a213</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejca.2024.114261$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39128185$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mortier, Laurent</creatorcontrib><creatorcontrib>Blom, Astrid</creatorcontrib><creatorcontrib>van Hille, Benoît</creatorcontrib><creatorcontrib>Samimi, Mahtab</creatorcontrib><creatorcontrib>Luciani, Laura</creatorcontrib><creatorcontrib>Cahuzac, Capucine</creatorcontrib><creatorcontrib>Robert, Caroline</creatorcontrib><creatorcontrib>Quereux, Gaelle</creatorcontrib><creatorcontrib>Maubec, Eve</creatorcontrib><creatorcontrib>Miotti, Hakima</creatorcontrib><creatorcontrib>Maillard, Cathy</creatorcontrib><creatorcontrib>Aubin, François</creatorcontrib><creatorcontrib>Lenormand, Cédric</creatorcontrib><creatorcontrib>Solbes, Marie-Noëlle</creatorcontrib><creatorcontrib>Joly, Pascal</creatorcontrib><creatorcontrib>Kachaner, Isabelle</creatorcontrib><creatorcontrib>Lebbé, Céleste</creatorcontrib><creatorcontrib>Dutriaux, Caroline</creatorcontrib><creatorcontrib>Saiag, Philippe</creatorcontrib><title>Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Avelumab has been approved worldwide for treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. This study evaluated outcomes in patients with mMCC in France who received avelumab as second-line or later (2L+) treatment in routine clinical practice.
This retrospective, noninterventional study evaluated all patients diagnosed with mMCC using two databases: CARADERM (French national database of rare dermatological cancers) and SNDS (national healthcare database), identified via probabilistic linkage. Eligible patients initiated avelumab as 2L+ treatment between August 2016 and December 2019 and were followed for 24 months. The primary endpoint was overall survival (OS) at 24 months.
Overall, 180 patients who received 2L+ avelumab were identified (112 from CARADERM, 68 after SNDS linkage). Median age at diagnosis was 74.0 years and 177 (98.3 %) had received chemotherapy alone as first-line treatment. Median follow-up was 13.1 months. Median OS from start of avelumab was 14.6 months (95 % CI, 9.9–21.3) in the overall population, 15.9 months (95 % CI, 8.6–28.3) in CARADERM patients, and 13.3 months (95 % CI, 6.7–19.1) in non-CARADERM patients. OS rates at 12 and 24 months were 53.8 % (95 % CI, 46.2 %−60.8 %) and 40.5 % (95 % CI, 33.2 %−47.6 %), respectively. In evaluable patients (CARADERM database), median progression-free survival was 3.6 months (95 % CI, 2.7–7.5) and the objective response rate was 55.3 % (95 % CI, 45.3–65.4), including complete response in 31.9 %.
Real-world outcomes with 2L+ avelumab treatment for mMCC are consistent with clinical trial findings, supporting the recommendation of avelumab as a standard of care.
•This study examined patients with metastatic Merkel cell carcinoma in France.•180 patients who received second-line or later avelumab treatment were identified.•Median overall survival was 14.6 months and 24-month overall survival was 40.5 %.•Objective response rate was 55.3 % including complete response in 31.9 %.•Findings support the use of avelumab treatment for patients with this disease.</description><subject>Avelumab</subject><subject>CARADERM</subject><subject>Immunotherapy</subject><subject>Metastatic Merkel cell carcinoma</subject><subject>Overall survival</subject><subject>Progression-free survival</subject><subject>Second line</subject><subject>SNDS</subject><issn>0959-8049</issn><issn>1879-0852</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kc1u1DAUhSMEokPhBVigu2STwT9JxkFsRtMOILVCqmBtOfYN8TSxB9tp1QflfXCY0iUL_8g-57v2PUXxlpI1JbT5cFjjQas1I6xaU1qxhj4rVlRs2pKImj0vVqSt21KQqj0rXsV4IIRsREVeFme8pUxQUa-K39s7HOdJdaAiRNTemXK0DsEHGFXCACmgShO6BNbBUSWbtxHubRpgwqRiykcarjHc4ggaxzypoK3zk_oIW6fGh2gj-B4yZyzvfRgN-DlpP2FckPugnEaYo3U_IQ0Iu-3N9uLy5hqMSqpTESE_6BYNJP_3fh_Q6QFcruszHobMTUMuik-O18WLXo0R3zyu58WP_eX33Zfy6tvnr7vtVakZ36Sy00xwgoJzuqmEqUXV5K70vaZV0zE0SHohOsE603FN-sb0VdXWfWsa1XPFKD8v3p-4x-B_zRiTnGxceqAc-jlKTlpG8uCLlJ2kOvgYA_byGOykwoOkRC5xyoNc4pRLnPIUZza9e-TP3YTmyfIvvyz4dBJg_uWdxSCjzgFpNDagTtJ4-z_-H6DqtM4</recordid><startdate>20240901</startdate><enddate>20240901</enddate><creator>Mortier, Laurent</creator><creator>Blom, Astrid</creator><creator>van Hille, Benoît</creator><creator>Samimi, Mahtab</creator><creator>Luciani, Laura</creator><creator>Cahuzac, Capucine</creator><creator>Robert, Caroline</creator><creator>Quereux, Gaelle</creator><creator>Maubec, Eve</creator><creator>Miotti, Hakima</creator><creator>Maillard, Cathy</creator><creator>Aubin, François</creator><creator>Lenormand, Cédric</creator><creator>Solbes, Marie-Noëlle</creator><creator>Joly, Pascal</creator><creator>Kachaner, Isabelle</creator><creator>Lebbé, Céleste</creator><creator>Dutriaux, Caroline</creator><creator>Saiag, Philippe</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20240901</creationdate><title>Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database</title><author>Mortier, Laurent ; Blom, Astrid ; van Hille, Benoît ; Samimi, Mahtab ; Luciani, Laura ; Cahuzac, Capucine ; Robert, Caroline ; Quereux, Gaelle ; Maubec, Eve ; Miotti, Hakima ; Maillard, Cathy ; Aubin, François ; Lenormand, Cédric ; Solbes, Marie-Noëlle ; Joly, Pascal ; Kachaner, Isabelle ; Lebbé, Céleste ; Dutriaux, Caroline ; Saiag, Philippe</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c237t-bc2830e8331748d5846818ffc146b2ede0f88b82bdb3c0f6df4495f9d6af3a213</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Avelumab</topic><topic>CARADERM</topic><topic>Immunotherapy</topic><topic>Metastatic Merkel cell carcinoma</topic><topic>Overall survival</topic><topic>Progression-free survival</topic><topic>Second line</topic><topic>SNDS</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mortier, Laurent</creatorcontrib><creatorcontrib>Blom, Astrid</creatorcontrib><creatorcontrib>van Hille, Benoît</creatorcontrib><creatorcontrib>Samimi, Mahtab</creatorcontrib><creatorcontrib>Luciani, Laura</creatorcontrib><creatorcontrib>Cahuzac, Capucine</creatorcontrib><creatorcontrib>Robert, Caroline</creatorcontrib><creatorcontrib>Quereux, Gaelle</creatorcontrib><creatorcontrib>Maubec, Eve</creatorcontrib><creatorcontrib>Miotti, Hakima</creatorcontrib><creatorcontrib>Maillard, Cathy</creatorcontrib><creatorcontrib>Aubin, François</creatorcontrib><creatorcontrib>Lenormand, Cédric</creatorcontrib><creatorcontrib>Solbes, Marie-Noëlle</creatorcontrib><creatorcontrib>Joly, Pascal</creatorcontrib><creatorcontrib>Kachaner, Isabelle</creatorcontrib><creatorcontrib>Lebbé, Céleste</creatorcontrib><creatorcontrib>Dutriaux, Caroline</creatorcontrib><creatorcontrib>Saiag, Philippe</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of cancer (1990)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mortier, Laurent</au><au>Blom, Astrid</au><au>van Hille, Benoît</au><au>Samimi, Mahtab</au><au>Luciani, Laura</au><au>Cahuzac, Capucine</au><au>Robert, Caroline</au><au>Quereux, Gaelle</au><au>Maubec, Eve</au><au>Miotti, Hakima</au><au>Maillard, Cathy</au><au>Aubin, François</au><au>Lenormand, Cédric</au><au>Solbes, Marie-Noëlle</au><au>Joly, Pascal</au><au>Kachaner, Isabelle</au><au>Lebbé, Céleste</au><au>Dutriaux, Caroline</au><au>Saiag, Philippe</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2024-09-01</date><risdate>2024</risdate><volume>209</volume><spage>114261</spage><pages>114261-</pages><artnum>114261</artnum><issn>0959-8049</issn><issn>1879-0852</issn><eissn>1879-0852</eissn><abstract>Avelumab has been approved worldwide for treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. This study evaluated outcomes in patients with mMCC in France who received avelumab as second-line or later (2L+) treatment in routine clinical practice.
This retrospective, noninterventional study evaluated all patients diagnosed with mMCC using two databases: CARADERM (French national database of rare dermatological cancers) and SNDS (national healthcare database), identified via probabilistic linkage. Eligible patients initiated avelumab as 2L+ treatment between August 2016 and December 2019 and were followed for 24 months. The primary endpoint was overall survival (OS) at 24 months.
Overall, 180 patients who received 2L+ avelumab were identified (112 from CARADERM, 68 after SNDS linkage). Median age at diagnosis was 74.0 years and 177 (98.3 %) had received chemotherapy alone as first-line treatment. Median follow-up was 13.1 months. Median OS from start of avelumab was 14.6 months (95 % CI, 9.9–21.3) in the overall population, 15.9 months (95 % CI, 8.6–28.3) in CARADERM patients, and 13.3 months (95 % CI, 6.7–19.1) in non-CARADERM patients. OS rates at 12 and 24 months were 53.8 % (95 % CI, 46.2 %−60.8 %) and 40.5 % (95 % CI, 33.2 %−47.6 %), respectively. In evaluable patients (CARADERM database), median progression-free survival was 3.6 months (95 % CI, 2.7–7.5) and the objective response rate was 55.3 % (95 % CI, 45.3–65.4), including complete response in 31.9 %.
Real-world outcomes with 2L+ avelumab treatment for mMCC are consistent with clinical trial findings, supporting the recommendation of avelumab as a standard of care.
•This study examined patients with metastatic Merkel cell carcinoma in France.•180 patients who received second-line or later avelumab treatment were identified.•Median overall survival was 14.6 months and 24-month overall survival was 40.5 %.•Objective response rate was 55.3 % including complete response in 31.9 %.•Findings support the use of avelumab treatment for patients with this disease.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>39128185</pmid><doi>10.1016/j.ejca.2024.114261</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Avelumab CARADERM Immunotherapy Metastatic Merkel cell carcinoma Overall survival Progression-free survival Second line SNDS |
| title | Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database |
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