A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992)
The aim of this study is to determine efficacy and feasibility of the combination regimen irinotecan and cisplatin in patients with cisplatin advanced penile cancer. Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m2) on da...
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| Veröffentlicht in: | Annals of oncology 2008-07, Vol.19 (7), p.1304-1307 |
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| container_title | Annals of oncology |
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| creator | Theodore, C. Skoneczna, I. Bodrogi, I. Leahy, M. Kerst, J.M. Collette, L. Ven, K. Marréaud, S. Oliver, R.D.T. |
| description | The aim of this study is to determine efficacy and feasibility of the combination regimen irinotecan and cisplatin in patients with cisplatin advanced penile cancer.
Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m2) on days 1, 8 and 15 and cisplatin (80mg/m2) administered every 28 days. Patients were treated either in the neo-adjuvant setting for T3 or N1–N2 disease with a maximum of four cycles before surgery or up to eight cycles for T4 or N3 or M1 disease. The study was designed with the aim to exclude a response rate (complete response + partial response) 30%.The observation regarding M0 patients suggests to repeat this study in the neo-adjuvant setting. |
| doi_str_mv | 10.1093/annonc/mdn149 |
| format | Article |
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Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m2) on days 1, 8 and 15 and cisplatin (80mg/m2) administered every 28 days. Patients were treated either in the neo-adjuvant setting for T3 or N1–N2 disease with a maximum of four cycles before surgery or up to eight cycles for T4 or N3 or M1 disease. The study was designed with the aim to exclude a response rate (complete response + partial response) <30% (α = 10%, power = 95%).
Twenty-eight patients were included and evaluated for toxicity, and 26 eligible patients were evaluated for response. Toxicity was acceptable with three cases of grade 3 diarrhoea and two cases of grade 4 neutropenic fever. There were eight responses (two complete response and six partial response) (30.8%, 80% confidence interval 18.8% to 45.1%): three patients undergoing histological verification after chemotherapy had no evidence of malignancy.
The study fails to demonstrate a response rate significantly >30%.The observation regarding M0 patients suggests to repeat this study in the neo-adjuvant setting.</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdn149</identifier><identifier>PMID: 18417462</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Adult ; advanced penile cancer ; Aged ; Antineoplastic agents ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents, Phytogenic - administration & dosage ; Antineoplastic Agents, Phytogenic - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Camptothecin - administration & dosage ; Camptothecin - analogs & derivatives ; Carcinoma, Squamous Cell - drug therapy ; Carcinoma, Squamous Cell - pathology ; chemotherapy ; cisplatin ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Drug Administration Schedule ; Feasibility Studies ; Follow-Up Studies ; Gynecology. Andrology. Obstetrics ; Humans ; Irinotecan ; Male ; Male genital diseases ; Medical sciences ; Middle Aged ; Penile Neoplasms - drug therapy ; Penile Neoplasms - pathology ; Pharmacology. Drug treatments ; Time Factors ; Treatment Outcome ; Tumors</subject><ispartof>Annals of oncology, 2008-07, Vol.19 (7), p.1304-1307</ispartof><rights>2008 European Society for Medical Oncology</rights><rights>The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org 2008</rights><rights>2008 INIST-CNRS</rights><rights>The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c506t-9e67e38c236f0a4646b683769129481584d2f6819903fe5475140fc17317d3b93</citedby><cites>FETCH-LOGICAL-c506t-9e67e38c236f0a4646b683769129481584d2f6819903fe5475140fc17317d3b93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20474953$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18417462$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Theodore, C.</creatorcontrib><creatorcontrib>Skoneczna, I.</creatorcontrib><creatorcontrib>Bodrogi, I.</creatorcontrib><creatorcontrib>Leahy, M.</creatorcontrib><creatorcontrib>Kerst, J.M.</creatorcontrib><creatorcontrib>Collette, L.</creatorcontrib><creatorcontrib>Ven, K.</creatorcontrib><creatorcontrib>Marréaud, S.</creatorcontrib><creatorcontrib>Oliver, R.D.T.</creatorcontrib><creatorcontrib>for the EORTC Genito-Urinary Tract Cancer Group</creatorcontrib><creatorcontrib>EORTC Genito-Urinary Tract Cancer Group</creatorcontrib><title>A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992)</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>The aim of this study is to determine efficacy and feasibility of the combination regimen irinotecan and cisplatin in patients with cisplatin advanced penile cancer.
Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m2) on days 1, 8 and 15 and cisplatin (80mg/m2) administered every 28 days. Patients were treated either in the neo-adjuvant setting for T3 or N1–N2 disease with a maximum of four cycles before surgery or up to eight cycles for T4 or N3 or M1 disease. The study was designed with the aim to exclude a response rate (complete response + partial response) <30% (α = 10%, power = 95%).
Twenty-eight patients were included and evaluated for toxicity, and 26 eligible patients were evaluated for response. Toxicity was acceptable with three cases of grade 3 diarrhoea and two cases of grade 4 neutropenic fever. There were eight responses (two complete response and six partial response) (30.8%, 80% confidence interval 18.8% to 45.1%): three patients undergoing histological verification after chemotherapy had no evidence of malignancy.
The study fails to demonstrate a response rate significantly >30%.The observation regarding M0 patients suggests to repeat this study in the neo-adjuvant setting.</description><subject>Adult</subject><subject>advanced penile cancer</subject><subject>Aged</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents, Phytogenic - administration & dosage</subject><subject>Antineoplastic Agents, Phytogenic - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Camptothecin - administration & dosage</subject><subject>Camptothecin - analogs & derivatives</subject><subject>Carcinoma, Squamous Cell - drug therapy</subject><subject>Carcinoma, Squamous Cell - pathology</subject><subject>chemotherapy</subject><subject>cisplatin</subject><subject>Cisplatin - administration & dosage</subject><subject>Cisplatin - adverse effects</subject><subject>Drug Administration Schedule</subject><subject>Feasibility Studies</subject><subject>Follow-Up Studies</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Irinotecan</subject><subject>Male</subject><subject>Male genital diseases</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Penile Neoplasms - drug therapy</subject><subject>Penile Neoplasms - pathology</subject><subject>Pharmacology. Drug treatments</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0UFv0zAYBuAIgVgZHLkiCwmpO4TZsWPHx9FutFKlVqMgtIvlOo7mkdiZ7Yz17_BLcUk1ToiTZevR91rfm2VvEfyIIMfn0lpn1XlXW0T4s2yCSsrzChL0PJtAXuCclZicZK9CuIMQUl7wl9kJqghihBaT7NcF6G9l0GC5BN3QRqO0jV6DEId6D1wDjDfWRa2kBdPZZgsQOgPGAuW6nbEyGmfBTxNvgTKhb9P9wObzzR_U6ShDTI8KOA9ap2Tb7oGsH6RVuga9tqbVQEmvUkYnwfRyfb2dgc31eruerVcAQ86Ls9fZi0a2Qb85nqfZ16vL7WyRr9afl7OLVa5KSGPONWUaV6rAtIGSUEJ3tMKMclRwUqGyInXR0ApxDnGjS8JKRGCjEMOI1XjH8Wn2fpzbe3c_6BDFnRu8TZECcUoRZSVNKB-R8i4ErxvRe9NJvxcIikMhYixEjIUk_-44dNh1uv6rjw0k8OEIZEj7aXzajQlProCEEV7i5Kajc0P_38zjH02I-vEJS_9DUIZZKRbfb0Q5X9x8WXzbik_Js9HrtN0Ho70IyuhDRcZrFUXtzD-SfgNrZ8K-</recordid><startdate>20080701</startdate><enddate>20080701</enddate><creator>Theodore, C.</creator><creator>Skoneczna, I.</creator><creator>Bodrogi, I.</creator><creator>Leahy, M.</creator><creator>Kerst, J.M.</creator><creator>Collette, L.</creator><creator>Ven, K.</creator><creator>Marréaud, S.</creator><creator>Oliver, R.D.T.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</general><scope>6I.</scope><scope>AAFTH</scope><scope>BSCLL</scope><scope>IQODW</scope><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>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope></search><sort><creationdate>20080701</creationdate><title>A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992)</title><author>Theodore, C. ; Skoneczna, I. ; Bodrogi, I. ; Leahy, M. ; Kerst, J.M. ; Collette, L. ; Ven, K. ; Marréaud, S. ; Oliver, R.D.T.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c506t-9e67e38c236f0a4646b683769129481584d2f6819903fe5475140fc17317d3b93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>advanced penile cancer</topic><topic>Aged</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents, Phytogenic - administration & dosage</topic><topic>Antineoplastic Agents, Phytogenic - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Camptothecin - administration & dosage</topic><topic>Camptothecin - analogs & derivatives</topic><topic>Carcinoma, Squamous Cell - drug therapy</topic><topic>Carcinoma, Squamous Cell - pathology</topic><topic>chemotherapy</topic><topic>cisplatin</topic><topic>Cisplatin - administration & dosage</topic><topic>Cisplatin - adverse effects</topic><topic>Drug Administration Schedule</topic><topic>Feasibility Studies</topic><topic>Follow-Up Studies</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Irinotecan</topic><topic>Male</topic><topic>Male genital diseases</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Penile Neoplasms - drug therapy</topic><topic>Penile Neoplasms - pathology</topic><topic>Pharmacology. Drug treatments</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Theodore, C.</creatorcontrib><creatorcontrib>Skoneczna, I.</creatorcontrib><creatorcontrib>Bodrogi, I.</creatorcontrib><creatorcontrib>Leahy, M.</creatorcontrib><creatorcontrib>Kerst, J.M.</creatorcontrib><creatorcontrib>Collette, L.</creatorcontrib><creatorcontrib>Ven, K.</creatorcontrib><creatorcontrib>Marréaud, S.</creatorcontrib><creatorcontrib>Oliver, R.D.T.</creatorcontrib><creatorcontrib>for the EORTC Genito-Urinary Tract Cancer Group</creatorcontrib><creatorcontrib>EORTC Genito-Urinary Tract Cancer Group</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Theodore, C.</au><au>Skoneczna, I.</au><au>Bodrogi, I.</au><au>Leahy, M.</au><au>Kerst, J.M.</au><au>Collette, L.</au><au>Ven, K.</au><au>Marréaud, S.</au><au>Oliver, R.D.T.</au><aucorp>for the EORTC Genito-Urinary Tract Cancer Group</aucorp><aucorp>EORTC Genito-Urinary Tract Cancer Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992)</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2008-07-01</date><risdate>2008</risdate><volume>19</volume><issue>7</issue><spage>1304</spage><epage>1307</epage><pages>1304-1307</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>The aim of this study is to determine efficacy and feasibility of the combination regimen irinotecan and cisplatin in patients with cisplatin advanced penile cancer.
Patients with T3, T4, N1, N2, N3 or M1 cisplatin advanced penile cancer were treated with a combination of irinotecan (60 mg/m2) on days 1, 8 and 15 and cisplatin (80mg/m2) administered every 28 days. Patients were treated either in the neo-adjuvant setting for T3 or N1–N2 disease with a maximum of four cycles before surgery or up to eight cycles for T4 or N3 or M1 disease. The study was designed with the aim to exclude a response rate (complete response + partial response) <30% (α = 10%, power = 95%).
Twenty-eight patients were included and evaluated for toxicity, and 26 eligible patients were evaluated for response. Toxicity was acceptable with three cases of grade 3 diarrhoea and two cases of grade 4 neutropenic fever. There were eight responses (two complete response and six partial response) (30.8%, 80% confidence interval 18.8% to 45.1%): three patients undergoing histological verification after chemotherapy had no evidence of malignancy.
The study fails to demonstrate a response rate significantly >30%.The observation regarding M0 patients suggests to repeat this study in the neo-adjuvant setting.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>18417462</pmid><doi>10.1093/annonc/mdn149</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0923-7534 |
| ispartof | Annals of oncology, 2008-07, Vol.19 (7), p.1304-1307 |
| issn | 0923-7534 1569-8041 |
| language | eng |
| recordid | cdi_proquest_journals_196616756 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult advanced penile cancer Aged Antineoplastic agents Antineoplastic Agents - administration & dosage Antineoplastic Agents, Phytogenic - administration & dosage Antineoplastic Agents, Phytogenic - adverse effects Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Camptothecin - administration & dosage Camptothecin - analogs & derivatives Carcinoma, Squamous Cell - drug therapy Carcinoma, Squamous Cell - pathology chemotherapy cisplatin Cisplatin - administration & dosage Cisplatin - adverse effects Drug Administration Schedule Feasibility Studies Follow-Up Studies Gynecology. Andrology. Obstetrics Humans Irinotecan Male Male genital diseases Medical sciences Middle Aged Penile Neoplasms - drug therapy Penile Neoplasms - pathology Pharmacology. Drug treatments Time Factors Treatment Outcome Tumors |
| title | A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992) |
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