{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T17:13:42Z","timestamp":1791220422761,"version":"4.1.0"},"reference-count":12,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2009,11,1]],"date-time":"2009-11-01T00:00:00Z","timestamp":1257033600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Tumori"],"published-print":{"date-parts":[[2009,11]]},"abstract":"<jats:sec>\n                    <jats:title>Aims and Background<\/jats:title>\n                    <jats:p>An appropriate use of drugs should follow the registered indications. Different reasons can induce oncologists to prescribe drugs off-label. The aim of this study was to describe incidence and characteristics of these prescriptions in Italy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients submitted to chemotherapy in 15 Italian oncology centers were evaluated for two randomized non-consecutive days of two weeks in May 2006.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The study enrolled 644 patients receiving 1,053 drugs. Overall, 199 of 1053 (18.9%) prescriptions were off-label. In 92 of 199 cases (46.2%), the drugs were used for a neoplasm for which they were not approved, but there was scientific evidence (one or more randomized clinical trials or more phase II studies published in a major oncology journal) justifying the prescription. In 27 cases (13.6%), the drugs were prescribed for a rare neoplasm (cisplatin and gemcitabine in mesothelioma). In 20\/21 cases (10.1%\/10.5%), drugs were used in association\/alone in contrast with the approved use (capecitabine in association in colorectal cancer). In 28\/11 cases (14.0%\/5.6%), the drugs were used in lines of chemotherapy subsequent\/previous to that approved.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Off-label use of antineoplastic drugs, in this observational survey, represents less than 20% of the prescriptions, and most of them are based on scientific evidence of efficacy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/030089160909500601","type":"journal-article","created":{"date-parts":[[2018,2,27]],"date-time":"2018-02-27T04:10:27Z","timestamp":1519704627000},"page":"647-651","source":"Crossref","is-referenced-by-count":18,"title":["Off-Label Prescription of Antineoplastic Drugs: An Italian Prospective, Observational, Multicenter Survey"],"prefix":"10.1177","volume":"95","author":[{"given":"Fausto","family":"Roila","sequence":"first","affiliation":[{"name":"Medical Oncology Division, S. Maria Hospital, Terni;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enzo","family":"Ballatori","sequence":"additional","affiliation":[{"name":"Dept of Internal Medicine and Public Health, University of L'Aquila, L'Aquila;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Labianca","sequence":"additional","affiliation":[{"name":"Dept of Medical Oncology, Bergamo;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filippo","family":"De Braud","sequence":"additional","affiliation":[{"name":"European Institute of Oncology, Milan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Borgonovo","sequence":"additional","affiliation":[{"name":"Dept of Oncology, Fatebenefratelli Hospital, Milan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Martelli","sequence":"additional","affiliation":[{"name":"Dept of Oncology, S. Giovanni Hospital, Rome;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ciro","family":"Gallo","sequence":"additional","affiliation":[{"name":"Dept of Medicine and Public Health, 2nd University of Naples, Naples;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelo","family":"Tinazzi","sequence":"additional","affiliation":[{"name":"Medical Informatics and Biometry Unit, Sendo Tech, Milan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Perrone","sequence":"additional","affiliation":[{"name":"National Cancer Institute, Naples, Italy."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2018,1,29]]},"reference":[{"key":"bibr1-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.06.8940"},{"key":"bibr2-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdg035"},{"key":"bibr3-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djj090"},{"key":"bibr4-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1097\/00004479-200404000-00005"},{"key":"bibr5-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.166.9.1021"},{"key":"bibr6-030089160909500601","first-page":"805","volume":"90","author":"Rae M.","year":"2003","journal-title":"J Natl Cancer Inst"},{"key":"bibr7-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1001\/jama.297.7.683"},{"key":"bibr8-030089160909500601","first-page":"295","volume":"12","author":"O'Reilly J.","year":"2003","journal-title":"Ann Health Law"},{"key":"bibr9-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1001\/jama.296.10.1266"},{"key":"bibr10-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1991.03470210064033"},{"key":"bibr11-030089160909500601","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-004-0593-6"},{"key":"bibr12-030089160909500601","unstructured":"Gazzetta Ufficiale n\u00b0 129 del 6.6.2007, Supplemento Ordinario n\u00b0 132, Agenzia Italiana del Farmaco, Determinazione 29.5.2007: Aggiornamento dell'elenco dei medicinali, istituito con il provvedimento della Commissione Unica del Farmaco (CUF) datato 20 luglio 2000, pubblicato nella GU n\u00b0 219 del 19.9.2000 con errata-corrige nella GU n\u00b0 232 del 4.10.2000, erogabili a totale carico del Servizio Sanitario nazionale, ai sensi dell'articolo 1 comma 4 del decreto legge 21.10.1996 n\u00b0 536 convertito dalla legge 23.12.1996 n\u00b0 648."}],"container-title":["Tumori Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/030089160909500601","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/030089160909500601","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T18:33:10Z","timestamp":1777660390000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/030089160909500601"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2009,11]]},"references-count":12,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2009,11]]}},"alternative-id":["10.1177\/030089160909500601"],"URL":"https:\/\/doi.org\/10.1177\/030089160909500601","relation":{},"ISSN":["0300-8916","2038-2529"],"issn-type":[{"value":"0300-8916","type":"print"},{"value":"2038-2529","type":"electronic"}],"subject":[],"published":{"date-parts":[[2009,11]]}}}