{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T07:18:32Z","timestamp":1777879112197,"version":"3.51.4"},"reference-count":22,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Endocrinology"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      To assess the safety (particularly the occurrence of malignancies) of growth hormone (GH) replacement (Omnitrope\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ) in adults with GH deficiency, using data from the ongoing PATRO Adults post-marketing surveillance study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      PATRO Adults is being conducted in hospitals and specialized endocrinology clinics across Europe. All enrolled patients who receive \u2a7e1 dose of Omnitrope\n                      <jats:sup>\u00ae<\/jats:sup>\n                      are included in the safety population. Malignancies are listed as adverse events under the MedDRA System Organ Class \u2018neoplasms, benign, malignant and unspecified (including cysts and polyps)\u2019.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      As of July 2018, 1293 patients had been enrolled in the study and 983 (76.0%) remained active in the study. Approximately half [ n\u2009=\u2009637 (49.3%)] of the patients were GH treatment-na\u00efve on study entry. The majority of enrolled patients had multiple pituitary hormone deficiency ( n\u2009=\u20091128, 87.2%). A total of 41 on-study malignancies were reported in 33 patients (2.6%; incidence rate 7.94\u2009per 1000 patient-years). The most common cancers were basal cell carcinoma ( n\u2009=\u200913), prostate ( n\u2009=\u20096), breast, kidney and malignant melanoma (each n\u2009=\u20093). Treatment with Omnitrope\n                      <jats:sup>\u00ae<\/jats:sup>\n                      was discontinued following diagnosis of malignancy in 16 patients. The tumors occurred after a mean of 79.4\u2009months of recombinant hormone GH (rhGH) treatment overall.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>\n                      Based on this snapshot of data from PATRO Adults, Omnitrope\n                      <jats:sup>\u00ae<\/jats:sup>\n                      treatment is tolerated in adult patients with GH deficiency in a real-life clinical practice setting. Our results do not generally support a carcinogenic effect of rhGH in adults with GH deficiency, although an increased risk of second new malignancies in patients with previous cancer cannot be excluded based on the current dataset.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2042018820943377","type":"journal-article","created":{"date-parts":[[2020,9,10]],"date-time":"2020-09-10T03:26:17Z","timestamp":1599708377000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":9,"title":["Malignancy risk in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope\n                    <sup>\u00ae<\/sup>\n                    ): data from the PATRO Adults study"],"prefix":"10.1177","volume":"11","author":[{"given":"Paolo","family":"Beck-Peccoz","sequence":"first","affiliation":[{"name":"Fondazione Istituto di Ricovero e Cura a Carattere Scientifico C\u00e0 Granda Ospedale Maggiore Policlinico, Milano, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlotte","family":"H\u00f6ybye","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Karolinska University Hospital and Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert D","family":"Murray","sequence":"additional","affiliation":[{"name":"Leeds Centre for Diabetes & Endocrinology, Leeds Teaching Hospitals NHS Trust, Leeds, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suat","family":"Simsek","sequence":"additional","affiliation":[{"name":"Northwest Clinics, Wilhelminalaan 12, 1815 JD, Alkmaar, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Markus","family":"Zabransky","sequence":"additional","affiliation":[{"name":"Sandoz Biopharmaceutical, c\/o HEXAL AG, Industriestr. 18, D-83607, Holzkirchen, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hichem","family":"Zouater","sequence":"additional","affiliation":[{"name":"Sandoz Biopharmaceuticals, c\/o HEXAL AG, Industriestr. 18, Holzkirchen, D-83607, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G\u00fcnter","family":"Stalla","sequence":"additional","affiliation":[{"name":"Medicover Neuroendokrinologie, Munich, Germany"},{"name":"Medizinische Klinik und Poliklinik IV der Ludwig-Maximilians-Universit\u00e4t, Munich, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2020,9,10]]},"reference":[{"key":"bibr1-2042018820943377","volume-title":"Endotext","author":"Feldt-Rasmussen U","year":"2000"},{"key":"bibr2-2042018820943377","doi-asserted-by":"crossref","first-page":"695","DOI":"10.1530\/EJE-07-0631","volume":"157","author":"Ho KK.","year":"2007","journal-title":"Eur J Endocrinol"},{"key":"bibr3-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2011-0179"},{"key":"bibr4-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-13-0389"},{"key":"bibr5-2042018820943377","first-page":"1868","volume":"86","author":"Critical evaluation of the safety of recombinant human growth hormone administration: statement from the growth hormone research society","year":"2001","journal-title":"J Clin Endocrinol Metab"},{"key":"bibr6-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1111\/cen.12477"},{"key":"bibr7-2042018820943377","doi-asserted-by":"publisher","DOI":"10.3390\/ijms19030893"},{"key":"bibr8-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2017-01899"},{"key":"bibr9-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1016\/j.beem.2017.02.004"},{"key":"bibr10-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2016-2046"},{"key":"bibr11-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1177\/2042018812444152"},{"key":"bibr12-2042018820943377","unstructured":"European Medicines Agency. Summary of product characteristics: Omnitrope\n                      \u00ae\n                      1.3 mg\/mL powder and solvent for solution for injection, http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000607\/WC500043695.pdf (2015, accessed 11 March 2020)."},{"key":"bibr13-2042018820943377","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline \u2013 guideline for good clinical practice E6(R1), https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e6-r1-guideline-good-clinical-practice_en.pdf (1996, accessed 11 March 2020)."},{"key":"bibr14-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.2006.02409.x"},{"key":"bibr15-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.2005.02404.x"},{"key":"bibr16-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1586\/eem.10.73"},{"key":"bibr17-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2012-2684"},{"key":"bibr18-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1016\/j.ghir.2010.10.005"},{"key":"bibr19-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.31551"},{"key":"bibr20-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1111\/cen.13502"},{"key":"bibr21-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-15-0873"},{"key":"bibr22-2042018820943377","doi-asserted-by":"publisher","DOI":"10.1016\/j.ghir.2015.06.006"}],"container-title":["Therapeutic Advances in Endocrinology and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2042018820943377","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2042018820943377","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2042018820943377","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:35:17Z","timestamp":1777592117000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/2042018820943377"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1]]},"references-count":22,"alternative-id":["10.1177\/2042018820943377"],"URL":"https:\/\/doi.org\/10.1177\/2042018820943377","relation":{},"ISSN":["2042-0188","2042-0196"],"issn-type":[{"value":"2042-0188","type":"print"},{"value":"2042-0196","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1]]},"article-number":"2042018820943377"}}