{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T23:46:52Z","timestamp":1783986412580,"version":"3.55.0"},"reference-count":18,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2018,7,17]],"date-time":"2018-07-17T00:00:00Z","timestamp":1531785600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>This SafeHer subgroup analysis assessed the safety of fixed-dose subcutaneous trastuzumab (H SC) as an adjuvant therapy in HER2-positive early breast cancer (EBC) by body weight.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients and Methods<\/jats:title>\n                  <jats:p>Patients with HER2-positive EBC not previously treated with anti-HER2 therapy received H SC 600 mg (every 3 weeks for 18 cycles), with neoadjuvant or adjuvant chemotherapy or without adjuvant chemotherapy. Adverse events (AEs) were assessed throughout treatment and at final follow-up (28 \u00b15 days after last treatment). Subgroups were categorized by body weight, Asian origin, and chemotherapy administration. All analyses were descriptive.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of 2,577 patients enrolled, 2,573 received \u22651 dose of study medication and were included in this safety analysis. Median body weight at baseline was 67.0 kg (range 33.6\u2013150.0 kg). Any-grade AEs occurred in 88.7% (2,282\/2,573) of the overall population, versus 87.1% (590\/677) of the lowest bodyweight quartile (\u226459 kg), 90.0% (561\/623) of the highest quartile (&amp;gt;77 kg), and 86.5% (327\/378) of the Asian population. Grade \u22653 AEs occurred in 23.2% (596\/2,573) of the overall population, 17.9% (121\/677) of the lowest bodyweight quartile, 26.8% (167\/623) of the highest quartile, and 15.3% (58\/378) of the Asian population. The highest bodyweight quartile had the highest incidence of medical conditions at baseline (highest quartile, 75.6%; lowest quartile, 56.1%).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>These data support the use of fixed-dose H SC as an adjuvant therapy in HER2-positive EBC and confirm the comparable safety profile of H SC in patients with low body weight or of Asian origin versus the overall population in SafeHer. ClinicalTrials.gov: NCT01566721.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Implications for Practice<\/jats:title>\n                  <jats:p>The safety profile of fixed-dose subcutaneous trastuzumab (H SC) was comparable between patients in the lowest bodyweight subgroup and the overall patient population, and also between patients of Asian origin (of whom a higher proportion often fall within the lower bodyweight quartiles) and the overall population. The safety data from this SafeHer subgroup analysis therefore support the use of fixed-dose H SC 600 mg administered every 3 weeks as an adjuvant therapy for patients with HER2-positive early breast cancer across different bodyweight subgroups and in the Asian patient population.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1634\/theoncologist.2018-0065","type":"journal-article","created":{"date-parts":[[2018,7,17]],"date-time":"2018-07-17T16:16:00Z","timestamp":1531844160000},"page":"1137-1143","source":"Crossref","is-referenced-by-count":13,"title":["Adjuvant Subcutaneous Trastuzumab for HER2-Positive Early Breast Cancer: Subgroup Analyses of Safety and Active Medical Conditions by Body Weight in the SafeHer Phase III Study"],"prefix":"10.1093","volume":"23","author":[{"given":"Kyung Hae","family":"Jung","sequence":"first","affiliation":[{"name":"Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beyhan","family":"Ataseven","sequence":"additional","affiliation":[{"name":"Kliniken Essen-Mitte, Essen, Germany"},{"name":"Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Verrill","sequence":"additional","affiliation":[{"name":"Northern Centre for Cancer Care, Newcastle upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Pivot","sequence":"additional","affiliation":[{"name":"Centre Paul Strauss, I'Institut R\u00e9gional du Cancer, Strasbourg, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelino","family":"De Laurentiis","sequence":"additional","affiliation":[{"name":"Istituto Nazionale Tumori \u201cFondazione G. Pascale\u201d, Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nedal","family":"Al-Sakaff","sequence":"additional","affiliation":[{"name":"F. Hoffmann-La Roche Ltd, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Lauer","sequence":"additional","affiliation":[{"name":"F. 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