{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T22:44:52Z","timestamp":1777934692773,"version":"3.51.4"},"reference-count":13,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Docetaxel is a key component of chemotherapy for non-metastatic breast cancer. In Tunisia, Cytotere\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , a local produced generic formulation of Docetaxel, has been used since 2017. Concerns have been raised regarding the safety of certain generic of taxanes, but prospective data on Cytotere\n                      <jats:sup>\u00ae<\/jats:sup>\n                      remain lacking. We aimed to evaluate the safety profile of Cytotere\n                      <jats:sup>\u00ae<\/jats:sup>\n                      in patients receiving adjuvant chemotherapy for non-metastatic breast cancer and to identify factors associated with toxicity.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We conducted a prospective, monocentric observational study including patients with HER2-negative, non-metastatic breast cancer treated with Cytotere\n                      <jats:sup>\u00ae<\/jats:sup>\n                      (100\u2005mg\/m\u00b2 every 21 days). Adverse events (AEs) were graded using CTCAE v5.0 and assessed for causality using the French B\u00e9gaud method. Associations between patient characteristics and toxicities were analyzed using Chi-square tests.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>60 patients were included. Asthenia (90%), arthralgia\/myalgia (71.7%), mucositis (50%), and hand-foot syndrome (36.7%) were the most frequent adverse events. Grade 3 toxicities were rare, occurring in 16.7% of patients, most commonly hand foot syndrome and neutropenia. Febrile neutropenia was reported in 8.3% of cases. One hypersensitivity reaction (1.7%) was observed despite standardized premedication. Dose reduction was required in 23.3% of patients, and significantly associated with the occurrence of grade 3 toxicities (p\u2009&lt;\u20090.001) and HFS (p\u2009=\u20090.008).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Cytotere\n                      <jats:sup>\u00ae<\/jats:sup>\n                      was associated with a toxicity profile comparable to that of originator Docetaxel in historical data. These findings support the continued use of Cytotere\n                      <jats:sup>\u00ae<\/jats:sup>\n                      in adjuvant chemotherapy, with careful monitoring. Larger multicenter studies are warranted to confirm these results and guide pharmacovigilance strategies in low-resource settings.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10781552251377766","type":"journal-article","created":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T17:39:48Z","timestamp":1757698788000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Tolerability of a Tunisian generic Docetaxel in early breast cancer: A prospective study"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4956-9551","authenticated-orcid":false,"given":"Wala","family":"Ben Kridis","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Habib Bourguiba Hospital University of Sfax, Sfax, Tunisia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rim","family":"Sahnoun","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance of Sfax, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chadha","family":"Maalej","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance of Sfax, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rim","family":"Atheymen","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance of Sfax, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serria","family":"Hammami","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance of Sfax, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nabil","family":"Toumi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Habib Bourguiba Hospital University of Sfax, Sfax, Tunisia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khaled","family":"Zeghal","sequence":"additional","affiliation":[{"name":"Regional Centre of Pharmacovigilance of Sfax, Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Afef","family":"Khanfir","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Habib Bourguiba Hospital University of Sfax, Sfax, Tunisia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2025,9,12]]},"reference":[{"key":"e_1_3_3_2_2","first-page":"209","article-title":"Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"73","author":"Sung H","year":"2023","unstructured":"Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2023; 73: 209\u2013249.","journal-title":"CA Cancer J Clin"},{"key":"e_1_3_3_3_2","volume-title":"Registre des Cancers Nord Tunisie 2020","unstructured":"Registre des Cancers Nord Tunisie 2020. Tunis: Institut Salah Aza\u00efz, 2020."},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa043681"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)61625-5"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.04.1665"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/83.4.288"},{"key":"e_1_3_3_8_2","first-page":"264","article-title":"Managing toxicity of chemotherapy in breast cancer","volume":"5","author":"Markman M","year":"2003","unstructured":"Markman M. Managing toxicity of chemotherapy in breast cancer. Curr Oncol Rep 2003; 5: 264\u2013271.","journal-title":"Curr Oncol Rep"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.02.027"},{"key":"e_1_3_3_10_2","unstructured":"Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament (ANSM). Doc\u00e9taxel : point d'information du 20 avril 2017."},{"key":"e_1_3_3_11_2","first-page":"231","article-title":"Comparative pharmacovigilance signal between Taxotere\u00ae and generic Docetaxel","volume":"73","author":"Poirier A","year":"2018","unstructured":"Poirier A, et al. Comparative pharmacovigilance signal between Taxotere\u00ae and generic Docetaxel. Therapie 2018; 73: 231\u2013238.","journal-title":"Therapie"},{"key":"e_1_3_3_12_2","unstructured":"Institut National du Cancer (INCa). Recommandations concernant l\u2019utilisation du doc\u00e9taxel dans les cancers du sein. F\u00e9vrier 2017."},{"key":"e_1_3_3_13_2","first-page":"422","article-title":"Comparison of adverse events between Taxotere and generic Docetaxel","volume":"24","author":"Tagawa M","year":"2017","unstructured":"Tagawa M, et al. Comparison of adverse events between Taxotere and generic Docetaxel. Breast Cancer 2017; 24: 422\u2013427.","journal-title":"Breast Cancer"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2023.11.016"}],"container-title":["Journal of Oncology Pharmacy Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10781552251377766","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10781552251377766","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10781552251377766","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T02:31:45Z","timestamp":1777689105000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10781552251377766"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,12]]},"references-count":13,"alternative-id":["10.1177\/10781552251377766"],"URL":"https:\/\/doi.org\/10.1177\/10781552251377766","relation":{},"ISSN":["1078-1552","1477-092X"],"issn-type":[{"value":"1078-1552","type":"print"},{"value":"1477-092X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,12]]},"article-number":"10781552251377766"}}