Wala Ben Kridis, Rim Sahnoun, Chadha Maalej, Rim Atheymen, Serria Hammami, Nabil Toumi, Khaled Zeghal, Afef Khanfir
{"title":"突尼斯仿制药多西他赛对早期乳腺癌的耐受性:一项前瞻性研究。","authors":"Wala Ben Kridis, Rim Sahnoun, Chadha Maalej, Rim Atheymen, Serria Hammami, Nabil Toumi, Khaled Zeghal, Afef Khanfir","doi":"10.1177/10781552251377766","DOIUrl":null,"url":null,"abstract":"<p><p>BackgroundDocetaxel is a key component of chemotherapy for non-metastatic breast cancer. In Tunisia, Cytotere<sup>®</sup>, 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<sup>®</sup> remain lacking. We aimed to evaluate the safety profile of Cytotere<sup>®</sup> in patients receiving adjuvant chemotherapy for non-metastatic breast cancer and to identify factors associated with toxicity.MethodsWe conducted a prospective, monocentric observational study including patients with HER2-negative, non-metastatic breast cancer treated with Cytotere<sup>®</sup> (100 mg/m² every 21 days). Adverse events (AEs) were graded using CTCAE v5.0 and assessed for causality using the French Bégaud method. Associations between patient characteristics and toxicities were analyzed using Chi-square tests.Results60 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 < 0.001) and HFS (p = 0.008).ConclusionCytotere<sup>®</sup> was associated with a toxicity profile comparable to that of originator Docetaxel in historical data. These findings support the continued use of Cytotere<sup>®</sup> in adjuvant chemotherapy, with careful monitoring. Larger multicenter studies are warranted to confirm these results and guide pharmacovigilance strategies in low-resource settings.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251377766"},"PeriodicalIF":0.9000,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Tolerability of a Tunisian generic Docetaxel in early breast cancer: A prospective study.\",\"authors\":\"Wala Ben Kridis, Rim Sahnoun, Chadha Maalej, Rim Atheymen, Serria Hammami, Nabil Toumi, Khaled Zeghal, Afef Khanfir\",\"doi\":\"10.1177/10781552251377766\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>BackgroundDocetaxel is a key component of chemotherapy for non-metastatic breast cancer. In Tunisia, Cytotere<sup>®</sup>, 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<sup>®</sup> remain lacking. We aimed to evaluate the safety profile of Cytotere<sup>®</sup> in patients receiving adjuvant chemotherapy for non-metastatic breast cancer and to identify factors associated with toxicity.MethodsWe conducted a prospective, monocentric observational study including patients with HER2-negative, non-metastatic breast cancer treated with Cytotere<sup>®</sup> (100 mg/m² every 21 days). Adverse events (AEs) were graded using CTCAE v5.0 and assessed for causality using the French Bégaud method. Associations between patient characteristics and toxicities were analyzed using Chi-square tests.Results60 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 < 0.001) and HFS (p = 0.008).ConclusionCytotere<sup>®</sup> was associated with a toxicity profile comparable to that of originator Docetaxel in historical data. These findings support the continued use of Cytotere<sup>®</sup> in adjuvant chemotherapy, with careful monitoring. Larger multicenter studies are warranted to confirm these results and guide pharmacovigilance strategies in low-resource settings.</p>\",\"PeriodicalId\":16637,\"journal\":{\"name\":\"Journal of Oncology Pharmacy Practice\",\"volume\":\" \",\"pages\":\"10781552251377766\"},\"PeriodicalIF\":0.9000,\"publicationDate\":\"2025-09-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Oncology Pharmacy Practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/10781552251377766\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Oncology Pharmacy Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/10781552251377766","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
Tolerability of a Tunisian generic Docetaxel in early breast cancer: A prospective study.
BackgroundDocetaxel is a key component of chemotherapy for non-metastatic breast cancer. In Tunisia, Cytotere®, 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® remain lacking. We aimed to evaluate the safety profile of Cytotere® in patients receiving adjuvant chemotherapy for non-metastatic breast cancer and to identify factors associated with toxicity.MethodsWe conducted a prospective, monocentric observational study including patients with HER2-negative, non-metastatic breast cancer treated with Cytotere® (100 mg/m² every 21 days). Adverse events (AEs) were graded using CTCAE v5.0 and assessed for causality using the French Bégaud method. Associations between patient characteristics and toxicities were analyzed using Chi-square tests.Results60 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 < 0.001) and HFS (p = 0.008).ConclusionCytotere® was associated with a toxicity profile comparable to that of originator Docetaxel in historical data. These findings support the continued use of Cytotere® in adjuvant chemotherapy, with careful monitoring. Larger multicenter studies are warranted to confirm these results and guide pharmacovigilance strategies in low-resource settings.
期刊介绍:
Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...