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.