CLO20-046: National Cancer Institute Experience With Generic Anastrozole (Anastrodex, Hikma) in Newly Diagnosed Postmenopausal Female Egyptian Patients With Low Burden Visceral Metastatic Breast Cancer

Context: The systemic treatment of metastatic breast cancer (MBC) prolongs survival and enhances quality of life but is not curative. Therefore, treatments associated with minimal toxicity are preferred. Thus, the use of the minimally toxic endocrine therapies is preferred to the use of cytotoxic therapy whenever reasonable. Objective: To evaluate the efficacy and safety of generic Anastrozole in newly diagnosed postmenopausal female Egyptian patients with low burden visceral MBC and to compare its results with the original brand. Design: This is observational, single center, retrospective, open-label study, postmenopausal patients with low burden visceral MBC female Egyptian patients from June 2017 to June 2019 were assigned to receive either original brand Anastrozole versus generic form with similar dose of one mg per day. Patients or Other Participants: Sixty postmenopausal female Patients newly diagnosed with low burden visceral MBC with ECOG performance≤ 2 . Interventions: Responses were defined using CT Chest, abdomen and pelvis. Adverse events (AEs) were evaluated using CTCAE,Version 5.0 Main Outcomes and Measures: To assess Progression free survival (PFS) at 1 and 2 year and degree of Adverse Events (AEs). RESULTS: Thirty eligible patients were assigned to original brand Anastrozole while other 30 received Generic Anastrozole. At 12 months, PFS rates were 70% (22/30) and 66% (20/30) respectively. PFS at 24 months were 46% (14/30) and 40% (12/30) respectively. With the Anastrazole arm, Overall grades 1 and 2 AEs were almost equal in both arms with mainly arthalgia and weight gain .Overall grades 3 and 4 AEs occurred in only 1 patient in original brand arm as skin rash while grades 3 and 4 AEs occurred in 4 patients (13%) with Generic Anastrozole in the form of GI toxicity. Treatment was discontinued in 10%(3/30) with original brand Anastrozole due to arthalgia while 30% (9/30) discontinued treatment with generic Anastrozole because of AEs mainly GI toxicity and depression. Conclusions: Albeit of short follow-up, PFS at 12 and 24 month are comparable in both arms. Also, safety profiles were quite similar, with slightly higher rates of grades 3-4 AEs and treatment discontinuation due AEs with generic form. However, more patients and longer follow up are needed to draw a firm conclusion.

If the inline PDF is not rendering correctly, you can download the PDF file here.

Corresponding Author: Mohamed Ali Maher
All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 34 34 34
PDF Downloads 90 90 90
EPUB Downloads 0 0 0