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Abstract
This two- arm prospective randomized comparative study was carried out in Clinical Oncology Department at Assuit University Hospital. The study was conducted between January 2021 and May 2023 The aim of the study was to detect if there is a valuable difference for the use of immediate in comparison to delayed ZOL in treating postmenopausal patients with ER/PR positive early breast cancer who are using adjuvant letrozole regarding BMD benefit, bone pain, survival, recurrence rates, together with the incidence of jaw osteonecrosis, hypocalcemia, and renal dysfunction in postmenopausal patients receiving immediate versus delayed ZOLPatients eligible for the study are those postmenopausal women with histologic evidence of ER/PR positive breast adenocarcinoma, ECOG performance status 0-2, baseline LS and total hip BMD T-score > -2.0, calculated creatinine clearance >= 30 mL/min., corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L), and good dental health A total of 65 postmenopausal patients with EBC were included and distributed as 45 patients in the immediate arm (A) to 20 patients in the delayed arms (B) The study is a two-arm comparative, prospective, interventional study. All patients who are receiving oral daily letrozole (2.5 mg), were assigned to receive either immediate or delayed ZOL (4 mg via 15-min infusion every 6 months) for 24 months. Immediate-ZOL patients received ZOL immediately after randomization; delayed- ZOL Patients were classified into 4 groups of equal number (5 patients in each group), baseline BMD was measured for all then after 3 months later, the first group (A) received zoledronate before measurement of BMD 6 months later, the 2nd group (B) received Zometa 9 months later, the 3rd(C) group received it 12 months later, and finally the 4th group (D) received Zometa 15 months later, Zometa was given to all groups every 6 months later on after the start of letrozole as their T-score fall below -2.0 in association with worsened bone pain, with 2 cases developed non traumatic clinical fractures detected by spinal X-ray at the 3- monthly assessment. All patients received daily supplements containing calcium (500 mg) and vitamin D (400–800 IU). Baseline bone mineral density and every 3 months was assessed for the enrolled patients. On the other hand, serum calcium and creatinine clearance were evaluated every 6 months before each ZOL injection for 24 months and revealed acceptable ranges together with absence of ZOL adverse events. All patients in the immediate arm have better quality of life in addition to delayed arm patients after starting ZOL. Moreover, remarkable gain was noted in patients survival in immediate arm patients and in delayed arm group after starting ZOL A comparability between both arms regarding the age with similar median age of 63 years in both arms(p=0.6), also >30% of patients in each arm were found to be both diabetic and hypertensive, followed by no comorbidities, then hypertension, and lastly diabetes (p=0.9) Invasive duct carcinoma was the only pathologic subtype encountered in immediate arm while it represented 55% in delayed arm followed by ILC (35%), and DCIS (10%) in the same arm with significant P-value (p=0.011), the predominant grade was G2, followed by G3, and G1 with also significant P-value p=0.033), T2, T3, and T1 were the T-stages reported in immediate arm compared to T2, T1, Tis, and T3 in delayed arm with significant P-value (p=0.046), we detected no significant differences in the distribution of N-stage (p=0.1), treatments received apart from aromatase inhibitors (p=0.2), and Her2 expressions in both arms (p=0.3).