Randomised Controlled Trial Evaluating the Impact of Intravenous Iron (ferric carboxymaltose) Supplementation Among Epithelial Ovarian Cancer Patients with Anemia.

Abstract

The prevalence of anemia is ≥ 50% during treatment (surgery and chemotherapy) in patients with diagnosis of ovarian cancer. The purpose of this study was to assess the effects of intravenous ferric carboxymaltose supplementation on blood transfusion rates and hemoglobin levels in anemic epithelial ovarian cancer patients from intervention to 3 months after the last chemotherapy cycle. Sixty-nine patients with diagnosis of epithelial ovarian cancer with hemoglobin levels ≤ 10 g/dl were randomized in a parallel-group randomized controlled trial conducted at a single institute. All-stage epithelial ovarian cancer patients who were on ≤ 3rd cycle of adjuvant chemotherapy after primary cytoreductive surgery or who underwent interval cytoreductive surgery after receiving ≤ 3 neoadjuvant chemotherapy were included. The intervention group received one 1000-mg dose of ferric carboxymaltose intravenously while the control group received 100 mg ferrous ascorbate orally twice daily for 3 months. The oncologic treatment plan in both groups remained unchanged. Biochemical parameters for iron deficiency anemia (ferritin, total iron binding capacity, iron, and C-reactive protein) were recorded at enrolment. Complete blood count was monitored before intervention and at 3 months of the last chemotherapy cycle. The time frame to evaluate the response of both groups was from inclusion in the study to 3 months from the last chemotherapy cycle. Blood was transfused if hemoglobin was ≤ 8 gm/dl and as per clinical judgement for perioperative blood loss. There were 35 patients in the control group and 32 patients in the intervention group. In total, 22 patients (63%) in the control group and 12 patients (37.5%) in the intervention group received blood transfusion during cancer treatment (p = 0.038). There was no improvement in hemoglobin level in the intervention group vs the control (72% vs. 57%; p 0.208). An intravenous iron supplementation decreased blood transfusion requirements during cancer treatment in patients with diagnosis of epithelial ovarian cancer. The current study is registered with the Clinical Trials Registry- India (CTRI); REF/2019/05/025907, registration date: 27 May 2019. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzQwNzU=&Enc=&userName=.

Supplementary information: The online version contains supplementary material available at 10.1007/s13193-024-02149-9.