Patel Viral, Rajanbabu Anupama, Pavithran Keechilat, Anandita Anandita
Department of Gynecological Oncology, Amrita Institute of Medical Sciences and Research Center, Kochi, India.
Department of Gynecological Oncology, HCG Cancer Centre, Ahmedabad, Gujarat 380060 India.
Indian J Surg Oncol. 2025 Jun;16(3):766-773. doi: 10.1007/s13193-024-02149-9. Epub 2024 Dec 2.
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 ( = 0.038). There was no improvement in hemoglobin level in the intervention group vs the control (72% vs. 57%; 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=.
The online version contains supplementary material available at 10.1007/s13193-024-02149-9.
卵巢癌患者在治疗（手术和化疗）期间贫血患病率≥50%。本研究的目的是评估静脉补充羧麦芽糖铁对贫血上皮性卵巢癌患者从干预到最后一个化疗周期后3个月的输血率和血红蛋白水平的影响。69例血红蛋白水平≤10 g/dl的上皮性卵巢癌患者在一家机构进行的平行组随机对照试验中被随机分组。纳入所有阶段的上皮性卵巢癌患者，这些患者在初次细胞减灭术后接受≤3周期辅助化疗，或在接受≤3周期新辅助化疗后接受间隔细胞减灭术。干预组静脉注射一剂1000 mg羧麦芽糖铁，而对照组口服100 mg抗坏血酸亚铁，每日两次，共3个月。两组的肿瘤治疗方案保持不变。在入组时记录缺铁性贫血的生化参数（铁蛋白、总铁结合力、铁和C反应蛋白）。在干预前和最后一个化疗周期的3个月时监测全血细胞计数。评估两组反应的时间范围是从纳入研究到最后一个化疗周期后的3个月。如果血红蛋白≤8 gm/dl且根据围手术期失血的临床判断进行输血。对照组有35例患者，干预组有32例患者。总共，对照组22例患者（63%）和干预组12例患者（37.5%）在癌症治疗期间接受了输血（P = 0.038）。干预组与对照组相比，血红蛋白水平没有改善（72%对57%；P = 0.208）。静脉补充铁剂可降低诊断为上皮性卵巢癌患者在癌症治疗期间的输血需求。本研究已在印度临床试验注册中心（CTRI）注册；注册号：REF/2019/05/025907，注册日期：2019年5月27日。https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MzQwNzU=&Enc=&userName=。
在线版本包含可在10.1007/s13193-024-02149-9获取的补充材料。
