Primary Cytoreductive Surgery Versus Neoadjuvant Chemotherapy Followed by Surgery in Patients with Advanced Primary Epithelial Ovarian Cancer in Low Resources Setting: A Randomized Clinical Trial

在资源匮乏地区,对晚期原发性上皮性卵巢癌患者进行原发性细胞减灭术与新辅助化疗后手术的疗效比较:一项随机临床试验

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Abstract

INTRODUCTION: Ovarian cancer (OV) stands as the deadliest female reproductive system malignancy. Globally, OV ranks as the seventh most prevalent cancer in women, with an estimated 240,000 new cases annually and being the second most common malignancy among women in Egypt. OBJECTIVES: We investigate the efficacy of cytoreductive surgery in achieving complete tumor removal (R0 resection) in OV, compared to neoadjuvant chemotherapy followed by surgery. METHOD: This randomized controlled trial at Women Health Hospital, Asyut University, Egypt from 2020 to 2023. Eighty patients were randomized (1:1) to primary surgery (Group I) or NACT (Group II), followed by further randomization (1:1) within each group to bevacizumab-containing chemotherapy or chemotherapy alone. The primary outcome was the rate of complete tumor removal (R0 resection). Secondary outcomes included surgical complexity, operative time, complications, and survival rates. RESULTS: Baseline demographic characteristics were similar between the groups (no statistically significant differences). The mean age for group I and group II were (56.3 and 57.23, respectively). Whereas, the BMI for group I and group II were (32.56 and 33.2, respectively). In addition, both groups achieved no significant difference of complete tumor removal (31 vs. 27). However, group II demonstrated significantly shorter operative times (182.34 vs. 219.85 min, p = 0.047), required fewer blood transfusions (9 vs. 21, p value 0.006), and experienced shorter hospital stays (6.13 vs. 11.9 days, p value < 0.001) compared to group I. Notably, no significant differences emerged in complication rates, progression-free survival (11.20 vs. 11.19 months), or overall survival (11.69 vs. 11.76 months) between the groups. CONCLUSION: Our study demonstrates that optimal cytoreduction is more feasible with NACT, with less surgical complexity, shorter operative duration, less blood transfusion and short hospital stay.Clinical Trials registration The study was registered on clincaltrail.gov with number: NCT04257786. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13224-024-02061-w.

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