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.
Hisham Abutaleb, Ali Hussien, Mohamed Khalaf, Dalia M Badary, Alaa M Ismail, Sara Hassanein, Samy AlGizawy, S A M Moustafa, Rabab Mohmed Mumdouh Farghaly, A F Abdel-Kawi
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引用次数: 0
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.
卵巢癌（OV）是最致命的女性生殖系统恶性肿瘤。在全球范围内，OV是女性中第七大最常见的癌症，每年估计有24万新病例，是埃及女性中第二大最常见的恶性肿瘤。目的：我们研究细胞减少手术在OV中实现完全肿瘤切除（R0切除）的效果，并与新辅助化疗后手术进行比较。方法：于2020 - 2023年在埃及阿斯尤特大学妇女保健医院进行随机对照试验。80例患者随机（1:1）分为初始手术组（I组）或NACT组（II组），随后每组进一步随机（1:1）分为含贝伐单抗化疗组或单独化疗组。主要结果是肿瘤完全切除率（R0切除术）。次要结局包括手术复杂性、手术时间、并发症和生存率。结果：两组间基线人口学特征相似（无统计学差异）。I组和II组的平均年龄分别为56.3岁和57.23岁。而I组和II组的BMI分别为32.56和33.2。此外，两组肿瘤完全切除无显著差异（31 vs. 27）。II组手术时间明显缩短（182.34 vs. 219.85 min, p = 0.047），输血次数明显减少（9 vs. 21, p = 0.006），住院时间明显缩短（6.13 vs. 11.9 d, p = 0.006）。结论：我们的研究表明，采用NACT进行最佳细胞减少更可行，手术复杂性更小，手术时间更短，输血次数更少，住院时间更短。该研究已在clincaltrail.gov上注册，编号：NCT04257786。补充信息：在线版本包含补充资料，提供地址为10.1007/s13224-024-02061-w。
期刊介绍：
Journal of Obstetrics and Gynecology of India (JOGI) is the official journal of the Federation of Obstetrics and Gynecology Societies of India (FOGSI). This is a peer- reviewed journal and features articles pertaining to the field of obstetrics and gynecology. The Journal is published six times a year on a bimonthly basis. Articles contributed by clinicians involved in patient care and research, and basic science researchers are considered. It publishes clinical and basic research of all aspects of obstetrics and gynecology, community obstetrics and family welfare and subspecialty subjects including gynecological endoscopy, infertility, oncology and ultrasonography, provided they have scientific merit and represent an important advance in knowledge. The journal believes in diversity and welcomes and encourages relevant contributions from world over. The types of articles published are: · Original Article· Case Report · Instrumentation and Techniques · Short Commentary · Correspondence (Letter to the Editor) · Pictorial Essay
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