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Neoadjuvant chemotherapy followed by conization in stage IB2–IIA1 cervical cancer larger than 2 cm: a pilot study
Fertility and Sterility ( IF 6.7 ) Pub Date : 2021-01-01 , DOI: 10.1016/j.fertnstert.2020.07.006
Rosa de Vincenzo 1 , Caterina Ricci 2 , Francesco Fanfani 1 , Benedetta Gui 3 , Valerio Gallotta 2 , Anna Fagotti 1 , Gabriella Ferrandina 1 , Giovanni Scambia 1
Affiliation  

OBJECTIVE To evaluate feasibility of neoadjuvant chemotherapy (NACT) followed by cold-knife conization (CKC) in patients with 2018 FIGO stage IB2-IIA1 cervical cancer who desired to maintain fertility. DESIGN Pilot study of conization after chemotherapy in stage IB2-IIA1 >2 cm cervical cancer. SETTING University hospital. PATIENT(S) From 2014 to 2018, 25 patients, <40 years of age, were enrolled. INTERVENTIONS(S) After laparoscopic pelvic lymph-node assessment, NACT with cisplatin/paclitaxel q21 was administered to eligible patients. Responsive patients were treated with CKC. MAIN OUTCOME MEASURE(S) Obstetrical outcome: pregnancy rate. Oncologic outcome. RESULT(S) Thirteen out of 25 patients were eligible for fertility-sparing treatment. Oncologic outcome: The clinical overall response rate was 84.5% (11 out of 13 patients). One patient achieved stable disease, was managed by radical surgery, and is still alive; another one experienced progression of disease and died after 15 months. The optimal pathologic response was 69.1%. In the setting of fertility preservation patients, the median follow-up was 37 months (range 18-76). In this group we registered one distant recurrence, 12 months after CKC, in the liver; the patient is still alive and without evidence of disease. Obstetrical outcome: Among the nine patients amenable, three tried to conceive, and two spontaneous pregnancy occurred a few months after the end of treatment, for a pregnancy rate of 66.7%. CONCLUSION(S) This pilot study supports the feasibility of CKC after NACT as conservative treatment in stage IB2-IIA1 cervical cancer, with oncologic outcomes similar to those reported for trachelectomy in the same stage and with potential benefits in terms of obstetrical outcomes. CLINICAL TRIAL REGISTRATION NUMBER NCT02323841.

中文翻译:

新辅助化疗后锥切术治疗大于 2 cm 的 IB2-IIA1 期宫颈癌:一项初步研究

目的 评估新辅助化疗 (NACT) 后冷刀锥切术 (CKC) 在希望保持生育能力的 2018 年 FIGO IB2-IIA1 期宫颈癌患者中的可行性。设计 IB2-IIA1 期 >2 cm 宫颈癌化疗后锥切术的初​​步研究。设置大学医院。患者 2014 年至 2018 年,25 名 <40 岁的患者入组。干预措施(S) 在腹腔镜盆腔淋巴结评估后,对符合条件的患者给予 NACT 和顺铂/紫杉醇 q21。有反应的患者接受 CKC 治疗。主要结果测量(S) 产科结果:妊娠率。肿瘤学结果。结果 25 名患者中有 13 名符合保留生育能力的治疗条件。肿瘤学结果:临床总体反应率为 84.5%(13 名患者中有 11 名)。1例患者病情稳定,经根治性手术治疗,至今仍健在;另一人经历了疾病进展并在 15 个月后死亡。最佳病理反应率为 69.1%。在保留生育能力的患者中,中位随访时间为 37 个月(范围 18-76)。在该组中,我们在 CKC 后 12 个月登记了肝脏远处复发;病人还活着,没有疾病的迹象。产科结果:9例患者中,3例尝试怀孕,2例治疗结束后数月自然妊娠,妊娠率为66.7%。结论(S)该初步研究支持 NACT 后 CKC 作为 IB2-IIA1 期宫颈癌保守治疗的可行性,具有与相同阶段宫颈切除术报告的相似的肿瘤学结果,并且在产科结果方面具有潜在益处。临床试验注册号 NCT02323841。
更新日期:2021-01-01
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