Serur E, Mathews R P, Gates J, Levine P, Maiman M, Remy J C
Department of Obstetrics and Gynecology, State University of New York-Health Science Center, Brooklyn 11203, USA.
Gynecol Oncol. 1997 May;65(2):348-56. doi: 10.1006/gyno.1997.4645.
To determine the effects of neoadjuvant chemotherapy (NAC) in the management of cervical carcinoma Stage IB2 (tumor diameter > 4 cm), we reviewed 52 surgically treated patients diagnosed between January 1987 and December 1993. There were 20 patients treated with preoperative neoadjuvant chemotherapy and 32 treated by primary radical hysterectomy. Mean tumor diameter was significantly larger in the neoadjuvant, compared with the primary surgery group (6.5 +/- 1.8 vs 5.4 +/- 0.7, P = 0.003). In the NAC group, 5 of 20 patients were treated with three courses of cisplatin, methotrexate, and bleomycin every 21 days, whereas 15 of 20 patients received three courses of cisplatin, vincristine, and bleomycin every 10 days. Postoperative adjuvant therapy consisting of either radiation or chemotherapy was employed in 13/20 patients (65%) in the NAC group and 20/32 patients (63%) in the primary surgical group. At a median follow-up of 52.5 months, 4/20 patients (20%) in the NAC group recurred vs 11/32 (34%) in the primary surgery group. The overall response rate to NAC was 90%, with 2/20 complete clinical responders and 16/20 partial responders. High-risk pathologic factors were less commonly observed in the NAC group when compared with the primary surgical group with the incidence of nodal metastases, positive vascular space involvement, undiagnosed parametrial disease, and > or = 75% depth of invasion observed in 10.0% vs 37.5%, 20.0% vs 46.9%, 0.0% vs 15.6%, and 30.0% vs 68.8%, respectively. No differences were noted in operative time or blood loss. Cox proportional-hazards analysis indicated that the most significant prognostic factor was depth of invasion. Although the patients who received neoadjuvant chemotherapy had significantly larger tumors at baseline, their 5-year survival rate was slightly higher than that of the primary surgery group (80.0% vs 68.7%, P = 0.162). Patients receiving neoadjuvant chemotherapy, despite having significantly larger pretreatment tumors, had fewer high-risk pathologic factors, postoperatively. Although this was a small, nonrandomized study, the relative improvement in pathologic response and long-term outcome associated with neoadjuvant chemotherapy was encouraging. This highlights the need for a prospective randomized clinical trial to establish whether neoadjuvant chemotherapy can significantly improve the long-term outcome of women with Stage IB2 squamous cell carcinoma of the cervix.
为了确定新辅助化疗(NAC)对IB2期宫颈癌(肿瘤直径>4cm)治疗的效果,我们回顾了1987年1月至1993年12月间52例接受手术治疗的患者。其中20例患者接受了术前新辅助化疗,32例接受了根治性子宫切除术。与初次手术组相比,新辅助化疗组的平均肿瘤直径显著更大(6.5±1.8 vs 5.4±0.7,P = 0.003)。在NAC组中,20例患者中有5例每21天接受三个疗程的顺铂、甲氨蝶呤和博来霉素治疗,而20例患者中有15例每10天接受三个疗程的顺铂、长春新碱和博来霉素治疗。NAC组20例患者中有13例(65%)和初次手术组32例患者中有20例(63%)接受了术后放疗或化疗的辅助治疗。在中位随访52.5个月时,NAC组20例患者中有4例(20%)复发,而初次手术组32例患者中有11例(34%)复发。NAC的总体缓解率为90%,其中2/20例为完全临床缓解者,16/20例为部分缓解者。与初次手术组相比,NAC组中高风险病理因素的观察频率较低,淋巴结转移、阳性脉管间隙受累、未诊断的宫旁组织疾病以及浸润深度≥75%的发生率分别为10.0% vs 37.5%、20.0% vs 46.9%、0.0% vs 15.6%以及30.0% vs 68.8%。手术时间和失血量方面未发现差异。Cox比例风险分析表明,最显著的预后因素是浸润深度。尽管接受新辅助化疗的患者在基线时肿瘤明显更大,但他们的5年生存率略高于初次手术组(80.0% vs 68.7%,P = 0.162)。接受新辅助化疗的患者尽管术前肿瘤明显更大,但术后高风险病理因素较少。尽管这是一项小型的非随机研究,但与新辅助化疗相关的病理反应和长期结果的相对改善令人鼓舞。这突出了进行前瞻性随机临床试验以确定新辅助化疗是否能显著改善IB2期宫颈鳞状细胞癌女性患者长期结果的必要性。