Benedetti-Panici P, Greggi S, Scambia G, Amoroso M, Salerno M G, Maneschi F, Cutillo G, Paratore M P, Scorpiglione N, Mancuso S
Department of Gynecology, Libero Istituto Universitario Campus Bio-Medico, Rome, Italy.
Eur J Cancer. 1998 Feb;34(3):341-6. doi: 10.1016/s0959-8049(97)10029-6.
The aim of this study was to analyse the long-term survival and the relationships between prognostic factors at presentation, chemoresponsiveness and disease outcome in patients with locally advanced cervical cancer treated by neoadjuvant chemotherapy and radical surgery (RS). Two consecutive studies of neoadjuvant chemotherapy containing cisplatin, bleomycin plus/minus methotrexate followed by radical hysterectomy and systematic aortic and pelvic lymphadenectomy were carried out between January 1986 and September 1990 on 130 patients with > or = 4 cm stage IB2-III cervical cancer. Survival analysis was performed using the Kaplan and Meier test and Cox's multivariate regression analysis. 128 (98%) of the patients enrolled were evaluable for clinical response and survival, 83% (106) of the patients responded to chemotherapy, with a 15% complete response rate. Logistic regression analysis demonstrated that International Federation of Gynecology and Obstetrics (FIGO) stage, cervical tumour size, parametrial involvement and histotype are highly predictive of response. Responding patients underwent laparotomy, but 8% were not amenable for radical surgery. The 10-year survival estimates were 91%, 80% and 34.5% for stage IB2-IIA bulky, IIB and III, respectively (P < 0.001). After Cox's regression analysis, the parameters significantly associated with survival were the same factors predicting response to neoadjuvant chemotherapy. No stage IB2-IIA bulky patient has so far relapsed, while 12% stage IIB and 56% stage III patients recurred. The 10-year disease-free survival estimates are 91% and 44% for stage IB2-IIB and III, respectively (P < 0.001). Metastatic nodes and persistent tumour in the parametria were the only two independent factors for disease-free survival after multiple regression analysis. After a long-term follow-up (median follow-up 98 months (20-129+)), our results give new evidence of the prognostic value of response to neoadjuvant chemotherapy and of a possible therapeutic benefit of the sequential treatment adopted which, however, must be verified in a randomised setting.
本研究旨在分析接受新辅助化疗和根治性手术（RS）治疗的局部晚期宫颈癌患者的长期生存率，以及初始预后因素、化疗反应性与疾病转归之间的关系。1986年1月至1990年9月期间，对130例IB2期至III期宫颈癌且肿瘤直径≥4 cm的患者进行了两项连续研究，研究采用含顺铂、博来霉素加/减甲氨蝶呤的新辅助化疗方案，随后行根治性子宫切除术及系统性主动脉旁和盆腔淋巴结清扫术。采用Kaplan-Meier检验和Cox多因素回归分析进行生存分析。128例（98%）入组患者可评估临床反应和生存情况，83%（106例）患者对化疗有反应，完全缓解率为15%。Logistic回归分析表明，国际妇产科联盟（FIGO）分期、宫颈肿瘤大小、宫旁组织受累情况和组织学类型对反应有高度预测性。有反应的患者接受了剖腹手术，但8%的患者不适合行根治性手术。IB2-IIA期大肿块、IIB期和III期患者的10年生存率估计分别为91%、80%和34.5%（P<0.001）。经过Cox回归分析，与生存显著相关的参数与预测新辅助化疗反应的因素相同。目前尚无IB2-IIA期大肿块患者复发，而IIB期患者复发率为12%，III期患者复发率为56%。IB2-IIB期和III期患者的10年无病生存率估计分别为91%和44%（P<0.001）。多因素回归分析后，转移淋巴结和宫旁组织残留肿瘤是无病生存的仅有的两个独立因素。经过长期随访（中位随访98个月（20-129+）），我们的结果为新辅助化疗反应的预后价值以及所采用的序贯治疗可能的治疗益处提供了新的证据，然而，这必须在随机研究中得到验证。
