Lacava J A, Leone B A, Machiavelli M, Romero A O, Perez J E, Elem Y L, Ferreyra R, Focaccia G, Suttora G, Salvadori M A, Cuevas M A, Acuña L R, Acuña J R, Langhi M, Amato S, Castaldi J, Arroyo A, Vallejo C T
Grupo Oncológico Cooperativo del Sur, Neuquen, Républica Argentina.
J Clin Oncol. 1997 Feb;15(2):604-9. doi: 10.1200/JCO.1997.15.2.604.
To evaluate the efficacy and toxicity of vinorelbine (VNB) as single-agent neoadjuvant chemotherapy in advanced cervical carcinoma (ACC).
Between December 1993 and October 1995, 43 untreated patients with stages IIB to IVA squamous cell cervical cancer were entered onto this study. Forty-two patients are assessable for response and 43 for toxicity. The median age was 46 years (range, 28 to 65). Distribution by stages (International Federation of Gynecology and Obstetrics [FIGO]) was as follows: IIB, 18 patients; IIIA, one; IIIB, 19; and IVA, five. Therapy consisted of VNB 30 mg/m2 by 20-minute intravenous (IV) infusion repeated weekly for 12 injections and followed by radical surgery if feasible or definitive radiotherapy. Both staging and response assessment were performed by a multidisciplinary team.
One patient was considered not assessable for response. A total of 493 cycles of therapy were administered and objective remissions were observed in 19 of 42 patients (45%; 95% confidence interval, 30% to 60%). Two patients (5%) had a complete response (CR) and 17 (40%) a partial response (PR); no change (NC) was observed in 16 (38%) and progressive disease (PD) in seven (17%). Six of 19 patients (32%) who achieved objective responses (ORs) underwent surgery. The median time to failure and median survival time have not been reached yet. There were no therapy-related deaths. The dose-limiting toxicity was myelosuppression. Leukopenia occurred in 35 patients (81%) and was grade 3 or 4 in seven (17%). Twelve patients (28%) developed peripheral neuropathy, while myalgias occurred in 10 (23%). Constipation was observed in nine patients (21%), one with a prolonged ileum. Phlebitis was recorded in 18 patients (41%). In contrast, emesis and mucositis were rarely observed. No patient developed alopecia grade 3. By the end of the twelfth course of treatment, the average received dose-intensity was 85.4% of that projected.
VNB is an active drug against ACC with moderate toxicity. Its activity is among the highest reported for single agents. Further evaluation in association with other agents is clearly justified.
评估长春瑞滨（VNB）作为晚期宫颈癌（ACC）单药新辅助化疗的疗效和毒性。
1993年12月至1995年10月，43例未经治疗的IIB至IVA期宫颈鳞状细胞癌患者进入本研究。42例患者可评估疗效，43例可评估毒性。中位年龄为46岁（范围28至65岁）。按国际妇产科联盟（FIGO）分期分布如下：IIB期18例；IIIA期1例；IIIB期19例；IVA期5例。治疗方案为VNB 30 mg/m²，静脉输注20分钟，每周重复1次，共注射12次，若可行则随后进行根治性手术或确定性放疗。分期和疗效评估均由多学科团队进行。
1例患者被认为无法评估疗效。共进行了493个周期的治疗，42例患者中有19例观察到客观缓解（45%；95%置信区间，30%至60%）。2例患者（5%）完全缓解（CR），17例（40%）部分缓解（PR）；16例（38%）病情无变化（NC），7例（17%）疾病进展（PD）。19例达到客观缓解（OR）的患者中有6例（32%）接受了手术。至失败的中位时间和中位生存时间尚未达到。无治疗相关死亡。剂量限制性毒性为骨髓抑制。35例患者（81%）发生白细胞减少，7例（17%）为3或4级。12例患者（28%）出现周围神经病变，10例（23%）出现肌痛。9例患者（21%）出现便秘，1例伴有肠梗阻延长。18例患者（41%）记录有静脉炎。相比之下，呕吐和黏膜炎很少见。无患者出现3级脱发。到第12个疗程结束时，平均接受的剂量强度为预计剂量强度的85.4%。
VNB是一种治疗ACC有效的药物，毒性中等。其活性是报道的单药中最高的之一。显然有理由与其他药物联合进行进一步评估。
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