Hempling R E, Piver M S, Baker T R
Department of Gynecologic Oncology, Roswell Park Cancer Institute, Buffalo, New York 14263, USA.
Am J Clin Oncol. 1995 Aug;18(4):282-6. doi: 10.1097/00000421-199508000-00002.
To assess the impact on progression-free survival of the use of the multiagent chemotherapy regimen of cyclophosphamide, vincristine, doxorubicin (Adriamycin), and dacarbazine (CYVADIC) as adjuvant treatment for patients with stage I uterine sarcoma: 20 evaluable patients who underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy for stage I uterine sarcoma received adjuvant multiagent chemotherapy with vincristine sulfate 1 mg/m2 days 1 and 4, doxorubicin (Adriamycin) 40 mg/m2 and cyclophosphamide 400 mg/m2 day 2, and dacarbazine 200 mg/m2 days 1 through 4 for a total of 9 monthly cycles or until recurrence of disease was documented. Patients were followed for a median of 65 months (range: 5-116 months). Myelotoxicity was monitored by weekly complete blood counts, cardiac toxicity by monthly radionuclide angiography, and neurotoxicity by monthly physical examination. Survival and progression-free survival were calculated by the method of Kaplan and Meier (17). The Fisher exact test was employed to determine the significance of recurrence rates between histologic groups (18). These 20 patients received 172 of a planned 180 cycles of chemotherapy. Dose reductions in response to myelotoxicity were necessitated in four cycles among three patients. Mild neurotoxicity was observed in six patients (30%) and moderate neurotoxicity in one patient (5%). A decrease in cardiac ejection fraction of > 10% was observed in two patients (10%). No deaths ascribable to complications arising from chemotherapy were observed. Seven patients (35%) developed recurrence of disease. Recurrence rates for pure sarcomas and mixed mesodermal tumors did not differ significantly (P = .65). Progression-free survival for the population at 2 years was 80% and at 5 years was 65%. This study describes the largest prospective trial of adjuvant combination chemotherapy for patients with stage I uterine sarcoma reported to date. Adjuvant chemotherapy employing the combination of cyclophosphamide, vincristine, doxorubicin (Adriamycin), and dacarbazine (CYVADIC) failed to impact significantly on long-term survival in this group of patients with stage I uterine sarcoma.
为评估采用环磷酰胺、长春新碱、阿霉素(多柔比星)和达卡巴嗪的多药化疗方案(CYVADIC)作为Ⅰ期子宫肉瘤患者辅助治疗对无进展生存期的影响:20例可评估患者因Ⅰ期子宫肉瘤接受了全腹子宫切除术和双侧输卵管卵巢切除术,接受辅助多药化疗,具体方案为硫酸长春新碱1mg/m²,第1天和第4天使用;阿霉素(多柔比星)40mg/m²,环磷酰胺400mg/m²,第2天使用;达卡巴嗪200mg/m²,第1天至第4天使用,共9个周期,或直至记录到疾病复发。患者的中位随访时间为65个月(范围:5 - 116个月)。通过每周进行全血细胞计数监测骨髓毒性,通过每月进行放射性核素血管造影监测心脏毒性,通过每月体格检查监测神经毒性。采用Kaplan - Meier方法计算生存率和无进展生存期(17)。采用Fisher精确检验确定组织学组之间复发率的显著性(18)。这20例患者共接受了计划的180个化疗周期中的172个周期。3例患者中有4个周期因骨髓毒性需要降低剂量。6例患者(30%)观察到轻度神经毒性,1例患者(5%)观察到中度神经毒性。2例患者(10%)观察到心脏射血分数下降>10%。未观察到因化疗并发症导致的死亡。7例患者(35%)出现疾病复发。纯肉瘤和混合性中胚层肿瘤的复发率无显著差异(P = 0.65)。该人群2年无进展生存率为80%,5年为65%。本研究描述了迄今为止报道的关于Ⅰ期子宫肉瘤患者辅助联合化疗的最大规模前瞻性试验。采用环磷酰胺、长春新碱、阿霉素(多柔比星)和达卡巴嗪联合(CYVADIC)的辅助化疗对这组Ⅰ期子宫肉瘤患者的长期生存未产生显著影响。