Vincristine with high-dose etoposide in advanced breast cancer: a phase II trial of the Piedmont Oncology Association.

Vincristine with high-dose etoposide in advanced breast cancer: a phase II trial of the Piedmont Oncology Association.
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长春新碱联合高剂量依托泊苷治疗晚期乳腺癌:皮埃蒙特肿瘤学协会的一项 II 期试验。

DOI:
10.1007/bf00686641
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发表时间:
1994
影响因子:
3
通讯作者:
Heath,R
Heath,R
中科院分区:
医学3区
文献类型:
--
作者:
Thomas,GW;Muss,HB;Jackson,DV;McCulloch,J;Ramseur,W;McFarland,J;Hoen,H;Pavy,M;Heath,R

文献摘要

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在小鼠模型中,已证明曲马新碱(VCR)和依托泊苷(VP-16)具有协同作用,并在II期试验中研究了该联合用药。合格性要求疾病可测量,体能状态为0-2,预期寿命≥2个月,自接受既往放疗或化疗后至少间隔3周并从相关毒性中恢复,既往未接受VCR或VP-16治疗,既往化疗方案不超过2种(仅1种用于治疗转移性疾病)。治疗包括0.5 mg VCR i. v.(推注),随后在2小时内给予200 mg/m2 VP-16。两种药物均每日给药,连续3天,每3周一次(总剂量:VCR,1.5 mg; VP-16,600 mg/m2)。共18例转移性乳腺癌患者获得治愈; 14例接受辅助化疗,8例接受晚期化疗。根据国际抗癌联合会(UICC)标准,获得1例完全缓解(CR)和3例部分缓解(PR),CR+PR率为22%(95%置信区间,6%-48%)。所有的反应者只有软组织参与。6例患者病情稳定,8例患者病情进展。至治疗失败的中位时间为3.5个月,进入研究的中位生存期为8.3个月。主要毒性是骨髓抑制,9名患者(50%)的总WBC <1,000/mm 3。6例患者(33%)出现2-3级神经毒性,5例患者(28%)出现3级恶心和呕吐。VCR和VP-16联合治疗在晚期乳腺癌中具有活性,但并不令人信服地上级单独使用这两种药物。
Vincristine (VCR) and etoposide (VP-16) have been shown to be synergistic in a murine model, and this combination was studied in a phase II trial. Eligibility required measurable disease, a performance status of 0–2, a life expectancy of ≥2 months, an interval of at least 3 weeks since the receipt of previous radiation therapy or chemotherapy and recovery from related toxicity, no prior treatment with VCR or VP-16, and no more than two prior chemotherapy regimens (only one for treatment of metastatic disease). Treatment consisted of 0.5 mg i.v. (bolus) VCR followed by 200 mg/m2VP-16 given over 2 h. Both drugs were given daily for 3 consecutive days every 3 weeks (total dose: VCR, 1.5 mg; VP-16, 600 mg/m2). A total of 18 patients with metastatic breast cancer were accured; 14 had adjuvant chemotherapy and 8 had chemotherapy for advanced disease. As judged by International Union Against Cancer (UICC) criteria, one complete response (CR) and three partial responses (PR) were obtained, for a CR+PR rate of 22% (95% confidence interval, 6%–48%). All responders had soft-tissue involvement only. Six patients had stable disease and 8 showed progression. The median time to treatment failure was 3.5 months, and the median survival from study entry was 8.3 months. The major toxicity was myelosuppression, with 9 patients (50%) experiencing a total WBC of <1,000/mm3. Grade 2–3 neurologic toxicity was noted in 6 patients (33%) and grade 3 nausea and vomiting was noted in 5 (28%). The combination of VCR and VP-16 is active in advanced breast cancer but is not convincingly superior to either of these agents used alone.