Phase II/III study of doxorubicin with fluorouracil compared with streptozocin with fluorouracil or dacarbazine in the treatment of advanced carcinoid tumors: Eastern Cooperative Oncology Group Study E1281
Phase II/III study of doxorubicin with fluorouracil compared with streptozocin with fluorouracil or dacarbazine in the treatment of advanced carcinoid tumors: Eastern Cooperative Oncology Group Study E1281
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DOI：
10.1200/jco.2005.03.616
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发表时间：
2005-08-01
影响因子：
45.3
通讯作者：
Haller, DG
中科院分区：
文献类型：
--
作者：
Sun, WJ;Lipsitz, S;Haller, DG
目的转移性类癌的最佳治疗方法仍不明确，化疗对于有症状的进展性疾病患者的作用也不确定。 患者和方法 249 例晚期类癌患者被随机分配接受阿霉素联合氟尿嘧啶 (FU/DOX) 或链佐星联合氟尿嘧啶 (FU/STZ) 治疗。一线治疗（FU/DOX 或 FU/STZ）后疾病进展后，患者交叉接受达卡巴嗪 (DTIC) 治疗，73 名患者根据其既往治疗情况或基线心肾功能异常被分配到这三种治疗中的一种。 结果在随机组中，FU/DOX 和 FU/STZ 在缓解率 (15.9% v 16%) 和无进展生存期 (4.5 v) 方面没有差异。 5.3 个月）。 FU/STZ（24.3 个月）的中位生存期优于 FU/DOX（15.7 个月；P =.0267）。交叉DTIC治疗的缓解率为8.2%，中位生存期为11.9个月。血液学毒性是 FU/DOX 和 FU/STZ 的主要治疗相关毒性，FU/STZ 组 115 名患者中有 40 名 (34.8%) 报告有轻度至中度肾毒性。 结论 对所有三种治疗方案的反应均为中等。与基于阿霉素的方案相比，FU/STZ 提高了生存率，这表明当化疗被认为是选定的类癌肿瘤患者的一种选择时，应将联合治疗视为一种积极的治疗方案。
PurposeOptimal treatments for metastatic carcinoid tumor remain undefined, and the role of chemotherapy for symptomatic patients with progressive disease is uncertain.Patients and MethodsTwo hundred forty-nine patients with advanced carcinoid tumors were randomized to either doxorubicin with fluorouracil (FU/DOX) or streptozocin with fluorouracil (FU/STZ). Patients crossed over to the dacarbazine (DTIC) treatment after disease progression following first-line treatment (either FU/DOX or FU/STZ), and 73 patients were assigned to one of these three treatments based on their previous treatment or on abnormal baseline cardiac or renal function.ResultsIn the randomized group, there was no difference between FU/DOX and FU/STZ in response rates (15.9% v 16%) and progression-free survival (4.5 v 5.3 months). FU/STZ (24.3 months) was superior to FU/DOX (15.7 months; P =.0267) in median survival. The response rate of crossover DTIC treatment was 8.2%, with a median survival of 11.9 months. Hematologic toxicities were the major treatment-related toxicities for both FU/DOX and FU/STZ, and mild to moderate renal toxicity was reported in 40 (34.8%) of 115 patients in the FU/STZ arm.ConclusionResponse to all three treatment regimens were modest. FU/STZ improved survival compared with the doxorubicin-based regimen, suggesting that the combination should be considered to be an active regimen of therapy when chemotherapy is judged to be an option for selected patients with carcinoid tumors.