Topotecan in patients with advanced neuroendocrine tumors - A phase II study with significant hematologic toxicity
Topotecan in patients with advanced neuroendocrine tumors - A phase II study with significant hematologic toxicity
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DOI：
10.1097/01.coc.0000054535.19808.f4
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发表时间：
2004-06-01
影响因子：
2.6
通讯作者：
Rubin, J
中科院分区：
文献类型：
--
作者：
Ansell, SM;Mahoney, MR;Rubin, J
神经内分泌肿瘤迫切需要新的抗肿瘤药物。因此，我们对22例晚期类癌和胰岛细胞肿瘤患者进行了一项II期研究，TOPA 1.5 mg/m(2)/d，每3周5天。11例患者中有8例（72%）严重中性粒细胞减少，最后11例患者的TOPA剂量减少30%至1.05 mg/m(2)。未观察到客观反应。18名患者出现进展，14名患者死亡。中位进展时间为4.2个月（95% CI: 2.9-6.5），中位生存期为1.9年（95% CI: 0.63-2.3）。血液学不良事件显著，22例患者中有16例发生IV级中性粒细胞减少症；然而，没有脓毒性死亡。非血液学不良事件很少发生，也不受剂量限制。总之，由于缺乏肿瘤反应和明显的血液学毒性，不建议在该患者群体中进一步研究这种TOPA方案。
New agents with antitumor activity in neuroendocrine tumors are sorely needed. We therefore conducted a phase II study of topotecan (TOPA) 1.5 mg/m(2)/d for 5 days every 3 weeks in 22 patients with advanced carcinoid and islet cell tumors. Severe neutropenia in 8 of 11 patients (72%) prompted a 30% dose reduction of TOPA to 1.05 mg/m(2) for the final 11 patients enrolled. No objective responses were observed. Eighteen patients have progressed and 14 have died. The median time to progression was 4.2 months (95% CI: 2.9-6.5) and the median survival was 1.9 years (95% CI: 0.63-2.3). Hematologic adverse events were significant, with 16 of 22 patients developing grade IV neutropenia; however, there were no septic deaths. Nonhematologic adverse events were infrequent and were not dose limiting. In conclusion, further studies of this schedule of TOPA in this patient population are not recommended due to the lack of tumor response and significant hematologic toxicity.