当前位置： SCI文献检索 > JAPANESE JOURNAL OF CLINICAL ONCOLOGY期刊下所有文献 > Phase I study of bevacizumab plus irinotecan in pediatric patients with recurrent/refractory solid tumors.

Phase I study of bevacizumab plus irinotecan in pediatric patients with recurrent/refractory solid tumors.

Abstract：

OBJECTIVE:Studies have suggested that bevacizumab has shown activity against various pediatric solid tumors. We, therefore, conducted a Phase I study of bevacizumab plus irinotecan in Japanese children with recurrent, progressive or refractory solid tumors. METHODS:The starting dose was bevacizumab 10 mg/kg over 60-90 min and irinotecan 125 mg/m(2) over 90 min intravenously on Days 1, 15 and 29. The dose of irinotecan was 340 mg/m(2) for patients receiving enzyme-inducing antiepileptic drugs. Treatment was repeated every 6 weeks for up to three courses in the absence of disease progression or unacceptable toxicity. RESULTS:Of 11 patients, 9 (median age, 9 years) were fully assessable for toxicity and received 24 courses. Dose-limiting toxicities were Grade 2 diarrhea and Grade 4 neutropenia/thrombocytopenia in two of the five patients at dose level 1. No dose-limiting toxicities were observed in four patients at dose level -1 at bevacizumab 10 mg/kg and irinotecan 100 mg/m(2) (270 mg/m(2) for patients taking enzyme-inducing antiepileptic drugs). The maximum-tolerated dose was bevacizumab 10 mg/kg and irinotecan 100 mg/m(2). The most frequent non-dose-limiting toxicities were Grade 1 or 2 hypertension, bleeding and hematologic toxicity. One patient with optic nerve glioma had a partial response. Three patients with medulloblastoma, optic nerve glioma and diffuse intrinsic pontine glioma had stable disease. CONCLUSIONS:Combination chemotherapy of bevacizumab plus irinotecan was well tolerated in children. We plan Phase II pediatric studies at doses of bevacizumab 10 mg/kg and irinotecan 100 mg/m(2) every 2 weeks (270 mg/m(2) for patients taking enzyme-inducing antiepileptic drugs).

journal_name

Jpn J Clin Oncol

journal_title

Japanese journal of clinical oncology

authors

Okada K,Yamasaki K,Tanaka C,Fujisaki H,Osugi Y,Hara J

doi

10.1093/jjco/hyt124

subject

Has Abstract

pub_date

2013-11-01 00:00:00

pages

1073-9

issue

11

eissn

0368-2811

issn

1465-3621

pii

hyt124

journal_volume

43

pub_type

杂志文章

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