Phase I trial of etoposide, carboplatin, and GM-CSF in extensive small-cell lung cancer: a Cancer and Leukemia Group B study (CALGB 8832).
Phase I trial of etoposide, carboplatin, and GM-CSF in extensive small-cell lung cancer: a Cancer and Leukemia Group B study (CALGB 8832).
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依托泊苷、卡铂和 GM-CSF 治疗广泛性小细胞肺癌的 I 期试验：癌症和白血病 B 组研究 (CALGB 8832)。
DOI：
10.1097/00000421-199702000-00006
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发表时间：
1997
期刊：
影响因子：
--
通讯作者：
Green,MR
中科院分区：
文献类型：
--
作者：
Luikart,SD;Herndon2nd,JE;Hollis,DR;MacDonald,M;Maurer,LH;Crawford,J;Clamon,GH;Wright,J;Perry,MC;Ozer,H;Green,MR
The maximum tolerated dose (MTD) of etoposide and carboplatin without growth factor support was previously defined by Cancer and Leukemia Group B (CALGB) as 200 and 125 mg/m 2/day× 3, respectively, given every 28 days to previously untreated patients who have extensive, small-cell lung cancer (SCLC). Myelosuppression was dose-limiting. The purpose of this phase I trial was to determine if granulocyte macrophage colony-stimulating factor (GM-CSF) support allows the dosage of the combination of etoposide and carboplatin to be increased above the previously determined MTD. In this CALGB study of 44 evaluable patients with performance status 0-2, cohorts were treated with etoposide and carboplatin given intravenously on days 1-3 followed by GM-CSF (molgramostim) given subcutaneously on days 4-18. Four dose levels of bacteria-derived recombinant GM-CSF (5, 10, 20 μg/kg/day and 5 μg/kg every 12 h), three dose levels of etoposide (200, 250, and 300 mg/m 2/day× 3), and two dose levels of carboplatin (125 and 150 mg/m 2/day× 3) were evaluated. There was no chemotherapy dose escalation in individual patients. With 5 μg/kg/d GM-CSF, the first etoposide and carboplatin cycle of 300 and 150 mg/m 2/day× 3, respectively, could be administered with acceptable toxicity. However, GM-CSF did not allow repeated administration of this dose-escalated regimen every 21 days, since delayed platelet and/or neutrophil recovery was dose limiting in later cycles. These results demonstrate that GM-CSF alone has limited capability to support the repeated administration of high doses of etoposide and carboplatin. CALGB currently is testing the ability of interleukin (IL)-6 given with GM-CSF to ameliorate the cumulative myelosuppression of this intense regimen.
