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卡铂联合氨磷汀与单纯卡铂治疗晚期实体瘤患者的随机试验。

Randomized trial of carboplatin plus amifostine versus carboplatin alone in patients with advanced solid tumors.

作者信息

Budd G T, Ganapathi R, Adelstein D J, Pelley R, Olencki T, Petrus J, McLain D, Zhang J, Capizzi R, Bukowski R M

机构信息

Department of Medical Oncology, The Cleveland Clinic Cancer Center, Ohio 44195, USA.

出版信息

Cancer. 1997 Sep 15;80(6):1134-40.

PMID:9305715
Abstract

BACKGROUND

To test the hypothesis that the cytoprotectant amifostine attenuates the thrombocytopenia produced by carboplatin, the authors performed a randomized trial comparing treatment with carboplatin alone versus the combination of amifostine and carboplatin.

METHODS

Patients with refractory or carboplatin-sensitive malignancies were randomized to receive either carboplatin, 500 mg/m2 alone or carboplatin, 500 mg/m2 in conjunction with 2 doses of amifostine of 910 mg/m2 each.

RESULTS

Fifty-five patients with a variety of malignancies were entered on this study. One patient withdrew from each arm prior to the administration of any therapy, leaving 30 evaluable patients treated with carboplatin alone and 23 treated with the combination of amifostine and carboplatin. For 82 cycles of therapy with amifostine plus carboplatin, the median platelet nadir was 127 x 10(9)/L while the median platelet nadir was 88 x 10(9)/L over the 80 courses of therapy with carboplatin alone (P = 0.023). The median platelet nadir after the first cycle of therapy was 144 x 10(9)/L for patients treated with amifostine plus carboplatin and 85 x 10(9)/L for patients treated with carboplatin alone (P = 0.24). The median survival for 9 patients with advanced nonsmall cell lung carcinoma treated with carboplatin alone was 39 weeks whereas the median survival for 12 such patients treated with amifostine plus carboplatin was 52 weeks (P = 0.116).

CONCLUSIONS

These data support the hypothesis that amifostine attenuates the myelosuppression of carboplatin. Additional studies of amifostine in combination with carboplatin-containing chemotherapy regimens are warranted.

摘要

背景

为验证细胞保护剂氨磷汀可减轻卡铂所致血小板减少这一假说,作者进行了一项随机试验,比较单独使用卡铂与氨磷汀联合卡铂的治疗效果。

方法

将难治性或对卡铂敏感的恶性肿瘤患者随机分组,一组单独接受500mg/m²卡铂治疗,另一组接受500mg/m²卡铂联合每次910mg/m²的两剂氨磷汀治疗。

结果

55例患有各种恶性肿瘤的患者参与了本研究。在任何治疗开始前,每组各有1例患者退出,最终有30例可评估患者单独接受卡铂治疗,23例接受氨磷汀联合卡铂治疗。在82个氨磷汀加卡铂的治疗周期中,血小板计数最低点的中位数为127×10⁹/L,而在单独使用卡铂的80个疗程中,血小板计数最低点的中位数为88×10⁹/L(P = 0.023)。接受氨磷汀加卡铂治疗的患者在第一个治疗周期后的血小板计数最低点中位数为144×10⁹/L,而单独接受卡铂治疗的患者为85×10⁹/L(P = 0.24)。9例单独接受卡铂治疗的晚期非小细胞肺癌患者的中位生存期为39周,而12例接受氨磷汀加卡铂治疗的此类患者的中位生存期为52周(P = 0.116)。

结论

这些数据支持氨磷汀可减轻卡铂骨髓抑制作用的假说。有必要对氨磷汀联合含卡铂化疗方案进行更多研究。

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