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卡铂-依托泊苷联合方案用于晚期胸段癌的Ⅰ期研究

Phase I study of a carboplatin-etoposide combination in advanced thoracic cancer.

作者信息

Tueni E, Sculier J P, Klastersky J

机构信息

Service de Médecine, Institut Jules Bordet, Université Libre de Bruxelles, Belgium.

出版信息

Eur J Cancer Clin Oncol. 1988 Jun;24(6):963-7. doi: 10.1016/0277-5379(88)90143-5.

Abstract

We conducted a phase I trial with the combination carboplatin (CBDCA)-etoposide (VP-16) in thoracic cancer. CBDCA, at a starting dose of 300 mg/m2 dl, was associated with a fixed dose of VP-16 (100 mg/m2 dl-3). Escalation of doses was permitted after three patients entered at each dose level without grade IV toxicity. As expected, hematologic toxicity was the limiting factor. Severe myelosuppression (grade IV) occurred in three out of four patients treated at 350 mg/m2. Only three out of 19 patients treated at 325 mg/m2 exhibited a reversible grade IV hematologic toxicity. Other toxicities were mild and acceptable. Among 15 evaluable patients three showed a partial response. Two of the three responders have previously had a progression while receiving cisplatin and etoposide. The recommended dose of carboplatin to be associated with VP-16 (100 mg/m2 dl-3) is thus 325 mg/m2 dl.

摘要

我们开展了一项卡铂(CBDCA)联合依托泊苷(VP - 16)用于治疗胸段癌的I期试验。卡铂起始剂量为300mg/m²(第1天给药),联合固定剂量的依托泊苷(100mg/m² 第1 - 3天给药)。在每个剂量水平有3名患者入组且无IV级毒性反应后,允许剂量递增。正如预期的那样,血液学毒性是限制因素。接受350mg/m²治疗的4名患者中有3名出现严重骨髓抑制(IV级)。接受325mg/m²治疗的19名患者中只有3名出现可逆性IV级血液学毒性。其他毒性反应较轻且可接受。在15名可评估患者中,3名出现部分缓解。这3名缓解者中有2名在接受顺铂和依托泊苷治疗时曾出现病情进展。因此,与依托泊苷(100mg/m² 第1 - 3天给药)联合使用时,卡铂的推荐剂量为325mg/m²(第1天给药)。

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