Mertens W C, Eisenhauer E A, Moore M, Venner P, Stewart D, Muldal A, Wong D
London Regional Cancer Centre, Canada.
Ann Oncol. 1993 Apr;4(4):331-2. doi: 10.1093/oxfordjournals.annonc.a058494.
Gemcitabine (2', 2'-difluorodeoxycytidine; dFdC) an anticancer agent with activity in preclinical models, was felt to be a promising new chemotherapy drug which warranted testing in patients with advanced renal cell carcinoma.
Eighteen patients with histologically proven metastatic or locally recurrent renal cell carcinoma and bidimensionally measurable disease were accrued to a phase II study of gemcitabine administered intravenously on days 1, 8 and 15 of a 28 day treatment cycle. Initial doses of gemcitabine were 800 mg/m2; doses in subsequent cycles were escalated to a maximum of 1250 mg/m2, toxicity permitting.
One partial response was seen for a response rate of 6%. Hematologic toxicity was not severe with this dosing schedule; however, two patients developed dyspnea with bronchospasm after repeated injections of drug.
The dose and schedule of gemcitabine employed results in only a modest response rate in patients with advanced renal carcinoma. Investigators should be aware of the possibility of dyspnea and bronchospasm developing shortly after gemcitabine administration.
吉西他滨（2'，2'-二氟脱氧胞苷；dFdC）是一种在临床前模型中具有活性的抗癌药物，被认为是一种有前景的新型化疗药物，值得在晚期肾细胞癌患者中进行测试。
18例经组织学证实为转移性或局部复发性肾细胞癌且具有二维可测量病灶的患者入组了一项吉西他滨的II期研究，在28天的治疗周期中，于第1、8和15天静脉给药。吉西他滨的初始剂量为800mg/m²；在后续周期中，剂量可增至最大1250mg/m²，前提是毒性允许。
观察到1例部分缓解，缓解率为6%。按照此给药方案，血液学毒性并不严重；然而，有2例患者在重复注射药物后出现了伴有支气管痉挛的呼吸困难。
所采用的吉西他滨剂量和给药方案在晚期肾癌患者中仅产生适度的缓解率。研究人员应意识到在吉西他滨给药后不久出现呼吸困难和支气管痉挛的可能性。
