Taal B G, Teller F G, ten Bokkel Huinink W W, Boot H, Beijnen J H, Dubbelman R
Department of Gastroenterology, Netherlands Cancer Institute/Antoni van Leeuwenhoekhuis, Amsterdam.
Ann Oncol. 1994 Jan;5(1):90-2. doi: 10.1093/oxfordjournals.annonc.a058705.
Because the ELF regimen (etoposide, leucovorin and 5-FU) in advanced gastric cancer was recently advocated as an active, non-toxic schedule, and drug scheduling of etoposide proved to be important, we performed a pilot study using the original ELF regimen (A), followed by a phase II study of a modified ELF schedule (B) using oral etoposide.
Of the 40 patients entered in the consecutive trials 15 were treated according to the original ELF (A) and 25 according to the modified ELF regimen (B). The primary tumor was originally in the stomach in 22 and the oesophago-cardiac junction in 18. In 6 there was locally advanced and in 34 metastatic disease.
Toxicity was mild in ELF (A): grade III leukopenia in 6/63 cycles. The ELF (B) caused slightly more myelosuppression: grade III leukopenia in 4/102 and grade IV in 2/102 cycles, resulting in septicaemia in two patients, and toxic death in one. No severe thrombocytopenia was seen. Hemorrhage (4 cases) was exclusively related to tumor progression. Response rates were 7% (0%-21%) and 28% (10%-46%) for ELF (A) and ELF (B), respectively. Subjective response, however, leading to a clinically significant decrease of dysphagia and pain, was seen in 53% and 56% of the patients.
The modified ELF regimen (B) can be applied safely on an out-patient basis, and shows moderate activity in advanced gastric cancer which leads to an improved quality of life.
由于近期有人主张,晚期胃癌的ELF方案(依托泊苷、亚叶酸钙和5-氟尿嘧啶)是一种有效的无毒方案,且依托泊苷的用药时间安排已被证明很重要,因此我们进行了一项初步研究,采用最初的ELF方案(A),随后进行了一项II期研究,使用口服依托泊苷的改良ELF方案(B)。
在连续试验纳入的40例患者中,15例按照最初的ELF方案(A)治疗,25例按照改良ELF方案(B)治疗。原发肿瘤最初位于胃的有22例,位于食管-贲门交界处的有18例。6例为局部晚期,34例为转移性疾病。
ELF方案(A)的毒性较轻:63个周期中有6个周期出现III级白细胞减少。ELF方案(B)导致的骨髓抑制略多:102个周期中有4个周期出现III级白细胞减少,2个周期出现IV级白细胞减少,导致2例患者发生败血症,1例患者出现毒性死亡。未观察到严重血小板减少。出血(4例)均与肿瘤进展有关。ELF方案(A)和ELF方案(B)的缓解率分别为7%(0%-21%)和28%(10%-46%)。然而,分别有53%和56%的患者出现主观缓解,导致吞咽困难和疼痛在临床上显著减轻。
改良ELF方案(B)可在门诊安全应用,在晚期胃癌中显示出中度活性,可改善生活质量。