Takada M, Fukuoka M, Ariyoshi Y, Furuse K, Niitani H, Ota K, Motomiya M, Hasegawa K, Tominaga K, Kuriyama T
Osaka Prefectural Habikino Hospital, Japan.
Cancer Chemother Pharmacol. 1992;31(3):182-6. doi: 10.1007/BF00685545.
We investigated the possibility of shortening the interval between courses of the commonly prescribed 28-day MVP (mitomycin C, vindesine, and cisplatin) regimen in patients with non-small-cell lung cancer (NSCLC). We conducted a nonrandomized phase II study using recombinant human granulocyte colony-stimulating factor (G-CSF, Chugai) to explore the possibility of shortening the cycle length to 21 days and compared the results with those obtained in historical controls who had received the standard 28-day regimen. A total of 40 patients, 37 of whom were evaluable, were entered in the 21-day treatment group of the trial and were compared with 38 historical controls who had received standard 28-day cycles of MVP at our institution. Patients in the 21-day group received mitomycin C at 8 mg/m2 on day 1, vindesine at 3 mg/m2 on days 1 and 8, and cisplatin at 80 mg/m2 on day 1, with the schedule being repeated every 21 days. Controls had received the same regimen, albeit at 28-day intervals. G-CSF was given s.c. to the patients in the 21-day group at a daily dose of 2 micrograms/kg from day 2 to day 21 of every MVP cycle. The administration of G-CSF to these patients accelerated neutrophil recovery as compared with that observed in the historical controls. Significant differences were found between the two groups in terms of mean neutrophil nadirs (2666/microliters in the first cycle and 1369/microliters in the second for the G-CSF group vs 416/microliters in the first cycle and 685/microliters in the second cycle for the control group; P < 0.0001) and the mean duration of neutropenia (< or = 1000/microliters; 1.0 day in the first cycle and 1.7 days in the second for the G-CSF group vs 8.0 days in the first cycle and 6.9 days in the second for the control group; P < 0.0001). This enabled 32 (86%) of 37 patients in the G-CSF group to complete > or = 2 cycles on schedule. In 10 patients, the bone marrow aspirates taken after G-CSF administration showed increases in band neutrophil and myelocyte percentages. In conclusion, MVP treatment of patients with NSCLC at 21-day intervals is possible with the support of G-CSF.
我们研究了缩短非小细胞肺癌(NSCLC)患者常用的28天MVP(丝裂霉素C、长春地辛和顺铂)方案疗程间隔的可能性。我们进行了一项非随机II期研究,使用重组人粒细胞集落刺激因子(G-CSF,中外制药公司生产)来探索将周期长度缩短至21天的可能性,并将结果与接受标准28天方案的历史对照进行比较。共有40例患者入组该试验的21天治疗组,其中37例可评估,将其与在我们机构接受标准28天MVP周期的38例历史对照进行比较。21天组的患者在第1天接受8mg/m²的丝裂霉素C,在第1天和第8天接受3mg/m²的长春地辛,在第1天接受80mg/m²的顺铂,每21天重复一次给药方案。对照组接受相同的方案,只是间隔为28天。在每个MVP周期的第2天至第21天,给21天组的患者皮下注射G-CSF,每日剂量为2μg/kg。与历史对照相比,对这些患者使用G-CSF加速了中性粒细胞的恢复。两组在平均中性粒细胞最低点(G-CSF组第一个周期为2666/μl,第二个周期为1369/μl;对照组第一个周期为416/μl,第二个周期为685/μl;P<0.0001)和中性粒细胞减少的平均持续时间(≤1000/μl;G-CSF组第一个周期为1.0天,第二个周期为1.7天;对照组第一个周期为8.0天,第二个周期为6.9天;P<0.0001)方面存在显著差异。这使得G-CSF组37例患者中的32例(86%)能够按时完成≥2个周期的治疗。在10例患者中,给予G-CSF后采集的骨髓穿刺物显示带状中性粒细胞和中幼粒细胞百分比增加。总之,在G-CSF的支持下,NSCLC患者每21天进行一次MVP治疗是可行的。