Fukuoka M, Takada M, Masuda N, Furuse K, Saijo N, Ikegami H, Nishiwaki Y
Department of Internal Medicine, Osaka Prefectural Habikino Hospital.
Nihon Kyobu Shikkan Gakkai Zasshi. 1993 Dec;31 Suppl:225-31.
This paper describes the results of a randomized trial comparing alternating chemotherapy with standard chemotherapy and of a trial of dose intensive chemotherapy with or without recombinant human granulocyte-colony stimulating factor (G-CSF) in small cell lung cancer (SCLC). 1) Between April 1985 and May 1988, the Japan Clinical Oncology Group conducted a randomized phase III trial of cyclophosphamide, doxorubicin and vincristine (CAV) versus cisplatin and etoposide (PE) versus CAV alternating with PE (CAV/PE). Three hundred patients were entered in the study, and 288 of them were eligible for analysis. The response rates for PE (78%) and CAV/PE (76%) were significantly higher than the rate for CAV (55%) (p < 0.01). The median survival time (MST) with CAV/PE (11.8 months) was superior to that with CAV (9.9 months) (p = 0.027) or that with PE (9.9 months) (p = 0.056); however, the survival advantage of CAV/PE disappeared when the data were adjusted for prognostic factors. These results have shown that CAB/PE is a reasonable approach for the management of SCLC. 2) Between May 1989 and September 1991, we carried out a randomized study to determine whether the dose intensity of the weekly CODE (cyclophosphamide, Oncovin, doxorubicin and etoposide) chemotherapy could be increased by the addition of G-CSF support. Sixty-three patients were entered in this study. The use of G-CSF was associated with a reduced incidence of neutropenic fever and an increase in the dose intensity. The MST for the patients treated with CODE plus G-CSF (58 weeks) was significantly longer than that for the patients treated with CODE alone (36 weeks). The results of this study showed that dose intensive weekly chemotherapy may improve the outcome of patients with ED-SCLC.
本文描述了一项比较交替化疗与标准化疗的随机试验结果,以及一项在小细胞肺癌(SCLC)中使用或不使用重组人粒细胞集落刺激因子(G-CSF)的剂量密集化疗试验结果。1)1985年4月至1988年5月期间,日本临床肿瘤学组进行了一项随机III期试验,比较环磷酰胺、阿霉素和长春新碱(CAV)与顺铂和依托泊苷(PE)以及CAV与PE交替使用(CAV/PE)的疗效。300名患者进入该研究,其中288名符合分析条件。PE组(78%)和CAV/PE组(76%)的缓解率显著高于CAV组(55%)(p<0.01)。CAV/PE组的中位生存时间(MST)(11.8个月)优于CAV组(9.9个月)(p = 0.027)或PE组(9.9个月)(p = 0.056);然而,当对预后因素进行数据调整时,CAV/PE的生存优势消失。这些结果表明,CAB/PE是治疗SCLC的一种合理方法。2)1989年5月至1991年9月期间,我们进行了一项随机研究,以确定添加G-CSF支持是否可以提高每周CODE(环磷酰胺、长春新碱、阿霉素和依托泊苷)化疗的剂量强度。6名患者进入该研究。使用G-CSF与中性粒细胞减少性发热的发生率降低和剂量强度增加有关。接受CODE加G-CSF治疗的患者的MST(58周)显著长于仅接受CODE治疗的患者(36周)。这项研究的结果表明,剂量密集的每周化疗可能会改善广泛期小细胞肺癌(ED-SCLC)患者的预后。