Sculier J P, Paesmans M, Lafitte J J, Baumöhl J, Thiriaux J, van Cutsem O, Recloux P, Bureau G, Berchier M C, Zacharias C, Mommen P, Bosschaerts T, Berghmans T, van Houtte P, Ninane V, Klastersky J
Service de Médecine, Institut Jules Bordet, Brussels, Belgium.
Ann Oncol. 1999 Mar;10(3):295-303. doi: 10.1023/a:1008319506107.
A phase III randomised trial was conducted in patients with non-metastatic unresectable non-small-cell lung cancer in order to compare, in responders to induction chemotherapy, consolidation treatment by further chemotherapy to chest irradiation.
A total of 462 untreated NSCLC patients were eligible for three courses of induction chemotherapy (MIP) consisting of cisplatin (50 mg/m2), ifosfamide (3 g/m2) and mitomycin C (6 mg/m2). It was proposed that objective responders be randomised to either three further courses of MIP or to chest irradiation (60 Gy; 2 Gy per fraction given over six weeks).
An objective response rate of 35% was achieved; 115 patients (including 52% with initial stage IIIA and 44% with initial stage IIIB) were randomised to consolidation treatment, 60 of them to further chemotherapy and 55 to chest radiotherapy. There was no significant difference in survival between the two arms, with a respective median and two-year survival of 42 weeks (95% confidence intervals (95% CI: 35-51) and 18% (95% CI: 8-28) for chemotherapy and 54 weeks (95% CI: 43-73) and 22% (95% CI: 11-33) for irradiation. There was also no statistical difference for response duration between the two arms but chest irradiation was associated with a significantly greater duration of local control than chemotherapy (median duration times: 158 vs. 31 weeks, P = 0.0007).
For non-metastatic unresectable NSCLC treated by an induction chemotherapy regimen containing cisplatin and ifosfamide, if an objective response is obtained, consolidation treatments by further chemotherapy or by chest irradiation result in non-statistically different survival distributions, although a better local control duration is observed with radiotherapy.
对非转移性不可切除的非小细胞肺癌患者进行一项III期随机试验，以便在诱导化疗的缓解者中比较进一步化疗与胸部放疗的巩固治疗效果。
共有462例未经治疗的非小细胞肺癌患者符合接受三个疗程诱导化疗（MIP方案，包括顺铂（50mg/m²）、异环磷酰胺（3g/m²）和丝裂霉素C（6mg/m²））的条件。提议将客观缓解者随机分为接受另外三个疗程的MIP方案或胸部放疗（60Gy；每周6次，每次2Gy）。
客观缓解率为35%；115例患者（包括52%的初始IIIA期和44%的初始IIIB期患者）被随机分配接受巩固治疗，其中60例接受进一步化疗，55例接受胸部放疗。两组的生存率无显著差异，化疗组的中位生存期和两年生存率分别为42周（95%置信区间（95%CI：35 - 51））和18%（95%CI：8 - 28），放疗组分别为54周（95%CI：43 - 73）和22%（95%CI：11 - 33）。两组的缓解持续时间也无统计学差异，但胸部放疗的局部控制持续时间明显长于化疗（中位持续时间：158周对31周，P = 0.0007）。
对于采用含顺铂和异环磷酰胺的诱导化疗方案治疗的非转移性不可切除的非小细胞肺癌，如果获得客观缓解，进一步化疗或胸部放疗的巩固治疗导致的生存分布无统计学差异，尽管放疗的局部控制持续时间更好。
