Corvò R, Merlano M, Scarpati D, Grimaldi A, Benasso M, Franzone P, Santelli A, Scasso F, Rosso R, Vitale V
Istituto Nazionale per la Ricerca sul Cancro, Università, Genova.
Radiol Med. 1988 Jun;75(6):653-9.
Between 1983 and 1986, a multicenter randomized study was conducted to compare a sequential program of induction chemotherapy (CT) followed by radiotherapy (RT), Arm A, with an alternation of 4 cycles of CT with 3 courses of RT (20 Gy/10 fractions up to a total dose of 60 Gy), Arm B, in advanced head and neck cancer patients. The same CT (VBM: Vinblastine, Bleomycin, Methotrexate) was used on both arms; one hundred and sixteen patients (pts) entered the study, 55 in Arm A, 61 in Arm B. Fourty-five pts had stage III and 71 stage IV cancers. The two arms are fully comparable. Up to October 1987, 116 pts are evaluable for survival, while 112 are evaluable for toxicity and 105 for response. In 21 patients (10 in Arm A, 11 in B) the association CT-RT was followed by surgery. Response analysis shows 14 complete responses in Arm A and 30 in Arm B (p less than or equal to 0.03). The median disease-free survival and median overall survival are also statistically different, with an advantage for Arm B (33 vs 22 weeks, p less than or equal to 0.0007, and 59 vs 38 weeks, p less than 0.03 respectively). The actuarial overall survival of complete responders at 50 months is 43% (B) and 21% (A). Toxicity (mainly stage III-IV mucositis) is superior in Arm B (30% vs 4%). Our experience demonstrates the advantages of alternate over sequential CT-RT. A comparison of this cyclic association with RT alone is in progress.
1983年至1986年间,开展了一项多中心随机研究,以比较晚期头颈癌患者中,诱导化疗(CT)序贯放疗(RT)方案(A组)与4周期CT与3疗程RT交替方案(20 Gy/10次分割,总剂量达60 Gy,B组)的疗效。两组均采用相同的CT方案(VBM:长春碱、博来霉素、甲氨蝶呤);116例患者进入研究,A组55例,B组61例。45例患者为III期癌症,71例为IV期癌症。两组具有完全可比性。截至1987年10月,116例患者可评估生存情况,112例可评估毒性,105例可评估反应。21例患者(A组10例,B组11例)在CT-RT联合治疗后接受了手术。反应分析显示,A组有14例完全缓解,B组有30例(p≤0.03)。无病生存期和总生存期的中位数也有统计学差异,B组更具优势(分别为33周对22周,p≤0.0007;59周对38周,p<0.03)。完全缓解者50个月时的精算总生存率为43%(B组)和21%(A组)。毒性(主要为III-IV级黏膜炎)在B组更严重(30%对4%)。我们的经验表明,CT-RT交替方案优于序贯方案。目前正在将这种周期联合方案与单纯放疗进行比较。