Herod J, Burton A, Buxton J, Tobias J, Luesley D, Jordan S, Dunn J, Poole C J
CRC Trials Unit, Institute for Cancer Studies, University of Birmingham, Edgbaston, UK.
Ann Oncol. 2000 Sep;11(9):1175-81. doi: 10.1023/a:1008346901733.
Phase II studies have shown primary (neo-adjuvant) chemotherapy with bleomycin, ifosfamide and cisplatin (BIP) is active against inoperable cervical cancer. We present here results of a randomised phase III multicentre trial comparing radical radiotherapy with neo-adjuvant BIP chemotherapy followed by radical radiotherapy in patients with inoperable cervical cancer, designed to discover whether this combination might improve survival.
Patients with inoperable cervical carcinoma were randomised to pelvic radiotherapy alone [RT] or two to three cycles of bleomycin 30 units/24-hour infusion, ifosfamide 5 g/m2/24 hours, and cisplatin 50 mg/m2) chemotherapy followed by pelvic radiotherapy (BIP + RT). Randomisation was stratified by stage and radiotherapy centre.
One hundred seventy-two eligible women were randomised into this trial; eighty-six to RT and eighty-six to BIP + RT. A total of 190 cycles of chemotherapy were given. Median follow-up for the 47 patients still alive is 9 years with a minimum follow-up of 3 years. Complete or partial response occurred in 51 of 86 (59%) of those randomised to RT and 60 of 86 (69%) of those randomised to BIP + RT. The difference between response rates does not reach statistical significance (chi2 = 2.06, P = 0.15). Median survival is two years with an actuarial survival at five years of 32% (95% confidence interval (95% CI): 25%-39%). There is no significant difference between the treatment groups (chi2log-rank = 0.11, P = 0.74).
This study does not show any survival benefit from the use of neo-adjuvant BIP chemotherapy in advanced cervical cancer.
II期研究表明，博来霉素、异环磷酰胺和顺铂（BIP）进行的新辅助化疗对无法手术的宫颈癌有效。我们在此展示一项随机III期多中心试验的结果，该试验比较了根治性放疗与新辅助BIP化疗后再进行根治性放疗，用于无法手术的宫颈癌患者，旨在发现这种联合治疗是否能提高生存率。
无法手术的宫颈癌患者被随机分为单纯盆腔放疗组[RT]或接受两至三个周期的化疗（博来霉素30单位/24小时静脉输注、异环磷酰胺5g/m²/24小时和顺铂50mg/m²），随后进行盆腔放疗（BIP + RT）。随机分组按分期和放疗中心进行分层。
172名符合条件的女性被随机纳入该试验；86人接受RT，86人接受BIP + RT。共进行了190个周期的化疗。47名存活患者的中位随访时间为9年，最短随访时间为3年。随机分配至RT组的86名患者中有51名（59%）出现完全或部分缓解，随机分配至BIP + RT组的86名患者中有60名（69%）出现完全或部分缓解。缓解率之间的差异未达到统计学显著性（卡方 = 2.06，P = 0.15）。中位生存期为两年，五年精算生存率为32%（95%置信区间（95%CI）：25% - 39%）。治疗组之间无显著差异（卡方对数秩检验 = 0.11，P = 0.74）。
本研究未显示在晚期宫颈癌中使用新辅助BIP化疗有任何生存获益。
