Keys H M, Bundy B N, Stehman F B, Muderspach L I, Chafe W E, Suggs C L, Walker J L, Gersell D
Department of Radiation Oncology, Albany Medical College, NY, USA.
N Engl J Med. 1999 Apr 15;340(15):1154-61. doi: 10.1056/NEJM199904153401503.
Bulky stage IB cervical cancers have a poorer prognosis than smaller stage I cervical cancers. For the Gynecologic Oncology Group, we conducted a trial to determine whether weekly infusions of cisplatin during radiotherapy improve progression-free and overall survival among patients with bulky stage IB cervical cancer.
Women with bulky stage IB cervical cancers (tumor, > or =4 cm in diameter) were randomly assigned to receive radiotherapy alone or in combination with cisplatin (40 mg per square meter of body-surface area once a week for up to six doses; maximal weekly dose, 70 mg), followed in all patients by adjuvant hysterectomy. Women with evidence of lymphadenopathy on computed tomographic scanning or lymphangiography were ineligible unless histologic analysis showed that there was no lymph-node involvement. The cumulative dose of external pelvic and intracavitary radiation was 75 Gy to point A (cervical parametrium) and 55 Gy to point B (pelvic wall). Cisplatin was given during external radiotherapy, and adjuvant hysterectomy was performed three to six weeks later.
The relative risks of progression of disease and death among the 183 women assigned to receive radiotherapy and chemotherapy with cisplatin, as compared with the 186 women assigned to receive radiotherapy alone, were 0.51 (95 percent confidence interval, 0.34 to 0.75) and 0.54 (95 percent confidence interval, 0.34 to 0.86), respectively. The rates of both progression-free survival (P<0.001) and overall survival (P=0.008) were significantly higher in the combined-therapy group at four years. In the combined-therapy group there were higher frequencies of transient grade 3 (moderate) and grade 4 (severe) adverse hematologic effects (21 percent, vs. 2 percent in the radiotherapy group) and adverse gastrointestinal effects (14 percent vs. 5 percent).
Adding weekly infusions of cisplatin to pelvic radiotherapy followed by hysterectomy significantly reduced the risk of disease recurrence and death in women with bulky stage IB cervical cancers.
大块病灶的IB期宫颈癌患者的预后比病灶较小的I期宫颈癌患者差。我们为妇科肿瘤学组开展了一项试验，以确定放疗期间每周输注顺铂是否能改善大块病灶的IB期宫颈癌患者的无进展生存期和总生存期。
将大块病灶的IB期宫颈癌（肿瘤直径≥4 cm）女性患者随机分配，分别接受单纯放疗或放疗联合顺铂治疗（40 mg/每平方米体表面积，每周1次，最多6剂；每周最大剂量70 mg），所有患者随后均接受辅助性子宫切除术。计算机断层扫描或淋巴管造影显示有淋巴结病迹象的女性患者不符合入组条件，除非组织学分析显示无淋巴结受累。盆腔外照射和腔内照射的累积剂量为：A点（宫颈旁组织）75 Gy，B点（盆腔壁）55 Gy。顺铂在体外放疗期间给予，辅助性子宫切除术在3至6周后进行。
与186例接受单纯放疗的女性患者相比，183例接受放疗联合顺铂化疗的女性患者疾病进展和死亡的相对风险分别为0.51（95%置信区间为0.34至0.75）和0.54（95%置信区间为0.34至0.86）。联合治疗组4年时的无进展生存率（P<0.001）和总生存率（P=0.008）均显著更高。联合治疗组中短暂性3级（中度）和4级（重度）血液学不良事件（21%，放疗组为2%）和胃肠道不良事件（14%对5%）的发生率更高。
对于大块病灶的IB期宫颈癌女性患者，盆腔放疗后行子宫切除术并每周输注顺铂可显著降低疾病复发和死亡风险。
