Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix.
Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix.
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DOI：
10.1097/00006254-200008000-00017
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发表时间：
2000-04
期刊：
影响因子：
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通讯作者：
W. Peters;P. Liu;R. Barrett;R. Stock;B. Monk;J. Berek;L. Souhami;P. Grigsby;W. Gordon;
中科院分区：
文献类型：
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作者：
W. Peters;P. Liu;R. Barrett;R. Stock;B. Monk;J. Berek;L. Souhami;P. Grigsby;W. Gordon;
目的：确定在盆腔放疗（RT）基础上加用顺铂化疗（CT）是否能提高早期高危宫颈癌患者的生存率。患者和方法临床分期为IA（2）、IB和IIA的宫颈癌患者，最初接受广泛性子宫切除术和盆腔淋巴结切除术治疗，并且盆腔淋巴结阳性和/或边缘阳性和/或镜下宫旁组织受累，符合本研究的条件。患者随机接受RT或RT + CT。每组患者分29次接受49.3戈伊放射治疗至标准盆腔野。化疗包括顺铂70 mg/m2和氟尿嘧啶1，000 mg/m2/d，每3周一次，持续96小时，共4个周期，第1周期和第2周期与RT同时进行。243例患者可评估（127例RT + CT患者和116例RT患者）。接受CT的患者的无进展生存期和总生存期显著改善。单纯RT组与RT + CT组的无进展生存期和总生存期的风险比分别为2.01（P =.003）和1.96（P =.005）。007）分别。RT和RT + CT的4年无进展生存率分别为63%和80%。RT和RT + CT的4年总生存率分别为71%和81%。RT + CT组中3级和4级血液学和胃肠道毒性更常见。结论：放疗同时加用顺铂为基础的CT可显著提高高危、早期宫颈癌根治性子宫切除术和盆腔淋巴结清扫术患者的无进展生存率和总生存率。
PURPOSE To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. PATIENTS AND METHODS Patients with clinical stage IA(2), IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m(2) and a 96-hour infusion of fluorouracil 1,000 mg/m(2)/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT. RESULTS Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P =.003) and 1.96 (P =. 007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group. CONCLUSION The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.