Grigsby P W, Lu J D, Mutch D G, Kim R Y, Eifel P J
Radiation Oncology Center, Washington University School of Medicine, St. Louis, MO 63110, USA.
Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):817-22. doi: 10.1016/s0360-3016(98)00132-1.
The purpose of this study was to evaluate the toxicity and efficacy of twice-daily external irradiation to the pelvis and para-aortics with brachytherapy and concurrent chemotherapy for carcinoma of the cervix with positive para-aortic lymph nodes.
This study was designed to administer twice-daily radiation doses of 1.2 Gy to the pelvis and para-aortics at 4- to 6-h intervals, 5 days per week. The total external radiation doses were 24 to 48 Gy to the whole pelvis, 12 to 36 Gy parametrial boost, and 48 Gy to the para-aortics with an additional boost to a total dose of 54 to 58 Gy to the known metastatic para-aortic site. One or two intracavitary applications were performed to deliver a total minimum dose of 85 Gy to point A. Cisplatin (75 mg/m2, days 1 and 22) and 5-FU (1000 mg/m2/24 h x 4 days; days 1 and 22) were given for two or three cycles.
Twenty-nine patients with clinical Stages I to IV carcinoma of the cervix with biopsy-proven para-aortic lymph nodes were enrolled in this study. Hyperfractionated external radiotherapy was completed in 86% (25 of 29). Brachytherapy was given in two applications to 48% (14 of 29), 31% (9 of 29) had one intracavitary application, 14% (4 of 29) had no brachytherapy, one had three applications, and one had five HDR applications. Radiotherapy was completed per protocol in 69%. Three courses of chemotherapy were given to 24% (7 of 29), 72% (21 of 29) received two courses, and one patient did not receive chemotherapy. The acute toxicity from chemotherapy was Grade 1 in 3%, Grade 2 in 17%, Grade 3 in 48%, and Grade 4 in 28%. Radiotherapy toxicity was Grade 1 in 7%, Grade 2 in 34%, Grade 3 in 21%, and Grade 4 in 28%. One Grade 5 toxicity occurred and the patient died from a myocardial infarction from chemotherapy and radiotherapy colitis during her course of therapy. The median follow-up time was 18.9 months. The overall survival estimates were 59% at 1 year and 47% at 2 years. The probability of local-regional failure was 38% at 1 year and 49% at 2 years. The probability of disease failure at any site was 45% at 1 year and 59% at 2 years.
The results suggest that twice-daily external irradiation to the pelvis and para-aortics with brachytherapy and concurrent chemotherapy resulted in an unacceptably high rate (31%, 9 of 29) of Grade 4 nonhematologic toxicity. One patient died from complications of therapy. Radiotherapy was completed per protocol in 69%. The survival estimates appear no better than standard fractionation radiotherapy without chemotherapy. Additional follow-up is necessary for long-term survival estimates.
本研究旨在评估对伴有主动脉旁淋巴结阳性的宫颈癌患者，每日两次对盆腔和主动脉旁区域进行外照射，并联合近距离放疗及同步化疗的毒性和疗效。
本研究设计为每周5天，以4至6小时间隔，每日两次对盆腔和主动脉旁区域给予1.2 Gy的放射剂量。全盆腔的外照射总剂量为24至48 Gy，宫旁加量剂量为12至36 Gy，主动脉旁区域为48 Gy，对已知转移的主动脉旁部位额外加量至总剂量54至58 Gy。进行1或2次腔内照射，使A点的总最小剂量达到85 Gy。给予顺铂（75 mg/m²，第1天和第22天）和5-氟尿嘧啶（1000 mg/m²/24 h×4天；第1天和第22天），共进行2或3个周期。
29例经活检证实有主动脉旁淋巴结转移的临床I至IV期宫颈癌患者纳入本研究。86%（29例中的25例）完成了超分割外照射放疗。48%（29例中的14例）进行了2次近距离放疗，31%（29例中的9例）进行了1次腔内照射，14%（29例中的4例）未进行近距离放疗，1例进行了3次照射，1例进行了5次高剂量率照射。69%的患者按方案完成了放疗。24%（29例中的7例）给予了3个周期的化疗，72%（29例中的21例）接受了2个周期化疗，1例患者未接受化疗。化疗的急性毒性反应中，1级占3%，2级占17%，3级占48%，4级占28%。放疗毒性反应中，1级占7%，2级占34%，3级占21%，4级占28%。发生了1例5级毒性反应，该患者在治疗过程中死于化疗和放疗性结肠炎引发的心肌梗死。中位随访时间为18.9个月。1年时的总生存率估计为59%，2年时为47%。1年时局部区域复发的概率为38%，2年时为49%。任何部位疾病复发的概率1年时为45%，2年时为59%。
结果表明，对盆腔和主动脉旁区域每日两次进行外照射，并联合近距离放疗及同步化疗，导致4级非血液学毒性发生率高得令人无法接受（31%，29例中的9例）。1例患者死于治疗并发症。69%的患者按方案完成了放疗。生存率估计似乎并不优于未进行化疗的标准分割放疗。需要进一步随访以进行长期生存评估。
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