Varia M A, Bundy B N, Deppe G, Mannel R, Averette H E, Rose P G, Connelly P
Department of Radiation Oncology, University of North Carolina at Chapel Hill, 27514, USA.
Int J Radiat Oncol Biol Phys. 1998 Dec 1;42(5):1015-23. doi: 10.1016/s0360-3016(98)00267-3.
A multicenter trial of chemoradiation therapy to evaluate the feasibility of extended field radiation therapy (ERT) with 5-fluorouracil (5-FU) and cisplatin, and to determine the progression-free interval (PFI), overall survival (OS), and recurrence sites in patients with biopsy-confirmed para-aortic node metastases (PAN) from cervical carcinoma.
Ninety-five patients with cervical carcinoma and PAN metastases were entered and 86 were evaluable: Stage I--14, Stage II--40, Stage III--27, Stage IVA--5. Seventy-nine percent of the patients were followed for 5 or more years or died. ERT doses were 4500 cGy (PAN), 3960 cGy to the pelvis (Stages IB/IIB), and 4860 cGy to the pelvis (Stages IIIB/IVA). Point A intracavitary (IC) doses were 4000 cGy (Stages IB/IIB), and 3000 cGy (Stages IIIB/IVA). Point B doses were raised to 6000 cGy (ERT + IC) with parametrial boost. Concomitant chemotherapy consisted of 5-FU 1000 mg/m2/day for 96 hours and cisplatin 50 mg/m2 in weeks 1 and 5.
Eighty-five of 86 patients completed radiation therapy and 90% of patients completed both courses of chemotherapy. Gynecologic Oncology Group (GOG) grade 3-4 acute toxicity were gastrointestinal (18.6%) and hematologic (15.1%). Late morbidity actuarial risk of 14% at 4 years primarily involved the rectum. Initial sites of recurrence were pelvis alone, 20.9%; distant metastases only, 31.4%; and pelvic plus distant metastases, 10.5%. The 3-year OS and PFI rate were 39% and 34%, respectively, for the entire group. OS was Stage I--50%, Stage II--39%, and Stage III/IVA--38%.
Extended field radiation therapy with 5-FU and cisplatin chemotherapy was feasible in a multicenter clinical trial. PFI of 33% at 3 years suggests that a proportion of patients achieve control of advanced pelvic disease and that not all patients with PAN metastases have systemic disease. This points to the importance of assessment and treatment of PAN metastases.
开展一项多中心化疗放疗试验,以评估扩大野放射治疗(ERT)联合5-氟尿嘧啶(5-FU)和顺铂的可行性,并确定经活检证实有宫颈癌腹主动脉旁淋巴结转移(PAN)患者的无进展生存期(PFI)、总生存期(OS)及复发部位。
纳入95例有宫颈癌和PAN转移的患者,86例可评估:Ⅰ期-14例,Ⅱ期-40例,Ⅲ期-27例,ⅣA期-5例。79%的患者随访5年及以上或死亡。ERT剂量为4500 cGy(腹主动脉旁淋巴结),盆腔剂量为3960 cGy(ⅠB/ⅡB期)和4860 cGy(ⅢB/ⅣA期)。A点腔内(IC)剂量为4000 cGy(ⅠB/ⅡB期)和3000 cGy(ⅢB/ⅣA期)。B点剂量通过宫旁野加量提高至6000 cGy(ERT + IC)。同步化疗包括5-FU 1000 mg/m²/天,持续96小时,以及第1周和第5周给予顺铂50 mg/m²。
86例患者中有85例完成放射治疗,90%的患者完成两个疗程的化疗。妇科肿瘤学组(GOG)3-4级急性毒性反应为胃肠道反应(18.6%)和血液学反应(15.1%)。4年时晚期发病精算风险为14%,主要累及直肠。初始复发部位仅为盆腔,占20.9%;仅远处转移,占31.4%;盆腔加远处转移,占10.5%。整个组的3年总生存期和无进展生存期分别为39%和34%。总生存期Ⅰ期为50%,Ⅱ期为39%,Ⅲ/ⅣA期为38%。
在多中心临床试验中ERT联合5-FU和顺铂化疗是可行的。3年PFI为33%表明一部分患者实现了对晚期盆腔疾病的控制,且并非所有有PAN转移的患者都有全身疾病。这凸显了评估和治疗PAN转移的重要性。