Lee J W, Kim B G, Lee S J, Lee S H, Park C S, Lee J H, Huh S J, Bae D S
Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Clin Oncol (R Coll Radiol). 2005 Sep;17(6):412-7. doi: 10.1016/j.clon.2005.02.006.
To evaluate the efficacy and toxicity of consolidation chemotherapy after concurrent chemoradiation (CCRT) with 5-fluorouracil (5-FU) and cisplatin in the treatment of high-risk, early stage cervical carcinoma after radical surgery.
Women with clinical stage IB and IIA cervical carcinoma, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes, positive margins, parametrial involvement, or all three, were divided into either a CCRT alone group or a consolidation chemotherapy after CCRT group. Three cycles of chemotherapy were given to the CCRT alone group, and six cycles to the consolidation chemotherapy group. Women in each group received 50.4 Gy external radiation in 28 fractions to a standard pelvic field. Chemotherapy consisted of cisplatin 60 mg/m2 (X 1) and 5-FU 1000 mg/m2/d (X 5) every 3 weeks, with the first and second cycles given concurrent with radiation. Survival and toxicity were compared between the two groups.
Forty women were evaluable (25 in the CCRT alone group and 15 in the consolidation chemotherapy group). The estimated 2-year progression-free survival was 87.7% in the CCRT alone group and 67.0% in the consolidation chemotherapy group. The estimated 2-year overall survival was 95.8% in the CCRT alone group and 100% in the consolidation chemotherapy group. However, no significant differences were found in progression-free and overall survival in the two groups (P = 0.17 and P = 0.29, respectively). Grade 2 or higher leukopenia and neutropenia were significantly more frequent in the consolidation chemotherapy group than in the CCRT alone group (P = 0.02 and P < 0.01, respectively).
Although the sample size was small, and this study was not randomised, these results suggest that consolidation chemotherapy may not improve survival. Rather, it may increase haematologic toxicities for women with high-risk, early stage cervical carcinoma who undergo radical surgery followed by CCRT.
评估同步放化疗（CCRT）联合5-氟尿嘧啶（5-FU）和顺铂进行巩固化疗，在根治性手术后治疗高危早期宫颈癌的疗效和毒性。
临床分期为IB期和IIA期的宫颈癌女性患者，最初接受根治性子宫切除术和盆腔淋巴结清扫术，且盆腔淋巴结阳性、切缘阳性、宫旁组织受累或三者皆有，被分为单纯CCRT组或CCRT后巩固化疗组。单纯CCRT组给予3个周期化疗，巩固化疗组给予6个周期化疗。每组女性患者接受50.4 Gy外照射，分28次照射至标准盆腔野。化疗方案为每3周给予顺铂60 mg/m²（第1天）和5-FU 1000 mg/m²/天（共5天），第1和第2周期与放疗同步进行。比较两组的生存率和毒性。
40名女性患者可进行评估（单纯CCRT组25名，巩固化疗组15名）。单纯CCRT组估计2年无进展生存率为87.7%，巩固化疗组为67.0%。单纯CCRT组估计2年总生存率为95.8%，巩固化疗组为100%。然而，两组在无进展生存率和总生存率方面未发现显著差异（P分别为0.17和0.29）。巩固化疗组2级或更高等级的白细胞减少和中性粒细胞减少明显比单纯CCRT组更频繁（P分别为0.02和P<0.01）。
尽管样本量小且本研究未随机分组，但这些结果表明巩固化疗可能无法提高生存率。相反，对于接受根治性手术并随后进行CCRT的高危早期宫颈癌女性，巩固化疗可能会增加血液学毒性。
