Cancer Res Treat. 2002 Jun;34(3):191-7. doi: 10.4143/crt.2002.34.3.191.
A prospective, randomized phase III, clinical trial was performed to assess treatment related acute toxicity, early response and survival difference, between a monthly 5-FU cisplatin, and a weekly cisplatin group alone, for concurrent chemoradiotherapy in the locally advanced uterine cervical carcinoma patients. MATERIALS AND METGODS: Between March 1998 and March 2000, 35 patients, with locally advanced (FIGO stage IIB to IVA) cervical carcinoma, were studied, but 5 patients were excluded inform the analysis due to their refusal of treatment. The patients were randomly assigned to 'monthly 5-FU cisplatin' (arm I), or 'weekly cisplatin' (arm II), groups. The patients of arm I received 5-FU cisplatin (5-FU 1,000 mg/m2/day cisplatin 20 mg/m2/day, IV continuous infusion, for 5 days, 3 cycles with 4-week intervals) with radiation therapy. Those of arm II received only cisplatin (cisplatin 30 mg/m2/day, IV bolus, 6 cycles with 1-week intervals) with radiation therapy. The radiation therapy consisted of external beam irradiation of 41.450.4 Gy/2328 fractions, and high dose rate intracavitary treatments, delivering a dose of 3035 Gy to point A in 67 fractions. During intracavitary radiation, a parametrial boost was delivered for a point B dose of 60 Gy in the non-thickened side, and 65 Gy in the thickened side. Treatment related acute toxicities were assessed using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria. The response to treatment, and survival, were analyzed. The median follow-up period was 19 months.
The FIGO stage distributions of arm I (n=16) and arm II (n=14) were as follows; IIB 10, IIIA 1, IIIB 4, IVA 1 in arm I, 12, 0, 1 and 1 in arm II respectively. The compliance of both arms were 80.0% and 93.3%, respectively (p=0.37). During radiation therapy, the incidences of leukopenia, greater than RTOG grade 2, were 25.0%, 14.3%, respectively. There were no patients with gastrointestinal or genitourinary toxicity greater than RTOG grade 2. The complete response rates at 3 months, following radiation therapy, were 87.5% and 92.9% respectively. Two-year disease free survival rates were 81.3%, 85.7%, respectively, for each arms.
There was no significant difference in response to treatment, or patterns of failure, between the monthly FP and weekly cisplatin arms. Although there were no statistically significant differences, the patients of the weekly cisplatin arm had better compliance. More patients, and a longer follow up, are needed for improved evaluation of the regimen.
一项前瞻性、随机的 III 期临床试验，旨在评估局部晚期宫颈癌患者同期放化疗中，每月 5-FU 顺铂与每周顺铂组之间治疗相关急性毒性、早期反应和生存差异。
1998 年 3 月至 2000 年 3 月，35 例局部晚期（FIGO 分期 IIB 至 IVA）宫颈癌患者入组，但由于拒绝治疗，5 例患者被排除在分析之外。患者被随机分为“每月 5-FU 顺铂”（I 组）或“每周顺铂”（II 组）。I 组患者接受 5-FU 顺铂（5-FU1000mg/m2/天，顺铂 20mg/m2/天，静脉持续输注，5 天，4 周间隔 3 个周期）联合放疗。II 组患者仅接受顺铂（顺铂 30mg/m2/天，静脉推注，6 周间隔 1 个周期）联合放疗。放疗采用外照射 41.450.4Gy/2328 次，高剂量率腔内治疗，A 点 3035Gy，67 次。腔内放疗时，非增厚侧 B 点给予 60Gy，增厚侧给予 65Gy 进行宫旁加量。使用放射治疗肿瘤学组（RTOG）急性发病率评分标准评估治疗相关急性毒性。分析治疗反应和生存情况。中位随访时间为 19 个月。
I 组（n=16）和 II 组（n=14）FIGO 分期分布如下；I 组 IIB 10 例，IIIA1 例，IIIB4 例，IVA1 例；II 组 IIB12 例，IIIA0 例，IIIB1 例，IVA1 例。两组依从性分别为 80.0%和 93.3%（p=0.37）。放疗期间，白细胞减少症发生率大于 RTOG 2 级分别为 25.0%和 14.3%。无胃肠道或泌尿生殖道毒性大于 RTOG 2 级的患者。放疗后 3 个月完全缓解率分别为 87.5%和 92.9%。两组 2 年无病生存率分别为 81.3%和 85.7%。
每月 FP 和每周顺铂组之间的治疗反应或失败模式无显著差异。虽然没有统计学意义上的差异，但每周顺铂组的患者依从性更好。需要更多的患者和更长的随访时间来更好地评估该方案。
