Hatae M, Noda K, Yajima A, Sato S, Terashima Y, Ochiai K, Sasaki H, Mizutani K, Honjo H, Yamamoto T, Ozaki M, Yamamoto K, Hasegawa K, Nishimura R, Kudo T, Kobashi Y, Yakushiji M, Sugiyama T, Hasuo Y, Onishi Y
Dept. of Obstetrics and Gynecology, Kagoshima City Hospital.
Gan To Kagaku Ryoho. 1998 Apr;25(5):705-11.
We conducted a preliminary controlled study in order to evaluate 5'-DFUR dose dependency in efficacy and safety in combination therapy of radiotherapy, 5'-DFUR and SPG for patients with uterine cervical cancer, which was regarded as suitable for cases of radiotherapy. The patients were randomly allocated into group A (5'-DFUR 600 mg/body/day) and group B (5'-DFUR 800 mg/body/day), who underwent radiotherapy with simultaneous administration of 5'-DFUR and SPG (20 mg twice/week or 40 mg/ week). Those enrolled were 33 patients in stage II, III or IV a with histologically diagnosed primary squamous cell carcinoma of uterine cervix. CR was shown in 19, PR in 7, NC in 1, and PD in 2 out of 29 efficacy-evaluable cases, so the overall response rate was 89.7% (26/29, 95% CI 72.7%-97.8%). Regarding safety, some side effects were observed in 26 out of 33 safety-evaluable cases (81.3%, 95%, CI 63.6%-92.8%), but no serious cases. No significant difference in efficacy and safety was observed between the two treatment groups. These results suggested that the combination therapy of radiotherapy, 5'-DFUR and SPG might be one of the therapies whose effectiveness must be confirmed for advanced squamous cell carcinoma of uterine cervix. To confirm dose dependency of 5'-DFUR, it seems further consideration with more patients is needed.
我们进行了一项初步对照研究，以评估5'-脱氧氟尿苷（5'-DFUR）在子宫颈癌患者放疗、5'-DFUR和螺普利（SPG）联合治疗中的疗效和安全性的剂量依赖性，该联合治疗被认为适用于放疗病例。患者被随机分为A组（5'-DFUR 600mg/体/天）和B组（5'-DFUR 800mg/体/天），两组均在放疗的同时给予5'-DFUR和SPG（20mg，每周两次或40mg/周）。入组患者为33例组织学诊断为子宫颈原发性鳞状细胞癌的II、III或IV a期患者。在29例可评估疗效的病例中，19例显示完全缓解（CR），7例部分缓解（PR），1例疾病稳定（NC），2例疾病进展（PD），因此总缓解率为89.7%（26/29，95%可信区间72.7%-97.8%）。关于安全性，在33例可评估安全性的病例中，26例观察到一些副作用（81.3%，95%可信区间63.6%-92.8%），但无严重病例。两个治疗组在疗效和安全性方面均未观察到显著差异。这些结果表明，放疗、5'-DFUR和SPG联合治疗可能是一种其有效性必须在晚期子宫颈鳞状细胞癌中得到证实的治疗方法之一。为了确认5'-DFUR的剂量依赖性，似乎需要更多患者进行进一步研究。
