PREVENTION OF 2ND PRIMARY TUMORS WITH ISOTRETINOIN IN SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK
PREVENTION OF 2ND PRIMARY TUMORS WITH ISOTRETINOIN IN SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK
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DOI：
10.1056/nejm199009203231205
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发表时间：
1990-09-20
影响因子：
158.5
通讯作者：
GOEPFERT, H
中科院分区：
文献类型：
--
作者：
HONG, WK;LIPPMAN, SM;GOEPFERT, H
背景：局部治疗后未复发的头颈癌患者仍有复发和二次原发肿瘤的高风险。维甲酸已被证明是治疗口腔癌前病变的有效药物，是预防上皮癌变的有前途的药物。方法：我们前瞻性地研究了103名喉部、咽部或口腔鳞状细胞癌初次治疗后无病的患者。在完成手术和/或放射治疗后，这些患者被随机分配接受异维A酸(13-顺式维甲酸)(每天每平方米体表面积50-100毫克)或安慰剂，连续12个月每天服用。结果：在原发癌的局部、区域或远处复发的数量上，两组之间没有显著差异。然而，异维A酸组的第二原发瘤明显较少。经过32个月的中位随访期，异维A酸组只有2名患者(4%)出现第二原发瘤，而安慰剂组有12名患者(24%)(P<；0.005)。在4名患者中发生了多个第二原发瘤，所有患者都在安慰剂组。在14例第二癌症中，13例(93%)发生在头颈部、食道或肺部。结论：每日大剂量异维A酸治疗能有效预防头颈部鳞状细胞癌患者的第二原发癌，尽管它不能防止原发灶的复发。
Background: Patients with head-and-neck cancers who are free of disease after local therapy remain at high risk for both recurrent and second primary tumors. Retinoids have proved efficacious in the treatment of premalignant oral lesions and are promising agents for the prevention of epithelial carcinogenesis. Methods: We prospectively studied 103 patients who were disease-free after primary treatment for squamous-cell cancers of the larynx, pharynx, or oral cavity. After completion of surgery or radiotherapy (or both), these patients were randomly assigned to receive either isotretinoin (13-cis-retinoic acid) (50 to 100 mg per square meter of body-surface area per day) or placebo, to be taken daily for 12 months. Results: There were no significant differences between the two groups in the number of local, regional, or distant recurrences of the primary cancers. However, the isotretinoin group has significantly fewer second primary tumors. After a median follow-up of 32 months, only 2 patients (4 percent) in the isotretinoin group had second primary tumors, as compared with 12 (24 percent) in the placebo group (P < 0.005). Multiple second primary tumors occurred in four patients, all of whom were in the placebo group. Of the 14 second cancers, 13 (93 percent) occurred in the head and neck, esophagus, or lung. Conclusions: Daily treatment with high doses of isotretinoin is effective in preventing secon primary tumors in patients who have been treated for squamous-cell carcinoma of the head and neck, although it does not prevent recurrences of the original tumor.