Hong W K, Lippman S M, Itri L M, Karp D D, Lee J S, Byers R M, Schantz S P, Kramer A M, Lotan R, Peters L J
Department of Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston, TX 77030.
N Engl J Med. 1990 Sep 20;323(12):795-801. doi: 10.1056/NEJM199009203231205.
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.
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.
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 had 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.
Daily treatment with high doses of isotretinoin is effective in preventing second 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.
头颈部癌症患者在局部治疗后无疾病残留，但仍面临原发肿瘤复发和发生第二原发肿瘤的高风险。维甲酸已被证明在治疗口腔癌前病变方面有效，并且是预防上皮细胞癌变的有前景的药物。
我们前瞻性地研究了103例喉、咽或口腔鳞状细胞癌初次治疗后无疾病的患者。在完成手术或放疗（或两者）后，这些患者被随机分配接受异维甲酸（13 - 顺式维甲酸）（每天每平方米体表面积50至100毫克）或安慰剂，持续服用12个月。
两组在原发癌的局部、区域或远处复发数量上没有显著差异。然而，异维甲酸组的第二原发肿瘤明显较少。在中位随访32个月后，异维甲酸组只有2例患者（4%）发生第二原发肿瘤，而安慰剂组有12例（24%）（P = 0.005）。4例患者出现多个第二原发肿瘤，均在安慰剂组。在14例第二原发癌中，13例（93%）发生在头颈部、食管或肺部。
高剂量异维甲酸每日治疗对预防头颈部鳞状细胞癌患者的第二原发肿瘤有效，尽管它不能预防原发肿瘤的复发。
