Low-dose isotretinoin versus beta-carotene to prevent oral carcinogenesis: Long-term follow-up
Low-dose isotretinoin versus beta-carotene to prevent oral carcinogenesis: Long-term follow-up
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DOI：
10.1093/jnci/89.3.257
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发表时间：
1997-02-05
期刊：
影响因子：
--
通讯作者：
Lippman, SM
中科院分区：
文献类型：
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作者：
Papadimitrakopoulou, VA;Hong, WK;Lippman, SM
1993 年，我们报告了第一个口腔癌前病变随机维持化学预防试验的结果 (1)。在该研究中，70 名患有晚期口腔癌前病变的患者接受了 3 个月的高剂量异维A酸（每天 1.5 mg/kg）诱导治疗，随后对 59 名有反应或稳定的口腔癌前病变患者进行了 9 个月的 β-胡萝卜素或低剂量异维A酸维持治疗。 59 名患者中的 33 名接受了 β-胡萝卜素（30 毫克/天）治疗，59 名患者中的 26 名接受了低剂量异维A酸（每天 0.5 毫克/公斤）。低剂量异维A酸的耐受性良好，并且比β-胡萝卜素更有效：异维A酸的12个月口腔癌前病变进展率显着低于β-胡萝卜素（8% vs 55%）(1)。我们之前的 3 个月试验 (2) 证明，高剂量异维A酸可有效逆转口腔癌前病变，但具有显着的毒性和停药后的高复发率，为维持研究提供了理由。中位随访时间为 66 个月，我们现在报告了这项维持性口腔癌前病变研究的长期头颈癌发病率 (1)。总体而言，24% 的患者（70 名患者中有 17 名）发展为原位癌或浸润癌，年增长率为 5.8%。 11 名接受诱导治疗的患者中，有 2 名患者发展为侵袭性鳞状细胞癌。
In 1993, we reported the results of the first randomized maintenance chemoprevention trial in oral premalignancy (1). In that study, 70 patients with advanced oral premalignant lesions underwent 3 months of induction therapy with high-dose isotretinoin (1.5 mg/kg per day), followed by 9 months of maintenance therapy with ß-carotene or lowdose isotretinoin in 59 patients with responding or stable oral premalignant lesions. Thirty-three of 59 patients received ß-carotene (30 mg/day) and 26 of 59 patients received low-dose isotretinoin (0.5 mg/kg per day). Lowdose isotretinoin was well tolerated and more effective than ß-carotene: the 12-month oral premalignant lesion progression rate was significantly lower with isotretinoin than with ß-carotene (8% versus 55%)(1). Our prior 3-month trial (2) proved that high-dose isotretinoin was effective in reversing oral premalignant lesions, but with substantial toxicity and high relapse rate upon discontinuation, providing the rationale for the maintenance study.With a median follow-up of 66 months, we now report long-term head and neck cancer rates from this maintenance oral premalignancy study (1). Overall, in situ or invasive carcinoma developed in 24% of the patients (17 of 70), an annual rate of 5.8%. Invasive squamous cell carcinoma developed in two of 11 patients who received induc-