Rusciani Luigi, Proietti Ilaria, Paradisi Andrea, Rusciani Antonio, Guerriero Giuseppe, Mammone Alessia, De Gaetano Andrea, Lippa Silvio
Department of Dermatology, Catholic University of the Sacred Heart, Rome, Italy.
Melanoma Res. 2007 Jun;17(3):177-83. doi: 10.1097/CMR.0b013e32818867a0.
Early surgical intervention remains the most successful therapy for melanoma. Despite better outcomes observed in soft tissue and lymph node metastases, the results of pharmacological therapies are still disappointing. Currently, there is no standard adjuvant therapy for melanoma. Low concentrations of coenzyme Q10 have been demonstrated in melanoma cell lines and in sera of melanoma patients. These data and the results of clinical trials of patients with other advanced cancers prompted this study of the long-term administration of an optimized dose of recombinant interferon alpha-2b and coenzyme Q10 to patients with stage I and II melanoma. A 3-year trial envisaging uninterrupted treatment with low-dose recombinant interferon alpha-2b (9 000 000 000 IU weekly) administered twice daily and coenzyme Q10 (400 mg/day) was conducted in patients with stage I and II melanoma (American Joint Committee on Cancer criteria 2002) and surgically removed lesions. Treatment efficacy was evaluated as incidence of recurrences at 5 years. All patients completed the treatment and the follow-up. Significantly different rates of disease progression were observed in the interferon+coenzyme Q10 and the interferon group for both stages. No patient withdrew from the study owing to side effects. Long-term administration of an optimized dose of recombinant interferon alpha-2b in combination with coenzyme Q10 seemed to induce significantly decreased rates of recurrence and had negligible adverse effects. A survival study could not be undertaken owing to the small patient sample and the short duration of follow-up.
早期手术干预仍然是黑色素瘤最成功的治疗方法。尽管在软组织和淋巴结转移方面观察到了更好的结果,但药物治疗的效果仍然令人失望。目前,黑色素瘤尚无标准的辅助治疗方法。在黑色素瘤细胞系和黑色素瘤患者的血清中已证实辅酶Q10浓度较低。这些数据以及其他晚期癌症患者的临床试验结果促使开展了这项针对I期和II期黑色素瘤患者长期给予优化剂量的重组干扰素α-2b和辅酶Q10的研究。一项为期3年的试验对I期和II期黑色素瘤患者(根据2002年美国癌症联合委员会标准)且手术切除病变后,进行了连续治疗,给予低剂量重组干扰素α-2b(每周9000000000国际单位),每日两次,以及辅酶Q10(400毫克/天)。以5年复发率评估治疗效果。所有患者均完成了治疗和随访。在干扰素+辅酶Q10组和干扰素组中,两个阶段的疾病进展率均存在显著差异。没有患者因副作用退出研究。长期给予优化剂量的重组干扰素α-2b联合辅酶Q10似乎能显著降低复发率,且副作用可忽略不计。由于患者样本量小且随访时间短,未能进行生存研究。