Di Lauro Vincenzo, Scalone Simona, La Mura Nicoletta, Zanetti Martina, Nigri Paola, Freschi Andrea, Veronesi Andrea
Division of Medical Oncology C, Centro di Riferimento Oncologico, Aviano, Italy.
Melanoma Res. 2005 Jun;15(3):209-12. doi: 10.1097/00008390-200506000-00011.
The addition of cytokines, such as interferon alpha-2b and interleukin-2, to chemotherapy in metastatic melanoma has produced conflicting results in phase II and III trials. We report our experience with a chemoimmunotherapeutic regimen using subcutaneous cytokines. Twenty-eight patients with advanced melanoma (median age, 45 years; male to female ratio, 19 : 9) were treated. Doses were as follows: cisplatin, 20 mg/m intravenously (iv) days 1-4; vinblastine, 1.6 mg/m iv days 1-4; dacarbazine, 800 mg/m iv day 1; interferon alpha-2b, 5 MIU/m subcutaneously (sc) days 1-5; interleukin-2, 9 MIU/m sc days 1-5 and 8-12. Treatment was repeated every 3 weeks for a maximum of six cycles. The response was assessed after two cycles and toxicity at every cycle, according to World Health Organization (WHO) and National Cancer Institute (NCI) criteria, respectively. At a median follow-up of 8 months, only four patients (14%) were still alive. The overall response rate was 33%, with three (11%) complete responses lasting for 17, 14 and >24 months. There were six (22%) partial responses and three stable disease. Amongst the responders, three patients progressed at the level of the central nervous system. The median time to progression and overall survival were 3.5 and 9 months, respectively. The most common grade 3-4 toxicity was neutropenia, reported in 25 of the 28 patients (92%). Only two patients (7%) experienced neutropenic fever. Thrombocytopenia grade 3-4 occurred in seven of the 28 patients (25%), with only one patient needing transfusional support. One toxic death due to neutropenic fever occurred. It can be concluded that the chemoimmunotherapy schedule evaluated is active and may be considered for patients with metastatic melanoma who have a good performance status and a limited disease burden.
在转移性黑色素瘤化疗中添加细胞因子，如干扰素α-2b和白细胞介素-2，在II期和III期试验中产生了相互矛盾的结果。我们报告了使用皮下注射细胞因子的化疗免疫治疗方案的经验。28例晚期黑色素瘤患者（中位年龄45岁；男女比例为19:9）接受了治疗。剂量如下：顺铂，20mg/m²静脉注射（iv）第1 - 4天；长春碱，1.6mg/m²静脉注射第1 - 4天；达卡巴嗪，800mg/m²静脉注射第1天；干扰素α-2b，5MIU/m²皮下注射（sc）第1 - 5天；白细胞介素-2，9MIU/m²皮下注射第1 - 5天和第8 - 12天。每3周重复治疗一次，最多6个周期。分别根据世界卫生组织（WHO）和美国国立癌症研究所（NCI）标准在两个周期后评估反应，每个周期评估毒性。中位随访8个月时，只有4例患者（14%）仍存活。总缓解率为33%，3例（11%）完全缓解持续17、14和>24个月。有6例（22%）部分缓解和3例病情稳定。在缓解者中，3例患者在中枢神经系统水平进展。中位进展时间和总生存期分别为3.5个月和9个月。最常见的3 - 4级毒性是中性粒细胞减少，28例患者中有25例（92%）报告。只有2例患者（7%）发生中性粒细胞减少性发热。28例患者中有7例（25%）发生3 - 4级血小板减少，只有1例患者需要输血支持。发生1例因中性粒细胞减少性发热导致的毒性死亡。可以得出结论，所评估的化疗免疫治疗方案具有活性，对于具有良好身体状况和有限疾病负担的转移性黑色素瘤患者可考虑使用。
