Bédane C, Le Brun V, Boulinguez S, Berdah J F, Bouyssou M L, Delpuget N, Bernard P, Tubiana-Mathieu N, Bonnetblanc J M
Service de dermatologie, CHU, Hôpital Dupuytren, Limoges.
Ann Dermatol Venereol. 1999 Feb;126(2):142-6.
The use of high-dose interferon alpha as adjuvant therapy has been shown for the first time to improve recurrence-free and overall survival in stage II malignant melanoma. The aim of our work was to evaluate the toxicity of this therapeutic scheme during a 1-year period in 13 patients with malignant melanoma.
Thirteen patients, mean age 56 years, with stage II melanoma were included. Interferon alpha was administered at the dose of 20 MU per m2 body surface area five days per week for four weeks during the induction phase and at the dose of 10 MU subcutaneously three times a week for 48 weeks in the maintenance phase. Patients underwent clinical assessment daily and had blood tests twice a week during the induction phase. Weekly blood tests and monthly examinations were then performed during the maintenance phase. Clinical and biological toxicity was evaluated in accordance with the WHO scores. Grade 3 toxicity led to a 30 p. 100 dose reduction and treatment was interrupted in case of grade 4 toxicity.
A flu-like syndrome (grade 1-2) and digestive disorders, nausea, anorexia related to dysgeusia or dry mouth were observed in most of the patients during the induction phase and persisted in 30% of the patients during the maintenance phase. Six patients developed a state of depression (grade 2-3) which persisted during the maintenance phase, inciting us to prescribe an antidepressor regimen for all our patients. One patient developed major reversible alopecia at dose reduction. Nine patients had grade 1 or grade 2 neutropenia and four had grade 3 neutropenia. Seven patients developed grade 1-2 thrombocytopenia, six had elevated transaminase levels (grade 1-2) and two moderately elevated CPK.
At the end of the induction phase of interferon alpha therapy in 13 patients with malignant melanoma, 8/13 had received 100 p. 100 of the theoretical dose and 11/13 had received 80 p. 100. At the end of the treatment protocol, 5/10 patients had received 100 p. 100 of the theoretical dose and 8/10 more than 80 p. 100. The proposed protocol appears to be feasible without major risk. Rigorous clinical and biological surveillance is mandatory.
高剂量干扰素α作为辅助治疗首次被证明可改善II期恶性黑色素瘤患者的无复发生存率和总生存率。我们研究的目的是评估该治疗方案在13例恶性黑色素瘤患者1年治疗期内的毒性。
纳入13例平均年龄56岁的II期黑色素瘤患者。诱导期，干扰素α按每平方米体表面积20 MU的剂量每周给药5天，共给药4周；维持期，按每周皮下注射10 MU，每周3次，共给药48周。诱导期患者每天接受临床评估，每周进行2次血液检查。维持期则每周进行血液检查，每月进行检查。根据世界卫生组织评分评估临床和生物学毒性。3级毒性导致剂量减少30%，4级毒性则中断治疗。
大多数患者在诱导期出现流感样综合征（1 - 2级）以及消化系统紊乱、恶心、与味觉障碍或口干相关的厌食症状，30%的患者在维持期这些症状仍持续存在。6例患者出现抑郁状态（2 - 3级），在维持期持续存在，促使我们为所有患者开具抗抑郁治疗方案。1例患者在剂量减少时出现严重可逆性脱发。9例患者出现1级或2级中性粒细胞减少，4例出现3级中性粒细胞减少。7例患者出现1 - 2级血小板减少，6例转氨酶水平升高（1 - 2级），2例肌酸磷酸激酶中度升高。
在13例恶性黑色素瘤患者的干扰素α治疗诱导期结束时，13例中有8例接受了理论剂量的100%，13例中有11例接受了理论剂量的80%。在治疗方案结束时，10例患者中有5例接受了理论剂量的100%，10例中有8例接受了理论剂量的80%以上。所提出的方案似乎可行，且风险不大。严格的临床和生物学监测是必要的。
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