Reali U M, Martini L, Borgognoni L, Semino C, Pietra G, Chiarugi C, Guastella M, Melioli G
Unita' di Chirurgia Plastica, Clinica Dermatologica, Universita' di Firenze, Italy.
Melanoma Res. 1998 Feb;8(1):77-82.
A pilot study was set up in order to evaluate the feasibility and safety of infusing in vitro expanded tumour-infiltrating lymphocytes (TILs) and recombinant interleukin-2 (rIL-2) in a group of patients with advanced melanoma after radical resection of lymph node metastases. Twenty-four patients were eligible for the study and proliferating TILs were collected in 16. These patients were infused with TILs and then treated with rIL-2 and alpha-interferon. Short-term toxic effects (such as fever) were in general controlled by symptomatic drugs, whereas chronic toxicities were absent. The median follow-up period was 19 months; at present, 13 patients are alive and disease free, one patient is in progression and two patients have died. The approach was feasible and safe and the clinical results observed are comparable to those obtained by long-term treatment with other biological response modifiers.
开展了一项试点研究，以评估在一组根治性切除淋巴结转移灶后的晚期黑色素瘤患者中输注体外扩增的肿瘤浸润淋巴细胞（TIL）和重组白细胞介素-2（rIL-2）的可行性和安全性。24例患者符合研究条件，其中16例收集到增殖的TIL。这些患者接受了TIL输注，然后接受rIL-2和α干扰素治疗。短期毒性作用（如发热）一般通过对症药物控制，未出现慢性毒性。中位随访期为19个月；目前，13例患者存活且无疾病，1例患者病情进展，2例患者死亡。该方法可行且安全，观察到的临床结果与长期使用其他生物反应调节剂获得的结果相当。
