Khayat D, Borel C, Tourani J M, Benhammouda A, Antoine E, Rixe O, Vuillemin E, Bazex P A, Thill L, Franks R
Service d'Oncologie Médicale, Hopital de la Salpétrière, Paris, France.
J Clin Oncol. 1993 Nov;11(11):2173-80. doi: 10.1200/JCO.1993.11.11.2173.
To evaluate the activity and the toxicity of the combination of cisplatin (CDDP)/recombinant interleukin-2 (rIL-2) and interferon alfa-2a (IFN alpha) in disseminated malignant melanoma (DMM).
Between December 1990 and March 1992, 39 patients with biopsy-proven metastatic malignant melanoma (MM), bidimensionally measurable lesions and an Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 entered this protocol. Seventy-nine percent had received previous chemotherapy including platinum complex (15%) and alpha interferon (44%). They received CDDP (100 mg/m2 on day 0) followed by IL-2 18.10(6) IU/m2/d continuous intravenous (IV) infusion from day 3 to day 6 and from day 17 to day 21. The cycle was repeated on day 28. Subcutaneous IFN alpha 9.10(6) IU three times weekly was administered throughout the treatment period. From day 66 or 94, patients were administered a maintenance cycle with CDDP 100 mg/m2, subcutaneous IL-2 5.10(6) IU/m2/d from day 15 to day 19 and from day 22 to day 26 and IFN alpha 9.10(6) IU three times weekly repeated every 5 weeks (maximum four cycles).
Among 39 assessable patients, five patients achieved complete responses (CRs). Sixteen patients had partial responses (PRs). The overall objective response rate was 53.8%. The number of metastatic sites was the only response-predictive factor. Toxicity was manageable in a routine patient setting and there was no life-threatening toxicity.
These results seem to indicate a possible synergy between CDDP/rIL-2 and IFN alpha in MM.
评估顺铂（CDDP）/重组白细胞介素-2（rIL-2）与干扰素α-2a（IFNα）联合应用于播散性恶性黑色素瘤（DMM）的活性及毒性。
1990年12月至1992年3月，39例经活检证实为转移性恶性黑色素瘤（MM）、具有二维可测量病灶且东部肿瘤协作组（ECOG）体能状态≤2的患者进入本方案。79%的患者曾接受过包括铂类复合物（15%）和α干扰素（44%）在内的既往化疗。他们接受顺铂（第0天100mg/m²），随后从第3天至第6天以及第17天至第21天给予IL-2 18×10⁶IU/m²/d持续静脉输注。在第28天重复该周期。在整个治疗期间每周皮下注射3次IFNα 9×10⁶IU。从第66天或第94天起，患者接受维持周期治疗，给予顺铂100mg/m²，从第15天至第19天以及第22天至第26天皮下注射IL-2 5×10⁶IU/m²/d，并且每5周重复一次每周皮下注射3次IFNα 9×10⁶IU（最多4个周期）。
在39例可评估患者中，5例患者达到完全缓解（CR）。16例患者有部分缓解（PR）。总体客观缓解率为53.8%。转移部位数量是唯一的反应预测因素。在常规患者环境中，毒性是可控的，且没有危及生命的毒性。
这些结果似乎表明CDDP/rIL-2与IFNα在MM中可能存在协同作用。
