Jansen R L, Slingerland R, Goey S H, Franks C R, Bolhuis R L, Stoter G
Department of Medical Oncology, Rotterdam Cancer Institute, Daniel den Hoed Kliniek, The Netherlands.
J Immunother (1991). 1992 Jul;12(1):70-3. doi: 10.1097/00002371-199207000-00009.
The role of combination chemotherapy in the treatment of advanced non-small-cell lung cancer is controversial. At best, a small survival benefit can be achieved. Therefore, other treatment modalities are needed. On the basis of the promising treatment results with interleukin-2 (IL-2) -containing immunotherapy in renal cell cancer and melanoma, we performed a phase I-II study with IL-2 and interferon alpha (IFN-alpha). Eligible patients were treated with IL-2 18 x 10(6) IU/m2/day by continuous intravenous infusion (c.i.v.) for 3 days. On the same days, 5 x 10(6) U/m2/day IFN-alpha was given intramuscularly. After a rest period of 4 days, patients at the first dose level received IL-2 2.4 x 10(6) IU/m2/day c.i.v. for a period of 28 days, followed by 14 days' rest, 14 days' treatment, 7 days' rest, and a final treatment for 14 days. Patients at the second dose level were treated according to the same schedule, in which the dose of IL-2 was increased to 3.6 x 10(6) IU/m2/day. During low-dose IL-2 treatment, patients received IFN-alpha 5 x 10(6) U/m2/day on days 1 and 4 of each week. Eleven patients were admitted to the study, six at the first and five at the second dose level. Median age was 54 years; all patients had a performance status of 0 or 1. The most important adverse effects included anorexia, fatigue, nausea, and headache, which were not dose limiting. In the 11 patients treated, no responses were seen. Nine patients developed progressive disease during the first 5 weeks of treatment. We concluded that this regimen of IL-2 and IFN-alpha is ineffective.
联合化疗在晚期非小细胞肺癌治疗中的作用存在争议。充其量只能获得微小的生存获益。因此，需要其他治疗方式。基于含白细胞介素-2（IL-2）的免疫疗法在肾细胞癌和黑色素瘤治疗中取得的有前景的治疗结果，我们开展了一项IL-2与α干扰素（IFN-α）的I-II期研究。符合条件的患者接受IL-2 18×10⁶IU/m²/天持续静脉输注（c.i.v.），共3天。在相同日期，给予5×10⁶U/m²/天的IFN-α肌肉注射。经过4天的休息期后，第一剂量水平的患者接受IL-2 2.4×10⁶IU/m²/天c.i.v.治疗28天，随后休息14天，再治疗14天，休息7天，最后再治疗14天。第二剂量水平的患者按相同方案治疗，其中IL-2剂量增加至3.6×10⁶IU/m²/天。在低剂量IL-2治疗期间，患者在每周的第1天和第4天接受5×10⁶U/m²/天的IFN-α治疗。11名患者入组本研究，6名处于第一剂量水平，5名处于第二剂量水平。中位年龄为54岁；所有患者的体能状态均为0或1。最重要的不良反应包括厌食、疲劳、恶心和头痛，这些均非剂量限制性不良反应。在接受治疗的11名患者中，未观察到缓解情况。9名患者在治疗的前5周内病情进展。我们得出结论，这种IL-2和IFN-α方案无效。
