Jett J R, Maksymiuk A W, Su J Q, Mailliard J A, Krook J E, Tschetter L K, Kardinal C G, Twito D I, Levitt R, Gerstner J B
Mayo Clinic, Rochester, MN.
J Clin Oncol. 1994 Nov;12(11):2321-6. doi: 10.1200/JCO.1994.12.11.2321.
We evaluated the effect of recombinant interferon gamma (rIFN-gamma) on survival and toxicity in small-cell lung cancer (SCLC) patients in complete remission (CR).
One hundred patients in CR following treatment with six cycles of combination chemotherapy, thoracic radiotherapy (TRT), and prophylactic cranial irradiation (PCI) were studied. All patients had been enrolled onto a cooperative group trial (North Central Cancer Treatment Group [NCCTG] 86-20-51). Patients received observation only or rIFN-gamma at a dose of 4 x 10(6) U subcutaneously per day for 6 months.
Six patients (12%) did not comply with rIFN-gamma treatment. Substantial nonhematologic toxicities consisting of chills, myalgia, lethargy, and alteration of mood-personality were observed. No patient experienced life-threatening or fatal toxicity. The median times to progression for rIFN-gamma treatment or observation were 6.9 and 8.1 months (P = .54). The median survival times were 13.3 and 18.8 months, respectively (P = .43). Approximately 70% of all patients relapsed within 2 years.
Time to progression and survival were inferior in patients treated with rIFN-gamma compared with randomized control subjects, although this difference was not statistically significant. These data indicate that rIFN-gamma treatment is not associated with a 33% improvement in survival (P = .04). Because of the high rate of relapse, SCLC patients in CR are an ideal group in which to evaluate novel and minimally toxic agents.
我们评估了重组干扰素γ（rIFN-γ）对完全缓解（CR）的小细胞肺癌（SCLC）患者生存率和毒性的影响。
研究了100例接受六个周期联合化疗、胸部放疗（TRT）和预防性颅脑照射（PCI）后达到CR的患者。所有患者均参加了一项合作组试验（北中部癌症治疗组[NCCTG]86-20-51）。患者仅接受观察或皮下注射剂量为4×10⁶U/d的rIFN-γ，持续6个月。
6例患者（12%）未遵行rIFN-γ治疗。观察到包括寒战、肌痛、嗜睡以及情绪-性格改变在内的严重非血液学毒性。无患者出现危及生命或致命毒性。rIFN-γ治疗组或观察组的中位进展时间分别为6.9个月和8.1个月（P = 0.54）。中位生存时间分别为13.3个月和18.8个月（P = 0.43）。约70%的患者在2年内复发。
与随机对照受试者相比，接受rIFN-γ治疗的患者进展时间和生存期较差，尽管这种差异无统计学意义。这些数据表明，rIFN-γ治疗与生存率提高33%无关（P = 0.04）。由于复发率高，CR的SCLC患者是评估新型和低毒药物的理想群体。
