Pujade-Lauraine E, Guastalla J P, Colombo N, Devillier P, François E, Fumoleau P, Monnier A, Nooy M, Mignot L, Bugat R, Marques C, Mousseau M, Netter G, Maloisel F, Larbaoui S, Brandely M
Hôtel Dieu Hospital, Paris, France.
J Clin Oncol. 1996 Feb;14(2):343-50. doi: 10.1200/JCO.1996.14.2.343.
The purpose of this study was to evaluate the efficacy and tolerance of recombinant human interferon gamma (rIFN-gamma) as second-line treatment in patients with persistent disease at second-look laparotomy.
One hundred eight patients with residual disease at second-look laparotomy were treated with rIFN-gamma (20 x 10(6) IU/m2) administered intraperitoneally (IP) twice a week for 3 to 4 months. In the absence of clinically assessable disease, response to rIFN-gamma was assessed with a third-look laparotomy.
Of 98 assessable patients, 31 (32%) achieved a surgically documented response, including 23 patients (23%) with a complete response (CR). The age and size of residual tumor were significant prognostic factors for the response to rIFN-gamma. A 41% CR rate was observed in 41 patients younger than 60 years and with residual tumor less than 2 cm. The probability of response was independent of previous response to first-line chemotherapy. The median duration of response was 20 months and the 3-year survival rate in responders was 62%. Response to rIFN-gamma was the most significant prognostic factor for survival of patients with residual disease. Adverse events included fever, flu-like syndrome, neutropenia, and liver enzyme disturbances. No significant peritoneal fibrosis was noted.
These results support the potential interest of IP rIFN-gamma as adjuvant treatment in ovarian cancer. Controlled prospective trials are required to determine its place in the therapeutic strategy of this malignancy.
本研究旨在评估重组人干扰素γ(rIFN-γ)作为二次剖腹探查时持续性疾病患者二线治疗的疗效和耐受性。
108例二次剖腹探查时有残留病灶的患者接受rIFN-γ(20×10⁶IU/m²)治疗,每周经腹腔内(IP)给药2次,共3至4个月。在无临床可评估疾病的情况下,通过三次剖腹探查评估对rIFN-γ的反应。
98例可评估患者中,31例(32%)获得手术记录的反应,其中23例(23%)完全缓解(CR)。残留肿瘤的年龄和大小是对rIFN-γ反应的重要预后因素。在41例年龄小于60岁且残留肿瘤小于2 cm的患者中观察到41%的CR率。反应概率与既往对一线化疗的反应无关。反应的中位持续时间为20个月,反应者的3年生存率为62%。对rIFN-γ的反应是残留疾病患者生存的最重要预后因素。不良事件包括发热、流感样综合征、中性粒细胞减少和肝酶紊乱。未观察到明显的腹膜纤维化。
这些结果支持IP rIFN-γ作为卵巢癌辅助治疗的潜在价值。需要进行对照前瞻性试验以确定其在这种恶性肿瘤治疗策略中的地位。