一项关于白细胞介素-2 淋巴因子激活的杀伤细胞免疫疗法联合化疗或放疗用于原发性肺癌根治性或非根治性切除术后的 III 期随机研究。

A phase III randomized study of interleukin-2 lymphokine-activated killer cell immunotherapy combined with chemotherapy or radiotherapy after curative or noncurative resection of primary lung carcinoma.

作者信息

Kimura H, Yamaguchi Y

机构信息

Division of Thoracic Diseases, Chiba Cancer Center, Chuo-ku, Japan.

出版信息

Cancer. 1997 Jul 1;80(1):42-9.

PMID:9210707

Abstract

BACKGROUND

Adoptive immunotherapy with interleukin-2 (IL-2) and lymphokine-activated killer (LAK) cells has resulted in response among some patients with advanced malignant disease. However, the relative therapeutic benefit of adoptive immunotherapy as an adjuvant to surgery has not been determined.

METHODS

A Phase III prospective randomized controlled study of adjuvant immunotherapy combined with chemotherapy or radiotherapy was conducted for 174 primary lung carcinoma patients postsurgically. After a pathologic examination of resected tissues, patients were divided into curative and noncurative cases and randomized to receive either combined immunotherapy (Group A) or control standard therapy (Group B). Patients who had undergone curative resection of lung carcinoma were stratified according to the stages and histologic types of their disease, and those who had undergone noncurative resection were stratified according to the causes of noncurative resection. The patients of Group A received IL-2 and LAK cells after either chemotherapy or radiotherapy, and those in Group B received either no adjuvant therapy (curative cases) or radiotherapy or chemotherapy alone (noncurative cases), according to the causes of noncurative resection.

RESULTS

The 5- and 9-year survival rates of the Group A patients were 54.4% and 52.0%, respectively, and those of the Group B patients were 33.4% and 24.2%, respectively. The difference was statistically significant (P < 0.001, according to the generalized Wilcoxon's test and the Cox-Mantel test). The difference was also statistically significant in the curative cases (65.5% for Group A vs. 40.6% for Group B; 5-year survival rate, P < 0.01), noncurative cases (43.0% for A vs. 20.8% for B; P < 0.01), adenocarcinoma cases (47.5% for A vs. 23.0% for B; P < 0.05), and squamous cell carcinoma cases (62.1% for A vs. 34.8% for B; P < 0.01).

CONCLUSIONS

Adoptive immunotherapy with IL-2 and LAK cells combined with chemotherapy or radiotherapy improved the survival of patients after surgical resection of primary lung carcinoma. A multi-institutional group study should be carried out to verify the significance of this study.

摘要

背景

采用白细胞介素-2（IL-2）和淋巴因子激活的杀伤细胞（LAK）进行过继性免疫治疗已使部分晚期恶性疾病患者产生反应。然而，过继性免疫治疗作为手术辅助治疗的相对疗效尚未确定。

方法

对174例原发性肺癌术后患者进行了一项辅助免疫治疗联合化疗或放疗的Ⅲ期前瞻性随机对照研究。在对切除组织进行病理检查后，将患者分为治愈性和非治愈性病例，并随机分为接受联合免疫治疗组（A组）或对照标准治疗组（B组）。肺癌根治性切除患者根据疾病分期和组织学类型进行分层，非根治性切除患者根据非根治性切除原因进行分层。A组患者在化疗或放疗后接受IL-2和LAK细胞治疗，B组患者根据非根治性切除原因，对于治愈性病例不接受辅助治疗，对于非治愈性病例单独接受放疗或化疗。

结果

A组患者的5年和9年生存率分别为54.4%和52.0%，B组患者的5年和9年生存率分别为33.4%和24.2%。差异具有统计学意义（根据广义Wilcoxon检验和Cox-Mantel检验，P<0.001）。在治愈性病例（A组为65.5%，B组为40.6%；5年生存率，P<0.01）、非治愈性病例（A组为43.0%，B组为20.8%；P<0.01）、腺癌病例（A组为47.5%，B组为23.0%；P<0.05）和鳞状细胞癌病例（A组为62.1%，B组为34.8%；P<0.01）中差异也具有统计学意义。