英國《柳葉刀—腫瘤學(xué)》雜志日前刊登報(bào)告說,，一種肺癌疫苗在人類臨床試驗(yàn)中顯出初步成效,，將它與化學(xué)療法聯(lián)合使用可以更好地控制癌癥病情。
本次試驗(yàn)由法國斯特拉斯堡大學(xué)等機(jī)構(gòu)研究人員完成,，共涉及148名已經(jīng)到癌癥后期的非小細(xì)胞肺癌患者,。非小細(xì)胞肺癌是肺癌的一種，癌癥后期通常采用化學(xué)療法進(jìn)行治療,。在本次試驗(yàn)中,，一半患者采用常規(guī)化學(xué)療法，另一半患者在接受化療的同時(shí)還注射這種名為TG4010的疫苗,。
結(jié)果顯示,，注射疫苗的患者病情得到了更好控制，有43%的患者在6個(gè)月后癌癥沒有進(jìn)一步發(fā)展,，而只采取化學(xué)療法的患者中這一比例為35%,。
據(jù)介紹，這種疫苗通過人體免疫系統(tǒng)發(fā)揮作用,，它能夠“訓(xùn)練”免疫系統(tǒng)辨識(shí)一些特殊的蛋白質(zhì),。如果肺部細(xì)胞發(fā)生癌變，細(xì)胞表面的蛋白質(zhì)會(huì)發(fā)生相應(yīng)變化,，經(jīng)過“訓(xùn)練”的免疫系統(tǒng)就可以憑此辨別出癌變細(xì)胞,，對其發(fā)起攻擊，控制病情發(fā)展,。
研究人員說,，雖然疫苗顯示出初步成效，但效果并不特別顯著,，接下來將繼續(xù)研究,，爭取能讓疫苗發(fā)揮更大的治療作用。（生物谷 Bioon.com）
doi:10.1016/S1470-2045(11)70259-5
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Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial
Elisabeth Quoix
Background
Chemotherapy is the standard of care for advanced stages of non-small-cell lung cancer (NSCLC). TG4010 is a targeted immunotherapy based on a poxvirus (modified vaccinia virus Ankara) that codes for MUC1 tumour-associated antigen and interleukin 2. This study assessed TG4010 in combination with first-line chemotherapy in advanced NSCLC.
Methods
148 patients with advanced (stage IIIB [wet] or IV) NSCLC expressing MUC1 by immunohistochemistry, and with performance status 0 or 1, were enrolled in parallel groups in this open-label, phase 2B study. 74 patients were allocated to the combination therapy group, and received TG4010 (108 plaque forming units) plus cisplatin (75 mg/m2 on day 1) and gemcitabine (1250 mg/m2 on days 1 and 8) repeated every 3 weeks for up to six cycles. 74 patients allocated to the control group received the same chemotherapy alone. Patients were allocated using a dynamic minimisation procedure stratified by centre, performance status, and disease stage. The primary endpoint was 6-month progression-free survival (PFS), with a target rate of 40% or higher in the experimental group. Analyses were done on an intention-to-treat basis. This study is completed and is registered with ClinicalTrials.gov, number NCT00415818.
Findings
6-month PFS was 43·2% (32 of 74; 95% CI 33·4—53·5) in the TG4010 plus chemotherapy group, and 35·1% (26 of 74; 25·9—45·3) in the chemotherapy alone group. Fever, abdominal pain, and injection-site pain of any grade according to National Cancer Institute Common Toxicity Criteria were more common in the TG4010 group than in the chemotherapy alone group: 17 of 73 patients (23·3%) versus six of 72 (8·3%), 12 (16·4%) versus two (2·8%), and four (5·5%) versus zero (0%), respectively. The most common grade 3—4 adverse events were neutropenia (33 [45·2%] of patients in the TG4010 plus chemotherapy group vs 31 [43·1%] in the chemotherapy alone group) and fatigue (18 [24·7%] vs 13 [18·1%]); the only grade 3—4 events that differed significantly between groups were anorexia (three [4·1%] vs 10 [13·9%]) and pleural effusion (none vs four [5·6%]). 38 of 73 patients (52·1%) in the TG4010 plus chemotherapy group and 34 of 72 (47·2%) in the chemotherapy alone group had at least one serious adverse event.
Interpretation
This phase 2B study suggests that TG4010 enhances the effect of chemotherapy in advanced NSCLC. A confirmatory phase 2B—3 trial has been initiated.
Funding
Transgene SA, Advanced Diagnostics for New Therapeutic Approaches (ADNA)/OSEO.
