THIRD PARTY CLINICAL STUDIES / NEXT GENERATION PDT

STUDY BY:
李力军 首都医科大学附属北京世纪坛医院肿瘤中心
Li Lijun Beijing Sijitan Hospital ,Medical University, Beijing China 100038,
曹汉韶 广州友好医院新一代光动力肿瘤治疗中心
Michael Honsue Cho NGPDT cancer center of Guangzhou friendship hospital
史葛•沃特 广州友好医院新一代光动力肿瘤治疗中心
Scott Waters NGPDT cancer center of Guangzhou friendship hospital
王丹丹 广州友好医院新一代光动力肿瘤治疗中心
Wang Dandan NGPDT cancer center of Guangzhou friendship hospital
阮晶晶 广州友好医院新一代光动力肿瘤治疗中心
Ruan Jingjing NGPDT cancer center of Guangzhou friendship hospital
曹 瑞 北京普祥肿瘤医院光动力光动力治疗中心
Cao Rui NGPDT center of Beijing puxiang cancer hospital
凌胤淇 北京普祥肿瘤医院光动力光动力治疗中心
Ling Yinqi NGPDT center of Beijing puxiang cancer hospital


【摘要】目的:初步探讨新一代光动力治疗晚期肺癌近期临床疗效。方法: 选择经病理学或细胞学确诊的晚期非小细胞肺癌66例,将其分为两组。新一代光动力治疗组32例。将光敏剂按每公斤体重2mg量摄入体内,将其中的三分之二经超声雾化方式吸入,另三分之一口服。确定光照部位, CT下激光精确导航经皮穿刺将激光治疗光纤置入肺肿瘤中, 设定光照强度200J/ cm2, 光照功率1000mw, 开始激发, 时间8~10分钟, 激光长度2~5cm, 可根据肿瘤大小分段照射, 或分时多次照射。同期放化疗组(外照射+全身化疗)34例,采用15MVX线放射治疗照射野包括肺部原发灶和纵膈淋巴引流区,剂量65-70Gy,每周放疗第一日应用顺铂20mg静脉输入。结果:新一代光动力治疗组和同期放化疗组1,2年生存率分别为93.75%,70.60%和68.75,32.35%(P < 0.05)两组的完全缓解率加部分缓解率分别为56.20%和21.30%,新一代光动力组明显高于同期放化疗组,两组差异有显著性意义(P < 0.05)。结论: 新一代光动力疗法能延长晚期NSCLC患者的生存期,改善其生活质量,是治疗晚期非小细胞肺癌的较有效手段之一。

Objective: To investigate the clinical efficacy of the Next Generation Photodynamic Therapy (NGPDT) (www.ngpdt.com) against advanced lung cancer.

Methods: Through pathology or cytology diagnosis, 66 cases of advanced non-small cell lung cancer patients were selected and divided into two groups. The Next Generation Photodynamic Therapy (NGPDT) group had 32 patients. Photosensitizer was administered on a dosage of 2mg per kilogram of body weight, wherein two-thirds via ultrasonic atomization inhalation and one-third via oral intake. After the irradiation target(s) were determined, optical fiber for laser treatment purposes was guided into lung tumor(s) via interstitial, percutaneous puncture under precious laser navigation, irradiation light intensity was 200J/cm2, irradiation power was 1000mw, activation was then started and last for 8 to 10 minutes, laser irradiation into tumor was 2-5cm in length, irradiation could be performed phase by phase (sub-paragraph treatment) based on tumor size or irradiations could be performed repeatedly. While in the mean time in the chemotherapy/radiotherapy group (external beam radiotherapy + whole body chemotherapy) 34 cases were observed, 15MV X ray radiation therapy irradiation field covers primary lung tumor lesion(s) and mediastinal lymphatic drainage area, dosage was 65-70Gy, on every first day in a week of radiotherapy, 20mg cisplatin was administered via intravenous application.

Result: In the Next Generation Photodynamic Therapy (NGPDT) group and simultaneous radiotherapy/chemotherapy group, 1 and 2 years survival rate were 93.75%, 70.60% and 68.75, 32.35% respectively (P < 0.05). The complete remission rate and partial remission rate were 56.20% and 21.30%, rate of the Next generation PDT group was significantly higher than that of the corresponding radiotherapy and chemotherapy group, the difference was statistically significant (P < 0.05).

Conclusion: The Next Generation Photodynamic Therapy (NGPDT) can prolong survival in patients with advanced NSCLC, improving their quality of life; it proved to be the most effective measure for advanced non-small cell lung cancer treatment of the treatments tested in this study.