Choy H, Safran H, Akerley W, Graziano S L, Bogart J A, Cole B F
Center for Radiation Oncology, Nashville, Tennessee 37232-5671, USA.
Clin Cancer Res. 1998 Aug;4(8):1931-6.
We conducted a prospective Phase II study to determine the response rate, toxicity, and 2-year survival rate of concurrent weekly paclitaxel and radiation therapy (RT) for locally advanced unresectable non-small cell lung cancer. The weekly paclitaxel regimen was designed to optimize the radiosensitizing properties of paclitaxel. Thirty-three patients with unresectable stage IIIA and IIIB non-small cell lung cancer from six institutions were entered into the study between March 1994 and February 1995. Weekly i.v. paclitaxel (60 mg/m2; 3-h infusion) plus concurrent chest RT (60 Gy over 6 weeks) was delivered for 6 weeks. Twenty-nine patients were evaluable for response. Three patients achieved a complete response (10%), and 22 patients (76%) achieved a partial response, for an overall response rate of 86% (95% confidence interval, 68-96%). One patient progressed during the therapy, and three patients had stable disease. Esophagitis was the principal toxicity. Grade 3 or 4 esophagitis occurred in 11 patients (37%). One patient died of pneumonia after completion of therapy. Additional grade > or =3 toxicities included pneumonitis (12%) and neutropenia (6%). One patient had a grade 3 hypersensitivity reaction. The median overall survival duration for all 33 patients who entered the study was 20 months, and 1-, 2-, and 3-year overall survival rates were 60.6%, 33.3%, and 18.2%, respectively. The median progression-free survival duration for all 33 patients was 10.7 months, and 1-, 2-, and 3-year progression-free survival rates were 39.4%, 12.1%, and 6.1%, respectively. Weekly paclitaxel plus concurrent RT is a well-tolerated outpatient regimen. The survival outcome from this regimen is encouraging and seems to be at least equivalent to that of other chemotherapy/radiation trials. These findings warrant further clinical evaluation of weekly paclitaxel/RT in Phase II trials in the neoadjuvant setting and in combination with other cytotoxic agents.
我们开展了一项前瞻性II期研究，以确定每周一次紫杉醇与放射治疗（RT）同步用于局部晚期不可切除非小细胞肺癌的缓解率、毒性及2年生存率。每周一次紫杉醇方案旨在优化紫杉醇的放射增敏特性。1994年3月至1995年2月期间，来自6家机构的33例不可切除的IIIA期和IIIB期非小细胞肺癌患者进入该研究。每周静脉注射紫杉醇（60mg/m²；输注3小时）加同步胸部放疗（6周内60Gy），持续6周。29例患者可评估缓解情况。3例患者达到完全缓解（10%），22例患者（76%）达到部分缓解，总缓解率为86%（95%置信区间，68 - 96%）。1例患者在治疗期间病情进展，3例患者病情稳定。食管炎是主要毒性反应。11例患者（37%）发生3级或4级食管炎。1例患者在治疗完成后死于肺炎。其他≥3级毒性反应包括肺炎（12%）和中性粒细胞减少（6%）。1例患者发生3级过敏反应。所有33例进入研究的患者的中位总生存时间为20个月，1年、2年和3年总生存率分别为60.6%、33.3%和18.2%。所有33例患者的中位无进展生存时间为10.7个月，1年、2年和3年无进展生存率分别为39.4%、12.1%和6.1%。每周一次紫杉醇加同步放疗是一种耐受性良好的门诊治疗方案。该方案的生存结果令人鼓舞，似乎至少与其他化疗/放疗试验相当。这些发现值得在新辅助治疗环境下的II期试验中以及与其他细胞毒性药物联合使用时对每周一次紫杉醇/放疗进行进一步的临床评估。
