Phase II trial of weekly paclitaxel and concurrent radiation therapy for locally advanced non-small cell lung cancer.
Phase II trial of weekly paclitaxel and concurrent radiation therapy for locally advanced non-small cell lung cancer.
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每周紫杉醇和同步放射治疗局部晚期非小细胞肺癌的 II 期试验。
作者：
H. Choy;H. Safran;W. Akerley;S. Graziano;J. Bogart;B. Cole
我们进行了一项前瞻性II期研究，以确定每周紫杉醇和放疗（RT）同时治疗局部晚期不可切除的非小细胞肺癌的反应率、毒性和2年生存率。设计每周紫杉醇方案以优化紫杉醇的放射增敏特性。1994年3月至1995年2月，来自6个机构的33例不可切除的IIIA期和IIIB期非小细胞肺癌患者进入了研究。每周静脉注射紫杉醇（60mg /m2, 3小时输注），同时进行胸部放射治疗（60gy / 6周），持续6周。29例患者可评估反应。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例患者在治疗期间出现进展，3例患者病情稳定。食管炎是主要的毒性反应。11例（37%）患者发生3级或4级食管炎。1例患者在治疗结束后死于肺炎。其他>或=3级毒性包括肺炎（12%）和中性粒细胞减少症（6%）。1例患者出现3级超敏反应。所有进入研究的33例患者的中位总生存期为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期为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。这些发现为在新辅助治疗和与其他细胞毒性药物联合使用的II期临床试验中对每周紫杉醇/RT进行进一步的临床评估提供了依据。
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.
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门诊每周紫杉醇和同步放射治疗晚期非小细胞肺癌的 I 期试验。
DOI：
10.1200/jco.1994.12.12.2682
发表时间：
1994
期刊：
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
影响因子：
--
作者：
Choy,H;Akerley,W;Safran,H;Clark,J;Rege,V;Papa,A;Glantz,M;Puthawala,Y;Soderberg,C;Leone,L
通讯作者：
Leone,L
DOI：
10.1016/0360-3016(92)90888-o
发表时间：
1992-01-01
影响因子：
7
作者：
TISHLER, RB;SCHIFF, PB;HALL, EJ
通讯作者：
HALL, EJ
影响因子：
158.5
作者：
DILLMAN, RO;SEAGREN, SL;GREEN, MR
通讯作者：
GREEN, MR
紫杉醇与急性低剂量率照射相结合。
DOI：
10.1016/0167-8140(94)90098-1
发表时间：
1994
期刊：
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
影响因子：
--
作者：
Minarik,L;Hall,EJ
通讯作者：
Hall,EJ
DOI：
10.1093/jnci/85.5.384
发表时间：
1993-03-03
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
MURPHY, WK;FOSSELLA, FV;HONG, WK
通讯作者：
HONG, WK