Kaplan Bunyamin, Altýnbas Mustafa, Eroglu Celalettin, Karahacioglu Eray, Er Ozlem, Ozkan Metin, Bilgin Mehmet, Canoz Ozlem, Gulmez Inci, Gulec Mustafa
Department of Radiation Oncology, Erciyes University Medical Faculty, Kayseri, Turkey.
Am J Clin Oncol. 2004 Dec;27(6):603-10. doi: 10.1097/01.coc.0000135739.37072.ff.
Concurrent chemoradiotherapy plays an important role in the treatment of unresectable NSCLC. This phase II study was conducted to evaluate the efficacy and toxicity of paclitaxel (PTX) and carboplatin (CBDCA) at a recommended dose, based on other previous phase I studies. Twenty-two unresectable stage III NSCLC patients participated in this trial. Of those 22 patients, 19 were evaluable, with a median age of 57 (with ages ranging between 42 and 74), in stages IIIA/IIIB: 6/13. Every patient displayed adequate organ functions. Treatment consisted of a 1-hour i.v. infusion of 50 mg/m2 of PTX followed by a half-hour infusion of CBDCA AUC 2 administered weekly concurrently with radiation treatment, every first day of those weeks in which the patient underwent radiotherapy. Concurrent thoracic radiation therapy was performed in daily doses of 2 Gy to a total dose of 66 Gy over a period of 6.5 weeks. After completion of chemoradiotherapy, consolidation chemotherapy was administered via a 3-hour i.v. infusion of 175 mg/2 PTX on days 1 and 22, in combination with a 1-hour i.v. infusion of CBDCA AUC 6 on days 1 and 22, q 4 weeks for 4 cycles. The overall response rate was 78.9% (95% CI: 62-87.7) with 5 CR (26.3%), 10 PR (52.6%), 2 SD (15.8%), and 1 PD (5.3%). The median survival rate of the patients was 13.9 months, and the 1-year survival rate was 65.1%. Toxicity was moderate: grade 2 neutropenia was seen in 8, and grade 3 neutropenia in 5 patients. Grade 2 thrombocytopenia was seen in 3 patients, and grade 3 thrombocytopenia was not observed. Nonhematologic toxicities were moderate: esophagitis was the most common, and significant toxicity was noted in this study (89.4%). Grade 1 asthenia/fatigue was observed in 5, and grade 2 asthenia/fatigue in 3 patients; furthermore, grade 1 peripheral neuropathy was seen in 4 of the cases and grade 2 peripheral neuropathy in 3 of the cases. Concurrent chemoradiotherapy with weekly PTX/CBDCA, followed by consolidation chemotherapy with the same regimen in patients with stage III unresectable NSCLC is feasible and well tolerated.
同步放化疗在不可切除的非小细胞肺癌（NSCLC）治疗中发挥着重要作用。基于之前的其他I期研究，本II期研究旨在评估推荐剂量的紫杉醇（PTX）和卡铂（CBDCA）的疗效和毒性。22例不可切除的III期NSCLC患者参与了该试验。在这22例患者中，19例可评估，中位年龄为57岁（年龄范围在42至74岁之间），处于IIIA/IIIB期：6/13。每位患者均表现出足够的器官功能。治疗包括静脉输注1小时50mg/m²的PTX，随后半小时输注CBDCA AUC 2，每周与放疗同时进行，在患者接受放疗的每周第一天给药。同步胸部放疗每日剂量为2Gy，在6.5周内总剂量达66Gy。放化疗完成后，进行巩固化疗，于第1天和第22天通过静脉输注3小时175mg/2的PTX，并在第1天和第22天联合静脉输注1小时CBDCA AUC 6，每4周进行1次，共4个周期。总缓解率为78.9%（95%CI：62 - 87.7），其中完全缓解（CR）5例（26.3%），部分缓解（PR）10例（52.6%），疾病稳定（SD）2例（15.8%），疾病进展（PD）1例（5.3%）。患者的中位生存率为13.9个月，1年生存率为65.1%。毒性为中度：8例出现2级中性粒细胞减少，5例出现3级中性粒细胞减少。3例出现2级血小板减少，未观察到3级血小板减少。非血液学毒性为中度：食管炎最为常见，本研究中观察到明显毒性（89.4%）。5例出现1级乏力/疲劳，3例出现2级乏力/疲劳；此外，4例出现1级周围神经病变，3例出现2级周围神经病变。对于III期不可切除的NSCLC患者，每周PTX/CBDCA同步放化疗，随后采用相同方案进行巩固化疗是可行的，且耐受性良好。
