Brunsvig Paal F, Hatlevoll Reidulv, Berg Randi, Lauvvang Grethe, Owre Kristin, Wang Mari, Aamdal Steinar
Department of Medical Oncology, The Norwegian Radium Hospital, N-0310 Oslo, Norway.
Lung Cancer. 2005 Oct;50(1):97-105. doi: 10.1016/j.lungcan.2005.05.010.
This Phase I/II study investigated weekly docetaxel (Taxotere) with concurrent radiotherapy in 42 patients with untreated stage III non-small cell lung cancer (NSCLC). All patients were treated with chest irradiation: 2Gy administered 5 days/week for 5 weeks, to a total of 50Gy. Docetaxel (1-h infusion) was administered on days 1, 8, 22, and 29< or =2 h before radiation fractions 1, 6, 16, and 21 (i.e. every week excluding the third week of treatment). In the Phase I study (n=12), docetaxel was started at 20 mg/m2 per week (n=3) and escalated in 10 mg/m2 increments (30 mg/m2, n=3; 40 mg/m2, n=6). Dose-limiting toxicity (grade 3-4 esophagitis) occurred with docetaxel 40 mg/m2. The Phase II study (n=30), therefore, evaluated docetaxel 30 mg/m2 (considered recommended dose). All patients except one experienced asymptomatic grade 3-4 lymphopenia; four patients (9.5%) had grade 3-4 esophagitis. The overall response rate was 45.5%, with eight (24.2%) complete responses. The median time to progression at the recommended dose of 30 mg/m2 (n=33) was 12.0 months and the median survival time was 13.6 months. The 1-year survival rate was 60.6%. Five patients (one from Phase I and four from Phase II) were alive after >5 years. In conclusion, weekly docetaxel 30 mg/m2 plus radiotherapy is active and well tolerated in stage III NSCLC.
这项I/II期研究调查了42例未经治疗的III期非小细胞肺癌（NSCLC）患者接受每周多西他赛（泰索帝）同步放疗的情况。所有患者均接受胸部照射：每周5天，每天给予2Gy，共5周，总计50Gy。多西他赛（1小时静脉输注）在第1、8、22和29天，即在放疗分次1、6、16和21之前（即每周，不包括治疗的第三周）<或=2小时给药。在I期研究（n = 12）中，多西他赛起始剂量为每周20mg/m²（n = 3），并以10mg/m²的增量递增（30mg/m²，n = 3；40mg/m²，n = 6）。多西他赛40mg/m²时出现剂量限制性毒性（3 - 4级食管炎）。因此，II期研究（n = 30）评估了多西他赛30mg/m²（视为推荐剂量）。除1例患者外，所有患者均出现无症状的3 - 4级淋巴细胞减少；4例患者（9.5%）出现3 - 4级食管炎。总缓解率为45.5%，8例（24.2%）完全缓解。推荐剂量30mg/m²（n = 33）时的中位进展时间为12.0个月，中位生存时间为13.6个月。1年生存率为60.6%。5例患者（1例来自I期，4例来自II期）在5年以上仍存活。总之，每周30mg/m²多西他赛联合放疗在III期NSCLC中具有活性且耐受性良好。
