Marangolo M, Emiliani E, Rosti G, Giannini M, Vertogen B, Zumaglini F
Medical Oncology Unit, City Hospital, Ravenna, Italy.
Semin Oncol. 1996 Dec;23(6 Suppl 15):31-4.
Sixteen patients affected by previously untreated non-small cell lung cancer stage IIIB or IV received radiotherapy and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) as radiation sensitizer in an open, nonrandomized pilot study to find the maximum tolerated dose of the drug concomitantly combined with radiation. Paclitaxel was given as a 3-hour infusion once weekly at a dose escalating by 10 mg/m2/wk for every patient cohort, starting at 40 mg/m2/wk and continuing to 80 mg/m2/wk. Conventionally fractionated (2 Gy/d for 5 d/wk for 5 weeks) radiotherapy up to 50 Gy was delivered to the primary tumor and mediastinum with a 6-mv linear accelerator. Hematologic toxicity has been very low; grade 3 World Health Organization nonhematalogic toxicities have been registered only at the 80 mg/m2/wk dose level. Seven patients achieved a major response, three patients had stable disease, and five patients progressed; three patients are still responding, whereas the others are relapsed and five of them died of disease. The median duration of response was 5 months. Paclitaxel may be safely combined with radiation at the maximum tolerated dose of 70 mg/m2/wk. Our data seem to confirm the radiosensitizing effect of the drug, independent of the dose level. Low doses of paclitaxel given as a single agent are unable to control metastatic disease.
在一项开放、非随机的试点研究中，16例先前未接受过治疗的ⅢB期或Ⅳ期非小细胞肺癌患者接受了放疗，并使用紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）作为放射增敏剂，以确定该药物与放疗联合使用时的最大耐受剂量。紫杉醇通过3小时静脉输注给药，每周一次，每个患者队列的剂量以10mg/m²/周递增，从40mg/m²/周开始，持续至80mg/m²/周。使用6兆伏直线加速器对原发肿瘤和纵隔进行常规分割放疗（每周5天，每天2Gy，共5周），总剂量达50Gy。血液学毒性非常低；仅在80mg/m²/周剂量水平记录到3级世界卫生组织非血液学毒性。7例患者获得主要缓解，3例患者病情稳定，5例患者病情进展；3例患者仍在缓解，而其他患者复发，其中5例死于疾病。中位缓解持续时间为5个月。紫杉醇可以与放疗安全联合，最大耐受剂量为70mg/m²/周。我们的数据似乎证实了该药物的放射增敏作用，与剂量水平无关。低剂量单一使用紫杉醇无法控制转移性疾病。
