Frasci G, Nicolella G, Comella P, Carreca I, DeCataldis G, Muci D, Brunetti C, Natale M, Piantedosi F, Russo A, Palmeri S, Comella G, Panza N
Southern Italy Cooperative Oncology Group (SICOG)-c/o National Tumor Institute of Naples via M. Semmola 80131, Italy.
Br J Cancer. 2001 May 4;84(9):1166-71. doi: 10.1054/bjoc.2001.1741.
The present study was aimed at defining the antitumour activity of the cisplatin-paclitaxel-topotecan (CPT) weekly administration with G-CSF support in chemo-naive SCLC patients with extensive disease (ED-SCLC). Chemonaive ED-SCLC patients received cisplatin 40 mg/m(2), paclitaxel 85 mg/m(2), and topotecan 2.25 mg/m(2)weekly, with G-CSF (5 microg/kg days 3-5) support, for a maximum of 12 weeks. 37 patients were treated, for a total of 348 cycles delivered. 8 complete responses (22%) and 22 partial responses (59%) were recorded, giving an 81% [95% CI = 65-92%] ORR. At a 13-month (range, 4-26) median follow-up, median progression-free and overall survival were 8 months and 12.5 months, with 1-year and 2-year projected survivals of 55% and 21%, respectively. No toxic deaths occurred. Grade 4 neutropenia and thrombocytopenia occurred in 6 and 3 patients, respectively. Only one case of neutropenic sepsis was recorded, while haemorrhagic thrombocytopenia was never observed. Diarrhoea, paraesthesias and fatigue were the main nonhaematologic toxicities being severe in 6, 2 and 10 patients, respectively. The weekly CPT combination with G-CSF support represents a well tolerated therapeutic approach in chemo-naive ED-SCLC patients. The activity rate seems at least similar to that achievable with the standard front-line approaches.
本研究旨在确定在粒细胞集落刺激因子（G-CSF）支持下，顺铂-紫杉醇-拓扑替康（CPT）每周给药方案对初治广泛期小细胞肺癌（ED-SCLC）患者的抗肿瘤活性。初治ED-SCLC患者每周接受顺铂40mg/m²、紫杉醇85mg/m²和拓扑替康2.25mg/m²治疗，并给予G-CSF（第3 - 5天5μg/kg）支持，最多治疗12周。共治疗37例患者，总计进行了348个周期的治疗。记录到8例完全缓解（22%）和22例部分缓解（59%），客观缓解率为81%[95%置信区间=65 - 92%]。在13个月（范围4 - 26个月）的中位随访期内，中位无进展生存期和总生存期分别为8个月和12.5个月，1年和2年预计生存率分别为55%和21%。未发生毒性死亡。4级中性粒细胞减少和血小板减少分别发生在6例和3例患者中。仅记录到1例中性粒细胞减少性败血症，未观察到出血性血小板减少。腹泻、感觉异常和疲劳是主要的非血液学毒性反应，分别有6例、2例和10例患者出现严重反应。每周CPT联合G-CSF支持方案在初治ED-SCLC患者中是一种耐受性良好的治疗方法。其活性率似乎至少与标准一线治疗方法相当。
