Van Kooten Maximiliano, Rosenberg Moisés, Orlando Mauro, Morero José, Vilanova Manuel, Rojas Oscar, Vicente Héctor, Bagnes Claudia, Silva Carlos, Chacón Reinaldo D
Alexander Fleming Institute, Buenos Aires, Argentina.
Invest New Drugs. 2002 Nov;20(4):439-46. doi: 10.1023/a:1020618313969.
We studied cisplatin plus gemcitabine as induction (neoadjuvant) therapy in patients with stage III non-small cell lung cancer (NSCLC) to assess its objective remission rate, resectability, survival, and toxicity.
Patients with stage III NSCLC received 2 cycles of gemcitabine 1250 mg/m2 on days 1, 8, and 15, plus cisplatin 100 mg/m2 on day 2. Subsequently, patients were assigned to local therapy--surgery or radiotherapy.
Twenty-nine eligible patients (male/female: 21/8) with a median age of 59 years (range, 43-71 years) were enrolled between October 1996 and February 1999. A total of 80 cycles were given, with a median of 3 per patient (range, 1-4 cycles). Overall, toxicities were mild; only one patient had febrile neutropenia, and there were no grade 4 non-hematological toxicities. There was one toxic death following afebrile grade 4 neutropenia. Overall clinical response rate (2 complete responses [CRs] + 16 partial responses [PRs]) was 62% (95% CI, 45%-79%); 10 patients had stable disease and none progressed; one patient was not evaluable. Eight of the 18 operated patients had pathological response: 1 CR and 7 downstagings to N(-); 14 patients were resected. Median survival was 17 months (95% CI, 13-21 months), with 1-year and 2-year actuarial survival rates of 61% and 29%, respectively.
Gemcitabine plus cisplatin is a very active and well-tolerated induction regimen in stage III NSCLC. Comparative studies with other standard regimens are warranted.
我们研究了顺铂联合吉西他滨作为Ⅲ期非小细胞肺癌（NSCLC）患者的诱导（新辅助）治疗方案，以评估其客观缓解率、可切除性、生存率及毒性。
Ⅲ期NSCLC患者在第1、8和15天接受2个周期的吉西他滨治疗，剂量为1250mg/m²，在第2天接受顺铂治疗，剂量为100mg/m²。随后，患者被分配接受局部治疗——手术或放疗。
1996年10月至1999年2月期间，共纳入29例符合条件的患者（男/女：21/8），中位年龄59岁（范围43 - 71岁）。共给予80个周期的治疗，每位患者中位接受3个周期（范围1 - 4个周期）。总体而言，毒性较轻；仅1例患者出现发热性中性粒细胞减少，无4级非血液学毒性。1例患者在无发热的4级中性粒细胞减少后出现毒性死亡。总体临床缓解率（2例完全缓解[CR] + 16例部分缓解[PR]）为62%（95%CI，45% - 79%）；10例患者病情稳定，无进展；1例患者无法评估。18例接受手术的患者中有8例出现病理缓解：1例CR，7例降期为N(-)；14例患者接受了手术切除。中位生存期为17个月（95%CI，13 - 21个月），1年和2年的精算生存率分别为61%和29%。
吉西他滨联合顺铂是Ⅲ期NSCLC一种非常有效的且耐受性良好的诱导方案。有必要与其他标准方案进行对比研究。
