Langer Corey, Li Sigui, Schiller Joan, Tester William, Rapoport Bernardo L, Johnson David H
Thoracic Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
J Clin Oncol. 2007 Feb 1;25(4):418-23. doi: 10.1200/JCO.2005.04.9452.
Appropriate therapy for Eastern Cooperative Oncology Group (ECOG) performance status (PS) -2 patients with advanced non-small-cell lung cancer (NSCLC) remains challenging. PS-2 patients on ECOG 1594 had a median survival (MS) of only 4.1 months and 1-year overall survival (OS) of 19%. Three percent had grade 5 toxicity.
ECOG 1599, the first PS 2-specific, US cooperative group trial for treatment-naïve advanced NSCLC, randomly assigned patients to dose-attenuated carboplatin/paclitaxel (the least toxic regimen in ECOG 1594) or gemcitabine/cisplatin (which yielded an MS of 7.9 months in PS-2 patients). Patients received either carboplatin (area under the concentration-time curve, 6) and paclitaxel 200 mg/m2 every 3 weeks (CbP) or gemcitabine 1 g/m2 days 1 and 8 and cisplatin 60 mg/m2 day 1 every 3 weeks (CG).
One hundred three patients were enrolled; 100 proved eligible. Median age was 66 years; 46% had at least 5% weight loss; 88% had stage IV or recurrent disease. Median number of cycles administered was three per arm. CbP featured more grade 3 neutropathy (10% v 0%) and more grade > or = 3 neutropenia (59% v 33%), whereas CG yielded more grade 3 thrombocytopenia (33% v 14%), more grade 3 fatigue (22% v 14%), and more grade > or = 1 creatinine elevations (43% v 6%). One grade 5 toxicity, confined to the CbP arm, occurred. Response rate, time to progression, MS, and 1-year OS rates for CG and CbP, were 23%, 4.8 months, 6.9 months, and 25%, and 14%, 4.2 months, 6.2 months, and 19%, respectively.
Platinum-based combination chemotherapy for PS-2 patients with NSCLC is feasible with acceptable toxicity, but survival in these patients remains inferior to that of PS-0 to -1 patients.
对于东部肿瘤协作组（ECOG）体能状态（PS）为2的晚期非小细胞肺癌（NSCLC）患者，选择合适的治疗方案仍具有挑战性。ECOG 1594研究中PS-2的患者中位生存期（MS）仅为4.1个月，1年总生存率（OS）为19%。3%的患者出现5级毒性反应。
ECOG 1599是首个针对初治晚期NSCLC的PS 2特异性美国协作组试验，将患者随机分配至剂量递减的卡铂/紫杉醇组（ECOG 1594中毒性最小的方案）或吉西他滨/顺铂组（该方案在PS-2患者中的MS为7.9个月）。患者每3周接受一次卡铂（浓度-时间曲线下面积为6）和紫杉醇200mg/m²（CbP），或吉西他滨1g/m²第1天和第8天、顺铂60mg/m²第1天（CG）。
共入组103例患者；100例符合条件。中位年龄为66岁；46%的患者体重减轻至少5%；88%的患者为IV期或复发疾病。每组中位给药周期数为3个。CbP组3级中性粒细胞减少症更多（10%对0%），≥3级中性粒细胞减少更多（59%对33%），而CG组3级血小板减少症更多（33%对14%），3级疲劳更多（22%对14%），≥1级肌酐升高更多（43%对6%）。出现1例5级毒性反应，仅限于CbP组。CG组和CbP组的缓解率、疾病进展时间、MS和1年OS率分别为23%、4.8个月、6.9个月和25%，以及14%、4.2个月、6.2个月和19%。
对于PS-2的NSCLC患者，铂类联合化疗具有可行性且毒性可接受，但这些患者的生存率仍低于PS-0至-1的患者。
