JCO:非小细胞肺癌(NSCLC)患者可加用卡铂
2013-06-03 青楚 医学论坛网
德国学者的一项研究显示,联合培美曲塞(P)贝伐单抗(B) 卡铂(C) 治疗非小细胞肺癌患者明显有效,平均总体生存率(OS)为15.2个月,且毒性反应可被老年患者接受,因此可以为适合PB治疗患者加用C。然而,对于ECOG PS评分为2的患者在给予C时要谨慎。 该研究在2009年9月到2012年1月期间,纳入德国27个中心参加临床三期试验的IIIb/IV期非小细
德国学者的一项研究显示,联合培美曲塞(P)贝伐单抗(B) 卡铂(C) 治疗非小细胞肺癌患者明显有效,平均总体生存率(OS)为15.2个月,且毒性反应可被老年患者接受,因此可以为适合PB治疗患者加用C。然而,对于ECOG PS评分为2的患者在给予C时要谨慎。
该研究在2009年9月到2012年1月期间,纳入德国27个中心参加临床三期试验的IIIb/IV期非小细胞肺癌(NSCLC)患者251例,随机分配使用P (500 mg/m2) 或1 B (7.5 mg/kg) ,或在维持B 或P1B治疗后4-6个周进行P1B1C (AUC5)治疗,每周三次。主要治疗终点时无进展生存率(PFS),次要治疗终点为包括整体生存率(OS)、1年生存率、总体缓解率(ORR) 以及耐受性(AEs/SAEs)。
结果显示,PB组和PBC组患者分别为118例和133例,平均年龄分别为71岁和72岁。平均PFS时间分别为4.8个月和6.8个月,平均OS分别为11.6个月和15.2个月,1年生存率分别为48.2% 和58.8%。
Phase II Study of Pemetrexed and Carboplatin Plus Bevacizumab With Maintenance Pemetrexed and Bevacizumab As First-Line Therapy for Nonsquamous Non–Small-Cell Lung Cancer
Purpose
This study evaluated the efficacy and safety of pemetrexed, carboplatin, and bevacizumab followed by maintenance pemetrexed and bevacizumab in patients with chemotherapy-naive
stage IIIB (effusion) or stage IV nonsquamous non–small-cell lung cancer (NSCLC).
Patients and Methods
Patients received pemetrexed 500 mg/m2 , carboplatin area under the concentration-time curve of 6, and bevacizumab 15 mg/kg every 3 weeks for six cycles. For patients with response or stable disease, pemetrexed and bevacizumab were continued until disease progression or unacceptable toxicity.
Results
Fifty patients were enrolled and received treatment. The median follow-up was 13.0 months, and the median number of treatment cycles was seven (range, one to 51). Thirty patients (60%) completed six treatment cycles, and nine (18%) completed 18 treatment cycles. Among the 49 patients assessable for response, the objective response rate was 55% (95% CI, 41% to 69%).Median progression-free and overall survival rates were 7.8 months (95% CI, 5.2 to 11.5 months) and 14.1 months (95% CI, 10.8 to 19.6 months), respectively. Grade 3/4 hematologic toxicity was modest—anemia (6%; 0), neutropenia (4%; 0), and thrombocytopenia (0; 8%). Grade 3/4 nonhematologic toxicities were proteinuria (2%; 0), venous thrombosis (4%; 2%), arterial thrombosis (2%; 0), fatigue (8%; 0), infection (8%; 2%), nephrotoxicity (2%; 0), and diverticulitis (6%; 2%). There were no grade 3 or greater hemorrhagic events or hypertension cases.
Conclusion
This regimen, involving a maintenance component, was associated with acceptable toxicity and relatively long survival in patients with advanced nonsquamous NSCLC. These results justify a phase III comparison against the standard-of-care in this patient population.
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#铂#
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#非小细胞#
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#JCO#
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#卡铂#
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