【进展】2008 ASCO肺癌研究进展
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A phase III randomized study comparing concomitant standard cisplatin (P) - etoposide (E) and chest irradiation to concomitant etoposide plus daily cisplatin and chest irradiation as induction therapy for limited (LD) small-cell lung cancer (SCLC).
局限期小细胞肺癌胸部放疗+EP方案化疗同胸部放疗+E+每日顺铂方案化疗之间比较的III期临床试验。
Abstract No: 7521
Citation: J Clin Oncol 26: 2008 (May 20 suppl; abstr 7521)
Author(s): T. Berghmans, P. Van Houtte, J. Lafitte, A. Efremidis, M. Florin, M. Paesmans, N. Leclercq, J. Sculier, European Lung Cancer Working Party
Abstract:
Background: Early concomitant chemoradiotherapy is a standard of care in LD SCLC. The primary endpoint addressed by the trial was to look to a survival benefit if cisplatin was administered daily during radiotherapy compared to a standard approach.
背景：局限期小细胞肺癌同步放化疗是标准治疗方案。此项研究终点目标是顺铂每天给药方案同标准放化疗方案间生存是否获益。
Methods: Patients with previously untreated pathologically proven LD SCLC, Karnofsky performance status > 60, adequate hematologic, hepatic, renal, lung and cardiac functions were eligible. After central randomization, patients received a first course of E (100 mg/m² D1-3) plus P given either at 90 mg/m² on D1 (arm A) or at 6 mg/m² (D1-5, D8-12, D15-19) (arm B) one hour prior to chest irradiation (15 fractions of 2.66 Gy). Afterwards, all patients received P (90 mg/m² D1) plus E (100 mg/m² D1-3) up to 6 cycles. We planned to randomize 232 patients to detect a 10% increase in 2-year survival rate in the experimental arm (α 5%, β 20%).
方法：病理证实为局限期小细胞肺癌患者初始治疗，KPS评分大于60分，足够血液学、肝脏、肾脏、肺、心功能储备。患者通过随机分为两组，arm A：E 100mg/m² d1-3 + DDP 90 mg/m² d1；arm B：E 100mg/m² d1-3 + DDP 6mg/m² D1-5, D8-12, D15-19，放疗（15次，2.66 Gy）前1小时输注顺铂。然后所有患者接受DDP 90 mg/m² d1+ E 100mg/m² d1-3 +给药方式至6个周期，我们希望232例病人两年生存率增加10%。
Results: From 1993 to 2006, 204 eligible patients were randomized (arm A 104, arm B 100), without any significant imbalance between both arms. Objective response rates were 84% (arm A) and 80% (arm B) (p = 0.59). Sixty-nine deaths occurred in each arm. Median, 2- and 5-years survivals were 15.5 m, 35%, 18% (arm A) and 17 m, 38%, 21% (arm B) (HR 0.89, 95% CI 0.65-1.22; p = 0.48). There was more leucopenia and nephrotoxicity during the first course in arm A and more thrombopenia and esophagitis in arm B.
结果：1993年至2006年，204例患者入组，arm A 104例, arm B 100例，两组比较均衡。客观反应率分别为84% (arm A)和80% (arm B) (p = 0.59) 。69例死亡出现在各自组内，中位生存期 2年及5年生存率分别为15.5月, 35%, 18% (arm A) 和17月, 38%, 21% (arm B) (HR 0.89, 95% CI 0.65-1.22; p = 0.48).第一周期arm A出现更多的白细胞减少和肾毒性，arm B出现较多的血小板减少和食道炎。
Conclusions: In both arms, patients with LD SCLC obtained good long-term survival with early concurrent chemoradiotherapy regardless the way cisplatin was administered during radiotherapy.
结论：两组均取得较长的生存率，不同顺铂给药方式对生存无明显影响
局限期小细胞肺癌胸部放疗+EP方案化疗同胸部放疗+E+每日顺铂方案化疗之间比较的III期临床试验。
Abstract No: 7521
Citation: J Clin Oncol 26: 2008 (May 20 suppl; abstr 7521)
Author(s): T. Berghmans, P. Van Houtte, J. Lafitte, A. Efremidis, M. Florin, M. Paesmans, N. Leclercq, J. Sculier, European Lung Cancer Working Party
Abstract:
Background: Early concomitant chemoradiotherapy is a standard of care in LD SCLC. The primary endpoint addressed by the trial was to look to a survival benefit if cisplatin was administered daily during radiotherapy compared to a standard approach.
背景：局限期小细胞肺癌同步放化疗是标准治疗方案。此项研究终点目标是顺铂每天给药方案同标准放化疗方案间生存是否获益。
Methods: Patients with previously untreated pathologically proven LD SCLC, Karnofsky performance status > 60, adequate hematologic, hepatic, renal, lung and cardiac functions were eligible. After central randomization, patients received a first course of E (100 mg/m² D1-3) plus P given either at 90 mg/m² on D1 (arm A) or at 6 mg/m² (D1-5, D8-12, D15-19) (arm B) one hour prior to chest irradiation (15 fractions of 2.66 Gy). Afterwards, all patients received P (90 mg/m² D1) plus E (100 mg/m² D1-3) up to 6 cycles. We planned to randomize 232 patients to detect a 10% increase in 2-year survival rate in the experimental arm (α 5%, β 20%).
方法：病理证实为局限期小细胞肺癌患者初始治疗，KPS评分大于60分，足够血液学、肝脏、肾脏、肺、心功能储备。患者通过随机分为两组，arm A：E 100mg/m² d1-3 + DDP 90 mg/m² d1；arm B：E 100mg/m² d1-3 + DDP 6mg/m² D1-5, D8-12, D15-19，放疗（15次，2.66 Gy）前1小时输注顺铂。然后所有患者接受DDP 90 mg/m² d1+ E 100mg/m² d1-3 +给药方式至6个周期，我们希望232例病人两年生存率增加10%。
Results: From 1993 to 2006, 204 eligible patients were randomized (arm A 104, arm B 100), without any significant imbalance between both arms. Objective response rates were 84% (arm A) and 80% (arm B) (p = 0.59). Sixty-nine deaths occurred in each arm. Median, 2- and 5-years survivals were 15.5 m, 35%, 18% (arm A) and 17 m, 38%, 21% (arm B) (HR 0.89, 95% CI 0.65-1.22; p = 0.48). There was more leucopenia and nephrotoxicity during the first course in arm A and more thrombopenia and esophagitis in arm B.
结果：1993年至2006年，204例患者入组，arm A 104例, arm B 100例，两组比较均衡。客观反应率分别为84% (arm A)和80% (arm B) (p = 0.59) 。69例死亡出现在各自组内，中位生存期 2年及5年生存率分别为15.5月, 35%, 18% (arm A) 和17月, 38%, 21% (arm B) (HR 0.89, 95% CI 0.65-1.22; p = 0.48).第一周期arm A出现更多的白细胞减少和肾毒性，arm B出现较多的血小板减少和食道炎。
Conclusions: In both arms, patients with LD SCLC obtained good long-term survival with early concurrent chemoradiotherapy regardless the way cisplatin was administered during radiotherapy.
结论：两组均取得较长的生存率，不同顺铂给药方式对生存无明显影响
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