OBJECTIVES SPECTRA is a multicenter, randomized phase II study of chemotherapy with cisplatin (CDDP) plus S-1 versus CDDP plus pemetrexed (PEM) in combination with thoracic radiotherapy (TRT) for locally advanced non-squamous non-small cell lung cancer, in order to determine which of these two regimens might be preferable for comparison with standard therapies in a future phase III study. MATERIALS AND METHODS Patients were randomly assigned to receive CDDP + S-1 (CDDP 60 mg/m2 on day 1 and S-1 80 mg/m2 on days 1-14, every 4 weeks, up to 4 cycles) or CDDP + PEM (CDDP 75 mg/m2 + PEM 500 mg/m2 on day 1, every 3 weeks, up to 4 cycles) combined with TRT (60 Gy in 30 fractions). The primary endpoint was the 2-year progression-free survival (PFS) rate. The sample size had been set at 100 patients. RESULTS A total of 102 patients were randomized to receive CDDP + S-1 or CDDP + PEM (CDDP + S-1, n = 52; CDDP + PEM, n = 50) between January 2013 and October 2016. The results in the CDDP + S1 group and CDDP + PEM group were as follows: completion rates of TRT (60 Gy)/chemotherapy (4 cycles) was 92 %/73 % and 98 %/86 %, respectively; the response rates were 60 % and 64 %, respectively; median PFS after a median follow-up of 32.1 months, 12.7/13.8 months (hazard ratio [HR] = 1.16; 95 % confidence interval [CI], 0.73-1.84); 2-year PFS rate, 36.5 % (95 % CI, 23.5-49.6)/32.1 % (95 %CI, 18.9-45.4); median OS, 48.3/59.1 months (HR = 1.05; 95 %CI, 0.58-1.90); 2-year OS rate, 69.2 % (95 %CI, 56.7-81.8)/66.4 % (95 %CI, 53.0-79.9); Grade 3 toxicities: febrile neutropenia (12 %/2 %), anorexia (8 %/16 %), diarrhea (8 %/0 %), esophagitis (6 %/8 %), and neutropenia (35 %/50 %); Grade 2 or worse radiation pneumonitis, 15 % (8 patients)/4 % (2 patients). CONCLUSION The 2-year PFS rate in the CDDP + S-1 arm was higher than that in the CDDP + PEM arm. Both treatments were safe, with manageable toxicities.

中文翻译：

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顺铂+ S-1与顺铂+培美曲塞联合化疗治疗局部晚期非鳞状非小细胞肺癌的随机II期研究：SPECTRA研究。

目的SPECTRA是一项多中心随机II期研究，用于在局部晚期非鳞状非小细胞肺癌中采用顺铂（CDDP）+ S-1与CDDP +培美曲塞（PEM）联合胸腔放疗（TRT）进行化疗。为了确定在未来的III期研究中将这两种方案中的哪一种与标准疗法进行比较可能更可取。材料和方法患者被随机分配接受CDDP + S-1（第1天为CDDP 60 mg / m2，第1-14天为S-1 80 mg / m2，每4​​周，最多4个周期）或CDDP + PEM （第1天的CDDP 75 mg / m2 + PEM 500 mg / m2，每3周，最多4个周期）与TRT（60 Gy分30次）结合。主要终点是2年无进展生存率（PFS）。样本量已设置为100名患者。结果2013年1月至2016年10月之间，共有102例患者被随机分配接受CDDP + S-1或CDDP + PEM（CDDP + S-1，n = 52； CDDP + PEM，n = 50）。 + S1组和CDDP + PEM组如下：TRT（60 Gy）/化疗（4个周期）的完成率分别为92％/ 73％和98％/ 86％；回应率分别为60％和64％；中位随访32.1个月，中位PFS为12.7 / 13.8个月（危险比[HR] = 1.16； 95％可信区间[CI]，0.73-1.84）；2年PFS率，36.5％（95％CI，23.5-49.6）/32.1％（95％CI，18.9-45.4）; 中位操作系统，48.3 / 59.1个月（HR = 1.05; 95％CI，0.58-1.90）; 2年OS率：69.2％（95％CI，56.7-81.8）/66.4％（95％CI，53.0-79.9）; 3级毒性：发热性中性粒细胞减少症（12％/ 2％），厌食症（8％/ 16％），腹泻（8％/ 0％），食道炎（6％/ 8％），和中性粒细胞减少症（35％/ 50％）；2级或更严重的放射性肺炎，占15％（8位患者）/ 4％（2位患者）。结论CDDP + S-1组的2年PFS率高于CDDP + PEM组。两种治疗均安全，毒性可控。