近日，Cancer杂志上的一篇报道指出，对于复发或转移性头颈部肿瘤，添加培美曲塞到顺铂治疗中，不提高总体生存率（OS）。然而，作者提到，在预设的亚组分析中，对于体能状态良好（得分0或1）或口咽癌的患者，培美曲塞-顺铂方案可以改善OS和PFS。
Susan Urba博士指出，复发或转移性头颈部鳞状细胞癌的生存期短，顺铂被认为是标准治疗，之前的试点研究表明添加培美曲塞可能有益。
本次随机双盲试验调查了近800名不能手术的复发或转移性头颈部鳞状细胞癌患者的结局，他们随机分配接受顺铂联合培美曲塞或安慰剂治疗。
培美曲塞-顺铂组的中位总生存期为7.3个月，安慰剂-顺铂组为6.3个月，无统计学差异（P=0.082）。相应的无进展生存期分别为3.6和2.8个月（P=0.166）。
然而，在那些身体状态良好的病人中，加或不加培美曲塞的总体生存期分别为8.4和6.7个月（P=0.026），无进展生存期分别为4.0和3.0个月（P=0.044）。
同样，对于口咽癌患者，培美曲塞具有较好的疗效，培美曲塞-顺铂组的中位总生存期为9.9个月，安慰剂-顺铂组为6.1个月（P=0.002），相应的无进展生存期分别为4.0和3.4个月（P=0.047）。（生物谷Bioon.com）
doi:10.1002/cncr.27449
PMC:
PMID:
Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer
Final results of a randomized, double-blind, placebo-controlled, phase 3 study
Susan Urba MD Carla M. L. van Herpen MD, PhD, Tarini Prasad Sahoo MD, Dong M. Shin MD, Lisa Licitra MD, Klara Mezei MD, Christoph Reuter MD, PhD, Ricardo Hitt MD, PhD, Francesca Russo MD, Shao-Chun Chang MD, PhD, Anwar M. Hossain MStat, Bente Frimodt-Moller MSc, Andrew Koustenis BPharm10, Ruey-Long Hong MD, PhD
BACKGROUND:
Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) is associated with poor survival. Platinum-based chemotherapy is often a first-line treatment. Pemetrexed has shown single-agent activity in SCCHN and in combination with cisplatin for other tumors. This trial examined the efficacy of pemetrexed-cisplatin for SCCHN.
METHODS:
In a double-blind phase 3 trial, patients with recurrent or metastatic SCCHN and no prior systemic therapy for metastatic disease were randomized to pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2; n = 398) or placebo plus cisplatin (75 mg/m2; n = 397) to assess overall survival (OS) and secondary endpoints.
RESULTS:
Median OS was 7.3 months in the pemetrexed-cisplatin arm and 6.3 months in the placebo-cisplatin arm (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.75-1.02; P = .082). Median progression-free survival (PFS, months) was similar in both treatment arms (pemetrexed-cisplatin, 3.6; placebo-cisplatin, 2.8; HR, 0.88; 95% CI, 0.76-1.03; P = .166). Among patients with performance status 0 or 1, pemetrexed-cisplatin (n = 347) led to longer OS and PFS than placebo-cisplatin (n = 343; 8.4 vs 6.7 months; HR, 0.83; P = .026; 4.0 vs 3.0 months; HR, 0.84; P = .044, respectively). Among patients with oropharyngeal cancers, pemetrexed-cisplatin (n = 86) resulted in longer OS and PFS than placebo-cisplatin (n = 106; 9.9 vs 6.1 months; HR, 0.59; P = .002; 4.0 vs 3.4 months; HR, 0.73; P = .047, respectively). Pemetrexed-cisplatin toxicity was consistent with studies in other tumors.
CONCLUSIONS:
Pemetrexed-cisplatin compared with placebo-cisplatin did not significantly improve survival for the intent-to-treat population. However, in a prespecified subgroup analysis, pemetrexed-cisplatin showed OS and PFS advantage for patients with performance status 0 or 1 or oropharyngeal cancers. Cancer 2012;. ? 2012 American Cancer Society.
