近日,Cancer雜志上的一篇報道指出,,對于復(fù)發(fā)或轉(zhuǎn)移性頭頸部腫瘤,,添加培美曲塞到順鉑治療中,不提高總體生存率(OS),。然而,,作者提到,在預(yù)設(shè)的亞組分析中,,對于體能狀態(tài)良好(得分0或1)或口咽癌的患者,,培美曲塞-順鉑方案可以改善OS和PFS。
Susan Urba博士指出,,復(fù)發(fā)或轉(zhuǎn)移性頭頸部鱗狀細胞癌的生存期短,,順鉑被認為是標準治療,之前的試點研究表明添加培美曲塞可能有益,。
本次隨機雙盲試驗調(diào)查了近800名不能手術(shù)的復(fù)發(fā)或轉(zhuǎn)移性頭頸部鱗狀細胞癌患者的結(jié)局,,他們隨機分配接受順鉑聯(lián)合培美曲塞或安慰劑治療。
培美曲塞-順鉑組的中位總生存期為7.3個月,,安慰劑-順鉑組為6.3個月,,無統(tǒng)計學(xué)差異(P=0.082)。相應(yīng)的無進展生存期分別為3.6和2.8個月(P=0.166),。
然而,,在那些身體狀態(tài)良好的病人中,加或不加培美曲塞的總體生存期分別為8.4和6.7個月(P=0.026),,無進展生存期分別為4.0和3.0個月(P=0.044),。
同樣,對于口咽癌患者,,培美曲塞具有較好的療效,,培美曲塞-順鉑組的中位總生存期為9.9個月,安慰劑-順鉑組為6.1個月(P=0.002),,相應(yīng)的無進展生存期分別為4.0和3.4個月(P=0.047),。(生物谷Bioon.com)
doi:10.1002/cncr.27449
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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.