Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer
Urba, Susan; van Herpen, Carla M. L.; Sahoo, Tarini Prasad; Shin, Dong M.; Licitra, Lisa; Mezei, Klara; Reuter, Christoph; Hitt, Ricardo; Russo, Francesca; Chang, Shao‐chun; Hossain, Anwar M.; Frimodt‐moller, Bente; Koustenis, Andrew; Hong, Ruey‐long
2012-10-01
Citation
Urba, Susan; van Herpen, Carla M. L.; Sahoo, Tarini Prasad; Shin, Dong M.; Licitra, Lisa; Mezei, Klara; Reuter, Christoph; Hitt, Ricardo; Russo, Francesca; Chang, Shao‐chun ; Hossain, Anwar M.; Frimodt‐moller, Bente ; Koustenis, Andrew; Hong, Ruey‐long (2012). "Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer ." Cancer 118(19): 4694-4705. <http://hdl.handle.net/2027.42/93741>
Abstract
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/m 2 ) plus cisplatin (75 mg/m 2 ; n = 398) or placebo plus cisplatin (75 mg/m 2 ; 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. In a double‐blind, placebo‐controlled, phase 3 trial, patients with recurrent or metastatic squamous cell carcinoma of the head and neck are randomized to pemetrexed plus cisplatin or placebo plus cisplatin to assess overall survival and secondary endpoints. Pemetrexed‐cisplatin does not significantly improve survival for the intention‐to‐treat population. However, in a preplanned subgroup analysis, pemetrexed‐cisplatin leads to longer overall survival and progression‐free survival for patients with performance status 0 or 1 and patients with oropharyngeal cancers.Publisher
Wiley Subscription Services, Inc., A Wiley Company
ISSN
0008-543X 1097-0142
Other DOIs
PMID
22434360
Types
Article
Metadata
Show full item recordCollections
Remediation of Harmful Language
The University of Michigan Library aims to describe library materials in a way that respects the people and communities who create, use, and are represented in our collections. Report harmful or offensive language in catalog records, finding aids, or elsewhere in our collections anonymously through our metadata feedback form. More information at Remediation of Harmful Language.
Accessibility
If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.