Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer
dc.contributor.author | Urba, Susan | en_US |
dc.contributor.author | van Herpen, Carla M. L. | en_US |
dc.contributor.author | Sahoo, Tarini Prasad | en_US |
dc.contributor.author | Shin, Dong M. | en_US |
dc.contributor.author | Licitra, Lisa | en_US |
dc.contributor.author | Mezei, Klara | en_US |
dc.contributor.author | Reuter, Christoph | en_US |
dc.contributor.author | Hitt, Ricardo | en_US |
dc.contributor.author | Russo, Francesca | en_US |
dc.contributor.author | Chang, Shao‐chun | en_US |
dc.contributor.author | Hossain, Anwar M. | en_US |
dc.contributor.author | Frimodt‐moller, Bente | en_US |
dc.contributor.author | Koustenis, Andrew | en_US |
dc.contributor.author | Hong, Ruey‐long | en_US |
dc.date.accessioned | 2012-10-02T17:20:23Z | |
dc.date.available | 2013-11-04T19:53:16Z | en_US |
dc.date.issued | 2012-10-01 | en_US |
dc.identifier.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> | en_US |
dc.identifier.issn | 0008-543X | en_US |
dc.identifier.issn | 1097-0142 | en_US |
dc.identifier.uri | https://hdl.handle.net/2027.42/93741 | |
dc.description.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. | en_US |
dc.publisher | Wiley Subscription Services, Inc., A Wiley Company | en_US |
dc.subject.other | Pemetrexed | en_US |
dc.subject.other | Phase 3 | en_US |
dc.subject.other | Clinical Trial | en_US |
dc.subject.other | Head and Neck Cancer | en_US |
dc.subject.other | Cisplatin | en_US |
dc.title | Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer | en_US |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | en_US |
dc.subject.hlbsecondlevel | Public Health | en_US |
dc.subject.hlbsecondlevel | Oncology and Hematology | en_US |
dc.subject.hlbtoplevel | Health Sciences | en_US |
dc.description.peerreviewed | Peer Reviewed | en_US |
dc.contributor.affiliationum | Division of Hematology/Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan | en_US |
dc.contributor.affiliationum | University of Michigan Comprehensive Cancer Center, Division of Hematology/Oncology, 1500 E. Medical Center Drive, C347 MIB, SPC 5848, Ann Arbor, MI 48109 | en_US |
dc.contributor.affiliationother | Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan | en_US |
dc.contributor.affiliationother | Department of Medical Oncology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands | en_US |
dc.contributor.affiliationother | Jawaharlal Nehru Cancer Hospital & Research Centre, Bhopal, India | en_US |
dc.contributor.affiliationother | Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia | en_US |
dc.contributor.affiliationother | Head and Neck Medical Oncology Unit, National Tumor Institute, Milan, Italy | en_US |
dc.contributor.affiliationother | Onkoradiologiai Osztaly Szent Istvan, Nyiregyhaza, Hungary | en_US |
dc.contributor.affiliationother | Department of Hematology, Hannover Medical School, Hemostasis, Oncology and Stem Cell Transplantation, Hannover, Germany | en_US |
dc.contributor.affiliationother | Medical Oncology Service, University Hospital 12th of October, Madrid, Spain | en_US |
dc.contributor.affiliationother | Eli Lilly and Company, Florence, Italy | en_US |
dc.contributor.affiliationother | Eli Lilly and Company, Indianapolis, Indiana | en_US |
dc.contributor.affiliationother | Eli Lilly and Company, Copenhagen, Denmark | en_US |
dc.identifier.pmid | 22434360 | en_US |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/93741/1/27449_ftp.pdf | |
dc.identifier.doi | 10.1002/cncr.27449 | en_US |
dc.identifier.source | Cancer | en_US |
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dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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