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document
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 . 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 .
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Intervention_Pharmacological
Pemetrexed in combination with cisplatin versus cisplatin monotherapy
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
Platinum-based chemotherapy
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Intervention_Pharmacological
Pemetrexed
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Intervention_Pharmacological
pemetrexed-cisplatin
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Intervention_Pharmacological
pemetrexed
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Intervention_Pharmacological
plus cisplatin
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Intervention_Control
placebo plus cisplatin
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Intervention_Pharmacological
pemetrexed-cisplatin
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Intervention_Control
placebo-cisplatin
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Intervention_Pharmacological
( pemetrexed-cisplatin
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Intervention_Pharmacological
pemetrexed-cisplatin
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Intervention_Pharmacological
pemetrexed-cisplatin
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Intervention_Pharmacological
Pemetrexed-cisplatin
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Intervention_Pharmacological
Pemetrexed-cisplatin
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Intervention_Pharmacological
pemetrexed-cisplatin
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Outcome_Physical
overall survival ( OS )
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Outcome_Physical
Median OS
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Outcome_Physical
Median progression-free survival ( PFS , months )
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Outcome_Physical
longer OS
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Outcome_Other
and
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Outcome_Physical
PFS
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Outcome_Physical
OS
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Outcome_Physical
PFS
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Outcome_Physical
Pemetrexed-cisplatin toxicity
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Outcome_Mortality
survival
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Outcome_Physical
OS
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Outcome_Physical
PFS
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Participant_Condition
head and neck cancer
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Participant_Condition
squamous cell carcinoma
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Participant_Condition
SCCHN
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Participant_Condition
oropharyngeal cancers