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document
Gemcitabine combined with either pemetrexed or paclitaxel in the treatment of advanced non-small cell lung cancer : a randomized phase II SICOG trial . PURPOSE To estimate the safety , activity , and impact on quality of life of a combination of gemcitabine and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer ( NSCLC ) in the context of a randomized two-stage phase II study . PATIENTS AND METHODS Patients in stage IIIB or IV NSCLC were randomly allocated to receive either gemcitabine 1250 mg/m ( 2 ) on day 1 , and pemetrexed ( Alimta ) 500 mg/m ( 2 ) followed by gemcitabine 1250 mg/m ( 2 ) on day 8 of a 3-weekly cycle ( GA arm ) , or paclitaxel 120 mg/m ( 2 ) followed by gemcitabine 1000 mg/m ( 2 ) , both given on days 1 and 8 of a 3-weekly cycle ( PG arm ) . RESULTS 105 ( GA arm , 51 ; PG arm , 54 ) eligible patients ( stage IV , 32 and 30 , respectively ) were enrolled into this study ; thereafter , accrual was stopped due to first-stage analysis . The response rate was 20 % ( 95 % confidence interval [ CI ] , 10-33 % ) in the GA arm , and 32 % ( 95 % CI , 20-46 % ) in the PG arm . Median progression-free survival was 5.1 ( 95 % CI , 3.7-6.5 ) months in the GA arm , and 8.3 ( 95 % CI , 5.9-10.7 ) months in the PG arm , while median overall survival was 10.5 ( 95 % CI 7.1-13.9 ) , and 13.3 ( 95 % CI 11.7-14.9 ) months , respectively . Severe neutropenia ( 36 % vs 22 % ) , and febrile neutropenia ( 14 % vs 7 % ) were more common with the GA regimen , while hair loss ( 52 % vs 16 % ) and any grade peripheral neuropathy ( 31 % vs 2 % ) occurred more frequently with PG regimen . Other severe side effects of GA regimen were diarrhoea ( 10 % ) , liver enzyme derangement ( 10 % ) , and fatigue ( 8 % ) . CONCLUSION The GA regimen was tolerated and moderately active in advanced or metastatic NSCLC . However , this combination did not yield any advantage in comparison with the PG regimen , and does not deserve further evaluation .
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Intervention_Pharmacological
Gemcitabine
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Intervention_Pharmacological
pemetrexed
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Intervention_Pharmacological
paclitaxel
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Intervention_Pharmacological
combination of gemcitabine
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Intervention_Pharmacological
pemetrexed
40807
Intervention_Pharmacological
gemcitabine
40808
Intervention_Pharmacological
pemetrexed
40809
Intervention_Pharmacological
gemcitabine
40810
Intervention_Pharmacological
paclitaxel
40811
Intervention_Pharmacological
gemcitabine
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Intervention_Pharmacological
PG
40813
Intervention_Pharmacological
PG regimen
40814
Intervention_Pharmacological
GA regimen
40815
Outcome_Other
safety ,
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Outcome_Physical
activity
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Outcome_Other
, and impact on quality of life
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Outcome_Physical
response rate
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Outcome_Mortality
Median progression-free survival
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Outcome_Mortality
median overall survival
40821
Outcome_Adverse-effects
Severe neutropenia
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Outcome_Adverse-effects
febrile neutropenia
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Outcome_Adverse-effects
hair loss
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Outcome_Adverse-effects
any grade peripheral neuropathy
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Outcome_Adverse-effects
severe side effects
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Outcome_Adverse-effects
diarrhoea
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Outcome_Adverse-effects
liver enzyme derangement
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Outcome_Adverse-effects
fatigue
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Participant_Condition
advanced non-small cell lung cancer
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Participant_Condition
advanced or metastatic non-small cell lung cancer ( NSCLC )
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Participant_Condition
NSCLC
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Participant_Sample-size
105
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Participant_Sample-size
51
40834
Participant_Sample-size
54
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Participant_Sample-size
32
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Participant_Sample-size
30