42682
document
First-line cisplatin with docetaxel or vinorelbine in patients with advanced non-small-cell lung cancer : a quality of life directed phase II randomized trial of Gruppo Oncologico Italia Meridionale . BACKGROUND Quality of life ( QoL ) has gained greater importance in the management of metastatic non-small-cell lung cancer due to the palliative nature of treatment . Docetaxel ( DCT ) and cisplatin ( CDDP ) doublet has been reported to be associated to a better QoL than the weekly vinorelbine ( VNR ) and CDDP regimen . Recently a newer more tolerated schedule of the VNR/CDDP regimen has been published and is widely employed in medical practice . The impact of these regimens on patients ' QoL as well as symptoms control and type and grading chemo-related side-effects has been compared prospectically . METHODS Patients received CDDP 75 mg/m ( 2 ) plus DCT 75 mg/m ( 2 ) on day 1 every weeks ( arm A ) or CDDP 80 mg/m ( 2 ) on day 1 plus VNR 30 mg/m ( 2 ) day 1 and 8 every 3 weeks ( arm B ) . G-CSF and/or EPO were employed as needed . Health-related QoL was assessed at entry and after every cycle by the EORTC-QLQ-C30 and LC13 questionnaires , toxicity by the NCI-NCCN CTC vs 2 , and intent-to-treat objective response by the Recist criteria . RESULTS The QoL questionnaires were completed by 37 pts ( 88 % ) in the DCT/CDDP arm and 39 pts ( 87 % ) in the VNR/CDDP one . Baseline mean scores and rates at which pts failed to complete QoL assessment were similar in the two arms . Global health status of the EORTC QLQ-C30 scale and specific symptoms control ( LC13 module ) improved during treatment without any statistically significant difference between the two arms . Emotional functioning remained stable in both groups during treatment , whereas physical and role improved slightly . In the DCT/CDDP arm 14 pts ( 33 % ; 95 % CL 24-40 % ) had PR , and 10 ( 24 % ) SD for a 57 % TGCR . In the VNR/CDDP arm 12 pts ( 27 % ) achieved PR , 18 ( 41 % ) SD a 68 % TGCR . Differences were not statistically significant . Median time-to-progression was 4.2 months in the DCT/CDDP arm and 4.5 months in the VNR/CDDP one , and median overall survival was 12.1 ( range 1-26+ months ) and 12.5 months ( range 1-28+ months ) for DCT/CDDP and VNR/CDDP arms , respectively . Febrile neutropenia rate was higher in the VNR/CDDP arm ( p=0.02 ) as well as G3-4 anemia ( p=0.005 ) and G-CSF/EPO use ( p=0.019 ) . CONCLUSIONS Global and specific health-related QoL data similar in both treatment groups with no statistically significant difference . Efficacy measures , overall response rate , time-to-progression and overall survival were equivalent in both arms . However , severe anemia and febrile neutropenia are statistically more frequent in the VNR/CDDP arm than in the DCT/CDDP one . These data should be considered in treatment decision-making for pts with advanced non-small-cell lung cancer and for the design of future trials with chemotherapy plus biologics .
42683
Intervention_Pharmacological
First-line cisplatin with docetaxel
42684
Intervention_Pharmacological
vinorelbine
42685
Intervention_Pharmacological
Docetaxel ( DCT )
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Intervention_Pharmacological
cisplatin ( CDDP ) doublet
42687
Intervention_Pharmacological
vinorelbine ( VNR )
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Intervention_Pharmacological
CDDP
42689
Intervention_Physical
VNR/CDDP
42690
Intervention_Pharmacological
CDDP 75 mg/m ( 2 ) plus DCT 75 mg/m ( 2 )
42691
Intervention_Pharmacological
CDDP 80 mg/m ( 2 ) on day 1 plus VNR 30 mg/m ( 2 )
42692
Intervention_Pharmacological
G-CSF
42693
Intervention_Pharmacological
EPO
42694
Intervention_Pharmacological
DCT/CDDP
42695
Intervention_Pharmacological
VNR/CDDP
42696
Intervention_Pharmacological
DCT/CDDP
42697
Intervention_Pharmacological
VNR/CDDP
42698
Intervention_Pharmacological
DCT/CDDP
42699
Intervention_Pharmacological
VNR/CDDP
42700
Intervention_Pharmacological
DCT/CDDP
42701
Intervention_Pharmacological
VNR/CDDP
42702
Intervention_Pharmacological
VNR/CDDP
42703
Intervention_Pharmacological
DCT/CDDP
42704
Outcome_Mental
Quality of life ( QoL )
42705
Outcome_Physical
symptoms control
42706
Outcome_Mental
Health-related QoL
42707
Outcome_Mental
LC13 questionnaires
42708
Outcome_Physical
toxicity
42709
Outcome_Physical
objective response
42710
Outcome_Physical
QoL questionnaires
42711
Outcome_Mental
Global health status
42712
Outcome_Physical
EORTC QLQ-C30 scale
42713
Outcome_Mental
Emotional functioning
42714
Outcome_Mental
physical
42715
Outcome_Mental
role
42716
Outcome_Physical
PR
42717
Outcome_Physical
Median time-to-progression
42718
Outcome_Mortality
overall survival
42719
Outcome_Physical
Febrile neutropenia rate
42720
Outcome_Physical
anemia
42721
Outcome_Physical
Global and specific health-related QoL
42722
Outcome_Other
Efficacy measures
42723
Outcome_Physical
response rate
42724
Outcome_Physical
time-to-progression
42725
Outcome_Mortality
overall survival
42726
Outcome_Physical
severe anemia
42727
Outcome_Physical
febrile neutropenia