59794
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A randomised trial comparing preoperative to perioperative chemotherapy in early-stage non-small-cell lung cancer ( IFCT 0002 trial ) . HYPOTHESIS There will be a detectable increase in overall survival ( OS ) using preoperative ( PRE ) as opposed to perioperative ( PERI ) chemotherapy in resectable StageI-II non-small-cell lung cancer ( NSCLC ) . METHODS This multicenter , open-label , randomised trial with a 2×2 factorial design first compared two chemotherapy strategies ( PRE versus PERI ) , then two chemotherapy regimens ( gemcitabine-cisplatin [ GP ] versus paclitaxel-carboplatin [ TC ] ) . The PRE group received two preoperative cycles followed by two additional preoperative cycles , while the PERI group underwent two preoperative cycles followed by two postoperative cycles , the 3rd and 4th cycles being given only to responders in both cases . RESULTS A total of 528 patients were randomised , 267 of which were assigned to the PRE group and 261 to the PERI group . Three-year OS did not differ between the two groups ( 67.4 % and 67.7 % , respectively ; hazard ratio ( HR ) =1.01 [ 0.79-1.30 ] , p=0.92 ) , nor did 3-year disease-free survival , response rates , toxicity , or postoperative mortality . Pathological complete response was observed in 22 ( 8.2 % ) and 16 patients ( 6.1 % ) , respectively . Although quality of life did not differ significantly , chemotherapy compliance was significantly higher in the PRE group . The proportion of responders who received Cycles 3 and 4 was significantly higher in the PRE group ( 90.4 % versus 75.2 % , p=0.001 ) . In responders , the dose intensity of Cycles 3 and 4 was higher in the PRE group than in the PERI group ( mean relative dose intensity of 90.4 % versus 82.6 % , respectively ; p=0.0007 ) . There was no difference between GP and TC in 3-year OS ( HR=0.97 [ 95 % confidence interval ( CI ) : 0.76-1.25 ] , p=0.80 ) or response rates . However , the regimens ' toxicity profiles differed . CONCLUSIONS This study failed to demonstrate any difference in survival between patients receiving preoperative and perioperative chemotherapy in early-stage NSCLC . The increase from two to four preoperative chemotherapy cycles did not increase the pathological response rate .
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Intervention_Pharmacological
preoperative to perioperative chemotherapy
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Intervention_Pharmacological
preoperative ( PRE ) as opposed to perioperative ( PERI ) chemotherapy
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Outcome_Mortality
overall survival ( OS )