IFCT-0002：早期非小细胞肺癌的新辅助-围术期化疗

IFCT-0002研究-----新辅助或新辅助+辅助未获生存差异
528例患者分为4组: 术前4个周期GP方案化疗;2个周期GP方案化疗后手术,随后给予2个周期GP方案;术前4个周期TC方案; 2个周期TC方案化疗后手术,随后给予2个周期TC方案
结果: 研究旨在比较术前新辅助化疗(PRE)和新辅助\辅助联合(PREI)两组的疗效; 结果显示: PRE 和PREI3年生存率67.8% vs 68.6(p=0.96), 无显著差异.GP方案和TC方案的RR和生存无显著差异(p=0.54, p=0.84)




A randomised trial comparing preoperative to perioperative chemotherapy in early-stage non-small-cell lung cancer (IFCT 0002 trial)
Virginie Westeel 1, Elisabeth Quoix, Marc Puyraveau, A Lavolé, Denis Braun, Silvy Laporte, Laurence Bigay-Game, Jean-Louis Pujol, Gervais Ozenne, Alain Rivière, Jean-Yves Douillard, Bernard Lebeau, Didier Debieuvre, Michel Poudenx, Philippe David, Olivier Molinier, Gérard Zalcman, Etienne Lemarié, Franck Morin, Alain Depierre, Bernard Milleron; Intergroupe Francophone de Cancérologie Thoracique

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.

Trial registration: ClinicalTrials.gov NCT00198354.

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Westeel V, Quoix E, Puyraveau M, Lavolé A, Braun D, Laporte S, Bigay-Game L, Pujol JL, Ozenne G, Rivière A, Douillard JY, Lebeau B, Debieuvre D, Poudenx M, David P, Molinier O, Zalcman G, Lemarié E, Morin F, Depierre A, Milleron B; Intergroupe Francophone de Cancérologie Thoracique. A randomised trial comparing preoperative to perioperative chemotherapy in early-stage non-small-cell lung cancer (IFCT 0002 trial). Eur J Cancer. 2013 Aug;49(12):2654-64. doi: 10.1016/j.ejca.2013.04.013. Epub 2013 Jun 1. PMID: 23735703.

• A randomised trial comparing preoperative to perioperative chemotherapy in early-stage non-small-cell lung cancer (IFCT 0002 trial) - PubMed (nih.gov)
  

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