Clinical Epidemiology and Ageing

Non-small cell lung cancer recurrence following surgery and perioperative chemotherapy: Comparison of two chemotherapy regimens (IFCT-0702: A randomized phase 3 final results study).

Moro-Sibilot D, Audigier-Valette C, Merle P, Quoix E, Souquet P-J, Barlesi F, Chouaid C, Molinier O, Bennouna J, Lavole A, Mazières J, Toffart A-C, Langlais A, Morin F, Zalcman G Lung Cancer. 2015;89(2):139-45.

<p><b>INTRODUCTION: </b>This study compared the efficacy of docetaxel alone vs. docetaxel plus cisplatin/carboplatin in resected NSCLC patients relapsing after preoperative, adjuvant, or perioperative platinum-based chemotherapy.</p><p><b>MATERIALS AND METHODS: </b>Patients were randomly assigned to receive docetaxel plus cisplatin/carboplatin (Arm A) or docetaxel alone (Arm B). Primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate at 6 weeks, toxicity, quality of life, and overall survival (OS).</p><p><b>RESULTS: </b>From November 2007 to August 2012, 88 patients were enrolled. Due to an unexpectedly slow accrual, the trial was prematurely stopped. Adding platinum to docetaxel caused a non-significant increase in PFS. Median PFS was 8.0 months (95% CI: 5.3-10.4) for Arm A vs. 5.6 months (95% CI: 4.0-7.3) for Arm B (HR: 0.71, 95% CI: 0.45-1.1, p=0.15). Median OS was 16.0 months (95% CI: 10.1-23.9) for Arm A vs. 12.4 months (95% CI: 8.2-19.6) for Arm B. In pre-planned subgroup analyses, a time to recurrence ≥12 months and non-squamous histology favorably influenced OS (HR: 0.51, 95% CI: 0.29-0.91, p=0.02 and HR: 0.54, 95% CI: 0.33-0.91, p=0.02, respectively). There were no unexpected adverse events, and Grade 3-4 toxicity was comparable in both groups.</p><p><b>CONCLUSIONS: </b>Our study failed to demonstrate significant PFS improvement with the docetaxel-platinum doublet compared to single-agent docetaxel. The 3.6-month improvement in OS with the cisplatin-based doublet proves, however, appealing and merits further investigation.</p>

MeSH terms: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Female; Follow-Up Studies; Humans; Lung Neoplasms; Male; Middle Aged; Neoplasm Recurrence, Local; Neoplasm Staging; Perioperative Period; Survival Analysis; Treatment Outcome
DOI: 10.1016/j.lungcan.2015.05.016