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Clinical Trial
. 2006 Apr 24;94(8):1099-106.
doi: 10.1038/sj.bjc.6603075.

Prognostic factors affecting long-term outcomes in patients with resected stage IIIA pN2 non-small-cell lung cancer: 5-year follow-up of a phase II study

Affiliations
Clinical Trial

Prognostic factors affecting long-term outcomes in patients with resected stage IIIA pN2 non-small-cell lung cancer: 5-year follow-up of a phase II study

D C Betticher et al. Br J Cancer. .

Abstract

The aim was to investigate the efficacy of neoadjuvant docetaxel-cisplatin and identify prognostic factors for outcome in locally advanced stage IIIA (pN2 by mediastinoscopy) non-small-cell lung cancer (NSCLC) patients. In all, 75 patients (from 90 enrolled) underwent tumour resection after three 3-week cycles of docetaxel 85 mg m-2 (day 1) plus cisplatin 40 or 50 mg m-2 (days 1 and 2). Therapy was well tolerated (overall grade 3 toxicity occurred in 48% patients; no grade 4 nonhaematological toxicity was reported), with no observed late toxicities. Median overall survival (OS) and event-free survival (EFS) times were 35 and 15 months, respectively, in the 75 patients who underwent surgery; corresponding figures for all 90 patients enrolled were 28 and 12 months. At 3 years after initiating trial therapy, 27 out of 75 patients (36%) were alive and tumour free. At 5-year follow-up, 60 and 65% of patients had local relapse and distant metastases, respectively. The most common sites of distant metastases were the lung (24%) and brain (17%). Factors associated with OS, EFS and risk of local relapse and distant metastases were complete tumour resection and chemotherapy activity (clinical response, pathologic response, mediastinal downstaging). Neoadjuvant docetaxel-cisplatin was effective and tolerable in stage IIIA pN2 NSCLC, with chemotherapy contributing significantly to outcomes.

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Figures

Figure 1
Figure 1
Overall survival (patients who underwent surgery, n=75).
Figure 2
Figure 2
Risk of (A) distant metastases stratified by pathological response (percentage of tumour necrosis and fibrosis), (B) distant metastases stratified by mediastinal downstaging (N0/1 vs N2), (C) local relapse stratified by pathological response and (D) local relapse stratified by mediastinal downstaging. The risk of developing distant metastases decreased rapidly after 24 months in patients where chemotherapy was active. Conversely, local relapses occurred throughout the entire observation period.

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