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G.B. Ratto



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    O22 - Mesothelioma III (ID 122)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
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      O22.07 - Does surgery improve survival of patients with malignant pleural mesothelioma? A multicenter retrospective analysis of 1365 consecutive patients. (ID 2962)

      16:15 - 17:45  |  Author(s): G.B. Ratto

      • Abstract
      • Presentation
      • Slides

      Background
      Medical management of malignant pleural mesothelioma (MPM) has obtained a moderate survival improvement over the years, while surgery with pleurectomy / decortication (P/D) or extrapleural pneumonectomy (EPP) can be an option for selected patients with resectable disease. The aim of this study was to investigate the impact of surgical treatment on the outcome of patients with MPM.

      Methods
      We retrospectively reviewed data from 1365 consecutive patients with histologically proven MPM, treated from 1982 to 2012 in six Institutions.Patients received either chemotherapy alone (n=172) or best supportive care (n=690) or surgical treatment (n=503), by either P/D (n=202) or EPP (n=301) with or without chemotherapy. All patients were followed up until death or for a minimum period of one year. The cox proportional hazards regression model was used to estimate relative improvements and to test the statistical hypothesis; a p-value less than 0.05 was considerd statistical significant.

      Results
      Figure 1 Figure1. Kaplan-Meier survival curves according to the treatment (non surgical treatment vs EPP vs P/D) considering only patients with independent good prognostic factors After a median follow-up of 6.7 years (range 1.1-14.8), 230 (16.8%) patients were alive; median survival for patients who received palliative treatment or chemotherapy alone, P/D and EPP groups were 11.7 (95%CI: 10.5-12.5) months, 20.5 (95%CI: 18.2-23.1) months, and 18.8 (95%CI: 17.2-20.9) months, respectively. Testing the hypothesis of equal survival distributions the statistical significance was reached for the P/D and EPP groups versus non surgical treatment group (p <0.001) but not for the EPP versus P/D groups (p=0.885). The 30 day mortality was 2.6% after P/D and 4.1% after EPP (p=0.401). According to multivariate analysis (n=1227) age < 70, epithelial histology and chemotherapy were independent favourable prognostic factors. In the subset of 312 (25.4%) patients with all favourable prognostic factors median survival was 15.5 months after medical therapy alone, 19.4 months after P/D, and 18.7 months after EPP (Figure 1). A risk reduction of 31% (95%CI: 14-45%) for the P/D group and of 23% (95%CI: 7-36%) for the EPP group was observed compared to the medical treatment group.

      Conclusion
      Our data suggest that patients with good prognostic factors had a similar survival whether they received medical therapy only, P/D or EPP. The modest benefit observed after surgery over medical treatment requires further investigation, and a large multicenter randomized trial, testing P/D after induction chemotherapy versus chemotherapy alone in MPM patients with good prognostic factors, is needed.

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    P3.12 - Poster Session 3 - NSCLC Early Stage (ID 206)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.12-024 - A multi-center phase II randomized study of customized neoadjuvant therapy vs. standard chemotherapy (CT) in non-small cell lung cancer (NSCLC) patients with resectable stage IIIA (N2) disease (CONTEST trial) (ID 3107)

      09:30 - 16:30  |  Author(s): G.B. Ratto

      • Abstract

      Background
      Stage IIIA NSCLC constitutes 30% of all NSCLCs. The most powerful prognostic factors identified in this stage are mediastinal lymph node clearance and a pathologic complete response (pCR). A pCR is obtained in 5-15% of patients (pts) with significant prolongation of survival. The identification of molecular biomarkers, such as excision repair cross-complementation 1 (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and thymidylate synthase (TS), may predict the response to CT. Similarly, EGFR mutations may predict the response to EGFR inhibitors.

      Methods
      CONTEST, a multicenter (19 Italian centers), randomized (2:1), 2-arm, phase II study, will recruit pts with resectable stage IIIA (N2) NSCLC. Pts will be randomized to receive before resection either standard CT with cisplatin (CDDP) 75 mg/m2 + docetaxel (Doc) 75 mg/m2 on day (d) 1 q 21 d for 3 cycles (cys) or customized therapy using predetermined values for ERCC1, RRM1, TS and EGFR mutations. Specimens will be sent to Response Genetics (Los Angeles, CA, USA) for the evaluation of ERCC1, RRM1 and TS using RT-PCR and EGFR using Sanger sequencing. The customized arms are as follows: -EGFR+: Gefitinib 250 mg/d for 8 weeks. -EGFR-/non-squamous (NS)/TS-/ERCC1-: CDDP 75 mg/m2 + pemetrexed 500 mg/m2 d 1 q 21 d for 3 cys. -EGFR-/squamous (S) or NS TS+/ERCC1-/RRM1+: CDDP 75 mg/m2 + Doc 75 mg/m2 d 1 q 21 d for 3 cys. -EGFR-/S or NS TS+/ERCC1-/RRM1-: CDDP 75 mg/m2 d 1+ gemcitabine (Gem) 1250 mg/m2 d 1, 8 q 21 d for 3 cys. -EGFR-/S or NS TS+/ERCC1+/RRM1+: Doc 75 mg/m2 d 1 + vinorelbine 20 mg/m2 d 1, 8 q 21 d for 3 cys. -EGFR-/S or NS TS+/ERCC1+/RRM1-: Doc 40 mg/m2 y 1, 8 + Gem 1200 mg/m2 d 1, 8 q 21 d for 3 cys. The primary end point is pCR, and all randomized pts will be compared by treatment arm. Because pCR is a surrogate endpoint and given the expected proportion of pCRs in the control group (pc= 5%), the minimal clinically worthwhile effect of this customized treatment is an increase to 20%. To detect such an effect at the 0.05 (1-sided) significance level with 80% power, a total of 168 pts (112 in the investigational arm and 56 in the standard arm) will be enrolled. The secondary endpoints are overall survival, disease-free survival, overall survival at 1, 2 and 5 years, overall response and safety. The major eligibility criteria are as follows: histologically confirmed NSCLC appropriate for surgery; ≥18 years old; ECOG performance status (PS) 0-1; sufficient tissue to perform marker analyses; medically fit for resection by lobectomy or pneumonectomy; stage IIIA (N2) patients with technically operable disease limited to T1a, b, T2a, b N2 M0; T3 (>7 cm) N2 M0 are eligible; stage IIIA pts limited to T3 N1 M0, T3 (invasion) N2 M0; T4 N0, N1 M0 are not eligible; NSCLC confirmed by mediastinoscopy; informed consent. This study is open for accrual; further details can be found at ClinicalTrials.gov (NCT01784549). Funded by the Italian Ministry of Health – RF 2009-1530324.

      Results
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      Conclusion
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