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P.A. Zucali



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    MINI 38 - Biology and Prognosis (ID 167)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
    • Presentations: 1
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      MINI38.13 - Survival Outcomes in Malignant Pleural Mesothelioma Patients Fit for Surgery According to Type of Procedure and Completeness of Resection (ID 2786)

      18:30 - 20:00  |  Author(s): P.A. Zucali

      • Abstract
      • Presentation
      • Slides

      Background:
      The value of surgical treatment for malignant pleural mesothelioma is still an open question. We analysed a surgical series of MPM patients undergoing surgery for MPM in a single institution

      Methods:
      A retrospective analysis was carried out of all surgical patients treated in our Department from 2000 to February 2015. Selection criteria were age<75, performance status 0-1, non-sarcomatoid histology, pretreatment stage I-III, and fit for major surgery. The procedure of choice was extrapleural pneumonectomy (EPP) until 2010 and radical pleurectomy/decortication (PD) thereafter. Patients that were found to be unresectable underwent palliative pleurectomy. The IMIG system was used for pathological staging, complications were scored based on WHO-derived criteria and the Charlson Co-morbidity Index was used to stratify patients.

      Results:
      Radical surgery was attempted in 163 patients: 91 received EPP, 47 underwent PD (1 with macroscopic residual disease) and 25 a palliative pleurectomy. Their main features and survival outcomes are summarized in table 1. Mean age and Charlson score were higher in PD than in EPP patients. A mixed histology was more prevalent in those who received palliative pleurectomy. Complications were equally frequent after EPP and PD but less frequent after palliative surgery. However, EPP patients had a high frequency of early- and late-occurring (30-600+ days postop) pleural sepsis (p=0.002) that had an unfavorable effect on OS (p=0.035). Induction chemotherapy was associated with better outcomes in PD but not in EPP. At multivariate analysis, epithelial histology (p=0.0419, grade 3+ complications (p=0.001) and Charlson index (p=0.001) were associated with better overall survival (OS). PD was associated with better OS compared with palliative pleurectomy (p=0.05), while EPP was not. Figure 1

      EP (%) P/D (%) R2 (%)
      91 47 25
      Mean Age (95% CI) 60 (58 - 61) 65 (62 - 67) 63 (60 - 66)
      Males 66 (72) 31 (66) 22 (88)
      Trimodal** 28 (30.77) 33 (70.21) 6 (24.00)
      Epithelioid 81 (89.01) 46 (97.87) 20 (80.00)
      p-Stage 0-II 18 (19.8) 18 (38.3) -
      p-Stage III 68 (74.73) 20 (42.55) 2 (8.00)
      p-Stage IV 5 (5.49) 9 (19.15) 21 (92.00)
      Grade 3+ Complications 25 (25.47) 12 (25.53) 2 (8.00)
      30-Day Mortality 3 (3.30) 1 (2.13) -
      Median OS (IQI) 19.0 (9.3 - 35.6) 29.9 (13.7 - 35.2) 13.3 (4.7 - 31.6)
      Median DFS (IQI) 11.5 (7.1 - 21.8) 12.1 (6.4 - 19.2) -
      Title table: Patients' features and survival outcomes in surgical MPM patients * Surgery + either chemo or RT, **induction + Surgery + Postoperative radiotherapy, IQI= Interquartile Interval



      Conclusion:
      EPP does not offer a significant benefit while PD may offer an advantage over palliative pleurectomy. The Charlson index is a major independent prognosticator in patients undergoing surgery for MPM.

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    P2.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 225)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
    • Presentations: 1
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      P2.08-005 - Vinorelbine as Second or Third-Line Therapy in Pemetrexed-Pretreated Malignant Pleural Mesothelioma (MPM) Patients (ID 2403)

      09:30 - 17:00  |  Author(s): P.A. Zucali

      • Abstract

      Background:
      There is no standard treatment for patients (pts) with MPM progressing during or after pemetrexed/platinum-based chemotherapy (PBC). Single agent chemotherapy is often administered in everyday practice, although its use is poorly supported by clinical trials. The aim of this retrospective study (NCI01865045) was to analyze the efficacy and toxicity of second (2nd) and third (3rd) line vinorelbine (VNR) in a large cohort of PBC-pretreated MPM patients.

      Methods:
      The clinical records of MPM pts consecutively treated in 8 Italian Centers with intravenous (iv) or oral (po) VNR as 2nd or 3rd line treatment following PBC were reviewed. Radiological response was assessed by modified RECIST criteria. Toxicity was reported according to CTCAEv4 criteria. Relative dose-intensity (DI) of VNR was calculated. Progression-free survival (PFS) and overall survival (OS) were estimated and correlated to clinical variables: age, gender, histological subtype, ECOG performance status (PS), line of VNR therapy (2nd vs 3rd) and outcome of first-line treatment.

      Results:
      From August 2001 to September 2014, 161 pts (M/F 120/41) were treated, 128 with iv and 33 with po VNR. Most of the cases included (92%) were treated after 2007. Histological subtype was epithelioid in 134, biphasic in 15, sarcomatoid in 8 and unspecified in 4 pts. Median age was 67 years (range 41-82). VNR was administered as 2nd or 3rd line treatment in 94 and 67 pts, respectively. Median number of VNR cycles was 3 (range 1-26), median relative DI was 88%. Main grade 3-4 toxicities were neutropenia in 9%, fatigue in 4% and constipation in 5% of pts. No toxic death occurred. A partial response was observed in 10 pts (6%), stable disease in 57 (35%), for an overall disease control rate of 41%. Median PFS and OS were 2.5 and 6.7 months, respectively. In multivariate analysis, only ECOG PS (0 vs 1-2) was significantly associated with improved PFS and OS. An analysis of molecular predictors of VNR response is ongoing.

      Conclusion:
      In this large retrospective patient cohort, 2nd and 3rd line VNR had modest but definite activity in PBC-pretreated MPM patients, with an excellent toxicity profile. Although inclusion in prospective clinical trials of new agents should be always considered in this setting, single agent VNR remains a reasonable option for palliation.