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J. Mazieres



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    MO08 - NSCLC - Early Stage (ID 117)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO08.02 - Adjuvant pazopanib or placebo in resected stage I NSCLC patients: results of the NSCLC adjuvant randomized phase II trial (IFCT-0703) from the French collaborative Intergroup (ID 2274)

      16:15 - 17:45  |  Author(s): J. Mazieres

      • Abstract
      • Presentation
      • Slides

      Background
      Although UFT is approved in eastern countries, most guidelines do not recommend any adjuvant treatment in resected Stage I NSCLC. Pazopanib (P) is a potent, orally active multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, platelet derived growth factor (PDGFR) type-α and –β, approved in metastatic renal cell carcinoma and sarcoma. Neoadjuvant P demonstrated single-agent activity in patients with early stage NSCLC. We report the feasibility and tolerance of adjuvant P in stage I NSCLC.

      Methods
      In this double-blind randomized multicenter phase II/III trial, completely resected patients (pts) with stage I NSCLC (7[th] TNM edition) were randomized to receive either placebo or P 800 mg/d during 6 months. The Fleming’s two stage phase II primary endpoint was compliance (i.e. % of pts able to receive at least 3 months of P, whatever the dose). After 64 pts included (interim analysis), IDMC recommended to start with P 400 mg/d because of initial insufficient compliance. A one-step Fleming design was used with the new dose. Phase II design was not comparative.

      Results
      143 pts were randomized in 29 centers between March 2009 and August 2012, 71 and 72 in the placebo and P arms respectively. Most pts were male (61%) and smokers (91%), median age was 60. Pathological stage was IA in 111 pts (78%) and 16% were squamous cell carcinomas. Compliance for P800 was adequate in 38% (95% confidence interval [21-56]) vs. 87% [71-96] in placebo; for P400 in 69% [50-84] (p=0.01, compared to P800) vs. 93% [77-99] in placebo. Dose modifications were seen in 44% and 34% of P800 and P400 groups. The proportion of patient with at least one grade 3/4 toxicity was 53% [35-71] in P800 (13% [4-29] for placebo) and 38% [21-56] in P400 (27% [12-46] for placebo). No toxic deaths were observed. Only 2 pts has grade 4 toxicities in P800 (fatigue in P arm, GGT in the placebo arm). Most common toxicities G3 in P800 were diarrhea (9%), hypertension (9%), and increased transaminases (16% vs. 0% in P400); in P400 gastro-intestinal disorders (16%, 6% diarrhea) and hypertension (6%).

      Conclusion
      IFCT-0703 is the first feasibility study demonstrating that full dose of P is safe but not feasible in the adjuvant setting in NSCLC. Compliance and tolerance with reduced dose appeared acceptable for adjuvant settings.

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    P1.14 - Poster Session 1 - Mesothelioma (ID 194)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P1.14-008 - Clinical features and current management of malignant pleural mesothelioma in France. TheGFPC 0804 study. (ID 2378)

      09:30 - 16:30  |  Author(s): J. Mazieres

      • Abstract

      Background
      Malignant pleural mesothelioma (MPM) is a rare and aggressive primitive pleural tumour, which is associated with exposure to asbestos. Chemotherapy is the main part of therapy with new cytotoxic agents resulting in superior survival time. Recently the European Respiratory Society and the European Society of Thoracic Surgeons proposed practical and up-to-date guidelines on the management of MPM. The objective of this study was to assess the current management of MPM in France between January 2005 and December 2008.

      Methods
      Observational, multicentric, national, study. The medical records of patients with MPM diagnosed during the study period in the 37 participating centers were retrospectively reviewed. Epidemiological data, clinical data, diagnosis procedures and several components of management were recorded. Mains inclusion criteria’s were a new diagnosis of MPM, a histology diagnosis and a management in the center.

      Results
      Four hundred and six patients (males: 76%) were included; median age: 68.9± 9.8 years; > 75 years: 27.8%; Asbestos exposure was found out in 259(63.8%) patients (251 professional exposure, 8 environmental exposure). Histological diagnosis was: epithelial MPM: 82.9%, sarcomatoid MPM: 10%, biphasic MPM 7.1%. The main diagnosis procedure was thoracoscopy (296 (73.1%)). Thirty patients underwent surgery (25 radical surgery, 5 pleurectomy). Pleurodesis was performed 191 times. Prophylactic drain site radiotherapy was performed in 268. Three hundred and three patients (74.6%) received first-line combination chemotherapy (mean cycles: 4.7 ± 1.7, median 6); 162 (40.2%) received second line chemotherapy (mean cycles: 3.5 ± 1.9, median 3); 56 ( 13 %) received third line chemotherapy (3.1± 2, median 3). One and two year survival rates will be updated at the congress.

      Conclusion
      This study provides an assessment of diagnosis modes and therapeutic strategies for the management of MPM in France. Further analyses are needed to model the management strategies and assess the cost-effectiveness of this disease.

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    P3.14 - Poster Session 3 - Mesothelioma (ID 197)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P3.14-001 - Assessing the role of chemotherapy for solitary fibrous tumors of the pleura in a routine practice setting (ID 306)

      09:30 - 16:30  |  Author(s): J. Mazieres

      • Abstract

      Background
      Solitary Fibrous Tumors of the Pleura (SFTP) refer as to a heterogeneous group of mesenchymal malignancies with various anatomic and histologic features. Upfront surgical resection is the standard approach, but the outcome of patients is unpredictable. Recurrences may be aggressive and difficult to treat.The most widely accepted staging system has been proposed by De Perrot et al., and is based on the anatomy of the tumor implantation (sessile/pedunculated), and the presence of histologic signs of aggressiveness, including cellularity with crowding and overlapping of nuclei, cellular pleomorphism, high mitotic count, necrosis, or stromal/vascular invasion. Given the rarity of the tumor, limited evidence is available about the role and the modalities of perioperative and definite chemotherapy for SFTP.

      Methods
      Multicenter retrospective study of patients (pts) with histologically-proven SFTP with complete follow-up from surgical diagnostic to tumor recurrence and death.

      Results
      68 pts (28 males/40 females) were included. Median age at diagnosis was 62 year-old. Tumor stage according to the De Perrot system was 0/I for 29 pts, II for 23 pts, III for 7 pts, and IV for 4 pts. Adjuvant chemotherapy was given to 7 patients, mostly with stage III/IV SFTP, consisting of doxorubicin-based regimen. Recurrence rate and median time-to-progression (TTP) after surgery were 3%, 52%, 71%, and 75% (p<0.001), and 107, 70, 29, 11 months (p=0.006) for stage 0/I, II, III, and IV tumors, respectively. Besides tumor stage, predictors of shorter TTP were incomplete resection (p<0.001) and a higher number of histologic signs of malignancy (p=0.009). At time of tumor recurrence, 12 pts received chemotherapy. Highest disease control rates were observed with trabectedine (7/9 pts; Disease Control Rate (DCR): 78%; median TTP: 3,4 months), and gemcitabine-dacarbazine combination (2/3 pts, DCR: 66%; median TTP: 1,9 months). Median overall survival of the whole cohort was 56 months.

      Conclusion
      This study 1) confirms the prognostic value of the De Perrot staging system, 2) indicates a high recurrence rate in patients with stage II tumors, for which perioperative chemotherapy may be considered, and 3) suggests an interest for trabectedine in the setting of recurrent tumors. Besides clinical data, further molecular characterization, including recently identified specific gene fusions, may help to better predict the outcome of patients with SFTP.