Virtual Library

 x 
My Library Virtual Library FAQ

Start Your Search

D. Roda



Author of

  • +

    P1.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 224)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
    • Presentations: 1
    • +

      P1.08-011 - Clinical Outcome and Prognostic Factors for Advanced Malignant Mesothelioma (MM) Patients (pts) Treated on Phase I Trials (ID 2595)

      09:30 - 09:30  |  Author(s): D. Roda

      • Abstract
      • Slides

      Background:
      Relapse after approved anticancer treatments is inevitable in MM pts. Novel agents in phase I trials may benefit such pts and the development of a prognostic score can help identify those who are likely to benefit most. We review the outcome of pts with relapsed MM who have participated in phase I trials in the drug development unit (DDU) of the Royal Marsden Hospital (RMH).

      Methods:
      The RMH prognostic score (RPS) (albumin < 35 g/L, lactate dehydrogenase [LDH] > upper limit of normal [ULN], and > 2 sites of metastases) is an objective tool used to select pts for phase I trials. In view of the pattern of disease spread in MM, we sought to define a MM-specific RPS (m-RPS), by assessing baseline patient factors. Data from consecutive patients who participated in 33 phase I trials between 09/2003 and 12/2014 were included in this analysis. The endpoints were time to progression (TTP) overall survival (OS) and safety. Kaplan-Meier analysis using a log rank test was used to determine survival outcomes.

      Results:
      Data from 54 pts, M:F (36:18), median age 62 years (range, 25-76) were studied. All pts had ECOG PS 0-1. TTP was 2.5 (95% CI 1.7-3) months, OS was 7.6 (95% CI 5.3-8.4) months and the clinical benefit rate was 15%; Three (6%) pts had RECIST confirmed partial response (to PI3K pathway inhibitors [n=2] and immunotherapy [n=1]); 5 (9%) pts had RECIST stable disease ³6 months. Male gender was highlighted as a factor of poor prognosis (p=0.004) in a multivariate analysis and therefore, we propose m-RPS for MM pts that now incorporates gender instead of the number of metastatic sites (Table). The good prognosis group [A] (m-RPS 0-1; n=23) had a median OS of 13.7 (95% CI 7.9-24) months and the poor prognosis group [B] (m-RPS 2-3; n=28) had a median OS of 4 (95% CI 2.8-7.5) months, p<0.001. 13 pts (24%) had an OS < 12 weeks: 3 (11%) pts from Group [A] and 10 (36%) pts from Group [B]. 39 (72%) pts experienced G1-G2 toxicities, ³G3 toxicities were seen in 8 (15%) pts and 7 (13%) pts discontinued trial due to toxicity.

      Variable Score
      LDH
      ≤Upper limit of normal (ULN) 0
      >ULN 1
      Albumin
      ³35g/L 0
      <35g/L 1
      Gender
      Female 0
      Male 1
      Table. modified RMH prognostic score (m-RPS)


      Conclusion:
      Experimental agents in the phase 1 setting appeared to be well tolerated with preliminary signals of benefit in selected advanced MM pts. The m-RPS should be prospectively validated as a screening tool for MM pts considered for phase I studies

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.