1508PD - Patient-reported outcomes (PROs) and impact of lactate dehydrogenase (LDH) levels on outcomes in a phase 3 trial (NGR015) with best investigator ch...

Date 10 October 2016
Event ESMO 2016 Congress
Session Non-metastatic NSCLC and other thoracic malignancies
Topics Mesothelioma
Presenter Vanesa Gregorc
Citation Annals of Oncology (2016) 27 (6): 522-525. 10.1093/annonc/mdw391
Authors V. Gregorc1, A. Bulotta1, M.G. Viganò1, G. Citterio1, G. Petrella1, E. Brioschi1, M. Ducceschi1, L. Gianni1, S. Colombi2, G. Rossoni2, G. Salini2, V. Savia2, A. Lambiase2, C. Bordignon2
  • 1Department Of Oncology, San Raffaele Scientific Institute, 20133 - Milano/IT
  • 2Clinical Development, MolMed, 20133 - Milan/IT

Abstract

Background

NGR-hTNF selectively binds to CD13-expressing blood vessels. CD13 is upregulated by tumor hypoxia/angiogenesis, which are associated with high LDH serum levels. Patients (pts) failing a 1st-line pemetrexed-based regimen were randomized in NGR015 trial to weekly NGR-hTNF (N; n = 200) or placebo (P; n = 200) both given with BIC, including gemcitabine, vinorelbine or doxorubicin (95% of pts) or supportive care (5%).

Methods

PROs were assessed with the MPM-LCSS questionnaire, based on a 100-mm visual analog scale (with 0 as best rating) for 5 major symptoms (appetite loss, fatigue, cough, dyspnea and pain) and 3 summary items (total distress, activity and quality of life [QoL]). PROs measures were time to symptomatic deterioration (TSD; ≥ 25% increase) and responder analysis (≥ 10% decrease). We explored also the predictivity of baseline LDH (median 274 U/L; IQR 196 to 388) for N benefit.

Results

At baseline, PROs completion rate (88% vs 92%) and scores (median 36 vs 36) were balanced between N and P arms, respectively. Scores inversely correlated with OS (p 

Conclusions

NGR-hTNF has improved OS in MPM pts rapidly progressing after front-line therapy, without altering QoL and with increasing effects noted with increasing LDH levels.

Clinical trial identification

NCT01098266

Legal entity responsible for the study

N/A

Funding

MolMed

Disclosure

S. Colombi, G. Rossoni, G. Salini, V. Savia, A. Lambiase, C. Bordignon: Employee of MolMed.

All other authors have declared no conflicts of interest.