Patient-reported outcomes (PROs) and impact of lactate dehydrogenase (LDH) levels on outcomes in a phase 3 trial (NGR015) with best investigator choice (BIC) plus or minus NGR-hTNF in previously treated patients with malignant pleural mesothelioma (MPM)

Date

10 Oct 2016

Session

Non-metastatic NSCLC and other thoracic malignancies

Presenters

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

Author affiliations

  • 1 Department Of Oncology, San Raffaele Scientific Institute, 20133 - Milano/IT
  • 2 Clinical Development, MolMed, 20133 - Milan/IT
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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.

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