Koranyi National Institute for TB and Pulmonology

Budapest, Hungary

Koranyi National Institute for TB and Pulmonology

Budapest, Hungary
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Giaccone G.,U.S. National Cancer Institute | Bazhenova L.A.,University of California at San Diego | Nemunaitis J.,Mary Crowley Cancer Research Centers | Tan M.,Georgetown University | And 15 more authors.
European Journal of Cancer | Year: 2015

Background Treatment options after first-line chemotherapy are limited in non-small cell lung cancer (NSCLC). Belagenpumatucel-L is a therapeutic vaccine comprised of 4 transforming growth factor (TGF)-β2-antisense gene-modified, irradiated, allogeneic NSCLC cell lines that may be useful for maintenance after initial treatment. Methods Stage III/IV NSCLC patients who did not progress after platinum-based chemotherapy were randomised 1:1 to receive maintenance belagenpumatucel-L or placebo. Patients were eligible for randomisation between one and four months from the end of induction chemotherapy. The primary endpoint was overall survival. Results This phase III trial enrolled 270 patients in the belagenpumatucel-L arm and 262 in the control arm. Belagenpumatucel-L was well tolerated with no serious safety concerns. There was no difference in survival between the arms (median survival 20.3 versus 17.8 months with belagenpumatucel-L versus placebo, respectively; hazard ratio (HR) 0.94, p = 0.594). There were also no differences in progression-free survival (4.3 months versus 4.0 for belagenpumatucel-L vs placebo, respectively; HR 0.99, p = 0.947). A prespecified Cox regression analysis demonstrated that the time elapsed between randomisation and the end of induction chemotherapy had a significant impact on survival (p = 0.002) and that prior radiation was a positive prognostic factor (median survival 28.4 months with belagenpumatucel-L versus 16.0 months with placebo; HR 0.61, p = 0.032). Conclusions Although the overall trial did not meet its survival endpoint, improved survival for belagenpumatucel-L is suggested in patients who were randomised within 12 weeks of completion of chemotherapy and in those who had received prior radiation. Further studies of belagenpumatucel-L in NSCLC are warranted. © 2015 Published by Elsevier Ltd.


PubMed | University of Washington, NovaRx Corporation, Netherlands Cancer Institute, Guys Hospital and 12 more.
Type: Clinical Trial, Phase III | Journal: European journal of cancer (Oxford, England : 1990) | Year: 2015

Treatment options after first-line chemotherapy are limited in non-small cell lung cancer (NSCLC). Belagenpumatucel-L is a therapeutic vaccine comprised of 4 transforming growth factor (TGF)-2-antisense gene-modified, irradiated, allogeneic NSCLC cell lines that may be useful for maintenance after initial treatment.Stage III/IV NSCLC patients who did not progress after platinum-based chemotherapy were randomised 1:1 to receive maintenance belagenpumatucel-L or placebo. Patients were eligible for randomisation between one and four months from the end of induction chemotherapy. The primary endpoint was overall survival.This phase III trial enrolled 270 patients in the belagenpumatucel-L arm and 262 in the control arm. Belagenpumatucel-L was well tolerated with no serious safety concerns. There was no difference in survival between the arms (median survival 20.3 versus 17.8months with belagenpumatucel-L versus placebo, respectively; hazard ratio (HR) 0.94, p=0.594). There were also no differences in progression-free survival (4.3months versus 4.0 for belagenpumatucel-L vs placebo, respectively; HR 0.99, p=0.947). A prespecified Cox regression analysis demonstrated that the time elapsed between randomisation and the end of induction chemotherapy had a significant impact on survival (p=0.002) and that prior radiation was a positive prognostic factor (median survival 28.4months with belagenpumatucel-L versus 16.0months with placebo; HR 0.61, p=0.032).Although the overall trial did not meet its survival endpoint, improved survival for belagenpumatucel-L is suggested in patients who were randomised within 12weeks of completion of chemotherapy and in those who had received prior radiation. Further studies of belagenpumatucel-L in NSCLC are warranted.


Juhasz E.,Koranyi National Institute for TB and Pulmonology | Kim J.-H.,Yonsei University | Klingelschmitt G.,Hoffmann-La Roche | Walzer S.,Hoffmann-La Roche
European Journal of Cancer | Year: 2013

Introduction: Maintenance therapy can delay progression and prolong survival in metastatic non-small-cell lung cancer (mNSCLC). As treatment for mNSCLC is non-curative, its impact on patient health-related quality of life (HRQoL) is an important consideration. SATURN (Sequential Tarceva in Unresectable NSCLC) was a randomised, double-blind, placebo-controlled, multicentre study investigating the impact of erlotinib maintenance therapy on HRQoL in patients with locally advanced or recurrent NSCLC. Patients and Methods: Eligible patients who had previously completed four cycles of platinum-based chemotherapy were randomised 1:1 to receive erlotinib 150 mg/day or placebo until disease progression, unacceptable toxicity or death. Patient HRQoL was assessed using the Functional Assessment of Cancer Therapy-Lung questionnaire, in terms of time to symptom progression (TSP), time to deterioration (TTD) in Trial Outcome Index (TOI) and TTD. Exploratory analysis was based on time to analgesia and appearance of key symptoms (pain, cough and dyspnoea). Results: Compared with placebo, erlotinib maintenance therapy prolonged progression-free and overall survival by 41% and 23%, respectively. At baseline, HRQoL measures were comparable between the two treatment groups. Maintenance therapy with erlotinib did not impact on deterioration in HRQoL: TSP (hazard ratio [HR] = 0.91 [95% confidence interval (CI) 0.74-1.12]; n = 785), TTD in TOI (HR = 1.06 [95% CI 0.87-1.31]; n = 781) and TTD in HRQoL (HR = 0.96 [95% CI 0.79-1.16]; n = 776). Time to pain and time to analgesic use were significantly delayed in patients receiving erlotinib compared with placebo (HR = 0.61 [95% CI 0.42-0.88]; p = 0.0080 and HR = 0.66 [95% CI 0.46-0.94]; p = 0.0199, respectively). A non-significant trend towards delayed time to cough and time to dyspnoea (HR = 0.77 [95% CI 0.49-1.21] and HR = 0.75 [95% CI 0.48-1.17], respectively) was also observed. Conclusions: Erlotinib maintenance therapy significantly extends progression-free survival without compromising patient HRQoL in comparison with placebo, with some improvement in symptoms. © 2012 Published by Elsevier Ltd.


PubMed | Clinical Pharmacokinetics and Pharmacodynamics, Abbvie Inc., Oncology, Koranyi National Institute for TB and Pulmonology and 10 more.
Type: | Journal: Clinical cancer research : an official journal of the American Association for Cancer Research | Year: 2016

PARP plays an important role in DNA repair. Veliparib, a PARP inhibitor, enhances the efficacy of platinum compounds, and has been safely combined with carboplatin and paclitaxel. The primary endpoint of this phase 2 trial determined whether addition of veliparib to carboplatin and paclitaxel improved PFS in previously untreated advanced/metastatic non-small cell lung cancer patients.Patients were randomized 2:1 to carboplatin and paclitaxel with either veliparib or placebo. Veliparib (120 mg) or placebo was given on days 1-7 of each 3-week cycle, with carboplatin (AUC=6 mg/mL/min) and paclitaxel (200 mg/m2) administered on day 3, for a maximum of 6 cycles.Overall, 158 were included (median age 63 years, male 68%, squamous histology 48%). Median PFS was 5.8 months in the veliparib group vs 4.2 months in the placebo group (HR 0.72 [95% CI 0.45-1.15, P=0.17]). Median OS was 11.7 months and 9.1 months in the veliparib and placebo groups, respectively (HR 0.80 [95% CI 0.54-1.18, P=0.27]). In patients with squamous histology, median PFS (HR 0.54 [95% CI 0.26-1.12, P=0.098]) and OS (HR 0.73 [95% CI 0.43-1.24, P=0.24]) favored veliparib treatment. ORR was similar between groups (veliparib: 32.4%; placebo: 32.1%), but duration of response favored veliparib treatment (HR 0.47 [95% CI 0.16-1.42, P=0.18]). Grade 3/4 neutropenia, thrombocytopenia, and anemia were comparable between groups.Veliparib combination with carboplatin and paclitaxel was well tolerated and demonstrated a favorable trend in PFS and OS vs chemotherapy alone. Patients with squamous histology had the best outcomes with veliparib combination.

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