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M.F. Vázquez
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MA06 - Locally Advanced NSCLC: Risk Groups, Biological Factors and Treatment Choices (ID 379)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:P. Van Houtte, M. Zemanová
- Coordinates: 12/05/2016, 16:00 - 17:30, Strauss 2
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MA06.09 - Efficacy RENO Study Results of Oral Vinorelbine or Etoposide with Cisplatin & Chemo-Radiation in Stage III NSCLC. SLCG 10/02 (ID 4238)
17:00 - 17:06 | Author(s): M.F. Vázquez
- Abstract
- Presentation
Background:
This study aims to compare efficacy and safety of two widely used combinations of cisplatin (P) in this setting: as etoposide (E) and vinorelbine. This last, in its oral formulation (oV) which has achieved comparable results as the IV formulation and patients (pts) prefer it.
Methods:
Pts between 18-75years, with histologically proven untreated and unresectable locally-advanced NSCLC (LA-NSCLC), adequate respiratory function, V20≤35% and ECOG-PS 0-1, were randomized 1:1 to oV-P arm: 2 induction cycles (cy) of oV-P followed by 2 cy more with RT; or to E-P arm: 2 cy of E-P concomitants to RT. Both arms with a total radiation dose of 66Gy administered 2 Gys daily. Primary endpoint was progression free survival (PFS) by RECIST 1.1. Secondary endpoints: overall response rate (ORR), overall survival (OS) and safety. With α-error of 0.05 (one-tailed test) and 0.1 β-error, median PFS unacceptable for the oV-P arm of 10 months (m) (p0) and a very acceptable of 15 m (p1), 122 eligible pts were required.
Results:
140 pts from 23 institutions of SLCG were randomized between 08/2011-12/2014. 134 pts were treated (66 in oV-P and 68 in E-P arms). Results based on this 134 pts are presented. Median age 62 years [39-76]; PS 0/1, 45%/55%; current smoker 51%; squamous cell 51%; stage IIIB 54%. 244 and 131 cy were given in the oV-P and E-P arms, respectively. All irradiated pts in oV-P arm received at least 60Gy, 7 pts in the E-P arm received less than 60Gy (4 due to toxicity). 1 pt (1.5%) in oV-P arm and 12 pts (17.6%) in E-P arm presented esophagitis G3/4 (p=0.002). 121 confirmed eligibility for efficacy analysis. ORR were 39 (64%) and 40 pts (67%) in the oV-P and E-P arms, respectively (p=0.889). After 16 m [1-43] of follow-up, 66% pts progressed and 43% pts died. Median PFS is 11.4 m (IC95%; 6-17) in oV-P arm and 11.8 m (IC95%; 7-16) in E-P arm (p=0.374).
Conclusion:
Both regimens achieve similar efficacy however oV-P has less toxicity, especially esophagitis G3/4. Further follow-up is needed for the survival analysis.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-098 - An Observational Study of the Efficacy and Safety of Nivolumab in Patients with Advanced NSCLC. A Galician Lung Cancer Group (ID 5581)
14:30 - 14:30 | Author(s): M.F. Vázquez
- Abstract
Background:
Nivolumab is an immune checkpoint inhibitor antibody and it has demonstrated durable responses and tolerability in pretreated patients with advanced NSCLC. This is an observational study to evaluate the efficacy and safety of nivolumab in previously treated patients with advanced NSCLC in the expanded access programme.
Methods:
Elegibility criteria included, histologically confirmed NSCLC clinical stage IIIB vs IV, evaluable disease, at least one prior therapy, performance status of 0/1 and an adequate organ function. Exclusion criteria included, positive test for hepatitis B, C or human immunodeficiency virus, severe autoinmune disease and patients with systemic corticosteroids or immunosuppressive medications. Patients received nivolumab 3 mg/kg IV (60 min) every 2 weeks until progressive disease (PD) or unacceptable toxicity. The aim of the study was to report the efficacy and safety profile of Nivolumab in pretreated patients with advanced NSCLC of our everyday clinical practice. The exploratory assessments include response rate (RR), progression-free survival (PFS), overall survival (OS) and treatment related adverse events (AEs).
Results:
From August of 2015 to February of 2016, with a median follow time of 7 months, 66 patients were enrolled from 7 different centers. The patients demographics were: median age 60 years, 19 female and 47 male; 7 never smoked and 59 former or current smoker; 45 patients adenocarcinoma, 4 large-cell carcinoma, 12 squamous-cell carcinoma and 4 NSCLC; 20 stage IIIB and 46 stage IV; 17 with central nervous system metastasis; 30 received 2 or more prior therapy lines and 62 had PS 1. Among 48 patients evaluated, 3% had complete response, 21% partial response, 27% disease stabilization and 21% disease progression. At the time of database lock, the median of PFS was 2.03 IC 95% (1.2-2.7) and OS was not reached. Grade 1-2 treatment related adverse events (AEs) occurred in 38 patients and the most common ones were asthenia (25), rash/pruritis (12), anorexia (7), endocrine (5) and diarrhea (4). Each of the toxicities were manageable and there were no grade 3-4 AEs or treatment-related deaths.
Conclusion:
Early data from this study suggests that Nivolumab is effective and well tolerated in patients with pretreated advanced NSCLC.
