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J.L. Fírvida
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P2.02 - Poster Session with Presenters Present (ID 462)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.02-012 - Long-Term Survival of Phase II of Full-Dose Oral Vinorelbine Combined with Cisplatin & Radiotherapy in Locally Advanced NSCLC (ID 4708)
14:30 - 14:30 | Author(s): J.L. Fírvida
- Abstract
Background:
Chemo-radiotherapy is the standard of care for the treatment of inoperable locally advanced non-small cell lung cancer (LA-NSCLC). Cisplatin (P) plus vinorelbine is one of the chemotherapy (CT) regimens widely used concurrently with radiotherapy (RT). Since oral vinorelbine (oV) has achieved comparable results to the IV formulation, the optimal dose for the oV administration with P and concurrent RT is still being investigated. The aim of this study is to evaluate the efficacy and safety of full-dose oV combined with P and radical RT for LA-NSCLC patients (pts).
Methods:
Untreated pts between 18-70 years (y), with histologically proven inoperable LA-NSCLC (supraclavicular lymph node involvement excluded), V20<30%, adequate bone marrow, respiratory, hepatic and renal function, and ECOG PS0-1; received 4 cycles (cy) of oV 60 mg/m[2] D1 & 8 plus P 80 mg/m[2] D1, every 3 weeks, plus 2Gy/day of RT started on D1 of 2[nd] cy (total dose 66Gy). Primary endpoint was overall response rate (ORR) by RECIST 1.1. Secondary endpoints were: progression free survival (PFS), overall survival (OS) & safety profile. To guarantee a type-1 () error (one side) no greater than 0.05 and a type II (β) error 0.1 for the primary endpoint, a sample size of 45 eligible pts was planned. EudraCT 2009-010436-17.
Results:
Forty-eight pts were included between 02/2010-12/2011. Median age 61y [34-72], male 90%, PS1 58%; smokers 52%; squamous 63%; stage IIIB 54%. Main G3-4 toxicities (% cy) were: neutropenia 33%, febrile neutropenia 14.6%, anemia 12.5%, thrombocytopenia 16.6%, & esophagitis 12.5%. Two treatment-related deaths during the 1[st] cy. RT was administered to 87.5% of pts; 7.1% received less than 60Gy and 23.8% had delays due to adverse events. The ORR was 77.3% (2 complete responses). With a median follow-up of 28.2 months (m) [0.5-70.6], 33 pts (68.8%) have progressed and 32 (66.7%) have died. Median PFS and OS were 11.8m (CI~95%~ 7.2-16.5) and 29.8m (CI~95%~ 21.4-38.1), respectively. PFS at 1y was 48.8% pts (CI[95%] 33.9-63.7%). OS at 1 and 2y were 72.7% (CI95% 60-85.4%) and 57.3% (C95% 43-71.6%), respectively.
Conclusion:
This long-term analysis confirms the good efficacy results of the administration of full doses of oral vinorelbine combined with cisplatin and concurrent RT in patients with LA-NSCLC.
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P2.02-029 - Concomitant ChemoRadiotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Phase II Study from the Galician Lung Cancer Group (ID 4492)
14:30 - 14:30 | Author(s): J.L. Fírvida
- Abstract
Background:
Concomitant platinum-based ChemoRadiotherapy (CT-RT) is the recommended treatment for unresectable locally advanced Non-Small Cell Lung Cancer (NSCLC). We conducted a phase II study to evaluate the efficacy and safety of concomitant CT-RT with cisplatin (C) and intravenous and oral vinorelbine (V) and thoracic radiotherapy.
Methods:
31 chemo-naive patients with histologically confirmed inoperable locally advanced NSCLC, stage IIIA (T4 or N2)/IIIB, PS 0-1 and adequate lung function (FEV1 > 1.1, V20 < 30%) were included in concomitant CT-RT with: C 80 mg/m2 day 1 and intravenous V 25 mg/m2 day 1 and oral V 25 mg/m2 day 8 for three cycles, during conformal thoracic radiotherapy (66 Gys, 180 cGy/day). The primary objective was overall survival (OS); secondary objectives were progression free survival (PFS), response rate (RR) and toxicity. Median follow-up: 18,1 months.
Results:
The patients characteristics were: mean age 59,6 years (44-75); male/female: 26/5; ECOG PS 0/1: 5/26; adeno/squamous/large cell carcinoma: 15/12/4; stage IIIA 16 patients and stage IIIB 15 patients. 28 patients were evaluable for response (3 patients in treatment) and 31 for toxicity. RR: 3 CR, 18 PR (RR 75%; 95% CI: 59-91), 5 SD (17.8%) and 2 PD (7.2%). The median PFS was 12 months (95% CI:6-18) and median OS was 28 months (95% CI:21-34). The PFS at 1/3 years were 47%/20% and the OS at 1/3 years were 77%/45%. Main toxicities (NCI-CTC 4.0) per patient in CT-RT (89 cycles of chemotherapy, 2.9 per patient; mean doses RT: 65,4 Gys) grade 1-2/3-4 (%) were: neutropenia 32/22.5; anemia 39/10; thrombocytopenia 13/0; nausea/vomiting 31/3; fatigue 29/0; esophagitis 39/6 and pneumonitis 16/0; hospitalizations was necesary in 9 patients: febrile neutropenia in 3 patients and grade 3 esophagitis in 2 patients.
Conclusion:
Concomitant CT-RT with Cisplatin and intravenous and oral Vinorelbine during thoracic radiotherapy is a feasible treatment option for inoperable locally advanced stage III NSCLC, showing good clinical efficacy and tolerability with acceptable long-term survival.
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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): J.L. Fírvida
- 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.
