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X. Mielgo Rubio
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-023 - Induction-Maintenance Treatment Sequence in Non-Squamous Non-Small Cell Lung Cancer (neNSCLC): Pemetrexed vs Vinorelbine-Based Induction (ID 5795)
14:30 - 14:30 | Author(s): X. Mielgo Rubio
- Abstract
Background:
Non-squamous non-small cell lung cancer (neNSCLC) is the most frequent lung cancer subtype. Prognosis of advanced disease is poor, but in recent years, the treat-to-progression strategy has emerged, demonstrating significant improvement in overall survival (OS) of maintenance regimen with pemetrexed (Pem). There are limited head-to-head clinical trial data of various treat-to-progression strategies, and a Pem-based platin doublet induction strategy has never been directly compared to vinorelbine (VNR)-based one.
Methods:
We reviewed retrospectively patients diagnosed of advanced neNSCLC from 2006 to 2015 who were treated with Pem-based and VNR-based platinum doublet as induction chemotherapy, followed by Pem maintenance if they had not progressed. We evaluated clinicopathological features and clinical outcomes. The main objective was to assess if there were survival differences between both induction strategies in terms of progression free survival (PFS) and OS.
Results:
51 patients were reviewed, 74.5% men and 25.5% women. Mean diagnosis age was 64 (range 37-78). 15.7% never smoked and 84.3% had ever smoked. 70.6% received Pem-platin doublet and 29.4% VNR-platin doublet. Initial PS was 0 in 35%, 1 in 63%, 2 in 2%. In Pem group 69.4%. did not progress during induction and in VNR group 46.7%. 55,6% received maintenance Pem in Pem group and 33,3% in VNR group (p=0,08).More treatment delays were done in VNR doublet (53,3% vs 30,6%, p=0,047). Objective response rate (ORR) and disease control rate (DCR) were better with Pem-doublet. Pem: partial response (PR) 35.3%; stable disease (SD) 44.1%, disease progression (DP) 20.6%; VNR: PR 38.5%, SD 23.1%, DP 38.5%. Median PFS was slightly better in Pem group than in VNR one (6,2 vs 4,5 months; p=0,28) and median OS was also better with Pem (16,1 vs 11,2 months; p=0,39), but there were no significant statistical differences. More patients in VNR group needed hospitalization during induction (42,9 vs 25%; p=0,06). Most frequent adverse effects (AEs) were asthenia, anemia and neutropenia. Grade 3-4 asthenia, anemia and neutropenia were more frequent in VNR group.
Conclusion:
No big differences were found between both induction-maintenance strategies. Os and PFS were similar in both groups but Pem group presented a trend to better OS and PFS. More patients presented DP during induction treatment in VNR group. Pem group had better toxicity profile and less hospitalizations during treatment.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-084 - Predictive and Prognostic Clinical and Pathological Factors of Nivolumab Efficacy in Non-Small-Cell Lung Cancer (NSCLC) Patients (ID 5085)
14:30 - 14:30 | Author(s): X. Mielgo Rubio
- Abstract
Background:
Immunotherapy with anti-PD1 and anti-PDL1 monoclonal antibodies significantly increases overall response rate (ORR) and overall survival (OS) of patients with advanced NSCLC in comparison with second line conventional chemotherapy. Prognostic and predictive factors able to distinguish those patients with a higher benefit from immunotherapy are warranted. Our work retrospectively analyses several clinical, pathological and analytical variables with an eventual potential prognostic and predictive value in daily patients with advanced NSCLC receiving Nivolumab.
Methods:
A retrospective review of clinical charts of patients with advanced NSCLC from fourteen centres of the GIDO group receiving Nivolumab between May-2015 and May-2016 was performed. Age, sex, stage, Performance Status (PS), location of metastases, presence of tumour-related symptoms and comorbidities, number of organs with metastasis, previous chemotherapy, antiangiogenic and radiotherapy treatments, and analytical data from standard blood count and biochemistry were collected and statistically analyzed.
Results:
A total of 175 patients fulfilled inclusion criteria. Median age was 61.5 years. One hundred and twenty-eight male (73.1%), 136 ECOG-PS 0-1 (77.7%), 150 stage IV (86,7%) and 135 had non-squamous carcinoma histology (77.1%). Sixty-five received Nivolumab in second line (37.1%), 66 as third line (37.1%) and 44 as forth or further line of treatment (25.1%). Seventeen patients (9.7%) received antiangiogenic drug in previous line of treatment, and 30 were treated with radiotherapy within 30 days before Nivolumab. Thirty-eight patients had brain metastasis (22%), 39 liver metastasis (22.3%) and 126 had more than one metastatic location (72%). 140 patients were evaluable for response, the ORR was 15.7%, median Progression Free Survival was 2.8 months, and median OS 5.81 months. Stage III (OR 3.57) and time since the beginning of previous line of treatment longer than 6 months (OR 2.52) were associated in multivariable analysis with higher probability of response to Nivolumab. PS 2 vs 0-1 (HR 1.83), time since the beginning of previous line of treatment <6 vs >6 months (HR 1,70) and more than one metastatic location vs one location (HR 1.79) were independently associated with shorter overall OS in multivariable analysis.
Conclusion:
Poor Performance Status, short period of time since the beginning of previous treatment and more than one metastatic location are the clinical-pathological features associated with poorer prognostic in patients with advanced NSCLC treated with Nivolumab. Limitations of the study are the small numbers and the retrospective nature
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P3.02c-100 - Nivolumab beyond First-Line (1L) Treatment in Metastatic Non-Small Cell Lung Cancer (NSCLC) (ID 4935)
14:30 - 14:30 | Author(s): X. Mielgo Rubio
- Abstract
Background:
Patients with metastatic NSCLC progressing to 1L have a poor prognosis. Nivolumab is an anti-PD-1 monoclonal antibody, which has shown to prolong overall survival (OS) in patients who have progressed to platinum-based chemotherapy. We report our experience with nivolumab in pretreated metastatic NSCLC patients.
Methods:
Retrospective study of patients with metastatic NSCLC treated with nivolumab (3 mg/kg every 2 weeks) in second line (2L) and subsequent lines (SL). We evaluate response rate (RR), progression-free survival (PFS), OS and toxicity.
Results:
Twenty patients were included (2L: 17, SL: 13). Median age: 68 years. Histology: Adenocarcinoma (60%), Squamous cell (33%), Large cell (7%). ECOG PS: ECOG 0-1 (83%), ECOG 2 (17%). Median number of cycles: 8. RR (Twenty-three patients evaluable for response): Complete response (9%), partial response (35%), stable disease (26%), disease progression (30%). Objetive response rate (ORR) in 2L vs SL: 55% vs 33%, p=0.30. ORR in squamous vs non-squamous: 25% vs 47%, p=0.40. Median follow-up: 6 months. PFS and OS events at the time of analysis: 43% and 33%, respectively. Median PFS and OS: 7 months and not reached (NR), respectively. PFS in 2L vs SL: NR vs 5 months, HR 0.81, p=0.71. PFS in squamous vs non-squamous: 5 months vs NR, HR 1.39, p=0.58. OS in 2L vs SL: NR vs NR, HR 1.53, p=0.50. OS in squamous vs non-squamous: 7 months vs NR, HR 2.61, p=0.14. The incidence of adverse events was low. The most frequent toxicity (any grade) was asthenia (67%). A patient with chronic liver disease had hepatotoxicity grade 1 and continued treatment. Three patients discontinued treatment due to toxicity: pneumonitis grade 3 (1), rash grade 3 (1), impaired renal function grade 3 (1). There were no toxic deaths.
Conclusion:
In clinical practice, nivolumab is effective and safe in 2L and SL in patients with metastatic NSCLC.
