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Ó. Juan Vidal
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MINI 17 - WT EGFR, Angiogenesis and OMD (ID 131)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:R. Feld, R. Dziadziuszko
- Coordinates: 9/08/2015, 16:45 - 18:15, Mile High Ballroom 4a-4f
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MINI17.10 - Oligometastatic Non-Small-Cell Lung Cancer and Unresectable Primary Tumor: Safety and Efficacy of Radical Treatment (ID 2669)
16:45 - 18:15 | Author(s): Ó. Juan Vidal
- Abstract
- Presentation
Background:
Metastatic non-small cell lung cáncer (NSCLC) is associated with a poor prognosis, and palliative chemotherapy is the mainstay of treatment. However, long-time survival has been observed in oligometastatic patients treated with locally ablative therapies to all sites of tumoral disease. Oligometastatic NSCLC with unresectable primary tumor at diagnosis represents a therapeutic challenge, and nowadays there is limited evidence about the benefit of the treatment with radical intention of both primary tumor and metastases.
Methods:
Retrospective study of patients with oligometastatic (3 or less lesions, in a unique location) and unresectable NSCLC treated with radical chemo-radiotherapy at primary tumor and with surgery or stereotactic radiation therapy to the metastases. We have done a systematic review of clinical histories from NSCLC advanced patients diagnosed between October 2011 and March 2015. The aim of our study is to analyze the safety and efficacy of this treatment strategy in terms of response rate, progression free survival (PFS) and overall survival (OS).
Results:
Twenty-three patients met inclusion criteria. Median age 57 year, eighteen male (78,3%) and ECOG (0-1) 95,7%. Histology: 15 adenocarcinoma (65,2%), 5 squamous carcinoma (5%), and 3 (13%) others. All patients had unresectable mediastinal lymph nodes infiltration. Location of metastases included the brain (n=12, 52.2%), lung metastases (n=6, 26,1%), bone metastases (n= 3, 13%), adrenal (n=1, 4,3%) and lymph node (n=1, 4,3%). Chemotherapy: 9 CDDP-Pemetrexed (39,1%), 9 CDDP-Vinorelbina (39,1%), 3 Carboplatin-paclitaxel, 1 CDDP-Gemcitabina (4.3%), 1 CDDP-Docetaxel (4.3%). Ten patients (43.5%) received sequential thoracic radiotherapy and 12 (52.2%) concomitant. Metastases treatment: 12 stererotactic radiation (52.2%), 7 external radiotherapy (30, 4%), 3 surgery (13%), 1 radiofrequency (4.3%). Toxicity: four patients (17,39%) developed G3 toxicity (2 hematological, 1 pneumonitis, 1 esophagitis). Median follow up was 15 months, median OS 18 m, median PFS 11 months. The 1-year OS were 73.9%, 2-year OS 21,7% and 3-year OS 8.7%.
Conclusion:
Radical treatment of oligometastatic and unresectable NSCLC patients is a safe therapeutic strategy. Despite the limited data and the small numbers of our study, it could be contemplated as an effective therapeutic alternative for selected patients.
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ORAL 01 - Chemotherapy Developments for Lung Cancer (ID 88)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:G. Blumenschein, S. Lee
- Coordinates: 9/07/2015, 10:45 - 12:15, 401-404
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ORAL01.03 - A Randomized Phase 2 Trial of Vintafolide and Docetaxel in Folate-Receptor Positive (FR+) Advanced NSCLC Patients: Final Efficacy Results (ID 1600)
10:45 - 12:15 | Author(s): Ó. Juan Vidal
- Abstract
- Presentation
Background:
Vintafolide (folic acid-vinca alkaloid conjugate) binds to the folate receptor (FR), which is overexpressed in approximately 80% of patients with NSCLC, including patients with squamous cell and adenocarcinoma. Using the molecular imaging agent 99mTc-etarfolatide for SPECT imaging, the FR status of malignant lesions can be determined. Vintafolide has demonstrated single agent activity in patients with advanced NSCLC whose tumors all expressed FR [FR(100%)] compared to patients not FR(100%) (Edelman et al, 2012).
Methods:
This study randomized patients with advanced NSCLC whose tumors were FR(100%) to vintafolide, vintafolide + docetaxel, or docetaxel. Key eligibility criteria: age ≥18 years; 1 prior systemic therapy for advanced disease; ECOG PS 0-1. Patients underwent [99m]Tc-etarfolatide SPECT screening for FR assessment. Vintafolide (2.5 mg) was administered on days 1, 4, 8, 11 every 21 days and docetaxel (75 mg/m[2]) on day 1 every 21 days. The primary endpoint was progression-free survival (PFS). Pre-specified PFS comparisons were performed for vintafolide vs docetaxel and vintafolide+docetaxel vs docetaxel in all patients as well as those with adenocarcinoma. Significance testing for each PFS analysis was one-sided without adjustment for multiplicity (alpha=0.10). Overall survival (OS) was a secondary endpoint.
Results:
Over 14 months, 199 FR(100%) patients were randomized and treated (vintafolide: 63; vintafolide+docetaxel: 68; docetaxel: 68). Patient and disease characteristics were well-balanced between arms. The vintafolide+docetaxel arm met the primary endpoint of superior PFS over the docetaxel arm in all patients regardless of histology (17.0% censored; unstratified Cox model hazard ratio [HR] =0.75; unstratified one-sided p-value=0.0696) as well as in the prespecified 133 patient adenocarcinoma subgroup (18.8% censored; HR=0.73; p-value=0.0899). Trends in OS favored the vintafolide+docetaxel arm over the docetaxel arm in all patients (37.7% censored; HR=0.88; p-value=0.2874) and showed the greatest benefit in the adenocarcinoma subgroup (42.8% censored; HR=0.70; p-value=0.1018). The single-agent vintafolide arm was not superior to docetaxel. Vintafolide+docetaxel treatment was associated with more neutropenia (all grades: 77% versus 62%), febrile neutropenia (13% versus 6%), and peripheral neuropathy (34% versus 21%) compared to docetaxel alone.
Conclusion:
The addition of vintafolide to docetaxel resulted in a statistically significant improvement in PFS in FR(100%) NSCLC patients regardless of histology (PFS HR= 0.75) and in the adenocarcinoma subset (PFS HR= 0.73). Additionally, there was a trend towards improvement in OS in all patients regardless of histology (OS HR= 0.88) and in the adenocarcinoma subset (OS HR= 0.70). Vintafolide +docetaxel was generally well tolerated, although rates of neutropenia, neutropenic fever, and neuropathy were higher than with docetaxel alone. Final survival results will be presented at the conference.
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P1.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 224)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.08-015 - Malignant Pleural Mesothelioma: Observational and Retrospective Analysis of Spanish Database (BEMME). The Spanish Lung Cancer Group (SLCG) (ID 2355)
09:30 - 17:00 | Author(s): Ó. Juan Vidal
- Abstract
Background:
Malignant Pleural Mesothelioma (MPM) is a rare but aggressive malignancy of the pleura, with a strong causal link to asbestos exposure. Although in Spain asbestos was banned in 2002, it is estimated that occupationally related deaths due to MPM will continue to occur until 2040. BEMME (Base Epidemiológica Mesotelioma Maligno en España) is an observational and retrospective study sponsored by the Spanish Lung Cancer Group that aimed to characterize the patient’s and tumour’s features as well as the treatment modalities of patients diagnosed with mesothelioma in Spain.
Methods:
Clinical records of patients with malignant pleural and peritoneal mesothelioma were retrospectively reviewed to collect epidemiological data, diagnostic tests, treatment modalities and survival data into an electronic and anonymous database. Thirty-five Spanish hospitals participated in the project and 570 mesothelioma patients were included in the BEMME database. Here we present a descriptive analysis of MPM patients based upon these data.
Results:
From January 2008 to December 2013, 538 patients (p) had MPM. Most patients were males (77%) and 74% of patients were ≥ 60 years (60-70y: 33%, >70y: 41%). Most patients (49%) had a performance status 1 at diagnosis. Only 32% of patients were recorded as positive for asbestos exposure and 77% of patients were never-smokers. Dyspnoea (35%) and thoracic pain (26%) were reported as the most frequent symptoms at diagnosis. Epithelioid was the most frequent histological subtype (63%), followed by sarcomatoid (12%), biphasic (8%) and not specified (17%). Disease stages at diagnosis were: stage I, 7%; stage II, 9%; stage III, 17%; stage IV, 45%; not specified, 22%. Surgery was performed in 41p: extrapleural neumonectomy 16p, extended pleurectomy 15p and partial pleurectomy 10p. Palliative pleurodesis was performed in 22% of patients. A total of 70% of patients received chemotherapy (55% palliative, 11 neoadjuvant and 6% adjuvant). The median overall survival (OS) for all patients was 13.2 months (95% CI 12.2 – 15.2). There were no statistically significant differences in OS according to age, gender and asbestos exposure. In the univariate analysis, higher stage (III-IV vs. I-II, p=0.0003) and non-epithelioid subtype (non-epithelioid vs. epithelioid, p=0.00001) were significantly associated with shorter OS.
Conclusion:
In Spain, most MPM patients are diagnosed at advanced stages and are treated with palliative modalities: mainly chemotherapy and pleurodesis. Stage and histologic subtype were prognostic factors for survival. BEMME database is a helpful tool to describe the therapeutic strategies employed in MPM patients in Spain.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-010 - Early Radiographic Response to TKI in Non Small Cell Lung Cancer with EGFR Mutations (ID 429)
09:30 - 17:00 | Author(s): Ó. Juan Vidal
- Abstract
Background:
EGFR mutations have become an important target to choose a treatment for non-small cell lung cancer (NSCLC) patients. The response to chemotherapy is evaluated after the patient completes the second-third course of treatment. The response to tyrosine Kinase Inhibitor (TKI) could be observed in few days, the time for response evaluation is not well-defined.
Methods:
From January 2009 to November 2014, EGFR mutation status was analysed in 360 NSCLC patients’ samples. 55 patients (15,3%) were EGFR mutation positive. Among the 55 patients, 40 patients who were stage IIIB-IV and had received treatment with either gefitinib 250 mg, erlotinib 150 mg or afatinib 40 mg once daily were included in this analysis. The principal aim was to correlate the early radiological response (ERR) to TKI by computed tomography (TC) with progression‑free survival (PFS) and overall survival (OS) in NSCLC patients with EGFR mutations and stage IIIB-IV disease. Secondary objectives were to correlate the TKI response with different EGFR mutations and to evaluate the safety and efficacy of TKI treatment. The PFS and OS were estimated by the Kaplan–Meier method with (SPSSv.19). The log‑rank test was used to assess significant differences between‑groups (p<0.05).
Results:
The clinic-pathologic characteristics of the 40 eligible patients are listed in table 1. The EGFR mutations identified were mainly exon 19 deletions (12 patients) and L858R point mutations (16 patients). Twenty‑six patients (65%) had ERR. Four patients with a partial response (PR) on early CT achieved a complete response (CR). The median follow‑up time was 17 months (range 2-66 months). Among the 26 patients with ERR the median PFS was 11.8 months. The median PFS for patients with stable disease (SD) and progressive disease (PD) was 7.5 months. The overall log‑rank test for PFS, when comparing the groups of patients (ERR vs SD and PD) showed a significant difference (p<0.034). For patients with ERR the median OS was 20.1 months. The median OS for patients with SD and PD was 11.9 months. The overall log‑rank test for OS, when comparing the groups showed a significant difference (p<0.017).Table 1: The clinic-pathologic characteristics
VARIABLES NUMBER % Patients 40 100 Gender Male Female 19 21 47.5 52.5 Age (years) Median (range) 62 (40-85) Race European Others 38 2 95 5 Smoking Yes No Former smokers 9 22 9 22.5 55 22.5 Packs-year Median (range) 35.5 (5-185) PS 0 1 >2 14 22 4 35 55 10 Pathology diagnosis Adenocarcinoma Squamous Others 37 2 1 82.5 5 2.5 Stage IIIB IV 2 38 5 95 Number of prior chemotherapies 0 1-2 >2 17 20 3 42.5 50 7.5 TKI Erlotinib Gefitinib Afatinib 30 8 2 75 20 5
Conclusion:
The ERR to TKI could be a predictive factor of PFS and OS in NSCLC with activating EGFR mutation. Patients with SD at the first evaluation should be followed closely because of the risk of early progression.
