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Rosario Garcia Campelo
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P48 - Small Cell Lung Cancer/NET - Chemo - IO (ID 236)
- Event: WCLC 2020
- Type: Posters
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P48.04 - IMfirst; Phase IIIB Safety Study of Atezolizumab Plus Chemotherapy in a Real World Population of Untreated ES-SCLC (ID 1929)
00:00 - 00:00 | Presenting Author(s): Rosario Garcia Campelo
- Abstract
Introduction
The standard of care for first line extensive stage small cell lung cancer (ES-SCLC) has been platinum-based chemotherapy (C) for more than 2 decades. Carboplatin (CP)/cisplatin (CPT) plus etoposide (ET) have shown a median overall survival (mOS) of approximately 8-10 months (mo) according to randomized clinical trials and metanalysis. Real-world data show a mOS of 6 mo in stage IV disease and a 5 year survival rate under 2%, highlighting the need for more effective therapies. IMpower133, combining atezolizumab (anti–PD-L1) with CP plus ET, was the first clinical trial to show significant improvement over standard C with a good safety profile. The addition of atezolizumab to C resulted in significantly longer mOS and median progression free survival (mPFS), with a mOS of 12,3 mo (10.8, 15.9) for atezolizumab plus CP and ET and 10,3 mo (9.3, 11.3) with C alone, HR: 0.70 (0.54, 0.91). Also, the 18-month landmark OS increased a 13% in the atezolizumab plus CP/ET (34%) arm compared with the placebo plus CP/ET (21%) arm. As a result, the combination of atezolizumab plus C is considered a category 1 preferred option according to NCCN and SEOM Spanish guidelines.
Given the high-unmet need for new therapies for ES-SCLC, it is of considerable interest to evaluate the safety of atezolizumab in a broader spectrum of SCLC patients that mimics more closely a real world clinical practice population.
Methods
IMfirst (ML41599) is a phase IIIB, open label, single arm, multicenter study rolled out in Spain (30 sites) designed for patients with untreated ES-SCLC. The primary objective is to assess the safety of atezolizumab in combination with C (CP or CPT), according to investigator´s choice (IC), plus ET. This clinical trial includes a population of ES-SCLC patients that would have been screened out from some of the previous studies. ECOG performance status 2, asymptomatic untreated brain metastases, underlying stable autoimmune diseases or HIV+ patients are eligible. Induction phase includes 4 or 6 cycles (IC) of atezolizumab (1200 mg IV on day 1) plus C, with 21 day cycles. Maintenance therapy with atezolizumab every 3 weeks continues until evidence of persistent radiographic disease progression, loss of clinical benefit, symptomatic deterioration or unacceptable toxicity. The primary endpoint includes incidence, nature, and severity of adverse events. Key secondary endpoints are mPFS assessed by the investigator, mOS, objective response rate, duration of response and quality of life. Exploratory endpoints include comprehensive genomic profiling. Foundation Medicine panels will be performed in archival or freshly obtained tumor tissues if available, and it is mandatory for blood samples collected at baseline and progression. Currently the enrollment is ongoing and 10 patients have been included. IMfirst study recruitment will be open until 150 patients are enrolled. EudraCT Number: 2019-002784-10.
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P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P76.42 - OsimertinibTreatment in Non-Small Cell Lung Cancer (NSCLC) EGFR-T790M+. Activity in Patients with CNS Metastases. OSIREX (ID 1860)
00:00 - 00:00 | Author(s): Rosario Garcia Campelo
- Abstract
Introduction
Based on the lack of real-life results the Spanish Lung Cancer Group (SLCG) proposed to organize a retrospective study in which we can describe the experience in efficacy and safety of osimertinib in p with NSCLC EGFRm T790M and central nervous system CNS) metastases.
Methods
Observational, non-interventional, multicentre, one-arm, non comparative, retrospective study in T790M positive NSCLC p with advanced or metastatic disease. A total of 155 p were included. The observation period was from August 2016 to December 2018 in 30 Spanish hospitals. This corresponds to a total period of 29 months.
Results
155 p were included (108 women (69.7%), median age: 67 (37-88), 64% (99/155) were non-smokers and 99 % (154/155) had adenocarcinoma. Most p had received at least one prior treatment (97.4%, 151/155): 76.8% previous EGFR-TKIs, and 20.6% had received prior cytotoxic chemotherapy. At data cutoff, median duration of follow-up was 11.7 months (0.4-32).
A total of 155 p were evaluable for response analysis, 87(56%) as 1st and 2nd line therapy and 68 as ≥3rd line. 45 patients (30%) had CNS metastases at baseline. PFS was inferior en patients with CNS metastases than in those without (median, 7.2 months (95% CI, 3.9 to 10.6) vs 10.3 months (95% CI, 7.8 to 12.8) HR: 1.54 (95% CI, 1.03 to 2.32).
Conclusion
This retrospective study to assess the real-world clinical impact of osimertinib in p with advanced NSCLC and CNS metastases. Osimertinib had demonstrated greater penetration of blood brain barrier than gefitinib or erlotinib and these results could recommend us to use in first line.
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P84 - Targeted Therapy - Clinically Focused - ALK (ID 261)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P84.14 - Identification of Mechanisms of Resistance to ALK Inhibitors. Next-Generation Sequencing-Based Liquid Biopsy Profiling. (ID 3612)
00:00 - 00:00 | Author(s): Rosario Garcia Campelo
- Abstract
Introduction
Despite impressive and durable responses, patients treated with ALK inhibitors (ALK-Is) ultimately progress. We investigated potential resistance mechanisms in a series of ALK-positive non-small cell lung cancer (NSCLC) patients progressing on different types of ALK-Is.
Methods
26 plasma and 2 cerebrospinal fluid samples collected upon disease progression to an ALK-I, from 24 advanced ALK-positive NSCLC patients, were analyzed by next-generation sequencing (NGS). A tool to retrieve variants at the ALK locus was developed.
Results
61 somatic mutations were detected in 14 genes: TP53, ALK, PIK3CA, SMAD4, MAP2K1 (MEK1) FGFR2, FGFR3, BRAF, EGFR, IDH2, MYC, MET, CCND3 and CCND1. Overall, We identified at least one mutation in ALK locus in 10 (38.5%) plasma samples, being the G1269A and G1202R mutations the most prevalent among patients progressing to first- and second-generation ALK-I treatment, respectively. An exon 19 deletion in EGFR was identified in a patient showing primary resistance to ALK-I. Likewise, the G466V mutation in BRAF and the F129L mutation in MAP2K1 (MEK1) were identified as the underlying mechanism of resistance in three patients who gained no or little benefit from second-line treatment with an ALK-I. Putative ALK-I resistance mutations were also found in PIK3CA and IDH2. Finally, a c-MYC gain, along with a loss of CCND1 and a FGFR3, were detected in a patient progressing on a first-line treatment with crizotinib.
Conclusion
NGS analysis of liquid biopsies upon disease progression identified putative ALK-I resistance mutations in most cases, being a valuable approach to devise therapeutic strategies upon ALK-I failure.
