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Margarita Majem
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MA 15 - Lung Cancer Biology II (ID 670)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Biology/Pathology
- Presentations: 1
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MA 15.01 - LungBEAM: A Prospective Multicenter Trial to Monitor EGFR Mutations Using BEAMing Technology in Stage IV NSCLC Patients (ID 10145)
15:45 - 17:30 | Author(s): Margarita Majem
- Abstract
- Presentation
Background:
Liquid biopsy is a promising approach to improve the management of NSCLC patients, offering a minimally-invasive alternative to tumor tissue testing and enabling timely monitoring of patients on-therapy. The goal of the present study was to evaluate the performance of the OncoBEAM EGFR plasma vs EGFR tissue testing across 19 Spanish hospitals and to examine the timing of T790M mutation emergence in patients during first-line EGFR TKI therapy with respect to radiological progression.
Method:
Blood samples from 112 therapy-naïve advanced NSCLC patients were collected at baseline and throughout EGFR TKI therapy. Results from OncoBEAM EGFR mutation were performed by Sysmex in Hamburg, Germany and then compared to those obtained by the initial EGFR tissue testing obtained at the referring hospital. In addition, the time at which T790M was first detected was compared to the date of progression determined by radiological imaging.
Result:
112 stage IV NSCLC patients (p) were enrolled between Nov 2016 and May 2017. Clinical characteristics: median age 65 y. , 81 female. Smoking pattern: never 70 p (62,5%), former 33 p (29.4%) and active 9 (8%). M1a 28 p (25%), M1b only brain 10 p (8.9%), only bone 17 p (15%). Baseline tissue samples: Exon 19 deletion 74 p (66%) , L858R 38 p (34%). Initial positive percent agreement (PPA) in 69 out of 112 p was 52/69 or 75.4%. Interestingly, the agreement between plasma and tissue EGFR mutation results for patients diagnosed at M0 was 56%, versus 81% with patients diagnosed at M1. In addition, the average number of days between tissue biopsy and blood collection for concordant cases was 128 days, versus 358 days for discordant cases. Currently, the tissue EGFR mutation status of all discordant cases is being re-examined using BEAMing. Preliminary results from serial T790M plasma analyses revealed cases where detection by OncoBEAM was observed several weeks prior to documented progression by imaging. More mature results will be available at the time of the meeting
Conclusion:
Overall, these initial results show high PPA of plasma and tissue EGFR mutation status at baseline. Moreover, early detection of T790M in blood may assist in anticipating resistance to first-line EGFR TKI therapy.
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-022 - Nintedanib/Docetaxel Efficacy in Advanced Lung Adenocarcinoma Treated with 1L Chemotherapy/2L Immunotherapy in Nintedanib NPU (ID 8639)
09:00 - 16:00 | Author(s): Margarita Majem
- Abstract
Background:
Both antiangiogenic agents (nintedanib and ramucirumab) in combination with docetaxel and monotherapy with anti-PD-1/ PD-L1 immunotherapy have demonstrated efficacy as second-line (2L) treatment of patients with stage IV lung adenocarcinoma. However, selection of optimal candidates and the most appropriate therapeutic sequence is under discussion. Herein, we report on the efficacy of the nintedanib/docetaxel combination following first-line (1L) platinum-based chemotherapy and subsequent immunotherapy in a real-world setting.
Method:
From May 2014 to December 2015, 390 patients in 108 Spanish centers enrolled in the nintedanib Named Patient Use (NPU) program. NPU inclusion criteria were advanced lung adenocarcinoma with progressive disease following at least one line of platinum-based doublet chemotherapy. We retrospectively assessed patients that received immunotherapy (available through clinical trials or the nivolumab NPU program) prior to nintedanib/docetaxel. The aim of this analysis was to evaluate the efficacy of the nintedanib/docetaxel combination in this new clinical setting.
Result:
Eleven patients met the inclusion criteria for this analysis: 64% were men; median age of 67 years (range, 44–74); ECOG performance status 0-1 in 100% of patients; median number of treatment lines before inclusion in the nintedanib NPU program was 2 (range, 2-3); PD-L1 expression was positive (unknown cut-off) in 6 patients and was not determined in 5 patients. Median progression-free survival (PFS) of first-line platinum-based chemotherapy was 3.3 months (range 1.4-9.4): 9 patients (82%) had progressed <6 months since start of first-line treatment and 4 patients (36%) had progressed <3 months. Second-line immunotherapy was pembrolizumab (36.5%), atezolizumab (36.5%) and nivolumab (27%). Median PFS of second-line immunotherapy was 2.3 months (range, 0.7-11). The overall response rate (ORR) to second-line immunotherapy was 18% with a disease-control rate (DCR) of 45%. The median number of treatment cycles of nintedanib/docetaxel was 4.5 (range, 2-22). Median PFS of nintedanib/docetaxel post first-line chemotherapy and second-line immunotherapy was 3.2 months (range, 1.4-14.6). Best response was partial response in 4 patients (36%), stable disease in 5 patients (46%), and progressive disease in 2 patients (18%), for an ORR of 36% and a DCR of 82%.
Conclusion:
Our experience in the Spanish nintedanib NPU program in patients with adenocarcinoma NSCLC pretreated with platinum-based doublet chemotherapy and immunotherapy suggests an encouraging ORR and DCR of nintedanib/docetaxel as compared with clinical trial results. These results reinforce the importance of an optimal therapeutic sequence for managing advanced lung adenocarcinoma: 1) Nintedanib/docetaxel should be the recommended second-line treatment in early progressors and 2) Possible chemosensitization effect by immunotherapy.
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P2.05 - Early Stage NSCLC (ID 706)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.05-007 - Sterotactic-Body-Radiotherapy for Early-Lung Cancer: Is FDG-PET/TC a Predictor of Outcome? (ID 10045)
09:30 - 16:00 | Presenting Author(s): Margarita Majem
- Abstract
Background:
Follow-up recommendations after stereotactic body radiation therapy (SBRT) for early non–small cell lung cancer (NSCLC) patients are not well defined. We analyzed the prognostic value of early response evaluated by FDG-PET/TC scan.
Method:
Between April 2012 and September 2016, 63 primary lung lesions in unfit patients or who refused surgery were treated with SBRT. Three risk-adapted fractionation schemes that ensure DBE>100Gy were considered: 3x18Gy, 5x11Gy and 8x7.5Gy. In all patients two FDG-PET/TC scans were performed: one before the SBRT treatment and another one a month after the completion of the treatment. Changes in FDG-uptake were evaluated. We considered complete response (CR) when the FDG-uptake was normalized, partial response (PR) when there was a decrease and stable disease (SD) when no modification was observed. Local control (LC), cause-specific survival (CSS) and overall survival (OS) were analyzed according to response.
Result:
With a median follow-up of 16 months; LC, CSS, and OS at 2 years were 100%, 91% and 64%, respectively. We correlated the FDG-PET/TC response at one month with LC and OS at 2 years. The FDG-PET/CT response at one month was not related to LC at 2 years, which was above 95% for all patients. For patients who achieved CR at one moth, OS and CSS at 2 years was both 100% while patients with PR was 49% and 86% respectively and for those with SD were 63% and 92% respectively (Figure 1). Figure 1
Conclusion:
Our results suggest that an early complete response on FDG-PET/TC may be a good predictor factor of survival. Based on the grade of early PET-CT response, patients for stricter monitoring could be selected. Longer follow-up to confirm these findings is necessary.
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-041 - Immuno-Related Cutaneous Adverse Events (IRcutAEs) in Patients (P) with Advanced NSCLC: A Single-Institution Prospective Study (ID 9828)
09:30 - 16:00 | Author(s): Margarita Majem
- Abstract
Background:
Despite the impressive benefits of the immune checkpoint blockade in NSCLC, its use can be hampered by the occurrence of serious adverse events. IRcutAEs are underestimated and poorly described according to data from the clinical trials.
Method:
Before starting immunotherapy, all NSCLC p were prospectively referred to the Dermatology Department. Periodic monitoring visits were also scheduled for each p, in order to describe the IRcutAEs and their treatments. The study included data from all consecutive NSCLC p treated with immunotherapy in our institution.
Result:
Since May 2016, 50 p were recruited for the present study. According to clinical characteristics; 18 p had squamous histology, 43 p received treatment as second line or further, and 36 p were treated with nivolumab. During the follow-up period, 15 p (30%) developed IRcutAEs. Lichenoid reactions were the most common AE (9 p, 60%), but some specific conditions were also observed, such as a cutaneous lupus (1 p, 6.6%) or an eruptive pseudoangiomatosis (1 p, 6.6%).
Conclusion:
IRcutAEs are common during antiPD1-PDL1 therapy. By offering a dermatological follow-up, the diagnosis and management of this type of toxicity can be provided to NSCLC p initiating immunotherapy.
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P3.14 - Radiotherapy (ID 730)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiotherapy
- Presentations: 2
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.14-014 - Lung Stereotactic Body Radiotherapy (SBRT): Patient's Outcome and Prognostic Factors (ID 9866)
09:30 - 16:00 | Presenting Author(s): Margarita Majem
- Abstract
Background:
Stereotactic body radiotherapy (SBRT) is the standard of care in patients with medically inoperable early stage NSCLC and an effective method of treatment of lung metastases (LM) in oligometastatic patient.We evaluated local control (LC), overall survival (OS), cause-specific survival (CSS), and related toxicity in the both group of patients treated in our center.
Method:
Between April 2012 and September 2016, 107 lung lesions were treated with SBRT; 62 early NSCLC(58%) and 45 LM(42%). Three risk-adapted fractionation schemes that ensure DBE>100Gy were considered: 3x18Gy, 5x11Gy and 8x7.5Gy. Kaplan-Meier(KM) curves were used to evaluate LC,OS and CSS. We analyzed toxicity and predictive factors.
Result:
The median follow-up was 16 months(range 6-44). For primary NSCLC: LC,CSS, and OS at 2 years were 100%,91% and 64%, respectively.19 patients died, 5 because of a lung cancer and 14 due to concurrent disease. Regional relapse was observed in five patients(7.6%).Six patients(9.2%) developed distant metastases. There was no statistically significant difference in OS and CSS when comparing peripheral-central tumors or T1-T2 tumors. However, T2 and central tumors showed lower survival rates. For lung metastatic lesions: LC,CSS, and OS at 2 years were 69%, 66% and 66%, respectively.The primary tumors were:colorectal 17(38%), lung 15(33%) and others 13(29%).There was no statistically signficant difference in survival among primary tumor or 1-3 metastatic lesions, but colorectal primary tumors and more than one lung metastases had lower survival.We compared LC and CSS in both group of patients. There was a statistically significant difference in local control(p=0.002) and CSS(p=0.027) among the primary tumors or lung metastases(Figure 1).According to RTOG,≤G2 lung and skin acute toxicity was 5% and 3% respectively.Lung late toxicity ≤G2 was 22.4%. No patients developed >G2 toxicities. Figure 1
Conclusion:
With a 2-year LC rate >95% with limited toxicity, SBRT confirms as state-of-the-art treatment for medically inoperable early stage NSCLC and effective options for oligometastatic patients.
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P3.14-017 - Dosimetric Evaluation of Lung SBRT Treatment (ID 10204)
09:30 - 16:00 | Presenting Author(s): Margarita Majem
- Abstract
Background:
To analyse the relation between clinical outcomes and dosimetric indices for SBRT lung treatments.
Method:
96 lung lesions were treated with SBRT(6MV photons 3DCRT). Planning CT included whole lung. 4DCT of tumor area was used to obtain a MIP-based ITV, with three risk-adapted fractionation schemes [3x18Gy, 5x11Gy, 8x7.5Gy(BED>100Gy)]. In treatment delivery the tumor was centered online using CBCT and its movement validated by fluoroscopy adjusting the gating limits to the breathing amplitude. Toxicity and dosimetric indices for PTV and OAR were evaluated and correlated with the clinical outcomes 6 months after radiotherapy
Result:
Table1 shows the dose constraints as well as the results of the dosimetric indices. It was found that 95%/75% of the patients developed G=0 acute/late toxicity, 3%/0% G=2 acute lung/skin toxicity, 3% G=2 late lung toxicity and no patients developed G>2 toxicities. Figure 1 displays the correlation between V~100~, V~90~, CI and the clinical outcomes after 6 months of radiotherapy. Only the CI was statistically significant(t-test p=0.017) as an indicator of the ratio between complete/partial responses(mean CI=1.1/1.05) Figure 1 Figure 2
Conclusion:
The lung SBRT technique is safe(no G> 2 toxicity has been reported) even for cases with OAR compromise. The CI has been statistically significant as a predictor of complete tumor remission at 6 months.
