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Nir Peled
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EP1.11 - Screening and Early Detection (ID 201)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Screening and Early Detection
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.11-21 - Lung Cancer Screening Pilot in Israel (Now Available) (ID 2278)
08:00 - 18:00 | Author(s): Nir Peled
- Abstract
Background
Lung cancer kills more people than any other cancer, both in Israel and worldwide. In israel 2000 die from the disease each year where the prevalence of smoking is 22.5% above age 21. There is not yet a national lung cancer screening program in Israel, therefore the Israeli Lung Cancer foundation (ILCF) initiated and funded in cooperation with Assuta Medical centers, a pilot program, ILCF-A, calling participants at risk to come and get checked. The activity took place during the international Lung Cancer awareness month, November 2018.
Method
A call for free lung cancer screening was published and promoted on Facebook. People who enlisted filled a questionnaire to evaluate eligibility for screening, which was age 55–74 years, 30 pack-year of smoking history and current smokers or ones who quited within 15 years. There was only a screening arm and LDCT was performed for all subjects. CT reporting and management was performed using LUNGRADS.
Result
Overall 90 subjects were eligible and underwent screening of which, 45% were women and 55% men. The average age of subjects was 63 and the average pack years was 45. Most of the subjects were current smokers. In one third of the subjects, nodules were not detected., when detected, average size of nodules was 3.25 mm. Of all subjects, eight were classified with positive results. Four with LUNGRAD score of 3 are under LDCT follow-up. Of the four who had LUNGRAD score of 4, One subject was diagnosed with stage 1 Lung Cancer and had a successful surgery, two subjects were found to be healthy by PET-CT and Bronchoscopy and 1 is still under investigation. Lung Cancer detection rate was 1.11% and FP rate was 7.7%.
Conclusion
The ILCF-A trial provided evidence that Lung Cancer Screening in Israel is beneficial. In addition, raising awareness and calling the public to come get screened via digital media has an impact. Despite the limitation of this small study, results of cancer detection rate and FP rates were comparable with NLST and NELSON trials. Although the smoking rate of women in Israel is more then half then that of men (12% compared with 27%), their responsiveness for undergoing screening was as high. Based on this promising evidence, Lung Cancer National Screening program in Israel is recommended and feasible.
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EP1.12 - Small Cell Lung Cancer/NET (ID 202)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Small Cell Lung Cancer/NET
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.12-01 - Does PCI Still Have a Role in Limited SCLC? (Now Available) (ID 2721)
08:00 - 18:00 | Author(s): Nir Peled
- Abstract
Background
Prophylactic cranial irradiation (PCI) has long been an integral part of treatment protocols for limited stage small cell lung cancer (SCLC). PCI stands for "prophylactic" while it may be not really prophylactic, rather therapeutic for un-detectable brain disease.
Method
A survey of 39 questions was conducted on the online platform “Survey Monkey” for practicing oncologists, radiotherapists, pulmonologists and thoracic surgeons. The aim of this survey is to establish a practice baseline for a future multicenter study of overall survival (OS) benefits of PCI versus MRI follow-up in limited SCLC.
Result
41 respondents participated from 14 European countries (26 oncology centers) and from 4 US radiotherapy centers: medical oncologists (31%), radiation oncologist (25%), pulmonologists (34%). Brain imaging at diagnosis of SCLC is performed by MRI in 83% and CT with contrast in 49%. Brain follow up after chemotherapy is performed by MRI in 49%, CT with contract in 41%, and no imaging in asymptomatic patients in 20%. PCI is recommended to 67% of patients and performed immediately after the last chemotherapy in 37%, or 2 months after chemotherapy in 49%. The most important criteria whether patient needs PCI are performance status and response to chemotherapy. The most common schedule of PCI is 25Gy in 10 fractions, 41% of respondents. In case of a single brain metastasis after PCI the 1st choice of treatment is SRS, in 93%. Regarding the role of PCI 46% of respondents think that PCI prevents brain metastases from occurring, and 54% think that PCI treats occult brain metastases.
Conclusion
The lack of clinical trials about PCI for limited SCLC patients is undisputed. Our survey shows practice patterns to PCI for patients with limited SCLS depends on Institution and/or specialty. These results establish a practice baseline for a multicentral trial of PCI versus MRI observation, and 93% of our respondents agreed to take part in this trial.
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EP1.14 - Targeted Therapy (ID 204)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.14-27 - Retroperitoneal Pseudotumor Induced by Crizotinib Treatment for CMET ex14 Skip Mutation NCSLC (Now Available) (ID 292)
08:00 - 18:00 | Author(s): Nir Peled
- Abstract
Background
MET-exon-14-skipping(METex14) mutations have been described in 0.6-7% of non-small-cell-lung-carcinomas(NSCLC). METex14 enhance MET receptor pathway signalling through increasing MET protein stability. Patients with NSCLC harboring METex14 mutations may respond to MET tyrosine-kinase-inhibitors(TKI) such as crizotinib. A.E. Drilon et al presented in the Profile-1001 study that crizotinib also demonstrated clinical activity in NSCLC with MET amplification and further data were associated with METex14 skip mutation.
Method
A 63-year-old, non-smoking, female presented with right-upper-lobe (RUL) mass, Lymphangitis spread and bilateral mediastinal nodal involvement (figure 1). Lung adenocarcinoma (TTF1(+), PDL>20%) was diagnosed. The patient refused radiation nor chemo-therapy and therefore treated by pembrolizumab (KeyNote-042). Upon the presence of CMET ex 14 skip mutation detected on ctDNA (Gaurdnat360TM), crizotinib was started with a significant response that allowed a RUL lobectomy with free surgical margins (R0), 4 months later (pT1aN0M0). Following the surgery, she has continued crizotinib therapy and a retroperitoneal pseudotumor was seen on the 9th months post-surgery (figure 2). Needle biopsy indicated a fibrocollagenous tissue, bundles of striated muscle and mixed acute and chronic inflammation without malignant cells. Considering the pathological report, a cyst drainage was performed (figure 3) and crizotinib treatment continued in a lower dose of 250 mg X 1 with no evidence of disease until this report.
Result
Crizotinib has been shown to act clinically as a targeted selective inhibitor of ALK activity in NSCLC. It is a multi-kinase inhibitor of c-MET and ROS1 oncogenic tyrosine kinase. C-MET receptors are normally present in renal tubular epithelium. Previous publications have described complex renal cyst development as a side effect of crizotinib treatment[iv] [v]. It is not clear yet whether its target of c-MET may explain the crizotinib relation to pseudotumors and renal cysts development. Therefor cases of renal cysts should be registered and reported as rare side effects of crizotinib treatment.
Conclusion
"Section not applicable"
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MS18 - Role of Biomarkers in Lung Cancer Screening (ID 81)
- Event: WCLC 2019
- Type: Mini Symposium
- Track: Screening and Early Detection
- Presentations: 1
- Now Available
- Moderators:Luis M Montuenga, Luis M Seijo
- Coordinates: 9/10/2019, 14:30 - 16:00, Vancouver (2003)
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MS18.01 - Exhaled Breath Biomarkers (Now Available) (ID 3544)
14:30 - 16:00 | Presenting Author(s): Nir Peled
- Abstract
- Presentation
Abstract
The evoloving field of early detection of lung cancer is being implemented around the globe. Low Dose CT scans are standard of care in all guidelines, however real world implementation is stil lacking.
Biomarker to support early detection is the current UNMET need, as well as non-invasive biomarkers to follow early disease recurrence and monitoring response to therapy.
The exhaled breath approach is a growing field of interest, where several groups have contributed significant abount of data. There are numerous technologies available while clinical validation is varies between groups.
This talk will score the current knoledge associated with the exhaled breath analysis associated with lung cancer. Surprizingly, the volatille signature is associated with disesae existance, disesae burden, response to therapy, disease profile and even the related mutatoins.
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OA11 - Decomplexifying Molecular Targets, Immunotherapy and Treatment Settings in the Real World (ID 137)
- Event: WCLC 2019
- Type: Oral Session
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Now Available
- Moderators:Kumar Prabhash, Jyoti D Patel
- Coordinates: 9/09/2019, 14:00 - 15:30, Interlaken (1988)
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OA11.06 - Alternative Nivolumab (N) Duration and Scheduling in Advanced Non-Small Cell Lung Cancer (aNSCLC): Real-Life Data (Now Available) (ID 1921)
14:00 - 15:30 | Author(s): Nir Peled
- Abstract
- Presentation
Background
Little is known regarding the optimal scheduling and treatment (Tx) duration of N in aNSCLC. Stopping N after 1 year of Tx negatively affects outcomes.
Method
45 consecutive aNSCLC patients (pts) receiving N for ≥2 years (y) were identified in the electronic databases of 4 Israeli cancer centers. These were divided into Groups A (N continued for >2y at a dose 3mg/kg q2w/240mg q2w; n-21), B (N continued for >2y at a dose 3mg/kg q3w-q8w/480mg q4w; n-17), and C (N stopped at 2y for reason other than progressive disease or intolerable toxicity; n-7). PFS (RECIST 1.1) and safety since 2y after N initiation were assessed.
Result
Baseline, treatment characteristics and outcomes are presented in the Table and the Picture. Allocation to Group B and C was associated with HR for PFS-2.4 (95%CI, 0.3-18.8, p-0.4) and HR for PFS-3.3 (95%CI, 0.3-30.9, p-0.3), respectively. After 2y since N initiation, new N-related toxicity developed in 24%, 18%, and 28% of pts in Groups A, B, and C, respectively (p-NS).
Conclusion
A trend for worse outcomes was observed with alternative N scheduling/N quitting 2y after initiation. So far, continuing N at a standard dose until disease progression/ intolerable toxicity remains the standard treatment option.
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P1.04 - Immuno-oncology (ID 164)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.04-47 - Tumor Mutation Burden Through Hybrid Capture – Circulating Tumor DNA May Predict Response to Immunotherapy in NSCLC (ID 3011)
09:45 - 18:00 | Author(s): Nir Peled
- Abstract
Background
Immunotherapy has become the therapy backbone for patients with NSCLC. Currently, prediction to therapy response is based on tissue biopsy biomarkers such as PD-L1 expression, tumor mutation burden (TMB), genomic alterations in EGFR/ALK/ROS1 and KRAS/TP53/STK11 mutations, all competing for limited tissue biopsy samples. Therefore, we investigated whether these biomarkers can be detected from a non-invasive plasma sample. Challenges of assessment of TMB with cell-free DNA next-generation sequencing (NGS) include the limited size of liquid biopsy gene panels and the fact that low shedding of tumor DNA into circulation may fail to detect hypermutated tumors.
Method
In this retrospective study, data was collected from 100 NSCLC patients treated in medical centers in Israel and USA between 2014 and 2018. NGS on ctDNA was used to evaluate whether mutational burden influence the response to immunotherapy in these patients. Response to immunotherapy was defined by a cutoff of four months of progression free survival (PFS). Liquid biopsy tests were obtained three months or less before immunotherapy treatment start.
Result
Overall, 100 NSCLC patients underwent NGS on ctDNA.
Clinical treatment information and full clinical data was available for 66 patients. 23 patients underwent liquid biopsy tests within a range of 3 months or less before immunotherapy initiation. 9 patients were considered responders and 14 patients progressors by a cutoff of 4 months PFS. Preliminary results showed that in the group of responders, the median TMB was 5 with a standard deviation of 5.49. An average TMB of 2.3 was calculated for the group of progressors with a standard deviation of 1.44.
ctDNA signature will be further presented based on a 73-gene ctDNA NGS panel that adjusts for the degree of tumor shedding.
Conclusion
ctDNA collection was feasible in 66 patients, amongst which 23 underwent liquid biopsy testing 3 months or less before immunotherapy treatment initiation. As the preliminary data is promising on this pilot cohort, we are planning on expending the cohort study and presenting a complex analysis that includes multifactorial mutation load approach that integrates TMB and prediction to immunotherapy response.
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P2.14 - Targeted Therapy (ID 183)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.14-64 - Is ALK Inhibitor a Contraindication for Subsequent IVF Pregnancy? (ID 267)
10:15 - 18:15 | Author(s): Nir Peled
- Abstract
Background
Anaplastic lymphoma kinase (ALK) inhibitors drugs, such as crizotininb, are currently at the focus of treatment for ALK positive metastatic non-small cell lung cancer. Although the FDA statement that crizotinib may be detrimental to fetus development, there is no direct prohibition against the use of crizotinib during pregnancy, neither comment regarding its consumption under assisted reproductive pregnancy. Here we report, for the first time, a normal development of twins that their oocytes were aspirated while undergoing Crizotinib therapy. Furthermore, we discuss some ethical issues raises from this report. Our report along with the rapidly improvement of the ALK inhibitors therapies, raises ethical issues such as, the debate around the right for parenthood while having a progressive uncurable disease and the right for proceeding an assistant reproductive therapy while treated with biological therapies.
Method
"Section not applicable" - I am submitting a case report
Result
"Section not applicable" - I am submitting a case report
Conclusion
"Section not applicable" - I am submitting a case report
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PL02 - Presidential Symposium including Top 7 Rated Abstracts (ID 89)
- Event: WCLC 2019
- Type: Plenary Session
- Track:
- Presentations: 1
- Now Available
- Moderators:Giorgio Vittorio Scagliotti, Ramon Rami-Porta
- Coordinates: 9/09/2019, 08:00 - 10:15, Barcelona (2005)
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PL02.08 - Registrational Results of LIBRETTO-001: A Phase 1/2 Trial of LOXO-292 in Patients with RET Fusion-Positive Lung Cancers (Now Available) (ID 964)
08:00 - 10:15 | Author(s): Nir Peled
- Abstract
- Presentation
Background
No targeted therapy is currently approved for patients with RET fusion-positive non-small cell lung cancer (NSCLC). LOXO-292 is a highly selective RET inhibitor with activity against diverse RET fusions, activating RET mutations and brain metastases. Based on initial data from LIBRETTO-001, LOXO-292 received FDA Breakthrough Designation for the treatment of RET fusion-positive NSCLC in August 2018.
Method
This global phase 1/2 study (87 sites, 16 countries) enrolled patients with advanced RET-altered solid tumors including RET fusion-positive NSCLC (NCT03157128). LOXO-292 was dosed orally in 28-day cycles. The phase 1 portion established the MTD/RP2D (160 mg BID). The phase 2 portion enrolled patients to one of six cohorts based on tumor type, RET alteration, and prior therapies. The primary endpoint was ORR (RECIST 1.1). Secondary endpoints included DoR, CNS ORR, CNS DoR, PFS, OS, safety and PK.
Result
As of 17-June 2019, 253 RET fusion-positive NSCLC patients were treated. The primary analysis set (PAS) for LOXO-292 registration, as defined with the US FDA, consists of the first 105 consecutively enrolled RET fusion-positive NSCLC patients who received prior platinum-based chemotherapy; 58 patients (55%) also received prior anti PD-1/PD-L1 agents. The majority of PAS responders have been followed for ≥6 months from first response. Of the remaining 148 patients, 79 had previously been treated with platinum-based chemotherapy, 55 did not receive prior platinum-based chemotherapy and 14 did not have measurable disease at baseline.
Conclusion
Among PAS patients, the investigator-assessed ORR was 68% (95% CI 58-76%, n=71/105, 2 PRs pending confirmation). Responses did not differ by fusion partner or the type or number of prior therapies, including chemotherapy, anti PD-1/PD-L1 agents and multikinase inhibitors with anti-RET activity. The median DoR was 20.3 months (95% CI 13.8-24.0) with a median follow-up of 8 months; as evidenced by the wide confidence interval, this DoR estimate is not statistically stable due to a low number of events (16 of 69 confirmed responders). The intracranial ORR was 91% (n=10/11: 2 confirmed CRs, 8 confirmed PRs) for patients with measurable brain metastases at baseline.
The ORR in efficacy evaluable treatment naïve RET fusion-positive NSCLC patients was 85% (95% CI 69-95%, n=29/34, 7 PRs pending confirmation). In the safety data set of all 531 patients, 5 treatment-related AEs occurred in ≥15% of patients: dry mouth, diarrhea, hypertension, increased AST and increased ALT. Most AEs were grade 1-2. Only 9 of 531 (1.7%) patients discontinued LOXO-292 for treatment-related AEs.
LOXO-292 had marked antitumor activity in RET fusion-positive NSCLC patients and was well tolerated. These data will form the basis of an FDA NDA submission later this year.
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