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C. Baldotto



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    P2.21 - Poster Session 2 - Diagnosis and Staging (ID 170)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 2
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      P2.21-008 - Clinical and Epidemiologic Study of ALK Fusion Genes in Lung Cancer Patients in Latin America: challenges and perspectives (ID 3303)

      09:30 - 09:30  |  Author(s): C. Baldotto

      • Abstract

      Background
      Anaplastic Lymphoma kinase (ALK) alterations play a significant role in the pathogenesis of non-small-cell lung cancer (NSCLC), and the ALK pathway has become an important target for novel NSCLC treatment. Despite strong participation in industry-sponsored and recently investigator-initiated multicenter clinical trials, little is known about the prevalence, clinic-pathological parameters and clinical outcomes related to ALK fusion in Latin American (LATAM) NSCLC patients. Preliminary data from previous small studies suggest that the prevalence of other NSCLC driver genes such as EGFR and BRAF may be more frequent in LATAM than in other non-Asian populations. This highlights a clear need for a comprehensive molecular epidemiology investigation in this genetically heterogeneous region.

      Methods
      Collaboration with the Brazilian National Cancer Institute (INCA) and Latin America Oncology Group (LACOG), through a research agreement with Pfizer Inc., was established and 11 sites from 5 different LATAM countries were contacted for participation (Brazil, Mexico, Argentina, Peru and Bolivia). Countries and site selection was based on ethnic, social and cultural characteristics in order to (appropriately) represent the continent’s population. A total of 1,154 patients will be retrospectively enrolled for molecular analysis. Considering that the expected prevalence is no greater than 10%, this sample permits this estimation with a half-width of the 95% confidence interval < 1.7%. Tissue samples will be shipped to INCA (the coordinator center) for central analysis. Clinical data will be collected by local investigators and retrieved by the coordinator center. The primary goal of the study is to estimate the prevalence of ALK fusion gene in LATAM nonsquamous NSCLC patients and build a stable LATAM network for future molecular epidemiology studies. The secondary objective is to perform a comparison of FISH, PCR and IHC methods for ALK fusion gene detection. FISH will be considered the standard method for comparison and performed using the ALK Dual Color Break-Apart probe (Abbott Molecular Inc.). Real time PCR will be performed in collaboration with Fundación Santa Fé, Colombia (probes and primers synthesized at TIB MOLBIO, LLC and designed with Primer 3 software) and IHC performed with Ventana[TM] reagents.

      Results
      The protocol was planned in 2011. Since then, the first LATAM molecular epidemiology network was established with LACOG collaboration, and molecular analysis methodology standardization completed.

      Conclusion
      This trial represents the first cooperative effort for genotype patients in LATAM using sample shipment for central analysis. Enrollment of patients is still pending, waiting for final approval from country regulatory agencies which have different requirements and timeframes for review. Moreover, additional data on tumor specific biomarkers and diagnostic testing across the region may provide a basis to guide future decisions by regulators and treating physicians.

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      P2.21-009 - Results of Epidermal Growth Factor Receptor (EGFR) Reflex Testing implementation in the Brazilian National Cancer Institute (INCA) (ID 3337)

      09:30 - 09:30  |  Author(s): C. Baldotto

      • Abstract

      Background
      Patients with advanced lung cancer and EGFR mutations can derive significantly benefit by receiving first line EGFR tyrosine kinase inhibitor (TKI) therapy. Multiple trials have showed that clinical selection is not sufficient and that EGFR mutations test should be requested for all non-squamous patients. Moreover there is a suggestion that a lag time between diagnosis and molecular test could harm patients. In this retrospective trial we describe EGFR mutation analysis after the implementation of reflex testing in a cohort of Brazilian patients.

      Methods
      After May 2011 EGFR reflex testing was recommended for all stage IVA and IVB non-squamous lung cancer patients treated at INCA. EGFR exons 18, 19, 20 and 21 were examined using a commercially available Polymerase chain reaction and Sanger sequencing assay. We retrospectively reviewed clinical and EGFR tests characteristics from medical charts of all patients with available results.

      Results
      From May 2011 to May 2013 samples from 189 patients (56.2%) out of 336 were screened for EGFR mutations. Main reason for non-testing was insufficient material. Turn around time for EGFR mutation processing substantially improved over this period, from over three weeks to less than 5 working days. Of those patients tested 58.8% were women and 22% were non-smokers or light smokers. Results were obtained from cytological specimen in 33 cases (17.4%). Most patients had adenocarcinoma (95.2%) with only 6 cases (3.2%) of unspecified carcinoma. EGFR mutations were detected in 52 patients (27.5%). The incidence of mutations was higher in females (58.8%) and non-or light smokers (56%). Of the mutations identified 18 (34.6%) were in frame deletions in exon 19, and 8 (15.3%) were exon 21 L858R. Exon 18 G719A and exon 20 insertions were detected in only 1 (1.9%) and 2 (3.9%) cases respectively. We found a high incidence of atypical mutations (44.3%). All of them were single aminoacidic substitutions in exon 18 (7 cases; 30.5%), exon 19 (5 cases; 21.7%), exon 20 (5 cases; 21.7%), exon 21 (5 cases; 21.7%), and a single case of double mutation (exons 19 and 20). We did not detect any de novo T790M exon 20 mutation.

      Conclusion
      The results of the first 2 years of reflex molecular testing at a single Brazilian institution reported demonstrate the feasibility and potential for a non-clinical selective approach. This high frequency of atypical mutations must be further investigated since to date there are no published data regarding EGFR mutations in the Brazilian population.

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    P2.22 - Poster Session 2 - Epidemiology, Etiology (ID 167)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 2
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      P2.22-006 - Retrospective analysis of non small cell lung cancer patients submitted to ressection or radiosurgery for brain metastasis (BM) at Brazilian National Cancer Institute (ID 1606)

      09:30 - 09:30  |  Author(s): C. Baldotto

      • Abstract

      Background
      Lung cancer is the leading cause of death from cancer in the world and 70 to 85% of these tumors are non-small cell (NSCLC) type. Up to 50% of patients have metastatic disease at the diagnosis, and the brain is one of the most common sites of metastasis. Prognosis of patients with central nervous system (CNS) involvement is usually dismal and is determined by performance status (PS), systemic disease status and age. Recently there is a growing amount of evidence suggesting that aggressive treatment for patients with brain oligometastasis may improve prognosis.

      Methods
      In this retrospective cohort, forty-nine charts of patients with non-small cell lung cancer (NSCLC) metastatic to the brain and treated with neurosurgery (NS) or radiosurgery, between 1996 and 2008, were reviewed at the Brazilian National Cancer Institute. The primary outcome was overall survival (OS), defined as the interval from the diagnosis to death or last follow-up.

      Results
      Median age was 54 years (range 32-82), 61% were male and more than 95% had PS 0-1. Most patients were smokers (95.7%) and had adenocarcinoma (77.6%). Twenty-three patients (47.9%) presented with metastatic disease at diagnosis, and 13 (38.8%) with BM upfront. Imaging for the diagnosis of BM varied between computed tomography (CT) (n=19;38.8%), magnetic resonance (MRI) (n=12;24.5%), both CT and MRI (N=15;30.6%) and positron emission tomography (n=1;2%). Forty-three patients (87.8%) were submitted to NS and only one was treated with radiosurgery. Patients had more often single metastasis (84.8%), and none had more than three lesions. Most patients (80%) still received adjuvant whole brain radiotherapy (WBT) after NS. The median OS was 15.8 months (95% CI 9.4-22.2).

      Conclusion
      Our data confirmed that compared to historical control patients with good PS and brain oligometastasis could derive a better survival when submitted to aggressive local therapy. In our center, until 2008 NS was the most common procedure used and adjuvant WBT was still frequently indicated.

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      P2.22-013 - Evaluation of elderly patients with non-small-cell lung cancer in a private Cancer Center in Brazil. (ID 3298)

      09:30 - 09:30  |  Author(s): C. Baldotto

      • Abstract

      Background
      At diagnosis approximately 25-40% of patients with non-small-cell lung cancer (NSCLC) are older 70 years. There is a scarcity of data on this elderly subpopulation. The aim of this study was to report clinical characteristics of this subpopulation, highlighting some challenges in their clinical management.

      Methods
      In this retrospective cohort, data from 631 patients with lung cancer diagnosed from 1995 to 2011 at a private Cancer Center in Brazil were analyzed.

      Results
      At diagnosis, 33% patients (n=214) were older than 70 years. Within this elderly group most patients (n=193; 90%) were classified as NSCLC and became the focus of our analysis. As expected, performance status (PS), staging and smoking were associated with survival (table1). Metastatic disease was present in 60% of this subpopulation, and most patients had good PS (PS0-1: 83%) and 84% were smokers. Additionally, 70% of this group with NSCLC had at least one comorbidity. The median overall survival time was 15 compared to 22 months for patients aged <70 years (p<0.001). In the metastatic group the majority of patients (62%) received only one cycle of chemotherapy (CT) and only 10% received more than 3 cycles. Of note, in patients with stage II and III adjuvant CT was correlated with survival (14 months vs 69 months in no adjuvant CT and adjuvant CT group respectively; p=0,02), although this therapy was administered in only 30% of patients with stage II and 20% of those with stage III. Figure 1

      Conclusion
      These data show that in this cohort elderly patients with NSCLC do constitute a special subpopulation with associated comorbidities. However, despite most of them had good PS at diagnosis, limited oncology treatment options were offered leading to suboptimal treatment. The fact that oncologists do not feel confortable to offer standard oncology treatment for this population may be due to the fact most of clinical trials exclude elderly patients. Although these data were generated in a private Cancer Center in Brazil we believe it mirrors the stiatuation across the country. These results highlight the urgent need for clinical trials focused on elderly patients, in order to provide a better care for those patients.