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A. Bearz



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    MO21 - Prognostic and Predictive Biomarkers V - EGFR (ID 98)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO21.01 - Randomized Proteomic Stratified Phase III Study of Second Line Erlotinib (E) versus Chemotherapy (CT) in Patients with Inoperable Non-Small Cell Lung Cancer (PROSE): VeriStrat analysis of longitudinal samples (ID 3122)

      10:30 - 10:35  |  Author(s): A. Bearz

      • Abstract
      • Presentation
      • Slides

      Background
      2nd-line therapy for advanced NSCLC patients (pts) after progression on platinum-based regimens typically employs CT or E. A test for optimizing choice of treatment in these pts is of clinical value. VeriStrat (VS) is a serum protein test that assigns "good" (VSG) or "poor" (VSP) classification and has demonstrated prognostic and predictive utility. PROSE is a multicenter prospective randomized biomarker validation trial, designed to evaluate the ability of VS to predict survival in 2nd- line NSCLC pts treated with E or CT. As reported at 2013 ASCO1, PROSE met its primary endpoint of demonstrating significant treatment*VS interaction with a p value of 0.031, with VSG pts deriving similar overall survival (OS) benefit from both treatments (hazard ratio (HR) for E=1.06; p=0.71) and VSP pts benefitting more from CT than E (HR for E=1.72; p=0.02). Previous studies in EGFR-TKI-treated pts have shown that at progression around 30% of pre-treatment VSG pts have changed classification to VSP2. The present report discusses the exploratory analysis of longitudinal VS classifications generated during the PROSE study.

      Methods
      Of the 263 pts in the PROSE primary analysis population, 89 provided serum samples during treatment and 108 at progression, with 47 pts providing both. VS testing was performed on these longitudinal samples blinded to all clinical and treatment outcomes and pts and physicians remained blinded to VS results.

      Results
      VSG or VSP classifications were obtained for 89 pts from treatment samples (67 VSG / 22 VSP) and 107 pts (one sample was classified as indeterminate) from progression samples (59 VSG / 48 VSP). In pts with matched baseline and progression samples, the percentage of VSG classifications was lower at progression (55%) than at baseline (77%) (p < 0.001 ). Twenty eight pts (34%) classified at baseline as VSG changed to VSP at progression, in line with previous studies2, and this did not show any significant dependence on treatment. When treated with E, pts whose classification changed from VSG at baseline to VSP during treatment (n=6) had inferior PFS to the 25 pts who remained VSG (p=0.001, median PFS: 3.6 and 7.7 months (mos), respectively). Patients whose classification changed from VSG at baseline to VSP at progression on E (n=18) had numerically inferior OS (median 10.0 mos) compared with the 31 pts who remained VSG at progression (median 14.6 mos) and significantly superior OS (median 5.0 mos) compared with the 10 pts who were VSP at both time points (p<0.001).

      Conclusion
      The observed changes in VS classification at progression demonstrate the importance of obtaining a VS result prior to each line of therapy for which erlotinib is considered as a therapeutic option. The proportion of patients who are good candidates for erlotinib therapy (VSG) decreases from 2[nd] to 3[rd] line and the possible impact of this on treatment sequencing and monitoring for 2[nd] and higher line advanced NSCLC pts merits further studies.

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    P1.24 - Poster Session 1 - Clinical Care (ID 146)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P1.24-005 - Impressive retinal response to crizotinib in a patient with NSCLC and ALK translocation (ID 740)

      09:30 - 09:30  |  Author(s): A. Bearz

      • Abstract

      Background
      Adenocarcinoma of the lung EML4-ALK-rearranged are about 5-7% of all Non-Small-Cell-Lung Cancer (NSCLC). Treatment for patients affected by metastatic adenocarcinoma of the lung harbouring an EML4-ALK translocation is the oral compound anti-Met, Crizotinib. Crizotinib is considered to be poorly active over cerebral localizations, due to a possible difficult CNS penetration.

      Methods
      Herein we report a case of a patient with adenocarcinoma of the lung and ALK translocation, with bone and retinal metastases at diagnosis and impressive response to Crizotinib in all those sites.

      Results
      In August 2012 a 43-year-old man was hospitalized for a severe impairment in his left eye, onset abruptely the day before. In his medical history no trauma had occurred in the days before hospital admission. He had been reporting cephalea for one month, mostly in the left eye area, with metamorphopsias.He underwent a fluoroangiography,showing signs of left retinal detachment due to multiple, non-primitive, retinal neoplasias, mostly in the left eye, but also in the right retina. CT-scan of the brain showed abnormal tissue in the left retina, with important choroidal swelling. A thorax CT-scan revealed a 5-cm nodule in his right lung, median lobe, with enlargement of right mediastinal lymph nodes. Bone scan showed involvement of several bones, cervical and dorsal vertebral bodies, sternum. Biopsy was done through mediastinoscopy and adenocarcinoma of the lung was diagnosed. Genetic characterizazion was: EGFR and KRAS wild type, EML4-ALK translocation, diagnosed by FISH. Clinical TNM at the diagnosis was T2aN2M1, and distant localizations were at the bone and bilateral retinal tissue, mostly on the left.The patient reported pain at his head, neck, dorsal back, severe asthenia; his left eye was off, he had been spending most of his daily time resting at bed since one week. He started to receive Crizotinib 250 mg BID orally at the beginning of October 2012. Treatment was well tolerated, with few G1 episodes of diarrhoea.In few weeks his symptoms improved with resolution of pain and asthenia, the patient returned progressively to a normal life. CT-scan showed a reduction of the main nodule in the right lung and mediastinal lymph nodes, partial response according to RECIST criteria. Surprisingly he reported an improvement in his left eye vision, he could see the light and some objects in the lower left eye field of view. Ophtalmologist reported a reduction of the temporal nodule in the right retina, while in the left retina there was an impressive reduction of the swelling; for that reason at the end of January 2013 the patient underwent surgery to the left eye for the retinal detachment, gaining a complete left eye field of view. He is still on Crizotinib and no progression of disease has been documented up to now.

      Conclusion
      Crizotinib has induced an impressive response over retinal metastasis from NSCLC; the patient had an eye off at the diagnosis of NSCLC and on treatment gained a complete left eye field of view. Crizotinib is active over cerebral tissue like retina.