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P. Garrido



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    MINI 11 - Tobacco Control and Prevention (ID 108)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Prevention and Tobacco Control
    • Presentations: 1
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      MINI11.12 - Is There Any Role for Residential Radon in Patients with Non Small Cell Lung Cancer (NSCLC) Harbouring Molecular Alterations? Preliminary Results (ID 993)

      17:35 - 17:40  |  Author(s): P. Garrido

      • Abstract
      • Presentation
      • Slides

      Background:
      World Health Organization (WHO) recommends radon concentration lower than 100 Bq/m3. Previous studies have demonstrated the correlation between high level of residential radon exposure and lung cancer especially in non-smokers patients (p.). Similarly, most of the advances in personalized therapy in NSCLC p. also occurred in non-smoker. We hypothesized that residential radon could be associated to some specific molecular alterations in NSCLC p.

      Methods:
      A detector alpha-track was delivered to each p. to measure radon concentration in residence for 3 months and a questionnarie to fill out. The elegible population were NSCLC p. harbouring molecular alterations (EGFR, KRAS or BRAF mutations (m)), ALK or ROS1 rearrangements (r)) and non-smoker p. treated in the Medical Oncology Department, at Hospital Universitario Ramon y Cajal, Madrid. Incident cases and prevalent cases collected from lung cancer patients database have been included from September 2014 to March 2015. We collected demographic information, smoking history, environmental exposure and clinicopathological characteristics including histology, molecular profile, stage, treatment and survival. The radon concentration was analysed using optical microscopy with radosys system 2000. EGFR, KRAS, BRAF mutation (m) were analysed using quantitative real-time polymerase chain reaction (PCR) and ALK and ROS1 rearrangements by fluorescence in situ hybridization (FISH). Statistical analysis was performed using IBM SPSS.

      Results:
      So far now, 48 NSCLC adenocarcinoma p. have been enrolled although only 31 have already completed radon measurement. Median age 59 years (range 33- 82); 58,1% female; 77% ECOG 0; 74,4% stage IV; 90,3% living in Madrid. Smoking habits: non-smokers 58% (9p. EGFRm, 7p. ALKr, 2p. BRAFm), light smokers 6,45% (1p. EGFRm, 1p. ALKr) and heavy smokers 35,4% (6p. EGFRm, 5p. KRASm). Median pack-years: light smokers 2,5 (2-3), heavy smokers 44 (20-80). Non-smoker p. reported 27,8% passive-smoking exposure and 44,4% childhood exposure. Radon measurement characteristics: type of building 83.9% flat; building material: 87.1% bricks. Median time of permanence in the same house: 25 years (2-55). Median height of house 3 floors (0-6). Most of measurement at bedroom (93,5%). Median of radon concentration: 103 Bq/m3 (42- 852); 51.6% over WHO recommendation. By molecular alteration: EGFRm median 91 Bq/m3 (42-164), ALKr median 128 Bq/m3 (64-852), BRAFm median 125 Bq/m3, KRASm median 80 Bq/m3 (44-149). ALKr demonstrated association with levels higher than WHO recommendation (p=0.045 Fisher's exact test).

      Conclusion:
      Our preliminary results show that radon concentrations in NSCLC harbouring molecular alterations are higher than WHO recommendation, particularly in patients with ALK rearrangement. Final results will help to confirm this possible association.

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    P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P2.01-085 - Abemaciclib in Combination with Single Agent Options in Stage IV NSCLC, a Phase 1b Study (ID 125)

      09:30 - 09:30  |  Author(s): P. Garrido

      • Abstract
      • Slides

      Background:
      Abemaciclib, a cell cycle inhibitor selective for CDK4/6, demonstrated acceptable safety and early clinical activity in metastatic NSCLC, given orally as monotherapy on a continuous schedule. Combinations of abemaciclib showed greater activity compared with monotherapy in KRAS-mutant NSCLC preclinical models. Primary aim of study NCT02079636 was safety/tolerability of combination therapy with abemaciclib; secondary aims included pharmacokinetics and antitumor activity.

      Methods:
      In this open-label 3+3 dose-escalation study with expansion cohorts, eligibility included stage IV NSCLC, measurable or nonmeasurable disease (RECISTv1.1), ECOG PS ≤1, and 1-3 prior therapies. Abemaciclib was combined with pemetrexed (Part A, nonsquamous, 500 mg/m[2] IV day 1), gemcitabine (Part B, 1250 mg/m[2] IV days 1 and 8), ramucirumab (Part C, 10 mg/kg IV day 1, or 8 or 10 mg/kg IV days 1 and 8) (Q21), or LY3023414 (dual PI3K-mTOR inhibitor) (Part D, 100 mg, 150 mg or 200 mg orally Q12H). In escalation, patients were dosed continuously until progression with abemaciclib at 100 mg (Part D), 150 mg or 200 mg orally Q12H.

      Results:
      As of February 27, 2015, 70 patients (Parts A-C) received ≥1 dose; 15 patients at 150 mg and 55 patients (including all 39 patients in expansion) at 200 mg Q12H abemaciclib. The MTD was established at 200 mg Q12H abemaciclib for Parts A-C. See Table 1 for treatment-emergent adverse events (TEAEs). Stable disease was observed in 13/23 patients in Part A; 7 unknown, 4/24 patients in Part B; 10 unknown, and 7/23 patients in Part C; 12 unknown. In Parts A-C, 18/70 (26%) patients started ≥4 cycles (Part A=9, Part B=3, Part C=6). Three confirmed PRs were observed: Part B, 1 patient with squamous histology (unknown mutation status), Part C, 1 patient with nonsquamous histology (KRAS mutation positive; EGFR mutation negative), and 1 patient with squamous histology (unknown mutation status). Updated analyses will be presented including Part D and longer term follow-up for Parts A-C through approximately June 2015. Table 1. TEAEs related to treatment (≥20% in ≥1 part)

      % All grades (% Gr3/4) Part A (n=23) Part B (n=24) Part C (n=23)
      Diarrhea 65 (4) 50 (17) 52 (9)
      Fatigue 57 (9) 63 (8) 17 (4)
      Nausea 35 (0) 50 (4) 48 (9)
      Neutropenia 61 (61) 50 (33) 17 (4)
      Anemia 57 (26) 33 (17) 9 (0)
      Thrombocytopenia 39 (9) 38 (8) 17 (13)
      Decreased appetite 30 (0) 25 (0) 22 (0)
      Vomiting 9 (0) 21 (0) 35 (0)
      Blood creatinine increased 30 (0) 8 (0) 17 (4)
      Leukopenia 30 (22) 17 (8) 9 (4)


      Conclusion:
      Abemaciclib combined with single-agents with acceptable toxicity. Safety findings observed in Parts A and B are consistent with AEs expected when combining myelosuppressive compounds with abemaciclib, resulting in an increased myelosuppressive effect. In Part C, safety findings are consistent with those of single-agents. Tumor responses were observed in Parts B and C.

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P3.01-089 - Nab-Paclitaxel with or without CC-486 as Second-Line Therapy for NSCLC (ABOUND.2L) (ID 719)

      09:30 - 09:30  |  Author(s): P. Garrido

      • Abstract
      • Slides

      Background:
      Many patients with advanced non-small cell lung cancer (NSCLC) will experience disease progression during first-line chemotherapy. Effective and well-tolerated second-line treatment options for this patient population are limited. In a multicenter phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) significantly improved the primary endpoint of overall response rate (ORR) compared with solvent-based paclitaxel plus C in patients with advanced NSCLC (33% vs 25%; P = 0.005; Socinski et al. J Clin Oncol. 2012;30:2055-2062). nab-P combined with CC-486, an oral formulation of azacitidine, resulted in promising outcomes in a phase I trial of patients with relapsed/refractory solid tumors (LoRusso et al. Mol Cancer Ther. 2013;12(11 Suppl):Abstract A120). In the open-label, multicenter phase II ABOUND.2L trial, the safety and efficacy of nab-P with or without CC-486 will be evaluated in the second-line treatment of patients with advanced nonsquamous NSCLC.

      Methods:
      Approximately 160 patients who have received 1 platinum-containing chemotherapy regimen for treatment of advanced disease will be randomized 1:1 to CC-486 200 mg/day on days 1 to 14 every 21 days plus nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 8 and 15 every 21 days or nab-P 100 mg/m[2] IV (30-minute infusion) on days 1 and 8 every 21 days. Key eligibility criteria include histologically or cytologically confirmed advanced nonsquamous NSCLC, ECOG performance status ≤ 1, adequate organ function, no active brain metastases, no prior taxane therapy, no known EGFR mutation or EML4-ALK translocation, and peripheral neuropathy grade < 2. Randomization will be stratified by ECOG performance status (0 vs 1), sex, and smoking status (yes vs no). ClinicalTrials.gov identifier NCT02250326.

      Key Endpoints
      Primary -Progression-free Survival
      Secondary -Disease control rate -Overall Survival -ORR -Safety
      Exploratory -Changes in quality of life -Healthcare resource utilization throughout the study -Correlation between pretreatment tumor characteristics and response to treatment


      Results:
      Not applicable

      Conclusion:
      Not applicable

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