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M. Gutierrez



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    MINI 29 - Meta Analyses and Trial Conduct (ID 156)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      MINI29.02 - Effect of Statins and Metformin on Survival in Patients with Non-Small Cell Lung Cancer (ID 363)

      18:35 - 18:40  |  Author(s): M. Gutierrez

      • Abstract
      • Presentation
      • Slides

      Background:
      Lung cancer is the number one cause of cancer-related death worldwide; with the incidence of non-small cell lung cancer (NSCLC) risen dramatically, the importance of understanding the influence of comorbidities and their treatments takes a great importance. The aim of this study was to investigate the effect of statins and metformin on survival in patients with NSCLC.

      Methods:
      We reviewed the records of all patients diagnosed with NSCLC at our institution from 2011 to 2013. Demographics, tumor characteristics, comorbidities, statin/ metformin use and survival were analyzed. Cox regression was used for multivariate analysis.

      Results:
      A total 205 patients were studied. Median age at diagnosis was 65 years (40-91), there were more males than females (56% vs. 44%, p<0.01. 74% (152) were current or former smokers with average 40 pack years (5-60). The Median BMI was 26.5kg/m2 (18-44), ECOG status was 1 (0-4) and serum creatinine of 1.0 (0.4-3.5). Regarding comorbidities: 48% (98) had hypertension, 45% (93) hyperlipidemia, 22% (44) COPD and 19% (39) diabetes mellitus. At diagnosis, 66% (136) of the patients had stage III/IV disease vs. 25% (69) with stage I/II, p<0.0001. Adenocarcinoma was the most common histologic subtype (61%), followed by squamous cell carcinoma (27%). 42% received surgery, 80% systemic chemotherapy and 32% radiation. Median survival was 1520 days (95% CI: 1310-1765). 42% (87) of the patients were taking statins and 13% (27) metformin. About the statin use, 58% of the patients were using statins for 25-48 months, 12% for >48 months, 11% for 13-24 months and 18% for less than 12 months. Female gender (OR: 1.98, p<0.001), age<65 years (OR: 0.89, p<0.01) and statin use (OR: 0.78, p<0.02) were independent predictors of survival by multivariate analysis. Metformin use was not a predictor of survival by univariate or multivariate analysis in this group of patients.

      Conclusion:
      In our cohort, we observed that almost half of the patients had hypertension and hyperlipidemia with statin use been a significant predictor of survival. Statins are one of the mostly widely prescribed drugs in the US; their proven anti-inflammatory effects may play a role in inhibiting cancer growth. However, the exact mechanisms by which statins inhibit cancer proliferation remains unclear. While other observational studies have looked at statins and risk of developing cancer, we specifically looked at the effect of statins on survival in patients on statin therapy prior to cancer diagnosis. More studies are needed to enhance our understanding of the effect of statins on lung cancer.

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    P1.03 - Poster Session/ Treatment of Locoregional Disease – NSCLC (ID 212)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      P1.03-013 - Clinical Characteristics and Survival in Stage IIIA NSCLC Patients Treated with Neoadjuvant Chemotherapy and Surgery (ID 1020)

      09:30 - 09:30  |  Author(s): M. Gutierrez

      • Abstract

      Background:
      The role of surgery in the management of stage IIIA non-small cell lung cancer (NSCLC) is controversial, with several studies reporting mixed results regarding the benefit of surgery in this group of patients. This study aimed to analyze the clinical characteristics and prognostic factors in stage IIIA patients treated with neoadjuvant chemotherapy followed by surgery.

      Methods:
      We reviewed the medical records of all patients diagnosed with stage IIIA NSCLC at our institution from 2000 to 2012. Tissue diagnosis and PET-Scan at our institution were required. Median follow up was 36 months. Cox regression model was used for multivariate analysis.

      Results:
      A total of 275 stage IIIA patients were identified, and 84 of those patients were treated with induction chemotherapy followed by surgery. Median age at diagnosis was 65 years (range: 42-82). There were more males than females (68% vs. 32%). 64% of the tumors were located in the upper, 24% lower and 12% middle lobe. Adenocarcinoma was the most prevalent histologic subtype (69%) followed by squamous cell (24%). 57% were poorly differentiated tumors. All patients received cisplatin based chemotherapy; response to induction therapy was: CR 0%, PR 55%, and SD 44%. Median time from induction chemotherapy to surgery was 80 days (range: 15-126). About surgery: 69% were lobectomies, 26% pneumonectomies and 5% wedge resections. Post-operatively, microscopic residual tumor was found in 8% of the patients. Pneumonectomies had a higher post-operatively mortality when compared with lobectomies (5% vs 2%). 50% of the patients received post-surgical radiation. Median overall survival was 19.5 months (95%CI: 14.5-26.7) and when comparing these patients with stage IIIA patients that received chemoradiation alone, a survival benefit was observed (19.5 months vs. 15.8 months). Recurrence was observed in 26% of the patients (64% had local and 36% distal recurrence). Patients that did not receive radiation had a higher risk of recurrence. Male gender (OR: 0.33, p<0.002), age>65 (OR: 2.61, p<0.03) tumor size >4cm (OR: 3.10, p<0.01) and partial response with induction therapy (OR. 0.69, p<0.005) were significant predictors of survival in this group of patients.

      Conclusion:
      In our cohort, we observed that patients who underwent induction chemotherapy followed by surgery had a higher overall median survival than patients treated with chemoradiation alone. Gender, age, tumor size and response to induction therapy were independent and significant predictors of survival in these patients. Adding radiation therapy to the regimen was associated with a lower recurrence rate. Further research is needed to identify the optimal management of stage IIIA NSCLC as well as the effect of other clinical characteristics on survival.

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    P1.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 224)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
    • Presentations: 1
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      P1.08-032 - Primary Pulmonary Lymphoma: Clinical Analysis of 34 Cases (ID 635)

      09:30 - 09:30  |  Author(s): M. Gutierrez

      • Abstract

      Background:
      Primary pulmonary lymphoma (PPL) accounts for only 0.5% of all primary lung cancers and 10% of all extranodal lymphomas. Though the majority are non-Hodgkin lymphomas (NHL), PPL can easily be misdiagnosed or missed due to their nonspecific clinical features and imaging findings. Our goal was to investigate the clinical characteristics, treatment and prognosis of PPL.

      Methods:
      We reviewed the clinical data of 34 patients diagnosed with PPL at our cancer center from 2005 to 2013. Initial diagnosis at our institution and minimum 24 month follow up were required. Kaplan-Meier method was used for survival analysis.

      Results:
      A total of 34 patients were identified. Median age at diagnosis was 55 years (range: 35-84), 53% were males and 47% females. 61% were current or former smokers. 14 patients (41%) had an autoimmune disorder (8 patients had Hashimoto’s hypothyroidism, 4 rheumatoid arthritis and 1 DM type 1). 32% had family history of cancer and 27% of autoimmune disorders. The major clinical manifestations were: cough (53%), weight loss (41%), incidental finding on chest x-ray (29%) and only 11% presented with B symptoms. Regarding tumor characteristics, 41% of the patients were stage I, 18% stage II, 6% stage III and 35% stage IV. Marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue lymphoma were the most prevalent subtypes, representing 97% of the cases. Patients were more likely to have upper lobe lesions (50%) vs. middle (29%) or lower lobe (21%) lesions. Regarding treatment, 15 patients (44%) were treated with surgery, 79% with chemotherapy (44% CHOP vs. 35% Rituximab monotherapy) and 24% with radiation (+/- chemotherapy or surgery). Overall median survival was 67.5 months (95%CI: 48.0-87.2) Factors associated with poor prognosis were: bilateral lung disease, presence of B symptoms and pleural involvement.

      Conclusion:
      PPL is a rare type of primary lung malignancy with an equal gender distribution. It is usually seen in middle-aged patients with history of autoimmune disorders and carries a good overall survival. The high incidence of misdiagnosis in PPL is associated with the lack of specific clinical features, making preoperative diagnosis difficult with most of the patients requiring lung tissue biopsy and immunohistochemistry studies.

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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: 2
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      P2.01-038 - Prognostic Factors for Brain Metastasis in Non-Small Cell Lung Cancer (ID 430)

      09:30 - 09:30  |  Author(s): M. Gutierrez

      • Abstract

      Background:
      Non-Small Cell Lung Cancer (NSCLC) patients tend to develop brain metastasis (BM) early in the course of the disease, usually within 2 years of diagnosis. BM are an important cause of morbidity and mortality, the study of prognostic factors for its development are invaluable in implementing measures to prevent or decrease the incidence of BM. The aim of this study was to evaluate the prognostic value of certain clinical characteristics in the development of BM in NSCLC patients.

      Methods:
      We retrospectively analyzed all patients diagnosed with NSCLC at our institution between 2000 and 2013. Demographics, tumor characteristics and metastatic patterns were studied. Median follow up was 45 months. Cox regression was used for multivariate analysis.

      Results:
      A total of 1062 patients were studied. Of these, 172 (16%) had BM at the time of analysis, with 61 (35%) patients having BM at diagnosis. Median age was 68 years (range, 18-91); median time from diagnosis to BM was 259 days. There were more females than males (64% vs. 36%, p < 0.0001). About NSCLC characteristics, patients with BM were more likely to have upper lobe tumors than all other tumor locations combined (63% vs. 37%, p < 0.0001). 32% of the lung tumors were 5-7cm in diameter and adenocarcinoma represented 68% of all the histologic subtypes. In regards to other distant metastases: 34% of the patients had bone metastasis, 23% adrenal and 17% hepatic. BM were most commonly located in the frontal (41%), parietal (17%) and occipital (14%) lobes. There was a significant survival difference between Stage IV patients with and without BM; patients with BM survived 6.1 months compared with 11.9 months in those without BM (p < 0.0001). In univariate analysis, female sex, histologic grade, upper lobe tumors and high LDH levels were associated with BM. Age < 65 years (HR: 0.60, 95%CI: 0.37-0.95, p < 0.03), T3-4 tumors (HR: 3.4, 95%CI: 2.04-5.64, p < 0.0001), adrenal metastasis (HR: 5.2 95%CI: 2.5-10.7, p < 0.0001) and liver metastasis (HR: 8.6, 95%CI: 4.3-17.2, p < 0.0001) were independent risk factors for the development BM.

      Conclusion:
      The results of this study pose female sex, tumor histologic grade, tumor location, and LDH levels as important prognosticators of future BM. In addition, younger age, T3-4 tumors, and the presence of adrenal/liver metastases are noted as independent risk factors for BM development. With this information, criteria for the selection of patients as suitable candidates for intra-cranial irradiation, periodic brain imaging studies, and close outpatient follow-up may aid in further prevention of BM, early identification, and timely management.

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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): M. Gutierrez

      • 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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    P3.02 - Poster Session/ Treatment of Localized Disease – NSCLC (ID 211)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Localized Disease - NSCLC
    • Presentations: 1
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      P3.02-001 - Factors Affecting Tumor Recurrence in Early Stage Non-Small Cell Lung Cancer (ID 459)

      09:30 - 09:30  |  Author(s): M. Gutierrez

      • Abstract

      Background:
      For early stage non-small cell lung cancer (NSCLC) surgery is potentially the only curative treatment. However, a proportion of lung cancer patients develop recurrence, even after complete resection. The factors affecting recurrence in these patients are largely unknown. This study aimed to identify the predictive factors for recurrence in patients with stage I/II NSCLC.

      Methods:
      We retrospectively reviewed all patients diagnosed with stage I/II NSCLC at our institution from 2000 to 2013. Initial diagnosis at our institution and a minimum follow up of 36 months were required. Cox regression model was used for multivariate analysis.

      Results:
      A total of 673 patients with stage I/II were identified, of those 175 (26%) developed local or distant recurrence, with a median time to recurrence of 18 months. Median age was 74 (range: 44-96 years), 56% were current or former smokers. Patients were more likely to have upper lobe tumors than all other tumor locations combined (58% vs 42%), adenocarcinoma was the most prevalent histologic subtype (53%) and 47% had poorly differentiated or anaplastic tumors. 152 patients (87%) received surgery with lobectomy being the most common procedure followed by wedge resection. 24% received chemotherapy and 7% radiation. Median overall survival was 26 months (95%CI: 17.2-34.5). Patients with squamous cell carcinoma had a shorter median time to recurrence when compared with adenocarcinomas (13.2 months vs. 19.7 months) (p<0.02). Smoking history (HR: 1.98, 95%CI: 1.62-2.82, p<0.007), central tumor location (HR: 1.24, 95%CI: 1.09-1.56, p<0.01), squamous subtype (HR: 1.46, 95%CI: 1.22-1.84, p<0.002) , high histologic grade (HR: 2.76, 95%CI: 1.34-5.97, p<0.01) and lymphovascular invasion (HR: 4.3, 95%CI: 3.32-5.00, p<0.001) were independent predictors of recurrence by multivariate analysis. Poorly differentiated tumors were associated with a higher frequency of distant recurrence when compared with well differentiated tumors (OR: 2.7 vs. 1.2). In 43% of the patients with recurrence lung cancer was the primary cause of death.

      Conclusion:
      In our cohort, we observed that patients with lymphovascular invasion have the highest recurrence risk followed by high histologic grade tumors with the former having a direct correlation with distant metastasis. Patients with these risk factors may benefit from close surveillance after surgical resection, adjuvant therapy and aggressive management of local recurrence.