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Apar Kishor Ganti



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    MA 13 - New Insights of Diagnosis and Update of Treatment (ID 674)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Early Stage NSCLC
    • Presentations: 1
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      MA 13.04 - Adjuvant Systemic Therapy in Patients with Early-Stage Non-Small Cell Lung Cancer (NSCLC) Treated with Stereotactic Body Radiation Therapy (ID 10216)

      15:45 - 17:30  |  Author(s): Apar Kishor Ganti

      • Abstract
      • Presentation
      • Slides

      Background:
      Stereotactic body radiation therapy (SBRT) is currently the standard of care for inoperable patients with early stage non-small cell lung cancer (NSCLC). Despite this, ≈20% will relapse at 2 years. While adjuvant chemotherapy is recommended for surgically resected patients with early stage NSCLC (IB-IIIA), data on the role of adjuvant systemic therapy following SBRT for early stage NSCLC are sparse. The goal of this study was to evaluate the role of adjuvant chemotherapy following SBRT in early-stage, inoperable NSCLC.

      Method:
      Adults diagnosed with early-stage (clinical stage I and II) between the years of 2004 and 2013 were identified from the National Cancer Database (NCDB). Variables abstracted included: age, gender, clinical stage, race, comorbidity, insurance status, treating facility, treatment received and survival. Chi-square tests were used to compare clinical characteristics by therapy type. Kaplan-Meier, Cox regression, and propensity score analyses were employed for survival analyses.

      Result:
      Data from 12,414 patients with early-stage NSCLC were analyzed. Of these, 75.6% and 25.4% had clinical stage I and II disease, respectively. A total of 9,164 (73.6%) patients received SBRT alone and 3,268 (26.4%) had SBRT followed by chemotherapy. Among patients with clinical stage I, 83.5% received SBRT alone and 16.5% received SBRT followed by chemotherapy. Among those with clinical stage II, 43% received SBRT alone while 57% received SBRT followed by systemic therapy. On multivariate analysis, increasing age, male gender and stage II disease were associated with worse overall survival (OS). There was evidence of a clinical stage by treatment interaction (p <0.001). When treatment effect was analyzed by stage after adjusting for age and gender, patients with stage I treated with SBRT alone had a better median OS, 26.2 months compared to 22.4 months in the combined arm (HR=0.78; p<0.001; CI: 0.73-0.83). In contrast, among patients with stage II NSCLC, median OS was 15 months in the SBRT compared to 20.2 months in the combined group (HR=1.3; p<0.001; CI: 1.22-1.44).

      Conclusion:
      SBRT should be the sole modality treatment for patients with inoperable stage I NSCLC. However, patients with stage II disease appear to benefit from adjuvant chemotherapy. Randomized trials are needed in this area to answer this question conclusively.

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    MA 18 - Global Tobacco Control and Epidemiology II (ID 676)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Epidemiology/Primary Prevention/Tobacco Control and Cessation
    • Presentations: 1
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      MA 18.06 - Clinical Prognostic Model for Older Patients with Advanced Non-Small Cell Lung Cancer (ID 8113)

      15:45 - 17:30  |  Presenting Author(s): Apar Kishor Ganti

      • Abstract
      • Presentation
      • Slides

      Background:
      The median age at diagnosis of lung cancer is 70 years. Older patients are often not prescribed standard therapy. Due to multiple competing causes of death, older patients often do not demonstrate a benefit in overall survival (OS). It is important to know which older patients would actually be candidates for aggressive therapy based on their prognosis, and to develop a simple prognostic model that can help clinicians determine individual prognosis.

      Method:
      Data on patients enrolled on 38 NCI-sponsored cooperative group clinical trials of advanced non-small cell lung cancer (NSCLC) from 1991 to 2011 were analyzed. Multivariable Cox PH model was built with a stepwise procedure with all potential predictors: age, sex, race, ethnicity (Hispanic or non-Hispanic), performance status, initial stage, BMI, and weight loss in the past 3/6 months. We derived a prognostic score using the estimated Cox PH regression coefficient in the training set. To assess the performance of our prognostic model, we calculated the area under receiver operating characteristic (ROC) curve of 1- and 2-year survival in the testing set.

      Result:
      The final analysis included 1454 NSCLC patients ≥70 years of age. These patients were randomly divided into a training set (n=962) and a testing set (n=492). The prognostic risk score was calculated as: 3 (if male) + 3 (if PS=1) + 8 (if PS=2) + 11 (if initial stage=IV) + 4 (if weight loss). Patients were classified into three prognostic groups by tertiles: good (0-6), intermediate (7-14) and poor (≥15). The median OS in the three groups in the testing set were: 14.6 months (95% CI, 12.2-18.5); 12.2 months (95% CI, 10.7-14.4) and 7.0 months (95% CI, 5.6-8.9), respectively. Despite its simplicity, the present model had area under the 1-year and 2-year ROCs (0.63 and 0.68, respectively) that were higher than existing models.

      Conclusion:
      Male gender, poor performance status, distant metastases and weight loss immediately prior to diagnosis predict for poor OS in older patients with advanced NSCLC. This study proposes a simple prognostic model for older adults with advanced NSCLC based on basic clinical characteristics that are part of the routine evaluation process for every patient with NSCLC.

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    P2.14 - Radiotherapy (ID 715)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Radiotherapy
    • Presentations: 1
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      P2.14-006 - A Pilot, Randomized Trial of Daily Lisinopril vs Placebo to Prevent Radiation-Induced Pulmonary Distress (Alliance MC1221) (ID 8868)

      09:30 - 16:00  |  Author(s): Apar Kishor Ganti

      • Abstract

      Background:
      We report the results of a randomized, placebo-controlled pilot study for measuring the effect of lisinopril, an angiotensin-converting enzyme (ACE) inhibitor, on pulmonary distress in patients receiving thoracic radiotherapy (TRT) with or without chemotherapy. We aimed to evaluate the practicality for developing a larger-scale, randomized phase III study in the future.

      Method:
      Twenty-three (23) eligible patients receiving TRT (≥45 Gy) for predominantly non-small cell lung cancers were enrolled; an ECOG performance of 2 or better was required. The patients were randomized to receive either 20 mg of lisinopril or placebo once daily during and up to 3 months post-RT. The trial stopped early due to lower accrual than anticipated. The baseline and weekly during RT patient-reported outcome (PRO) results for Symptom Experience Questionnaire (SEQ), Lung Cancer Symptom Scale (LCSS), the EORTC for Lung Cancer Questionnaire (EORTC-QLQ-LC13), and Function Assessment of Cancer Treatment were analyzed. Adverse events (AE) were measured according to CTCAE v4.0. Our primary endpoint was safety and AE profile of lisinopril, followed by PRO comparisons; multiple comparisons for secondary analyses were not adjusted.

      Result:
      There were 11 and 12 eligible patients on the placebo and lisinopril arms, respectively. Mean age was 63.5 years; 13 (62%) were male. Eighteen (86%) were either former or current smokers. All baseline characteristics were balanced. All baseline PRO results were balanced except for more shortness of breath by SEQ/LCSS which were slightly worse in the placebo arm. The placebo patients reported more dyspnea on climbing stairs at baseline on EORTC-QLQ-LC13. The incidences of grade 2 hypotension were 2 vs. 4 patients for placebo and lisinopril, respectively (P=0.26). One (1) patient taking lisinopril had grade 2 acute kidney injury (P=0.20). One (1) patient developed grade 4 dyspnea on placebo arm. No patients experienced grade 5 toxicities. Patients taking lisinopril did not have more cough or allergic reaction. Acute respiratory distress as measured by worst dyspnea score was poorer in placebo vs. lisinopril patients (42.0 vs. 77.5 respectively, P=0.006). The rest of the PRO indices were with no clinically meaningful differences between arms.

      Conclusion:
      Although this novel trial was underpowered which was not intended, the results provided a strong signal for safety and perhaps even efficacy, by PRO, in concurrently administering lisinopril, an ACE inhibitor, for advanced lung cancer patients who require RT-based therapies. Using lisinopril for mitigating or preventing radiation-induced pulmonary distress or pneumonitis will require future trial testing. Support: UG1CA189823.

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    P2.15 - SCLC/Neuroendocrine Tumors (ID 716)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: SCLC/Neuroendocrine Tumors
    • Presentations: 1
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      P2.15-013 - Doxorubicin and Topotecan for Relapsed/Refractory Small Cell Lung Cancer (SCLC): A FPBCC Clinical Trials Network Phase I Study (ID 9151)

      09:30 - 16:00  |  Presenting Author(s): Apar Kishor Ganti

      • Abstract
      • Slides

      Background:
      Relapsed or refractory small cell lung cancer (SCLC) has a poor prognosis, with no good therapeutic options. Topotecan, a topoisomerase I inhibitor, and doxorubicin, a topoisomerase II inhibitor, are both active drugs in SCLC. We evaluated the safety and efficacy of a novel combination of oral topotecan and weekly doxorubicin, providing sequential topoisomerase I and II inhibition, in this setting.

      Method:
      Adult patients (>19 years) with relapsed or refractory SCLC who had received at least one prior chemotherapy regimen were included in the study. Patients received escalating doses of oral topotecan for five days (Days 1-5 of each cycle) every three weeks for a maximum of 5 cycles. The dosing cohorts were: DL1: 0.85 mg/m[2], DL2: 1.05 mg/m[2], DL3: 1.35 mg/m[2], DL4: 1.65 mg/m[2] and DL5: 2.30 mg/m[2]. All patients received weekly doxorubicin 20 mg/m[2] intravenously starting Day 6 of the first cycle and continued weekly for the duration of the study (maximum 15 weeks). The study design involved a standard 3+3 approach. In the absence of pre-specified criteria for dose limiting toxicities (DLT), patients were enrolled serially to escalated dose level cohorts. Patients received therapy until disease progression, undue toxicity or completion of the study. Primary objectives were safety and efficacy, dose limiting toxicity and response rate.

      Result:
      A total of 22 patients were enrolled in the study, of which 18 were evaluable for toxicity. Median age was 60.5 years, 72% were male and 95% were Caucasian. Most common adverse events observed were hematological toxicities. Grade 3/4 adverse events included: anemia (44%), thrombocytopenia (50%), neutropenia (44%), lymphopenia (33%), leucopenia (39%), transaminitis (17%), hypokalemia (11%), hypotension (5%) and dehydration (5%). There were no therapy-related Grade 5 toxicities. Incidence of DLT based on cohorts were: DL1: 0/3, DL2: 1/6 (Grade 4 Thrombocytopenia), DL3: 1/6 (AST Elevation) and DL4: 2/4 (Grade 4 Thrombocytopenia). Response rate was 16.6% (3/18) and disease control rate (SD + PR) was 33%. The median progression free and overall survival were 3.4 months and 5.8 months, respectively.

      Conclusion:
      The novel combination of oral topotecan and weekly doxorubicin was safe and showed promising efficacy in relapsed/refractory SCLC. The maximum tolerated dose of oral topotecan was 1.35 mg/m[2] when given concurrently with weekly doxorubicin. A phase 2 trial using this regimen is being developed.

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    P3.01 - Advanced NSCLC (ID 621)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.01-040 - Real-World Management of Patients with EGFR Mutation-Positive NSCLC in the US (ID 9408)

      09:30 - 16:00  |  Presenting Author(s): Apar Kishor Ganti

      • Abstract
      • Slides

      Background:
      Clinical trials have demonstrated the efficacy and safety of EGFR tyrosine kinase inhibitors (TKIs), as first-line therapy in patients with metastatic non-small-cell lung cancer (NSCLC) whose tumours harbour activating mutations in the EGFR gene. However, there are limited data in the real-world setting describing TKI use among patients with EGFR-mutated NSCLC.

      Method:
      A retrospective non-interventional study was conducted using the Flatiron Health database, a longitudinal database containing electronic health record data, of patients seen in over 265 United States cancer clinics (~800 sites of care). Adult patients with histologically confirmed stage IIIB or IV NSCLC, with documented EGFR-mutated disease (del 19 or L858R), and who had received the first sequence of systemic therapy between January, 2011 and March, 2016 were included. Patient demographic and clinical disease characteristics were analysed and time-to-next treatment (TTNT) was used as a surrogate measure for progression-free survival. If validated in time, overall survival data will be presented.

      Result:
      Overall 20,924 adult patients with advanced NSCLC were identified, of whom 12,148 (58.1 %) were tested for EGFR mutations. Among these, 1,919 (15.8 %) patients had a positive EGFR result with 1,412 patients carrying del 19 or exon 21 mutations. Of these, 886 patients were treated with regimens in the first-line setting. Median age was 69.0 years; 67.7% were female; 55.5% were Caucasian; 54.3% were non-smokers; 97.5% had non-squamous histology and 57.3% received at least one subsequent treatment. Most patients received a TKI (71.8%) and 28.2% received other therapy. There were no differences observed in a patient’s type of insurance and the type of treatment (TKI or chemotherapy) that they were likely to receive. Patients treated with an EGFR TKI had a significantly longer median TTNT [erlotinib (13.2 months [95% CI 12.2–14.4; p=<0.001]) afatinib (12.6 months [95% CI 8.6–16.2; p=<0.001]), gefitinib (not evaluable; due to small sample size n=9) than those treated with other anti-cancer agents (4.6 months [95% CI 4.0–5.4]).

      Conclusion:
      These real world data mirror the results shown in randomised clinical trials, with the exception of patients being generally older. Importantly, patients who did not receive a TKI had significantly shorter TTNT. A large proportion of patients (42%) are not being tested for EGFR mutations, although there was an improvement over time. The reasons for not testing all eligible patients for EGFR mutations should be investigated further.

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