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Kristin A Higgins



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    OA 01 - The New Aspect of Radiation Therapy (ID 652)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Radiotherapy
    • Presentations: 1
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      OA 01.06 - Radiation Therapy is Associated with an Increased Incidence of Cardiac Events in Small Cell Lung Cancer Patients (ID 8469)

      11:00 - 12:30  |  Author(s): Kristin A Higgins

      • Abstract
      • Presentation
      • Slides

      Background:
      Radiation (RT) dose to the heart was a predictor of inferior overall survival (OS) in the non-small cell lung cancer trial RTOG 0617, but little data quantifies cardiac morbidity for small cell lung cancer (SCLC) patients treated with RT.

      Method:
      The Surveillance, Epidemiology, and End Results (SEER) Program database and Medicare claims data were queried to establish rates of cardiac events (CE) among SCLC patients treated with chemotherapy (CTX) +/- RT. CE were defined as any new cardiac diagnosis including ischemic disease, cardiomyopathy, dysrhythmia, heart failure, and pericarditis. Chronic/pre-existing diagnoses were not counted as events. CTX-only patients were matched to CTX + RT patients to account for start date of RT. Second phase of propensity score matching (PSM) balanced demographical and clinical differences. Multivariate analysis (MVA) determined effect of tumor and RT covariates on CE and OS. Kaplan-Meier and cumulative incidence (CI) function curves were generated.

      Result:
      From 2000 – 2011, 7,060 patients were available: 2,892 (40.9%) limited-stage and 4,168 (59.0%) extensive-stage. As expected, CTX + RT patients had better OS (p < 0.001). OS for the CTX + RT and CTX-only groups: 35.0 vs. 21.4% at 12 months, and 6.6 vs 2.3% at 60 months, respectively. RT was associated with CE (p = 0.008), with CI as follows for the CTX + RT and CTX-only groups: 36.4 vs. 35.4% at 12 months, and 44.1 vs 39.0% at 60 months, respectively. MVA demonstrated higher hazard ratio of CE for extensive-stage patients (p < 0.001), black race (p < 0.001), and increased Charlson-Deyo score (p = 0.001). After PSM, 5,286 patients were included. Again, CTX + RT patients had better OS (p < 0.0001). OS for the CTX + RT and CTX-only groups: 30.6 vs. 22.5% at 12 months, and 5.3 vs 2.7% at 60 months, respectively. RT was still associated with CE (p = 0.033) after PSM, with CI of CE for the CTX + RT and CTX-only groups: 36.3 vs. 34.8% at 12 months, and 43.0 vs 38.6% at 60 months, respectively. Tumor laterality (p = 0.84) and RT modality (p = 0.62) were not associated with CE, though low numbers were treated with intensity-modulated versus 3D conformal RT (1:15 ratio).

      Conclusion:
      In this large database study we demonstrated RT is associated with an absolute increase in the rate of CE at 5-years of approximately 5%. Further evaluation of cardiac sparing radiation techniques should be evaluated for patients with SCLC.

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    P1.08 - Locally Advanced NSCLC (ID 694)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      P1.08-003 - Concomitant Chemotherapy and Radiotherapy with SBRT Boost for Unresectable, Stage III Non-Small Cell Lung Cancer: A Phase I Study (ID 8181)

      09:30 - 16:00  |  Presenting Author(s): Kristin A Higgins

      • Abstract

      Background:
      Stereotactic Body Radiation Therapy (SBRT) is now the standard of care in medically inoperable stage I non-small cell lung cancer, yielding high rates of local control. It is unknown if SBRT can be safely utilized in the locally advanced NSCLC setting. This multi-institution phase I study evaluated the safety of 44 Gy conventionally fractionated thoracic radiation with concurrent chemotherapy plus a dose escalated SBRT boost to both the primary tumor and involved mediastinal lymph nodes. The primary endpoint of this study was to establish the maximum tolerated dose (MTD) of the SBRT boost.

      Method:
      Inclusion criteria included unresectable stage IIIA or IIIB disease, primary tumor ≤8 cm, and N1 or N2 lymph nodes ≤5 cm. Tumors were staged with PET/CT while four dimensional CT simulation was employed for radiation planning. The treatment schema was 44 Gy thoracic radiation (2 Gy/day) with weekly carboplatin and paclitaxel chemotherapy. A second CT simulation was obtained after 40 Gy was delivered, and a SBRT boost was planned to the remaining gross disease at the primary site and involved lymph nodes. Four SBRT boost dose cohorts were tested: Cohort 1 (9 Gy x 2); cohort 2 (10 Gy x 2); cohort 3 (6 Gy x 5); and cohort 4 (7 Gy x 5). Patients were treated in cohorts of three patients and using Bayesian Escalation with Overdose Control (EWOC) method to determine Maximum tolerated dose of the SBRT boost. Dose limiting toxicities (DLT) were defined as any grade 3 or higher toxicities within 30 days of treatment attributed to treatment, not including hematologic toxicity, or any grade 5 toxicity attributed to treatment.

      Result:
      The study enrolled 19 patients from 11/2012-12/2016. There were 4 screen failures and 15 patients were treated on study. There were no DLTs in dose cohort 1 (n = 3) and 2 (n = 6). One patient in dose cohort 3 (n = 3) developed a DLT, and 2 patients in dose cohort 4 (n = 3) developed a DLT. The calculated MTD was 6 Gy x 5. The DLT observed at this dose level was a tracheoesophageal fistula; given this substantial toxicity, there was investigator reluctance to enroll further patients in this dose level. Thus the calculated MTD is 6 Gy x5, however 10 Gy x 2 is felt to be a reasonable dose as well given no grade 5 toxicities occurred with this dose.

      Conclusion:
      The MTD of a SBRT boost combined with 44 Gy thoracic chemoradiation is 6 Gy x 5. A SBRT boost dose of 10 Gy x 2 could be considered very safe with no grade 3 or higher toxicities observed at this dose level.

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    P3.13 - Radiology/Staging/Screening (ID 729)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      P3.13-027 - Utilization of PET Scan in Advanced Stage Non-Small Cell Lung Cancer in the United States (ID 10031)

      09:30 - 16:00  |  Author(s): Kristin A Higgins

      • Abstract

      Background:
      PET scans are used during diagnosis and staging of lung cancer. The role of PET scan in guiding therapy for advanced stage non-small cell lung cancer (NSCLC) is not proven, but it continues to be used during the treatment course at many centers. We studied the Surveillance, Epidemiology, and End Results (SEER) Program database and Medicare claims data to evaluate the use of PET scan in advance stage NSCLC patients in the United States and the impact on patient outcome.

      Method:
      The SEER-Medicare database was queried to capture patients with stage IV non-small cell lung cancer diagnosed between the years 2000-2011. The cohort of patients that received PET scan after diagnosis were analyzed and compared with the cohort that did not receive PET. The univariate (UV) association between covariates and overall survival (OS) were compared by log-rank tests. Time dependent Cox Model was used in multivariable (MV) analysis, with time from diagnosis to first PET scan as time-dependent variable, while the other covariates as time-independent. All analyses were performed using SAS Version 9.4.

      Result:
      A total of 52,712 eligible patients with stage IV NSCLC were identified between 2000-2011, out of which 13,873 (26.3%) had received PET scan. Characteristics of PET cohort: median age 74 years, 53% male, 87% white and 82% from metro locations. 87% of the patients that received PET were diagnosed between 2006-2011. In the first year after diagnosis, 70% of the patients had 1 PET, 16% had 2 PETs and 14% had 3 or more PETs. About 64% of the patients had received their first PET scan within 2 months of diagnosis and 19% had it between 2 to 6 months. The average Medicare cost associated with patients that received PET was significantly higher than that of patients that did not receive PET scan ($60,417 vs. $34,287; p<0.001). Chemotherapy and radiation were given in a higher proportion of patients that received PET versus those that did not receive it (56% and 45% versus 26% and 36% respectively; p<0.001). Though univariate analysis revealed that a PET scan within a year of diagnosis was associated with better 1-year survival (HR 0.87, P<0.001), this did not translate into overall survival advantage on multivariable analysis (HR 0.99, P=0.56).

      Conclusion:
      The utilization of PET scan in stage IV NSCLC patients was associated with higher cost, but without a tangible improvement in survival compared to those that did not have a PET scan.