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A. Marr



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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): A. Marr

      • 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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    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  |  Author(s): A. Marr

      • 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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