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Rathi N Pillai



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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 - 09:30  |  Author(s): Rathi N Pillai

      • 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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    P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Clinical Design, Statistics and Clinical Trials
    • Presentations: 1
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      P3.04-008 - A Phase 1b/2 Study of Atezolizumab With or Without Daratumumab in Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) (ID 10214)

      09:30 - 09:30  |  Presenting Author(s): Rathi N Pillai

      • Abstract

      Background:
      Daratumumab (DARA), a human CD38 monoclonal antibody, is approved for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). DARA produces deep clinical responses in RRMM and induces T-cell expansion through the reduction of immune suppressive cell populations, such as CD38[+] myeloid-derived suppressor cells and regulatory T and B cells. Atezolizumab (atezo) is a humanized programmed death-ligand 1 (PD-L1) monoclonal antibody that blocks the interaction between PD-L1 and the programmed death-1 and B7.1 receptors, reinvigorating anticancer immune responses. Atezo was recently approved for patients with metastatic NSCLC that progressed on or during platinum therapy based on data showing improved overall survival (OS) in the atezo vs docetaxel treatment arm in two clinical trials. The combination of DARA and atezo may improve clinical responses in NSCLC by enhancing anti-tumor T-cell responses facilitated by checkpoint inhibition. This study will assess the anti-tumor activity and safety profile of DARA plus atezo vs atezo alone in patients (pts) with previously treated advanced or metastatic NSCLC.

      Method:
      This is an ongoing phase 1b/2 randomized, open-label, multicenter study of DARA (16 mg/kg intravenous [IV] weekly for 3 cycles [Days 1, 8, and 15] and then Day 1 of each 21-day cycle thereafter) in combination with atezo (1200 mg IV; Day 2 of Cycle 1 and Day 1 of each 21-day cycle thereafter) versus atezo alone (1200 mg IV; Day 1 of Cycle 1 of each 21-day cycle). Eligible pts (≥18 years) must have advanced or metastatic NSCLC and have received 2 or more cycles of standard platinum-based therapy with disease progression or intolerance to therapy. Eastern Cooperative Oncology Group performance status of ≤1 and known PD-L1 tumor status are required. Pts previously treated with anti-CD38 therapy, including DARA, CD137 agonists, or immune checkpoint inhibitors are excluded. The primary endpoint is overall response rate. Secondary outcomes include safety, duration of response, clinical benefit rate (≥16 weeks duration), progression-free survival, OS, and pharmacokinetics and immunogenicity of DARA and atezo when given in combination. Approximately 96 pts will be enrolled; 6 pts will receive combination therapy in a safety run-in cohort for evaluation of dose-limiting toxicity followed by 90 pts randomly (1:1) assigned to the 2 treatment arms. ClinicalTrials.gov number, NCT03023423.

      Result:
      Section not applicable

      Conclusion:
      Section not applicable

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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 - 09:30  |  Author(s): Rathi N Pillai

      • 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.