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Chandra Belani



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    MA23 - Early Stage Lung Cancer: Present and Future (ID 926)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 10:30 - 12:00, Room 105
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      MA23.05 - Post-Operative Radiation Improves Overall Survival in Patients with Node-Positive Non-Small Cell Lung Cancer Undergoing Sublobar Resections (ID 14350)

      11:00 - 11:05  |  Author(s): Chandra Belani

      • Abstract
      • Presentation
      • Slides

      Background

      The incidence and prognosis associated with patients undergoing sub-lobar resections and having positive lymph nodes(PLN) has been rarely studied. Our investigation will retrospectively review this topic.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The National Cancer Database(NCDB) was queried during the years 2004-2014 to assess patients undergoing sub-lobar resection (wedge, segmentectomy, and sub-lobar-NOS, N = 38,599) and specifically the patients with PLN (N = 5484). Patients were excluded who had any pre-op chemotherapy and/or radiation, had follow-up of less than 3 months, had stage IV disease or >1 tumor nodule. Multi-variable modeling(MVA) was used to determine factors for overall survival (OS). Propensity score matching(PSM) was used to determine pre-operative risk factors for PLN in patients having at least one node examined(N=22712) (matched by median number of nodes examined) and to assess the role of radiation in those patients with node positive disease (matched by age, sex, stage, chemotherapy, and number of nodes positive).

      4c3880bb027f159e801041b1021e88e8 Result

      The incidence of PLN decreased progressively during our study from 17.9% in 2004 to 9.4% in 2014 (N1 8.3-5.0% and N2 9.6-4.4%). A lower risk of PLN was noted for squamous cell carcinomas, bronchoalveolar (minimally invasive) adenocarcinomas, and right upper lobe locations; but the risk increased with age, tumor size and clinical stage. In the node positive group, MVA demonstrated that OS was worse with males, older ages, non-Hispanic Whites (compared to Asian and Hispanic Whites), lowest income quartile, Charlson co-morbidity > 0, grade, tumor size, number of positive nodes, positive surgical margins, length of stay, and not receiving chemotherapy or radiation. PSM demonstrated that radiation increased OS in patients having PLN regardless of margin status or N level involvement.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The incidence of node positive sub-lobar resections has decreased during the years of our study, but still can be found in nearly 10%. In both MVA and PSM, post-operative radiation improves OS.

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-86 - BTCRC-LUN15-017: Phase-Ib Study of Imprime PGG and Pembrolizumab in Stage IV NSCLC after Progression on Platinum Based Therapy (ID 12794)

      16:45 - 18:00  |  Author(s): Chandra Belani

      • Abstract
      • Slides

      Background

      Imprime PGG (Imprime) is a β-glucan isolated from a proprietary strain of Saccharomyces cerevisiae. It acts as pathogen associated molecular pattern, creating ‘non-self’ signals, enhancing innate immune cell killing, and possibly T-cell cross-talk, thereby enhancing efficacy of checkpoint inhibitor therapy like pembrolizumab. Clinical use of Imprime in combination with chemotherapy and monoclonal-antibodies has been reported, however no studies to date have evaluated its use with anti-PD-1 therapy. We aimed to evaluate safety and tolerability of Imprime with pembrolizumab.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This is a single-arm, phase-1b, open-label, dose-escalation trial for patients with stage IV NSCLC after progression on platinum-based chemotherapy. Key eligibility included measurable disease, adequate organ function and ECOG performance status of 0-2. Patients received 2 mg/kg or 4 mg/kg IV Imprime on day 1, 8, 15, and 200mg IV pembrolizumab on day 1, every 21 days. “3+3” design was used to establish highest tolerated dose. The dose with toxicity rate of <33% in first cycle would be considered the recommended phase-II dose i.e.≤1 out of 6 patients experience dose limiting toxicity (DLT). Primary endpoint was to establish highest tolerated dose of Imprime for recommendation for phase-II study. Secondary objectives were to define safety and tolerability, and to correlate clinical benefit with biomarkers on immune cells, soluble PD-L1 levels, anti-β-glucan antibody and FcγRIIa polymorphism. This trial is registered with ClinicalTrials.gov, NCT03003468.

      4c3880bb027f159e801041b1021e88e8 Result

      Between 07/2017-02/2018, nine patients were enrolled: three patients received 2 mg/kg and six received 4 mg/kg dose of Imprime. Eight out of nine patients had one line of treatment prior to participation, and one had two lines. Two patients received eleven cycles with 4 mg/kg Imprime. To date, no DLTs have been recorded and the highest dose of Imprime was well tolerated. Five patients stopped treatment due to progression. Four patients are continuing treatment. No patients stopped treatment due to toxicity. Most common adverse event (AE) at 2 mg/kg was grade 1 sore throat in two patients. One Grade 3 diarrhea and one grade 3 neutropenia were reported. Most common AE in the 4 mg/kg group was grade 1 headache in three patients. One episode of grade 3 diarrhea was reported. There were no grade 4 or 5 toxicities. The results of the immunopharmacodynamic analysis will be reported when available.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Imprime in combination with pembrolizumab is well tolerated in outpatient settings and the role of this combination in treatment of NSCLC warrants further investigation. Phase-II enrollment of this trial is ongoing.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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