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Daniel Gomez



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    OA01 - Improving Outcomes in Locoregional NSCLC I (ID 892)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 107
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      OA01.06 - DETERRED:  Phase II Trial Combining Atezolizumab Concurrently with Chemoradiation Therapy in Locally Advanced Non-Small Cell Lung Cancer (ID 12842)

      11:25 - 11:35  |  Author(s): Daniel Gomez

      • Abstract
      • Presentation
      • Slides

      Background

      While consolidation immunotherapy after chemoradiation (CRT) is the current standard of care for locally advanced NSCLC (LA-NSCLC), the effectiveness of immunotherapies may be enhanced when combined concurrently with CRT. We report on the safety and preliminary efficacy of combining PD-L1 blockade using atezolizumab (atezo) and concurrent CRT followed by consolidation full dose carboplatin/paclitaxel (CP) with atezo and maintenance atezo up to 1 year for LA-NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This is a single institution phase II study in LA-NSCLC assessing the safety and feasibility of adding atezo to CRT in two parts: I) sequentially (N=10) with CP after completing CRT, or II) concurrently (N=30) with CRT followed by consolidation atezo with CP. Atezo was given at 1200 mg IV Q3 weeks for up to one year from the first dose. Radiation dose at 60-66 Gy in 30-33 fractions was combined with weekly low dose CP, followed by 2 cycles of full dose CP. Severe adverse events (AEs) ≥ grade 3 are defined within 15 weeks of start of therapy or any immune-related AEs during atezo treatment. Evaluable patients (pts) have received at least one dose of atezo.

      4c3880bb027f159e801041b1021e88e8 Result

      From February 2016 to April 2018, we accrued 40 evaluable pts. For part 1, any grade 3+ AEs was seen in 6 pts (60%), with most common being pneumonia (2 of 10, 20%). Three grade 3+ AEs (30%) were attributed to atezo, including dyspnea, arthralgia and a grade 5 TE fistula. Grade 2 radiation pneumonitis (RP) was seen in 3 pts. Four progressed with disease during atezo maintenance and have died, ranging from 0.93 to 1.86 years. Four pts completed atezo and are in follow up without recurrence. For part 2, 17 of 30 pts had any grade 3+ AEs (57%), with pneumonia being the most common (6 of 30, 20%). Three (10%) were attributed to atezo (dyspnea, fatigue and heart failure). RP was seen in 3 pts, with 2 grade 2 and 1 grade 3, which led to atezo discontinuation. So far, 4 pts have progressed and 4 have died, 2 due to disease and 2 due to treatment (neutropenic sepsis and gastric hemorrhage). All others have completed CRT and are on maintenance atezo, ranging from 5 to 19 doses. Updated efficacy results will be presented.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Concurrent atezo with CRT followed by consolidation and maintenance atezo appears safe without increased toxicities compared to CRT alone followed by consolidation and maintenance atezo.

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    P2.04 - Immunooncology (Not CME Accredited Session) (ID 953)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.04-25 - Randomized Clinical Trial Comparing Immunotherapy Plus SABR (I-SABR) Versus SABR Alone for Early Stage NSCLC (ID 12620)

      16:45 - 18:00  |  Author(s): Daniel Gomez

      • Abstract
      • Slides

      Background

      Section not applicable

      Stereotactic ablative radiotherapy (SABR), which delivers high biologically effective radiation doses, can kill cancer cells, release tumor-associated antigens, and activate tumor-specific T cells, thereby functioning as a cancer-specific vaccine in situ. The combination of the immune-triggering effects of ionizing radiation with immune check point PD-1inhibitor may leverage the effects of radiotherapy, transforming what was once considered a local therapy to a novel systemic treatment. Further, the combined effects of local tumor control plus systemic control may improve cure rate in early stage NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Section not applicable

      This is a randomized phase II trial (NCT03110978) designed to study SABR (biological effective dose >100 Gy) with or without concurrent and adjuvant Nivolumab for total of 7 doses in early stage or isolated recurrent NSCLC. Inclusion criteria: stage I disease (tumor size ≤5 cm, N0M0) OR selected cases of stage IIa disease (tumor size >5 cm but ≤7 cm, N0M0), including multiple primary tumors, OR isolated lung-parenchymal recurrent or persistent NSCLC suitable for SABR. Tumor tissue /blood/stool samples will be collected before/during/after treatment and at the time of recurrence. Primary endpoints: Event-free survival (EFS), defined as local recurrence, regional recurrence, distant metastasis, secondary malignancy and death; secondary endpoints: overall survival; toxicity; exploratory analyses of potential predictive markers and immunologic mechanisms of action.

      Statistical design: It is considered clinically significant with a decrease of the 4-year cumulative event rate from 46% to 23%. Assuming a one-sided type I error rate of 0.05, an accrual rate of 3.5 patients per month, and an additional 20 months of follow-up, a study with 70 patients in each arm will have 85% power to detect an improvement of 23% in 4-year EFS rate. One interim analysis will be done to allow early termination of the trial should evidence at that time reveal that I-SABR is superior to SABR-only or that no difference is found between the two treatment arms.

      4c3880bb027f159e801041b1021e88e8 Result

      Section not applicable

      Up to April 30, 2018, 36 of planned 140 patients have been enrolled.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Section not applicable

      Phase II randomized clinical trial comparing immunotherapy plus Stereotactic Ablative Radiotherapy (I-SABR) versus SABR Alone for stage I, selected stage IIa or isolated lung parenchymal recurrent Non-Small Cell Lung Cancer is ongoing and met with anticipated enrolment rate.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-26 - A Framework for Systematic Clinical Evaluation of Technical Innovations in Lung Cancer Patients Treated on the MR-Linac (MRL) (ID 12562)

      12:00 - 13:30  |  Author(s): Daniel Gomez

      • Abstract
      • Slides

      Background

      A recent innovation in radiotherapy is the MRL developed by Elekta and Philips. The MRL combines a 1.5 T MRI with a 7 MV linac. It allows the acquisition of high resolution MR images for on treatment verification, adaption and response monitoring.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Seven cancer institutions from Europe and North America, are working within the Elekta MR-Linac Consortium to evaluate the MRL within a framework called ‘R-IDEAL’ (Radiotherapy Idea Development Exploration Assessment Long-term Evaluation) 1.

      4c3880bb027f159e801041b1021e88e8 Result

      The table below summarizes the ongoing and planned work within the Elekta MR-Linac Consortium.

      table for wlcc 3-5-2018.jpg

      Progress to date:
      Stage 0:
      We defined in 80 patients the optimal MRI sequences suitable for GTV and organ at risk (OAR) contouring: T2 Turbo Spin Echo (TSE), T2 TSE with fat sat, T1 radial gradient echo, and DIXON TSE. Two radiology-led workshops were organized and inter-observer agreement was assessed for OARs. These led to a consensus-based OAR atlas. A study is being prepared to compare the image quality of the current standard CBCT and MR images at baseline and mid-treatment for treatment verification and set-up correction.
      Stage 1: we will investigate the clinical feasibility of the MRL for standard of care radiotherapy and the scope for adaptive radiotherapy (margin reductions) and detecting changes in oxygenation during treatment on the MRL in patients with locally advanced (LA) NSCLC .
      Stage 2a/b : Based on the results from stage 1 we will design a study aiming to reduce margins around the tumour and dose escalate in patients with LA NSCLC.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The aim of this programme of work is to generate robust evidence to support the introduction of the MRL and to improve outcomes of patients with LA NSCLC.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    PC03 - Controversies in Management of Resectable Thymoma (ID 842)

    • Event: WCLC 2018
    • Type: Pro-Con Session
    • Track: Thymoma/Other Thoracic Malignancies
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 15:15 - 16:45, Room 205 AC
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      PC03.02 - Post-Operative Radiation Therapy or NOT: CON (ID 11609)

      15:25 - 15:35  |  Presenting Author(s): Daniel Gomez

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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