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Jimmy Ruiz



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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-76 - Randomized Phase II Study of Immunotherapy With or Without Low Dose Chemotherapy for Patients with Performance Status of 2 (ID 2698)

      09:45 - 18:00  |  Author(s): Jimmy Ruiz

      • Abstract
      • Slides

      Background

      Combination chemo-immunotherapy has become a standard of care for patients with non-small cell lung cancer (NSCLC) who have performance status (PS) of 0-1. Limited information is available regarding optimal immunotherapy treatment options for patients with PS 2. In the current study, we examined the clinical and immunologic effects of immunotherapy alone or in combination with low dose carboplatin and paclitaxel as a potential treatment option for the PS 2 population.

      Method

      This randomized phase II study will enroll 40 patients total with 1:1 randomization to pembrolizumab 200 mg day 1 every 3 weeks or pembrolizumab 200 mg day 1 with carboplatin AUC 1 and paclitaxel 25 mg/m2 days 1, 8, and 15 every 3 weeks. At the time abstract preparation, 36 evaluable patients have been enrolled with 28 patients having completed response evaluation. Blood for circulating immune cell phenotyping, soluble program death ligand 1 (sPD‑L1), and immune-modulatory miRs was collected prior to treatment and at weeks 4 and 7. Investigator assessed irRECIST responses were examined at week 8 and every 12 weeks thereafter.

      Result

      Responses have been observed in 6 out of 16 patients (38%) in the control arm and 7 out of 12 patients (58%) in the experimental arm. Treatment related adverse events have been similar between the two arms with increases in infusion reactions in patients receiving low-dose carboplatin and paclitaxel. Interim biomarker analyses indicate circulating myeloid derived suppressor cells numbers decreased in patients receiving pembrolizumab combined with carboplatin and paclitaxel but not in patients receiving pembrolizumab alone. Accrual is expected to complete soon with updated response rates and progression free survival are anticipated to be mature and will be presented at the time of the meeting.

      Conclusion

      The combination of pembrolizumab with low-dose weekly carboplatin and paclitaxel is well-tolerated and active in the PS 2 population. Comparison of this regimen to pembrolizumab alone will be performed once data have matured.

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    P2.04 - Immuno-oncology (ID 167)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.04-93 - Performance Status and Age as Predictors of Immunotherapy Outcomes in Advanced Non-Small Cell Lung Cancer (ID 2666)

      10:15 - 18:15  |  Author(s): Jimmy Ruiz

      • Abstract
      • Slides

      Background

      Immunotherapy has become a standard of care treatment for patients with advanced non-small cell lung cancer (NSCLC). While a survival advantage has been proven for patients who are medically fit, it is unknown whether a benefit exists for patients with poor performance status (PS). PS has been established as one of the most powerful independent prognostic factors in advanced NSCLC since it is a strong predictor of survival and adverse events. When treated with conventional chemotherapy, patients with poor PS have worse outcomes and higher rates of toxicity which is why they have been excluded from many clinical trials. Standard treatment is generally recommended in patients with PS 0-1, while best supportive care is offered to patients with PS 4. Clinical trials are needed to define the best practices for patients with PS 2 and PS 3.

      Method

      We performed a retrospective analysis of NSCLC patients who received immunotherapy in our health system. Patients were identified using drug administration and diagnosis codes. Age and PS at the time of initial immunotherapy administration were assigned based on physician documentation. Radiographic response and date of progression were initially assigned according to the treating physician’s assessment and confirmed by the study team. Immune related adverse events (irAE) were extracted from records. All steroid prescriptions and hospitalizations were independently reviewed and attributions assigned.

      Result

      We identified 285 NSCLC patients who received immunotherapy between January 2014 and April 2018. In this group, 153 patients (53.7%) had PS 0-1, 114 (40.0%) had PS 2, and 18 (6.3%) had PS 3. Response rates were similar across PS groups with responses in 26.6% for PS 1, 25.2% for PS 2, and 23.1% for PS 3 (p=.95). Survival outcomes varied with pre-treatment PS. For PS 0-1, PS 2, and PS 3, median overall survivals (OS) were 14.7 months, 8.3 months, and 1.5 months (p<0.001), and progression-free survivals (PFS) were 7.4 months, 5.1 months, and 1.3 months (p<0.001). OS and PFS outcomes were not significantly different for older and younger patients. Patients less than 70 years had a lower rate (7.6%) of irAE requiring steroids compared to patients over 70 (15%) (p=0.04). Patients less than 70 had a higher mean number of ICU admissions (p=0.04) and total days in the ICU (p=0.007) compared to patients over 70.

      Conclusion

      Patients with poor baseline PS demonstrate similar response rates but inferior PFS and OS compared to medically fit patients. Prospective trials are needed to optimize treatment for this large population. Differences in irAE management and irAE severity according to age warrant further investigation.

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