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Ellen A Wiegner
MA02 - Miscellaneous Topics in the Management of Early Stage Lung Cancer (ID 116)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Now Available
- Moderators:Mireia Serra-Mitjans, Thomas A. D'Amico
- Coordinates: 9/08/2019, 10:30 - 12:00, Interlaken (1988)
MA02.07 - A Phase I Trial of an Immune Checkpoint Inhibitor Plus Stereotactic Ablative Radiotherapy in Patients with Early Stage Non-Small Cell Lung Cancer (Now Available) (ID 1967)
10:30 - 12:00 | Author(s): Ellen A Wiegner
Stereotactic ablative radiation therapy (SABR) is the standard-of-care for medically inoperable, early stage non-small cell lung cancer (NSCLC), but regional and distant failures remain problematic. Based on in vivo preclinical data showing synergy between radiation and immune checkpoint inhibitors (ICI) and the known efficacy and mild toxicity profile of ICI in Stage III and IV NSCLC, we conducted a phase I study to determine the safety, tolerability and maximum tolerated dose of neoadjuvant, concurrent, and adjuvant atezolizumab with SABR for high risk early stage NSCLC (NCT02599454).Method
Eligible patients had histologically confirmed T1-3 NSCLC with one or more features predictive of increased recurrence risk: diameter ≥1 cm, SUV ≥6.2 on FDG PET, or moderately/poorly differentiated histology. Patients were medically inoperable or refused surgery, and had a Zubrod PS ≤2. Patients received 6 cycles of atezolizumab IV in 21 day cycles. A 3+3 dose finding design was employed with three dose levels: 3 mg/kg, 10 mg/kg, and 1200 mg flat dosing. SABR was delivered starting cycle 3 to 50 Gy over 4-5 fractions. Patients were restaged after cycle 2, prior to SABR. Dose limiting toxicity (DLT) was assessed during the first 9 weeks of treatment.Result
From April 2016-June 2018, a total of 15 patients enrolled, with 12 evaluable for DLT assessment. Three patients chose to discontinue treatment due to travel issues (1 pt), a COPD exacerbation (1 pt) and grade 2 liver function tests (LFTs) (1 pt). One patient on dose level 2 developed DLT, a grade 3 rash requiring discontinuation of protocol therapy. No other DLTs occurred, resulting in a recommended dose of 1200 mg for future studies. Eleven patients completed protocol treatment. Other grade 3 toxicities include transient lymphopenia in 4 patients. One patient each developed grade 2 pneumonitis, grade 2 hypothyroidism, and grade 2 hyperthryoidism. Three patients had a radiographic partial response and 1 patient had a minor response following 2 cycles. No patient had progressive disease prior to SABR. Results of correlative blood and tissue studies will also be reported.Conclusion
Neoadjuvant, concurrent, and adjuvant atezolizumab in combination with SABR for early stage NSCLC is well-tolerated, with radiographic PR prior to SABR in 25% of our cohort. Overall efficacy data is premature. Enrollment to an expansion cohort is ongoing, and this combination will be tested in an upcoming randomized phase III trial SWOG/NRG S1914.
This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Lung Cancer Research Program under Award no. W81XWH-15-2-0063.
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