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CIARAN J McNamee
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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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P2.04-88 - Surgical Outcomes of a Multicenter Phase II Trial of Neoadjuvant Atezolizumab in Resectable Stages IB-IIIB NSCLC: Update on LCMC3 Clinical Trial (ID 1817)
10:15 - 18:15 | Author(s): CIARAN J McNamee
- Abstract
Background
The role of immune checkpoint inhibitors in resectable NSCLC remains undefined. We report the updated safety results of the first multicenter trial assessing neoadjuvant atezolizumab (a PD-L1 inhibitor) for resectable NSCLC.
Method
Eligible patients with clinical stage IB-IIIB resectable NSCLC received 2 cycles of neoadjuvant atezolizumab (1200 mg, days 1, 22) followed by surgical resection (day 40±10). Pre- and post-treatment PET/CT, pulmonary function tests (PFT), and bio-specimens were obtained. Adverse events (AE) were recorded according to CTCAEv.4.0. Preoperative treatment-related TRAE (preop-TRAE) and postoperative TRAE (postop-TRAE) defined as AE onset on, or after date of surgery, were analyzed.
Result
Follow-up data to post-surgery visit were analyzed for 101 patients out of planned 180: mean age: 64.6 years; male: 47/101(46.5%); current smokers: 23/101(22.8%); non-squamous histology: 66/101(65.3%); and clinical stages IB(10.9%), IIA(15.8%), IIB(27.7%), IIIA(38.6%), and IIIB(6.9%). Two cycles of atezolizumab were not completed in 5/101(5.0%) patients due to grade 1 or 2 AEs. Surgery was not performed in 11/101(10.9%) patients: 5 demonstrated disease progression, and 6 for ‘other’ reasons. 6/101(5.9%) patients were deemed unresectable. Surgery was delayed (outside of 10-day window) in 10/90(11.1%) patients by an average of 11(1-39) days. Two of these delays were due to TRAEs (hypothyroidism and pneumonitis), 3 were patient-elected delays, 2 were surgeon-related, and 3 for ‘other’ reasons. Intraoperative vascular complications occurred in 2/90(2.2%) and extensive hilar fibrosis was noted in 20/90(22.2%) patients. Overall, there was insignificant mean change in the PFTs pre- vs. post-atezolizumab therapy. Only 3/101(3.0%) patients had treatment-related dyspnea, dyspnea on exertion, or pneumonitis.
Table 1
ConclusionTreatment Related Adverse Events
(TRAE)
Preoperative TRAE
(N = 101)
Postoperative TRAE
(N = 90)
All AEs
Any grade
55 (54.5%)
20 (22.2%)
Grade 1
29 (28.7%)
7 (7.8%)
Grade 2
24 (23.8%)
9 (10.0%)
Grade 3
2 (2.0%)
4 (4.4%)
Grade 4
0
0
Grade 5
0
0
Specific AEs
Dyspnea
1 (1.0%; grade 2)
3 (3.3%; grade 1)
Dyspnea on exertion
1 (1.0%; grade 1)
0
Myalgia
4 (4.0%; grade 1 or 2)
0
Hyperthyroidism
3 (3.0%; grade 1 or 2)
1 (1.1%; grade 1)
Hypothyroidism
0
1 (1.1%; grade 2)
Pneumonitis
1 (1.0%; grade 3)
3 (3.3%; grade 2 or 3)
Transaminitis (AST or ALT)
8 (7.9%; grade 1 or 2)
3 (3.3%; grade 1 or 2)
Post-atezolizumab Change in Pulmonary Function Tests
PFT factor
Mean change (95% Confidence Interval)
FEV1 (N = 72)
-0.6% (-2.6% to 1.3%)
FVC (N = 72)
0.0% (-1.8% to 1.8%)
DCLO (N = 64)
-1.2% (-4.1% to 1.7%)
Treatment with neoadjuvant atezolizumab in resectable stage IB-IIIB NSCLC was well tolerated, with minimal delay to surgery, and few treatment associated AEs. This trial continues to accrue and assess MPR, survival, and other long-term endpoints.