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Maria Virginia Bluthgen
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FP07 - Pathology (ID 109)
- Event: WCLC 2020
- Type: Posters (Featured)
- Track: Pathology, Molecular Pathology and Diagnostic Biomarkers
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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FP07.06 - Lung Immune Prognostic Index (LIPI) in Advanced NSCLC Patients Treated with Immunotherapy, Chemotherapy and both Combined Upfront. (ID 823)
00:00 - 00:00 | Author(s): Maria Virginia Bluthgen
- Abstract
Introduction
The Lung Immune Prognostic Index (LIPI) that combines the neutrophils/[leucocytes minus neutrophils] ratio (dNLR) and lactate dehydrogenase (LDH), is associated with outcomes in pretreated advanced NSCLC patients receiving single agent immune checkpoint inhibitors (ICI). However, its role in first line treatment of advanced NSCLC patients has not been explored yet. We assessed the value of baseline LIPI in the first line setting, for ICI-monotherapy, ICI-combination or platinum-based chemotherapy alone (CT).
Methods
We retrospectively collected data of patients treated with first-line ICI between 2016 and 2019 as single agent if PD-L1 ≥50% (ICI-cohort), or in combination with a CTLA4-inhibitor (ICI+ICI cohort), or with chemotherapy (ICI+CT cohort), from 18 centers worldwide. A control cohort of patients treated with platinum-based CT (CT-cohort) was also collected between 2011 and 2019 from 2 centers. Baseline LIPI was calculated as previously reported and correlated with overall survival (OS) and progression-free survival (PFS) in each treatment cohort.
Results
Overall, 930 patients were enrolled, 561 in the ICI-cohort, 186 in the combo ICI+CT, 55 in the ICI+ICI and 128 in the CT-cohort. Median (m) follow-up was 12.5 months. In the whole cohort, median age was 66 years, 70% male, 80% had non-squamous histology, and 84% had PS ≤1. Based on LIPI (available for 792 patients): 305 (38%) were considered good, 331 (42%) intermediate and 156 (20%) poor group.
Treatment outcomes according to LIPI scores are depicted in Table 1. The LIPI poor population had significantly worse OS compared with other LIPI groups, in the whole cohort (P<0.001) as well as in the ICI monotherapy and combo ICI+CT cohorts (both P<0.0001); and in the CT cohort (P=0.004). In term of PFS, we observed correlation between LIPI groups and outcomes in the whole cohort (P<0.001) and in the ICI- monotherapy cohort (P=0.008); however, no differences were observed in the cohorts of patients receiving chemotherapy regimens, alone (P=0.08) or combined with ICI (P=0.08). The analysis by PD-L1 expression in 756 patients with available data will be presented in the Congress.
Table 1: Median OS and PFS according to LIPI subgroups. NR = non reached.
ConclusionOutcomes
LIPI
subgroups
Overall cohort
N= 925
ICI-cohort
N=558
ICI + CT-cohort
N= 185
ICI + ICI cohort
N= 55
CT-cohort
N=127
Median OS
(95% CI)
All
16.3 (14.7-18.8)
21.0 (17.1-NR)
24.7 (16.9-27.1)
20.5 (14.1-NR)
9.79 (8.3-14.4)
LIPI good, 38.5%
19.8 (17.2-25.7)
NR (NR-NR)
25.7 (25.6-NR)
33.6 (14.7-NR)
14.42 (8.9-17.9)
LIPI interm, 41.8%
15.8 (14.3-20.3)
21.2 (17.1-NR)
20.3 (12.8-NR)
14.6 (5.5-NR)
9.30 (7.0-14.5)
LIPI poor, 19.7%
6.96 (5.6-12.5)
8.5 (3.4-13.7)
6.1 (4.9-NR)
14.1 (10.3-NR)
6.1 (5.0-NR)
Global LogRank P value
<0.0001
<0.0001
<0.0001
0.4
0.004
Overall cohort
N= 909
ICI-cohort
N=543
ICI + CT-cohort
N= 185
ICI + ICI cohort
N= 54
CT-cohort
N=127
Median PFS
(95% CI)
All
6.5 (5.9-7.1)
6.3 (5.0-7.6)
8.9 (6.80-10.9)
7.2 (5.7-30.6)
5.7 (5.3-6.4)
LIPI good, 38.7%
7.0 (5.9-8.5)
6.4 (4.5-10.8)
9.8 (7.8-13.0)
9.2 (5.7-NR)
6.0 (5.3-7.8)
LIPI interm, 41.6%
6.6 (6.1-7.6)
6.6 (5.6-8.1)
10.4 (6.4-12.4)
5.5 (2.5-NR)
6.1 (4.3-7.6)
LIPI poor, 19.7%
3.6 (3.1-5.6)
3.3 (1.9-6.7)
4.5 (2.8-8.2)
7.1 (2.56- NR)
3.7 (3.4-NR)
Global LogRank P value
<0.0001
0.008
0.08
0.4
0.08
Pretreatment LIPI was prognostic in untreated advanced NSCLC patients regardless of the type of therapy. However, LIPI was associated with PFS only in patients receiving ICI-monotherapy, with no statistically significant differences in CT-containing cohorts (alone or combined with ICI). This value of LIPI to guide treatment selection should be further explored in prospective studies.
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P21 - Locoregional and Oligometastatic Disease - Treatment of Locally Advanced NSCLC (ID 131)
- Event: WCLC 2020
- Type: Posters
- Track: Locoregional and Oligometastatic Disease
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P21.13 - Durvalumab in Locally-Advanced NSCLC in LATAM: Real World Data from Patients Included in the Early Access Program (ID 3051)
00:00 - 00:00 | Author(s): Maria Virginia Bluthgen
- Abstract
Introduction
Most patients with locally advanced, unresectable, non-small cell lung cancer (NSCLC) have disease progression after definitive chemoradiotherapy. The phase III PACIFIC trial comparing durvalumab versus placebo after chemoradiotherapy lead to the approval of durvalumab as a new standard of care for patients with unresectable stage III disease. Durvalumab improved progression-free survival (PFS) vs placebo and overall survival (OS) [13.5% absolute benefit at 36-month overall survival rate].
We present disease characteristics from patients included in the Early Access Program (EAP) in Argentina and Chile.
Methods
The EAP opened in Argentina and Chile in December 2017 and October 2018, respectively. Key inclusion criteria were adults with locally advanced, unresectable stage III NSCLC (according to 7th edition of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) who have completed treatment with platinum-based chemotherapy concurrently or sequentially with radiation therapy, without evidence of disease progression within 3 months from the end of radiation and have adequate organ and marrow function. Patients received durvalumab 10 mg/kg every 2 weeks up to 12 months or until disease progression, toxicity or withdrawal of consent.
Results
Argentina and Chile enrolled 44 patients from 16 centers, both private and public health care centers. Median follow-up was 20.2 months (range 6.5-37.3). The median age was 66 years (42-79); 22 (50%) were females; 27 (61,4%) former smokers and 29 (66%) had ECOG 0. Thirty (68.2%) were non-squamous histology. Nineteen (43.2%) were staged with mediastinoscopy, 4 (9.1%) with EBUS, 3 (6.8%) had a videothoracoscopy and 18 (40.9%) were considered clinically as locally advanced disease. Twelve (27,3%) patients were stage IIIA and 32 (72.7%) IIIB. Forty (90,9%) had received concurrent chemoradiotherapy (ChRT), with platinum-pemetrexed 22 (52.3%) and weekly carboplatin-paclitaxel 19 (43.2%). All patients completed planned radiotherapy; 30 (68.2%) received 60Gy (45-66). Median time for first CT scan after ChRT was 34 days (range 0-144). Twenty-seven (61,4%) had partial response after ChRT and one had disease progression. Thirty-three (75%) patients had PD-L1 testing, 8 with >25%. One patient had EGFR mutation. At data cut-off (July 8 2020), 41 patients had started treatment, 4 (9.7%) were still on-going, 15 (36.5%) had completed treatment and 32 (78%) were alive. Median time to initiation of durvalumab was 82 days (range 19-260) from the end of RT. Median cycles of durvalumab 15 (range 2-26). Twenty-one (51.2%) had disease progression during treatment. Main sites of progression were lung, lymph nodes and CNS. After progression, 13 (31.7%) patients received other treatment (24.4% chemotherapy (ChT), 4.9% ChT and IO, 2.4% EGFR TKI). Thirty-three (80,5%) patients had grade 1-2 toxicities (asthenia, hypothyroidism, diarrhea and pneumonitis). One patient discontinued treatment due to grade 3 (G3) pneumonitis and one had G3 increase in transaminases. No grade 4/5 adverse events were reported.
Conclusion
The use of durvalumab in patients with locally-advanced unresectable stage III NSCLC in a real-word setting in two LATAM countries was well tolerated. Most of the patients completed concurrent ChRT, both private and public setting. Efficacy data is still immature and will be presented in subsequent analysis
