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Pablo Gallardo
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P1.04 - Immuno-oncology (ID 164)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.04-19 - Association Between Efficacy and irAEs in Patients with Advanced Non-Small Cell Lung Cancer Receiving Immune-Checkpoint Inhibitors (ID 2020)
09:45 - 18:00 | Author(s): Pablo Gallardo
- Abstract
Background
Immune-checkpoint inhibitors (ICIs) are a standard treatment in advanced non-small cell lung cancer (NSCLC). They can induce immune-related adverse events (irAEs) that may compromise treatment continuation.
We report our experience in advanced NSCLC patients receiving ICIs, the incidence of irAEs and its correlation with efficacy.
Method
267 patients with advanced NSCLC receiving ICIs in two Spanish institutions from March 2013 to August 2018 were analyzed. IrAEs were graded following CTCAE v4.0. Kaplan Meier and log-rank tests were used to evaluate progression-free (PFS) and overall survival (OS) using landmark analysis.
Result
Median age was 66.1 years [26-85], 70% were male. 86 (32%) patients presented squamous and 181 (68%) non-squamous histology. Most frequent ICIs were nivolumab (44%), pembrolizumab (26%) and atezolizumab (17%), used as monotherapy (78%), in combination with chemotherapy (12%) or with anti-CTLA4 (9%). 30% patients were treated with ICIs in first line and 70% in second line or beyond. Median duration of treatment was 2.8 months [0.1-56.4].
152 patients (57%) experienced a total of 255 irAEs, and the median number of irAEs/patient was 1 [0-5]. Most frequent irAEs was skin toxicity (34%), followed by diarrhea (16%) and hypothyroidism (11%). 36 patients (14%) presented grade 3-4 irAEs and there were 5 treatment-related deaths: 4 pneumonitis and 1 hepatitis. Patients receiving ICIs in second line or beyond experienced significantly less irAEs (49%) than those treated in first line (74%) (p <0.001).
With a median follow-up time of 8.5 months [0.3-56.4], the landmark analysis showed that PFS was significantly longer in patients with irAEs: 12.4 months (95%CI, 1.9-22.9) vs 4.1 months (95%CI, 2.6-5.6) (p < 0.001). Similarly, OS among patients with irAEs was significantly higher: 28.2 months (95%CI, not calculated) vs 12.5 months (95%CI, 10.8-14.2) (p < 0.001). Disease control rate was significantly better in patients with irAEs: 77% vs 39%, odds ratio 0.20 (95%CI, 0.11-0.34) (p < 0.001). Besides, duration of response was significantly longer: 6.1 months [0.5-50] vs 2.6 months [0.2-51.9] (p < 0.001).
44 patients (17%) discontinued treatment due to toxicity. Within this group, 66% patients did not progress after immunotherapy, in contrast to 29% in the rest of the population (p < 0.001).
Multivariable analysis revealed that cutaneous, endocrinological and reumathological toxicities were significantly associated with increased OS.
Conclusion
The presence of irAEs in advanced NSCLC patients treated with ICIs was associated with better outcomes. Patients who discontinued ICIs due to toxicity showed a higher disease control rate.
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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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P2.04-52 - Impact of Corticosteroids and Antibiotics on Efficacy of Immune-Checkpoint Inhibitors in Patients with Advanced Non-Small Cell Lung Cancer (ID 2015)
10:15 - 18:15 | Author(s): Pablo Gallardo
- Abstract
Background
Immune-checkpoint inhibitors (ICIs) are a standard-of-care in advanced non-small cell lung cancer (NSCLC). Corticosteroids are frequently used in symptomatic advanced NSCLC patients, but their immunosuppressive effect may reduce the efficacy of ICIs.
Here we report our experience in patients with NSCLC and the potential impact of on-treatment use of corticosteroids and antibiotics.
Method
Medical records of 267 patients with advanced NSCLC receiving ICIs from March 2013 to August 2018 were reviewed. Corticosteroid usage at the time of initiation or during ICIs treatment and administration of antibiotics from three months before the initiation of ICIs to 3 months after treatment end were collected. Kaplan Meier and log-rank tests were used to evaluate progression-free (PFS) and overall survival (OS). A multivariable analysis was performed to study the influence of clinical characteristics on treatment efficacy.
Result
146 patients (55%) received corticosteroids: 63 (43%) for the treatment of irAEs and 83 (57%) for the management of baseline conditions. Prednisone (40%) and dexamethasone (35%) were the most commonly used types of corticosteroids. Median dose of prednisone equivalent was 50mg daily [5-1250mg], 92% patients received ≥10mg of prednisone equivalent daily. Median duration of corticosteroids was 59 days [0.5-83.0].
OS was longer in the group of patients that did not receive corticosteroids or received <10mg prednisone equivalent daily: 14.7 months (95%CI, 11.1-18.3) vs 8.3 months (95%CI, 6.9-9.8) (p = 0.009). No differences in PFS were observed: 4.6 months (95%CI, 2.9-6.3) vs 4.2 months (95%CI, 2.5-5.9) (p = 0.359).
Patients receiving corticosteroids for baseline condition presented shorter median overall survival than the rest of the study population: 6.5 months (95%CI, 4.6-8.3) vs 16.5 months (95%CI, 12.1-20.8) (p <0.001). Multivariable analysis identified corticosteroids usage as an independent variable related to poorer outcomes.
141 patients (52.8%) received antibiotics. Quinolone (37%) and penicillin (33%) were the most commonly used groups of antibiotics. No correlation between the usage of antibiotics and efficacy of ICIs was found, with median OS of 10.2 months (95%CI, 6.4-13.9) vs 12.5 months (95%CI, 9.9-15.0) (p = 0.924).
Conclusion
In our series, corticosteroid use of ≥10mg of prednisone equivalent daily was associated with significantly poorer outcomes, especially when given for baseline condition. No correlation was found between antibiotics and survival. It is important to underline that the use of corticosteroids may simply identify a population with higher volume and aggressive tumors. Prudent use of corticosteroids needs to be warranted.
