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G. Gao
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-047 - Poor Performance Status and BRAF Mutation Predict Grade 3-5 Immune-Related Adverse Events in Pts with Advanced NSCLC (ID 10175)
09:30 - 09:30 | Author(s): G. Gao
- Abstract
Background:
Anti-PD1/PDL1 immunotherapy has been regarding as standard second line therapy in patients with advanced NSCLC, also as the 1[st] line setting in subpopulation with PDL1 expression of more than 50%. Anti-PD1/PDL1 drugs such as nivolumab, pembrolizumab and atezolizumab showed a durable response in those benefit population, while immune-related adverse events(irAEs) were also frequently happened. This study aimed to describe the high-risk factors for irAEs in patients with advanced NSCLC after the treatment of anti-PD1/PDL1 monoclonal antibody.
Method:
We retrospectively reviewed 72 patients with advanced non small cell lung cancers treated with PD-1/PD-L1 inhibitors (nivolumab =27, pembrolizumab =44, atezolizumab =1) in Shanghai Pulmonary Hospital from Jun 2015 to May 2017. All adverse events were assessed and classified by grades according to NCI CTCAE (version 4.0).
Result:
AEs occurred in 34 patients (47.22%). Grade 1 or 2 events included increased amylase (5), increased lipase (5), transaminitis (4), rash/ pruritus (4), xerostomia (3), nausea (3), fatigue(3), anemia (3), decreased WBC (2), hypokalemia (2) and fever, arthralgia, sense of neck stiffness, cardiac arrhythmia, decreased PLT and hypocalcemia in 1 patient each.Twelve (16.67%) patients experienced grades 3-5 events including 6 cases with ILD(grade 5=1), 3 with pleural effusions/pericardial effusions, 2 with hypothyroidism, and 1 with grade 3 fatigue. Subgroup analysis showed that patients with BRAF mutations(2 with adenocarcinomas,1 with squamous carcinomas and 1 with NSCLC) experienced significantly higher rate of serious AEs (2 ILD and 2 pleural effusions) after receiving pembrolizumab (100%vs 11.76%,p＜0.001), while it was similar according to the other driver genes mutation status (EGFR, KRAS, HER2, ALK). Patients with poor ECOG PS experienced a marginally statistically significant higher grade 3-5 AEs (p=0.063), while it was similar according to different subgroup of age (p=0.538), gender (p=0.189), histological type (p = 0.999), smoking status (0.122), lines of previous therapy (p=0.172), baseline serum LDH level(p=0.290) and CD8+ of peripheral blood (p=0.814). In addition, prior thoracic radiation has a numerical higher prone to develop ILD (23.07%vs 5.08%, p = 0.116).
Conclusion:
Poor performance status and BRAF mutation might predict irAEs in patients with advanced NSCLC receiving PD-1/PD-L1 inhibitors, further large cohort study is warranted to investigate the high-risk factors for irAEs in patients with advanced NSCLC.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-085 - A Phase 2 Trial of Apatinib in Advanced Non-Squamous NSCLC: Updated Data and Clinical Benefit of Continuing Apatinib after Initial Progression (ID 9039)
09:30 - 09:30 | Author(s): G. Gao
- Abstract
Background:
Apatinib exerts anti-tumor effects by selectively inhibiting VEGFR-2. A single-arm Phase 2 study of apatinib monotherapy in advanced non-squamous NSCLC patients showed promising response across multiple therapy lines (P3.02C-025, WCLC 2016 Abstracts). Here we report the updated efficacy and safety data, as well as the clinical benefit of continuing apatinib beyond initial progression.
Method:
Forty patients with previously heavily treated advanced non-squamous NSCLC were enrolled to receive apatinib until progression, unacceptable toxicity, withdrawal or death. After study discontinuation, apatinib monotherapy or combined therapy was allowed for patients on disease progression at the discretion of the investigators and under the consent of patients.
Result:
The cutoff date was March 12, 2017. The treatment duration of apatinib was 82 (43, 127) days with a mean dosage of 477.0 ± 85.3 mg/day. Thirty-eight patients were available for tumor response evaluation, and the best overall response rate (ORR) and disease control rate (DCR) were 21.1% and 76.3%, respectively. The median progression-free (PFS) and overall survival (OS) were 3.32 (95% CI, 2.37–4.86) and 9.26 (95% CI, 5.36–not estimable) months, respectively. Common adverse events (AEs) were hand-foot-skin reaction (HFSR) (30.0%), proteinuria (27.5%), hypertension (17.5%) and aphthous stomatitis (22.5%). Severe AEs included Grade 3 HFSR (5%), hypertension (5%) and thrombocytopenia (5%). Results of preliminary subgroup analyses indicated that age, gender, PS score, treatment line and having a driver gene mutation had no significant effects on ORR, DCR and survival. After initial progression following apatinib treatment, 9 patients received apatinib alone or combined therapy with docetaxel, gefitinib or erlotinib (Table). One PR and 6 SD were achieved. Encouragingly, 8 patients had treatment duration over 4 months.Table: Patients continued apatinib alone or combined therapy after progression
No. Regimens after progression Dose of apatinib (mg) Best efficacy Treatment duration (months) Reason for discontinue treatment 1 Apatinib plus Docetaxel 500 PR 13.11 Second progression 2 Apatinib plus Gefitinib 250 SD 7.98 Lost to follow-up 3 Apatinib plus Gefitinib 375 SD 7.82 Death 4 Apatinib plus Gefitinib 500 SD 5.82 Lost to follow-up 5 Apatinib plus Erlotinib 500 SD 4.27 Lost to follow-up 6 Apatinib 375 SD 5.13 Second progression 7 Apatinib 500 NE 4.44 Second progression 8 Apatinib 250 SD 4.24 Death 9 Apatinib 500 NE 0.33 Death
Conclusion:
This updated analysis further confirmed the efficacy and safety of apatinib for heavily treated advanced non-squamous NSCLC. Continuing apatinib monotherapy or combined therapy could bring clinical benefit.
