Different exposure duration of adjuvant icotinib in stage II-IIIA non-small cell lung cancer patients with positive EGFR mutation (ICOMPARE study): A randomized, open-label phase 2 study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8521-8521
Author(s):  
Chao Lyu ◽  
Rui Wang ◽  
Shaolei Li ◽  
Shi Yan ◽  
Yuzhao Wang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Egfr Mutation ◽  
Small Cell ◽  
Phase 2 ◽  
Small Cell Lung ◽  
Group A ◽  
Egfr Tki

8521 Background: EGFR-TKI has been widely used in the treatment for advanced non-small cell lung cancer (NSCLC). Previous studies, such as the EVIDENCE study and the ADAURA study, have confirmed that patients with EGFR-mutated NSCLC could benefit from adjuvant EGFR-TKI treatment. However, the optimal duration time of adjuvant EGFR-TKIs has not been clearly defined. Methods: In this multicenter, randomized, phase 2 trial, eligible patients with II-IIIA stage EGFR mutation-positive NSCLC after R0 resection were randomized in 1:1 to receive adjuvant icotinib for 1 year (group A) or 2 years (group B). The primary endpoint was disease-free survival (DFS). Results: Between September 2013, and September 2018, 109 patients from 8 centers were enrolled in this study, among whom 55 were randomized to group A and 54 to B. As of August 24, 2020 (data cutoff), the median follow-up was 44.1 months (95%CI 37.1-49.9), 31 (56%) of 55 patients in the 1-year group and 25 (46%) of 54 patients in the 2-year group had DFS events. The median DFS was 48.92 months (95%CI 33.15, 70.11) in 2-year group and 32.89 month (95%CI 26.61, 44.78) in 1-year group, respectively. 2-year icotinib significantly prolonged DFS (HR 0.521, 95%CI 0.278, 0.976; p = 0.039). OS events were observed in 20 patients, the OS was not mature yet. Icotinib was re-given for 32 patients with disease recurrence or metastasis as first-line treatment, objective response occurred in 66.7% of 30 patients with measurable disease. Treatment-related adverse events were recorded in 41 of 55 (75%) patients in 1-year group and 36 of 54 (67%) patients in 2-year group, and grade 3 or 4 treatment-related adverse events occurred in 4 (7%) of 55 patients in the 1-year group versus 3 (6%) of 54 in the 2-year group, respectively. No treatment-related deaths or interstitial lung disease were reported. Conclusions: 2-year adjuvant treatment with icotinib resulted in a significantly lower risk of recurrence than 1-year adjuvant icotinib in patients with stage II-IIIA NSCLC positive EGFR mutations and was not associated with increased toxic effects. Clinical trial information: NCT01929200.

scholarly journals Adjuvant treatment with EGFR TKI in resected non-small cell lung cancer with EGFR mutation: all that glitters is not gold!

2020 ◽  
Vol 8 (18) ◽  
pp. 1199-1199
Author(s):  
Alfonso Fiorelli ◽  
Fabiana Vitiello ◽  
Floriana Morgillo ◽  
Rosa Maria Di Crescenzo ◽  
Andrea Bianco ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Adjuvant Treatment ◽  
Egfr Mutation ◽  
Small Cell ◽  
Small Cell Lung ◽  
Egfr Tki

scholarly journals Reversal of Acquired Resistance to EGFR–TKI in T790M-negative Patients With Non–small-cell Lung Cancer Using Anlotinib

2021 ◽  
Author(s):  
Chen Zhang ◽  
Honggang Cao ◽  
Shidai Jin ◽  
Wen Gao ◽  
Chenjun Huang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Combination Therapy ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Treatment Effect ◽  
Acquired Resistance ◽  
Small Cell ◽  
Small Cell Lung ◽  
Egfr Tki

Abstract Background: Treatment options for epidermal growth factor receptor (EGFR) T790M-negative patients with non–small-cell lung cancer (NSCLC) and acquired resistance (AR) to EGFR–tyrosine kinase inhibitor (EGFR–TKI) are limited. The efficacy of EGFR–TKI and anti-angiogenic drug combination therapy in these patients is known. We investigated the effectiveness of EGFR–TKI+anlotinib combination therapy in patients with T790M-negative NSCLC. Method: We evaluated the antitumor effects of gefitinib combined with anlotinib in gefitinib-resistant lung adenocarcinoma cells. We also investigated the treatment effect and absence of adverse events of EGFR–TKI+anlotinib therapy in 22 T790M-negative patients after EGFR–TKI treatment failure between January 2018 and August 2020. Results: Anlotinib reversed gefitinib resistance in the gefitinib-resistant cell line, PC9/GR, by enhancing anti-proliferative and pro-apoptotic effects of gefitinib. The gefitinib+anlotinib treatment exerted a synergistic antitumor effect by downregulating the activation of VEGFR2 and downstream effectors, Akt and ERK. The EGFR–TKI+anlotinib therapy exhibited an objective response rate of 18.2% and a disease control rate of 95.5%. The median progression-free survival (PFS) was 11.53 ± 1.94 months, whereas the median overall survival was not reached. The median PFS was longer in patients exhibiting gradual progression (13.30 ± 1.69 months) than in patients with dramatic progression (8.60 ± 5.39 months, p = 0.041). One Grade 3 adverse event was noted (diarrhea, n = 2, 9.1%), and Grade 4 or 5 adverse events were absent.Conclusion: EGFR–TKI combined with anlotinib demonstrated powerful antitumor activity in vitro and excellent treatment effect in T790M-negative NSCLC patients after AR.

Results of the phase 1b study of ABBV-399 (telisotuzumab vedotin; teliso-v) in combination with erlotinib in patients with c-Met+ non-small cell lung cancer by EGFR mutation status.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3011-3011 ◽  
Author(s):  
D. Ross Camidge ◽  
Fabrice Barlesi ◽  
Jonathan Wade Goldman ◽  
Daniel Morgensztern ◽  
Rebecca Suk Heist ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Egfr Mutation ◽  
Single Agent ◽  
Sensory Neuropathy ◽  
Small Cell ◽  
Small Cell Lung ◽  
Phase 1B ◽  
Egfr Tki

3011 Background: Telisotuzumab vedotin (ABBV-399; teliso-v [T]) is a c-Met–targeted antibody and MMAE drug conjugate. Activity of T was shown in late-line c-Met+ non-small cell lung cancer (NSCLC) irrespective of EGFR mutation (M+) status. We present mature data from the T+ erlotinib (E) cohort of a phase 1b study (NCT02099058) by EGFR M+ status. Methods: T was administered at 2.4 mg/kg (dose-escalation phase) or 2.7 mg/kg IV Q3W, and E at 150 mg PO QD/prior tolerated dose in adult patients (pts) with advanced NSCLC. Efficacy-evaluable pts were c-Met+ (central lab IHC H-score ≥150 or local lab MET amplification/Ex 14 skipping) and had ≥1 postbaseline scan or discontinued study. EGFR M+ was defined as del19 or L858R by local lab. PK was assessed. Results: As of Dec 2018, 42 NSCLC pts received T+E; 37 were c-MET+ (36 evaluable; 35 H-score≥150, 1 MET amplified). Median age was 65 years, 25 pts (69%) had ECOG PS 1, 29 (81%) were EGFR M+ (97% had prior EGFR TKI, 55% 3rd-generation TKI, 69% TKI as last prior therapy, and 62% platinum doublet). All-grade (Gr; ≥20%) adverse events (AEs) were dermatitis acneiform (38%), diarrhea (36%), peripheral motor/sensory neuropathy (52%; 7% Gr 3), dyspnea, fatigue, hypoalbuminemia (31% each), decreased appetite, nausea (24% each), asthenia, vomiting (21% each). Gr ≥3 (≥10%) AE: pulmonary embolism (14%). PK of T+E was similar to single-agent T. The table presents efficacy data. Conclusions: These data suggest acceptable safety and promising activity of T+E and support further study in EGFR M+ c-Met+ NSCLC pts for whom frontline EGFR TKI failed. Clinical trial information: NCT02099058. [Table: see text]

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