Two analyzes support the use of osimertinib in patients with stage IB to IIIA non-small cell lung cancer

Lung CA seen on chest radiograph. Credits: James Heilman, MD / Wikipedia

Two presentations from the ADAURA clinical trial advance previous studies showing improved outcome survival (DFS) results in surgically resected non-small cell lung cancer (NSCLC) patients receiving osimertinib. I was allowed to. The data were reported today at the 2020 World Lung Cancer Conference (WCLC) Singapore of the International Lung Cancer Society.

Osimertinib is a third-generation irreversible central nervous system activity epidermal growth factor receptor (EGFR) -tyrosine kinase inhibitor. ADAURA is a randomized phase III trial comparing adjuvant osimertinib with placebo in patients with surgically resected stage IB to IIIA (AJCC 7th edition, pathological stage) NSCLC, Exxon. It has an activated EGFR mutation with either a 19 deletion or an Exxon 21 L858R substitution. Postoperative chemotherapy was allowed at the doctor’s and patient’s choice. Adult patients were randomized 1: 1 and treated with osimertinib 80 mg once daily with oral tablets or placebo for 3 years, or until the disease recurred.

In one analysis (summary 3505) presented by Dr. Margarita Magem of the Department of Oncology at Santa Creu Sanpau Hospital in Barcelona, ​​Spain, adjuvant osimertinib was staged IB-IIIA EGFRm NSCLC with or without prior adjuvant chemotherapy. It affects health-related quality of life (HRQoL), a secondary endpoint of the study, in patients who are completely resected and disease-free.

HRQoL was evaluated in a short form-36 (SF-36) health survey consisting of eight domains and two aggregated summary scores. [PCS] And mental [MCS] A summary of the components, randomized, completed by patients every 24 weeks until completion or discontinuation of treatment for 12 and 24 weeks.

The SF-36 T scoring system evaluates a variety of physical and mental health parameters. The higher the T-score, the better your health. Survey compliance is high

Analysis of survey data shows that patients treated with adjuvant osimertinib maintain quality of life and that there are no clinically significant differences in physical or mental health scores between the osimertinib and placebo groups. Shown (PCS-1.18 [95% CI: -2.02, -0.34]MCS -1.34 [95% CI: -2.40, -0.28].. There was no difference in the time to deterioration (TTD) of PCS (HR: 1.17) or MCS (HR: 0.98).

“The effect of adjuvant therapy on health-related quality of life is an important clinical consideration for patients who are disease-free after curative surgery and require long-term treatment to reduce the risk of recurrence.” Dr. Magem said. Said.

In the next trial (summary 3464), one of the co-chairs of WCLC, Dr. Yi-Long Wu of the Guangdong Provincial People’s Hospital and the Guangdong Institute of Medical Sciences (Guangdong / China), will assist osimertinib. Presented the data. Statistically significant improvements in DFS and placebo were shown in patients with resected stage IB-III AEGFRm NSCLC. Quality of life was maintained during osimertinib treatment and no clinically meaningful differences were observed between the two groups.

Dr. Wu et al. Give patients with resected stage IB-IIIA (AJCC 7th edition, pathological stage) EGFR mutant NSCLC daily 80 mg of osimertinib or placebo for 3 years (study completed) or disease Randomly assigned until recurrence. Disease staging was based on electronic case reports with baseline trait data and interactive voice response systems (IVRS) with efficacy data (per statistical analysis plan).

At ADAURA, 60% (410/682) of all randomly assigned patients received adjuvant chemotherapy with a median 4.0 (Q1: 4.0, Q3: 4.0) cycle, balancing between treatment groups. It was. Overall, 409 patients received platinum-based chemotherapy, most of whom were stage IIIIIA (II: 71%). [165/231]IIIA: 80% [187/235]), Less in stage IB (26% [57/216]), Disease. Throughout the stage, the overall proportion of patients receiving chemotherapy was 66% (338/509) for patients under 70 years, compared to 42% (72/173) for patients over 70 years. , 27% (21/78) Patients over 75 years old.

The chemotherapy-treated group (n = 230) experienced 22 DFS events (11%) and the placebo group (n = 207) experienced 103 DFS events (50%). The treatment group (n = 136) who received osimertinib without chemotherapy experienced 15 DFS events or 11%, while the placebo group who did not receive chemotherapy experienced 56 DFS events or 40%. Did.

Dr. Wu reported that the DFS effects of osimertinib and placebo on patients who had previously received chemotherapy were similar to those who did not previously receive chemotherapy, regardless of stage.

“These data further support the adjuvant osimertinib as a new therapeutic strategy in this setting, benefiting DFS significantly and maintaining quality of life,” said Dr. Wu.

Tagrisso approved as an adjunct therapy for NSCLC with EGFR mutations

Provided by the International Association for the Study of Lung Cancer

Quote: Two analyzes were taken from on January 29, 2021 for stage IB to IIIA non-small cell lung cancer (January 2021). 29th) Supports the use of osimertinib in patients-stage-ib.html

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Two analyzes support the use of osimertinib in patients with stage IB to IIIA non-small cell lung cancer

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