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Lung Cancer: Efficacy and safety of dacomitinib in the first-line treatment of EGFR mutation-positive NSCLC patients in Asian population: results of phase 3 study ARCHER 1050

 Last Update: 2021-08-02
 Source: Internet
 Author: User

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The ARCHER 1050 study (NCT01774721) is an ongoing, randomized, open-label, phase 3 trial to evaluate newly diagnosed patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC), dacomitinib vs.
Efficacy and safety of gefitinib as first-line treatment
.

The results of the previous analysis showed that in the overall population, dacomitinib improved the prognosis of patients compared with gefitinib, even in patients with adjusted doses of dacomitinib

Between May 9, 2013 and March 20, 2015, a total of 452 patients were randomized, including 346 Asian patients (76.
5% of the total population of the ITT ARCHER 1050 study), who were randomized to receive Dakota Treatment with tinib (170 cases) or gefitinib (176 cases)
.

Among the Asian population, there were 231 Chinese patients (51.

Between May 9, 2013 and March 20, 2015, a total of 452 patients were randomized, including 346 Asian patients (76.

Dacomtinib significantly improved the PFS of patients compared with gefitinib

PFS

Similarly, dacomitinib improves the patient's OS compared with gefitinib
.

The independent committee (IRC) assessed the OS of the dacomitinib and gefitinib groups as 37.

Similarly, dacomitinib improves the patient's OS compared with gefitinib

The ORRs of the two groups assessed by IRC were 77.

In the Asian population of dacomitinib dose-adjusted patients, the median OS of dacomitinib treatment did not reach (95% CI: 39.

Dose adjustment OS

The most common adverse events (AEs) of dacomitinib treatment were diarrhea (154 cases (90.
6%)), paronychia (110 cases [64.
7%]), acne-like dermatitis (96 cases [56.
5%]) and stomatitis (87 cases [51.
2%]); the common AEs in the treatment of gefitinib were diarrhea (100 cases [56.
8%]), elevated alanine aminotransferase (81 cases [46.
0%]) and elevated aspartate aminotransferase High (75 cases [42.
6%])
.

There were 16 cases (9.

The most common adverse events (AEs) of dacomitinib treatment were diarrhea (154 cases (90.

Adverse events

In summary, among Asian NSCLC patients with positive EGFR mutations, first-line treatment with dacomitinib versus gefitinib can improve PFS and OS in patients
.

The adverse events in the Asian population are consistent with those reported in the general population
.

In summary, among Asian NSCLC patients with positive EGFR mutations, first-line treatment with dacomitinib versus gefitinib can improve PFS and OS in patients
.
The adverse events in the Asian population are consistent with those reported in the general population
.
Among Asian EGFR mutation-positive NSCLC patients, first-line treatment with dacomitinib versus gefitinib can improve PFS and OS in patients
.
The adverse events in the Asian population are consistent with those reported in the general population
.
Among Asian EGFR mutation-positive NSCLC patients, first-line treatment with dacomitinib versus gefitinib can improve PFS and OS in patients
.
The adverse events in the Asian population are consistent with those reported in the general population
.

Original source:

Cheng Y, Mok TS, Zhou X, et al.
Safety and efficacy of first-line dacomitinib in Asian patients with EGFR mutation-positive non-small cell lung cancer: Results from a randomized, open-label, phase 3 trial (ARCHER 1050 ).
Lung Cancer.
2021 Apr;154:176-185.
doi: 10.
1016/j.
lungcan.
2021.
02.
025.
PMID: 33721611.

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