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Target Oncol: Prof. Wu Yilong's Phase IIIb study focuses on the efficacy of afatinib (afatinib) in the treatment of EGFR mutation-positive NSCLC patients in the near real world

 Last Update: 2022-03-04
 Source: Internet
 Author: User

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Afatinib is an option for patients with advanced epidermal growth factor receptor mutation-positive (EGFRm + ) non-small cell lung cancer (NSCLC) in a randomized controlled study
.

However, patients treated in real-world clinical practice, including elderly patients, patients with brain metastases, or patients with poor ECOG scores , were often excluded from these studies

Afatinib is an option for patients with advanced epidermal growth factor receptor mutation-positive (EGFRm + ) non-small cell lung cancer (NSCLC) in a randomized controlled study

Recently, Professor Wu Yilong from Guangdong Provincial People's Hospital, as the corresponding author, published a prospective phase IIIb study (NCT01953913) in the journal Targeted Oncology , mainly to evaluate the treatment of Afatinib (afatinib) in the near real world.

The study is a single-arm, open-label Phase IIIb, near-real-world study conducted at 34 centers in Asia
.

Patients received afatinib 40 mg/day until tumor progression, no clinical benefit, or poor tolerance

The study is a single-arm, open-label Phase IIIb, near-real-world study conducted at 34 centers in Asia

Of the 577 patients enrolled in the trial, 541 received afatinib

Of the 541 patients, 412 were from China

In the overall population, nearly all patients (98.

In the overall population, the median TTSP was 14.
0 months (95% CI 12.
9-15.
9) and the median PFS was 12.
1 months (95% CI 11.
0-13.
6)
.

In the overall population, the median TTSP was 14.

Overall population TTSP and PFS

Overall Population TTSP and PFS Overall Population TTSP and PFS

The median TTSP (13.
8 months, 95% CI 12.
7 16.
1) and PFS (11.
4 months, 95% CI 10.
9 13.
7) of Chinese patients were similar to the overall population
.

The median TTSP (13.

Chinese population TTSP and PFS

China Chinese population TTSP and PFS population TTSP and PFS

The ORR for the overall population was 59.
1% (95% CI 54.
9-63.
3)
.

A total of 13 patients (2.

The ORR for the overall population was 59.
1% (95% CI 54.
9-63.
3)
.
A total of 13 patients (2.
4%) achieved a complete response and 307 patients (56.
7%) achieved a partial response
.
The median duration of objective response was 12.
2 months (95% CI 11.
1 to 13.
5)
.
The ORR for the overall population was 59.
1% (95% CI 54.
9-63.
3)
.
A total of 13 patients (2.
4%) achieved a complete response and 307 patients (56.
7%) achieved a partial response
.
The median duration of objective response was 12.
2 months (95% CI 11.
1 to 13.
5)
.

Among Chinese patients, progression-free survival (PFS) was 13.
9 months in patients with dose reductions, which was significantly longer than 11.
1 months in patients without dose reductions (HR 1.
46; 95% CI 1.
04-2.
04; P = 0.
0275)
.
The median TTSP was 11.
0 months for patients with brain metastases at baseline and 14.
4 months for patients without brain metastases (HR, 1.
29; 95% CI 0.
96-1.
73; P = 0.
0869)
.
Compared with patients without brain metastases, patients with brain metastases had significantly shorter progression-free survival (9.
2 months vs.
12.
9 months; HR 1.
45; 95% CI 1.
10-1.
90; P = 0.
0075)
.
Among Chinese patients, progression-free survival (PFS) was 13.
9 months in patients with dose reductions, which was significantly longer than 11.
1 months in patients without dose reductions (HR 1.
46; 95% CI 1.
04-2.
04; P = 0.
0275)
.
The median TTSP was 11.
0 months for patients with brain metastases at baseline and 14.
4 months for patients without brain metastases (HR, 1.
29; 95% CI 0.
96-1.
73; P = 0.
0869)
.
Compared with patients without brain metastases, patients with brain metastases had significantly shorter progression-free survival (9.
2 months vs.
12.
9 months; HR 1.
45; 95% CI 1.
10-1.
90; P = 0.
0075)
.

Taken together, the study shows that the safety data of afatinib (afatinib) in patients with EGFRm+ NSCLC close to the real world are consistent with the known safety profile
.
Tolerability-guided dose reductions of afatinib allowed patients to remain on treatment and continue to experience clinical benefit
.
Taken together, the study shows that the near-real-world study shows that the near-real-world study shows that the safety data of afatinib (afatinib) in patients with EGFRm+ NSCLC in the near- real world are consistent with the known safety profile .
Tolerability-guided dose reductions of afatinib allowed patients to remain on treatment and continue to experience clinical benefit .
The safety data for afatinib in patients with EGFRm+ NSCLC were consistent with the known safety profile .
Tolerability-guided dose reductions of afatinib allowed patients to remain on treatment and continue to experience clinical benefit .

Original source:

Tu HY, Feng J, Shi M, Zhao J, Wang Y, Chang J, Wang J, Cheng Y, Zhu J, Tan EH, Li K, Zhang Y, Lee V, Yang CT, Su WC, Lam DC, Srinivasa BJ , Rajappa S, Ho CL, Lam KC, Hu Y, Bondarde SA, Liu X, Tian Y, Xue Z, Cseh A, Huang DC, Zhou C, Wu YL.
A Phase IIIb Open-Label, Single-Arm Study of Afatinib in EGFR TKI-Naïve Patients with EGFRm+ NSCLC: Final Analysis, with a Focus on Patients Enrolled at Sites in China.
Target Oncol.
2022 Jan;17(1):1-13.
doi:10.
1007/s11523-021-00859-6 .
Epub 2022 Jan 12.
PMID: 35020119; PMCID: PMC8783858.

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