Recently, scholars from Italy published observational PANHER research results in Therapeutic Advances in Medical Oncology, mainly to evaluate the efficacy and prognosis of anti-HER2 therapy in patients with HER2+ advanced breast cancer (BC)
.
The PANHER study included 1328 HER2-positive advanced BC patients who received anti-HER2 therapy from June 2000 to July 2020
.
The efficacy endpoints are progression-free survival (PFS) and overall survival (OS)
.
Among the 1328 patients, the median age at initial diagnosis was 52 years (range 24-88), the Eastern Cooperative Oncology Group (ECOG) median PS status was 1 (range 0-3), and 564 (42.
5%) patients were Before menopause, 764 patients (57.
5%) were postmenopausal
.
In total, 680 (51.
2%) HER2-positive tumors also expressed hormone receptor-positive, that is, triple-positive (TP), and 202 (15.
2%) tumors only expressed ER or PgR
.
Neither hormone receptor was expressed in 397 cases (29.
9%)
.
First-line treatment: 358 patients (26.
9%) with trastuzumab + chemotherapy, 749 patients (56.
4%) with Pertuzumab/trastuzumab/taxane, and 37 patients (2.
8%) with T-DM1 Among the patients, 41 patients (3.
4%) of lapatinib/capecitabine, and 143 patients (10.
7%) of other treatments, such as endocrine therapy + trastuzumab
.
Second-line treatment: 335 cases (41.
5%) for T-DM1, 175 cases (21.
7%) for lapatinib/capecitabine, 152 cases (18.
8%) for trastuzumab + chemotherapy, trastuzumab Anti-+endocrine therapy was 37 cases (4.
6%), and other treatments were 108 cases (13.
4%)
.
Third-line treatment: Lapatinib/Capecitabine is the most commonly used dosing regimen (144, 29.
3%), and T-DM1 has 102 (20.
5%) patients
.
The median follow-up time for the overall population was 52 months (95% CI, 48-56)
.
In the first-line treatment, the 2-year PFS rate of 749 patients who received Pertuzumab/trastuzumab/taxane was 50.
5%, and the median PFS was 25 months (95% CI, 20.
8 29.
2)
.
In contrast, in the 412 patients receiving trastuzumab-based first-line therapy, the 2-year PFS rate was 30.
5%, and the median PFS was 14 months (95% CI, 12.
2-15.
6, p = 0.
0001)
.
In addition, the 2-year PFS rate of Pertuzumab as the basic treatment regimen was 50.
5%, while the 2-year PFS rate of trastuzumab + chemotherapy was 34.
6%.
The median PFS of the two groups was 25 (95% CI , 21–29) and 17 (95% CI, 15–19) months (p <0.
0001)
.
5%, and the median PFS was 25 months (95% CI, 20.
8 29.
2)
.
In contrast, in the 412 patients receiving trastuzumab-based first-line therapy, the 2-year PFS rate was 30.
5%, and the median PFS was 14 months (95% CI, 12.
2-15.
6, p = 0.
0001)
.
In addition, the 2-year PFS rate of Pertuzumab as the basic treatment regimen was 50.
5%, while the 2-year PFS rate of trastuzumab + chemotherapy was 34.
6%.
The median PFS of the two groups was 25 (95% CI , 21–29) and 17 (95% CI, 15–19) months (p <0.
0001)
.
In the first-line treatment, the 2-year PFS rate of 749 patients who received Pertuzumab/trastuzumab/taxane was 50.
5%, and the median PFS was 25 months (95% CI, 20.
8 29.
2)
.
In contrast, in the 412 patients receiving trastuzumab-based first-line therapy, the 2-year PFS rate was 30.
5%, and the median PFS was 14 months (95% CI, 12.
2-15.
6, p = 0.
0001)
.
In addition, the 2-year PFS rate of Pertuzumab as the basic treatment regimen was 50.
5%, while the 2-year PFS rate of trastuzumab + chemotherapy was 34.
6%.
The median PFS of the two groups was 25 (95% CI , 21–29) and 17 (95% CI, 15–19) months (p <0.
0001)
.
807 patients received second-line treatment, the 2-year PFS rate was 20%, and the median PFS was 8 months (95% CI, 7.
1-8.
7)
.
The 2-year PFS rate of patients treated with T-DM1 was 24.
4%, and the median PFS was 8 months, while the 2-year PFS rate of patients receiving other second-line treatments was 17%, and the median PFS was 9 months
.
No differences were observed statistical significance (= the p-0.
22)
.
In the second-line treatment of TDM-1, the 2-year PFS rate of patients treated with Patolizumab was 22.
6%, the median PFS was 7 months (95% CI, 5.
1-8.
9), and Patolizumab was not used before The 2-year PFS rate of treated patients was 30.
3%, and the median PFS was less than 12 months (95% CI, 5.
8–18.
2) (p = 0.
01)
.
1-8.
7)
.
The 2-year PFS rate of patients treated with T-DM1 was 24.
4%, and the median PFS was 8 months, while the 2-year PFS rate of patients receiving other second-line treatments was 17%, and the median PFS was 9 months
.
No differences were observed statistical significance (= the p-0.
22)
.
In the second-line treatment of TDM-1, the 2-year PFS rate of patients treated with Patolizumab was 22.
6%, the median PFS was 7 months (95% CI, 5.
1-8.
9), and Patolizumab was not used before The 2-year PFS rate of treated patients was 30.
3%, and the median PFS was less than 12 months (95% CI, 5.
8–18.
2) (p = 0.
01)
.
807 patients received second-line treatment, the 2-year PFS rate was 20%, and the median PFS was 8 months (95% CI, 7.
1-8.
7)
.
The 2-year PFS rate of patients treated with T-DM1 was 24.
4%, and the median PFS was 8 months, while the 2-year PFS rate of patients receiving other second-line treatments was 17%, and the median PFS was 9 months
.
No differences were observed statistical significance (= the p-0.
22)
.
In the second-line treatment of TDM-1, the 2-year PFS rate of patients treated with Patolizumab was 22.
6%, the median PFS was 7 months (95% CI, 5.
1-8.
9), and Patolizumab was not used before The 2-year PFS rate of treated patients was 30.
3%, and the median PFS was less than 12 months (95% CI, 5.
8–18.
2) (p = 0.
01)
.
statistics
The median PFS of first-line patolizumab was 7 months (95% CI, 2.
1-11.
9) and 7 months (95%) for second-line lapatinib/capecitabine or TDM-1 treatment, respectively CI 5.
1–8.
9) (p = 0.
80)
.
For patients who have not previously been treated with patolizumab, the median PFS of second-line lapatinib/capecitabine or TDM-1 treatment was 8 months (95% CI, 6.
4–9.
6) and 12 months, respectively (95% CI, 5.
8–18.
2) (p = 0.
004)
.
1-11.
9) and 7 months (95%) for second-line lapatinib/capecitabine or TDM-1 treatment, respectively CI 5.
1–8.
9) (p = 0.
80)
.
For patients who have not previously been treated with patolizumab, the median PFS of second-line lapatinib/capecitabine or TDM-1 treatment was 8 months (95% CI, 6.
4–9.
6) and 12 months, respectively (95% CI, 5.
8–18.
2) (p = 0.
004)
.
The median PFS of first-line patolizumab was 7 months (95% CI, 2.
1-11.
9) and 7 months (95%) for second-line lapatinib/capecitabine or TDM-1 treatment, respectively CI 5.
1–8.
9) (p = 0.
80)
.
For patients who have not previously been treated with patolizumab, the median PFS of second-line lapatinib/capecitabine or TDM-1 treatment was 8 months (95% CI, 6.
4–9.
6) and 12 months, respectively (95% CI, 5.
8–18.
2) (p = 0.
004)
.
The 2-year PFS rate of the third-line treatment was 8.
5%, and the median PFS was 7 months (95% CI, 6.
3-7.
7).
There was no significant difference between different treatment regimens
.
In the overall population, the median OS was 60 months (95% CI, 55 65), the 3-year OS rate was 68.
4%, and the 5-year OS rate was 49.
7%
.
In 1328 patients, after diagnosis of metastatic disease, the 3-year OS rate, 5-year OS rate and median OS rate of Pertuzumab/Trastuzumab/Taxane treatment after diagnosis of metastatic disease were 71.
4% and 56.
4%, respectively , And 70 months (95% CI, 60-80); while those receiving treatment without patolizumab were 65.
4%, 45.
5%, and 55 months (95% CI, 49-61) (p = 0.
004)
.
4%, and the 5-year OS rate was 49.
7%
.
In 1328 patients, after diagnosis of metastatic disease, the 3-year OS rate, 5-year OS rate and median OS rate of Pertuzumab/Trastuzumab/Taxane treatment after diagnosis of metastatic disease were 71.
4% and 56.
4%, respectively , And 70 months (95% CI, 60-80); while those receiving treatment without patolizumab were 65.
4%, 45.
5%, and 55 months (95% CI, 49-61) (p = 0.
004)
.
In the overall population, the median OS was 60 months (95% CI, 55 65), the 3-year OS rate was 68.
4%, and the 5-year OS rate was 49.
7%
.
In 1328 patients, after diagnosis of metastatic disease, the 3-year OS rate, 5-year OS rate and median OS rate of Pertuzumab/Trastuzumab/Taxane treatment after diagnosis of metastatic disease were 71.
4% and 56.
4%, respectively , And 70 months (95% CI, 60-80); while those receiving treatment without patolizumab were 65.
4%, 45.
5%, and 55 months (95% CI, 49-61) (p = 0.
004)
.
Overall, among the 807 patients who received second-line treatment, the median OS from the second-line was 28 months (95% CI, 24.
8 31.
1), the 3-year OS rate was 41.
0%, and the 5-year OS rate was 24.
8%
.
Among the 749 patients who received first-line pembrolizumab treatment, those who received second-line T-DM1 treatment (N: 259) had a 3-year OS rate of 63.
6% and a 5-year OS rate of 39.
5%, from the diagnosis to metastatic disease The initial median OS was 48 months (95% CI, 42 54)
.
In the second-line patients receiving lapatinib/capecitabine, the 3-year OS rate was 51.
8%, the 5-year OS rate was 32.
2%, and the median OS was 41 months (95% CI, 28 54) (p = 0.
45) )
.
8 31.
1), the 3-year OS rate was 41.
0%, and the 5-year OS rate was 24.
8%
.
Among the 749 patients who received first-line pembrolizumab treatment, those who received second-line T-DM1 treatment (N: 259) had a 3-year OS rate of 63.
6% and a 5-year OS rate of 39.
5%, from the diagnosis to metastatic disease The initial median OS was 48 months (95% CI, 42 54)
.
In the second-line patients receiving lapatinib/capecitabine, the 3-year OS rate was 51.
8%, the 5-year OS rate was 32.
2%, and the median OS was 41 months (95% CI, 28 54) (p = 0.
45) )
.
Overall, among the 807 patients who received second-line treatment, the median OS from the second-line was 28 months (95% CI, 24.
8 31.
1), the 3-year OS rate was 41.
0%, and the 5-year OS rate was 24.
8%
.
Among the 749 patients who received first-line pembrolizumab treatment, those who received second-line T-DM1 treatment (N: 259) had a 3-year OS rate of 63.
6% and a 5-year OS rate of 39.
5%, from the diagnosis to metastatic disease The initial median OS was 48 months (95% CI, 42 54)
.
In the second-line patients receiving lapatinib/capecitabine, the 3-year OS rate was 51.
8%, the 5-year OS rate was 32.
2%, and the median OS was 41 months (95% CI, 28 54) (p = 0.
45) )
.
When OS was diagnosed with metastatic disease, TDM-1 was the second-line treatment.
The 3-year OS rate of patients who had not been treated with Pertuzumab was 78%, and the 5-year OS rate was 55.
4%.
From the diagnosis of metastatic disease The initial median OS was 72 months (95% CI, 44-100), which significantly improved the prognosis of patients compared with previous treatment with patozumab (p = 0.
003)
.
The 3-year OS rate of patients who had not been treated with Pertuzumab was 78%, and the 5-year OS rate was 55.
4%.
From the diagnosis of metastatic disease The initial median OS was 72 months (95% CI, 44-100), which significantly improved the prognosis of patients compared with previous treatment with patozumab (p = 0.
003)
.
When OS was diagnosed with metastatic disease, TDM-1 was the second-line treatment.
The 3-year OS rate of patients who had not been treated with Pertuzumab was 78%, and the 5-year OS rate was 55.
4%.
From the diagnosis of metastatic disease The initial median OS was 72 months (95% CI, 44-100), which significantly improved the prognosis of patients compared with previous treatment with patozumab (p = 0.
003)
.
When OS starts from second-line treatment, TDM-1 is second-line treatment.
The 3-year OS rate of patients who have not been treated with Pertuzumab in the past was 58.
9%, and the 5-year OS rate was 38.
5%, the median from the diagnosis of metastatic disease OS was 45 months (95% CI, 36–54); the 3-year OS rate of patients treated with Pertuzumab was 32.
2%, and the 5-year OS rate was 24.
4%, the median from the diagnosis of metastatic disease OS was 24 months (95% CI, 19-29) (p = 0.
002)
.
The 3-year OS rate of patients who have not been treated with Pertuzumab in the past was 58.
9%, and the 5-year OS rate was 38.
5%, the median from the diagnosis of metastatic disease OS was 45 months (95% CI, 36–54); the 3-year OS rate of patients treated with Pertuzumab was 32.
2%, and the 5-year OS rate was 24.
4%, the median from the diagnosis of metastatic disease OS was 24 months (95% CI, 19-29) (p = 0.
002)
.
When OS starts from second-line treatment, TDM-1 is second-line treatment.
The 3-year OS rate of patients who have not been treated with Pertuzumab in the past was 58.
9%, and the 5-year OS rate was 38.
5%, the median from the diagnosis of metastatic disease OS was 45 months (95% CI, 36–54); the 3-year OS rate of patients treated with Pertuzumab was 32.
2%, and the 5-year OS rate was 24.
4%, the median from the diagnosis of metastatic disease OS was 24 months (95% CI, 19-29) (p = 0.
002)
.
In summary, studies have shown that compared with patients who were not treated with first-line patolizumab, the efficacy of second-line use of TDM-1 after treatment with patolizumab in the past has been reduced
.
.
Studies have shown that, compared with patients who were not treated with first-line patolizumab, the efficacy of second-line TDM-1 after the previous treatment with patolizumab is reduced
.
Original source:
Laura Pizzuti, Eriseld Krasniqi, Isabella Sperduti,et al.
PANHER study: a 20-year treatment outcome analysis from a multicentre observational study of HER2-positive advanced breast cancer patients from the real-world setting.
Ther Adv Med Oncol.
2021, Vol .
13: 1 -18.
DOI: 10.
1177/17588359211059873.
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