Professor Ouyang commented on the PHILA study: THPy protocol benefits from all subgroups or rewrites the first-line treatment pattern of HER2-positive advanced breast cancer

With the emergence and widespread use of anti-HER2-targeted drugs, the prognosis of HER2-positive breast cancer patients has improved significantly, but in view of domestic medical resources and the actual situation of drug applications, some patients are still unable to fully benefit

The 2022 Annual Meeting of the European Society of Oncology (ESMO) recently concluded, and the results of a Chinese multicenter pyrrolidinib Phase III study (PHILA study) released at the meeting were gratifying, revealing that pyrrolidinib combined with trastuzumab and docetaxel (THPy) regimen benefited significantly in the first-line treatment of HER2-positive advanced breast cancer, and also allowed the world to see the wisdom

Expert Profiles

Professor Ouyang Zhichang

• Director of the Department of Breast Medicine, Hunan Provincial Cancer Hospital, Chief Physician, Doctor of Medicine, Master Supervisor

• Standing Member of the Breast Cancer Expert Committee of the Chinese Society of Clinical Oncology (CSCO).

  
  

• Member of the Breast Cancer Committee of the Chinese Anti-Cancer Association

• Standing Committee Member of Breast Cancer Group of Cancer Professional Committee of Chinese Medical Doctor Association

• Member of the National Expert Committee for Clinical Application Monitoring of Anti-tumor Drugs

• Member of the Breast Cancer Expert Committee of the National Center for Cancer Quality Control

• Deputy Leader of the Breast Science Group of the Precision Medicine and Tumor MDT Professional Committee of the Chinese Society of Research Hospitals

• He is the chairman of the Oncology Professional Committee of Hunan Medical Association and the leader of the breast cancer group

• Chairman of the Gynecology and Breast Tumor Prevention and Treatment Professional Committee of Hunan Maternal and Child Health and Eugenics Association

• Member of the Editorial Board of the Journal of Clinical Oncology Chinese Edition

• Associate Editor of Oncology Pharmacy

Looking back, piroctinib has borne fruit

Pyrrolidinib is China's first domestic anti-HER2 treatment of small molecule TKI innovative drugs, from drug development to clinical research, has always attracted much attention

As one of the main investigators of phase II-III clinical research, Professor Ouyang Zhichang said that pirrotinib can stand out among many drugs, which is inseparable from its superior performance in various clinical studies

The highlights are presented, and the original Research institute of China is loud and clear

Pyrrolidinib has shown amazing strength in previous large-scale studies, and the good treatment effect has made the pace of clinical protocol exploration never stop

The excellent results of the PHILA study are nothing less than a light, opening up a new situation in the first-line treatment of HER2-positive breast cancer and bringing new hope

In the existing domestic clinical guidelines for breast cancer, the combined regimen of pirlotinib and capecitabine is a class I recommendation for patients who have failed treatment with trastuzumab and a grade II recommendation for

Looking at the big picture, piroctinib benefits the whole population

The results of the PHILA study showed that pyrrolidinib combined with trastuzumab and docetaxel benefited not only significantly in the overall population of HER2-positive advanced breast cancer, but also in different subgroups

Hormone receptor status:

In the POLA study, regardless of hormone receptor status, the pyrrolidinib combined group showed a significant benefit

Trastuzumab treatment:

The results of neosphere, PEONY, and APOHINITY made THP the gold standard
for the treatment of early HER2-positive breast cancer.

With the entry of trastuzumab into the national medical insurance directory in 2018, trastuzumab resistance in the clinical diagnosis and treatment process has become more and more common
.

However, the trastuzumab subgroup of the trastuzumab in the PHILA study had not yet reached mPFS, suggesting that the treatment of pyrrolidinib combined with trastuzumab and docetaxel versus trastuzumab plus docetaxel had a PFS benefit (HR=0.
23) in the treated population of trastuzumab, which had practical clinical significance
.

with visceral metastasis:

Visceral metastases are a common poor prognostic factor
for HER2-positive breast cancer.

In the PHILA study, the combination of piraritinib in combination therapy with both lung and liver metastases significantly improved patient PFS (HR=0.
35).

Ten years to sharpen a sword, the future of the first choice

As China's first domestic 1.
1 class anti-HER2 innovative drug, pyrrolidinib has lasted for ten years from drug discovery to market approval, which can be described as a real "ten years of grinding a sword"
.

Compared with other anti-HER2 drugs, pyrrolidinib has two major "innate advantages", namely the Chinese original research and the whole Chinese group study
.

On the one hand, the approval of pirrolidinib to market has broken the monopoly of imported drugs, helped more clinical HER2-positive advanced breast cancer patients to have drug accessibility, and contributed to the promotion of academic progress in the field of breast cancer
.

On the other hand, the patients included in the various large-scale studies of pyrrolidinib are all Chinese patients, and the study population is closer to the real situation in China, providing more practical and reliable research evidence
for clinical decision-making.

Professor Ouyang said that piroctinib will become a powerful "national weapon" for the first-line treatment of HER2-positive advanced breast cancer
.

In clinical practice, for patients who meet the characteristics of the population, the treatment modalities of pirrolidinib plus trastuzumab and chemotherapy will provide one more option
for advanced first-line therapy.

In addition, Professor Ouyang also talked about the experience and experience of practical application of pyrrolidinib: pyrrolatinib combined treatment of PATIENTS with HER2-positive advanced breast cancer, PFS was significantly prolonged; On the other hand, longer dosing times also pose greater challenges for patient management, and long-term, well-developed response measures are particularly important
.

In the process of treatment, it is necessary to continue to pay attention to drug safety and properly deal with adverse reactions such as diarrhea to increase patients' treatment compliance and exert good efficacy of
drugs.

 

epilogue

"The data report of the PHILA study once again confirms the amazing efficacy of pyrrolidinib in the treatment of HER2-positive breast cancer, allowing the world to witness the strong strength
of China's original research.
"
Professor Ouyang Zhichang concluded, "In the follow-up clinical application, more attention should be paid to the prevention and treatment of adverse reactions, so that the drug can bring new hope to
more PATIENTS WITH HER2-positive advanced breast cancer.
"
”

References:

[1] Yan M, Bian L, Hu X, et al.
Pyrotinib plus capecitabine for human epidermal factor receptor 2-positive metastatic breast cancer after trastuzumab and taxanes (PHENIX) : a randomized, double-blind, placebo controlled phase 3 study [J].
Transl Breast Cancer Res, 2020,1-13.

[2] Xu B, Yan M, Ma F, et al.
Pyrotinib plus capecitabine versus lapa-tinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, operrlabel, randomised, controlled, phase 3 trial[J].
Lancet Oncol, 2021, 22(3):351-360.

Chinese Society of Clinical Oncology.
Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines (2020 Edition)[M].
Beijing:People's Medical Publishing House.
2020.
79-82.

National Health Commission of the People's Republic of China.
Guidelines for the diagnosis and treatment of breast cancer (2022 edition)[M].
2022.
64-65.