Alina's research group is completed, and Alk+NSCLC's postoperative targeted therapy may start!

*For medical professionals for reading reference

The first step of Alk-TKI's enlistment of perioperative treatment may bring a surprising research result!

Since the EGFR-TKI was approved for listing in 2003, the diagnosis and treatment of gene-positive non-small cell lung cancer (NSCLC) had undergone a "revolutionary" change. Enter the era of targeted therapy. With the development of genetic testing technology, more and more driving genes are discovered.

Among many gene mutations, the incidence of ALK gene mutations in Asian people is about 4%-7%. Because ALK mutant positive patients have a good response to ALK-TKI treatment and can get long-term survival benefits, the ALK gene mutation is called "diamond mutation".

Based on the excellent efficacy of the late NSCLC, can ALK-TKI be further promoted to NSCLC perioperative treatment, can it benefit more people? The ongoing ALINA research explored the perioperative application of Alaitinib. Professor Zhang Lanjun, Director of the Department of Deep Surgery of the Cancer Hospital of Sun Yat -sen University in the medical circles, told us that the latest progress and wonderful insights of ALK inhibitor in ALK's positive NSCLC perioperative treatment.

Professor Zhang interview video

Can Alaitini re-engraved the road of EGFR-TKI?

EGFR is the most common mutation of Asian people. EGFR-TKI has been applied to lung cancer targeted therapy for nearly 20 years. Based on its excellent efficacy in NSCLC, EGFR-TKI has pushed the earlier surgical NSCLC treatment from advanced NSCLC.

Regarding the auxiliary treatment of EGFR for surgery, Professor Zhang Lanjun believes that there is no very satisfactory result at present. "But postoperative phase II-Phase-IIIA patients using EGFR-TKI adjuvant therapy can significantly extend their disease-free survival (DFS). The results of the EVAN research also see the OS benefit of EGFR-TKI for postoperative assist therapy."

"EGFR-TKI brings better postoperative survival than chemotherapy in postoperative targeted treatment, while reducing the risk of postoperative recurrence and death. This experience may be migrated to Alk-TKI."

As a second-generation ALK-TKI, Alaitinib achieved very good results in patients with positive NSCLC in the late ALK mutation. Alex research shows that the median no progressive survival (PFS) of Alantinib reached an unprecedented 34.8 months. "This has allowed late ALK -positive patients to reach the level of cure."

In view of this, can I apply Alaitinib to the early patients, including the preoperative neo -assisted therapy or postoperative auxiliary treatment, including surgical patients?

Professor Zhang said that in the current research of many real worlds and small samples, the patients who have been treated with NSCLC for surgery during the treatment period have made good progress, but they also lack the forward -looking random control of large samples in the III stage. Test (RCT) research. The results of the ongoing ALINA research may bring surprises.

ALINA research took the lead in completing the group. ALK -positive NSCLC postoperative adjuvant treatment may usher in a new choice!

ALINA research is a large-scale III period of international multi-center clinical studies. The retired IB-IIIA phase, ECOG PS 0-1ALK positive NSCLC patients, random (1: 1) are divided into Alaitinib group and chemotherapy group Essence The Alaitinib group received a 600mg BID treatment for 2 years, and the chemotherapy group received a 4 -cycle of platinum -containing chemotherapy schemes until the patient had recurrence, unacceptable toxicity, exit or death. The main ending point is to survive -free (DFS), and the secondary end point is OS, security results, etc.

Figure 1 ALINA Research and Design Professor Zhang Lanjun expressed his expectations for the results of Alina's research. "Because ALK is fused in our drive gene mutation, we call it a diamond mutation. Once there is a suitable drug, the patient's survival is very good. Auxiliary therapy is more difficult to enter the group. And ALK-TKI has a better curative effect, which leads to a longer research observation period. It is reassuring that the research on Alantinib for postoperative auxiliary treatment in ALINA research has been completed. . We look forward to ALINA research can publish mid-term data as soon as possible to provide a good evidence-based medical evidence for ALK-TKI application for postoperative assisted treatment, or it can change the clinical guide. "

Professor Zhang Lanjun expressed his views on the issues that Alina studied. "First, ALINA studies the seventh edition of the seventh edition of AJCC staging, patients with the IB stage (tumor diameter ≥4cm), but in the eighth edition of AJCC staging have been attributed to the IIA stage. Benefits still need to be discussed. Second, can chemotherapy after using ALK-TKI? I think there are still many problems in the current assisted treatment and postoperative adjuvant treatment. "

Late NSCLC benefits are obvious

The efficacy of new assisted treatment of Alaidi before surgery is expected

In addition to postoperative adjuvant treatment, perioperative treatment also includes neo -assisted treatment before surgery. Preoperative neo -assisted therapy includes new assisted chemotherapy, targeted therapy, and immunotherapy.

Professor Zhang Lanjun said: "At present, neo-assisted chemotherapy does not bring better OS benefits to patients, and it also brings more toxic and side reactions to patients. However, for patients with IIIA-N2 stage On the one hand, it is demanding surgery for surgery, on the other hand, reducing whole lung resection and retaining lung function for patients. Newly assisted immunohistochemical treatment is also exploring. "

As for the newly -assisted targeted therapy, although it is being explored, there is no study that it can benefit from OS for patients with NSCLC. Professor Zhang Lanjun analyzed: "I think there are two problems: one is that the use time is too short. Most of them use 6-9 weeks. If targeted therapy is extended to 3 or 4 months, Can it bring better survival benefits to patients? Second, the drug efficacy of new assisted targeted therapy before surgery may not be good enough. Now, many three generations of TKI are used for pre -surgery. In progress, I also hope to see the three generations of TKI brings better benefits to patients in the new assisted targeted therapy. For ALK -positive NSCLC patients, Alaitinib has achieved a very good effect in the late stages of the late stage. Pitch PFS can reach 34.8 months. Whether we can play a good effect in the newly -assisted treatment of these patients before surgery, we wait and see. "

The clinical manifestation is strong, Alaidi helps

ALK mutation positive NSCLC tumor control

Professor Zhang Lanjun shared 2 ALK mutations positive NSCLC cases.

"The first patient was ALK -positive mutation NSCLC with a brain metastases. It was already a stage of IV during the diagnosis. Therefore, considering choosing Alaitinib for treatment, the lesions were significantly reduced after March. According to the guide Surgical resection. Postoperative pathological shows that the tumor tissue of primary lung ppaloma has been inactivated. After surgery, patients have been used for nearly 1 year, and the brain metastases have not changed. The brain metastases have also been lost. "

"The second patient is the NSCLC of ALK mutations in the IIB stage. Because the patient resolutely refuses the chemotherapy, after we sought the patient's opinion, we have chosen Alaitinib for treatment after surgery. At present, we are also closely observing this patient. Among them, the indicators are stable, the tumor markers are normal, and there is no recurrence. "

Based on clinical practice experience, Professor Zhang Lanjun recognized Alaitini's efficacy in ALK mutation positive NSCLC and put forward his own views on the future exploration direction of Alaitinib.

"First of all, the duration of the use of Alaitinib. ALK mutant -positive patients use Alaitinib, and the tumor control is better. Do you need to continue taking the medicine for 2 years? Or a longer period of time? Is there a corresponding indicator measurement? The patient's condition is stable and can be stopped? For example, MRD may be a good detection method. You can suggest that patients can do 'DRUG HOLIDAY' or suggest that patients continue to take medicine and continue to monitor regularly according to the results of the MRD test results. "

"Second, a considerable part of the patients will not accept chemotherapy due to various circumstances. ALINA studies will provide new choices for patients if they get indications. ","

summary

Alk-TKI's excellent efficacy in the treatment of patients with a positive NSCLC in ALK mutations, further promotion to the demand for clinical diagnosis and treatment in the perinatal treatment of earlier patients. In many real-world cases and small sample studies, the treatment of ALK-TKI perioperative treatment shows certain potential. The case shared by Professor Zhang Lanjun can also see the effect of the second-generation ALK-TKI A Laitinib in the real world.

However, at present, the ALK-TKI application perioperative period still needs higher evidence-based medical evidence support. Fortunately, Alina's research group is completed, and it is expected that its research results will bring the gospel to patients with positive mutations in Alk. Expert Introduction

Professor Zhang Lanjun

Professor, chief physician, doctoral supervisor

Chief instructor of the Department of Deep Surgery at Sun Yat -sen University Cancer Hospital, Chief Expert of Lung Cancer

Member of the Chinese Medical Association's chest cardiovascular vascular surgery branch and deputy team leader of lung cancer external science group

Standing Committee Member of the Standing Committee of the Chinese Medical Medical Association and Deputy Chairman of the Lonopolic Cancer Expert Committee

Deputy Chairman of the Chinese Medical Association Integrated Medicine Association's Cheung Surgery Branch

Member of the Professional Committee of the China Anti -Cancer Association

Standing Committee Member of the Chinese Anti -Cancer Association Popularization Professional Committee

Member of the Chinese Anti -Cancer Association esophageal cancer professional committee

Standing Committee Member of the China Anti -Cancer Association Endoscopy Branch

Deputy Chairman of the Chinese Medical Promotional Promotional Cancer Prevention and Control Branch

Deputy Secretary -General and Standing Committee of the Chinese Medical Promotion Association's Chestacochia Surgery Branch

Standing Member of the Chinese Medical Promotion Association's chest tumor branch

Standing Committee Member of the China Tobacco Control Association Lung Cancer Prevention and Control Professional Committee

Standing Committee Member of the Professional Committee of Non -Cell Cancer Cancer of China Clinical Oncology Society

Member of the Tumor Plastic Surgery Group of Plastic Surgery Branch of the Chinese Medical Association

Deputy Chairman of the Chinese Medical Education Society

Deputy Chairman of the Chinese Medical Education Society's Chestacochroma Branch

Deputy Chairman of the Chemical Surgery Branch of the Medical and Health Exchange Association Cross -Strait Medical and Health Exchange Association

Deputy Chairman of the World Chinese Oncology Association

Chinese Cheung Cancer Alliance CLCU Southern Alliance Chairman

Member of the European Breit Science Society (ESTS)

Member of the International Cancer Research Association (IASLC)

International Rare Tumor Assistance Organization (RCN) members

The 3rd National Name Medical Excellent Style Winners

Member of the National Cancer Quality Control Center Cancer Cancer Quality Control Commission

*This article is only used to provide scientific information to medical people, and does not represent the viewpoint of this platform

- END -