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How are domestic and foreign guidelines recommended for adjuvant treatment of EGFR mutation NSCLC?

 Last Update: 2022-12-30
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After EGFR mutation-positive NSCLC resection, adjuvant EGFR-TKI therapy maximizes survival benefits
.

For patients with early and intermediate non-small cell lung cancer (NSCLC), surgical radical resection is an important local treatment to
achieve tumor cure.
However, patients who undergo complete tumor resection are still at risk of tumor recurrence and metastasis, and the risk increases with staging
.
Therefore, postoperative medication or other forms of treatment, i.
e.
, "adjuvant therapy", are required [1].

Epidermal growth factor receptor (EGFR) mutations are one of
the important driver genes for NSCLC.
Studies have shown that the positive rate of EGFR mutation in Asian patients with early and intermediate lung adenocarcinoma is similar to that of advanced patients, both of which are about 50% [1].

So, for these patients with early and intermediate NSCLC with positive EGFR mutation, how to choose a postoperative adjuvant treatment plan to better reduce the risk of postoperative tumor recurrence and metastasis, improve efficacy, and prolong survival? Let's take a look at how authoritative guides at home and abroad recommend it
.

Adjuvant treatment of EGFR-TKI has been recommended by domestic and foreign guidelines

▌The guidelines
for adjuvant therapy after complete resection of stage I.
~III.
B NSCLC are based on the "Guidelines for Adjuvant Treatment after Complete Resection of Stage I.
~III.
B Non-small Cell Lung Cancer (2021 Edition)" jointly formulated by the Lung Cancer Professional Committee of the Chinese Anti-Cancer Association, the Lung Cancer Group of the Oncology Branch of the Chinese Medical Association, and the Chinese Thoracic Cancer Research Collaborative Group.
Adjuvant therapy recommendations for patients with positive EGFR mutations (TNM staging using IASLC/UICC 8th edition staging criteria) [1]:

Patients with EGFR mutation-positive stage IA NSCLC are regularly followed up after complete tumor resection and adjuvant chemotherapy is not recommended (class 1 evidence, recommended).
Adjuvant osimertinib therapy may be considered after complete tumor resection in patients with stage I.
B NSCLC with positive EGFR mutations (class 1A evidence, recommended).
Patients with stage IIA and II.
B NSCLC with positive EGFR mutations are recommended adjuvant therapy with EGFR-TKI [eg, osimertinib (class 1A evidence), eclitinib (class 1B evidence)
] after complete tumor resection (consistent recommendation).
Patients with stage IIIA and III.
B NSCLC with positive EGFR mutations are recommended adjuvant therapy with EGFR-TKI [eg, osimertinib (class 1A evidence), eclitinib (class 1B evidence)] after complete tumor resection, and adjuvant therapy with osimertinib (consistent recommendation)
is preferred.

Regarding the treatment model, the guidelines state that when using EGFR-TKI for adjuvant therapy, EGFR-TKI alone or adjuvant chemotherapy sequential EGFR-TKI can be used; Clinicians can select appropriate adjuvant targeted therapy modalities based on the patient's risk, fitness status, and individual preferences [1].

Regarding the duration of treatment, the guidelines state that the timing of initiation of adjuvant EGFR-TKI therapy can be determined according to the patient's postoperative recovery status, and the latest is no more than 10 weeks after surgery; EGFR-mutant-positive patients who have received adjuvant chemotherapy can continue to receive third-generation EGFR-TKI osimertinib adjuvant therapy, usually starting osimertinib no later than 26 weeks postoperatively; The duration of postoperative adjuvant EGFR-TKI therapy should be no less than two years[1].

▌CSCO NSCLC diagnosis and treatment guidelines According to the Chinese Society of Clinical Oncology (CSCO) NSCLC diagnosis and treatment guidelines
(2022 edition), the treatment of NSCLC still adopts comprehensive treatment based on pathological type, stage (according to the 8th edition of lung cancer staging criteria) and molecular classification [2]
。
Regarding the adjuvant therapy of EGFR mutation-positive NSCLC, guidelines state that for patients with stage IIA, IIB, IIIA, or III.
B (T3N2M0) NSCLC who are suitable for surgery, undergo radical surgery, and are tested as EGFR-sensitive mutation-positive after surgery, postoperative osimertinib (after adjuvant chemotherapy) or adjuvant exertinib (class 1A) is recommended for grade I [2].

。
The guidelines also point out that for operable stage I.
~III.
NSCLC, grade I recommends "EGFR mutation detection for postoperative stage II.
/III.
non-squamous cell carcinoma to guide adjuvant targeted therapy" [2].

▌NCCN NSCLC Clinical Practice Guidelines
The National Comprehensive Cancer Network (NCCN) NSCLC Clinical Practice Guidelines (2022.
V5) state that osimertinib is recommended as an adjuvant therapy option for patients with stage IB~IIIA EGFR mutation-positive NSCLC who have previously received adjuvant chemotherapy or are not candidates for platinum-containing chemotherapy and undergo complete resection (R0) (TNM staging adopts AJCC 8th edition staging criteria) [3].

It is worth noting that osimertinib was first recommended as an adjuvant therapy option in the NCCN NSCLC clinical practice guidelines (2021.
V1) and the first NSCLC adjuvant targeted therapy drug recommended by the NCCN guidelines [4].

Evidence-based evidence for approval of indications for adjuvant EGFR-TKI

Although a variety of EGFR-TKIs have been recommended in domestic and foreign guidelines, only osimertinib or eclitinib have been approved by the National Medical Products Administration (NMPA) for postoperative adjuvant therapy [2].

What evidence-based medical evidence do they support?
▌ADAURA study
The approval of osimertinib adjuvant therapy indications is based on the results of ADAURA research
.
The ADAURA study is an international multicenter, randomized, double-blind, placebo-controlled, phase III.
clinical study to explore the efficacy and safety
of osimertinib as an adjuvant therapy in patients with stage I.
B~III.
A, EGFR mutation, and NSCLC after complete resection.
The primary endpoint was disease-free survival (DFS) in patients with stage II.
~III.
A assessed by the investigators; Secondary endpoints included DFS, overall survival (OS), and safety
in the general population (patients with stage I.
B~III.
A).

The results showed that in stage II.
~III.
A patients, compared with the placebo group, osimertinib group significantly prolonged median DFS (19.
6 months vs not reached), reduced the risk of disease recurrence or death by 83% (HR = 0.
17, P< 0.
001), and significantly increased<b20> the 2-year DFS rate (44% vs 90%) and 3-year DFS rate (28% vs 80%) 。 In the general population (stage I.
B~III.
A), the median DFS in the osimertinib group was also significantly better than that in the placebo group (less than 27.
5 months, HR = 0.
20, P<</b21>0.
001) Based on this, osimertinib was approved by the NMPA in April 2021 for adjuvant therapy after tumor resection in adult patients with NSCLC with EGFR-sensitive mutations in stage IB~IIIA (AJCC version 7).

In addition, ADAURA research data are constantly updated, this year's European Lung Cancer Congress (ELCC) published Chinese subgroup analysis data [6], the European Society of Medical Oncology (ESMO) Congress announced updated data on the past 4 years of follow-up (additional follow-up 2 years) [7], and ESMO ASIA Conference released long-term safety data [8]
。 They show the advantages of osimertinib adjuvant therapy from different dimensions, and further confirm the efficacy and good safety
of osimertinib adjuvant therapy.

▌EVIDENCE study The approval of the indication for adjuvant therapy with eclitinib is based on the results of the EVIDENCE study

.
EVIDENCE is a multicenter, randomized, open-label, phase III.
study to compare the efficacy and safety
of eclitinib with standard adjuvant chemotherapy for adjuvant therapy after complete resection of stage II.
~III.
A with EGFR mutation NSCLC.
The primary endpoint was DFS
.

The results showed that median DFS was significantly longer in the eclitinib group (22.
1 versus 47.
0 months, HR = 0.
36, P < 0.
0001) compared with the standard adjuvant chemotherapy group, and the three-year DFS rates in the eclitinib group and standard adjuvant chemotherapy groups were 63.
9 percent and 32.
5 percent, respectively <b20>[9].

Based on this, eclitinib was approved by NMPA in June 2021 for postoperative adjuvant therapy of stage II.
~III.
A (AJCC version 7) EGFR mutant NSCLC.

total

knot

In summary, EGFR-TKI rewrites the pattern of postoperative adjuvant therapy for early and intermediate NSCLC, and is an important choice
for postoperative adjuvant therapy in patients with EGFR mutation-positive NSCLC.
In clinical practice, clinicians should choose the appropriate adjuvant targeted treatment plan for patients based on the patient's situation and guideline recommendations, so as to reduce the risk of postoperative recurrence and prolong survival
.

References:

[1] Lung Cancer Professional Committee of Chinese Anti-Cancer Association, Lung Cancer Group of Oncology Branch of Chinese Medical Association, Chinese Thoracic Cancer Research Collaborative Group.
Guidelines for adjuvant therapy after complete resection of stage I.
~III.
B non-small cell lung cancer (2021 edition)[J].
Chinese Medical Journal.
2021; 101(16):1132-1142.

[2] Chinese Society of Clinical Oncology Guidelines Working Committee.
Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer (2022).

[3] NCCN Clinical Practice Guidelines:Non-Small Cell Lung Cancer(Version 5.
2022).

[4] NCCN Clinical Practice Guidelines:Non-Small Cell Lung Cancer(Version 1.
2021).

[5] Wu YL,Tsuboi M,He J,et al.
Osimertinib in Resected EGFR-Mutated Non–Small-Cell Lung Cancer.
N Engl J Med.
2020; 383:1711-23.

[6] W.
jie,Y.
Wu,S.
Lu,et al.
Adjuvant osimertinib in patients(pts)with stage IB-IIIA EGFR mutation positive(EGFRm)NSCLC after complete tumour resection:ADAURA China subgroup analysis.
2022 ELCC,85P.

[7] M.
Tsuboi,Y.
Wu,C.
Grohe,et al.
Osimertinib as adjuvant therapy in patients(pts)with resected EGFR-mutated(EGFRm)stage IB-IIIA non-small cell lung cancer(NSCLC):Updated results from ADAURA.
2022 ESMO,LBA47.

[8] T.
John,C.
Grohe,J.
W.
Goldman,et al.
Long-term tolerability of adjuvant osimertinib in patients with resected EGFR-mutated(EGFRm)stage IB–IIIA non-small cell lung cancer(NSCLC)from ADAURA.
2022 ESMO Asia Congress,LBA5.

[9] ZHOU C,HE J,SU C,et al.
Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC(EVIDENCE):A Randomized,Open-Label,Phase 3 Study[J].
J Thorac Oncol.
2021; 16(3):S232-233.

Approval number: CN-107145 Expiration Date: 2023-12-31

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.

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