September 3-4, the third Sino German Lung Cancer Forum held in Shanghai. In the two day of the forum, dozens of well-known domestic and fore
September 3-4, the third Sino German Lung Cancer Forum held in Shanghai. In the two day of the forum, dozens of well-known domestic and foreign experts on lung cancer in 2011 the global academic hot spots in the field of lung cancer, the difficulty of the annual inventory, and the participants to conduct a comprehensive exchange and discussion.
Professor Wu Yilong, Guangdong General Hospital, reports on the consensus of experts in the treatment of epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC).
As we all know, EGFR mutant lung cancer is a special type of non-small cell lung cancer, lung cancer cells rely on the "EGFR pathway" to maintain growth, proliferation and metastasis and other biological behavior. There are a lot of researches on the treatment of lung cancer both at home and abroad. On the basis of more and more clinical research, the experts of lung cancer in China have reached a consensus on the treatment of lung cancer.
The EGFR mutant NSCLC from EGFR- tyrosine kinase inhibitor (TKI) treatment benefit, and regarded as the first-line drug for the treatment of patients with EGFR mutations, compared with the traditional chemotherapy can achieve longer progression free survival (PFS) and less side effects, patients easily tolerated, but overall survival (OS) did not extend.
EGFR-TKI is currently used primarily for NSCLC first-line, second-line and maintenance therapy. According to the survey, the majority of doctors in our country will be used for second-line (69.4%) treatment, but there are also 41.7% of the doctors will be used for first-line treatment, in addition, 27.8% of the doctors as a maintenance therapy. Current clinical studies supporting its use in first-line therapy include Asian IPASS studies, WJTOG3405 and NEG002 studies in Japan, and OPTIMAL studies in china.
The IPASS study showed that the mutation rate of EGFR was relatively high in patients with Asian, female and non smoking (or mild smoking), which could reach 60%. The results showed that the EGFR mutation positive patients, the use of first-line gefitinib alone conventional chemotherapy in patients with PFS significantly increased (P < 0.0001), while in EGFR mutation negative patients, the use of gefitinib alone traditional chemotherapy for patients with PFS was significantly shortened (P < 0.0001). Subsequently, South Korea's First-Signal study, which was similar to the IPASS study, confirmed the reproducibility of the IPASS findings.
The WJTOG3405 study is a prospective randomized controlled study, was proved to be a EGFR mutation, one group received first-line gefitinib treatment, another group received traditional chemotherapy. The results showed that gefitinib group and chemotherapy group PFS were 9.2 and 6.3 months (P < 0.001) no, but the difference between the two OS (gefitinib group 30.9 months did not reach to the chemotherapy group, P=0.211). Another NEJ002 study published in the new England Journal of medicine is similar to WJTOG.
OPTIMAL research professor Zhou Caicun Pulmonary Hospital Affiliated to Tongji University of China Shanghai city led also was named to the EGFR mutation in patients given first-line erlotinib or GP (gemcitabine + cisplatin) chemotherapy, the results showed that erlotinib group made up to 13.1 months of PFS, while the traditional chemotherapy group only 4.6 months. Subgroup analysis also showed that each subgroup had benefit. The same results were obtained from the EURTAC study of the Spanish Lung Cancer Collaborative group.
These results suggest that patients with EGFR mutations may benefit from first-line EGFR-TKI treatment, whether in the east or in the west.
EGFR-TKI as a first-line treatment for NSCLC: Patients with PFS can be extended for 3 to 8 months of life; patients compared chemotherapy improved; curative effect is better than that of first-line chemotherapy EGFR-TKI (for patients with EGFR mutations), and equivalent to the effect of chemotherapy as second-line treatment.
Controversially, EGFR-TKI as a first-line therapy for NSCLC did not prolong the overall survival of patients compared with chemotherapy. However, if a careful analysis of the results of these clinical trials, we will find that the end point of these clinical trials is PFS rather than OS, the sample size is not large, and EGFR mutations are heterogeneous. Increase the sample size, it is possible to have a statistically significant difference OS.
If we know the patient's EGFR mutation, how to use EGFR-TKI? The current clinical data suggest that EGFR-TKI is a first-line or second-line therapy, but there is no difference between the OS, but after 1 to 2 cycles of chemotherapy for TKI, OS is shortened. CALGB30406 studies have shown that TKI combined chemotherapy is not beneficial for patients, and the SATURN study has shown that patients who benefit from chemotherapy after TKI maintenance therapy. The Spanish SLCG study also demonstrated that EGFR mutations in patients with first-line or second-line PFS using EGFR-TKI and OS are indistinguishable. As to whether EGFR-TKI is used as a maintenance therapy or as a second line, we are looking forward to the results of the ENSURE study.
Therefore, during chemotherapy, if patients with EGFR mutation positive words, not immediately converted to EGFR-TKI treatment, do not recommend chemotherapy with treatment; and should be used as second-line therapy or maintenance therapy EGFR-TKI.
At present, we reached a consensus: 1 EGFR-TKI can be used as first-line therapy in patients with EGFR mutations, until disease progression or unacceptable toxicity during chemotherapy; 2 patients, EGFR mutation detection for positive words, do not recommend treatment together immediately into EGFR-TKI therapy or chemotherapy; 3 course of chemotherapy, patients with EGFR mutation detection positive words, suggest EGFR-TKI as maintenance therapy or second-line therapy.
Clinical study on the treatment of most of the EGFR-TKI are concentrated in the late NSCLC, BR.19 research and Azzoli exploration for the EGFR mutation in patients with early treatment, positive results, EGFR-TKI is used as a new adjuvant chemotherapy can benefit the patients. We have looked forward to the results of the two EGFR-TKI initiated by the China Lung Cancer Cooperative Group as a clinical trial of neoadjuvant or adjuvant chemotherapy. For the time being, EGFR-TKI as evidence of adjuvant chemotherapy is insufficient and more clinical trials are needed to be explored.
For locally advanced NSCLC, it is not recommended that EGFR-TKI be used as a treatment for chemotherapy and radiotherapy or combined with radiotherapy and chemotherapy.