5.3.2 Treatment of HER-2 Positive Advanced Breast ...
HER-2 positive recurrent metastatic breast cancer who has not received trastuzumab therapy，the rescue treatment is based on trastuzumab；patients who have been treated with trastuzumab in the adjuvant therapy phase have recurrence and metastasis，the treatment plan should be considered according to the time of disease recurrence.If the patient relapses within 12 months after completing the treatment with trastuzumab or relapses during treatment，second-line anti-HER-2 treatment should be selected，if recur after 12 months，choose first-line anti-HER-2 treatment.One of the first-line treatments should be based on trastuzumab，taking into account the patient's previous treatment，hormone receptors and other drugs combined with the combination of drugs，can be combined with docetaxel，vinorelbine and so on.In patients who are resistant to dual-agent chemotherapy，trastuzumab can be combined with docetaxel and capecitabine.The international standard treatment for HER-2 positive advanced breast cancer is pertuzumab，trastuzumab plus docetaxel，before the market for pertuzumab in the country，in guide the“TH+P”is recommended for Level Ⅱ.In 2018，pertuzumab is marketed in China.With the availability of drugs，the“TH+P”program evidence level is adjusted from 2A to 1A in the 2019 guidelines，but pertuzumab At present，medical insurance has not yet entered，and the price is relatively expensive.In China，only a small number of patients can afford dual-target treatment.Second-line treatment of anti-HER-2，level I recommended lapatinib+capecitabine，and trastuzumab+other chemotherapeutic drugs down from level Ⅰ in 2017 to level Ⅱ in 2018，and level Ⅲ in 2019.Trastuzumab+lapatinib also fell to Level Ⅲ recommendations from 2018.The EMILIA study［9］enrolled 980 patients with HER-2 positive advanced breast cancer who had failed to receive treatment with vaginal and trastuzumab.They were randomized into two groups receiving T-DM1 and lapapa.In the combination with the capecitabine group，the median PFS was 9.6 months vs 6.4 months（p＜0.0001），and OS was 30.9 months vs 25.1 months（p＜0.0001），with significant differences.Based on the results of this study，T-DM1 is recommended as a Level Ⅱ recommendation for anti-HER-2 second-line therapy in the 2017-2019 guidelines，and 1B is raised to 1A in 2019，but because T-DM1 has not been listed in China，patients are recommended by experts to actively participate in their clinical research.
In 2018，China's breast cancer treatment achieved a milestone.China's self-developed breast cancer targeting drug，pyrrolidine，was approved for marketing.According to the results of its phase Ⅱclinical clinical study，128 HER-2 positive breast cancers were enrolled.Patients were randomly divided into experimental group（pyrlotinib+capecitabine）and control group（lapatinib+capecitabine）according to 1：1.The results showed that the pyrrolidine group was compared with the lapatinib group.Significantly improved ORR（78.5%vs 57.1%，p=0.01），mPFS was also significantly better than the controlgroup（18.1 months vs 7.0 months，p＜0.0001）.Based on this study，pyrrolidine in the 2019 guideline Combined with capecitabine as a class II recommendation for anti-HER-2 second-line therapy.In the 2019 guideline for brain metastases in the treatment of HER-2 positive advanced breast cancer，the option of“replacement to TKI”was added to the alternative treatment regimen.(https://www.daowen.com)
Table 3 2019 CSCO Guideline in Rescue Chemotherapy
