Femara clinical research process active endocrine therapy for breast cancer
Application of breast cancer after Femara for endocrine therapy? No chemotherapy directly with Femara work? The world at present, after receptor-positive breast cancer patients using complementary therapy...
Breast cancer endocrine therapy Breast cancer endocrine therapy, it refers primarily to drug treatment. Endocrine therapy are two ways : One, the use of antagonists to es...
Aromatase inhibitors (ve class — AI) is the study of endocrine therapy for breast cancer the most active part. With the third generation of AI research and development and in-depth applications, tamoxifen (TAM) in the treatment of breast cancer endocrine status of the standards being challenged, Femara (letrozole) in the most clinical research system, the conclusion most certainly against recurrence of the metastases second-line treatment of the rescue good results in ammonia Mian-guided energy (AR/BC2 pilot) and megestrol acetate (AR/BC3 test); femara frontline rescue therapy (025 tests) and preoperative new secondary treatment (024 tests), they are significantly better than TAM; Although TAM compared with the postoperative adjuvant treatment, a million people the largest group of international clinical trials (MA17 NCIC CTG and BIG1-98 pilot) also ongoing, but is expected to get better results.
Femara series of clinical studies demonstrating the breast cancer drug study the integrity of the process, covering the medical treatment of breast cancer, the various stages of the clinical expression of a clear sequence of ideas, but also for our endocrine therapy for breast cancer again provided a lot of worthwhile ideas from the right.
1. Should endocrine therapy alone
Femara clinical study to examine the whole process, we will first discovered in the world, has completed dozens of countries, hundreds of hospitals and thousands of patients in clinical trials, no matter what stage to accept the treatment, regardless of the Study Group or the control group of patients, are in a separate application endocrine drugs , are not required to meet the latter of chemotherapy. And our country is most doctors and patients dare not alone endocrine means doing rescue treatment, and do not dare to do new adjuvant therapy. Because they can hardly imagine the daily dose of 1-2 tablets drugs can control tumor growth. They are worried about endocrine therapy alone, if ineffective, the patient will complain, but how can assure everyone effective if chemotherapy. We should clearly tell patients, endocrine therapy on receptor-positive patients and the efficacy of chemotherapy similar, it is part of an effective, but there are always some people invalid, only through therapy practice only know whether you effective, you can choose a suitable means of rescue.
We should also tell you, endocrine therapy and chemotherapy, the onset is slow, after 1-2 months of treatment efficacy can see the results or trends. So we save in the course of treatment, must each program each cycle for the results of careful evaluation, in other words, whether to chemotherapy or endocrine therapy, up to spend 1-2 months in the evaluation time, we will be able to suspend ineffective programs and would never endocrine treatment a delay of illness. Conversely, if we do not timely medical evaluation, or serious evaluation, then the whole treatment will be in a state of chaos.
Breast cancer in the long course of treatment, we do not reject chemotherapy. If endocrine treatment failure, the progress of the disease, even ER ( ), should also categorically out of endocrine therapy, chemotherapy or sequential switch to other treatment. If chemotherapy fail again, they can change the endocrine treatment, apply to a new endocrine drugs. Of course, like 025 Test crossover design is feasible, in the forefront restack TAM or failure, if it is suitable for endocrine therapy, cross-switch TAM and Femara as second-line treatment. In short chemotherapy and endocrine therapy not at the same time, the joint application, in order to let them in different time periods, each play the biggest role.
2. Should try to extend the use of endocrine therapy time
Because of the recurrence and metastasis of breast cancer treatment, and in particular the progress made repeated Retreated patients can not be radical in nature. Therefore, our therapeutic purposes, not only for tumor shrinkage, but also to improve the patient's quality of life and prolong the survival time of patients. If there are two different treatments, to achieve the same results of a treatment, then we can not only use seriously damaged the quality of life in treatment. Based on such a consideration, the right receptor-positive patients, it should first use of endocrine therapy; Right postmenopausal patients, the first to use AI.
1997 TAM was done in the treatment of front-line rescue, amino do I. Mian second-line treatment, they found ≥ June SD survival time of patients with CR and PR similar patients, and patients with PD are obviously different. In subsequent endocrine therapy clinical research, but also able to repeat this result. Therefore, we must not only fight for the CR PR efficiency, but also attaches great importance to CR PR SD ≥ June clinical benefit rate and the clinical benefit of time. Its purpose is to use the smallest price to acquire greater effectiveness. We should not be forced use of painful chemotherapy, to pursue their goal of CR PR efficient, and can be relatively easily through the endocrine treatment, was ≥ June SD, the same can be extended to achieve the purpose of life.
In endocrine treatment process, as long as the disease does not progress, it should have been used on consecutive medication for several months or even years are possible. We only try to extend the use of endocrine therapy time, we can gain a higher rate of clinical benefit, the longer the clinical benefit of time. But long-term course of medication, patients and their families must repeatedly informed consent and fully understands the drug with the intent to prevent future lesions progress frustrating; As a doctor should be more carefully tracking target lesion to the efficacy of the best stage for the light and found lesion (deterioration) on the cessation of treatment. However, the degree of deterioration, but it may not achieve the clear PD performance.
3. As it should be used as first-line endocrine therapy treatment
China's treatment of breast cancer recurrence and metastasis is a behavior that can be removed lesions on the body surface removal, radiotherapy can be on the site of radiotherapy, chemotherapy patients can be on chemotherapy, there is really no way to recall when endocrine therapy. In such circumstances Application endocrine therapy, efficacy sure poor. We Femara series from the results of clinical trials, the second-line rescue efficiency of around 20% first save 30% or so, the new adjuvant therapy clinical examination of the efficiency of around 50%. Only with new preoperative adjuvant therapy, is the real significance of the first-line treatment because many front-line rescue the patients received postoperative adjuvant therapy, it seems, endocrine therapy is used sooner the better.
We advocate of early medication, but the patient does not renounce the post. We recently under the sponsorship of the West Domestic Exemestane You follow the Phase II clinical trial of second-tier and second-line patients over the efficiency 18.1% (17/94), or even five lines, with six lines of efficiency could reach 3 / 6 and 1 / 5. Femara series of international clinical studies have shown that, although the first and second line treatment of patients with an efficient and benefit rate differential, but they benefit, the benefit of the median time almost, in about 20 months.
Because very few endocrine drug cross-resistance, the last time the patients effectively, and then the new endocrine drug also might work. But the drugs have failed, you should not repeat. For example, some people in the postoperative treatment Auxiliary TAM has less than five years of recurrence and metastasis that TAM has failed invalid. But some doctors have with patients, said : "You can not stop this habit, we must use the full five years Zaixing!" While this is a typical dogmatism. Not only this, rescue treatment, you should not repeat the past treatment of any drug. Femara treatment of 025 front-line rescue pilot has also provided us with such a negative example.
Because the 025 - Test "into the group of standards", the auxiliary TAM relapse for more than a year to stop the transfer of patients, can be included in first-line treatment targets. But careful, come to think of these patients essentially are no doubt TAM failure patients. Results showed that these patients receive further treatment TAM rescue efficient only 8%, and has never used the habit of patients was 23%. But Furlong as the first rescue, regardless of the past with no supporting TAM used, the efficiency of 29-31%. In response to this stratification, with logarithmic regression model Furlong and TAM than the ratio (odds ratio) close to 4.0, in other words, used auxiliary habit of patients with first-line rescue restack the objective and effective opportunity than TAM nearly 300%. After application of our TAM is very common, even many ER (-) patients also unreasonable application of TAM. Therefore our participation in 025 tests of 24, 48 of the patients, the prevalence of complementary TAM used in the Femara group was 83% (20/24), TAM Group is 96% (23/24). International Test and 025 spent the entire group supporting habit of only 19% (Strengthening) and 18% (83/454). So in China or unknown receptor-positive postmenopausal patients, as the first rescue, an early application of aromatase inhibitors are the general trend can not change the trend.
4. Should not abandon bone metastases of breast cancer treatment
Rescue treatment of breast cancer, the majority of people treated for bone metastasis is very difficult, because they think the "bone have 100 days," tumor metastatic bone repair more difficult, not to conduct an objective evaluation, often with a pessimistic attitude, pushing patients to radiotherapy Bureau.
Bone metastases are actually unmeasured lesions, but it is still evaluating lesions, back in 1981 it had a definite WHO efficacy standards, PR is osteolytic lesions again calcification. Based on our clinical experience, after the administration from January to February, as long as the symptoms and seriously read the target lesion CT or X-ray films, and the carefully before therapy compared to the baseline test results, it is very likely find clear and calcification. Even if only to see some clues of the calcification performance, and do not give up, because the WHO standard had no further provisions and the extent of calcification and may then have entered the PR areas, and extend the period of administration, will gradually found significant calcification performance.
Femara international clinical studies, second-line rescue treatment of bone metastasis efficiency is 15-16%, frontline relief is 22%. Femara in first-line therapy, metastatic bone lesions emerging diseases progress median time of 9.7 months, the effects are clear of. Incidentally, chemotherapy on bone metastases are equally effective. Because chemotherapy and endocrine therapy for breast cancer are effective systemic therapy for bone metastases is certainly effective. So in clinical practice, even if only patients with bone metastasis, as long as the MRI showed no signs of spinal cord compression vertebral transfer can be the first use of systemic treatment of breast cancer. Because of effective systemic therapy has not only controls the formation of bone metastasis, but also the same time, treatment of systemic spread of subclinical lesions. And then if we use radiation therapy, although the effect of partial lesion is yes, but on systemic subclinical lesions can not do anything about, the possibility of systemic radiotherapy during hematogenous spread can continue to develop. At the same time, radiotherapy or subsequent use of systemic treatment, because he has lost the evaluable target lesions, which might blindly into systemic treatment applied by the state.
In short, a series of Femara clinical research, as a textbook and demonstrate in front of us. We interpret this textbook process, the specific internal controls, there are many new awareness and understanding. These new ideas will be a strong impetus to our treatment of breast cancer endocrine active; China will make some breast cancer patients, from endocrine therapy to be more effective opportunities and benefit from time.
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