Use of docetaxel/doxorubicin/cyclophosphamide in breast and ovary accessory therapy

FIELD: medicine, oncology, pharmacy.

SUBSTANCE: invention relates to drugs and concerns docetaxel as a drug used in accessory therapy for treatment of metastatic cancer breast in combination with doxorubicin and cyclophosphamide. Proposed combination of drugs provides the enhanced viability coefficient in patients with superexpressed glands ER, PR and/or HER2.

EFFECT: enhanced effectiveness of treatment.

6 cl, 36 ex

 

The technical field to which the invention relates.

The present invention relates to a new therapeutic combination of Taxotere with other antineoplastic drugs, which are suitable for adjunctive therapy for metastatic breast cancer and ovarian cancer.

Background of invention

More specifically the present invention relates to the use of docetaxel in combination with doxorubicin and cyclophosphamide as adjuvant therapy in the treatment of cancer after surgery or other therapy of first choice.

Definitions of selected terms used in the description of the invention and in tables 1-36, are as follows:

the term "adjuvant therapy" refers to chemotherapy, which begin within, but not later than 60 days from the time of the intervention;

the term "AT" refers to the combination of adriamycin/Taxotere;

the term "docetaxel" refers to the active ingredient of the medicinal product TAXOTERE®or actual drug-drug TAXOTERE®;

the term "doxorubicin" refers to the active ingredient of the drug ADRIAMYCIN®or the actual medicine ADRIAMYCIN®;

the term "ER" refers to estrogen receptors;

the term "FAC" apply the to the combination of 5-fluorouracil, doxorubicin and cyclophosphamide;

the term "HER2" refers to a transmembrane tyrosinekinase receptor partial homology with the receptor-2 epidermal growth factor, both receptors belong to the superfamily tyrosinekinase receptor type 1;

the term "KPS" refers to the health status in Karnovsky, which is an indicator of the physical condition of the patient;

the term "MF" refers to the combination of methotrexate/5-fluorouracil;

the term "MV" refers to the combination of mitomycin/vinblastine;

the term "PR" refers to the progesterone receptor;

the term "TAC" refers to the combination drug TAXOTERE®(docetaxel), drug ADRIAMYCIN (doxorubicin) and cyclophosphamide;

and

the term "drug" or "drugs" refers to the above-mentioned active ingredients or drugs, or containing pharmaceuticals.

Previously, researchers noted that docetaxel (TAXOTERE®) and its derivatives (such as TAXOL®, paclitaxel) are suitable for the treatment of malignant tumors, such as solid tumors and other malignant tumors. In the European patent EP 0253738 and in the application for the grant of an international patent WO 92/09589 describes how prepared is I of docetaxel. Typically, varying depending on the patient dosage contains from 60 to 400 mg/m2docetaxel. Usually docetaxel administered intravenously at a dosage of 60 to 100 mg/m2within 1 hour once every 3 weeks (Textbook of Medical Oncology, Franco Cavelli et al., Martin Dunitz Ltd., p.4623 (1997)).

In many clinical studies have confirmed the efficacy of docetaxel in the treatment of many types of cancer, particularly breast cancer, non-small cell lung cancer and ovarian cancer. Efficacy of docetaxel and is shown in therapy of first choice and second choice therapy. It is believed that the mechanism of action of docetaxel is by strengthening the Assembly of microtubules and inhibition of depolymerization of tubulin at the cellular level.

However, in all treatments based on the use of taxonic derivatives, including docetaxel may cause serious and distressing toxic manifestations such as inhibition of the activity of myeloid number of bone marrow neutropenia, hypersensitivity, peripheral neuropathy and, among other things, fluid retention (Fumoleau et al., Bull. Cancer, (82) 8:629-636 (1995)). In the event of such toxic effects dosage of drugs may be limited with the resulting limited effectiveness of treatment is.

Therefore, in this technical field, there is an unmet need for pharmaceutical preparations and methods of treatment of cancer, increased activity of docetaxel without increasing the quantity of the injected doses and without amplification of unwanted side effects.

In the art there is also an unmet need in the treatment of cancer that spread beyond the initial tumor localization. The need for effective postoperative adjuvant therapy, which would lead to a remission or at least increase the duration of remission, there is especially for metastatic breast cancer and ovarian cancer.

In recent studies it was shown that the drug regimen with the use of docetaxel are more effective compared to standard schemes medicinal treatment of metastatic breast cancer. Drug regimen based on the use anthracyclines, for example, with the use of doxorubicin, are standard supportive therapy of patients with breast cancer with regional metastases. Therefore, taking into account mutual efficacy of docetaxel and doxorubicin in the treatment of progressive breast cancer and the potential lack of m is waiting for them in cross-resistance it was decided to combine them together with cyclophosphamide as a possible scheme for a more effective adjunctive therapy for metastatic breast cancer. The combination of docetaxel, doxorubicin and cyclophosphamide (TAC) has been tested in phase III trials in 20 countries, more than 112 researchers. Discussed below are the results indicate that, used as adjunctive therapy combination increases the effect of docetaxel without increasing the dosage and leads to increased survival in patients with metastatic breast cancer.

BRIEF description of the INVENTION

The present invention relates to methods for treating metastatic cancer, particularly metastatic breast cancer and ovarian cancer, including the introduction of docetaxel, doxorubicin and cyclophosphamide (TAC) in amounts effective to suppress or eliminate the tumor. The efficacy of this combination was demonstrated during the 33-month period of time on more than 700 cancer patients with regional metastases, who underwent postoperative treatment with the use of TAC.

Another aspect of the present invention relates to new reagent kits for the preparation of pharmaceutical preparations and medicines containing docetaxel in combination with doxorubicin the nome and cyclophosphamide, for the treatment of malignant tumors.

Another aspect of the present invention relates to the mode of introduction of the TAC for adjuvant therapy of cancer, where for one and the same day there is a separate infusion of each individual medicinal product included in the combination of TAC, once every three weeks. This cycle is repeated six times.

Description of the PREFERRED OPTIONS

The authors of the present invention in clinical trials it was shown that the dose of TAC, in particular, have unexpected and strong therapeutic effect in the treatment of tumors, particularly malignant tumors of the breast, and more specifically metastatic malignant tumors of the breast, in which ER/PR and HER2 sverkhekspressiya. As a rule, in accordance with the present invention docetaxel is administered at a dose of 75 mg/m2, doxorubicin at a dose of 50 mg/m2and cyclophosphamide at a dose of 500 mg/m2once every three weeks. This cycle is usually repeated six times.

Actually for docetaxel in several laboratory studies have shown the limit of efficiency from 40% to 43% (in therapy second choice at the dosage of 100 mg/m2), 48% (in the treatment of first choice at the dosage of 75 mg/m2) and 61% (in the treatment of first choice when dozer is VCE 100 mg/m 2).

For comparison, in the example below 75 mg/m2docetaxel was administered in combination with 50 mg/m2doxorubicin and 500 mg/m2cyclophosphamide, resulting in an efficiency index was 82%.

In accordance with the present invention a new use of docetaxel as a component of the TAC is very effective for the treatment of malignant tumors of the breast, ovary and lung; even more preferably, a new use of docetaxel is particularly suitable for the treatment of metastatic breast cancer.

The safety and efficacy of the combination of docetaxel, doxorubicin and cyclophosphamide have been tested on patients in accordance with the following Protocol:

Patients were considered suitable for the study if they had histologically proven breast cancer, if there was a final operation on excision of axillary lymph nodes (at least 6 lymph nodes), if between surgery and randomization is not more than 60 days, if the cancer is treated 1-3 stage, if there was at least one regional metastasis in the lymph node, if the age of the patient did not exceed 70 years, if the indicator KPS was more than or equal to 80%, and if the patient was noted the normal functioning of the bone marrow, liver, kidney and heart. See table 4.

To study what was b selected 1491 patient. As adjunctive therapy 745 patients were receiving TAC and 746 patients received FAC. The average age of patients receiving TAC was 49 years, 51% of patients were premenopausal, and 60% of patients underwent mastectomy. 68% of patients received radiation therapy, and 68% of patients received tamoxifen. The characteristics of the group of patients receiving FAC, were similar (see table 6).

Of 745 patients receiving TAC, in 62% of patients were found 1-3 regional metastasis in lymph nodes, in 30% of patients were found 4-10 regional metastases in the lymph nodes, and in 8% of patients were found more than 10 regional metastases in the lymph nodes. In 40% of patients with tumor size less than 2 cm, 53% of patients with tumor size greater than 2 cm, but was equal to or less than 5 cm, and in 7% of patients the tumor size exceeded 5 cm In 69% of patients were diagnosed with tumors with overexpression of ER or PR, and in 19% of patients, tumors with overexpression of HER2+(FISH). In this case, tumor characteristics in patients receiving FAC, were comparable (see table 7).

The primary result of this phase III trials was to assist in the achievement of remission, while secondary outcomes were overall survival, toxicity, quality of life and monitoring markers of pathology and molecular markers.

Treatment after application of the TAC and FAC included 1) radiation therapy for in the ex patients, undergoing gentle on the breast operation, and 2) the appointment of tamoxifen (20 mg/day for 5 years) for patients with ER - or PR-positive tumors. See table 3.

The following example illustrates how a new use of docetaxel in accordance with the present invention, without limiting it.

EXAMPLE:

As a drug for sedation of patients within 3 days received dexamethasone 8 mg BID. Then on the 4th day was administered combination for adjuvant therapy. One group of patients received docetaxel, doxorubicin and cyclophosphamide (TAC), which was injected intravenously in the specified order. Another group of patients received 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), which was injected intravenously in the specified order. Then, 5-14 day patients in both groups prophylactic received Cipro dosage 500 mg BID. Six cycles of this course drugs were repeated every three weeks. See table 2.

679 patients (91%) completed six cycles of adjuvant therapy with TAC subsequent postchemotherapy, the scheme described above. After six cycles of treatment, the average total dose for the patient amounted to 446 mg/m2docetaxel, 297 mg/m2doxorubicin and 2978 mg/m2cyclophosphamide. See table 8.

711 patients (96%) underwent six cycles of ancillary therapy FAC followed by postchemotherapy, the scheme described above. After six cycles of treatment, the average total dose for the patient was 2985 mg/m25-fluorouracil, 298 mg/m2doxorubicin and 2985 mg/m2cyclophosphamide. See table 8.

After 33 months after adjuvant therapy 82% of patients treated with TAC, were alive and were in remission compared with 74% of patients treated with FAC (table 10). At the same time, overall survival in the group of patients treated with TAC, was 92% compared with 87% in the group of patients treated with FAC (table 13).

The results of the assessment of the status of lymph nodes

If remission in groups of patients treated with TAC and FAC, to compare the status of lymph nodes, 90% of patients with 1-3 regional metastases in the lymph nodes treated with TAC, were alive and were in remission after 33 months after therapy compared with 79% in the group of patients who received FAC. In patients with 4 regional metastases in the lymph nodes of the statistical differences between the two types of adjuvant therapy was not observed, although 69% of patients treated with TAC, were alive and were in remission after 36 months compared to 67% in the group of patients who received FAC. See table 15.

The overall survival rate among patients with 1-3 regional metastases in the lymph nodes was 96% for patients receiving TAC and 89% for patients receiving FAC. In this case,patients with 4 or more metastases in the lymph nodes of the statistical differences between the two types of adjuvant therapy was not observed, although patients treated with TAC, again there was a large survival rate (86%) compared with patients treated with FAC (84%). See table 16 and 32.

The results of the evaluation of hormonal status

In patients with ER/PR-negative tumors, the proportion of patients in remission was approximately 70% among patients receiving supportive therapy TAC, and approximately 62% among patients receiving supportive therapy FAC. In patients with ER/PR-positive tumors, the proportion of patients in remission was approximately 88% among patients receiving TAC, compared with 82% among patients receiving FAC. See tables 17 and 33.

If the total survival rate to calculate the evaluation of hormonal status in patients with ER/PR-negative tumors treated with TAC, it is approximately 83% compared with approximately 72% among patients receiving FAC. Patients with a positive tumors survived approximately 90% of patients treated with TAC, compared to approximately 88% of patients receiving FAC. See tables 18 and 35.

The results of the assessment of HER2 status

In patients with HER2-negative tumors, the proportion of patients in remission, after 33 months was approximately 86% among patients receiving supportive therapy TAC, and approximately 80% of patients, the floor is ausich supportive therapy FAC. In patients with HER2-positive tumors, the proportion of patients in remission was approximately 75% among patients receiving TAC, compared to 60% among patients receiving FAC. See table 19.

Based on these data, the combination of docetaxel, doxorubicin and cyclophosphamide as adjuvant therapy is well tolerated, and the results reflect a significant advantage of this combination in comparison with the combination of 5-fluorouracil, doxorubicin and cyclophosphamide as adjuvant therapy. If remission to quantify, in comparison with the use of FAC after 33 months of application of the TAC was reduced overall mortality by 32%, to reduce mortality in patients with 1-3 metastases in lymph nodes by 50%, to reduce mortality in patients with tumors with negative hormonal status by 38% and in patients with tumors with positive hormonal status by 32%. See table 22.

If overall survival to quantify, among patients receiving supportive therapy TAC, there is a marked reduction in mortality by 24%, and among patients with 1-3 metastases in lymph nodes were observed reduction in mortality by 54%. See table 22.

The combination of TAC is different from the combination of FAC content of docetaxel instead of 5-fluorouracil. Preveden the statistics I objectively proves the observed effect of docetaxel in combination with doxorubicin and cyclophosphamide is large enough to be of clinical value for adjunctive therapy for patients with breast cancer with regional metastases.

In all respects it is believed that the described options are shown only for the purpose of illustration and are not limiting. Therefore, the scope of the present invention more fully described by the attached claims and not the foregoing description of the invention. All changes corresponding to the sense and equivalent range of the claims should be covered by the scope of the present invention.

1. The use of docetaxel as a medicine adjunctive therapy for the treatment of metastatic breast cancer in combination with doxorubicin and cyclophosphamide, ensuring a high survival rate in patients with sverhagressivnym glands ER, PR and/or HER2.

2. The use according to claim 1, where docetaxel, doxorubicin and cyclophosphamide is administered separately.

3. The use according to claim 2, where docetaxel, doxorubicin and cyclophosphamide is administered once every 3 weeks.

4. The use according to claim 2, where docetaxel is administered at a dose of approximately 75 mg/m2for the cycle.

5. The use according to claim 2, where doxorubicin is administered at a dose of approximately RA is Noah 50 mg/m 2for the cycle.

6. The use according to claim 2, where the cyclophosphamide is administered at a dose of approximately 500 mg/m2for the cycle.



 

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