Ixempra Plus Xeloda Survival In Triple
Ixempra plus Xeloda® Improves Progression-free Survival in Triple-negative Metastatic Breast Cancer
The combination of Ixempra® and Xeloda® significantly increases progression-free survival in women with triple-negative metastatic breast cancer, according to the results of a study presented at the San Antonio Breast Cancer Symposium on December 12, 2008.
Some breast cancers display different characteristics that require different types of treatment. The majority of breast cancers are hormone receptor-positive breast cancers, meaning that the cancer cells are stimulated to grow from exposure to the female hormones estrogen and/or progesterone. These cancers are typically treated with hormone therapy to prevent or reduce these hormones, thereby preventing the growth of cancer cells. Other cancers are referred to as HER2-positive, which means that they overexpress the human epidermal growth factor receptor 2, a biologic pathway that is involved in replication and growth of a cell. HER2-positive breast cancers account for approximately 25% of breast cancers and are treated with agents that target the receptor to slow growth and replication.
Breast cancers that are not stimulated to grow from exposure to estrogen or progesterone and are HER2-negative are called triple-negative breast cancers. Triple-negative breast cancers tend to be more aggressive than other breast cancers and have fewer treatment options.
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Xeloda And Herbs And Supplements
Taking folic acid supplements with Xeloda can increase the risk of side effects from Xeloda. These include mouth sores, diarrhea, and low blood cell counts. You should not take folic acid supplements with Xeloda unless your doctor recommends them.
Be sure to check with your doctor or pharmacist before using any herbs or supplements while taking Xeloda.
Dosage For Adjuvant Treatment Of Colon Cancer
The usual dosage for adjuvant treatment of colon cancer is 1,250 mg/m2. It is taken twice a day for 2 weeks, followed by a 1-week rest period. Adjuvant treatment is used to prevent cancer from coming back after it has been treated in the past.
For example, lets say your doctor determines that you have a BSA of 1.6 m2. In this case, your dosage would be 2,000 mg taken twice a day for 2 weeks. This would be followed by a week off to complete your 3-week cycle.
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Xeloda/ixempra Effective In Resistant Triple
The combination of capecitabine and ixabepilone appears to be robust in patients with the so-called triple-negative breast cancer phenotype
SAN ANTONIO-The combination of capecitabine and ixabepilone appears to be robust in patients with the so-called triple-negative breast cancer phenotype, according to an analysis of a predefined subset of the larger 752-patient phase III trial of the combination vs capecitabine alone.
In 187 heavily pretreated metastatic breast cancer patients with the triple-negative subtype, the regimen yielded an overall response rate of 27% and median progression-free survival of 4.1 months, Hope Rugo, MD, of the University of California, San Francisco, reported at the 2007 San Antonio Breast Cancer Symposium .
“This study was an attempt to cull out this very resistant group of patients, which represented 25% of patients in our larger trial. These patients have limited treatment options, and this was quite an effective treatment for them,” Dr. Rugo commented.
An aggressive phenotype
Triple-negative breast cancer is characterized by tumors that are estrogen-receptor negative, progesterone-receptor negative, and HER2 negative. This is an aggressive phenotype with poor prognosis as a result of its increased mitotic index, central necrosis, proportion of apoptotic cells, and other high-risk pathological features.
Prolonged PFS
Lack of resistance a factor
Well tolerated
New studies on the horizon
‘A reasonable option’
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Fda Warning: Risk Of Interaction With Warfarin
This drug has a boxed warning . This is the most serious warning from the Food and Drug Administration . A boxed warning alerts doctors and patients about drug effects that may be dangerous.
Xeloda has the risk of increasing the effect of coumarin-type blood thinners such as warfarin . This interaction can increase the time it takes your blood to clot. It can lead to serious, or in rare cases, fatal bleeding. When taking Xeloda with warfarin, this interaction can occur within days or months of starting treatment. It can also occur up to a month after you stop treatment. Its more common in people older than age 60 years.
If you take Xeloda with warfarin, you should have frequent tests to check the time it takes your blood to clot. If needed, your doctor will adjust your dose of warfarin.
To read more about this interaction, see the section above called Xeloda interactions.
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Is Xeloda A Chemotherapy Drug
Yes, Xeloda is a chemotherapy drug. However, its different from most other chemotherapy drugs. Xeloda is taken by mouth instead of being given as an injection. Its also slightly more targeted against cancer cells than other chemotherapy drugs.
Chemotherapy drugs kill most cells in the body that are multiplying rapidly. This includes cancer cells, but it also includes many healthy cells. As a result, chemotherapy often has several side effects.
Xeloda mainly targets cancer cells. As a result, Xeloda usually causes fewer side effects than other chemotherapy medications.
To read more about this, see the How Xeloda works section below.
Platinum In Treating Patients With Residual Triple
| The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| Recruitment Status : Active, not recruitingFirst Posted : May 15, 2015Results First Posted : October 5, 2022Last Update Posted : December 9, 2022 |
| Intervention/treatment | Phase | |
|---|---|---|
| Estrogen Receptor NegativeHER2/Neu NegativeInvasive Breast CarcinomaProgesterone Receptor NegativeStage II Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage III Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerTriple-Negative Breast Carcinoma | Drug: CapecitabineDrug: CarboplatinDrug: Cisplatin | Phase 3 |
PRIMARY OBJECTIVES:
I. To compare the invasive disease-free survival in triple-negative breast cancer patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to capecitabine.
SECONDARY OBJECTIVES:
I. To evaluate overall survival and response-free survival in the two arms in patients with TNBC with residual basal-like disease after neoadjuvant chemotherapy.
EXPLORATORY OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
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Is Xeloda Used For Pancreatic Cancer
Yes, Xeloda is sometimes used to treat pancreatic cancer. However, this is an off-label use of the drug. Off-label use refers to using a drug for a purpose that hasnt been approved by the Food and Drug Administration .
The National Comprehensive Cancer Network recommends Xeloda as a treatment option for pancreatic cancer in its guidelines.
If youd like to find out more about taking Xeloda for pancreatic cancer, talk with your doctor.
Is Xeloda Used With Radiation Therapy
Yes, Xeloda is sometimes used with radiation therapy. This is called chemoradiation. Taking Xeloda with radiation therapy can make the radiation more effective. But it can also increase certain side effects, such as nausea, tiredness, and hair loss.
Xeloda is commonly used in this way to treat colorectal cancer when surgery isnt an option. However, in some cases, the drug is also used in this way after surgery for colorectal cancer.
In addition, Xeloda may be used with radiation therapy for other types of cancer. However, these are off-label uses for Xeloda. The drug is not specifically FDA-approved for treatment of cancers other than breast cancer and colorectal cancer. To learn more, see Xeloda uses below.
If youd like to find out more about taking Xeloda as part of chemoradiation, talk with your doctor.
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Why Is Chemo Used After Surgery
In this way, it may be possible to shrink tumors and make them easier to remove, which can increase the likelihood of a successful surgical outcome. Additionally, because it is not always possible for a surgeon to completely remove a patients cancer, chemotherapy may be recommended after surgery to target any remaining cancer cells and help prevent spread and recurrence. Alternatively, chemo can be used as a primary form of treatment to control the growth and ease the symptoms of large tumors that cannot be surgically removed.
No Improvement After Standard Chemo Though Subset May Derive Some Benefit
SAN ANTONIO Women with early triple-negative breast cancer did not appear to benefit from treatment with capecitabine after surgery and standard anthracycline and/or taxane-containing chemotherapy given in either the neoadjuvant or adjuvant setting, researchers reported here.
After 5 years, the disease-free survival for women on capecitabine after chemotherapy was 79.6% versus 76.8% among patients who were observed and not given adjuvant treatment , according to Miguel Martin, MD, of the Instituto de Investigacion Sanitaria Gregorio Maranon, Universidad Complutense de Madrid, and colleagues.
Overall survival was 86.2% in the investigational arm and 85.9% in the observation arm , they noted in a presentation at the San Antonio Breast Cancer Symposium .
“This study failed to show a statistically significant increase in disease-free survival by adding capecitabine to standard neoadjuvant/adjuvant chemotherapy in early triple-negative breast cancer,” Martin said at a press conference.
However, in women with non-basal like phenotype, capecitabine did offer some advantage, with a 5-year DFS rate of 82.6% versus 72.9% among women with other phenotypes , the authors reported. OS was better in this subtype as well, with 5-year survival of 89.5% for women with the non-basal phenotype versus 76.6% of women with other cancer phenotypes .
Patients were randomized to either eight cycles of capecitabine or observation. Median follow-up was 7.3 years.
Disclosures
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Financial And Insurance Assistance
If you need financial support to pay for Xeloda, or if you need help understanding your insurance coverage, help is available.
Genentech, the manufacturer of Xeloda, offers cost assistance for their drug. For more information and to find out if youre eligible for support, call 877-GENENTECH or visit the manufacturers website.
To learn more about saving money on prescriptions, check out this article.
Dosage For Treatment Of Metastatic Breast Cancer
The usual dosage of Xeloda for metastatic breast cancer is 1,250 mg/m2. It is taken twice a day for 2 weeks . This is followed by a 1-week rest period. Metastatic means the cancer has spread to other parts of your body, such as your bones or brain.
For example, lets say your doctor determines that you have a BSA of 1.6 m2. In this case, your dosage would be 2,000 mg taken twice a day for 2 weeks. This would be followed by a week off to complete your 3-week cycle.
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Xeloda For Adjuvant Treatment Of Colon Cancer
Xeloda is FDA-approved for adjuvant treatment of Dukes C colon cancer . For this purpose, Xeloda is used alone after youve had surgery to remove the cancer.
Xeloda is used to treat this type of cancer when a group of drugs called fluoropyrimidines is the preferred treatment. Xeloda is an example of a fluoropyrimidine.
Adjuvant treatment helps prevent cancer from coming back after it has been treated in the past. In this situation, Xeloda helps kill any cancer cells that may be left in the body after surgery.
With this form of colon cancer, the cancer has spread through the colon wall to nearby lymph nodes. Symptoms of this may include swelling, abdominal bloating, or decreased appetite.
Effectiveness for colon cancer
Xeloda has been found effective for adjuvant treatment of colon cancer. NCCN guidelines include Xeloda as a treatment option for colon cancer.
To find out how the drug performed in clinical studies, see Xelodas prescribing information.
Can Xeloda Be Crushed Split Or Chewed
No, you should not crush, split, or chew Xeloda. Taking Xeloda in a way other than how your doctor prescribes could be harmful. For example, particles from crushed Xeloda tablets could irritate your eyes or cause a skin rash.
You should swallow Xeloda tablets whole with a drink of water.
If you have trouble swallowing Xeloda whole, talk with your doctor. They may be able to provide you with tips to help with administration. A health professional needs to use the appropriate equipment and safety procedures for handling chemotherapy drugs.
Taking more than the recommended dosage of Xeloda can lead to serious side effects.
Do not take more Xeloda than your doctor recommends.
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Sex Contraception And Pregnancy
Youre advised not to become pregnant while having treatment because capecitabine can harm a developing baby. If you havent been through the menopause, talk to your team about the most suitable method of contraception for you. Its still possible to become pregnant even if your periods become irregular or stop.
Find out more about how breast cancer and its treatment can affect sex and intimacy and read our tips on how to manage these changes.
What Is Triple Negative Breast Cancer
The diagnosis of triple negative breast cancer is established with a core needle biopsy of the breast cancer. Sometimes the lymph nodes are also biopsied if they are abnormal. The patient will then receive chemotherapy +/- immunotherapy. At the end of treatment, they are re-evaluated again to decide what type of operation they need. Surgery is then performed, but in approximately 30 to 50% of women no cancer is found after the tissues are analyzed! This is what we call a pathologic complete response .
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What Happens At The End Of Chemo
At the end of chemotherapy, they will undergo image-guided, vacuum-assisted biopsies of the primary breast tumor site. Patients who dont have any residual cancer on biopsy will receive radiation therapy without surgery. Patients who do have residual cancer will receive standard surgery and radiation. The patients in this study will be evaluated
Drug Interactions And Supplements
Coumadin and other blood thinners are drugs that interact with Xeloda. It’s important to note that some nutritional supplements may also work as blood thinners, and you should talk to your oncology team before taking them.
In those 80 years old or older, Xeloda may cause more diarrhea, nausea, and vomiting than in younger people.
Hand-foot syndrome can occur with Xeloda. It often starts with darkening of the palms of the hands and soles of the feet. As it progresses, it can become more like a sunburn. There are several things you can do to help prevent this including keeping your hands and feet cool, wearing good shoes, and not going barefoot.
Xeloda can cause , which means you may get a sunburn more easily. Consider the following precautions to help protect your skin:
- Avoid sun exposure if possible
- Use a good sunscreen
- Cover up using UV clothes, hats, or an umbrella
Since Xeloda can make you more susceptible to infections, its best to avoid situations that might put you at risk, such as crowded places and visiting ill friends.
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Xeloda Use With Other Drugs
Your doctor may prescribe Xeloda in combination with other drugs to treat your cancer. This is because, in some cases, taking Xeloda with other drugs can make the drug more effective than when its taken alone.
For example, for metastatic breast cancer, you may take Xeloda with a chemotherapy drug called docetaxel . Your doctor may prescribe this combination if youve previously had chemotherapy with an anthracycline drug*, but it hasnt helped your cancer. In this case, youll receive docetaxel as an IV infusion once every 3 weeks.
Xeloda may also be used off-label with other medications to treat different forms of cancer. Off-label use refers to using a drug in a way or for a purpose that hasnt been approved by the Food and Drug Administration . Your doctor can tell you more about this. A few examples include:
- Xeloda with oxaliplatin for colon cancer
- Xeloda with bevacizumab for metastatic colorectal cancer
Xeloda may also be used off-label with various other medications to treat other forms of cancer.
* Anthracycline drugs include doxorubicin and epirubicin .
What Is The Best Treatment For Triple Negative Breast Cancer
Twitter. Linkedin. Pinterest. Email. Chemotherapy is often recommended for treating triple negative breast cancer. Unlike most other types of breast cancer, triple negative breast cancer does not respond to the presence of certain hormones, such as estrogen and progesterone, nor does it have an abnormally high level of HER2 receptors.
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Does Hormonal Therapy Help With Cancer
In a separate analysis, hormonal therapy alone did seem very effective in deterring the spread of cancer for women with an Oncotype score of 10 or below. And for those with scores of 26 or above, 13 percent went on to develop metastatic cancer despite receiving both hormonal treatment and chemotherapy, the team said.
The Most Common Side Effects Caused By Xeloda Were:
- hand-foot syndrome
- low white blood cell counts
In summary, a year of low-dose Xeloda reduced the risk of recurrence and offered a modest improvement in overall survival. This result could change further with longer follow up.
Platinum based chemotherapy has been compared to Xeloda in TNBC following neoadjuvant chemotherapy and found not to be superior, but platinum was associated with greater side effects. Adjuvant Xeloda can be considered as standard of care for patients with TNBC with residual cancer after neoadjuvant chemotherapy but better treatments are needed.2
If youve been diagnosed with early-stage triple-negative breast cancer and have had surgery, completed standard chemotherapy, and are very concerned about the cancer coming back, you may want to talk to your doctor about this study. You can discuss the potential risks and benefits of a year of maintenance Xeloda and also look to see if there are any other clinical trials using Xeloda in this way that may be a good fit for you. Together, you and your doctor can make the best choices for you and your unique situation.
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