PATIENTS | More Than Survival

TheraCIM add additional treatment benefit
while not worsening the side effects of your other treatments given
at the same time.

More Than Survival

Highlights

  • Safe to use
    When TheraCIM is given, it does not add toxicity to your other concurrent treatment. To date over 65,000 patients have used TheraCIM and only 2.3% of the patients have reported related-serious adverse events with the treatment, making TheraCIM the safest drug in its class targeting EGFR receptor.
  • Long-term use
    TheraCIM is well tolerated even when it was used for longer periods beyond TheraCIM standard treatment (which is normally for 60 days).
  • Simple administration
    Easy and effective administration time of 30-60 minutes, No premedication, No loading dose, No monitoring, and having standard dose per patients.
  • Can be used in children
    TheraCIM has been approved in several countries outside US, EU, Japan for glioma, which is a brain cancer in children arising from glial cells which are the most abundant cell types in the central nervous system.
  • Approved in countries outside US, EU and Japan
    TheraCIM has been approved in 25 countries outside US, EU and Japan, including China, India, Brazil, ASEAN and Latin America for head and neck cancer, glioma, esophageal, nasopharyngeal carcinoma and pancreatic cancer
  • Wide experience use
    TheraCIM has been successfully given to more than 65,000 patients to date and based on over 130 publications in peer review journals, 92 clinical studies and approvals in 25 countries for multiple tumor types

Learn more on how TheraCIM can benefited you

Locally advanced unrescectable of head and neck cancer

What is locally advanced unresectable of head and neck cancer?
Head and neck cancer is a type of cancer that starts in the tissues and organs of the head and neck. They include cancers of the larynx (voice box), throat, lips, mouth, nose, and salivary glands. Most head and neck cancers begin in squamous cells, which are cells that line moist surfaces such as those inside the head and neck (for example, the mouth, nose, and throat). This type of head and neck cancer is called squamous cell carcinoma head and neck cancer (SCCHN)1. Locally advanced unresectable SCCHN is a stage of SCCHN which has spread from the site of the original tumor only to surrounding tissue or lymph nodes and cannot be removed completely through surgery2

 

How many people have head and neck cancer?
If you have head and neck cancer, you are not alone!
Head and neck cancer is a common cancer, with a number of new case in the world in 2012 is 600,000 cases3. Head and neck cancer is more common in men and was reported to have higher lifetime risk for men than for women3.

 

What are the risk factors for getting head and neck cancer?
It is important to know that having 1 or more risk factors does not mean that you will certainly have head and neck cancer and some people may get this type of cancer even if they don’t have any risk factors. The risk factors that is associated with head and neck cancer, including:

 

Tobacco use4-7
Cigarette smoking is a strong risk factor for head and neck cancer independent of alcohol drinking. Smoking frequency, duration, and cumulative consumption is associated with increased risk for getting head and neck cancer6

Heavy alcohol use4-7
In the patients that never smokes, the association between alcohol consumption and the risk of head and neck cancer is only apparent at high doses of alcohol6.

Infection with human papillomavirus (HPV)8
HPV is a type of virus that is commonly transmitted sexually. HPV infection is high-risk for with one type of head and neck cancer that occur in oropharynx, which is in the middle part of the throat that includes the base of the tongue, the tonsils, the soft palate, and the walls of the pharynx8.

 

What are the treatment options for locally advanced unresectable head and neck cancer patients?

If you are diagnosed with locally advanced unresectable head and neck cancer, you will be receiving standard treatment of radiotherapy and chemotherapy combination.

 

TheraCIM has been studied in eight (8) completed clinical trials with a total number of 852 patients with head and neck cancer. Based on our phase II study9, if TheraCIM was added to the combination of radiotherapy and chemotherapy in patients with locally-advanced head and neck cancer, the possibility to stay alive at 5-year was 31% higher compared with radiotherapy and chemotherapy alone. The combination of TheraCIM, chemotherapy and radiotherapy was also showed to be well tolerated by patient9.

 

Your doctor may recommend treatment with TheraCIM based on the stage of your cancer, or your overall health. Please consult with your doctor for more information.

 

TheraCIM approval for locally advanced unresectable head and neck
Locally advanced unresectable SCCHN has been approved in several countries outside US, EU and Japan, including India, Argentina, Mexico, Thailand, El Salvador, Costa Rica, Myanmar, Bolivia, Ivory Coast, Nepal, Bhutan, Venezuela, Algeria, Vietnam, Cambodia, Mauritania, Somalia, Sri Lanka, Paraguay, Cuba, Peru.

 

Locally advanced unrescectable Nasopharyngeal cancer

What is Locally advanced unresectable nasopharyngeal cancer?
Nasopharyngeal carcinoma (NPC) is a type of cancer that arise from epithelial cells that line the surface of the nasopharynx. The nasopharynx is an air passage located at the very upper part of the throat, just behind the nose. NPC is a subtype of head and neck cancer, however risk factors, diagnosis and treatment is differed from other subtypes of head and neck cancer. Locally advanced unresectable of nasopharyngeal cancer is a stage of NPC which has spread from the site of the original tumor only to surrounding tissue or lymph nodes and cannot be removed completely through surgery11.

 

How many people have NPC?
NPC is fairly rare in the western world. However, in some countries NPC is particularly common, including in China, and Southeast Asia. In Southern China, the number of new cases is around 150 per 100,000 people. Younger-age (15-45 years of age) tends to have NPC compared with older age (65-74 years of age)11,12.

 

What are the risks for getting nasopharyngeal cancer?
It is important to know that having 1 or more risk factors does not mean that you will certainly have head and neck cancer and some people may get this type of cancer even if they don’t have any risk factors. The risk factors that have been associated with Nasopharyngeal cancer, including:

 

Ethnicity and where you live
NPC is most common in southern China (including Hong Kong), Singapore, Vietnam, Malaysia, and the Philippines. It is also fairly common in Northwest Canada and Greenland.

  • Infection with the Epstein-Barr virus
  • Family history12,13

 

Treatment of locally advanced unresectable nasopharyngeal cancer?
If you are diagnosed with locally advanced unresectable NPC, you will be receiving standard treatment of chemotherapy and radiotherapy with or without initial chemotherapy12.

 

Use of Nimotuzumab in nasopharyngeal cancer has been studied in 1 completed clinical trial and 1 ongoing clinical trial with 140 and 482 subjects, respectively. Based on one of our phase II study14, if TheraCIM was added to radiotherapy following initial chemotherapy in patients with LA-NPC, the possibility to stay alive after 3 year was 94.8% compared with radiotherapy alone (93.5%). Patients that received Nimotuzumab has lower event of nausea, fatigue, low amount of platelets (thrombocytopenia) and red blood cells (anemia) compared to the radiotherapy group14.

 

Your doctor may recommend treatment with TheraCIM based on the stage of your cancer, or your overall health. Please consult with your doctor for more information.

 

Unresectable nasopharyngeal cancer approval
TheraCIM has been approved in unresectable nasopharyngeal cancer in countries outside US, EU and Japan including Cuba, and China

 

Glioma

What is Glioma?
Glioma is one of the most common types of tumor that occurs in the brain and spinal cord. Gliomas begin in the glial cell that surround nerve cells and help them function15,16. Glioma has different types based on their location and rate of growth. High grade glioma is a type of glioma that is more agressive and rapidly growing. High grade Glioma has high rate of progression and recurrence compared to low grade glioma15, 16, 17.

 

How many people have Glioma?
High grade glioma is fairly rare. It is estimated that the number of adults having high grade glioma in 2015 is 11,882 with number of new cases 3 per 10,000 adults per year3,17.

 

What are the risks for getting glioma?
It is important to know that having 1 or more risk factors does not mean that you will certainly have glioma and some people may get this type of cancer even if they don’t have any risk factors. The risk factors that is associated with glioma:

  • Gender
    Male slightly has higher risk than females
  • Family history
    Genetically inhirited tendency
  • Ionising radiation15

 

What are the treatment options for high grade glioma?
If you are diagnosed with glioma, you will be given mainstay treatment of surgery followed by radiation and chemotherapy. However, most of the times, it is impossible to ever remove the tumor entirely through surgery17.

 

TheraCIM has been studied in 7 clinical trials with 530 adult and pediatric patients that were diagnosed with high grade glioma. Phase III clinical clinical trial studying TheraCIM use in combination with radiotherapy in adult patients with glioma showed longer survival of 17.76 months compared to patients that received radiotherapy alone with survival of 12.63 months18.

 

Your doctor may recommend treatment with TheraCIM based on the location, stage of your cancer, age or your overall health. Please consult with your doctor for more information.

 

TheraCIM approval for high grade glioma
TheraCIM has been approved for glioma in countries outside US, EU and Japan, including Thailand, Myanmar, Mexico, Philippines, Cuba, Ukraine and Argentine.

 

Pancreatic cancer

What is locally advanced and metastatic Pancreatic cancer?
Pancreatic cancer, specifically pancreatic ductal adenocarcinoma is a type of cancer that arises in the duct of gland in pancreas, which lies behind the stomach and in front of the spine19. Locally advanced pancreatic cancer is a type of pancreatic cancer which has spread from the site of the original tumor only to surrounding tissue or lymph nodes and cannot be removed completely through surgery. Metastatic pancreatic cancer is a type of pancreatic cancer that has spread to the distant sites or organs in the body11,19

How many people have Pancreatic cancer?
Pancreatic cancer is slightly rare with 338,000 of new cases in 20123. It was estimated that 85-90% of pancreatic cancer patients were presented with locally advanced or metastatic disease20.

What are the risks for getting Pancreatic cancer?
It is important to know that having 1 or more risk factors does not mean that you will certainly have pancreatic cancer and some people may get this type of cancer even if they don’t have any risk factors. The risk factors that are associated with pancreatic cancer:

  • Smoking
  • Family history
  • Chronic pancreatitis
  • Diabetes mellitus
  • H. pylori infection
  • Non-O-blood group
  • Red meat intake
  • Alcohol
  • Obesity13, 21

What are the treatment options for locally-advanced or metastatic pancreatic cancer?
If you are diagnosed with locally advanced or metastatic pancreatic cancer, you will receive treatment options, including: single chemotherapy agent called Gemcitabine, Nab-paclitaxel (Abraxane©) in combination with Gemcitabine, combination of chemotherapy agents, FOLFIRINOX, and targeted anti cancer drug erlotinib (tarceva©)21. These options depend on the health condition of the patients.

 

TheraCIM has been studied in 2 clinical trials with patients that were diagnosed with locally advanced or metastatic pancreatic cancer22,23. Phase IIB/IIIA clinical trial studying TheraCIM use in combination with Gemcitabine in patients with locally advanced or metastatic pancreatic cancer showed longer survival of 8.6 months compared to patients that received Gemcitabine alone with 6.0 months23.

 

Your doctor may recommend treatment with TheraCIM based on the location, stage of your cancer, age or your overall health. Please consult with your doctor for more information.

TheraCIM approval for locally advanced and metastatic pancreatic cancer
TheraCIM has been approved for locally advanced and metastatic pancreatic cancer in Cuba.

Safety Information
Please refer to safety information attached in email

Prescription information
Please refer to prescription information attached in email

Articles

Cancer Survivors: 6 Tips for Staying Healthy

With more than 15.5 million cancer survivors alive today in the US, chances are that you or someone you know has faced cancer. Each June, cancer survivors celebrate National Cancer Survivors Day, sponsored by the National Cancer Survivors Day Foundation. The event, which includes hundreds of life-affirming gatherings across the US, is a time to celebrate life – and if you’re a cancer survivor, it’s also a good time to reflect on what you could be doing to be even healthier.

 

Whether you’re still in treatment or long since finished, be sure you’re doing everything you can to safeguard your health.

 

1. Achieve and maintain a healthy weight.

  • Avoid weight gain during cancer treatment, whether you are at a healthy weight or overweight.
  • If you’re overweight or obese, talk to your health care provider about safely losing weight after you recover from treatment.

2. Be physically active.

  • Studies show that exercise is generally safe during cancer treatment, and can improve many aspects of health, including muscle strength, balance, fatigue, and depression. Talk to your health care provider about what would work best for you.
  • Physical activity after diagnosis is linked to living longer and a reduced risk of the cancer returning among people living with breast, colorectal, prostate, and ovarian cancer – among other forms of the disease.

3. Eat a healthy diet, with an emphasis on fruits, vegetables, and whole grains.

  • The most health benefits are associated with a diet high in fruits, vegetables, whole grains, poultry, and fish, and low in refined grains, red meat (beef, pork, and lamb) and processed meat (hot dogs, ham, bacon, sausage, and some deli meats), desserts, high-fat dairy products, and fried foods.
  • So far, studies have not shown that taking vitamins, herbs, and other nutritional supplements can help cancer patients live longer. Some may even shorten life. Before taking any supplement, discuss it with your health care provider.

4. Get recommended cancer screenings.

  • Cancer survivors should go to all the follow-up visits their cancer care team recommends, to make sure the cancer hasn’t come back.
  • Survivors can also get other cancers. Unless told otherwise by your health care provider, follow the same testing schedule for your age and gender as the general population.

5. Create a survivorship care plan.

  • Ask your cancer care team to give you a thorough record of the treatments you had and any follow-up they recommend.
  • Understand which provider – oncologist, primary care doctor, or other specialist – should be in charge of cancer-related and other medical care. If you don’t know, ask.

6. Take care of your emotional health.

  • Spend time with family and friends, and doing things you like.
  • Focus on your spiritual side, whether that means participating in organized religion, communing with nature, meditating, creating art, or whatever speaks to you.
  • Join a support group in your local area or online (such as Cancer Survivors Network) or speak to a mental health care professional.

Taken from https://www.cancer.org/latest-news/be-a-healthier-cancer-survivor.html

Women’s Guide to Sexuality During & After Cancer Treatment

During and after receiving treatment for cancer, women of all ages, with early and advanced diseases, will have concerns and questions about sexuality and sexual activity. It is common for women with different types of cancer to struggle with their body image; have less desire for sexual intimacy and/or find that penetration during sexual activity has become painful. Even if your health care providers do not ask about this normal and important aspect of health, you should not hesitate to discuss your feelings or ask questions about the impact of cancer treatments on your sexual health. This article attempts to answer common questions that arise, but certainly does not address every question. As with any concern, talk with your health care providers about your particular situation.

 

What Concerns Could Arise?
Some women experience a loss of desire for sex, an inability to have an orgasm, experience pain during sex or just do not find sex pleasurable. Sexuality is an important factor in quality of life for many women. Know that these concerns are not uncommon and your healthcare team can provide guidance. Write down your questions and concerns so you don’t forget to ask about them. If your provider cannot help, ask them to recommend someone who can.

 

Can I have sex during treatment?
There are a few factors that determine if sexual activity is safe during treatment.

  • In general, sexual activity is fine during treatment as interest, energy and comfort levels allow. While women may not feel up to sexual intimacy after surgeries or during chemo and radiation; hugging, holding hands and massages may feel good and be comforting.
  • If you had surgery involving the pelvic area (gynecologic cancers, colorectal and anal cancers), you may need to allow extra time for healing before having sex that involves vaginal or rectal penetration (with penis, fingers, toys, vibrators or dilators). If you are being treated for an oral cancer, use caution during oral sex.
  • If you have a low white blood cell count or low platelet count (concern arises with platelets below 50,000), you will need to refrain from any sexual activity that involves vaginal or anal penetration. This is because there is an increased risk of infection or bleeding when your counts are low.

Tips for healthy and safe sexual activity:

  • Be sure to use a reliable form of birth control to prevent pregnancy- even if you think your periods have stopped or your fertility has been affected.
  • Chemotherapy can be excreted in vaginal secretions for 48-72 hours after a treatment. You should use a condom for oral sex or intercourse during this period to prevent your partner from being exposed to the chemotherapy. (This includes IV and oral chemotherapy).
  • Think outside the box about sexual activity – it does not have to involve intercourse or oral sex. Use kissing, touching, caressing to satisfy each other.
  • Keep communication open. Talk about what feels good and what doesn’t; communicate with your partner when you are tired or uncomfortable.
  • Cancer surgery may result in a particular position being painful. Try different positions to find what is best for you and your partner. For example, if lying on your back during penetration is painful, having both partners lying on their sides may be more comfortable.
  • Talk with your healthcare team about coping with changes in your body image and sexual health. For some, talking with other women in a support group can help. While others may find more intensive help from a mental health provider, with expertise in working with women with cancer, useful.
  • Some practical tips for body image concerns include exercise, maintaining a healthy weight, dressing in clothing that makes you feel attractive, wearing pretty undergarments or learning beauty techniques to manage side effects such as facial coloring, eyebrow loss, etc. (see resources below). For women with an ostomy, using an ostomy cover or camisole as camouflage can help with concerns about others noticing the bag (do an online search for ostomy covers).

Coping with Vaginal Changes During and After Cancer Treatment
Vaginal dryness, which can cause intercourse/penetration to be painful, is one of the most common problems during and after cancer treatment. Vaginal atrophy is an inflammation, shrinking and thinning of the vaginal tissue. These are most often caused by a lack of estrogen to the vaginal tissue. Surgery can lead to a shortened vagina. Radiation therapy that includes the vaginal area can cause fibrosis (scarring).

There are a few steps that can help alleviate the discomfort caused by vaginal changes:

  • Use a vaginal lubricant during sexual activity (such as K-Y Jelly, Astroglide). There are many varieties or lubricants available; some contain fragrances, flavors or herbal ingredients. These can be irritating to some women.
  • Avoid Vaseline or skin lotion as a lubricant. These can damage condoms and may raise the risk of yeast infection.
  • Apply the lubricant to your vaginal area and your partner’s penis, fingers or any sex toys you may be using for penetration.
  • Use a vaginal moisturizer, such as Replens or K-Y SILK-E. These should be applied 2-3 times a week, regardless of sexual activity. These are estrogen free and work to help the vaginal tissue regain its natural moisture. They can also be used in conjunction with lubricants.
  • For some women, vaginal estrogens may be effective. These come in several forms, including a cream (typically used daily for 3 weeks, then 2x a week), tablet (inserted 2x a week), and a ring that excretes estrogen slowly over a 3-month period. Most of the estrogen is absorbed locally, with only a small amount entering the bloodstream. Discuss this option with your oncology team, as some women with a history of a hormonally based tumor are advised to avoid these products.
  • After radiation therapy, using dilators helps to keep the vagina open and decreases scarring, making intercourse/penetration as well as vaginal exams more comfortable. Learn more about dilator use after radiation therapy.

How to Get Started
You’ve had a period of time without sex and now feel ready to rekindle your sex life, but how do you get started? Set the mood- what sparked romance for you and your partner before cancer? Music, a romantic meal or an evening out? Relax and don’t pressure yourselves to have sex the first go at it. Take your time, enjoy each other and most of all, communicate.

 

Sexuality After Cancer
Sexuality encompasses much more than sex; it includes the physical, psychological, emotional and social aspects of sex. In the real world, this means how you see yourself, how does your partner view you, how do you date after cancer, how do you fulfill your need for sexual relationships after cancer and so much more.

 

How cancer affects your sexuality is different for every woman. Some find the support they need through their healthcare team, their partner, friends or fellow survivors. You may find the support you need to reconnect with your own sexuality through a support group or a close friend. There are a number of online groups that host discussion boards where you can “talk” about concerns with someone who has been there.

 

For those that find things more difficult, a mental health provider can help you cope with the physical and emotional trauma cancer brings and determine how to move forward, whether with a partner or looking for one. Look for a therapist with expertise in working with people with cancer and/or sexual and relationship issues.

 

Modify from https://www.oncolink.org/support/sexuality-fertility/sexuality/women-s-guide-to-sexuality-during-after-cancer-treatment

REFERENCES

  • ESMO/ACF Patient guide series head and neck cancer
  • Seiwert TY & Cohen EEW. 2005. State of the art management of locally advanced head and neck cancer. BJC 92: 1341-1348
  • Globocan. 2012
  • Gandini S, Botteri E, Iodice S, et al. 2008. Tobacco smoking and cancer: a meta-analysis. International Journal of Cancer 122(1):155–164.
  • Hashibe M, Boffetta P, Zaridze D, et al. 2006. Evidence for an important role of alcohol- and aldehyde-metabolizing genes in cancers of the upper aerodigestive tract. Cancer Epidemiology, Biomarkers and Prevention 15(4):696–703.
  • Hashibe M, Brennan P, Benhamou S, et al. 2007. Alcohol drinking in never users of tobacco, cigarette smoking in never drinkers, and the risk of head and neck cancer: pooled analysis in the International Head and Neck Cancer Epidemiology Consortium. Journal of the National Cancer Institute ; 99(10):777–789.
  • Boffetta P, Hecht S, Gray N, Gupta P, Straif K. Smokeless tobacco and cancer. 2008. The Lancet Oncology ; 9(7):667–675.
  • Chaturvedi AK, Engels EA, Pfeiffer RM, et al. 2011. Human papillomavirus and rising oropharyngeal cancer incidence in the United States. Journal of Clinical Oncology ; 29(32):4294–4301.
  • Gregoire V, Lefebvre JL, Licitra L, Felip E. 2010. Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO clinical practice guidelines. Ann Oncol : vi184-vi186
  • Reddy BK, Lokesh V, Vidyasagar MS. 2014. Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: a randomized, open-label, phase IIb, 5-year study in Indian patients. Oral Oncol. 50(5):498-505
  • Edge SB & Compton CC. The American Joint committee on cancer: the 7th edition of the AJCC Cancer Staging Manual and the future of TNM. Ann Surg Oncol. 2010. 17: 1471
  • Chan ATC, Gregoire V, Lefebvre JL, et al. 2013. Nasopharyngeal cancer: EHNS-ESMO-ESTRO clinical practice guidelines. Ann Oncol. 23: vii83-vii85.
  • American Cancer Society. Cancer Facts & Figures 2015. Atlanta: American Cancer Society; 2015.
  • Kong L, Lin Q, Hu C, et al. 2016. Radiation plus concurrent nimotuzumab versus CDDP in locally advanced nasopharyngeal cancer. Results of phase III randomized trial. J Clin Oncol 34.
  • Adult Gliomas (Astrocytomas and oligodendrogliomas): A guide for patients, their families and carers. 2011. Clinical oncological Society of Australia.
  • Glioma: A guide for patients. Information based on ESMO Clinical Practice Guidelines.v2016.1.
  • Stupp R, Brada M, Bent VD, et al. 2014.High grade glioma: ESMO clinical practice for diagnosis, treatment and follow-up. Ann Oncol. 25: 93-101.
  • Solomon MT, Selva, JC, Figueredo J. 2013. Radiotherapy plus nimotuzumab or placebo in the treatment of high grade glioma patients: results from a randomized, double blind trial. BMC Cancer.
  • The Lustgarten Foundation for pancreatic cancer research. 2012. Understanding pancreatic cancer.
  • Cardenes HR, Chiorean EG, DeWitt J, et al. 2006. Locally Advanced Pancreatic cancer: Current Therapeutic approach. The Oncologist 11: 612-623.
  • Ducreux M, Cuhna AS, Caramella C, et al. 2015. Cancer of the pancreas: ESMO clinical practice guidelines for diagnosis, treatment and follow up. Ann Oncol 26: v56–v68.
  • Strumberg D, Schultheis B, Scheulen ME, Hilger RA, Krauss J, Marschner N, Lordick F, Bach F, Reuter D, Edler L, Mross K. 2012.Phase II study of nimotuzumab, a humanized monoclonal anti-epidermal growth factor receptor (EGFR) antibody, in patients with locally advanced or metastatic pancreatic cancer.  Invest New Drugs. 30:1138-43.
  • Schultheis B, Reuter D, Ebert MP, Siveke J, Kerkhoff A, et al. Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study. Ann Oncol.
  • https://www.cancer.org/latest-news/be-a-healthier-cancer-survivor.html
  • https://www.oncolink.org/support/sexuality-fertility/sexuality/women-s-guide-to-sexuality-during-after-cancer-treatment