KEYTRUDA for head and neck squamous cell cancer (HNSCC) 


About head and neck squamous cell cancer

If you have been diagnosed with head and neck squamous cell cancer (HNSCC), or you know somebody who has, you're probably looking for reliable information about the disease and its treatments. This section may help to answer some of your questions.

Most head and neck cancers start in cells called squamous cells. These cells line the moist surfaces of the mouth, nose and throat. How head and neck cancers are named depends on the area of the head or neck where the cancer starts, and includes:

  • mouth cancer (oral cancer)
  • nose (nasal) or paranasal sinus cancer
  • salivary gland (parotid gland) cancer
  • throat (oropharyngeal) cancer
  • voice box (laryngeal) cancer

How common is it?

In 2020, head and neck cancers represented approximately 5 percent of all cancers worldwide. They are more common in men.

What are the symptoms?

The signs and symptoms of HNSCC depend on where the cancer is, but may include:

  • a lump in your neck
  • a change in your voice
  • a growth in your mouth
  • difficulty swallowing
  • changes in your skin

If you have one or more of these symptoms it does not mean you have cancer, but it is important that you speak to your doctor about any changes that you notice.

How is it diagnosed?

If your doctor suspects that you may have HNSCC they will note all of your symptoms and risk factors, and the following tests may be used to help make a diagnosis:

  • Physical examination
    Your doctor may examine your mouth, throat, nose, neck, ears and eyes for any lumps or abnormalities.
  • Nasendoscopy
    Your doctor may examine your nose and throat, and take a tissue sample (biospy) using a thin flexible tube with a light and camera, called a nasendoscope. The nasendoscope is passed into one of your nostrils and down your throat using a local anaesthetic.
  • Laryngoscopy
    Your doctor may examine your throat and voice box, and take a tissue sample (biospy) using a tube with a light and camera, called a laryngoscope. The laryngoscope is inserted into your mouth and throat under a general anaesthetic.
  • Imaging tests
    An X-ray scan, CT scan, MRI scan, PET scan or ultrasound may be required to provide more details about where a tumour is located and if the cancer has spread.

Treatment

  • Tumour surgery
    Surgery aims to remove cancerous tissue in a way that doesn’t affect how your head and neck functions, such as breathing, swallowing and talking. The type of surgery and recovery times will differ depending on the location and extent of your cancer.
  • Lymph node removal
    Depending on whether your cancer has spread, or is likely to spread, your surgeon may remove some lymph nodes. This operation is called a lymphadenectomy. There is a possibility it will affect the movement and appearance of your neck or shoulder, but physiotherapy can help improve movement and function.
  • Radiotherapy
    Radiotherapy is used to kill or damage cancer cells. It is carefully targeted at the cancer to do as little harm as possible to surrounding healthy tissue.
  • Chemotherapy
    Chemotherapy involves the use of drugs to kill or slow the growth of cancer cells in the body. The aim is to destroy cancer cells while damaging healthy cells as little as possible.
    It is usually given by injection into a vein at treatment sessions over several weeks.
  • Targeted therapy
    Targeted therapy drugs are treatments that attack specific parts of cancer cells to help prevent cell growth.
  • lmmunotherapy
    KEYTRUDA is an immunotherapy that works by helping your immune system to fight your cancer. It may be used:
    • alone, as your first treatment, when your HNSCC has spread or returned and cannot be removed by surgery, and your tumour tests positive for PD-L1
    • in combination with certain chemotherapy medicines as your first treatment when your HNSCC has spread or returned, and cannot be removed by surgery
    • alone, when your HNSCC has spread or returned and cannot be removed by surgery, and you have received chemotherapy that contains platinum and it did not work or is no longer working

The information on this website should be discussed with your healthcare professional and does not replace their advice.

Questions to ask your doctor about head and neck squamous cell cancer

About KEYTRUDA

How to access KEYTRUDA

References:
Cancer Council Australia. 2019. Understanding Head and Neck Cancers. Available at: https://www.cancer.org.au/assets/pdf/understanding-head-and-neck-cancer-booklet
Accessed on: 21/03/2021.

Cancer Society New Zealand. 2021. Head and Neck Cancers. Available at: https://www.cancer.org.nz/cancer/types-of-cancer/head-and-neck-cancers/
Accessed on: 31/05/2021.

Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.fr/today
Accessed on: 9/09/2021.

KEYTRUDA Data Sheet.

KEYTRUDA Consumer Medicine Information.


NZ-KEY-00620 TAPS NA 13285 TAPS DA 2150KN Last Updated October 2021


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KEYTRUDA has risks and benefits. Additional product information and the KEYTRUDA Consumer Medicine Information (CMI) is available at www.medsafe.govt.nz.

IMPORTANT SAFETY INFORMATION

Tell your doctor if you have a disease of your immune system such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or have had a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of your lungs (called pneumonitis); or have liver problems.

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. KEYTRUDA can cause harm or death to your unborn baby. Effective contraception must be used during treatment with KEYTRUDA and for at least 4 months after the last dose of KEYTRUDA for woman who could become pregnant.

If you are breastfeeding, tell your doctor. Do not breastfeed while taking KEYTRUDA.

Tell your doctor if you are taking any other medicines, including medicines that can be bought without a prescription from a pharmacy, supermarket or health food shop, or other medicines that make the immune system weak. Examples of these may include steroids, such as prednisone.

What are the possible side effects of KEYTRUDA?

KEYTRUDA can have some serious side effects. These side effects can sometimes become life- threatening and can lead to death. These side effects may happen any time during treatment or even after treatment has ended. More than one side effect can be experienced at the same time.

Call or see your doctor right away if you develop any of the following symptoms:

Lung problems. Signs and symptoms of lung problems may include shortness of breath, chest pain, or coughing.

Intestinal problems. Signs and symptoms of problems with your intestines may include diarrhea or more bowel movements than usual, stools that are black, tarry, sticky, or have blood or mucus, or severe stomach pain or tenderness.

Liver problems. Signs and symptoms of liver problems may include nausea or vomiting, feeling less hungry, pain on the right side of your stomach, your skin looks yellow, the whites of your eyes look yellow, dark urine or you bleed or bruise more easily than normal.

Hormone gland problems (especially the thyroid, pituitary, adrenal glands). Signs and symptoms of hormone gland problems may include rapid heartbeat, weight loss or weight gain, increased sweating, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, or headaches that will not go away or unusual headache.

Kidney problems. Signs and symptoms of kidney problems may include change in the amount or color of your urine.

Blood sugar problems. Signs and symptoms of blood sugar problems may include feeling more hungry or thirsty, needing to urinate more often or weight loss.

Skin problems. Signs and symptoms of skin problems may include rash, itching, blisters, peeling or skin sores, or ulcers in mouth or in lining of nose, throat, or genital area.

Problems in other organs. and symptoms of problems in other organs may include muscle pain or weakness; changes in eyesight; stomach area pain with nausea and vomiting (pancreatitis); shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis); confusion, fever, memory problems, or seizures (encephalitis); swollen lymph nodes, rash or tender lumps on skin, cough, or eye pain (sarcoidosis); pain, numbness, tingling, or weakness in the arms or legs, bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis); inflammation of the blood vessels (vasculitis); or pain in the upper right part of the stomach, swelling of the liver or spleen, fatigue, itching or yellowing of the skin or whites of eyes.

Infusion (IV) reactions. Signs and symptoms of infusion reactions may include shortness of breath, itching or rash, dizziness or fever.

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Graft-versus-host-disease (GVHD) in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). GVHD may occur if you had this transplant in the past. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhoea.

Common side effects:

Common side effects (may affect more than 1 in 10 people) include: diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain and decreased sodium levels in the blood.

Common side effects (reported in more than 1 in 5 people) when KEYTRUDA was given in combination with chemotherapy include: hair loss, feeling tired, diarrhoea, vomiting, decrease in white blood cell count, joint pain, rash, swelling of the lining of the digestive system (for example mouth, intestines) and mouth sores.

The most common side effects when KEYTRUDA is given in combination with axitinib are: diarrhoea, high blood pressure, fatigue, low levels of thyroid hormone, decreased appetite, blisters or rash on the palms of your hands or soles of your feet, nausea, increase in liver enzyme levels, hoarseness, cough and constipation.

The most common side effects when KEYTRUDA is given alone to children are: fever, vomiting, headache, stomach pain, decrease in number of red blood cells, cough, and constipation.

Less common side effects can happen. KEYTRUDA may cause other side effects that are not listed. If you have any side effect that bothers you or that does not go away, tell your doctor.

For more information, please talk to your doctor.

Based on the KEYTRUDA CMI dated 16th September 2021.

Merck Sharp & Dohme (New Zealand) Limited, Level 3, 123 Carlton Gore Road, Newmarket, Auckland.

TAPS NA 13013 TAPS DA 2150KN NZ-KEY-00522 Last Updated November 2021

Copyright © 2016-2021 Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All rights reserved.


KEYTRUDA has risks and benefits. Additional product information and the KEYTRUDA Consumer Medicine Information (CMI) is available at www.medsafe.govt.nz.

KEYTRUDA® (pembrolizumab) 100 mg/4 mL concentrate solution for infusion is a Prescription Medicine and is used to treat:

  • a kind of skin cancer in adults called melanoma
  • a kind of lung cancer in adults called non-small cell lung cancer
  • a kind of cancer in adults and children called classical Hodgkin Lymphoma
  • kind of cancer in adults called urothelial carcinoma, including bladder cancer
  • a kind of head and neck cancer in adults called head and neck squamous cell carcinoma
  • a kind of cancer in adults and children that can occur in any part of the body and is shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
  • a kind of cancer in adults called renal cell carcinoma
  • a kind of cancer in adults called oesophageal carcinoma

It is not known if KEYTRUDA is safe and effective in children with MSI-H or dMMR cancer of the brain or spinal cord (central nervous system cancers).

Ask your doctor if KEYTRUDA is right for you. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist, or health professional.

KEYTRUDA is only funded for the treatment of melanoma which has spread and cannot be removed by surgery. KEYTRUDA is unfunded for the treatment of all other cancers listed above. Ask your health professional about the cost of the medicine and any other medical fees that may apply.

IMPORTANT SAFETY INFORMATION

Tell your doctor if you have a disease of your immune system such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or have had a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of your lungs (called pneumonitis); or have liver problems.

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. KEYTRUDA can cause harm or death to your unborn baby. Effective contraception must be used during treatment with KEYTRUDA and for at least 4 months after the last dose of KEYTRUDA for woman who could become pregnant.

If you are breastfeeding, tell your doctor. Do not breastfeed while taking KEYTRUDA.

Tell your doctor if you are taking any other medicines, including medicines that can be bought without a prescription from a pharmacy, supermarket or health food shop, or other medicines that make the immune system weak. Examples of these may include steroids, such as prednisone.

What are the possible side effects of KEYTRUDA?

KEYTRUDA can have some serious side effects. These side effects can sometimes become life- threatening and can lead to death. These side effects may happen any time during treatment or even after treatment has ended. More than one side effect can be experienced at the same time.

Call or see your doctor right away if you develop any of the following symptoms:

Lung problems. Signs and symptoms of lung problems may include shortness of breath, chest pain, or coughing.

Intestinal problems. Signs and symptoms of problems with your intestines may include diarrhea or more bowel movements than usual, stools that are black, tarry, sticky, or have blood or mucus, or severe stomach pain or tenderness.

Liver problems. Signs and symptoms of liver problems may include nausea or vomiting, feeling less hungry, pain on the right side of your stomach, your skin looks yellow, the whites of your eyes look yellow, dark urine or you bleed or bruise more easily than normal.

Hormone gland problems (especially the thyroid, pituitary, adrenal glands). Signs and symptoms of hormone gland problems may include rapid heartbeat, weight loss or weight gain, increased sweating, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, or headaches that will not go away or unusual headache.

Kidney problems. Signs and symptoms of kidney problems may include change in the amount or color of your urine.

Blood sugar problems. Signs and symptoms of blood sugar problems may include feeling more hungry or thirsty, needing to urinate more often or weight loss.

Skin problems. Signs and symptoms of skin problems may include rash, itching, blisters, peeling or skin sores, or ulcers in mouth or in lining of nose, throat, or genital area.

Problems in other organs. and symptoms of problems in other organs may include muscle pain or weakness; changes in eyesight; stomach area pain with nausea and vomiting (pancreatitis); shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis); confusion, fever, memory problems, or seizures (encephalitis); swollen lymph nodes, rash or tender lumps on skin, cough, or eye pain (sarcoidosis); pain, numbness, tingling, or weakness in the arms or legs, bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis); inflammation of the blood vessels (vasculitis); or pain in the upper right part of the stomach, swelling of the liver or spleen, fatigue, itching or yellowing of the skin or whites of eyes.

Infusion (IV) reactions. Signs and symptoms of infusion reactions may include shortness of breath, itching or rash, dizziness or fever.

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Graft-versus-host-disease (GVHD) in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). GVHD may occur if you had this transplant in the past. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhoea.

Common side effects:

Common side effects (may affect more than 1 in 10 people) include: diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain and decreased sodium levels in the blood.

Common side effects (reported in more than 1 in 5 people) when KEYTRUDA was given in combination with chemotherapy include: hair loss, feeling tired, diarrhoea, vomiting, decrease in white blood cell count, joint pain, rash, swelling of the lining of the digestive system (for example mouth, intestines) and mouth sores.

The most common side effects when KEYTRUDA is given in combination with axitinib are: diarrhoea, high blood pressure, fatigue, low levels of thyroid hormone, decreased appetite, blisters or rash on the palms of your hands or soles of your feet, nausea, increase in liver enzyme levels, hoarseness, cough and constipation.

The most common side effects when KEYTRUDA is given alone to children are: fever, vomiting, headache, stomach pain, decrease in number of red blood cells, cough, and constipation.

Less common side effects can happen. KEYTRUDA may cause other side effects that are not listed. If you have any side effect that bothers you or that does not go away, tell your doctor.

For more information, please talk to your doctor.

Based on the KEYTRUDA CMI dated 16th September 2021.

Merck Sharp & Dohme (New Zealand) Limited, Level 3, 123 Carlton Gore Road, Newmarket, Auckland.

TAPS NA 13013 TAPS DA 2150KN NZ-KEY-00522 Last Updated November 2021

Copyright © 2016-2021 Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All rights reserved.