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In 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether treatment with nivolumab (Opdivo) alone has an added benefit over the standard treatment for advanced melanoma. The results of their assessment were different for the following three groups of patients: The manufacturer did not provide any suitable data on people who used nivolumab after unsuccessful treatment. So it remains unclear whether nivolumab has any advantages or disadvantages for this group of people compared with individually tailored treatment.The manufacturer did not provide any suitable data related to how vemurafenib compares with nivolumab used as a first treatment for people with a BRAF V600 mutation. It therefore remains unclear whether nivolumab has any advantages or disadvantages for these people.The Institute analyzed the results of one study comparing nivolumab as a first treatment for people without a BRAF V600 mutation with the drugs dacarbazine and ipilimumab. 418 people took part in this study. Half of them were treated with the drug nivolumab, and the other half were given dacarbazine. The following results were found for patients without a BRAF V600 mutation who were treated for the first time.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: October 5, 2017

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of nivolumab (trade name: Opdivo) combined with ipilimumab (trade name: Yervoy) for people with advanced melanoma. The results of their assessment were different for the following three groups of patients: The manufacturer did not provide any suitable data on people who had previous treatment. So it remains unclear whether nivolumab combined with ipilimumab has any advantages or disadvantages for this group of people compared with individually tailored treatment.The manufacturer did not provide any suitable data related to how vemurafenib compares with nivolumab combined with ipilimumab used as a first treatment for people with a BRAF V600 mutation. So it remains unclear whether nivolumab combined with ipilimumab has any advantages or disadvantages for this group of people.The manufacturer provided one study related to how nivolumab plus ipilimumab as a first treatment compares with nivolumab alone for people without a BRAF V600 mutation. In this study, results from 429 people were available for analysis. Half of them had received treatment with nivolumab and ipilimumab, while the other half had used nivolumab only. Both groups received nivolumab at different doses during the first 12 weeks of the study. In this phase, those patients who had treatment with nivolumab alone received 3 mg of the drug per kilogram of bodyweight every two weeks. Those people who had treatment with nivolumab and ipilimumab received a much lower dose at 1 mg of nivolumab per kilogram of bodyweight every three weeks. The study involved patients without BRAF V600 mutation whose cancer had already spread (metastasized) at the time of diagnosis or who could not have surgery. Despite the advanced stage of their condition, the patients were in good general health. The following results were found:

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: October 5, 2017

Talimogene laherparepvec (trade name: Imlygic) has been approved in Germany since December 2015 for the treatment of advanced melanoma in adults.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: October 6, 2016

If someone is diagnosed with melanoma, doctors usually first try to remove the tumor surgically. Medication or radiotherapy may also be options, especially if the cancer has reached a more advanced stage. Melanomas can grow quickly and are more likely than other kinds of skin cancer to spread to other parts of the body (metastasis). The treatment options mostly depend on how advanced the cancer is. It is generally easier to treat cancer that has not yet spread. Surgery Skin cancer can often be completely removed through surgery, so it is the treatment of first choice. In surgery, the doctor not only removes the tumor itself, but also some of the tissue around it. This is done to try to make sure that no cancer cells are left behind. One of the goals of surgery is to stop cancer cells from spreading to other parts of the body. Smaller wounds often heal without scarring, but bigger operations can leave visible scars. Radiotherapy Radiotherapy, also known as radiation therapy, aims to destroy cancerous tissue using high-energy radiation. It is most often used to treat melanoma that is already at a very advanced stage, has already developed metastatic tumors or cannot be surgically removed. Medication Medication can be used to treat skin cancer that has already spread. The following therapies are suitable for melanomas: Chemotherapy: This therapy uses substances that are intended to damage the cancer cells. Cytostatic drugs, which stop cell division, are the most common. They are transported through the bloodstream so they also reach metastatic tumors that may not have been detected yet. Chemotherapy is often considered if other therapies are not effective enough.Targeted therapy: This kind of therapy is relatively new. It makes use of the fact that the reason why cancer cells grow uncontrollably is often because certain parts of the cells have changed. The therapy is “targeted” because it uses drugs to specifically inhibit those parts of the cells. This is only an option for people with tumors that have these kinds of cell changes.Immunotherapy: Here substances are used to stimulate the body’s immune system. More specifically, the substances activate immune cells that are capable of destroying cancer cells. Interferon-alpha, a chemical messenger in the immune system, is one example. Antibodies can also be used in immunotherapy. These can, for instance, attach to immune cells and activate them so they kill cancer cells. It is also possible to combine different therapies.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

Nivolumab (trade name: Opdivo) has been approved in Germany since June 2015 for the treatment of advanced melanoma in adults. Since May 2016, it has also been approved in combination with the drug ipilimumab.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: October 5, 2017

Some studies have suggested that medicines (such as statins and fibrates) taken to lower blood cholesterol may reduce the risk of melanoma skin cancer. Our review of 16 studies did not find any clear evidence to support such a suggestion, but we cannot exclude a useful effect of such drugs until more studies become available.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: October 19, 2005

Non-melanoma skin cancers include basal cell cancer and squamous cell cancer. Basal cell cancer is the most common kind of skin cancer, but it usually grows slowly. Squamous cell cancer is somewhat more aggressive. Most of these tumors are discovered before they spread to other parts of the body, though. Basal cell cancer Basal cell cancer (basal cell carcinoma) mainly affects people over the age of 40 and is most commonly found on the face, neck or other parts of the head that are frequently exposed to sunlight. It usually grows slowly and stays in the area where it first developed. So it is generally discovered at a stage where it can be completely removed in surgery. But it is still not totally harmless: if it is only treated at a later stage, or not treated at all, it can enter deeper layers of tissue. This can cause damage to things like your nose, eyes and facial bones. Basal cell cancer rarely spreads to other parts of the body (metastasis), so it is rarely fatal. Only about 1 out of 1,000 people who have basal cell cancer die of it. Squamous cell cancer Squamous cell cancer (squamous cell carcinoma) is particularly common in older people over the age of 60. It nearly always develops on parts of the body that are exposed to the sun, especially on the face, ears, lower lip and the back of your hands. Like basal cell cancer, squamous cell cancer grows where it first developed, damaging nearby tissue. But it is more aggressive than basal cell cancer, particularly if it grows in an old scar, a sore, or on your lips or ears. If left untreated, there is a danger that the cancer might spread to other parts of the body. But most squamous cell cancer tumors are discovered before metastases develop. Then it is usually quite easy to treat them. About 40 to 50 out of 1,000 people with this type of cancer die of it.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

There are different kinds of non-melanoma skin cancer. It is a lot more common than melanoma. Non-melanoma skin cancer grows very slowly, rarely spreads to other parts of the body, and can usually be removed completely. This topic includes information about the signs and course of the disease, as well as the screening and treatment options.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

Melanomas often look like dark moles. They can grow very quickly and spread to other parts of the body (metastasis). The treatment options will mainly depend on the stage of the disease.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

In order to detect non-melanoma skin cancer, you can either check your skin for abnormalities yourself or have a doctor examine it. Non-melanoma skin cancer can be treated more effectively if it is detected before it spreads to other parts of the body. It can be worrying if a spot on your skin changes in size, shape, color or looks abnormal. A lot of people know that changes like this could be a sign of skin cancer. But most suspicious-looking areas of skin are harmless. The older you get, the more your skin changes, and new moles or age spots (solar lentigo) may develop. This is a normal part of aging. So some people decide to wait and keep an eye on any skin abnormalities. It is only rarely a serious medical condition. Carefully checking your skin on a regular basis is a good way to notice any changes, or any wounds that do not heal as quickly as usual. It isn’t always easy to know what is normal and what isn’t. If you find something that looks abnormal to you, it is best to have your doctor inspect it more closely if it does not go away after four to eight weeks. Skin cancer is not usually painful in early stages. If it does hurt, the cancer may have already reached an advanced stage.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

Non‐melanoma skin cancer is still the most common cancer in the UK, the United States and Australia. People at increased risk of getting non‐melanoma skin cancer include those with lowered immunity, a history of non‐melanoma skin cancer, rare inherited genetic skin disorders, trauma to the skin, exposure to arsenic, albinism or having had psoralen and ultraviolet A treatment. Very few studies have been conducted in people at increased risk of NMSC.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: October 17, 2007

In order to detect melanoma early on, you can either check your skin for abnormalities yourself or have a doctor examine it. Skin cancer can be treated more effectively if it is detected before it spreads to other parts of the body. The older you get, the more your skin changes, and new moles or age spots (solar lentigo) may develop. This is a normal part of aging. So some people decide to wait and keep an eye on any skin abnormalities. Others want to know right away if something is wrong, and go to a doctor to have it checked out. But it is only rarely a serious disease like cancer. People who have been diagnosed with melanoma say that the affected mole had changed in size, shape or color before. Carefully checking your skin on a regular basis is a good way to notice any changes. Women often devote more time to skin care than men and are more attentive. So it is often women who find abnormalities. A full-body check involves inspecting every square inch of your skin, including the skin between your toes, on the soles of your feet and on your ears. Some people use a mirror for parts of their body that are difficult to see, or they might ask a friend or partner to help. Keeping a record of things like the size of suspicious-looking moles or taking pictures of them can make it easier to tell later on whether it has changed. It is not always easy to know what kinds of skin changes might be cancer. If you find an abnormality, it is best to have your doctor inspect it more closely if it does not go away after four to eight weeks. Skin cancer is not painful at an early stage. If it does hurt, the cancer may have already reached an advanced stage.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

Whilst melanoma accounts for only 5% of skin cancers, it is important because it is the cause of 75% of all skin cancer deaths. For primary cutaneous melanoma, standard treatment is complete surgical removal of the melanoma with a safety margin some distance from the visible edges of the primary tumour. The purpose of the safety margin is to remove both the primary tumour and any melanoma cells that might have spread into the surrounding skin. However, the optimal width of the safety (excision) margin remains unclear.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: October 7, 2009

Cobimetinib (trade name: Cotellic) has been approved in Germany for the treatment of advanced melanoma (skin cancer) in adults since November 2015.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: June 6, 2016

If someone is diagnosed with non-melanoma skin cancer, the first treatment doctors usually suggest is surgery to try to remove it. Skin cancer can also be treated using medication or radiotherapy. The treatment options will depend on various factors such as the type of cancer, how big the tumor is, and how aggressive it is. Non-melanoma skin cancers like squamous cell cancer and basal cell cancer usually develop on parts of the body that are exposed to the sun a lot and easy to see. Basal cell cancer typically grows slowly and stays in one place. But if it is only treated after a long time, or not treated at all, it can enter deeper layers of tissue. This may end up damaging and deforming the face, bones, spinal cord or brain, making treatment more difficult. Like basal cell cancer, squamous cell cancer grows in the area where it first develops, and destroys tissue around it. But it is more aggressive than basal cell cancer. If left untreated, the cancer might spread to other parts of the body, causing metastatic tumors to arise in other organs. Most squamous cell cancer tumors are discovered beforehand, though. The treatment options will depend on many factors. These include the type of tumor, how big and aggressive it is, whether it has spread to other parts of the body and, if so, where. Cosmetic aspects and the patient’s preferences may play a role too.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

There are a number of factors that can increase your risk of developing melanoma. The main one that you can influence is sun exposure. Sunlight contains ultraviolet rays, which can damage the skin and cause cancer. Many different factors can influence your risk of developing melanoma over the course of your lifetime. For instance, the risk increases with age and is also higher if one of your close relatives (a parent or brother or sister) had or has skin cancer. Other important risk factors are: Sun exposureTanning bed useSkin typeNumber of moles Sun exposure is the biggest risk factor that you can do something about. The sun’s ultraviolet (UV) light is mostly made up of UV-A rays. These penetrate deep into your skin and give you a fast tan. But this kind of tan doesn’t last very long, and doesn’t offer much protection from further sun exposure. UV-A light damages your skin and causes it to age prematurely. Tanning beds also use UV-A rays. The sun’s UV-B rays affect the uppermost layer of your skin the most. There they cause a delayed but longer-lasting tan and help the skin to develop some protection from more sunlight. But they also irritate your skin and cause it to redden, and can cause sunburn. UV-B rays are believed to be more likely to cause skin cancer than UV-A rays.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

Several factors increase the likelihood of developing non-melanoma skin cancer. The main one that you can influence is sun exposure. Sunlight contains ultraviolet rays, which can damage your skin and cause cancer. A lot of factors influence your risk of developing non-melanoma skin cancer. For instance, the risk increases with age. Other than that, it will mainly depend on: where you live,how much you expose your skin to sunlight,whether or not you use tanning beds, andyour skin type. Sunlight is the risk factor that you have the most influence on yourself. The ultraviolet (UV) light in sunlight is mostly made up of UV-A rays. These rays go deep into your skin and give you a fast tan. But this kind of tan doesn’t last very long, and doesn’t offer much protection from further sun exposure. UV-A light damages your skin, causing it to age prematurely. Tanning beds also have UV-A rays in the light they use. The UV-B rays found in sunlight mainly enter the uppermost layer of skin. Your skin tans more slowly as a result, and the tan lasts longer and your skin builds up a certain amount of protection from further sunlight exposure. But UV-B rays also irritate skin and make it turn red, and may cause sunburn. It is thought that UV-B rays are more likely to cause skin cancer than UV-A rays are.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

Cutaneous melanoma is one of the deadliest types of skin cancer, and its incidence is rising in all Western countries. Furthermore, melanoma is one of the solid tumours most resistant to treatment with chemotherapy, which means that the outlook for people whose cancer has spread through their body (distant metastatic disease) is dismal, with only 10% of these patients surviving longer than 5 years.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: June 18, 2013

The aim of skin cancer screening is to detect skin cancer or pre-cancerous conditions at an early stage so that they can be treated more successfully. The idea is to help prevent skin cancer or at least improve the chances of a complete recovery and avoid severe complications. The main part of skin cancer screening is a full-body visual examination performed by a doctor. The following information applies to the German health care system. Some aspects may be different in other countries. All German statutory health insurers offer skin cancer screening for members over the age of 35. Participation is then free of charge and may not be billed as an individual health care service (IGeL). Under this plan you can have free screening every two years, where a doctor will carefully check for the main types of skin cancer: non-melanoma skin cancer (basal cell cancer and squamous cell cancer) and melanoma. If you are privately insured in Germany you can ask your insurer about coverage. You can go directly to your dermatologist (specialist for skin diseases) for skin cancer screening. Your family doctor may also be qualified to offer screening.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: September 10, 2015

Melanoma in situ (MIS) is the earliest stage of malignant melanoma. Over the past two decades, the incidence of MIS has increased. Lentigo maligna (LM) is a subtype of pre‐invasive melanoma associated with chronic exposure to ultraviolet radiation, primarily affecting the head and neck. It accounts for 79% to 83% of all MIS tumours. Delayed recognition is common.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: December 19, 2014

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