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Merck and Pfizer Collaborate on Potential Merkel Cell Carcinoma Treatment

Merkel cell carcinoma (MCC) is a rare form of skin cancer, making up fewer than 1% of all non-melanoma skin cancers (Canadian Cancer Society, “Merkel Cell Carcinoma”). It manifests as malignant cells that form in the upper layer of skin, near the nerve endings that sense touch (Merck-Pfizer Alliance, “Merkel Cell Carcinoma Fact Sheet”). Merkel cell carcinoma often appears on sun-exposed areas of the skin, such as the legs, arms, neck, and head, as a blue or red lump on the skin. It most frequently occurs in fair-skinned males over 50 years of age (Merck-Pfizer Alliance).

Merkel cell carcinoma has a higher mortality rate than melanoma, with a mortality rate of 33% within five years of diagnosis (all stages) (Merck-Pfizer Alliance). Due to low awareness of merkel cell carcinoma, late diagnosis often results in the disease having reached stage III or IV(Merck-Pfizer Alliance).

Current treatment options for merkel cell carcinoma include chemotherapy, radiotherapy and surgery. These treatments are generally ineffective for advanced stage merkel cell carcinoma, resulting in a mortality rate of roughly 80% for stage IV metastatic merkel cell carcinoma patients (Merck-Pfizer Alliance). There is a gap in treatments for merkel cell carcinoma, and a need for more research and the staging of clinical trials to fill that gap.

Fortunately, at least one new treatment is in the works. JAVELIN merkel 200 is the title of an ongoing clinical study investigating the effects of avelumab, a treatment jointly manufactured by pharmaceutical developers Merck (Germany) and Pfizer (USA), on pre-treated patients with merkel cell carcinoma. The treatment inhibits PD-L1 interactions (Pharmaceutical Technology, “Merck and Pfizer’s Avelumab gets Breakthrough Status for Merkel Cell Carcinoma”), acting as an immune checkpoint inhibitor. The trial produced the largest set of data, in this patient population, of any anti-PD-L1/PD-1 (Pfizer, “ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma”). The results reported at the 52nd annual American Society of Clinical Oncology (ASCO) in Chicago this past June were promising: of 88 patients, 28 (31.8%) demonstrated an objective response rate during the Phase II study of avelumab (Pfizer). Of those that responded, 8 (9.1%) achieved complete responses, with 20 (22.7%) achieving partial responses (Pfizer). Of the entire trial, 62 (70.5%) patients experienced treatment related adverse effects (AEs), with the most common being fatigue (23.9% of patients) and infusion-related reactions (17%), with four patients (4.5%) experiencing grade 3 side effects and zero with grade 4 side effects (Pfizer). The ages of the trial participants ranged from 33-88 years old, and every participant had been pre-treated with chemotherapy (Pfizer). The patients received 10mg/kg of treatment intravenously every two weeks (Pfizer).

While avelumab is still in the trial stage, if it is approved, it will be the first approved treatment for Merkel Cell Carcinoma. Current information about the status of the trial can be found on the American clinical trial database or Pfizer’s website.

 
Works Cited:

Canadian Cancer Society, “Merkel Cell Carcinoma”.

Merck-Pfizer Alliance, “Merkel Cell Carcinoma Fact Sheet”.

Pfizer, “ASCO 2016: Pivotal Avelumab Study Shows Positive Results in Metastatic Merkel Cell Carcinoma”.

Pharmaceutical Technology, “Merck and Pfizer’s Avelumab gets Breakthrough Status for Merkel Cell Carcinoma”.

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Save Your Skin Weekly Flashback! [Sept 5-11]

Welcome to the Save Your Skin Foundation media flashback- your weekly guide to the melanoma landscape, and the activities of the Save Your Skin Foundation! This week, we are excited to point you towards the most recent publication Save Your Skin has been involved in, CONSENSUS REPORT: Recognizing non-melanoma skin cancer, including actinic keratosis, as an occupational disease- A Call to Action,” in the Journal of the European Academy of Dermatology and Venereology! We’d also like to remind you of our next event, our “Mountain or Mole Hill?” skin cancer forum in Nanaimo, BC, on October 6th! Details can be found in the banner below.

 

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Here are some links we shared with you this week:

-A reminder to check out our “Melanoma Through my Lens” project, if you haven’t already!

This blog post by Doris Day, M.D., about the importance of sunscreens and choosing the right one for you

This Centers for Disease Control and Prevention guide to sun safety for children, which includes resources about sun safety for students

This article from the Canadian Cancer Society’s Research Information Outreach Team about the emergence of oncolytic virus therapy

This story in The Globe and Mail about Dr. Brian Day’s fight to lift the ban on paid-for private health care for “medically necessary” care

 

Thanks for reading, and be sure to stay sun safe even when the weather is cooling off!

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Event: The Third Annual Bill Fox Memorial Golf Tournament

Looking to golf for a good cause? If you’re in the Granton, Ontario area, check out the third annual Bill Fox Junior Memorial Golf Tournament! Held on September 10 at the Fox Golf Club, the event will honour late CPGA professional golfer Bill Fox, who passed away at fifty years old from melanoma. Since 2014, the Save Your Skin Foundation has collaborated with the tournament to ensure sun safety on the day, and promote melanoma and sun safety awareness. The tournament will consist of a shotgun scramble with teams of four, and a passport for purchase that allows participants to take part in the longest drive, closest to the pin, and other contests! The winning team will have their names engraved on the Bill Fox memorial trophy, which remains at The Fox year round. Registration fees include the cart, range balls, a hot dog lunch (with a drink ticket!), and a ticket to the steak dinner and silent auction that will round off the evening! Tickets for the dinner can be purchased individually without participation in the tournament. If you’re a golfer in the area, come out for a good cause- and don’t forget your sunscreen!

 

*Vegetarian option for dinner available upon request.

All skill levels are welcome.

Registration Deadline: September 3rd.

Registration is $115 per person.

Register at: 519-225-2757 or billfoxgolftournament@gmail.com

Registration deadline is August 10.

Tickets for dinner only available for $35.

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Save Your Skin Weekly Flashback! [August 28th-September 4th]

Welcome to the Save Your Skin Foundation media flashback- your weekly guide to the melanoma landscape, and the activities of the Save Your Skin Foundation! First off, we’d like to thank everyone who has tuned in to our last webinars, a post-ASCO review with Dr. Omid Hamid, and “Choosing the Right Sunscreen” with Renée-Claude Lachapelle! If you are interested in learning more about melanoma and are located on Vancouver Island, we’d love to see you at the forum we are running on October 6th in Nanaimo, B.C., with our friends at La Roche-Posay and Leo Pharma! It will be hosted by Dermatologist Dr. Gabriele Weichert, and melanoma survivors Nigel Deacon and Meloney Edghill! More details can be found in the banner below.

 

PatientForumPoster_Oct2016

 

Here are some links we shared with you this week:

-These amazing New York Times articles covering the emergence of immunotherapy and the story of one man’s intensive treatments

This piece in BC Cancer Foundation’s Partners in Discovery about NeTracer, a radionuclide therapy program that is set to begin in BC within the year

This video on Oncology Tube in which Dr. Omid Hamid discusses the future of immunotherapy and new clinical trials

This piece in News Medical about iris melanoma- Always wear sunglasses!

These sun safety tips from Doctors Nova Scotia

This piece on Dr. Yvette Lu’s blog debunking sun safety myths

This American Academy of Dermatology guide to skin self exams

These sun safety tips from Sunburn Alert

This Express article about the dangers of burning while driving

This Aim at Melanoma Foundation guide to a skin self-exam

 

Thanks for reading! Remember to keep checking the UV index to see if you should be wearing sunscreen, even as the weather turns more grey!

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Save Your Skin Weekly Flashback! [August 21st-27th]

Welcome to the Save Your Skin Foundation media flashback- your weekly guide to the melanoma landscape, and the activities of the Save Your Skin Foundation! This week, we’re excited to announce a public forum we are hosting in Nanaimo, B.C. with our friends at La Roche-Posay and Leo Pharma on October 6th! It will be hosted by Dermatologist Dr. Gabriele Weichert, and melanoma survivors Nigel Deacon and Meloney Edghill! More details can be found here and on the banner below. 

Also, if you haven’t registered yet, don’t forget about our Post-ASCO webinar tomorrow (Friday, August 26th!) with Dr. Omid Hamid, Director of the Melanoma Center at The Angeles Clinic and Research Institute. You can register here.

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Here are some links we shared with you this week:

The updated Nova Scotia Pharmacare Formulary, which will include Tafinlar and Mekinist as of September 1st

These Centers for Disease Control and Prevention sun safety tips

This article from the Skin Cancer Foundation about the increased rates of melanoma and other skin cancer in organ transplant recipients, and how to lessen your risk

This blog post on Mom’s Makeup Stash which might help you decide on a sunscreen brand

This piece on Vitamin Daily about the new UV patch from La Roche-Posay. Super cool!

This article on Science Daily about the correlation between eye colour mutation and skin cancer risk

Sunburn Map, which provides an up-to-date UV index map

This article on Medical Xpress about a tanning bed survey, which reported that while the majority of women asked support banning tanning beds for users under 18, few support a complete ban

This Centers for Disease Control and Prevention infographic about keeping school sun safe

This Canadian Cancer Society PSA about sun safety, and stopping cancer before it starts

This Targeted Oncology article about the future of immunotherapy and oncolytic viruses in cancer treatments

This list from Prevention of six surprising risk factors for skin cancer

This Vancouver Sun article about the shortage of dermatologists in British Columbia

This Daily Beast article about the potential discovery of chemical substances that can halt the metastasization of melanoma from researchers at Tel Aviv University, two other Israeli medical centres, and the German Cancer Research Center

This story in The Daily Telegraph about melanoma arising from a freckle

 

Thanks for reading, and stay sun safe out there!

 

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Treatment of Melanoma

Once you have been diagnosed and your melanoma has been staged, your medical team will begin planning a course of treatment for you. You can take as active or passive a role in creating your treatment plan as you would like. Your treatment plan defines the roles that will be played by you and your medical team during your treatment, and adheres to your specific needs and wishes as much as possible.

As you progress through treatment, your treatment plan will change to reflect your condition. Your treatment plan will consider factors such as your overall health, the location and stage of your cancer, side effects of treatment, treatment costs, and whether you have to travel for a given treatment. While much of your treatment plan will be determined by your medical team, the patient has the final say on all decisions. When you begin collaborating on your treatment plan with your medical team, be sure to communicate whether you want to take an active or passive role in your treatment planning, or somewhere in between. Regardless of the role you decide to take in your treatment planning, the NCCN suggests having an idea of your treatment goals (cancer elimination or symptom relief), having an understanding of your test results, writing down questions before medical appointments to get the most out of your time, and being willing to accept the help and advice of others (NCCN 87). The last of these include asking another doctor for a second opinion, which is a completely normal part of cancer care and should not offend your regular doctor.

 

Below are outlined some of the basic treatment options for melanoma:

 

  • Surgery is the most common treatment for melanoma, and is often successful in removing early stage, (usually) non metastasized melanomas. Wide excision surgery (removal of the melanoma and a margin of skin around it) may be used to remove an entire melanoma, and occasionally amputation is used to remove a melanoma on a finger or a toe. Lymph nodes may be removed to inhibit the spread of melanoma, and if the melanoma has metastasized to the organs, surgery may be used to remove it.
  • Chemotherapy is often used to treat advanced or metastasized melanoma. Chemotherapy is often given in cycles that last two to four weeks. While chemotherapy attempts to eliminate cancer cells, it may eliminate healthy cells, which will cause side effects. These might include a decrease in red blood cells, making you feel tired, white blood cells, which weaken your immune system, and platelets, which help your blood to clot. Chemotherapy may also damage cells in the hair roots, causing temporary hair loss during the chemotherapy cycle.
  • Radiation therapy is also often used to treat advanced melanoma, or if it is not possible to remove all cancerous cells with surgery. Radiation therapy utilizes lasers or x-rays in an attempt to kill cancer cells. In this process, both cancerous and regular cells may be killed. Side effects depend on the area of the body receiving the radiation treatment.
  • Targeted therapy is used to treat recurrent or metastatic melanoma. Targeted therapy requires a specific genetic mutation in a patient’s melanoma, such as a BRAF mutation. Side effects are varied. Targeted therapy is a relatively new treatment method to Canada, and new drugs are always in the process of being tested via clinical trials.
  • Immunotherapy or biological therapy is used to treat advanced melanoma, or as an adjuvant (additional therapy). Biological therapy generally damages fewer normal cells than chemotherapy or radiation therapy. Side effects are generally less severe than with other forms of treatment, though this depends on the medication used and the person receiving it. New forms of immunotherapy are currently undergoing clinical trials.

We hope that this helps answer some of your questions about the different methods of treatment for melanoma in Canada. If you require further information, we recommend looking at our sources. Please remember that while we keep the information we post as accurate for Canadians as possible, not all of the websites we source content from are Canadian.

 

Works cited:

About Melanoma: Signs and Symptoms of Melanoma”. NCCN Guidelines for Patients: Melanoma. 2014: National Comprehensive Cancer Network Foundation.

Targeted Therapy”. Melanoma Network of Canada.

Treating Melanoma- Chemotherapy”. Melanoma Network of Canada.

Treating Melanoma- Radiation”. Melanoma Network of Canada.

Treating Melanoma- Surgery”. Melanoma Network of Canada.

Treatment of Melanoma”. Canadian Cancer Society.

Treatment Options for Malignant Melanoma”. Canadian Skin Cancer Foundation.

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Save Your Skin Weekly Flashback! [August 14-20th!]

Welcome to the Save Your Skin Foundation media flashback- your weekly guide to the melanoma landscape, and the activities of the Save Your Skin Foundation! This week, we are very excited to announce the launch of our joint project with Novartis Pharmaceuticals, #MelanomaThroughMyLens! The photo diary beautifully illustrates the journeys of six Canadians’ battle with melanoma, including Kathleen Barnard and Danika Garneau of Save Your Skin. If you are interested in learning more about the Save Your Skin survivor community, check out our I’m Living Proof initiative!

Don’t forget to mark your calendars for Friday, August 26th and Save Your Skin’s next webinar! This post-ASCO review will feature Dr. Omid Hamid, Director of the Melanoma Center at the Angeles Clinic and Research Institute! More details can be found in the banner below.

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Here are some links we shared with you this week:

Our pal Natalie Richardson’s blog about the #MelanomaThroughMyLens project over at The Impatient Patient!

This University of California San Francisco article which predicts immunotherapy response in melanoma

This Newsmax Health article about sun damage removal procedures

This article on BBC News about the importance of sun safety for motorists

This blog post on Everyday Maeve about Sun Angels UV protective arm sleeves for kids!

This OncLive article about the rapid pace at which new treatment options are approved

This article in Melanoma News Today reporting a study by the Melanoma Institute Australia and Royal North Shore Hospital of The University of Sydney about the life quality improvement of patients receiving Opdivo

 

Thanks for reading, stay sun safe out there!

 

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Melanoma Staging

Staging is commonly used in melanoma diagnosis and treatment to indicate the advancement and severity and cancer in a patient. Melanoma stages range between 0-IV based on the TNM (tumour, nodes, metastasis) system. The TNM system is dictated by the size of the primary (first) tumour, the occurrence of cancer cells in the surrounding lymph nodes, whether the cancer has metastasized (spread to other regions in the body), and whether there is ulceration (if there is ulceration, the skin covering the melanoma cannot clearly be seen). While these figures can be intimidating in the later stages, the staging system is imperative for dictating the treatment process a patient will undergo.

Stage 0 is thin melanoma which has not penetrated (invaded) the deeper layers of the skin (in situ).

Stages I and II are melanomas that are limited to the skin. These melanomas vary in how thick they are and whether the skin covering the melanoma is ulcerated or not. Thicker melanomas and ulcerated melanomas have a higher risk of recurring.

Stage III is melanoma that has spread from the original site of your melanoma to 1 or more of the nearby lymph nodes or to the nearby skin/tissue in between. Stage III melanoma is divided into 4 groups, A, B, C, and D.

Stage IV is melanoma that has spread farther than regional lymph nodes, to distant sites such as the lung, liver, or brain.

To read more about the new (January 2018) 8th Edition AJCC Melanoma Staging System click here:

About Melanoma

 

While staging is clearly a complicated process with many variables, it is important to understand why a particular cancer case has been given its stage, and what that means for the future treatment of that patient.

Thank you for reading, and we hope this answers some of your questions about melanoma staging! For more information, take a look at our sources below. Be aware that while we write our blogs from a Canadian perspective, not every source we utilize is Canadian.

 

Works Cited Above:

Melanoma Staging”. NCCN Guidelines for Patients: Melanoma. 2014: National Comprehensive Cancer Network Foundation.

Canadian Cancer Society, “Stages of Melanoma“.

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Save Your Skin Weekly Flashback! [August 6th-13th]

Welcome to the Save Your Skin Foundation media flashback- your weekly guide to the melanoma landscape, and the activities of the Save Your Skin Foundation! We would like to start off this week with a little gratitude; here is our six month review and big thank you to all of our supporters, sponsors, and social media followers. We couldn’t do this work without you, and we love you! We are also very excited to announce our upcoming webinar, a post-ASCO review with Dr. Omid Hamid, Director of the Melanoma Center at the Angeles Clinic and Research Institute! More details, and where to register, can be found in the banner below. Lastly, if you are interested in the process of melanoma diagnosis, check out our new blog post “Diagnosis: Melanoma and Other Skin Cancers” here.

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Here are some links we shared with you this week:

This throwback to Market Wired’s coverage of our #NotJustSkinCancer campaign!

These details on the combination of Tafinlar and Mekinist being added to the BCCA “Formulary”

This article on Doctors of BC about the Canadian Cancer Society’s new sun safety guidelines

This piece and video on Mommy Talk Show about sun safety for children

-The Melanoma Just Got Personal web page, which has personal melanoma stories, information, and other resources

This Global News piece on immunotherapy

This Canadian Mining Journal article about the importances of sun safety in order to protect against skin cancer and increase morale

This article in Business Wire covering Incyte Corporation’s announcement that the first patient in the ECHO-301 study- the combination of Incyte’s epacadostat and Keytruda as a treatment for patients with advanced or metastatic melanoma- has been treated

These National Cancer Institute sun safety guidelines

The Saskatchewan Cancer Agency’s “Formulary,” which now lists Tafinlar as approved for some cases of advanced unresectable or metastatic melanoma

 

Thank you for reading, stay sun safe out there!

 

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Diagnosis: Melanoma and Other Skin Cancers

There are several different routes to being diagnosed with melanoma. The first step is generally a physical screening, during which your physician will check your skin for moles or other abnormalities and ask questions, such as if there have been any changes in your skin or moles, or the length of time you have had certain moles. In order to accurately answer these questions, it helps to self-examine your skin monthly to keep track of any changes; more information on moles and skin self-examinations can be found here. During the appointment, your physician will likely also ask you about your medical history, if you have a history of getting sunburned or using tanning beds, whether there has been skin cancer in your family, and other similar inquiries.

If a physician finds something of concern on your skin, they may perform additional tests. These tests are outlined below in some detail:

Dermoscopy

Is the process of using a hand-held microscope, computer imaging or a dermatoscope to more closely examine a lesion. Your physician might apply mineral oil to the lesion to lessen light reflection on the skin.

Biopsy

Is a process in which cells or tissue of concern are removed from the body to be tested for cancer cells. Depending on the size and location of the lesion, either an incisional or excisional biopsy will be performed. An incisional biopsy is the removal of part of the lesion because the location or size of the lesion renders a complete removal impossible. An excisional biopsy is the removal of the entire lesion, plus a small margin of surrounding normal tissue.

Biopsies are also often performed on the lymph nodes surrounding the cancer site, given that cancerous fluid is likely to move through them. The closest lymph node(s) to the cancer site is the sentinel node(s). As the most likely place a cancer will first spread, the sentinel node(s) and sentinel node biopsies (SLNB) are important for melanoma staging and prognosis. SLNB is often used when clinical evidence that cancer has spread to other lymph nodes is lacking. SLNB will generally not be performed in cases where the patient has stage 1A melanoma, melanoma in situ, metastatic melanoma, locally advanced melanoma that has spread to a lymph node, or has already had surgery on a lymph node. Ideally, an SLNB will be performed at the same time as another surgery. If cancer cells are present in the sentinel lymph node, it is likely that some of the lymph node biopsy procedures outlined below will be performed. If no cancer cells are present, it is unlikely that cancer has spread to the lymph nodes.

There are several other forms of lymph node related biopsy. A surgical lymph node biopsy involves the surgical removal of lymph nodes to see if they contain cancer cells. This is usually preceded by a fine needle aspiration (FNA) biopsy, in which fluid from a lymph node is removed and tested. There is also the lymph node dissection, in which all of the lymph nodes surrounding the cancer site are removed. This surgery is usually performed if the cancer has metastasized to the lymph nodes.

Understanding your Pathology Report – WEBINAR RECORDING AVAILABLE:

To diagnose diseases such as cancer, a sample of tissue called a biopsy is taken from a patient and examined by a pathologist to determine if cancer is present. A pathologist will then examine specimens removed during surgery (resections) for conditions such as cancer, to determine whether the tumour is benign or cancerous, and if cancerous, the exact cell type, grade and stage of the tumour. The pathologist, who is a member of your medical team, writes the pathology report that your treating doctor uses to provide the best care for you as a patient. In this webinar, Dr. Alan Spatz provides insight on understanding your pathology report so that you can play an active role in your treatment. Click here to view the recording on youTubeWith Dr. Alan Spatz, MD  Director, Pathology Department, Jewish General Hospital & Professor, Pathology and Oncology, McGill University

During your treatments, you may receive other tests to determine whether your melanoma has metastasized to other places in the body. These include x-rays, ultrasounds, blood tests, CT scans, or MRIs.

Thank you for reading; we hope this post answers some of the questions you might have had about the diagnosis procedures for melanoma and other skin cancers. If you would like more information, you can look at one of our sources below. While methods of diagnosing skin cancer are relatively universal, be aware that not every website we source content from is Canadian.

Works Cited

About Melanoma: Signs and Symptoms of Melanoma”. NCCN Guidelines for Patients: Melanoma. 2014: National Comprehensive Cancer Network Foundation.

Diagnosing Melanoma”. Canadian Cancer Society.

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