Yervoy for Melanoma Treatment Reviewed by Leading Dermatologists

Yervoy (ipilumamab), a new medication for the treatment of melanoma, is reviewed by leading dermatologists Dr. Ramzi Saad and Dr. Richard Eisen.

“The breakthrough cancer medication from Bristol-Myers Squibb is Yervoy and it is specifically for patients with late-stage or metastatic melanoma. This is an exciting new weapon in the fight against skin cancer. We have two drugs out there that are used in the treatment of stage 3 and stage 4 melanoma – Interferon (which was approved a decade ago) and Dacarbazine. Yervoy is the first medication shown to prolong survival,” explained Dr. Saad.

Dr. Saad added that “ Yervoy is going to be a promising option for many. It prolongs life by six and a half months or more. The big issue is the significant side effect profile. But, Yervoy will undergo further rigorous testing to define it’s optimal use on melanoma patients.”

“Skin cancer is primarily caused by prolonged exposure to Ultraviolet A (UVA) and Ultraviolet B (UVB) rays from the sun or from tanning booths. UVA and UVB rays are present in tanning booths as well as on cloudy days and exposed skin is left vulnerable without sunblock or sunscreen. We’re all exposed to these rays every day, each time we go outdoors and the repeated exposure builds over time,” noted Dr. Richard Eisen, M.D.

According to South Shore Skin Center’s dermatologists, early skin cancer detection is imperative in the prevention and treatment of melanoma. If undetected and untreated, melanoma can quickly spread to the major organs and lymph nodes.

The dermatologists emphasize the need to follow key steps to prevent skin cancer including avoiding prolonged exposure to the sun, wearing protective clothing, and  applying sunscreen or sunblock with an SPF of 30 or higher every day even if it is cloudy.

They add that a person’s skin should be checked regularly by a dermatologist regularly, and any moles or other spots on the skin that have changed should be checked by physician as soon as possible.

Both Dr. Saad and Dr. Eisen practice provide medical care to patients at South Shore Skin Center in Cohasset, Massachusetts.

Pediatricians Endorse Indoor Tanning Ban for Those Under 18.

The American Academy of Pediatrics (AAP), the professional organization representing the nation’s child care experts, says that indoor tanning salons should refuse to allow people younger than 18 to use their services in order to protect them from developing skin cancer.

Ultraviolet radiation (UVA and UVB rays) emitted from tanning bed lights has been implicated in rising numbers of melanoma and other skin cancers. Research shows people who start going to tanning salons before age 35 have a 75-percent increase in their chances of developing melanoma, the deadliest type of skin cancer.

A previous AAP study of indoor tanning by U.S. youths found that a substantial minority of American youth engages in indoor tanning. However, it is particularly prevalent among older youth, girls, and youth whose parents themselves use indoor tanning sunlamps.

“There are more tanning facilities in the U.S. than there are Starbucks or McDonald’s,” said Dr. Sophie J. Balk, who helped write the new statement for the American Academy of Pediatrics. “More than a million visits are made every day.”

According to the Centers for Disease Control and Prevention, more than one million skin cancers are diagnosed every year in the U.S. and most of them are sun-related. Eleven states already have tanning restrictions for kids, but none goes as high as 18 years, according to the National Conference of State Legislatures.

The AAP now joins the American Academy of Dermatology (AAD) and WHO in seeking an indoor tanning ban.

Melanoma Risk May be Reduced by Daily Sunscreen Use.

Regular use of sunscreen during a clinical trial of basal cell and squamous cell carcinomas was found to reduce the incidence of another type of skin cancer, melanoma, up to 10 years later, according to a new study published December 6, 2010 in an online edition of the Journal of Clinical Oncology.

The study showed that applying sunscreen every day to the head, neck, arms and hands reduced the chances of getting melanoma by half.

The study of 1,600 white adults randomized the participants into two groups 1) those that applied sunscreen every day and 2) those that applied sunscreen at their own discretion (prn).

During the 10-year follow-up period the researchers found that 11 people who used sunscreen daily were diagnosed with melanoma, compared to 22 people in the “discretionary use” group.

In addition, those that developed melanoma in the daily use” group were less likely to develop invasive melanoma, which is more difficult to effectively treat, than those in the “discretionary group”.

In a new story by Top News that covered the study, “Melanoma Risk ‘Lessens’ by Using Sunscreen“, Dr. Howard Kaufman, the Director of the Rush University Cancer Center in Chicago and a melanoma expert pointed out that “We have known for a long time that sunscreen prevents squamous and basal cell carcinomas but the data on melanoma has been a little bit confusing”.

This study strengthens the evidence showing that excessive UV exposure from the sun can increase the risk of developing melanoma, and that protecting oneself from those damaging UV rays can help to reduce that risk.

Skin Cancer Treatment with Mohs Paste (Zinc Chloride) Remains of Benefit

Zinc chloride paste, a skin cancer treatment in use for nearly 200 years, may still be of value in the treatment of melanoma according to dermatologist Dr. Norman Brooks. Dr. Norman Brooks presented his clinical opinion at the 2010 meeting the American Society for Mohs Surgery (ASMS) which was reported in a story published in Internal Medicine News, “Mohs Paste Should Not Be Discounted for Treating Melanoma“.

The current paste, often referred to as “Mohs paste” was formulated by Dr. Frederic E. Mohs who also developed the Mohs Surgery technique for treating skin cancer. Mohs paste is a compound comprised of several naturally occurring ingredients: the mineral stibnite (the inert paste-like vehicle), powdered root of the bloodroot plant (that causes cell death or ‘apoptosis’ in several types of cancer cells) and a saturated zinc chloride solution that destructively penetrates skin tissue.

Zinc chloride paste appears to kill cancerous cells and stimulate a strong immune reaction that decreases the likelihood of metastasis and recurrence. “I believe chemosurgery with zinc chloride paste, followed by wide excision, is a better way to remove a melanoma than fresh tissue surgery,” said Dr. Brooks. “That’s why I believe it’s so important to use zinc chloride when treating melanoma.”

Ken Gross, M.D. a San Diego dermatologist and Mohs Surgeon who served as Course Directory of the ASMS meeting, added that “Mohs paste is a tried and true compound that does what it’s purported to do.”

Dr. Ken Gross further explained that Mohs paste has fallen out of use over the years as fresh-tissue surgery (Mohs) has gained popularity. “Fresh-tissue replaced it because it allows immediate closure, while the paste causes a lot of inflammation and, the way Dr. Mohs did it, it left a wound that healed by secondary intention. It heals well but people won’t stand for that these days.”

Aside from some slight discomfort and the inflammatory reaction, however, there are few down sides to using the paste, added Dr. Gross.

Actinic Keratosis Treatment with Topical Diclofenac Shown To Be Effective

Topical diclofenac 3% gel, available under the brand name Solaraze®, was shown to be effective for the treatment of actinic keratoses in organ transplant recipients.

These findings were presented by dermatologist Dr. Eggert Stockfleth at the Annual Congress of the European Academy of Dermatology and Venereology (EADV). His presentation was based on results of new study that followed patients for 16 weeks who used 3% diclofenac twice daily. The study showed that the AK treatment proved effective and well tolerated and prevented invasive squamous cell carcinomas (SCCs) in organ transplant recipients.

With further follow-up, 55% of the patients who had previously showed clearance of their actinic keratoses developed new AKs in the treated areas. This occurred an average of 9.3 months after diclofenac treatment ended. None of these patients developed invasive SCC in the study area within 24 months of follow-up, suggesting that topical diclofenac gel may also prevent invasive SCCs in this high-risk population.

Other treatments have demonstrated efficacy for treatment of actinic keratoses and/or prevention of nonmelanoma skin cancer in high-risk organ transplant recipients, including regular use of a sunscreen, imiquimod 5% cream (Aldara®), imiquimod 3.75% (Zyclara®) topical 5-fluorouracil (Carac®, Efudex®), and photodynamic therapy (PDT).

Actinic keratoses are a precancerous skin lesions that appear on sun exposed areas of the body, such as the forehead and back of the hands and arms. Actinic keratoses are routinely treated by dermatologists with cryotherapy and other treatments because they can evolve into a type of skin cancer called squamous cell carcinoma (SCC).

Organ transplant recipients’ immunocompromised status renders them highly vulnerable to invasive skin cancer. As transplant survival rates have improved over the years, the high incidence of aggressive cutaneous malignancies in organ transplant recipients has become a significant issue for ongoing medical care.

Skin Cancer Treatment Among Elderly Requires Additional Caution

Mark Lebwohl, M.D.

Mark Lebwohl, M.D., Dermatologist

Leading dermatologist Mark Lebwohl, M.D. advises that additional caution needs to be taken when treating elderly patients for skin cancer.

In a recent publication in Dermatology Times, Dr. Lebwohl noted that the frequent use of aspirin or anticoagulants (warfarin, Plavix), common among elderly patients at risk for heart attacks or stroke, can complicate surgical treatments.

When patients are scheduled to undergo significant surgical procedures and are taking traditional anticoagulant medications such as warfarin, there is potential for increased perioperative bleeding. There are also serious risks, however, if patients stop taking their prescribed warfarin.

“While there is some controversy as to whether we should continue or stop such medications, we try to keep them on their medications in most cases, if it is possible.” However, Dr. Lebwohl added that for those patients undergoing skin grafting, use of an anticoagulant can increase the risk that the graft “will not take” because the anticoagulant can cause bleeding under the graft.

In addition, elderly patients are at higher risk of having dementia, such as Alzheimer’s disease, that can increase their risk for developing side effects to anesthesia.

Skin cancers arise due to previous sun exposure in younger life, as well as more recent sun exposure in older life, Dr. Lebwohl says. Older patients perceive they are not at further risk of developing skin cancers and that the skin cancers they have are the result of exposure in their younger years.

“If you have ‘old’ sun damage, you do extra harm by staying in the sun,” Dr. Lebwohl says. “The immune mechanisms that protect against skin cancers are actually suppressed by current sun exposure.”

Mark Lebwohl, M.D., is a New York Dermatologist and Chairman of the department of dermatology at Mount Sinai School of Medicine, in New York City.

Actinic Keratoses Treatment Results Improved with Use of Zyclara (Imiquimod)

Actinic keratoses (AKs) are common precancerous skin lesions that are normally treated by dermatologists using cryotherapy, (freezing). Now, a new study published in the September issue of the Journal of Drugs in Dermatology (JDD) shows that treatment outcomes may be improved by combining cryotherapy with Zyclara (imiquimod), 3.75%.

Imiquimod is a medication that is used for the treatment of a variety of skin conditions, including actinic keratoses, basal cell carcinoma and external genital warts. Imiquimod appears to activate the immune system to help rid the body of abnormal cells.

According to this study, “A Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of 3.75% Imiquimod Cream Following Cryosurgery for the Treatment of Actinic Keratoses”, the use of Zyclara cream following cryotherapy yielded better results when treating actinic keratoses over the use of cryotherapy alone.

There a several options available for removing an individual actinic keratosis (AK). However, the region around an AK lesion is also sun-damaged and at risk of developing new actinic keratoses over time, requiring additional treatments. In one previous study, only 4% of patients who received only cryotherapy as an actinic keratoses treatment had sustained clearance one year later in the area around the original AK lesion.

There has been growing in interest in combining a procedure that removes an actinic keratosis with a medication, such as 5-FU or imiquimod, that treats the surrounding region.

In this study, adults with at least 10 actinic keratoses on the face underwent cryotherapy of 5 to 14 lesions. Those with at least 5 actinic keratoses remaining were randomized to receive 3.75% imiquimod (Zyclara) or a placebo cream applied to the entire face daily for two two-week cycles. Efficacy of these two treatment options was assessed 26 weeks later.

Dermatologist Mark Lebwohl, M.D. and the other study authors concluded that “while cryosurgery is an effective treatment for actinic keratoses, the subsequent use of 3.75% imiquimod cream (Zyclara) is safe and well tolerated and provides additional therapeutic benefits to cryosurgery alone. These results suggest that dual-mode therapy with lesion-directed cryosurgery followed by field-directed 3.75% imiquimod cream may be an appropriate option for patients with multiple actinic keratoses on the face.”

The study also “confirmed the findings of previous investigators regarding the efficacy of two two-week treatment cycles of daily 3.75% imiquimod cream (Zyclara) to treat all actinic keratoses in a large field of application.”

It has been previously reported that imiquimod, the active ingredient of Aldara and Zyclara, can cause subclinical lesions to become visible. This “unmasking” effect is felt to be of clinical benefit as lesions that may have otherwise have been missed are being treated. Photographs of actinic keratosis and basal cell carcinomas before, during and after treatment show the unmasking of subclinical disease.

An actinic keratosis is a skin lesion that tends to appear on sun-exposed parts of the body, including the scalp, top of the ears, face and backs of the hand. AKs may be scaly or crusty, and may be red, pink, tan, or brown-colored. Actinic keratoses are routinely treated by dermatologists because they are at risk of developing into a type of skin cancer called “squamous cell carcinoma.”

Skin Cancer Recurrence May Be Prevented with Combination Therapy

Skin Cancer, Melanoma

Skin Cancer, Melanoma

Combining treatments in the treatment of skin cancer may provide better outcomes than skin excision alone according to a story published in the September issue of Dermatology Times, “Skin cancer recurrence may be prevented with combo of surgery and adjuvant therapies“.

James M. Spencer, M.D., M.S., a New York City dermatologist and Associate Professor at Mt. Sinai School of Medicine in New York spoke at the January 2010 Orlando Dermatology Aesthetic and Clinical conference where he argued that “dermatologists tend to use only one skin cancer treatment, despite the fact that there are tried-and-true adjuvant therapies and emerging medical therapies, such as imiquimod cream.”

Patients’ desire for a small scar following skin cancer excision leads Dr. Spencer to consider the use of imiquimod cream before surgery. This is not performed to cure the cancer, but rather to shrink the tumor before the procedure.

There are only a few studies looking at outcomes of skin cancer surgery with and without prior treatment with imiquimod, and results are mixed. A 2004 study by Torres A et al published in Dermatologic Surgery reported that use of 5 percent imiquimod cream prior to Mohs surgery resulted in a smaller defect than with excision only of basal cell carcinoma. A more recent 2009 study published in Dermatologic Surgery found no statistically significant benefit in using imiquimod 5 percent cream as an adjunctive treatment of nodular, nasal basal cell carcinomas before Mohs surgery. However, the authors noted that a larger study might show a benefit.

Despite this potential concern and limited data showing effectiveness, Dr. Spencer says it is reasonable to consider imiquimod cream use prior to surgery for the bigger, trickier skin cancers.

Lentigo maligna, or melanoma in situ, has a local recurrence rate of 10 percent to 20 percent. “Imiquimod has been studied as an effective monotherapy for lentigo maligna. So, in my practice, I excise lentigo maligna and follow that with topical imiquimod”, says Dr. Spencer. “Do I have proof that is helping anybody? No. But I would argue that falls into the ‘Why not?’ category.”

“The worst that could happen is nothing; the best that could happen is that your recurrence rate would go down,” said Dr. Spencer.

Laser Treatment Effective for Pre-Cancerous Lesion on Lips

Laser treatment has shown to be effective for actinic cheilitis according to a new study published in the October 2010 issue Journal of the American Academy of Dermatology (JAAD), “Treatment of actinic cheilitis with the Er:YAG laser“.

Actinic cheilitis is a common pre-cancerous skin lesion, similar to actinic keratosis (AKs). Like AKs, it has the potential to develop into squamous cell carcinoma.

Current treatments for actinic keratosis includes cryotherapy, and topical medication (5-FU and imiquimod) but the sensitivity of the tissue on the lips makes treatment a challenge.

The role of the erbium:yttrium-aluminum-garnet (Er:YAG) laser in the treatment of actinic cheilitis has not been widely published, despite offering theoretical advantages over current treatment modalities. The main outcome measures were a subjective improvement in lip symptoms related to actinic cheilitis and objective improvement in the lips at routine follow-up.

Of those interviewed, 92.2% believed there had been an improvement in the cosmetic appearance of their lips; one hundred percent believed the function of their lips had improved or remained unchanged; and 84.8% remained completely disease free at the time of follow-up. The majority of patients (93.5%) were satisfied with the laser treatment. Scarring as a direct result of the laser occurred in 5.1% of patients.

The authors concluded that the “Er:YAG laser should be considered as a first-line treatment for the disease.”

Melanoma Treatment with Immunotherapy Shows Potential

The American Society of Clinical Oncology will hold its annual meeting in Chicago this week where it will announce results of several studies investigating the use of immunotherapies for the treatment of melanoma.

Many of the immunotherapies used in the treatment of cancer are antibodies generated in a laboratory. These “monoclonal antibodies” bind to select portions of the immune system to alter the way the immune system responds to cancer cells.

Ipilimumab is one immunotherapy developed by Bristol-Myers Squibb (BMS) that has gained significant attention. Ipilimumab is a human monoclonal antibody that is undergoing clinical trials for the treatment of melanoma. Results from three small trials found that ipilimumab extended the life of stage IV melanoma patients.

(Tremelimumab another  monoclonal antibody produced by Pfizer was being investigated for the treatment of advanced melanoma, but a phase III trial was stopped in 2008 when interim data showed that results were not superior to standard chemotherapy)