User login
Skin Examinations for Early Melanoma Detection
Tips and Tools for Melanoma Diagnosis
What does your patient need to know at the first visit? Does it apply to all patients?
All patients should have a total-body skin examination at least once per year; however, the frequency may change based on a prior history of melanoma or skin cancer, number of nevi or dysplastic nevi, and a family history of melanoma.
Patients should be completely undressed, and all nail polish or artificial nails should be removed prior to the examination. A complete cutaneous examination involves inspecting all skin surfaces, scalp, ocular and oral mucosa, fingernails/toenails, and genitalia if the patient agrees. Melanoma can occur in non–UV-exposed areas and the patient should be educated. Explain the ABCDEs of melanoma diagnosis to all patients and discuss concerns of any new or changing lesions, pigmented or not.
The patient should be made aware that a series of digital images will be taken for any suspicious lesions for possible short-term monitoring. The patient also may be offered full-body photography or 3D body imaging if the number of nevi warrants it.
Different patient populations have different risks for melanoma. Although melanoma predominately afflicts patients with a light skin type, there are certain types of melanoma, such as acral melanoma, that can be more common in darker skin types.
If a patient has a history of cutaneous melanoma, then the site should be checked for any local recurrence as well as palpation of the draining lymph nodes and regional lymph nodes.
I also let patients know that I will be using tools such as dermoscopy and/or reflectance confocal microscopy to better diagnose equivocal lesions before pursuing a biopsy. A biopsy may be done if there is a level of suspicion for atypia.
The use of dermoscopy, digital imaging, and reflectance confocal microscopy has changed the way we can detect, monitor, and evaluate atypical nevi. These tools can augment practice and possibly cut down on the rate of biopsies. They also are great for equivocal lesions or lesions that are in cosmetically sensitive areas. I use these tools in my everyday practice.
How do you keep patients compliant?
Empowering patients to perform self-examinations as well as examinations with his/her partner may help to reinforce monitoring by a dermatologist.
Provide patients with reading materials on self-examination while they wait in the office for your examination.
What do you do if they refuse treatment?
If patients defer a full-body skin examination, then I try to educate them about risks for UV exposure and the risk factors for both melanoma and nonmelanoma skin cancer. I also provide information on self-examinations so they can check at home for any irregularly shaped or changing moles.
What resources do you recommend to patients for more information?
It is important for patients to understand the risk factors for melanoma and the long-term prognosis of melanoma. I direct them to the American Academy of Dermatology’s website (http://www.AAD.org) for education and background about melanoma. Also, the Skin Cancer Foundation has inspiring patient stories (http://www.SkinCancer.org).
What does your patient need to know at the first visit? Does it apply to all patients?
All patients should have a total-body skin examination at least once per year; however, the frequency may change based on a prior history of melanoma or skin cancer, number of nevi or dysplastic nevi, and a family history of melanoma.
Patients should be completely undressed, and all nail polish or artificial nails should be removed prior to the examination. A complete cutaneous examination involves inspecting all skin surfaces, scalp, ocular and oral mucosa, fingernails/toenails, and genitalia if the patient agrees. Melanoma can occur in non–UV-exposed areas and the patient should be educated. Explain the ABCDEs of melanoma diagnosis to all patients and discuss concerns of any new or changing lesions, pigmented or not.
The patient should be made aware that a series of digital images will be taken for any suspicious lesions for possible short-term monitoring. The patient also may be offered full-body photography or 3D body imaging if the number of nevi warrants it.
Different patient populations have different risks for melanoma. Although melanoma predominately afflicts patients with a light skin type, there are certain types of melanoma, such as acral melanoma, that can be more common in darker skin types.
If a patient has a history of cutaneous melanoma, then the site should be checked for any local recurrence as well as palpation of the draining lymph nodes and regional lymph nodes.
I also let patients know that I will be using tools such as dermoscopy and/or reflectance confocal microscopy to better diagnose equivocal lesions before pursuing a biopsy. A biopsy may be done if there is a level of suspicion for atypia.
The use of dermoscopy, digital imaging, and reflectance confocal microscopy has changed the way we can detect, monitor, and evaluate atypical nevi. These tools can augment practice and possibly cut down on the rate of biopsies. They also are great for equivocal lesions or lesions that are in cosmetically sensitive areas. I use these tools in my everyday practice.
How do you keep patients compliant?
Empowering patients to perform self-examinations as well as examinations with his/her partner may help to reinforce monitoring by a dermatologist.
Provide patients with reading materials on self-examination while they wait in the office for your examination.
What do you do if they refuse treatment?
If patients defer a full-body skin examination, then I try to educate them about risks for UV exposure and the risk factors for both melanoma and nonmelanoma skin cancer. I also provide information on self-examinations so they can check at home for any irregularly shaped or changing moles.
What resources do you recommend to patients for more information?
It is important for patients to understand the risk factors for melanoma and the long-term prognosis of melanoma. I direct them to the American Academy of Dermatology’s website (http://www.AAD.org) for education and background about melanoma. Also, the Skin Cancer Foundation has inspiring patient stories (http://www.SkinCancer.org).
What does your patient need to know at the first visit? Does it apply to all patients?
All patients should have a total-body skin examination at least once per year; however, the frequency may change based on a prior history of melanoma or skin cancer, number of nevi or dysplastic nevi, and a family history of melanoma.
Patients should be completely undressed, and all nail polish or artificial nails should be removed prior to the examination. A complete cutaneous examination involves inspecting all skin surfaces, scalp, ocular and oral mucosa, fingernails/toenails, and genitalia if the patient agrees. Melanoma can occur in non–UV-exposed areas and the patient should be educated. Explain the ABCDEs of melanoma diagnosis to all patients and discuss concerns of any new or changing lesions, pigmented or not.
The patient should be made aware that a series of digital images will be taken for any suspicious lesions for possible short-term monitoring. The patient also may be offered full-body photography or 3D body imaging if the number of nevi warrants it.
Different patient populations have different risks for melanoma. Although melanoma predominately afflicts patients with a light skin type, there are certain types of melanoma, such as acral melanoma, that can be more common in darker skin types.
If a patient has a history of cutaneous melanoma, then the site should be checked for any local recurrence as well as palpation of the draining lymph nodes and regional lymph nodes.
I also let patients know that I will be using tools such as dermoscopy and/or reflectance confocal microscopy to better diagnose equivocal lesions before pursuing a biopsy. A biopsy may be done if there is a level of suspicion for atypia.
The use of dermoscopy, digital imaging, and reflectance confocal microscopy has changed the way we can detect, monitor, and evaluate atypical nevi. These tools can augment practice and possibly cut down on the rate of biopsies. They also are great for equivocal lesions or lesions that are in cosmetically sensitive areas. I use these tools in my everyday practice.
How do you keep patients compliant?
Empowering patients to perform self-examinations as well as examinations with his/her partner may help to reinforce monitoring by a dermatologist.
Provide patients with reading materials on self-examination while they wait in the office for your examination.
What do you do if they refuse treatment?
If patients defer a full-body skin examination, then I try to educate them about risks for UV exposure and the risk factors for both melanoma and nonmelanoma skin cancer. I also provide information on self-examinations so they can check at home for any irregularly shaped or changing moles.
What resources do you recommend to patients for more information?
It is important for patients to understand the risk factors for melanoma and the long-term prognosis of melanoma. I direct them to the American Academy of Dermatology’s website (http://www.AAD.org) for education and background about melanoma. Also, the Skin Cancer Foundation has inspiring patient stories (http://www.SkinCancer.org).
Optical Imaging to Detect Lentigo Maligna
In an article published online on January 26 in the Journal of the American Academy of Dermatology, my colleagues and I (Menge et al) reported on the use of reflectance confocal microscopy (RCM) for challenging facial lesions. We studied the diagnosis of lentigo maligna (LM) based on RCM versus the histopathologic diagnosis after biopsy.
In this study 17 patients were seen for evaluation of known or suspected LM at Memorial Sloan Kettering Cancer Center (New York, New York). Among these patients, a total of 63 sites on the skin were evaluated using RCM and a presumptive diagnosis was made. These sites were then biopsied to compare the diagnosis using RCM with that made by histopathology. When LM was present as determined by biopsy, RCM also was able to detect it 100% of the time (sensitivity). When LM was absent as determined by biopsy, RCM also indicated it was absent 71% of the time (specificity).
What’s the issue?
Lentigo maligna is a form of melanoma in situ occurring on sun-damaged skin. It can be quite subtle to detect clinically and therefore may go undiagnosed for a while. Lentigo maligna also has been shown to have notable subclinical extension with which traditional surgical margins for truncal melanoma may be too narrow to clear LM on the head and neck. Therefore, presurgical consultation may be difficult due to the amorphous borders. Random blind biopsies also are discouraged because of sampling error.
Additionally, repetitive biopsies over time, which may be frequently needed in individuals with heavy sun exposure, can be costly and cause adverse effects.
This study showed the usefulness and reliability of using RCM for challenging facial lesions that are suspicious for LM. The sensitivity and specificity of RCM in this study indicated that this technology performs well in detecting LM when present; however, false-positives were noted in this study. False-positives included pigmented actinic keratosis and melanocytosis. Dermatologists who are advanced in RCM technology and interpretation also were utilized in this study. More research is needed to understand how to best utilize this technology, but overall the ability of RCM to accurately identify LM without biopsy represents an exciting new development in how dermatologists can better diagnose, manage, and treat melanoma.
How will you adopt advances in cutaneous noninvasive imaging?
In an article published online on January 26 in the Journal of the American Academy of Dermatology, my colleagues and I (Menge et al) reported on the use of reflectance confocal microscopy (RCM) for challenging facial lesions. We studied the diagnosis of lentigo maligna (LM) based on RCM versus the histopathologic diagnosis after biopsy.
In this study 17 patients were seen for evaluation of known or suspected LM at Memorial Sloan Kettering Cancer Center (New York, New York). Among these patients, a total of 63 sites on the skin were evaluated using RCM and a presumptive diagnosis was made. These sites were then biopsied to compare the diagnosis using RCM with that made by histopathology. When LM was present as determined by biopsy, RCM also was able to detect it 100% of the time (sensitivity). When LM was absent as determined by biopsy, RCM also indicated it was absent 71% of the time (specificity).
What’s the issue?
Lentigo maligna is a form of melanoma in situ occurring on sun-damaged skin. It can be quite subtle to detect clinically and therefore may go undiagnosed for a while. Lentigo maligna also has been shown to have notable subclinical extension with which traditional surgical margins for truncal melanoma may be too narrow to clear LM on the head and neck. Therefore, presurgical consultation may be difficult due to the amorphous borders. Random blind biopsies also are discouraged because of sampling error.
Additionally, repetitive biopsies over time, which may be frequently needed in individuals with heavy sun exposure, can be costly and cause adverse effects.
This study showed the usefulness and reliability of using RCM for challenging facial lesions that are suspicious for LM. The sensitivity and specificity of RCM in this study indicated that this technology performs well in detecting LM when present; however, false-positives were noted in this study. False-positives included pigmented actinic keratosis and melanocytosis. Dermatologists who are advanced in RCM technology and interpretation also were utilized in this study. More research is needed to understand how to best utilize this technology, but overall the ability of RCM to accurately identify LM without biopsy represents an exciting new development in how dermatologists can better diagnose, manage, and treat melanoma.
How will you adopt advances in cutaneous noninvasive imaging?
In an article published online on January 26 in the Journal of the American Academy of Dermatology, my colleagues and I (Menge et al) reported on the use of reflectance confocal microscopy (RCM) for challenging facial lesions. We studied the diagnosis of lentigo maligna (LM) based on RCM versus the histopathologic diagnosis after biopsy.
In this study 17 patients were seen for evaluation of known or suspected LM at Memorial Sloan Kettering Cancer Center (New York, New York). Among these patients, a total of 63 sites on the skin were evaluated using RCM and a presumptive diagnosis was made. These sites were then biopsied to compare the diagnosis using RCM with that made by histopathology. When LM was present as determined by biopsy, RCM also was able to detect it 100% of the time (sensitivity). When LM was absent as determined by biopsy, RCM also indicated it was absent 71% of the time (specificity).
What’s the issue?
Lentigo maligna is a form of melanoma in situ occurring on sun-damaged skin. It can be quite subtle to detect clinically and therefore may go undiagnosed for a while. Lentigo maligna also has been shown to have notable subclinical extension with which traditional surgical margins for truncal melanoma may be too narrow to clear LM on the head and neck. Therefore, presurgical consultation may be difficult due to the amorphous borders. Random blind biopsies also are discouraged because of sampling error.
Additionally, repetitive biopsies over time, which may be frequently needed in individuals with heavy sun exposure, can be costly and cause adverse effects.
This study showed the usefulness and reliability of using RCM for challenging facial lesions that are suspicious for LM. The sensitivity and specificity of RCM in this study indicated that this technology performs well in detecting LM when present; however, false-positives were noted in this study. False-positives included pigmented actinic keratosis and melanocytosis. Dermatologists who are advanced in RCM technology and interpretation also were utilized in this study. More research is needed to understand how to best utilize this technology, but overall the ability of RCM to accurately identify LM without biopsy represents an exciting new development in how dermatologists can better diagnose, manage, and treat melanoma.
How will you adopt advances in cutaneous noninvasive imaging?
What’s Trending in OTC Antiaging Products: Report From the AAD Meeting
Patient interest in over-the-counter (OTC) antiaging products is increasing; however, the number of products to choose from can be overwhelming and patients may end up spending a lot of money on products that do not work. Dr. Anthony Rossi provides an overview of the latest trends in OTC antiaging products, including antioxidant-containing sunscreens, growth factors, and topical hyaluronic acid. Dr. Rossi notes that patients often call on dermatologists to offer product recommendations. Therefore, it is important for dermatologists to be familiar with product ingredients and counsel patients accordingly in order to maximize their effects on the skin.
Patient interest in over-the-counter (OTC) antiaging products is increasing; however, the number of products to choose from can be overwhelming and patients may end up spending a lot of money on products that do not work. Dr. Anthony Rossi provides an overview of the latest trends in OTC antiaging products, including antioxidant-containing sunscreens, growth factors, and topical hyaluronic acid. Dr. Rossi notes that patients often call on dermatologists to offer product recommendations. Therefore, it is important for dermatologists to be familiar with product ingredients and counsel patients accordingly in order to maximize their effects on the skin.
Patient interest in over-the-counter (OTC) antiaging products is increasing; however, the number of products to choose from can be overwhelming and patients may end up spending a lot of money on products that do not work. Dr. Anthony Rossi provides an overview of the latest trends in OTC antiaging products, including antioxidant-containing sunscreens, growth factors, and topical hyaluronic acid. Dr. Rossi notes that patients often call on dermatologists to offer product recommendations. Therefore, it is important for dermatologists to be familiar with product ingredients and counsel patients accordingly in order to maximize their effects on the skin.
T-VEC: Advancing the Fight Against Melanoma
Following a phase III, open-label trial conducted by Andtbacka et al (J Clin Oncol. 2015;33:2780-2788), the US Food and Drug Administration recently approved the first oncolytic immunotherapy talimogene laherparepvec (T-VEC) for the treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with advanced melanoma (stage IIIB/C–stage IV) following initial surgery.
A group of 436 patients with injectable melanomas (melanomas that are accessible via a percutaneous injection) that were not surgically resectable were randomly assigned (2:1) to treatment with intralesional T-VEC or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). The primary endpoint of the study was durable response rate (DRR), defined as objective response lasting continuously for 6 months or longer. Secondary endpoints included overall survival (OS) and overall response rate.
Talimogene laherparepvec was shown to extend DRRs compared to GM-CSF. Durable response rates were significantly higher with T-VEC (16.3%; 95% confidence interval [CI], 12.1%–20.5%) versus GM-CSF (2.1%; 95% CI, 0%–4.5%)(odds ratio, 8.9; P<.001).
In the OS analysis, a 4.4-month extension with T-VEC was observed; however, this was not deemed to be statistically significant (P=.051). The median OS was 23.3 months (95% CI, 19.5–29.6 months) with T-VEC and 18.9 months (95% CI, 16.0–23.7 months) with GM-CSF (hazard ratio, 0.79; 95% CI, 0.62–1.00; P=.051). Overall response rate also was higher in the T-VEC arm (26.4%; 95% CI, 21.4%–31.5%) versus GM-CSF (5.7%; 95% CI, 1.9%–9.5%).
Talimogene laherparepvec is a herpes simplex virus type 1–derived oncolytic immunotherapy designed to replicate within tumors and produce GM-CSF, which enhances systemic antitumor immune responses and induces tumor lysis.
In this study, T-VEC efficacy was greatest in patients with stage IIIB, IIIC, or IVM1a melanomas and in patients with treatment-naive disease. Differences in DRRs in patients with stage IIIB/C melanomas were 33% in the T-VEC group versus 0% for patients treated with GM-CSF alone. In the stage IVM1a group, DRR was 16% with T-VEC versus 2% with GM-CSF. The difference between both treatments was smaller in more advanced melanomas (IVM1b group, 3% vs 4%; IVM1c, 7% vs 3%). In the first-line treatment, the DRR with T-VEC was 24% versus 0% with GM-CSF. In the second-line and beyond, the DRR with T-VEC was 10% compared to 4% for GM-CSF.
The main adverse events seen in this study were fatigue, chills, and pyrexia. Serious adverse events occurred in 25.7% and 13.4% of participants in the T-VEC and GM-CSF arms, respectively, with disease progression (3.1% vs 1.6%) and cellulitis (2.4% vs 0.8%) being the most common. Six immune-mediated events occurred in the T-VEC group compared to 3 in the GM-CSF group.
Twelve patient deaths occurred within 30 days of the last dose of T-VEC; 9 were associated with progressive disease and the other 3 were associated with myocardial infarction, cardiac arrest, and sepsis, respectively. Four patient deaths were reported in the GM-CSF arm within the same 30 days.
What’s the Issue?
Immunotherapy represents a promising treatment option for metastatic melanoma. These promising results along with the US Food and Drug Administration’s approval of T-VEC will lead to further studies of the uses of T-VEC in combination with other therapies, including a phase I/II study to assess T-VEC in combination with ipilimumab for unresected melanomas (NCT01740297) and a phase III study of T-VEC in combination with pembrolizumab for unresected melanomas (NCT02263508). It is important for dermatologists to be familiar with the new frontier of melanoma treatments. How will these new immunotherapies affect your treatment of melanoma?
Following a phase III, open-label trial conducted by Andtbacka et al (J Clin Oncol. 2015;33:2780-2788), the US Food and Drug Administration recently approved the first oncolytic immunotherapy talimogene laherparepvec (T-VEC) for the treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with advanced melanoma (stage IIIB/C–stage IV) following initial surgery.
A group of 436 patients with injectable melanomas (melanomas that are accessible via a percutaneous injection) that were not surgically resectable were randomly assigned (2:1) to treatment with intralesional T-VEC or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). The primary endpoint of the study was durable response rate (DRR), defined as objective response lasting continuously for 6 months or longer. Secondary endpoints included overall survival (OS) and overall response rate.
Talimogene laherparepvec was shown to extend DRRs compared to GM-CSF. Durable response rates were significantly higher with T-VEC (16.3%; 95% confidence interval [CI], 12.1%–20.5%) versus GM-CSF (2.1%; 95% CI, 0%–4.5%)(odds ratio, 8.9; P<.001).
In the OS analysis, a 4.4-month extension with T-VEC was observed; however, this was not deemed to be statistically significant (P=.051). The median OS was 23.3 months (95% CI, 19.5–29.6 months) with T-VEC and 18.9 months (95% CI, 16.0–23.7 months) with GM-CSF (hazard ratio, 0.79; 95% CI, 0.62–1.00; P=.051). Overall response rate also was higher in the T-VEC arm (26.4%; 95% CI, 21.4%–31.5%) versus GM-CSF (5.7%; 95% CI, 1.9%–9.5%).
Talimogene laherparepvec is a herpes simplex virus type 1–derived oncolytic immunotherapy designed to replicate within tumors and produce GM-CSF, which enhances systemic antitumor immune responses and induces tumor lysis.
In this study, T-VEC efficacy was greatest in patients with stage IIIB, IIIC, or IVM1a melanomas and in patients with treatment-naive disease. Differences in DRRs in patients with stage IIIB/C melanomas were 33% in the T-VEC group versus 0% for patients treated with GM-CSF alone. In the stage IVM1a group, DRR was 16% with T-VEC versus 2% with GM-CSF. The difference between both treatments was smaller in more advanced melanomas (IVM1b group, 3% vs 4%; IVM1c, 7% vs 3%). In the first-line treatment, the DRR with T-VEC was 24% versus 0% with GM-CSF. In the second-line and beyond, the DRR with T-VEC was 10% compared to 4% for GM-CSF.
The main adverse events seen in this study were fatigue, chills, and pyrexia. Serious adverse events occurred in 25.7% and 13.4% of participants in the T-VEC and GM-CSF arms, respectively, with disease progression (3.1% vs 1.6%) and cellulitis (2.4% vs 0.8%) being the most common. Six immune-mediated events occurred in the T-VEC group compared to 3 in the GM-CSF group.
Twelve patient deaths occurred within 30 days of the last dose of T-VEC; 9 were associated with progressive disease and the other 3 were associated with myocardial infarction, cardiac arrest, and sepsis, respectively. Four patient deaths were reported in the GM-CSF arm within the same 30 days.
What’s the Issue?
Immunotherapy represents a promising treatment option for metastatic melanoma. These promising results along with the US Food and Drug Administration’s approval of T-VEC will lead to further studies of the uses of T-VEC in combination with other therapies, including a phase I/II study to assess T-VEC in combination with ipilimumab for unresected melanomas (NCT01740297) and a phase III study of T-VEC in combination with pembrolizumab for unresected melanomas (NCT02263508). It is important for dermatologists to be familiar with the new frontier of melanoma treatments. How will these new immunotherapies affect your treatment of melanoma?
Following a phase III, open-label trial conducted by Andtbacka et al (J Clin Oncol. 2015;33:2780-2788), the US Food and Drug Administration recently approved the first oncolytic immunotherapy talimogene laherparepvec (T-VEC) for the treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with advanced melanoma (stage IIIB/C–stage IV) following initial surgery.
A group of 436 patients with injectable melanomas (melanomas that are accessible via a percutaneous injection) that were not surgically resectable were randomly assigned (2:1) to treatment with intralesional T-VEC or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). The primary endpoint of the study was durable response rate (DRR), defined as objective response lasting continuously for 6 months or longer. Secondary endpoints included overall survival (OS) and overall response rate.
Talimogene laherparepvec was shown to extend DRRs compared to GM-CSF. Durable response rates were significantly higher with T-VEC (16.3%; 95% confidence interval [CI], 12.1%–20.5%) versus GM-CSF (2.1%; 95% CI, 0%–4.5%)(odds ratio, 8.9; P<.001).
In the OS analysis, a 4.4-month extension with T-VEC was observed; however, this was not deemed to be statistically significant (P=.051). The median OS was 23.3 months (95% CI, 19.5–29.6 months) with T-VEC and 18.9 months (95% CI, 16.0–23.7 months) with GM-CSF (hazard ratio, 0.79; 95% CI, 0.62–1.00; P=.051). Overall response rate also was higher in the T-VEC arm (26.4%; 95% CI, 21.4%–31.5%) versus GM-CSF (5.7%; 95% CI, 1.9%–9.5%).
Talimogene laherparepvec is a herpes simplex virus type 1–derived oncolytic immunotherapy designed to replicate within tumors and produce GM-CSF, which enhances systemic antitumor immune responses and induces tumor lysis.
In this study, T-VEC efficacy was greatest in patients with stage IIIB, IIIC, or IVM1a melanomas and in patients with treatment-naive disease. Differences in DRRs in patients with stage IIIB/C melanomas were 33% in the T-VEC group versus 0% for patients treated with GM-CSF alone. In the stage IVM1a group, DRR was 16% with T-VEC versus 2% with GM-CSF. The difference between both treatments was smaller in more advanced melanomas (IVM1b group, 3% vs 4%; IVM1c, 7% vs 3%). In the first-line treatment, the DRR with T-VEC was 24% versus 0% with GM-CSF. In the second-line and beyond, the DRR with T-VEC was 10% compared to 4% for GM-CSF.
The main adverse events seen in this study were fatigue, chills, and pyrexia. Serious adverse events occurred in 25.7% and 13.4% of participants in the T-VEC and GM-CSF arms, respectively, with disease progression (3.1% vs 1.6%) and cellulitis (2.4% vs 0.8%) being the most common. Six immune-mediated events occurred in the T-VEC group compared to 3 in the GM-CSF group.
Twelve patient deaths occurred within 30 days of the last dose of T-VEC; 9 were associated with progressive disease and the other 3 were associated with myocardial infarction, cardiac arrest, and sepsis, respectively. Four patient deaths were reported in the GM-CSF arm within the same 30 days.
What’s the Issue?
Immunotherapy represents a promising treatment option for metastatic melanoma. These promising results along with the US Food and Drug Administration’s approval of T-VEC will lead to further studies of the uses of T-VEC in combination with other therapies, including a phase I/II study to assess T-VEC in combination with ipilimumab for unresected melanomas (NCT01740297) and a phase III study of T-VEC in combination with pembrolizumab for unresected melanomas (NCT02263508). It is important for dermatologists to be familiar with the new frontier of melanoma treatments. How will these new immunotherapies affect your treatment of melanoma?
The Skin Cancer Vitamin?
Martin et al recently presented a study at the 2015 American Society of Clinical Oncology Annual Meeting (J Clin Oncol. 2015;33[suppl]:9000) that reported on a phase 3 double-blind randomized trial to assess the use of oral nicotinamide to reduce actinic skin cancers, namely basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
This study was conducted in 2 tertiary treatment centers in Sydney, Australia, from 2012 to 2014, and it included 386 immunocompetent participants with 2 or more histologically confirmed nonmelanoma skin cancers (NMSCs) in the last 5 years. Two groups were randomized (1:1 ratio) to either receive oral nicotinamide 500 mg twice daily or matched placebo for 12 months. The primary end point measured was the number of new NMSCs to 12 months. Other secondary end points included number of SCCs, BCCs, and actinic keratoses to 12 months. Dermatologists performed skin checks every 3 months on the participants.
The results of the study showed that the average NMSC rate was significantly lower for the oral nicotinamide group (1.77) compared to the placebo group (2.42). The estimated relative rate reduction (RRR) was 0.23 (95% confidence interval [CI], 0.04-0.38; P=.02) adjusting for center and NMSC history, and 0.27 (95% CI, 0.05-0.44; P=.02) with no adjustment. The effects for BCC were comparable to SCC: BCC (RRR, 0.20; 95% CI, -0.06 to 0.39; P=.1) and SCC (RRR, 0.30; 95% CI, 0-0.51; P=.05). Additionally, actinic keratosis counts were reduced by 11% at 3 months (P=.01), 14% at 6 months (P<.001), 20% at 9 months (P<.0001), and 13% at 12 months (P<.005) for the oral nicotinamide group compared to the placebo group. There was no difference in the adverse event rates between the 2 groups.
What’s the issue?
This study reported the results of a double-blind randomized study of nicotinamide (vitamin B3) to reduce actinic cancer, called the ONTRAC (Oral Nicotinamide to Reduce Actinic Cancer) study, with favorable results for the use of oral nicotinamide, an inexpensive vitamin. There was a 20% reduction in BCC and a 30% reduction in SCC in the nicotinamide group compared to the group taking a placebo with no active ingredients. This study was conducted in a heavily sun-damaged group and it is postulated that nicotinamide helps cells repair DNA damage.
The thought of using a vitamin to reduce skin cancer rates is exciting; however, this study is singular, and while it did show promising results, the number of participants is not very large. There also was no evidence that nicotinamide prevents melanoma formation. Also, there was no protective effect seen once the vitamin B3 treatment was stopped. One must be cognizant that nicotinamide is not interchangeable with other forms of vitamin B3 such as niacin.
Although this study is promising, more research is needed to determine nicotinamide’s preventative effects. Of course, strict sun protection and skin checks are the first line in the prevention of skin cancer. Will you be prescribing oral nicotinamide to your patients to prevent NMSC?
Martin et al recently presented a study at the 2015 American Society of Clinical Oncology Annual Meeting (J Clin Oncol. 2015;33[suppl]:9000) that reported on a phase 3 double-blind randomized trial to assess the use of oral nicotinamide to reduce actinic skin cancers, namely basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
This study was conducted in 2 tertiary treatment centers in Sydney, Australia, from 2012 to 2014, and it included 386 immunocompetent participants with 2 or more histologically confirmed nonmelanoma skin cancers (NMSCs) in the last 5 years. Two groups were randomized (1:1 ratio) to either receive oral nicotinamide 500 mg twice daily or matched placebo for 12 months. The primary end point measured was the number of new NMSCs to 12 months. Other secondary end points included number of SCCs, BCCs, and actinic keratoses to 12 months. Dermatologists performed skin checks every 3 months on the participants.
The results of the study showed that the average NMSC rate was significantly lower for the oral nicotinamide group (1.77) compared to the placebo group (2.42). The estimated relative rate reduction (RRR) was 0.23 (95% confidence interval [CI], 0.04-0.38; P=.02) adjusting for center and NMSC history, and 0.27 (95% CI, 0.05-0.44; P=.02) with no adjustment. The effects for BCC were comparable to SCC: BCC (RRR, 0.20; 95% CI, -0.06 to 0.39; P=.1) and SCC (RRR, 0.30; 95% CI, 0-0.51; P=.05). Additionally, actinic keratosis counts were reduced by 11% at 3 months (P=.01), 14% at 6 months (P<.001), 20% at 9 months (P<.0001), and 13% at 12 months (P<.005) for the oral nicotinamide group compared to the placebo group. There was no difference in the adverse event rates between the 2 groups.
What’s the issue?
This study reported the results of a double-blind randomized study of nicotinamide (vitamin B3) to reduce actinic cancer, called the ONTRAC (Oral Nicotinamide to Reduce Actinic Cancer) study, with favorable results for the use of oral nicotinamide, an inexpensive vitamin. There was a 20% reduction in BCC and a 30% reduction in SCC in the nicotinamide group compared to the group taking a placebo with no active ingredients. This study was conducted in a heavily sun-damaged group and it is postulated that nicotinamide helps cells repair DNA damage.
The thought of using a vitamin to reduce skin cancer rates is exciting; however, this study is singular, and while it did show promising results, the number of participants is not very large. There also was no evidence that nicotinamide prevents melanoma formation. Also, there was no protective effect seen once the vitamin B3 treatment was stopped. One must be cognizant that nicotinamide is not interchangeable with other forms of vitamin B3 such as niacin.
Although this study is promising, more research is needed to determine nicotinamide’s preventative effects. Of course, strict sun protection and skin checks are the first line in the prevention of skin cancer. Will you be prescribing oral nicotinamide to your patients to prevent NMSC?
Martin et al recently presented a study at the 2015 American Society of Clinical Oncology Annual Meeting (J Clin Oncol. 2015;33[suppl]:9000) that reported on a phase 3 double-blind randomized trial to assess the use of oral nicotinamide to reduce actinic skin cancers, namely basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
This study was conducted in 2 tertiary treatment centers in Sydney, Australia, from 2012 to 2014, and it included 386 immunocompetent participants with 2 or more histologically confirmed nonmelanoma skin cancers (NMSCs) in the last 5 years. Two groups were randomized (1:1 ratio) to either receive oral nicotinamide 500 mg twice daily or matched placebo for 12 months. The primary end point measured was the number of new NMSCs to 12 months. Other secondary end points included number of SCCs, BCCs, and actinic keratoses to 12 months. Dermatologists performed skin checks every 3 months on the participants.
The results of the study showed that the average NMSC rate was significantly lower for the oral nicotinamide group (1.77) compared to the placebo group (2.42). The estimated relative rate reduction (RRR) was 0.23 (95% confidence interval [CI], 0.04-0.38; P=.02) adjusting for center and NMSC history, and 0.27 (95% CI, 0.05-0.44; P=.02) with no adjustment. The effects for BCC were comparable to SCC: BCC (RRR, 0.20; 95% CI, -0.06 to 0.39; P=.1) and SCC (RRR, 0.30; 95% CI, 0-0.51; P=.05). Additionally, actinic keratosis counts were reduced by 11% at 3 months (P=.01), 14% at 6 months (P<.001), 20% at 9 months (P<.0001), and 13% at 12 months (P<.005) for the oral nicotinamide group compared to the placebo group. There was no difference in the adverse event rates between the 2 groups.
What’s the issue?
This study reported the results of a double-blind randomized study of nicotinamide (vitamin B3) to reduce actinic cancer, called the ONTRAC (Oral Nicotinamide to Reduce Actinic Cancer) study, with favorable results for the use of oral nicotinamide, an inexpensive vitamin. There was a 20% reduction in BCC and a 30% reduction in SCC in the nicotinamide group compared to the group taking a placebo with no active ingredients. This study was conducted in a heavily sun-damaged group and it is postulated that nicotinamide helps cells repair DNA damage.
The thought of using a vitamin to reduce skin cancer rates is exciting; however, this study is singular, and while it did show promising results, the number of participants is not very large. There also was no evidence that nicotinamide prevents melanoma formation. Also, there was no protective effect seen once the vitamin B3 treatment was stopped. One must be cognizant that nicotinamide is not interchangeable with other forms of vitamin B3 such as niacin.
Although this study is promising, more research is needed to determine nicotinamide’s preventative effects. Of course, strict sun protection and skin checks are the first line in the prevention of skin cancer. Will you be prescribing oral nicotinamide to your patients to prevent NMSC?
A Prognostic Indicator for Melanoma Metastasis
Gerami et al (Clin Cancer Res. 2015;21:175-183) discussed the development and use of a genetic signature to predict the likelihood of metastasis from cutaneous melanoma. A genetic signature comprised of 28 prognostic genetic targets and 3 control genes was developed from the expression data available and reverse transcriptase–polymerase chain reaction analysis of more than 260 primary cutaneous melanoma cases was performed. Genetic expression data from public databases were used to identify genes that were similarly upregulated or downregulated in metastatic disease. The analysis of cutaneous melanoma and uveal melanoma tumors led to the selection of 54 gene targets that had different expression profiles for primary tumors compared with metastatic tumors. Of the 54 targets of interest, 20 were selected for further reverse transcriptase–polymerase chain reaction analysis based on genetic loci. Additionally, analysis of metastatic and nonmetastatic primary cutaneous melanoma tumors using a profile assay for uveal melanoma led to the selection of 5 additional gene targets. The sample set of cases included 107 stage I and stage II primary melanomas. Twenty cases had metastatic disease and 5 cases had regional recurrence.
Prediction of metastatic risk for this test was classified either as class 1 (low risk) or class 2 (high risk). In the development cohort, 43 of 107 cases were predicted to be class 2. All cases with documented metastatic progression were called class 2 (100% sensitivity), whereas 64 of 82 nonmetastatic cases were called class 1 (78% specificity; accuracy determined by the area under the receiver operating characteristic curve, 0.93). Kaplan-Meier survival analysis revealed that disease-free survival for the predicted classes was significantly different (P<.0001). Also, the median time to metastasis for class 2 cases was 2.5 years, whereas the median time for class 1 cases was not reached. Five-year disease-free survival was 100% for class 1 cases compared with 38% for class 2 cases.
What’s the issue?
Stage I cutaneous melanoma tumors have a 5-year overall survival rate of 91% to 97%. Although the majority of clinical stage I patients will be disease free at 5 years, some stage I patients will develop advanced disease. Furthermore, prognosis for clinical stage II and stage III cases by the TNM staging system is highly variable, as evidenced by a 5-year survival rate of 53% to 82% for stage II patients and a 5-year survival rate of 22% to 68% for stage III patients. However, up to 20% of stage I and stage II patients will die from the disease within 4 years of the initial diagnosis. This statistic can be difficult for patients, as it can be unclear which stage I and stage II patients are more at risk.
This test had a limited number of samples that were used to create this predictive tool. Would patients with stage I and stage II disease deemed to be high risk by this test benefit from adjuvant therapy and/or enhanced imaging protocols to allow for early detection of metastasis? Will you be recommending this test to your melanoma patients?
Gerami et al (Clin Cancer Res. 2015;21:175-183) discussed the development and use of a genetic signature to predict the likelihood of metastasis from cutaneous melanoma. A genetic signature comprised of 28 prognostic genetic targets and 3 control genes was developed from the expression data available and reverse transcriptase–polymerase chain reaction analysis of more than 260 primary cutaneous melanoma cases was performed. Genetic expression data from public databases were used to identify genes that were similarly upregulated or downregulated in metastatic disease. The analysis of cutaneous melanoma and uveal melanoma tumors led to the selection of 54 gene targets that had different expression profiles for primary tumors compared with metastatic tumors. Of the 54 targets of interest, 20 were selected for further reverse transcriptase–polymerase chain reaction analysis based on genetic loci. Additionally, analysis of metastatic and nonmetastatic primary cutaneous melanoma tumors using a profile assay for uveal melanoma led to the selection of 5 additional gene targets. The sample set of cases included 107 stage I and stage II primary melanomas. Twenty cases had metastatic disease and 5 cases had regional recurrence.
Prediction of metastatic risk for this test was classified either as class 1 (low risk) or class 2 (high risk). In the development cohort, 43 of 107 cases were predicted to be class 2. All cases with documented metastatic progression were called class 2 (100% sensitivity), whereas 64 of 82 nonmetastatic cases were called class 1 (78% specificity; accuracy determined by the area under the receiver operating characteristic curve, 0.93). Kaplan-Meier survival analysis revealed that disease-free survival for the predicted classes was significantly different (P<.0001). Also, the median time to metastasis for class 2 cases was 2.5 years, whereas the median time for class 1 cases was not reached. Five-year disease-free survival was 100% for class 1 cases compared with 38% for class 2 cases.
What’s the issue?
Stage I cutaneous melanoma tumors have a 5-year overall survival rate of 91% to 97%. Although the majority of clinical stage I patients will be disease free at 5 years, some stage I patients will develop advanced disease. Furthermore, prognosis for clinical stage II and stage III cases by the TNM staging system is highly variable, as evidenced by a 5-year survival rate of 53% to 82% for stage II patients and a 5-year survival rate of 22% to 68% for stage III patients. However, up to 20% of stage I and stage II patients will die from the disease within 4 years of the initial diagnosis. This statistic can be difficult for patients, as it can be unclear which stage I and stage II patients are more at risk.
This test had a limited number of samples that were used to create this predictive tool. Would patients with stage I and stage II disease deemed to be high risk by this test benefit from adjuvant therapy and/or enhanced imaging protocols to allow for early detection of metastasis? Will you be recommending this test to your melanoma patients?
Gerami et al (Clin Cancer Res. 2015;21:175-183) discussed the development and use of a genetic signature to predict the likelihood of metastasis from cutaneous melanoma. A genetic signature comprised of 28 prognostic genetic targets and 3 control genes was developed from the expression data available and reverse transcriptase–polymerase chain reaction analysis of more than 260 primary cutaneous melanoma cases was performed. Genetic expression data from public databases were used to identify genes that were similarly upregulated or downregulated in metastatic disease. The analysis of cutaneous melanoma and uveal melanoma tumors led to the selection of 54 gene targets that had different expression profiles for primary tumors compared with metastatic tumors. Of the 54 targets of interest, 20 were selected for further reverse transcriptase–polymerase chain reaction analysis based on genetic loci. Additionally, analysis of metastatic and nonmetastatic primary cutaneous melanoma tumors using a profile assay for uveal melanoma led to the selection of 5 additional gene targets. The sample set of cases included 107 stage I and stage II primary melanomas. Twenty cases had metastatic disease and 5 cases had regional recurrence.
Prediction of metastatic risk for this test was classified either as class 1 (low risk) or class 2 (high risk). In the development cohort, 43 of 107 cases were predicted to be class 2. All cases with documented metastatic progression were called class 2 (100% sensitivity), whereas 64 of 82 nonmetastatic cases were called class 1 (78% specificity; accuracy determined by the area under the receiver operating characteristic curve, 0.93). Kaplan-Meier survival analysis revealed that disease-free survival for the predicted classes was significantly different (P<.0001). Also, the median time to metastasis for class 2 cases was 2.5 years, whereas the median time for class 1 cases was not reached. Five-year disease-free survival was 100% for class 1 cases compared with 38% for class 2 cases.
What’s the issue?
Stage I cutaneous melanoma tumors have a 5-year overall survival rate of 91% to 97%. Although the majority of clinical stage I patients will be disease free at 5 years, some stage I patients will develop advanced disease. Furthermore, prognosis for clinical stage II and stage III cases by the TNM staging system is highly variable, as evidenced by a 5-year survival rate of 53% to 82% for stage II patients and a 5-year survival rate of 22% to 68% for stage III patients. However, up to 20% of stage I and stage II patients will die from the disease within 4 years of the initial diagnosis. This statistic can be difficult for patients, as it can be unclear which stage I and stage II patients are more at risk.
This test had a limited number of samples that were used to create this predictive tool. Would patients with stage I and stage II disease deemed to be high risk by this test benefit from adjuvant therapy and/or enhanced imaging protocols to allow for early detection of metastasis? Will you be recommending this test to your melanoma patients?
The Redness Remover
Tanghetti et al (J Drugs Dermatol. 2015;14:33-40) discuss the use of topical brimonidine for the redness associated with rosacea. Brimonidine is the newest therapeutic to combat the erythema associated with rosacea of all subtypes. It is a topical α2-adrenergic agonist that causes peripheral vasoconstriction via a direct effect on smooth muscle receptors. The authors describe 2 large studies that studied the safety and efficacy of topical brimonidine and also give consensus recommendations regarding optimal utilization while minimizing adverse effects, such as the “rebound” phenomena described. It is important to note that it is not a traditional rebound effect, as it does not occur once the medication has stopped; however, it is a worsening of the erythema during active treatment with brimonidine. The authors discuss the various cases reported to the manufacturer after the medication was released. The most frequently associated side effects reported were erythema in almost all cases, flushing, feeling of heat or burning sensation, and rarely pain. Other issues such as dermatitis, pruritus, facial swelling, and pallor were seen in less than 10% of reports each.
These rebound effects were most likely to occur in the first 15 days after initiation of therapy, mainly in the first week. They also were noticed at 2 other time points—3 to 6 hours and 10 to 12 hours after application—which allowed the identification of 2 types of reactions based on the time to onset postapplication: appearing within 3 to 6 hours and observed after 10 to 12 hours. These events have been given new names. “Paradoxical erythema” is the redness appearing within 3 to 6 hours after application, which can be worse than baseline. “Exaggerated recurrence of erythema” is the redness that is greater than baseline and occurs as therapy wears off, approximately 10 to 12 hours after application. Allergic contact dermatitis also has been associated with the medication and can therefore be a source of redness 3 to 4 months after initiation.
What’s the issue?
The erythema associated with rosacea can be a distressing symptom for both the patient and the dermatologist. It can be difficult to treat and quite often recalcitrant to multiple treatments. Although pulsed dye laser is an effective therapy for treating telangiectases and dilated blood vessels, it can be expensive for many patients. Topical brimonidine represents a novel therapeutic to combat one of the most remarkable symptoms of rosacea. However, because of the possibility of this increased redness after use, Tanghetti et al suggest the following treatment algorithm:
- “Assess” the patient and rule out other causes of redness or associated conditions, such as seborrheic dermatitis or lupus.
- “Educate” the patient regarding the known triggers of rosacea flair and how they can be best avoided. Also educate that brimonidine only treats redness and not the papules, pustules, or other symptoms of rosacea.
- “Inhibit” inflammation that is currently present using gentle skin care practices, mild cleansers, and barrier-restoring emollients.
- “Optimize” the application of brimonidine. Instruct how to apply a pea-sized amount in the morning or how patients can best time the application to coincide with daily events or social events.
- “Understand” that worsening redness may occur, which can be key to patient satisfaction. Patients should be made aware that there is a risk for worsening redness in 10% to 20% of patients. It usually occurs within the first 2 weeks of starting the medication and it may be seen soon after application (3–6 hours) or after treatment has subsided (10–12 hours). Generally this worsening will subside within 12 to 24 hours after discontinuation. Also symptoms can be treated throughout with the use of nonsteroidal anti-inflammatory medications, antihistamines, topical calcineurin inhibitors, and topical steroids, if necessary.
What has been your experience with brimonidine gel and how do you manage these patients?
Tanghetti et al (J Drugs Dermatol. 2015;14:33-40) discuss the use of topical brimonidine for the redness associated with rosacea. Brimonidine is the newest therapeutic to combat the erythema associated with rosacea of all subtypes. It is a topical α2-adrenergic agonist that causes peripheral vasoconstriction via a direct effect on smooth muscle receptors. The authors describe 2 large studies that studied the safety and efficacy of topical brimonidine and also give consensus recommendations regarding optimal utilization while minimizing adverse effects, such as the “rebound” phenomena described. It is important to note that it is not a traditional rebound effect, as it does not occur once the medication has stopped; however, it is a worsening of the erythema during active treatment with brimonidine. The authors discuss the various cases reported to the manufacturer after the medication was released. The most frequently associated side effects reported were erythema in almost all cases, flushing, feeling of heat or burning sensation, and rarely pain. Other issues such as dermatitis, pruritus, facial swelling, and pallor were seen in less than 10% of reports each.
These rebound effects were most likely to occur in the first 15 days after initiation of therapy, mainly in the first week. They also were noticed at 2 other time points—3 to 6 hours and 10 to 12 hours after application—which allowed the identification of 2 types of reactions based on the time to onset postapplication: appearing within 3 to 6 hours and observed after 10 to 12 hours. These events have been given new names. “Paradoxical erythema” is the redness appearing within 3 to 6 hours after application, which can be worse than baseline. “Exaggerated recurrence of erythema” is the redness that is greater than baseline and occurs as therapy wears off, approximately 10 to 12 hours after application. Allergic contact dermatitis also has been associated with the medication and can therefore be a source of redness 3 to 4 months after initiation.
What’s the issue?
The erythema associated with rosacea can be a distressing symptom for both the patient and the dermatologist. It can be difficult to treat and quite often recalcitrant to multiple treatments. Although pulsed dye laser is an effective therapy for treating telangiectases and dilated blood vessels, it can be expensive for many patients. Topical brimonidine represents a novel therapeutic to combat one of the most remarkable symptoms of rosacea. However, because of the possibility of this increased redness after use, Tanghetti et al suggest the following treatment algorithm:
- “Assess” the patient and rule out other causes of redness or associated conditions, such as seborrheic dermatitis or lupus.
- “Educate” the patient regarding the known triggers of rosacea flair and how they can be best avoided. Also educate that brimonidine only treats redness and not the papules, pustules, or other symptoms of rosacea.
- “Inhibit” inflammation that is currently present using gentle skin care practices, mild cleansers, and barrier-restoring emollients.
- “Optimize” the application of brimonidine. Instruct how to apply a pea-sized amount in the morning or how patients can best time the application to coincide with daily events or social events.
- “Understand” that worsening redness may occur, which can be key to patient satisfaction. Patients should be made aware that there is a risk for worsening redness in 10% to 20% of patients. It usually occurs within the first 2 weeks of starting the medication and it may be seen soon after application (3–6 hours) or after treatment has subsided (10–12 hours). Generally this worsening will subside within 12 to 24 hours after discontinuation. Also symptoms can be treated throughout with the use of nonsteroidal anti-inflammatory medications, antihistamines, topical calcineurin inhibitors, and topical steroids, if necessary.
What has been your experience with brimonidine gel and how do you manage these patients?
Tanghetti et al (J Drugs Dermatol. 2015;14:33-40) discuss the use of topical brimonidine for the redness associated with rosacea. Brimonidine is the newest therapeutic to combat the erythema associated with rosacea of all subtypes. It is a topical α2-adrenergic agonist that causes peripheral vasoconstriction via a direct effect on smooth muscle receptors. The authors describe 2 large studies that studied the safety and efficacy of topical brimonidine and also give consensus recommendations regarding optimal utilization while minimizing adverse effects, such as the “rebound” phenomena described. It is important to note that it is not a traditional rebound effect, as it does not occur once the medication has stopped; however, it is a worsening of the erythema during active treatment with brimonidine. The authors discuss the various cases reported to the manufacturer after the medication was released. The most frequently associated side effects reported were erythema in almost all cases, flushing, feeling of heat or burning sensation, and rarely pain. Other issues such as dermatitis, pruritus, facial swelling, and pallor were seen in less than 10% of reports each.
These rebound effects were most likely to occur in the first 15 days after initiation of therapy, mainly in the first week. They also were noticed at 2 other time points—3 to 6 hours and 10 to 12 hours after application—which allowed the identification of 2 types of reactions based on the time to onset postapplication: appearing within 3 to 6 hours and observed after 10 to 12 hours. These events have been given new names. “Paradoxical erythema” is the redness appearing within 3 to 6 hours after application, which can be worse than baseline. “Exaggerated recurrence of erythema” is the redness that is greater than baseline and occurs as therapy wears off, approximately 10 to 12 hours after application. Allergic contact dermatitis also has been associated with the medication and can therefore be a source of redness 3 to 4 months after initiation.
What’s the issue?
The erythema associated with rosacea can be a distressing symptom for both the patient and the dermatologist. It can be difficult to treat and quite often recalcitrant to multiple treatments. Although pulsed dye laser is an effective therapy for treating telangiectases and dilated blood vessels, it can be expensive for many patients. Topical brimonidine represents a novel therapeutic to combat one of the most remarkable symptoms of rosacea. However, because of the possibility of this increased redness after use, Tanghetti et al suggest the following treatment algorithm:
- “Assess” the patient and rule out other causes of redness or associated conditions, such as seborrheic dermatitis or lupus.
- “Educate” the patient regarding the known triggers of rosacea flair and how they can be best avoided. Also educate that brimonidine only treats redness and not the papules, pustules, or other symptoms of rosacea.
- “Inhibit” inflammation that is currently present using gentle skin care practices, mild cleansers, and barrier-restoring emollients.
- “Optimize” the application of brimonidine. Instruct how to apply a pea-sized amount in the morning or how patients can best time the application to coincide with daily events or social events.
- “Understand” that worsening redness may occur, which can be key to patient satisfaction. Patients should be made aware that there is a risk for worsening redness in 10% to 20% of patients. It usually occurs within the first 2 weeks of starting the medication and it may be seen soon after application (3–6 hours) or after treatment has subsided (10–12 hours). Generally this worsening will subside within 12 to 24 hours after discontinuation. Also symptoms can be treated throughout with the use of nonsteroidal anti-inflammatory medications, antihistamines, topical calcineurin inhibitors, and topical steroids, if necessary.
What has been your experience with brimonidine gel and how do you manage these patients?
Checklists to Improve Laser Practices
Hamilton and Dover (Dermatol Surg. 2014;40:1173-1174) discussed the use of checklists for improving laser and light-based procedures in their November 2014 editorial. The authors discussed how the use of checklists has become pervasive in many fields of medicine, including surgery. However, they also highlighted that the utility of checklists and their success do not come from just checking off boxes but rather from actively performing the tasks. The implementation of a laser checklist can seem daunting, but Hamilton and Dover proposed that for a dermatology practice or dermatology department it becomes easier because the dermatologist and staff work closely already, making communication less of a challenge. Also, the procedure lends itself to a systematic approach. In doing so, one can routinely ensure that the necessary practices are being done to ensure both patient and staff safety.
What’s the issue?
The implementation of checklists for medical procedures may seem straightforward; however, to be effective there has to be pertinent information gathered or actions taken. Our department utilizes checklists for our laser procedures. The different steps that we have included help to ensure that the nurses who prepare the patients will communicate the pertinent information to the physician. Our checklist starts with ensuring proper setup, such as connecting the necessary pieces, before starting the laser. Next is making sure all the necessary equipment is in place, such as the correct laser goggles for the patient and staff. We label all of our goggles with the name of the laser on them so it is readily apparent what to use. We also have a check box that ensures the proper signage is outside on the door and the laser shades are drawn. There also is a section relating to the patient. Depending on the type of laser being utilized the checklist may include the following: skin type, recent history of tanning, history of oral herpes, isotretinoin use, and time since last treatment. The next check box ensures consent is signed and pretreatment photographs are taken. Any prior complications also are noted. We have a section for treatment parameters used during the current visit and then another section for posttreatment instructions.
Although a checklist may seem like unnecessary work, we found that it actually helps to enhance productivity and ensures proper laser safety for the physician and patient. We have a different one for each laser, as it also serves as a documentation tool for the procedure. Do you utilize checklists for your laser procedures? If so, what else do you include?
Hamilton and Dover (Dermatol Surg. 2014;40:1173-1174) discussed the use of checklists for improving laser and light-based procedures in their November 2014 editorial. The authors discussed how the use of checklists has become pervasive in many fields of medicine, including surgery. However, they also highlighted that the utility of checklists and their success do not come from just checking off boxes but rather from actively performing the tasks. The implementation of a laser checklist can seem daunting, but Hamilton and Dover proposed that for a dermatology practice or dermatology department it becomes easier because the dermatologist and staff work closely already, making communication less of a challenge. Also, the procedure lends itself to a systematic approach. In doing so, one can routinely ensure that the necessary practices are being done to ensure both patient and staff safety.
What’s the issue?
The implementation of checklists for medical procedures may seem straightforward; however, to be effective there has to be pertinent information gathered or actions taken. Our department utilizes checklists for our laser procedures. The different steps that we have included help to ensure that the nurses who prepare the patients will communicate the pertinent information to the physician. Our checklist starts with ensuring proper setup, such as connecting the necessary pieces, before starting the laser. Next is making sure all the necessary equipment is in place, such as the correct laser goggles for the patient and staff. We label all of our goggles with the name of the laser on them so it is readily apparent what to use. We also have a check box that ensures the proper signage is outside on the door and the laser shades are drawn. There also is a section relating to the patient. Depending on the type of laser being utilized the checklist may include the following: skin type, recent history of tanning, history of oral herpes, isotretinoin use, and time since last treatment. The next check box ensures consent is signed and pretreatment photographs are taken. Any prior complications also are noted. We have a section for treatment parameters used during the current visit and then another section for posttreatment instructions.
Although a checklist may seem like unnecessary work, we found that it actually helps to enhance productivity and ensures proper laser safety for the physician and patient. We have a different one for each laser, as it also serves as a documentation tool for the procedure. Do you utilize checklists for your laser procedures? If so, what else do you include?
Hamilton and Dover (Dermatol Surg. 2014;40:1173-1174) discussed the use of checklists for improving laser and light-based procedures in their November 2014 editorial. The authors discussed how the use of checklists has become pervasive in many fields of medicine, including surgery. However, they also highlighted that the utility of checklists and their success do not come from just checking off boxes but rather from actively performing the tasks. The implementation of a laser checklist can seem daunting, but Hamilton and Dover proposed that for a dermatology practice or dermatology department it becomes easier because the dermatologist and staff work closely already, making communication less of a challenge. Also, the procedure lends itself to a systematic approach. In doing so, one can routinely ensure that the necessary practices are being done to ensure both patient and staff safety.
What’s the issue?
The implementation of checklists for medical procedures may seem straightforward; however, to be effective there has to be pertinent information gathered or actions taken. Our department utilizes checklists for our laser procedures. The different steps that we have included help to ensure that the nurses who prepare the patients will communicate the pertinent information to the physician. Our checklist starts with ensuring proper setup, such as connecting the necessary pieces, before starting the laser. Next is making sure all the necessary equipment is in place, such as the correct laser goggles for the patient and staff. We label all of our goggles with the name of the laser on them so it is readily apparent what to use. We also have a check box that ensures the proper signage is outside on the door and the laser shades are drawn. There also is a section relating to the patient. Depending on the type of laser being utilized the checklist may include the following: skin type, recent history of tanning, history of oral herpes, isotretinoin use, and time since last treatment. The next check box ensures consent is signed and pretreatment photographs are taken. Any prior complications also are noted. We have a section for treatment parameters used during the current visit and then another section for posttreatment instructions.
Although a checklist may seem like unnecessary work, we found that it actually helps to enhance productivity and ensures proper laser safety for the physician and patient. We have a different one for each laser, as it also serves as a documentation tool for the procedure. Do you utilize checklists for your laser procedures? If so, what else do you include?
Health-Related Quality of Life in Skin Cancer Patients
As the most common form of cancer in the United States,1 dermatologists often focus on treating the physical aspects of skin cancer, but it is equally important to consider the consequences that this disease has on a patient’s quality of life (QOL). Health is a dynamic process, encompassing one’s physical, emotional, and psychosocial well-being. There are a number of ways to measure health outcomes including mortality, morbidity, health status, and QOL. In recent years, health-related QOL (HRQOL) outcomes in dermatology have become increasingly important to clinical practice and may become factors in quality measurement or reimbursement.
Understanding a patient’s HRQOL allows health care providers to better evaluate the burden of disease and disability associated with skin cancer and its treatment. Clinical severity is not always able to capture the extent to which a disease affects one’s life.2 Furthermore, physician estimation of disease severity is not always consistent with patient-reported outcomes.3 As such, clinical questionnaires may be invaluable tools capable of objectively reporting a patient’s perception of improvement in health, which may affect how a dermatologist approaches treatment, discussion, and maintenance.
Nonmelanoma Skin Cancer
Most nonmelanoma skin cancer (NMSC) occurs in readily visible areas, namely the head and neck. Surgical treatment minimizes recurrence and complication rates. Nonmelanoma skin cancer has a low mortality and a high cure rate if diagnosed early; therefore, it may be difficult to assess treatment efficacy on cure rates alone. The amalgamation of anxiety associated with the diagnosis, aesthetic and functional concerns regarding treatment, and long-term consequences including fear of future skin cancer may have a lasting effect on an individual’s psychosocial relationships and underscores the need for QOL studies.
Most generic QOL and dermatology-specific QOL instruments fail to accurately detect the concerns of patients with NMSC.4-6 Generic QOL measures used for skin cancer patients report scores of patients that were similar to population norms,4 suggesting that these tools may fail to appropriately assess unique QOL concerns among individuals with skin cancer. Furthermore, dermatology-specific instruments have been reported to be insensitive to specific appearance-related concerns of patients with NMSC, likely because skin cancer patients made up a small percentage of the initial population in their design.4,7 Nevertheless, dermatology-specific instruments may be suitable depending on the objectives of the study.8
Recently, skin cancer–specific QOL instruments have been developed to fill the paucity of appropriate tools for this population. These questionnaires include the Facial Skin Cancer Index, Skin Cancer Index, and the Skin Cancer Quality of Life Impact Tool.7 The Skin Cancer Index is a 15-item questionnaire validated in patients undergoing Mohs micrographic surgery and has been used to assess behavior modification and risk perceptions in NMSC patients. Importantly, it does ask the patient if he/she is worried about scarring. The Facial Skin Cancer Index and the Skin Cancer Quality of Life Impact Tool do not take into account detailed aesthetic concerns regarding facial disfigurement and scarring or expectations of reconstruction.7 It may be prudent to assess these areas with supplemental scales.
Melanoma
Melanoma, the third most common skin cancer, is highly aggressive and can affect young and middle-aged patients. Because the mortality associated with later-stage melanoma is greater, the QOL impact of melanoma differs from NMSC. There are also 3 distinct periods of melanoma HRQOL impact: diagnosis, treatment, and follow-up. Approximately 30% of patients diagnosed with melanoma report high levels of psychological distress.9 The psychosocial effects of a melanoma diagnosis are longitudinal, as there is a high survival rate in early disease but also an increased future risk for melanoma, affecting future behaviors and overall QOL. The diagnosis of melanoma also affects family members due to the increased risk among first-degree relatives. After removal of deeper melanoma, the patient remains at risk for disease progression, which can have a profound impact on his/her social and professional activities and overall lifestyle. There may be a role for longitudinal QOL assessments to monitor changes over time and direct ongoing therapy.
The proportion of patients with melanoma who report high levels of impairment in QOL is comparable to that seen in other malignancies.10 Generic QOL instruments have found that melanoma patients have medium to high levels of distress and substantial improvement in HRQOL has been achieved with cognitive-behavioral intervention.11 Quality-of-life studies also have shown levels of distress are highest at initial diagnosis and immediately following treatment.12 In a randomized surgical trial, patients with a larger excision margin had poorer mental and physical function scores on assessment.13 Skin-specific QOL instruments have been used in studies of patients with melanoma and found that postmelanoma surveillance did not impact QOL. Also, women experienced greater improvements in QOL over time after reporting lower scores immediately postsurgery.13
The FACT-melanoma (Functional Assessment of Cancer Therapy) is a melanoma-specific HRQOL assessment that has been used in patients undergoing clinical trials. It has been shown to distinguish between early and advanced-stage (stages III or IV) HRQOL issues.14 Patients with early-stage melanoma are more concerned with cosmetic outcome, and those with later-stage melanoma are more concerned with morbidity and mortality associated with treatment.
Comment
Choosing the best QOL instrument depends on the specific objectives of the study. Although generic QOL questionnaires have performed poorly in studies of specific skin diseases and even dermatology-specific tools have shown limited responsiveness in skin cancer, a combination of tools may be an effective approach. However, dermatologists must be cautious when administering these valuable tools to ensure that they do not become a burdensome task for the patient.15 Although no single skin cancer–specific QOL tool is perfect, it is likely that the current questionnaires still allow for aid with appropriate patient management and comparison of treatments.16
It behooves clinicians to recognize and appreciate the value of QOL instruments as an important adjunct to treatment. These tools have shown QOL to be an independent predictor of survival among many types of cancer patients, including melanoma.10 Currently, the psychological and emotional needs of skin cancer patients often go overlooked and undetected by conventional methods. Within one’s own practice, introducing QOL assessments can improve patient self-awareness and physician awareness of matters that may have a greater impact on patient health. On a larger scale, introducing patient-reported outcome measures can affect resource allocation by identifying patient populations that may be most impacted and can give a comprehensive method for physicians to gauge treatment efficacy, leading to improved outcomes.
1. Robinson JK. Sun exposure, sun protection, and vitamin D. JAMA. 2005;294:1541-1543.
2. Motley RJ, Finlay AY. Practical use of a disability index in the routine management of acne. Clin Exp Dermatol. 1992;17:1-3.
3. Chren MM, Lasek RJ, Quinn LM, et al. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol. 1996;107:707-713.
4. Gibbons EC, Comabella CI, Fitzpatrick R. A structured review of patient-reported outcome measures for patients with skin cancer, 2013. Br J Dermatol. 2013;168:1176-1186.
5. Burdon-Jones D, Thomas P, Baker R. Quality of life issues in nonmetastatic skin cancer. Br J Dermatol. 2010;162:147-151.
6. Lear W, Akeroyd JD, Mittmann N, et al. Measurement of utility in nonmelanoma skin cancer. J Cutan Med Surg. 2008;12:102-106.
7. Bates AS, Davis CR, Takwale A, et al. Patient-reported outcome measures in nonmelanoma skin cancer of the face: a systematic review. Br J Dermatol. 2013;168:1187-1194.
8. Lee EH, Klassen AF, Nehal KS, et al. A systematic review of patient-reported outcome instruments of nonmelanoma skin cancer in the dermatologic population. J Am Acad Dermatol. 2013;69:e59-e67.
9. Kasparian NA. Psychological stress and melanoma: are we meeting our patients’ psychological needs? Clin Dermatol. 2013;31:41-46.
10. Cormier JN, Cromwell KD, Ross MI. Health-related quality of life in patients with melanoma: overview of instruments and outcomes. Dermatol Clin. 2012;30:245-254.
11. Trask PC, Paterson AG, Griffith KA, et al. Cognitive-behavioral intervention for distress in patients with melanoma: comparison with standard medical care and impact on quality of life. Cancer. 2003;98:854-864.
12. Boyle DA. Psychological adjustment to the melanoma experience. Semin Oncol Nurs. 2003;191:70-77.
13. Newton-Bishop JA, Nolan C, Turner F, et al. A quality-of-life study in high-risk (thickness > = or 2 mm) cutaneous melanoma patients in a randomized trial of 1-cm versus 3-cm surgical excision margins. J Investig Dermatol Symp Proc. 2004;9:152-159.
14. Winstanley JB, Saw R, Boyle F, et al. The FACT-Melanoma quality-of-life instrument: comparison of a five-point and four-point response scale using the Rasch measurement model. Melanoma Res. 2013;23:61-69.
15. Swartz RJ, Baum GP, Askew RL, et al. Reducing patient burden to the FACT-Melanoma quality-of-life questionnaire. Melanoma Res. 2012;22:158-163.
16. Black N. Patient-reported outcome measures in skin cancer. Br J Dermatol. 2013;168:1151.
As the most common form of cancer in the United States,1 dermatologists often focus on treating the physical aspects of skin cancer, but it is equally important to consider the consequences that this disease has on a patient’s quality of life (QOL). Health is a dynamic process, encompassing one’s physical, emotional, and psychosocial well-being. There are a number of ways to measure health outcomes including mortality, morbidity, health status, and QOL. In recent years, health-related QOL (HRQOL) outcomes in dermatology have become increasingly important to clinical practice and may become factors in quality measurement or reimbursement.
Understanding a patient’s HRQOL allows health care providers to better evaluate the burden of disease and disability associated with skin cancer and its treatment. Clinical severity is not always able to capture the extent to which a disease affects one’s life.2 Furthermore, physician estimation of disease severity is not always consistent with patient-reported outcomes.3 As such, clinical questionnaires may be invaluable tools capable of objectively reporting a patient’s perception of improvement in health, which may affect how a dermatologist approaches treatment, discussion, and maintenance.
Nonmelanoma Skin Cancer
Most nonmelanoma skin cancer (NMSC) occurs in readily visible areas, namely the head and neck. Surgical treatment minimizes recurrence and complication rates. Nonmelanoma skin cancer has a low mortality and a high cure rate if diagnosed early; therefore, it may be difficult to assess treatment efficacy on cure rates alone. The amalgamation of anxiety associated with the diagnosis, aesthetic and functional concerns regarding treatment, and long-term consequences including fear of future skin cancer may have a lasting effect on an individual’s psychosocial relationships and underscores the need for QOL studies.
Most generic QOL and dermatology-specific QOL instruments fail to accurately detect the concerns of patients with NMSC.4-6 Generic QOL measures used for skin cancer patients report scores of patients that were similar to population norms,4 suggesting that these tools may fail to appropriately assess unique QOL concerns among individuals with skin cancer. Furthermore, dermatology-specific instruments have been reported to be insensitive to specific appearance-related concerns of patients with NMSC, likely because skin cancer patients made up a small percentage of the initial population in their design.4,7 Nevertheless, dermatology-specific instruments may be suitable depending on the objectives of the study.8
Recently, skin cancer–specific QOL instruments have been developed to fill the paucity of appropriate tools for this population. These questionnaires include the Facial Skin Cancer Index, Skin Cancer Index, and the Skin Cancer Quality of Life Impact Tool.7 The Skin Cancer Index is a 15-item questionnaire validated in patients undergoing Mohs micrographic surgery and has been used to assess behavior modification and risk perceptions in NMSC patients. Importantly, it does ask the patient if he/she is worried about scarring. The Facial Skin Cancer Index and the Skin Cancer Quality of Life Impact Tool do not take into account detailed aesthetic concerns regarding facial disfigurement and scarring or expectations of reconstruction.7 It may be prudent to assess these areas with supplemental scales.
Melanoma
Melanoma, the third most common skin cancer, is highly aggressive and can affect young and middle-aged patients. Because the mortality associated with later-stage melanoma is greater, the QOL impact of melanoma differs from NMSC. There are also 3 distinct periods of melanoma HRQOL impact: diagnosis, treatment, and follow-up. Approximately 30% of patients diagnosed with melanoma report high levels of psychological distress.9 The psychosocial effects of a melanoma diagnosis are longitudinal, as there is a high survival rate in early disease but also an increased future risk for melanoma, affecting future behaviors and overall QOL. The diagnosis of melanoma also affects family members due to the increased risk among first-degree relatives. After removal of deeper melanoma, the patient remains at risk for disease progression, which can have a profound impact on his/her social and professional activities and overall lifestyle. There may be a role for longitudinal QOL assessments to monitor changes over time and direct ongoing therapy.
The proportion of patients with melanoma who report high levels of impairment in QOL is comparable to that seen in other malignancies.10 Generic QOL instruments have found that melanoma patients have medium to high levels of distress and substantial improvement in HRQOL has been achieved with cognitive-behavioral intervention.11 Quality-of-life studies also have shown levels of distress are highest at initial diagnosis and immediately following treatment.12 In a randomized surgical trial, patients with a larger excision margin had poorer mental and physical function scores on assessment.13 Skin-specific QOL instruments have been used in studies of patients with melanoma and found that postmelanoma surveillance did not impact QOL. Also, women experienced greater improvements in QOL over time after reporting lower scores immediately postsurgery.13
The FACT-melanoma (Functional Assessment of Cancer Therapy) is a melanoma-specific HRQOL assessment that has been used in patients undergoing clinical trials. It has been shown to distinguish between early and advanced-stage (stages III or IV) HRQOL issues.14 Patients with early-stage melanoma are more concerned with cosmetic outcome, and those with later-stage melanoma are more concerned with morbidity and mortality associated with treatment.
Comment
Choosing the best QOL instrument depends on the specific objectives of the study. Although generic QOL questionnaires have performed poorly in studies of specific skin diseases and even dermatology-specific tools have shown limited responsiveness in skin cancer, a combination of tools may be an effective approach. However, dermatologists must be cautious when administering these valuable tools to ensure that they do not become a burdensome task for the patient.15 Although no single skin cancer–specific QOL tool is perfect, it is likely that the current questionnaires still allow for aid with appropriate patient management and comparison of treatments.16
It behooves clinicians to recognize and appreciate the value of QOL instruments as an important adjunct to treatment. These tools have shown QOL to be an independent predictor of survival among many types of cancer patients, including melanoma.10 Currently, the psychological and emotional needs of skin cancer patients often go overlooked and undetected by conventional methods. Within one’s own practice, introducing QOL assessments can improve patient self-awareness and physician awareness of matters that may have a greater impact on patient health. On a larger scale, introducing patient-reported outcome measures can affect resource allocation by identifying patient populations that may be most impacted and can give a comprehensive method for physicians to gauge treatment efficacy, leading to improved outcomes.
As the most common form of cancer in the United States,1 dermatologists often focus on treating the physical aspects of skin cancer, but it is equally important to consider the consequences that this disease has on a patient’s quality of life (QOL). Health is a dynamic process, encompassing one’s physical, emotional, and psychosocial well-being. There are a number of ways to measure health outcomes including mortality, morbidity, health status, and QOL. In recent years, health-related QOL (HRQOL) outcomes in dermatology have become increasingly important to clinical practice and may become factors in quality measurement or reimbursement.
Understanding a patient’s HRQOL allows health care providers to better evaluate the burden of disease and disability associated with skin cancer and its treatment. Clinical severity is not always able to capture the extent to which a disease affects one’s life.2 Furthermore, physician estimation of disease severity is not always consistent with patient-reported outcomes.3 As such, clinical questionnaires may be invaluable tools capable of objectively reporting a patient’s perception of improvement in health, which may affect how a dermatologist approaches treatment, discussion, and maintenance.
Nonmelanoma Skin Cancer
Most nonmelanoma skin cancer (NMSC) occurs in readily visible areas, namely the head and neck. Surgical treatment minimizes recurrence and complication rates. Nonmelanoma skin cancer has a low mortality and a high cure rate if diagnosed early; therefore, it may be difficult to assess treatment efficacy on cure rates alone. The amalgamation of anxiety associated with the diagnosis, aesthetic and functional concerns regarding treatment, and long-term consequences including fear of future skin cancer may have a lasting effect on an individual’s psychosocial relationships and underscores the need for QOL studies.
Most generic QOL and dermatology-specific QOL instruments fail to accurately detect the concerns of patients with NMSC.4-6 Generic QOL measures used for skin cancer patients report scores of patients that were similar to population norms,4 suggesting that these tools may fail to appropriately assess unique QOL concerns among individuals with skin cancer. Furthermore, dermatology-specific instruments have been reported to be insensitive to specific appearance-related concerns of patients with NMSC, likely because skin cancer patients made up a small percentage of the initial population in their design.4,7 Nevertheless, dermatology-specific instruments may be suitable depending on the objectives of the study.8
Recently, skin cancer–specific QOL instruments have been developed to fill the paucity of appropriate tools for this population. These questionnaires include the Facial Skin Cancer Index, Skin Cancer Index, and the Skin Cancer Quality of Life Impact Tool.7 The Skin Cancer Index is a 15-item questionnaire validated in patients undergoing Mohs micrographic surgery and has been used to assess behavior modification and risk perceptions in NMSC patients. Importantly, it does ask the patient if he/she is worried about scarring. The Facial Skin Cancer Index and the Skin Cancer Quality of Life Impact Tool do not take into account detailed aesthetic concerns regarding facial disfigurement and scarring or expectations of reconstruction.7 It may be prudent to assess these areas with supplemental scales.
Melanoma
Melanoma, the third most common skin cancer, is highly aggressive and can affect young and middle-aged patients. Because the mortality associated with later-stage melanoma is greater, the QOL impact of melanoma differs from NMSC. There are also 3 distinct periods of melanoma HRQOL impact: diagnosis, treatment, and follow-up. Approximately 30% of patients diagnosed with melanoma report high levels of psychological distress.9 The psychosocial effects of a melanoma diagnosis are longitudinal, as there is a high survival rate in early disease but also an increased future risk for melanoma, affecting future behaviors and overall QOL. The diagnosis of melanoma also affects family members due to the increased risk among first-degree relatives. After removal of deeper melanoma, the patient remains at risk for disease progression, which can have a profound impact on his/her social and professional activities and overall lifestyle. There may be a role for longitudinal QOL assessments to monitor changes over time and direct ongoing therapy.
The proportion of patients with melanoma who report high levels of impairment in QOL is comparable to that seen in other malignancies.10 Generic QOL instruments have found that melanoma patients have medium to high levels of distress and substantial improvement in HRQOL has been achieved with cognitive-behavioral intervention.11 Quality-of-life studies also have shown levels of distress are highest at initial diagnosis and immediately following treatment.12 In a randomized surgical trial, patients with a larger excision margin had poorer mental and physical function scores on assessment.13 Skin-specific QOL instruments have been used in studies of patients with melanoma and found that postmelanoma surveillance did not impact QOL. Also, women experienced greater improvements in QOL over time after reporting lower scores immediately postsurgery.13
The FACT-melanoma (Functional Assessment of Cancer Therapy) is a melanoma-specific HRQOL assessment that has been used in patients undergoing clinical trials. It has been shown to distinguish between early and advanced-stage (stages III or IV) HRQOL issues.14 Patients with early-stage melanoma are more concerned with cosmetic outcome, and those with later-stage melanoma are more concerned with morbidity and mortality associated with treatment.
Comment
Choosing the best QOL instrument depends on the specific objectives of the study. Although generic QOL questionnaires have performed poorly in studies of specific skin diseases and even dermatology-specific tools have shown limited responsiveness in skin cancer, a combination of tools may be an effective approach. However, dermatologists must be cautious when administering these valuable tools to ensure that they do not become a burdensome task for the patient.15 Although no single skin cancer–specific QOL tool is perfect, it is likely that the current questionnaires still allow for aid with appropriate patient management and comparison of treatments.16
It behooves clinicians to recognize and appreciate the value of QOL instruments as an important adjunct to treatment. These tools have shown QOL to be an independent predictor of survival among many types of cancer patients, including melanoma.10 Currently, the psychological and emotional needs of skin cancer patients often go overlooked and undetected by conventional methods. Within one’s own practice, introducing QOL assessments can improve patient self-awareness and physician awareness of matters that may have a greater impact on patient health. On a larger scale, introducing patient-reported outcome measures can affect resource allocation by identifying patient populations that may be most impacted and can give a comprehensive method for physicians to gauge treatment efficacy, leading to improved outcomes.
1. Robinson JK. Sun exposure, sun protection, and vitamin D. JAMA. 2005;294:1541-1543.
2. Motley RJ, Finlay AY. Practical use of a disability index in the routine management of acne. Clin Exp Dermatol. 1992;17:1-3.
3. Chren MM, Lasek RJ, Quinn LM, et al. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol. 1996;107:707-713.
4. Gibbons EC, Comabella CI, Fitzpatrick R. A structured review of patient-reported outcome measures for patients with skin cancer, 2013. Br J Dermatol. 2013;168:1176-1186.
5. Burdon-Jones D, Thomas P, Baker R. Quality of life issues in nonmetastatic skin cancer. Br J Dermatol. 2010;162:147-151.
6. Lear W, Akeroyd JD, Mittmann N, et al. Measurement of utility in nonmelanoma skin cancer. J Cutan Med Surg. 2008;12:102-106.
7. Bates AS, Davis CR, Takwale A, et al. Patient-reported outcome measures in nonmelanoma skin cancer of the face: a systematic review. Br J Dermatol. 2013;168:1187-1194.
8. Lee EH, Klassen AF, Nehal KS, et al. A systematic review of patient-reported outcome instruments of nonmelanoma skin cancer in the dermatologic population. J Am Acad Dermatol. 2013;69:e59-e67.
9. Kasparian NA. Psychological stress and melanoma: are we meeting our patients’ psychological needs? Clin Dermatol. 2013;31:41-46.
10. Cormier JN, Cromwell KD, Ross MI. Health-related quality of life in patients with melanoma: overview of instruments and outcomes. Dermatol Clin. 2012;30:245-254.
11. Trask PC, Paterson AG, Griffith KA, et al. Cognitive-behavioral intervention for distress in patients with melanoma: comparison with standard medical care and impact on quality of life. Cancer. 2003;98:854-864.
12. Boyle DA. Psychological adjustment to the melanoma experience. Semin Oncol Nurs. 2003;191:70-77.
13. Newton-Bishop JA, Nolan C, Turner F, et al. A quality-of-life study in high-risk (thickness > = or 2 mm) cutaneous melanoma patients in a randomized trial of 1-cm versus 3-cm surgical excision margins. J Investig Dermatol Symp Proc. 2004;9:152-159.
14. Winstanley JB, Saw R, Boyle F, et al. The FACT-Melanoma quality-of-life instrument: comparison of a five-point and four-point response scale using the Rasch measurement model. Melanoma Res. 2013;23:61-69.
15. Swartz RJ, Baum GP, Askew RL, et al. Reducing patient burden to the FACT-Melanoma quality-of-life questionnaire. Melanoma Res. 2012;22:158-163.
16. Black N. Patient-reported outcome measures in skin cancer. Br J Dermatol. 2013;168:1151.
1. Robinson JK. Sun exposure, sun protection, and vitamin D. JAMA. 2005;294:1541-1543.
2. Motley RJ, Finlay AY. Practical use of a disability index in the routine management of acne. Clin Exp Dermatol. 1992;17:1-3.
3. Chren MM, Lasek RJ, Quinn LM, et al. Skindex, a quality-of-life measure for patients with skin disease: reliability, validity, and responsiveness. J Invest Dermatol. 1996;107:707-713.
4. Gibbons EC, Comabella CI, Fitzpatrick R. A structured review of patient-reported outcome measures for patients with skin cancer, 2013. Br J Dermatol. 2013;168:1176-1186.
5. Burdon-Jones D, Thomas P, Baker R. Quality of life issues in nonmetastatic skin cancer. Br J Dermatol. 2010;162:147-151.
6. Lear W, Akeroyd JD, Mittmann N, et al. Measurement of utility in nonmelanoma skin cancer. J Cutan Med Surg. 2008;12:102-106.
7. Bates AS, Davis CR, Takwale A, et al. Patient-reported outcome measures in nonmelanoma skin cancer of the face: a systematic review. Br J Dermatol. 2013;168:1187-1194.
8. Lee EH, Klassen AF, Nehal KS, et al. A systematic review of patient-reported outcome instruments of nonmelanoma skin cancer in the dermatologic population. J Am Acad Dermatol. 2013;69:e59-e67.
9. Kasparian NA. Psychological stress and melanoma: are we meeting our patients’ psychological needs? Clin Dermatol. 2013;31:41-46.
10. Cormier JN, Cromwell KD, Ross MI. Health-related quality of life in patients with melanoma: overview of instruments and outcomes. Dermatol Clin. 2012;30:245-254.
11. Trask PC, Paterson AG, Griffith KA, et al. Cognitive-behavioral intervention for distress in patients with melanoma: comparison with standard medical care and impact on quality of life. Cancer. 2003;98:854-864.
12. Boyle DA. Psychological adjustment to the melanoma experience. Semin Oncol Nurs. 2003;191:70-77.
13. Newton-Bishop JA, Nolan C, Turner F, et al. A quality-of-life study in high-risk (thickness > = or 2 mm) cutaneous melanoma patients in a randomized trial of 1-cm versus 3-cm surgical excision margins. J Investig Dermatol Symp Proc. 2004;9:152-159.
14. Winstanley JB, Saw R, Boyle F, et al. The FACT-Melanoma quality-of-life instrument: comparison of a five-point and four-point response scale using the Rasch measurement model. Melanoma Res. 2013;23:61-69.
15. Swartz RJ, Baum GP, Askew RL, et al. Reducing patient burden to the FACT-Melanoma quality-of-life questionnaire. Melanoma Res. 2012;22:158-163.
16. Black N. Patient-reported outcome measures in skin cancer. Br J Dermatol. 2013;168:1151.
