Cancer Association of South Africa (CANSA)

Transcription

1 Cancer Assciatin f Suth Africa (CANSA) Fact Sheet On Basal Cell Carcinma Intrductin Basal cell carcinma, r BCC, is a type f skin cancer. It invlves the basal cells f the skin at the bttm f the epidermis. It is very cmmn and accunts fr the majrity f skin cancers in Suth Africa. Mst Basal Cell Carcinmas are very slw-grwing and seldm spread t ther parts f the bdy. It ften start as a small, red, shiny spt r ndule that may bleed ccasinally. [Picture Credit: Basal Cell Carcinma Picture] In many cases f basal cell carcinmas (BCC), the skin ver the tp can remain intact fr mnths. Eventually they it develp int an ulcer that des nt heal. When BCCs are treated at an early stage, mst f the time it can be cmpletely cured. Hwever, sme BCCs are aggressive, and if left t grw may spread int the deeper layers f the skin and smetimes t the bnes, making treatment difficult. A small number f BCCs may als cme back in the same area f skin after treatment. This is knwn as a lcal recurrence. (Macmillan). Incidence f Skin Cancer Amng Individuals f Clur Mst skin cancers are assciated with ultravilet (UV) radiatin frm the sun r tanning beds, and many peple f clur are less susceptible t UV damage thanks t the greater amunts f melanin darker skin prduces. Melanin is the prtective pigment that gives skin and eyes their clur, hwever, peple f clur can still develp skin cancer frm UV damage. Additinally, certain skin cancers are caused by factrs ther than UV - such as genetics r ther envirnmental influences - and may ccur n parts f the bdy rarely expsed t the sun. Fr example, darker-skinned peple are mre susceptible t acral lentiginus melanma (ALM), an especially virulent frm f melanma (the deadliest type f skin cancer) that typically appears n the palms f the hands and sles f the feet. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 1

2 Acral lentiginus melanma (ALM) accunts fr abut 5% f melanma cases, and is a leading cause f skin cancer deaths. The disease initially appears as a bruise r nail streak n the skin. Mst patients d nt ntice ALM until it has already begun t spread aggressively thrughut the bdy. Bb Marley was killed frm this frm f malignant tumur under his tenail. ALM (als called subungual melanma) affects peple f Asian r African descent mre than any ther race r ethnicity. [Picture Credit: Acral Lentiginus Melanma] The average patient is between sixty and seventy years f age, but ALM can affect peple f any age. This classificatin f the disease is generally fund n the hands, feet and ther areas f the bdy where very little hair grws. Presently, sunlight is nt a prven cause f this cnditin. When the tumur is deeper than 1.0 mm r has spread t ther parts f the bdy thrugh the lymph ndes, the cancer frequently results in death. Different ethnicities are at higher risk fr particular skin malignancies: Latins, Chinese, and Japanese Asians tend t develp basal cell carcinma (BCC), the mst cmmn skin cancer. But the secnd mst cmmn, squamus cell carcinma (SCC), is mre frequent amng African Americans and Asian Indians. (Skin Cancer Fundatin; DermNet NZ; Knw Cancer). Incidence f Basal Cell Carcinma in Suth Africa Accrding t the Natinal Cancer Registry (2013) the fllwing number f Basal Cell Carcinma cases was histlgically diagnsed in Suth Africa during 2013: Grup - Males 2013 Actual N f Cases Estimated Lifetime Risk Percentage f All Cancers All males :16 25,53% Asian males 49 1:123 5,83% Black males 374 1:240 3,47% Clured males 934 1:15 22,37% White males :5 38,73% Grup - Females 2013 Actual N f Cases Estimated Lifetime Risk Percentage f All Cancers All females :35 17,96% Asian females 42 1:167 4,10% Black females 317 1:557 2,03% Clured females 680 1:30 16,77% White females :7 34,86% The frequency f histlgically diagnsed cases f Basal Cell Carcinma in Suth Africa fr 2013 were as fllws (Natinal Cancer Registry, 2013): Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 2

3 Grup - Males All males Asian males Black males Clured males White males Grup - Females All females Asian females Black females Clured females White females N.B. In the event that the ttals in any f the abve tables d nt tally, this may be the result f uncertainties as t the age, race r sex f the individual. The ttals fr all males and all females, hwever, always reflect the crrect ttals. Symptms f Basal Cell Carcinma Mst basal cell carcinmas are painless. Peple ften first becme aware f it as a scab that bleeds ccasinally and des nt heal cmpletely. Sme basal cell carcinmas are very superficial and lk like a scaly red flat mark - thers have a pearl-like rim surrunding a central crater. If left fr sme time, the latter type can eventually erde the skin causing an ulcer hence the name rdent ulcer. Other basal cell carcinmas are quite lumpy, with ne r mre shiny ndules crssed by small but easily seen bld vessels. (British Skin Fundatin). [Picture Credit: Basal Cell Carcinma] Basal cell carcinmas usually develp n sun-expsed parts f yur bdy, especially n the head and neck. A much smaller number ccur n the trunk and legs. Basal cell carcinmas can als ccur n parts f the bdy that are rarely expsed t sunlight. Althugh a general warning sign f skin cancer is a sre that wn't heal r that repeatedly bleeds and scabs ver, basal cell cancer may lk like: A pearly white r waxy bump, ften with visible bld vessels n the face, ears r neck. The bump may bleed, develp a crust r frm a depressin in the centre. In darker skinned peple, this type f cancer is usually brwn r black A flat, scaly, brwn r flesh-clured patch n the back r chest. Over time, these patches can grw quite large Mre rarely, a white, waxy scar. This type f basal cell carcinma is easy t verlk but it may be a sign f a particularly invasive and disfiguring cancer called mrpheafrm basal cell carcinma. (May Clinic). Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 3

4 Risk Factrs fr Basal Cell Carcinma The fllwing individuals are mre likely t get basal cell carcinma: Light-clured skin Freckled skin Blue, green, r grey eyes Blnd r red hair Overexpsure t x-rays r ther frms f radiatin Many mles Having clse relatives wh have r had skin cancer Many severe sunburns early in life (especially befre age 18) Lng-term daily sun expsure (such as the sun expsure peple wh wrk utside receive) Hydrchlrthiazide, a diuretic prescribed t cntrl fluid retentin and treat high bld pressure, has lng been linked t an increased risk f sunburns, a recent Danish study ffers fresh evidence that this cmmnly prescribed medicatin may als make peple mre likely t develp basal cell carcinma and squamus cell carcinma. Overall, peple wh tk hydrchlrthiazide daily fr at least six years were 29% mre likely t develp basal cell carcinma and almst fur times mre likely t get squamus cell carcinma than individuals wh did nt take this medicatin. With the highest cumulative hydrchlrthiazide expsure - apprximately 24 years f daily use - patients were 54% mre likely t develp basal cell carcinma and mre than seven times mre likely t get squamus cell carcinma. Patients wh use hydrchlrthiazide shuld take extra precautins t prtect their skin frm damage caused by the sun. Patients taking hydrchlrthiazide shuld nt stp taking it withut first seeing their treating physician. While there are ther safe, affrdable ptins t manage high bld pressure, patients already taking hydrchlrthiazide will nt meaningfully alter their skin cancer risk by staying n the drug fr a few mnths until a physician can advise them. Individuals wh are at an increased risk f skin cancer, due t high expsure t sunlight, have already experienced skin cancer, r are therwise predispsed t skin cancer, shuld cnsider cnsulting their physician regarding a ptential therapy shift. (PubMed Health; Reuters Health). Preventin Guidelines fr Basal Cell Carcinma While BCCs and ther skin cancers are almst always curable when detected and treated early, it is best t prevent them in the first place. Make these sun safety habits part f daily health care rutine: Seek shade, especially between 10:00 and 15:00 D nt sunburn Avid tanning bths Cver up with clthing, including a brad-brimmed hat and UV-blcking sunglasses (minimum UV400 prtectin) Use a brad spectrum (UVA/UVB) sunscreen. Refer t the CANSA Fact Sheet n Slar Radiatin and Skin Cancer fr additinal infrmatin Apply sunscreen at least 20 minutes befre ging ut int the sun Reapply sunscreen every tw hurs including after swimming r excessive sweating Keep newbrns ut f the sun until at least 6 mnths f age Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 4

5 Examine the skin head-t-te every mnth See a dctr r ther qualified health prfessinal every year fr a prfessinal skin examinatin Avid surfaces that reflect light mre, such as water, sand, cncrete, and whitepainted areas Skin burns faster at higher altitudes Avid sun lamps, tanning beds, and tanning salns (Skin Cancer Fundatin; PubMed Health; WebMD). Five Warning Signs f Basal Cell Carcinma Frequently, tw r mre f features are present in ne tumur. In additin, BCC smetimes resembles nn-cancerus skin cnditins such as psriasis r eczema. Only a trained physician r health care prfessinal, such as an nclgy nurse f specialist in diseases f the skin, can determine fr sure. If any f the warning signs are bserved r sme ther wrrisme change in the skin is nticed, ne shuld cnsult a physician immediately. A scar-like area that is white, yellw r waxy, and ften has prly defined brders; the skin itself appears shiny and taut. This warning sign may indicate the presence f an invasive BCC that is larger than it appears t be n the surface. An pen sre that bleeds, zes, r crusts and remains pen fr a few weeks, nly t heal up and then bleed again. A persistent, nn healing sre is a very cmmn sign f an early BCC. A reddish patch r irritated area, frequently ccurring n the face, chest, shulders, arms, r legs. Smetimes the patch crusts, and it may als itch. At ther times, it persists with n nticeable discmfrt. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 5

6 A shiny bump r ndule that is pearly r translucent and is ften pink, red, r white. The bump can als be tan, black, r brwn, especially in dark-haired peple, and can be cnfused with a mle. A scar-like area that is white, yellw r waxy, and ften has prly defined brders; the skin itself appears shiny and taut. This warning sign may indicate the presence f an invasive BCC that is larger than it appears t be n the surface. (Skin Cancer Fundatin). Diagnsis f Basal Cell Carcinma (BCC) Clinically, a number f lesins can simulate the appearance f BCC, and cnversely, BCC can be mistaken fr ther, mre benign, eyelid lesins. In a large study, 10.5% f cases diagnsed as BCC (by an experienced clinician) represented ther cnditins. The mst cmmn lesins cnfused with BCC include papillma, nevus, hidrcystma, epidermal inclusin cyst, and squamus cell carcinma. Small lesins (2 3 mm in size) are especially likely t be mistaken fr benign cnditins. The histpathlgic differential diagnsis includes trichepithelima, desmsplastic trichepithelima, and metastatic carcinma. Desmsplastic trichepithelima and metastatic carcinma demnstrate a pattern similar t that f infiltrative BCC. Basal cell carcinmas are stratified int lw- and high-risk categries, depending n tumur, site, and patient factrs. Tumur factrs include treatment histry, that is, whether the lesin is primary r recurrent, r has been incmpletely excised; histlgical subtype, including the presence f perineural invasin; tumur size; duratin; ease f clinical margin definitin; and site. Althugh basal cell carcinma rarely metastasizes, a tumur can extend beneath the skin t the bne, causing cnsiderable lcal damage due t tissue destructin. This prcess leads t an ulcer that is smetimes knwn as ulcus rdens, r a rdent ulcer. Other medical prblems/issues t cnsider include the fllwing: Dermatitis Desmplastic trichepithelima Eczema Intradermal nevus Lichenid benign keratsis Ringwrm Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 6

7 Fibrepithelima f Pinkus Adnexal carcinma (very rare) Actinic keratsis Sebaceus hyperplasia Nevi malignant melanma Keratacanthma Sebrrheic keratsis Bwen disease Darier disease (keratsis fllicularis)[5] Cutaneus T-cell lymphma (mycsis fungides) Metastatic malignancies (Medscape Reference; Harvard Medical Schl; Medscape). Staging f Basal Cell Carcinma Staging is the prcess f determining whether cancer has spread and, if s, hw far. It is imprtant t knw the stage f the disease in rder t plan treatment. The stage is based n the size f the tumur, hw deeply int the skin it has grwn, and whether cancer has spread beynd the tumur t the lymph ndes. The dctr will lk at the results f the bipsy t determine the stage. If there is a psitive diagnsis f squamus cell carcinma, the dctr may als test lymph ndes near the tumur t see if the cancer has spread beynd the skin. Stages are numbered in Rman numerals between 0 and IV: Stage 0. Cancer is fund nly in the riginal tumur in the skin. It is nly in the epidermis and has nt spread t the dermis. Stage 0 is als called carcinma in situ Stage I. The tumur is 2 centimetres wide r smaller. It may have spread int the dermis. Cancer des nt invade the muscle, cartilage, r bne and has nt spread t lymph ndes r ther rgans Stage II. The tumur is larger than 2 centimetres and may have spread frm the epidermis int the dermis. Cancer des nt invade the muscle, cartilage, r bne and has nt spread utside the skin. It may als have high risk features such as perineural invasin Stage III. The cancer has spread t areas belw the skin, such as int muscle, bne, cartilage, r lymph ndes, but nly thse near the riginal tumur. It has nt spread t distant rgans. This is mst wrrisme arund the nse, eyes, and ears Stage IV. The cancer can be any size and has spread t distant lymph ndes r rgans like the lungs r bne (Stanfrd Cancer Institute; PubMed Health). Recurrent Basal Cell Carcinma Basal cell carcinma (BCC) accunts fr 80% f all nn-melanma skin cancers. Its metastasis is extremely rare. The usual metastasis t lymph ndes, lungs, bnes, r skin is Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 7

8 frm the primary tumur situated in the head and neck regin in nearly 85% cases (Hindawi Publishing Crpratin). Prgnsis (Outlk) f Basal Cell Carcinma The basal cell carcinma prgnsis is very gd fr mst peple. It is ne f several types f skin cancers and is the easiest t deal with and carries the best prgnsis. (Carcinmaprgnsis.cm). Treatment f Basal Cell Carcinma Basal cell carcinma very rarely spreads t ther parts f the bdy, althugh it can grw int nearby tissues if nt treated. Several methds can be used t remve r destry these cancers. The chice may depend n factrs such as the tumur size and lcatin, and the patient s age, general health, and preferences. All f the treatment methds listed here can be effective. The chance f the cancer cming back (recurring) ranges frm less than 5% fr Mhs surgery t up t 15% r higher fr sme f the thers, but this depends n the size f the tumur. Small tumurs are less likely t recur than larger nes. Even if the tumur des recur, it can ften still be treated effectively. Curettage and Electrdesiccatin - Curettage and electrdesiccatin is a cmmn treatment fr basal cell carcinmas smaller than 1 centimeter (slightly less than a half inch) acrss. It might need t be repeated t help make sure all f the cancer has been remved. Simple Excisin - Simple excisin (cutting the tumur ut) is ften used t remve basal cell carcinmas, alng with a margin f nrmal skin. Mhs Surgery Mhs surgery has the best cure rate fr basal cell carcinma. It is especially useful in treating large tumurs, tumurs where the edges are nt well-defined, tumurs in certain lcatins (such as n r near the nse, eyes, ears, frehead, scalp, fingers, and genital area), and thse that have cme back after ther treatments. Hwever, it is als mre cmplex, time-cnsuming, and expensive than ther methds. New treatments fr skin cancer are appearing and evlving rapidly in recent years. Hwever, ne surgical technique has mre than std the test f time. Develped by Dr. Frederick Mhs in the 1930s, Mhs micrgraphic surgery has, with a few refinements, cme t be embraced ver the past decade by an increasing number f surgens fr an ever-widening variety f skin cancers. Tday, Mhs surgery has cme t be accepted as the single mst effective technique fr remving Basal Cell Carcinma (BCC) and Squamus Cell Carcinma (SCC), the tw mst cmmn skin cancers. It accmplishes the nifty trick f sparing the greatest amunt f healthy tissue while als mst cmpletely expunging cancer cells; cure rates fr BCC and SCC are an unparalleled 98 percent r higher with Mhs surgery, significantly better than the rates fr standard excisin r any ther accepted methd. The reasn fr the technique's success is its simple elegance. Mhs surgery differs frm ther techniques in that micrscpic examinatin f all excised tissues ccurs during, rather than after the surgery, thereby eliminating the need t estimate hw far ut r deep the Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 8

9 rts f the skin cancer g. This allws the Mhs surgen t remve all f the cancer cells while sparing as much nrmal tissue as pssible. The prcedure entails remving ne thin layer f tissue at a time; as each layer is remved, its margins are studied under a micrscpe fr the presence f cancer cells. If the margins are cancer-free, the surgery is ended. If nt, mre tissue is remved frm the margin where the cancer cells were fund, and the prcedure is repeated until all the margins f the final tissue sample examined are clear f cancer. In this way, Mhs surgery eliminates the guesswrk in skin cancer remval, prducing the best therapeutic and csmetic results. [Picture Credit: Mhs Surgery 1] In the past, Mhs surgery was rarely chsen fr Malignant Melanma surgery fr fear that sme micrscpic melanma cells might be missed and end up spreading arund the bdy (metastasising). Hwever, effrts t imprve the Mhs surgen's ability t identify melanma cells have led t special stains that highlight these cells, making them much easier t see under the micrscpe. Thus, mre Mhs surgens are nw using this prcedure with certain melanmas. With the rates fr melanma and ther skin cancers cntinuing t skyrcket, Mhs surgery will play an ever mre imprtant rle in the cming decades. (Skin Cancer Fundatin). [Picture Credit: Mhs Surgery 2] Radiatin Therapy - Radiatin therapy is ften a gd ptin fr treating patients wh might nt be able t tlerate surgery and fr treating tumurs n the eyelids, nse, r ears areas that can be hard t treat surgically. It is als smetimes used after surgery if it is nt clear that all f the cancer has been remved. Immune Respnse Mdifiers, Phtdynamic Therapy, r Tpical Chemtherapy - These treatments are smetimes cnsidered as ptins fr treating very superficial tumurs (tumurs that have nt extended t deeply under the skin surface). Clse fllw-up is needed because these treatments d nt destry any cancer cells that are deep under the surface. Crysurgery - Crysurgery can be used fr sme small basal cell carcinmas but is nt recmmended fr larger tumurs r thse n certain parts f the nse, ears, eyelids, scalp, r legs. Targeted Therapy fr Advanced Basal Cell Cancers - In rare cases where basal cell cancer spreads t ther parts f the bdy r can t be cured with surgery r radiatin therapy, the Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 9

10 targeted drug vismdegib (ErivedgeTM) can ften shrink r slw the grwth f the cancer. This drug is taken daily as a pill. Tpical Medicatins The fllwing tpical medicines are used: Imiquimd is FDA-apprved nly fr superficial BCCs, with cure rates generally between 80 and 90 percent. The 5% cream is rubbed gently int the tumur five times a week fr up t six weeks r lnger. It is the first in a new class f drugs that wrk by stimulating the immune system 5-Flururacil (5-FU) als has been FDA-apprved fr superficial BCCs, with similar cure rates t imiquimd. The 5% liquid r intment is gently rubbed int the tumur twice a day fr three t six weeks Trials with mre invasive BCCs are under way fr bth imiquimd and 5-FU. Side effects are variable, and sme patients d nt experience any discmfrt, but redness, irritatin, and inflammatin are predictable (American Cancer Sciety; Skin Cancer Fundatin; WebMD; Harvard Medical Schl). Cmplicatins f Basal Cell Carcinma Cmplicatins f basal cell carcinma can include: A risk f recurrence - Basal cell carcinmas cmmnly recur. Even after successful treatment, they may recur, ften in the same place. An increased risk f ther types f skin cancer - A histry f basal cell carcinma may als increase the chance f develping ther types f skin cancer, such as squamus cell carcinma and melanma. Cancer that spreads beynd the skin - Rare, aggressive frms f basal cell carcinma can invade and destry nearby muscles, nerves and bne. Very rarely, basal cell carcinma can spread t ther areas f the bdy. (May Clinic). Abut Clinical Trials Clinical trials are research studies that invlve peple. These studies test new ways t prevent, detect, diagnse, r treat diseases. Peple wh take part in cancer clinical trials have an pprtunity t cntribute t scientists knwledge abut cancer and t help in the develpment f imprved cancer treatments. They als receive state-f-the-art care frm cancer experts. Types f Clinical Trials Cancer clinical trials differ accrding t their primary purpse. They include the fllwing types: Treatment - these trials test the effectiveness f new treatments r new ways f using current treatments in peple wh have cancer. The treatments tested may include new drugs r new cmbinatins f currently used drugs, new surgery r radiatin therapy Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 10

11 techniques, and vaccines r ther treatments that stimulate a persn s immune system t fight cancer. Cmbinatins f different treatment types may als be tested in these trials. Preventin - these trials test new interventins that may lwer the risk f develping certain types f cancer. Mst cancer preventin trials invlve healthy peple wh have nt had cancer; hwever, they ften nly include peple wh have a higher than average risk f develping a specific type f cancer. Sme cancer preventin trials invlve peple wh have had cancer in the past; these trials test interventins that may help prevent the return (recurrence) f the riginal cancer r reduce the chance f develping a new type f cancer Screening - these trials test new ways f finding cancer early. When cancer is fund early, it may be easier t treat and there may be a better chance f lng-term survival. Cancer screening trials usually invlve peple wh d nt have any signs r symptms f cancer. Hwever, participatin in these trials is ften limited t peple wh have a higher than average risk f develping a certain type f cancer because they have a family histry f that type f cancer r they have a histry f expsure t cancer-causing substances (e.g., cigarette smke). Diagnstic - these trials study new tests r prcedures that may help identify, r diagnse, cancer mre accurately. Diagnstic trials usually invlve peple wh have sme signs r symptms f cancer. Quality f life r supprtive care - these trials fcus n the cmfrt and quality f life f cancer patients and cancer survivrs. New ways t decrease the number r severity f side effects f cancer r its treatment are ften studied in these trials. Hw a specific type f cancer r its treatment affects a persn s everyday life may als be studied. Where Clinical Trials are Cnducted Cancer clinical trials take place in cities and twns in dctrs ffices, cancer centres and ther medical centres, cmmunity hspitals and clinics. A single trial may take place at ne r tw specialised medical centres nly r at hundreds f ffices, hspitals, and centres. Each clinical trial is managed by a research team that can include dctrs, nurses, research assistants, data analysts, and ther specialists. The research team wrks clsely with ther health prfessinals, including ther dctrs and nurses, labratry technicians, pharmacists, dieticians, and scial wrkers, t prvide medical and supprtive care t peple wh take part in a clinical trial. Research Team The research team clsely mnitrs the health f peple taking part in the clinical trial and gives them specific instructins when necessary. T ensure the reliability f the trial s results, it is imprtant fr the participants t fllw the research team s instructins. The instructins may include keeping lgs r answering questinnaires. The research team may als seek t cntact the participants regularly after the trial ends t get updates n their health. Clinical Trial Prtcl Every clinical trial has a prtcl, r actin plan, that describes what will be dne in the trial, hw the trial will be cnducted, and why each part f the trial is necessary. The prtcl als Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 11

12 includes guidelines fr wh can and cannt participate in the trial. These guidelines, called eligibility criteria, describe the characteristics that all interested peple must have befre they can take part in the trial. Eligibility criteria can include age, sex, medical histry, and current health status. Eligibility criteria fr cancer treatment trials ften include the type and stage f cancer, as well as the type(s) f cancer treatment already received. Enrlling peple wh have similar characteristics helps ensure that the utcme f a trial is due t the interventin being tested and nt t ther factrs. In this way, eligibility criteria help researchers btain the mst accurate and meaningful results pssible. Natinal and Internatinal Regulatins Natinal and internatinal regulatins and plicies have been develped t help ensure that research invlving peple is cnducted accrding t strict scientific and ethical principles. In these regulatins and plicies, peple wh participate in research are usually referred t as human subjects. Infrmed Cnsent Infrmed cnsent is a prcess thrugh which peple learn the imprtant facts abut a clinical trial t help them decide whether r nt t take part in it, and cntinue t learn new infrmatin abut the trial that helps them decide whether r nt t cntinue participating in it. During the first part f the infrmed cnsent prcess, peple are given detailed infrmatin abut a trial, including infrmatin abut the purpse f the trial, the tests and ther prcedures that will be required, and the pssible benefits and harms f taking part in the trial. Besides talking with a dctr r nurse, ptential trial participants are given a frm, called an infrmed cnsent frm, that prvides infrmatin abut the trial in writing. Peple wh agree t take part in the trial are asked t sign the frm. Hwever, signing this frm des nt mean that a persn must remain in the trial. Anyne can chse t leave a trial at any time either befre it starts r at any time during the trial r during the fllw-up perid. It is imprtant fr peple wh decide t leave a trial t get infrmatin frm the research team abut hw t leave the trial safely. The infrmed cnsent prcess cntinues thrughut a trial. If new benefits, risks, r side effects are discvered during the curse f a trial, the researchers must infrm the participants s they can decide whether r nt they want t cntinue t take part in the trial. In sme cases, participants wh want t cntinue t take part in a trial may be asked t sign a new infrmed cnsent frm. New interventins are ften studied in a stepwise fashin, with each step representing a different phase in the clinical research prcess. The fllwing phases are used fr cancer treatment trials: Phases f a Clinical Trial Phase 0. These trials represent the earliest step in testing new treatments in humans. In a phase 0 trial, a very small dse f a chemical r bilgic agent is given t a small number f peple (apprximately 10-15) t gather preliminary infrmatin abut hw the agent is prcessed by the bdy (pharmackinetics) and hw the agent affects the bdy (pharmacdynamics). Because the agents are given in such small amunts, n infrmatin Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 12

13 is btained abut their safety r effectiveness in treating cancer. Phase 0 trials are als called micr-dsing studies, explratry Investigatinal New Drug (IND) trials, r early phase I trials. The peple wh take part in these trials usually have advanced disease, and n knwn, effective treatment ptins are available t them. Phase I (als called phase 1). These trials are cnducted mainly t evaluate the safety f chemical r bilgic agents r ther types f interventins (e.g., a new radiatin therapy technique). They help determine the maximum dse that can be given safely (als knwn as the maximum tlerated dse) and whether an interventin causes harmful side effects. Phase I trials enrl small numbers f peple (20 r mre) wh have advanced cancer that cannt be treated effectively with standard (usual) treatments r fr which n standard treatment exists. Althugh evaluating the effectiveness f interventins is nt a primary gal f these trials, dctrs d lk fr evidence that the interventins might be useful as treatments. Phase II (als called phase 2). These trials test the effectiveness f interventins in peple wh have a specific type f cancer r related cancers. They als cntinue t lk at the safety f interventins. Phase II trials usually enrl fewer than 100 peple but may include as many as 300. The peple wh participate in phase II trials may r may nt have been treated previusly with standard therapy fr their type f cancer. If a persn has been treated previusly, their eligibility t participate in a specific trial may depend n the type and amunt f prir treatment they received. Althugh phase II trials can give sme indicatin f whether r nt an interventin wrks, they are almst never designed t shw whether an interventin is better than standard therapy. Phase III (als called phase 3). These trials cmpare the effectiveness f a new interventin, r new use f an existing interventin, with the current standard f care (usual treatment) fr a particular type f cancer. Phase III trials als examine hw the side effects f the new interventin cmpare with thse f the usual treatment. If the new interventin is mre effective than the usual treatment and/r is easier t tlerate, it may becme the new standard f care. Phase III trials usually invlve large grups f peple (100 t several thusand), wh are randmly assigned t ne f tw treatment grups, r trial arms : (1) a cntrl grup, in which everyne in the grup receives usual treatment fr their type f cancer, r 2) an investigatinal r experimental grup, in which everyne in the grup receives the new interventin r new use f an existing interventin. The trial participants are assigned t their individual grups by randm assignment, r randmisatin. Randmisatin helps ensure that the grups have similar characteristics. This balance is necessary s the researchers can have cnfidence that any differences they bserve in hw the tw grups respnd t the treatments they receive are due t the treatments and nt t ther differences between the grups. Randmisatin is usually dne by a cmputer prgram t ensure that human chices d nt influence the assignment t grups. The trial participants cannt request t be in a particular grup, and the researchers cannt influence hw peple are assigned t the grups. Usually, neither the participants nr their dctrs knw what treatment the participants are receiving. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 13

14 Peple wh participate in phase III trials may r may nt have been treated previusly. If they have been treated previusly, their eligibility t participate in a specific trial may depend n the type and the amunt f prir treatment they received. In mst cases, an interventin will mve int phase III testing nly after it has shwn prmise in phase I and phase II trials. Phase IV (als called phase 4). These trials further evaluate the effectiveness and lng-term safety f drugs r ther interventins. They usually take place after a drug r interventin has been apprved by the medicine regulatry ffice fr standard use. Several hundred t several thusand peple may take part in a phase IV trial. These trials are als knwn as pst-marketing surveillance trials. They are generally spnsred by drug cmpanies. Smetimes clinical trial phases may be cmbined (e.g., phase I/II r phase II/III trials) t minimize the risks t participants and/r t allw faster develpment f a new interventin. Althugh treatment trials are always assigned a phase, ther clinical trials (e.g., screening, preventin, diagnstic, and quality-f-life trials) may nt be labelled this way. Use f Placebs The use f placebs as cmparisn r cntrl interventins in cancer treatment trials is rare. If a placeb is used by itself, it is because n standard treatment exists. In this case, a trial wuld cmpare the effects f a new treatment with the effects f a placeb. Mre ften, hwever, placebs are given alng with a standard treatment. Fr example, a trial might cmpare the effects f a standard treatment plus a new treatment with the effects f the same standard treatment plus a placeb. Pssible benefits f taking part in a clinical trial The benefits f participating in a clinical trial include the fllwing: Trial participants have access t prmising new interventins that are generally nt available utside f a clinical trial. The interventin being studied may be mre effective than standard therapy. If it is mre effective, trial participants may be the first t benefit frm it. Trial participants receive regular and careful medical attentin frm a research team that includes dctrs, nurses, and ther health prfessinals. The results f the trial may help ther peple wh need cancer treatment in the future. Trial participants are helping scientists learn mre abut cancer (e.g., hw it grws, hw it acts, and what influences its grwth and spread). Ptential harms assciated with taking part in a clinical trial The ptential harms f participating in a clinical trial include the fllwing: Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 14

15 The new interventin being studied may nt be better than standard therapy, r it may have harmful side effects that dctrs d nt expect r that are wrse than thse assciated with standard therapy. Trial participants may be required t make mre visits t the dctr than they wuld if they were nt in a clinical trial and/r may need t travel farther fr thse visits. Crrelative research studies, and hw they are related t clinical trials In additin t answering questins abut the effectiveness f new interventins, clinical trials prvide the pprtunity fr additinal research. These additinal research studies, called crrelative r ancillary studies, may use bld, tumur, r ther tissue specimens (als knwn as bispecimens ) btained frm trial participants befre, during, r after treatment. Fr example, the mlecular characteristics f tumur specimens cllected during a trial might be analysed t see if there is a relatinship between the presence f a certain gene mutatin r the amunt f a specific prtein and hw trial participants respnded t the treatment they received. Infrmatin btained frm these types f studies culd lead t mre accurate predictins abut hw individual patients will respnd t certain cancer treatments, imprved ways f finding cancer earlier, new methds f identifying peple wh have an increased risk f cancer, and new appraches t try t prevent cancer. Clinical trial participants must give their permissin befre bispecimens btained frm them can be used fr research purpses. When a clinical trial is ver After a clinical trial is cmpleted, the researchers lk carefully at the data cllected during the trial t understand the meaning f the findings and t plan further research. After a phase I r phase II trial, the researchers decide whether r nt t mve n t the next phase r stp testing the interventin because it was nt safe r effective. When a phase III trial is cmpleted, the researchers analyse the data t determine whether the results have medical imprtance and, if s, whether the tested interventin culd becme the new standard f care. The results f clinical trials are ften published in peer-reviewed scientific jurnals. Peer review is a prcess by which cancer research experts nt assciated with a trial review the study reprt befre it is published t make sure that the data are sund, the data analysis was perfrmed crrectly, and the cnclusins are apprpriate. If the results are particularly imprtant, they may be reprted by the media and discussed at a scientific meeting and by patient advcacy grups befre they are published in a jurnal. Once a new interventin has prven safe and effective in a clinical trial, it may becme a new standard f care. (Natinal Cancer Institute). Medical Disclaimer This Fact Sheet is intended t prvide general infrmatin nly and, as such, shuld nt be cnsidered as a substitute fr advice, medically r therwise, cvering any specific situatin. Users shuld seek apprpriate advice befre taking r refraining frm taking any actin in reliance n any infrmatin cntained in this Fact Sheet. S far as permissible by law, the Cancer Assciatin f Suth Africa (CANSA) des nt accept any liability t any persn (r Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 15

16 his/her dependants/estate/heirs) relating t the use f any infrmatin cntained in this Fact Sheet. Whilst the Cancer Assciatin f Suth Africa (CANSA) has taken every precautin in cmpiling this Fact Sheet, neither it, nr any cntributr(s) t this Fact Sheet can be held respnsible fr any actin (r the lack theref) taken by any persn r rganisatin wherever they shall be based, as a result, direct r therwise, f infrmatin cntained in, r accessed thrugh, this Fact Sheet. Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 16

17 References and Surces Acral Lentiginus Melanma American Cancer Sciety Basal Cell Carcinma Picture alte&utm_campaign=dc%2bweiterf%c3%bchrende%20inhalte%20pictures.dccheck.cm British Skin Fundatin ma.aspx Brwn University Carcinmaprgnsis.cm DermNet NZ Harvard Medical Schl d_treating_basal_cell_carcinma Hindawi Publishing Crpratin Knw Cancer Macmillan skincancer.aspx May Clinic Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 17

18 Medline Plus Medscape Medscape Reference Mh s Surgery 1 isch&sa=x&ei=wnhhun5nsam7aaridybq&sqi=2&ved=0cayq_auaq#facrc=_&imgdii=_&imgrc=f0ztoy4tzxt OIM%253A%3B3miN9- juglw69m%3bhttp%253a%252f%252fwww.skincancer.rg%252fmedia%252fdefault%2 52FPage%252Fskin-cancer-infrmatin%252Fmhs-surgery%252Fevlutin-f- mhs%252fmhs- Surgery.jpg%3Bhttp%253A%252F%252Fwww.skincancer.rg%252Fskin-cancerinfrmatin%252Fmhs-surgery%252Fevlutin-f-mhs%3B455%3B245 Mh s Surgery 2 isch&sa=x&ei=wnhhun5nsam7aaridybq&sqi=2&ved=0cayq_auaq#facrc=_&imgdii=_&imgrc=mfmqv2rh mw34xm%253a%3by_vhf88cc9y_pm%3bhttp%253a%252f%252fwww.hpkinsmedicin e.rg%252fsebin%252fz%252fl%252fskin_cancer_323.jpg%253f %3bhtt p%253a%252f%252fwww.hpkinsmedicine.rg%252ffacial_plastic_recnstructive_surger y%252frecnstructive_prcedures%252fskin_cancer_mhs_surgery.html%3b1028%3b68 8 Natinal Cancer Institute Reuters Health Skin Cancer Fundatin Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 18

19 PubMed Health Skin Cancer Fundatin Stanfrd Cancer Institute University f Maryland Medical Center WebMD Researched and Authred by Prf Michael C Herbst [D Litt et Phil (Health Studies); D N Ed; M Art et Scien; B A Cur; Dip Occupatinal Health; Dip Genetic Cunselling; Diagnstic Radigrapher; Dip Audimetry and Nise Measurement] Apprved by Ms Elize Jubert, Chief Executive Officer [BA Scial Wrk (cum laude); MA Scial Wk] December 2017 Page 19