Cancer Association of South Africa (CANSA)

Transcription

1 Cancer Assciatin f Suth Africa (CANSA) Fact Sheet On Nn-Hdgkin s Lymphma Intrductin Lymphma is a type f cancer invlving cells f the immune system, called lymphcytes. Just as cancer represents many different diseases, lymphma represents many different cancers f lymphcytes -- abut 35 different subtypes, Lymphma is a grup f cancers that affect the cells that play a rle in the immune system and primarily represents cells invlved in the lymphatic system f the bdy (emedicinehealth). The Lymphatic System The lymphatic system is an extensive drainage netwrk that helps keep bdily fluid levels in balance and defends the bdy against infectins. It is made up f a netwrk f lymphatic vessels that carry lymph - a clear, watery fluid that cntains prtein mlecules, salts, glucse, urea, and ther substances - thrughut the bdy. The spleen, which is lcated in the upper left part f the abdmen under the ribcage, wrks as part f the lymphatic system t prtect the bdy, clearing wrn ut red bld cells and ther freign bdies frm the bldstream t help fight ff infectin. [Picture Credit: Lymphatic System] One f the lymphatic system's majr jbs is t cllect extra lymph fluid frm bdy tissues and return it t the bld. This prcess is crucial because water, prteins, and ther substances are cntinuusly leaking ut f tiny bld capillaries int the surrunding bdy tissues. If the lymphatic system didn't drain the excess fluid frm the tissues, 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 Wrk] Nvember 2017 Page 1

2 the lymph fluid wuld build up in the bdy's tissues, and they wuld swell. The lymphatic system als helps defend the bdy against germs like viruses, bacteria, and fungi that can cause illnesses. Thse germs are filtered ut in the lymph ndes, small masses f tissue lcated alng the netwrk f lymph vessels. The ndes huse lymphcytes, a type f white bld cell. Sme f thse lymphcytes make antibdies, special prteins that fight ff germs and stp infectins frm spreading by trapping diseasecausing germs and destrying them. [Picture Credit Lymph Nde ] The spleen als helps the bdy fight infectin. The spleen cntains lymphcytes and anther kind f white bld cell called macrphages, which engulf and destry bacteria, dead tissue, and freign matter and remve them frm the bld passing thrugh the spleen (KidsHealth). Types f Lymphma Lymphmas fall int ne f tw majr categries: Hdgkin's lymphma (HL, previusly called Hdgkin's disease) Nn-Hdgkin s Lymphma (NHL, all ther lymphmas) These tw types ccur in the same places, may be assciated with the same symptms, and ften have similar appearance n physical examinatin. Hwever, they are readily distinguishable via micrscpic examinatin. Hdgkin's lymphma develps frm a specific abnrmal B lymphcyte lineage. NHL may derive frm either abnrmal B r T cells and are distinguished by unique genetic markers. There are five subtypes f Hdgkin's lymphma and abut 30 subtypes f nn-hdgkin's lymphma. Because there are s many different subtypes f lymphma, the classificatin f lymphmas is cmplicated (it includes bth the micrscpic appearance as well as genetic and mlecular markers). Many f the NHL subtypes lk similar, but they are functinally quite different and respnd t different therapies with different prbabilities f cure. HL subtypes are micrscpically distinct, and typing is based upn the micrscpic differences as well as extent f disease. Wrld Health Organizatin Classificatin System f Lymphma Types Over the years, varius classificatin systems have been used t differentiate lymphma types including the Rappaprt Classificatin (used until the 70's), the Wrking Frmulatin, 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 Wrk] Nvember 2017 Page 2

3 the Natinal Cancer Institute Wrking Frmulatin, and the Revised Eurpean-American Lymphma Classificatin (REAL). The WHO classificatin has its rigins in the 1850s. The first editin, knwn as the Internatinal List f Causes f Death, was adpted by the Internatinal Statistical Institute in The ICD is the internatinal standard diagnstic classificatin. It is used t classify diseases and ther health prblems recrded n many types f health and vital recrds including death certificates and health recrds. These recrds als prvide the basis fr the cmpilatin f natinal mrtality and mrbidity statistics by WHO Member States. The lder Rappaprt, Wrking Frmulatin, and REAL categries are described in a separate sectin fr reference. This might be helpful if a patient's recrds state sme f the classificatins f lder lymphma types. Hdgkin's lymphma Lymphcytic-histicytic predminance Ndular sclersis Mixed cellularity Lymphcytic depletin Hdgkin's, unspecified Fllicular (ndular) nn-hdgkin's lymphma Small cleaved cell, fllicular Mixed small cleaved and large cell, fllicular Large cell, fllicular Other fllicular nn-hdgkin's lymphma types Fllicular nn-hdgkin's lymphma, unspecified Ndular nn-hdgkin's lymphma NOS Diffuse nn-hdgkin's lymphma Small cell (diffuse) Small cleaved cell (diffuse) Mixed small and large cell (diffuse) Large cell (diffuse) Reticulum cell sarcma Immunblastic (diffuse) Lymphblastic (diffuse) Undifferentiated (diffuse) Burkitt's tumur (Burkitt's lymphma) Other diffuse nn-hdgkin's lymphma types Diffuse nn-hdgkin's lymphma, unspecified Peripheral and cutaneus T-cell lymphmas Mycsis fungides 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 Wrk] Nvember 2017 Page 3

4 Sézary's disease T-zne lymphma Lymphepitheliid lymphma Lennert's lymphma Peripheral T-cell lymphma Other and unspecified T-cell lymphmas Other and unspecified types f nn-hdgkin's lymphma Lymphsarcma B-cell lymphma, unspecified Other specified types f nn-hdgkin's lymphma Malignant: reticulendthelisis reticulsis Micrglima Nn-Hdgkin's lymphma, unspecified type Lymphma NOS Malignant lymphma NOS Nn-Hdgkin's lymphma NOS Malignant immunprliferative diseases Waldenström's macrglbulinaemia Alpha heavy chain disease Gamma heavy chain disease Franklin's disease Immunprliferative small intestinal disease Mediterranean disease Other malignant immunprliferative diseases Malignant immunprliferative disease, unspecified Immunprliferative disease NOS Multiple myelma and malignant plasma cell neplasms Multiple myelma Kahler's disease Myelmatsis Excludes: slitary myelma Plasma cell leukemia Plasmacytma, extramedullary Malignant plasma cell tumur NOS Plasmacytma NOS Slitary myelma Lymphid leukaemia Acute lymphblastic leukaemia 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 Wrk] Nvember 2017 Page 4

5 Excludes: acute exacerbatin f chrnic lymphcytic leukaemia Chrnic lymphcytic leukaemia Subacute lymphcytic leukaemia Prlymphcytic leukaemia Hairy-cell leukaemia Leukaemic reticulendthelisis Adult T-cell leukaemia Other lymphid leukaemia Lymphid leukaemia, unspecified Myelid leukaemia Includes: granulcytic myelgenus Acute myelid leukaemia Excludes: acute exacerbatin f chrnic myelid leukaemia Chrnic myelid leukaemia Subacute myelid leukaemia Myelid sarcma Chlrma Granulcytic sarcma Acute prmyelcytic leukaemia Acute myelmncytic leukaemia Other myelid leukaemia Myelid leukaemia, unspecified Mncytic leukaemia Includes: mncytid leukaemia Acute mncytic leukaemia Excludes: acute exacerbatin f chrnic mncytic leukaemia Chrnic mncytic leukaemia Subacute mncytic leukaemia Other mncytic leukaemia Mncytic leukaemia, unspecified Other leukaemias f specified cell type Acute erythraemia and erythrleukaemia Acute erythraemic myelsis Di Guglielm's disease Chrnic erythraemia Heilmeyer-Schöner disease Acute megakaryblastic leukaemia leukaemia : megakaryblastic (acute) megakarycytic (acute) Mast cell leukaemia 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 Wrk] Nvember 2017 Page 5

6 Acute panmyelsis Acute myelfibrsis Other specified leukaemia s Lymphsarcma cell leukaemia Leukaemia f unspecified cell type Acute leukaemia f unspecified cell type Blast cell leukaemia Stem cell leukaemia Chrnic leukaemia f unspecified cell type Subacute leukaemia f unspecified cell type Other leukaemia f unspecified cell type leukaemia, unspecified Other and unspecified malignant neplasms f lymphid, haematpietic and related tissue Letterer-Siwe disease Nnlipid: reticulendthelisis reticulsis Malignant histicytsis Histicytic medullary reticulsis Malignant mast cell tumur Malignant: mastcytma mastcytsis Mast cell sarcma Excludes: mast cell leukaemia mastcytsis (cutaneus) True histicytic lymphma Other specified malignant neplasms f lymphid, haematpietic and related tissue Malignant neplasm f lymphid, haematpietic and related tissue, unspecified (Lymphmainf.net) Nn-Hdgkin s Lymphma Nn-Hdgkin's lymphma is cancer f the lymphid tissue, which includes the lymph ndes, spleen, and ther rgans f the immune system. Causes, Incidence, and Risk Factrs fr Nn-Hdgkin s Lymphma White bld cells called lymphcytes are fund in lymph tissues. They help prevent infectins. Mst Nn-Hdgkin s Lymphmas (NHL) start in a type f white bld cells called B lymphcytes, r B cells. Sme f the Knwn Risk Factrs fr Nn-Hdgkin s Lymphma include: 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 Wrk] Nvember 2017 Page 6

7 Age - Nn-Hdgkin's lymphma can develp in peple f all ages, including children, it is mst cmmn in adults. The mst cmmn types f NHL usually appear in peple in their 60s and 70s. Sex - In general, NHL is mre cmmn in men than in wmen. Race - Overall, the risk fr NHL is slightly higher in Caucasians than in African- Americans and Asian Americans. Family Histry - Peple wh have clse family relatives wh have develped NHL may be at increased risk fr this cancer. Hwever, n definitive hereditary r genetic link has been established. Infectins - Viral r bacterial infectins may play a rle in sme lymphmas. These include: Epstein-Barr virus (EBV), the cause f mnnuclesis, is highly assciated with Burkitt's lymphma and NHLs assciated with immundeficiency diseases. It is als a risk factr fr Hdgkin's disease. The human immdeficiency virus (HIV), which causes AIDS, increases the risk fr Burkitt lymphma and diffuse large B-cell lymphma The hepatitis C virus (HCV) may increase the risk fr certain types f lymphmas. The Helicbacter pylri bacterium, which causes stmach ulcers, is assciated with increased risk fr mucsa-assciated lymphid tissue lymphmas (MALT). (The use f antibitics t get rid f the bacteria may cause remissin in sme patients wh have an early stage frm f lymphma in an early stage.) Immune System Deficiency Disrders - Patients with diseases r cnditins that affect the immune system may be at higher risk fr lymphmas: HIV-psitive patients and thse with full-blwn AIDS are at higher risk fr NHL, and the disease is mre likely t be widespread in these patients than in thse withut the immune disease. Mst AIDS-related NHLs are high-grade lymphmas. Peple wh have rgan transplants are at higher risk fr NHL, prbably due t multiple factrs, including the drugs used t suppress the immune system and the transplanted rgan itself. Patients wh have had high-dse chemtherapy with stem-cell transplantatin are at higher risk. Other immundeficiency syndrmes that put peple at risk fr NHL include Chediak- Higashi syndrme, ataxia-telangiectasia, B-cell lymphprliferative syndrme, Brutn agammaglbulinemia, cmmn variable immundeficiency, and Wisktt-Aldrich syndrme. Autimmune Disrders - Patients with a histry f autimmune diseases, including rheumatid arthritis (RA), systemic lupus erythematsus, Hashimt's thyriditis, Crhn's disease, and Sjgren syndrme, are at an increased risk fr certain NHLs, such as marginal zne lymphmas. Chemical Expsure - Overexpsure t a number f industrial and agricultural chemicals (such as pesticides, herbicides, and petrchemicals) has been frequently linked t an increased risk fr lymphmas. The data, hwever, are nt cnsistent. Researchers are als investigating whether sme chemtherapy drugs may increase the risk fr later develping nn-hdgkin's lymphma. At this pint, it is nt clear whether these drugs r the ther cancers themselves increase risk. Other types f drugs, such as tumur necrsis factr (TNF) inhibitrs that are used t treat autimmune disrders, are als being studied as pssible risk factrs fr lymphmas. 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 Wrk] Nvember 2017 Page 7

8 Radiatin Expsure - Peple wh have had radiatin treatment fr cancer, such as Hdgkin's lymphma, appear t have an increased risk fr later develping nn- Hdgkin s lymphma. The risk may be higher fr patients treated with bth chemtherapy and radiatin. Survivrs f nuclear reactr disasters have an increased risk f develping NHL, as well as ther types f cancers. Lifestyle Factrs - Lifestyle des nt seem t be a majr risk factr fr NHL. Sme studies have suggested that besity may increase risk, but this assciatin is nt definite. Other studies have investigated the rle f diet. Althugh sme research has indicated an increased risk fr diets high in cnsumptin f red meat and lwer risk fr diets high in vegetables, fr the mst part a strng assciatin remains speculative. There is n evidence that smking increases the risk fr NHL itself, althugh it has been linked with high-grade and fllicular NHLs in peple with lymphma. There are many different types f nn-hdgkin's lymphma (NHL). It is gruped accrding t hw fast the cancer spreads. The cancer may be lw grade (slw grwing), intermediate grade, r high grade (fast grwing). Burkitt's lymphma is an example f a high-grade lymphma. Fllicular lymphma is a lw-grade lymphma. The cancer is further gruped by hw the cells lk under the micrscpe, fr example, if there are certain prteins r genetic markers present. Incidence f Nn-Hdgkin s Lymphma in Suth Africa Accrding t the Natinal Cancer Registry (2013) the fllwing number f Nn-Hdgkin s Lymphma cases were histlgically diagnsed in Suth Africa during 2013: Grup - Males 2013 Actual N f Cases Estimated Lifetime Risk Percentage f All Cancers All males 882 1:221 2,45% Asian males 25 1:241 2,97% Black males 516 1:316 4,79% Clured males 88 1:192 2,12% White males 254 1:123 1,26% Grup - Females 2013 Actual N f Cases Estimated Lifetime Risk Percentage f All Cancers All females 802 1:327 2,19% Asian females 21 1:296 1,98% Black females 471 1:461 3,02% Clured females 76 1:267 1,87% White females 234 1:163 1,47% The frequency f histlgically diagnsed cases f Nn-Hdgkin s Lymphma in Suth Africa fr 2013 was 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 Wrk] Nvember 2017 Page 8

9 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 Nn-Hdgkin s Lymphma Symptms depend n what area f the bdy is affected by the cancer and hw fast the cancer is grwing. Symptms may include: [Picture Credit: Nn-Hdgkin s Lymphma] Night sweats (saking the bedsheets and pyjamas even thugh the rm temperature is nt t ht) Fever and chills that cme and g Itching Swllen lymph ndes in the neck, underarms, grin, r ther areas Weight lss Cughing r shrtness f breath may ccur if the cancer affects the thymus gland r lymph ndes in the chest, which may put pressure n the windpipe (trachea) r ther airways. Sme patients may have abdminal pain r swelling, which may lead t a lss f appetite, cnstipatin, nausea, and vmiting. If the cancer affects cells in the brain, the persn may have a headache, cncentratin prblems, persnality changes, r seizures. Signs and Tests fr Nn-Hdgkin s Lymphma The dctr will perfrm a physical exam and check bdy areas with lymph ndes t feel if they are swllen. The disease may be diagnsed after: 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 Wrk] Nvember 2017 Page 9

10 Bipsy f suspected tissue, usually a lymph nde bipsy Bne marrw bipsy Other tests that may be dne include: Bld test t check prtein levels, liver functin, kidney functin, and uric acid level Cmplete bld cunt (CBC) CT scans f the chest, abdmen and pelvis Gallium scan PET (psitrn emissin tmgraphy) scan Treatment f Nn-Hdgkin s Lymphma Treatment depends n: The type f lymphma The stage f the cancer when yu are first diagnsed Yur age and verall health Symptms, including weight lss, fever, and night sweats Cmmn treatments include: Radiatin therapy may be used fr disease that is cnfined t ne bdy area. Chemtherapy is the main type f treatment. Mst ften, multiple different drugs are used in cmbinatin tgether. Anther drug, called rituximab (Rituxan), is ften used t treat B-cell nn-hdgkin's lymphma. Radiimmuntherapy may be used in sme cases. This invlves linking a radiactive substance t an antibdy that targets the cancerus cells and injecting the substance int the bdy. Peple with lymphma that returns after treatment r des nt respnd t treatment may receive high-dse chemtherapy fllwed by a bne marrw transplant (using stem cells frm the patient). Additinal treatments depend n ther symptms. They may include: Transfusin f bld prducts, such as platelets r red bld cells Antibitics t fight infectin, especially if a fever ccurs In 2017 the Fd and Drug Administratin (FDA) has apprved Rituxan Hycela (rituximab and hyalurnidase human) fr subcutaneus injectin fr the treatment f Fllicular Lymphma and Diffuse Large B-cell Lymphma. In the treatment f Fllicular Lymphma (FL), Rituxan Hycela is indicated fr relapsed r refractry FL as a single agent; fr previusly untreated FL in cmbinatin with first line chemtherapy and, in patients achieving a cmplete r partial respnse t rituximab in cmbinatin with chemtherapy, as single-agent maintenance therapy; and fr nnprgressing (including stable disease) FL as a single agent after first-line cyclphsphamide, vincristine, and prednisne chemtherapy. 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 Wrk] Nvember 2017 Page 10

11 Rituxan Hycela is als indicated fr previusly untreated Diffuse Large B-cell lymphma in cmbinatin with cyclphsphamide, dxrubicin, vincristine, prednisne r ther anthracycline-based chemtherapy regimens and fr previusly untreated and previusly treated chrnic lymphcytic leukemia in cmbinatin with fludarabine and cyclphsphamide. (MPR). Expectatins (Prgnsis) f Nn-Hdgkin s Lymphma Lw-grade nn-hdgkin's lymphma usually cannt be cured by chemtherapy alne. Hwever, the lw-grade frm f this cancer prgresses slwly, and it may take many years befre the disease gets wrse r even requires any treatment. Chemtherapy can ften cure many types f high-grade lymphma. Hwever, if the cancer des nt respnd t chemtherapy drugs, the disease can cause rapid death. Cmplicatins f Nn-Hdgkin s Lymphma Cmplicatins include: Autimmune haemlytic anaemia Infectin Side effects f chemtherapy drugs (University f Maryland Medical Center; PubMed; American Cancer Sciety) Relatinship f Staging Systems Hdgkin Lymphma and Nn-Hdgkin Lymphmas Descriptin f Extent (Based n Ann Arbr Staging Systems) Summary Stage Ann Arbr Staging* AJCC Staging Stage** Invlvement f a single lymph nde regin Lcalised I I A single extralymphatic rgan r site Lcalised Ie Ie Invlvement f mre than ne lymphatic regin n nly ne side f the diaphragm Reginal NOS II II Lcalised invlvement f ne extralymphatic rgan r site and its reginal lymph ndes with r withut ther ndes n the same side f the diaphragm Reginal NOS IIe IIe Invlvement f mre than ne lymphatic regin n nly ne side f the diaphragm plus invlvement f the spleen Distant IIs IIs Invlvement f lymph nde regins n bth sides f the diaphragm Distant III III Invlvement f lymph nde regins n bth sides f the diaphragm plus lcalised invlvement f an extralymphatic rgan r site Distant IIIe IIIe Invlvement f lymph nde regins n bth sides f the diaphragm plus invlvement f the spleen Distant IIIs IIIs Diffuse r disseminated invlvement f ne r mre extralymphatic rgans r tissues with r withut assciated lymph nde enlarge3ment. Organs cnsidered distant include liver, bne, bne marrw, lung and/r pleura and kidney Distant IV IV Islated extralymphatic rgan invlvement with distant (nn-reginal) ndal invlvement Distant IV IV (Natinal Cancer Institute) 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 Wrk] Nvember 2017 Page 11

12 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 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, 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 Wrk] Nvember 2017 Page 12

13 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 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. 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 Wrk] Nvember 2017 Page 13

14 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 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. 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 Wrk] Nvember 2017 Page 14

15 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. 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. 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 Wrk] Nvember 2017 Page 15

16 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: 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 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 Wrk] Nvember 2017 Page 16

17 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 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 Wrk] Nvember 2017 Page 17

18 Surces and References American Cancer Sciety Autlgus Transplant Bstn Children s Hspital Cancer Research UK Cells f the Immune System emedicinehealth. Lymphma. Hdgkin s Lymphma X&ei=Kl- ZU_bUJaev7Ab_q4CwCA&sqi=2&ved=0CAYQ_AUAQ&biw=1517&bih=714&dpr=0.9#facrc =_&imgdii=wrukxr_rab8ehm%3a%3b3mtf6fazjsvlem%3bwrukxr_rab8ehm%3a&imgrc= wrukxr_rab8ehm%253a%3bywb- 1qzXMW4rDM%3Bhttp%253A%252F%252Fs2.hubimg.cm%252Fu%252F _f260.jp g%3bhttp%253a%252f%252fkimhdimin.blgspt.cm%252f2013%252f03%252fhdgki ns-disease-verview.html%3b260%3b195 KidsHealth. The Lymphatic System. Lymphatic System =1366&bih=613&tbm=isch&prmd=imvns&tbnid=fIgwTmsqqhLNM:&imgrefurl= M&imgurl= 0cah/%2540gen/dcuments/image/crukmig_1000img jpg&w=350&h=431&ei=YdRSUOCpMOSx0QXWr4DABQ&zm=1&iact=hc&vpx=110 6&vpy=249&dur=2671&hvh=249&hvw=202&tx=127&ty=114&sig= &page=4&tbnh=129&tbnw=105&ndsp=30&ved=1t:429,r:29,s:83,i:96] Lymph Nde h=613&tbm=isch&prmd=imvns&tbnid=y5upismy6d3v2m:&imgrefurl= cm/examples/view/nn-hdgkin%2blymphma%2b- %2Bcell/&dcid=r4nBtXE1dXFreM&imgurl= mples/10_healthcare/cancer_illustratins/nn-hdgkin_lymphma_- 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 Wrk] Nvember 2017 Page 18

19 _Cell_L.jpg&w=842&h=627&ei=RNRSUM_6O9DY0QX1vYDABQ&zm=1&iact=rc&dur=52 7&sig= &page=2&tbnh=131&tbnw=175&start=23&ndsp=29&ved=1 t:429,r:19,s:23,i:206&tx=110&ty=82] Lymphma Assciatin UK Lymphmainf.net Lymphma Research Fundatin MacMillan Cancer supprt Hdgkin/TypesfNHL/Burkitt.aspx Medscape Merseyside & Cheshire Cancer Netwrk itts%20lymphma%20dec% pdf May Clinic Medline Plus MPR injectin/article/670580/?dcmp=emc- MPR_DailyDse_cp &cpn=hemnc_all&hmSubId=i7VmYKZCM_41&hm =Od sibxrypdkldpz00apa5dx4uylpfyu0&nid=&c_id=&dl=0&spmailingid= &spuserid=mzmyodk3ntcxnt cs1&spjbid= &spreprtid=mta0mtcwote5nws2 Natinal Cancer Institute Nn-Hdgkin s Lymphma &sqi=2&ved=0cayq_auaq&biw=1517&bih=714&dpr=0.9#facrc=_&imgdii=kkb9p4gya_ Fu3M%3A%3B2h1pJ-GD7YW- PM%3BkKB9P4GyA_Fu3M%3A&imgrc=kKB9P4GyA_Fu3M%253A%3BNDhAy5EHR6ijXM %3Bhttp%253A%252F%252Fwww.cixip.cm%252FPublic%252Fkindeditr%252Fattached %252Fimage%252F %252F _31690.jpg%3Bhttp%253A%252F% 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 Wrk] Nvember 2017 Page 19

20 252Fwww.cixip.cm%252Findex.php%252Fpage%252Fcntent%252Fid%252F613%3B537 %3B600 PubMed Health. Hdgkin s Lymphma Rdriguez-Just, M., Attygalle, A.D., Munsn, P., Rncadr, G, Maragiti, T. & Pirisw, M.A Antiimmunblastic T-Cell lymphma with hyperplastic germinal centres: a neplasia with rigin in the uter zne f the germinal centre? Clinicpathlgical and immunhistchemical study f 10 cases with fllicular T-cell markers. Mdern Pathlgy, 22: di: /mdpathl ; published nline 27 March 2009 The Burkitt s Lymphma Sciety The Immune System 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 Wrk] Nvember 2017 Page 20