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Exposure data — an estimate of the total number of patients exposed in the time period covered by the bridging report (including from clinical trials if appropriate) treatment 2015 order 250 mg meldonium. Overall Safety Evaluation and Conclusion — mention only key unresolved issues and possible measures to treatment head lice buy meldonium 500mg cheap address the problem treatment plan goals buy 500 mg meldonium amex. Until then medicine yoga cheap meldonium 250 mg, an expedient approach is needed to manage the inconsistencies in harmonization without adding an undue burden for both companies and regulators in the preparation and review of extra reports. They should not be required routinely but should be prepared only on special regulatory request. However, recognizing the limitations of pharmacovigilance resources, the Working Group proposes the following minimum information for inclusion in an addendum report. Line listing and/or summary tabulations — inclusion of the new cases in the usual format. If the volume of reports is high, as already re commended consideration should be given to excluding the line-listing. Conclusion — a brief overview of the new cases included and a comment on whether or not they are in line with the known safety profile of the product. In summary, the purpose of an addendum report is to supplement, not replace, the basic reporting cycle. Subsequent five-year license renewal reports would be submitted at five year intervals following the submission of the first ‘‘five year’’ report (that really covers, as stated, 4. It was agreed that it should be acceptable to provide multiples of six-monthly or annual reports that have already been prepared by the company to cover the period requested by individual regulatory authorities to comply with their own local requirements. However, it was considered necessary that the reports be accompanied by a document chronologically summarizing the information contained in the series of reports (a Summary Bridging Report as described above). This same concept is applicable for all five-year license renewals subsequent to the first one. Individual regulators may define what is meant by ‘‘old’’ products; there is no general definition. However, it must be recognized that such a conversion for existing drugs is time consuming, expensive and not very practical especially for global companies with extensive portfolios and line extensions; each attempt requires a variation application within each country. It is also necessary, as usual, to indicate which countries, if any, have refused approval or license renewal, or in which the product has been withdrawn for safety reasons, along with an explanation. It is also important to remember that discussion of serious unlisted cases should cover cumulative data. There are two general situations for which regulators must consider whether it is necessary to ask companies to revert to a six-month reporting interval when a longer period (one or five years. The need to reset the clock under any circumstances should be driven by the data available to support the product’s safety profile and the relative 159 stability of that profile, not by regulatory approval dates. The safety profile of a product is best characterized according to the number and types of patients treated; reporting frequency should be influenced by the extent of clinical knowledge of the product. For such products, it is recommended that regulators in the new market accept a summary tabulation (with or without supporting line listings) of spontaneously reported adverse events over the shorter periods in the new market (say every 6 months for a reasonable length of time, perhaps two years). For such short-interval data submissions, review of the worldwide literature is not considered necessary, especially for older products already available generically in major markets. For both (a) and (b), in any event, consideration for restarting the clock should be discussed between the regulators and the company preferably prior to but certainly no later than time of approval of the relevant application dossier. There is a need for a greater degree of flexibility in the time line to ensure that not only all the relevant safety data are covered (line listings, tabulations, literature, studies) but appropriate analysis and interpretation of the data are made (overall analysis and conclusions). However, for a recently introduced product with multiple safety issues that is indicated for a complicated disease syndrome and is associated with a high volume of adverse event reports, a longer preparation time. When a company realizes that 60 days may not suffice, it should alert regulators to a possible delay and provide an explanation; this will allow the regulators to facilitate their own review planning, especially if it involves multiple agencies. It would provide the reader, especially the regulators, with a description of the basic content and most important findings as a guide to the full document. Introduction Obtaining and understanding patient exposure information (the ‘‘denominator’’) is important for both manufacturers and regulatory authorities to help assess the benefits and risks of any medicinal product 1 and to place such information in proper perspective. The need to evaluate the benefit-risk relationship spans the continuum of a product’s lifecycle, from early in clinical development through its use in the marketplace. In general, appropriate use of denominator data is part of good epidemiological and public health practices. There are many difficulties associated with obtaining and using the relevant data, particularly from sources outside the relatively controlled environment of clinical trials or other studies in which the size and characteristics of the treated populations are known with considerable accuracy. Estimating person-use for marketed drugs usually relies on gross approximations, especially for non-prescription products, and represents more of an art than a science. Of course, there are exceptions for which accurate counts are possible, such as administration of a single-dose treatment in hospital or clinic under direct supervision, or in vaccination programs. The level of detail and accuracy required for exposure statistics will depend on the intended use of the data. A simple denominator that defines broad exposure, useful for routine periodic safety reporting, might need only a count or estimate of all exposed subjects, without regard to their characteristics. On the other hand, an analysis of a subgroup, defined by age and/or gender, for example, might require considerably more effort. Although it may be useful, even important, to obtain breakdowns of patient exposure according to the many covariates that define user groups (see below), it is usually very difficult to obtain such detailed and extensive data outside a clinical trial environment. However, in this context, the word should be regarded as synonymous with ‘‘denominator,’’ a measure of the number of patients in a population that are treated with a medicine. The dimension of time on drug is obviously important in any real measure of drug-exposure. It was designed to collect information on sources of denominator information, exposure metrics, time period covered by exposure information, processes for compiling exposure data, circumstances surrounding the determination of exposure data, and regulatory experience with exposure data; the questionnaire and results are presented in Appendix 15 but are summarized here. Only 20% of the companies agreed that marketing data were sufficiently complete and accurate for the purpose of estimating drug exposure. Information on particulars such as duration of treatment, age or gender of exposed population, or the medical specialty of the prescriber, were not available through traditional sales information and when needed had to be obtained from other sources. Although the majority of companies were aware of one or more of the various non-company databases mentioned in the questionnaire. The most commonly used type of unit for describing marketed drug use was patient-time. However, most companies did not or were unable to routinely stratify patient exposure by age or gender. Estimates of off-label use were made by 5 (19%) companies but by three of the four regulators. However, most respondents did report attempts to collect and assess data relevant to overdose. They also regarded the use and interpretation of exposure data by Companies as ‘‘good’’ (1/4) or ‘‘poor’’ (3/4). For clinical trials and other studies in which the treated populations are usually well characterized by their nature and size, there are established methods for calculating and representing ‘‘drug exposure’’ (something that is deceptively simple, but can actually be quite compli 2 cated); this topic will be discussed briefly. There is another aspect to the concepts of numerator and denominator, particularly when attempting to use spontaneous report data for signal detection. One important statistic that is always valuable is the background rate for a condition within a specific population. For example, when faced with a case series involving a new, especially unusual, adverse medical condition, an estimate of the background rate for the type of population exposed to the drug can be very useful. Such data, when available, can be found in compilations of national health statistics databases. Several cases of an unusual adverse event in a population in which that event is very rare would suggest at least the possibility of a drug signal. In addition to helping place into perspective the numbers and types of safety reports over time, the data also are useful for detecting trends in drug use. Evaluation of Safety Data from Controlled Clinical Trials: the Clinical Principles Explained. One particular gap is the absence of hospital-based (inpatient exposure) statistics from the major use-monitoring sources. Thus, in the absence of special situations (important safety signal, for example), an overall estimate expressed in customary terms and units (see below) is adequate. Available sources of data and methods for estimating drug use depend on the setting. In clinical trials, compassionate treatment (named-patient) programs, observational studies and other situations in which a cohort of subjects is readily defined, the number of patients treated with a drug is easily obtained. However, the proper measure of patient-exposure as a function of time, demographics, and other parameters requires care.
Continued investigations due to symptoms synonym proven meldonium 500 mg persistent symptoms are not warranted and may ultimately undermine a patient’s confidence in both the disorder diagnosis and the attending physician medicine 018 quality 250 mg meldonium. Therapies may include fiber consumption for constipation medications look up meldonium 500 mg generic, anti-diarrheals medicine 657 cheap meldonium 500mg, smooth muscle relaxants for pain, and psychotropic agents for pain, diarrhea and depression. Patients with mild or infrequent symptoms may benefit from the establishment of a physician-patient relationship, patient education and reassurance, dietary modification, and simple measures such as fiber consumption. Stronger laxatives should be reserved for patients who do not respond to fiber consumption and gentle osmotic laxatives. It is very important, therefore, that the responsible physician foster a positive relationship with the patient in order to aid in successful clinical management. A positive, confident diagnosis, accompanied by a clear explanation of possible mechanisms and an honest account of probable disease course, can be critical in achieving desired management goals. In order to facilitate a positive relationship, it is important that the physician practice the following principles: Reassure the patient that they are not unusual Identify why the patient is currently presenting Obtain a history of referral experiences Examine patient fears or agendas Ascertain patient expectations of physician Determine patient willingness to aid in treatment Uncover the symptom most impacting quality of life and the specific treatment designed to improve management of that symptom In addition to addressing patient fears and concerns, physicians must evaluate whether or not the introduction of physician aids, such as dietitians, counselors, and support groups, may be of long-term assistance to the patient. Patient Education Patient education is essential to any successful management plan. Patients presented with detailed discussions about their diagnosis and treatment options have reduced symptom intensity and fewer return visits. In order to best educate patients, physicians must speak to the following issues with the patient: A. Gastrointestinal physiology including gastrocolonic response, production of gas, gut sensitivity to certain stimuli, and possible C. The potential impact of stress in triggering or exacerbating symptoms, with reassurance that symptoms are not psychosomatic D. The recognition that no panacea exits, but that therapies can greatly improve quality of life and significantly reduce symptom severity Well informed patients are more apt to make choices and changes in lifestyle and diet that can reduce the severity and the frequency of their symptoms. It is recommended that physicians discuss new information during patient visits, and build on previous information by disseminating any new educational materials that may have become available since the patient’s last visit. The excess production of hydrogen, along with a range of other compounds, is thought to impact colonic functioning. It has been demonstrated that patients with mild to moderate symptoms typically are most responsive to dietary modifications. Fiber supplements such as bran, psyllium derivatives, or polycarbophil (20–30 grams/day) may aid in relief of constipation and may also improve symptoms of diarrhea. However, the efficacy of bulking agents has not yet been clearly established—despite the fact that they are widely prescribed. Dietary modifications are the therapy of choice for patients with abdominal pain, diarrhea, flatulence and abdominal distension, with reported response rates of 50-70%. To determine dietary triggers, patients should try an exclusion diet—restricting their diet to basic bland foods, gradually adding new foods and recording symptoms. Elimination diets are intended for short-term use only as they are nutritionally deficient, and should be supervised by a dietitian or medical professional with experience in this field. A daily food diary is another important tool in identifying trends in food or stress triggers. For each day of the week, patients should be encouraged to record the types of foods and beverages they have consumed, the number of bowel movements they have experienced, any pain they have experienced (on a scale form 1-10), their mood while eating, the time of day for each variable and any other relevant symptoms (Figure 14). The diary should be brought to physician visits for review in order to provide valuable information about potential relationships between dietary triggers and symptoms. Dairy products are the most common dietary triggers of gas, bloating, and occasional abdominal pain. A lactose breath hydrogen test, measuring the spike of breath hydrogen when malabsorbed lactose enters the colon, is the definitive test for lactose intolerance. While lactose intolerant patients should avoid consumption of milk and milk products (cheese, ice cream, and butter), it remains unclear whether or not a lactose-free diet demonstrates symptom resolution. Other research speculates that patients who are lactose intolerant may experience improvement not solely by abstaining from dairy, but by adhering to a fully exclusionary diet. In cases where milk products are reduced, care must be taken that enough calcium is added to the diet through either foods high in calcium, or a calcium supplement. The sweeteners, fructose and sorbitol may produce symptoms similar to those of lactose intolerance. The sugar sorbitol is only passively absorbed in the small intestine, and in clinical studies 10 g doses produced symptoms identical to lactose malabsorption in about half the patients tested. However, several other researchers argued this conclusion by suggesting that some patients do react adversely to sorbitol-fructose intake (especially those with diarrhea). Generation of symptoms could therefore be related to both the nature of colonic fermentation and individual sensitivity. High levels of sorbitol are found in apples, pears, cherries, plums, prunes, peaches and their juices. Reducing or eliminating foods containing these products may be considered as part of an elimination diet. This means eliminating all products that might contain wheat and wheat flour, as well as other offending grains such as rye, oats and barley. Elimination of these products need not be lifelong, but adjusted according to symptom occurrence. Researchers suggest that lactobacillus supplement works by preventing disease causing bacteria from attaching to the bowel wall. In general, patients should be encouraged to adhere to a healthy, well-balanced diet avoiding foods that aggravate symptoms. Patients should be referred to a dietitian for additional assistance in menu planning if necessary. Psychiatric referral is recommended whenever the physician believes further assessment is in the patient’s best interest, for example when the patient is depressed and expresses suicidal ideation or when the patient has questions regarding psychotropics. As a result, patients can learn how to find healthier ways of responding to those situations, thereby reducing stress. Breathing techniques and physical activity have proven useful in alleviating or helping patients deal with stress in their lives. Biofeedback and relaxation techniques, such as imagery or self-hypnosis, encourage control of physical and emotional responses—especially when coping with stress. The diary should include the date and time, the symptom experienced and its severity (for example, pain or diarrhea on a scale of 1-10), associated factors (such as diet, activity or stress), emotional response (angry, sad, anxious), and thoughts associated with the incident (out of control, hopeless). A written record of stressors and associated responses may help patients more easily identify triggers and more rapidly implement appropriate stress management techniques. However, it should be noted that these trials have been criticized for methodological failings, and the efficacy of anticholinergics and antispasmodics has not yet been proven definitively. As a result, these drugs are only recommended on an “as needed” basis, with dosing up to twice a day for bloating, distention and acute attacks of pain. Currently available antispasmodics are separated into the general therapeutic classifications of anticholinergics, calcium-channel blockers, and opiod receptor modulators. Opiates such as trimebutine have often been used not only as antidiarrheals but also as antispasmodics. Antidiarrheal agents Antidiarrheal agents are used to treat diarrhea adjunctly with rehydration therapy to correct fluid and electrolyte depletion. In patients with diarrhea as the predominant symptom, small bowel and proximal colonic transit times are accelerated. Loperamide (2–4 mg up to 4 times/day) decreases transit time, enhances bile acid absorption, increases anal sphincter tone, and reduces abdominal pain. This synthetic opioid is also effective in reducing postprandial urgency and improving control at times of anticipated stress. Loperamide is preferable to other narcotics for treating irritable bowel patients with diarrhea and/or incontinence. Cholestyramine may also be useful as a second or third line treatment for bile acid malabsorption. This therapy is typically recommended in patients with severe symptoms, or symptoms resistant to first-line approaches, due to side effects. Lower dosages are used compared with dosages used for the treatment of depression Tricyclic agents function as analgesics by modulating pain via their anticholinergic properties. It is hypothesized that tricyclic antidepressants directly influence brain-gut axis abnormalities inherent to the function process.
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Hepatology ing in categorising small nodules (10-20 mm) detected in 2008;49:658-664 treatment 7th feb buy 500mg meldonium. Epidemiol Infect 92) Tremosini S medicine qid buy generic meldonium on line, Forner A symptoms torn rotator cuff discount 250 mg meldonium, Boix L symptoms 6 days dpo buy cheap meldonium 250 mg online, Vilana R, Bianchi L, 1988;100:481-492. Liver Imaging Reporting and Data System v2014 with gadoxetate disodium–enhanced magnetic tamine synthetase) in liver biopsies for diagnosis of very resonance imaging. European Organisation For Research And Treatment Of 80) Liu W, Qin J, Guo R, Xie S, Jiang H, Wang X, et al. Prospective validation of the imaging reporting and data system category 4 nodules in Barcelona Clinic Liver Cancer staging system. Validation of the Hong Kong Liver Cancer in cirrhotic patients: 10-year single-center experience. Patient-physician disagreement re treatment of patients with very early hepatocellular carci garding performance status is associated with worse noma. Recurrence of hepatocellular cancer after resec ment of small hepatocellular carcinomas in patients with tion: patterns, treatments, and prognosis. A model to pre cinoma with or without portal vein embolization: periop dict survival in patients with end-stage liver disease. Am J Transplant 2004(4 Suppl improve resectability and may improve disease-free sur 9):114-131. Long-term survival analysis of pure lap the current liver transplant allocation system. Am J aroscopic versus open hepatectomy for hepatocellular Transplant 2010;10:1643-1648. Downstaging of hepatocellular cancer before 110) Memeo R, de’Angelis N, Compagnon P, Salloum C, liver transplant: long-term outcome compared to tumors Cherqui D, Laurent A, Azoulay D. Clin Recommendations for liver transplantation for hepatocel Res Hepatol Gastroenterol 2016;40:309-314. Stereotactic body radiation therapy as an alternative 129) Escartin A, Sapisochin G, Bilbao I, Vilallonga treatment for small hepatocellular carcinoma. Randomized clinical trial compar injection for hepatocelullar carcinoma: a meta-analysis. Int J Radiat Oncol Biol Phys review of randomized trials for hepatocellular carcinoma 2016;95:477-482. Microwave coagulation therapy for hepatic tumors: unresectable hepatocellular carcinoma: a randomised review of the literature and critical analysis. Image-guided ablation of malignant liver odol chemoembolization for unresectable hepatocellular tumors: recommendations for clinical validation of novel carcinoma. Local-regional treatment of he chemoembolization in patients with hepatocellular patocellular carcinoma. Survival of patients with hepatocel noma: a meta-analysis of randomized-controlled trials. Drug sorafenib for intermediate-locally advanced hepatocellu eluting beads versus conventional chemoembolization for lar carcinoma: a cohort study with propensity score anal the treatment of unresectable hepatocellular carcinoma: a ysis. Cabozantinib in hepatocellular carci longs time to progression compared with chemoem noma: results of a phase 2 placebo-controlled random bolization in patients with hepatocellular carcinoma. Cabozantinib (C) versus pla radioembolization vs chemoembolization for hepatocar cebo (P) in patients (pts) with advanced hepatocellular cinoma patients: a systematic review and meta-analysis. List the age-specific causes of liver disease in neonates, infants, older more common, if not exclusive, to children, and adolescents. Explain why fractionation of serum bilirubin is necessary in infants focusing the evaluation and defining who remain jaundiced after 2 weeks of age. Characterize biliary atresia and identify findings from the history, physical examination, and laboratory evaluation that may suggest this associated with liver disease in the diagnosis. One contributing factor is who presents with classic signs, delay in the initiation of effective such as persistent jaundice, hepato therapies. Liver transplantation is a that injury to the pediatric liver manifests in a finite number of megaly, coagulopathy, or failure to reality for pediatric patients who thrive. At other times, incidental have severe or end-stage liver dis ways; hence, different disorders often have virtually identical initial findings of abnormalities on serum ease, and other therapies also are chemistries may suggest the diagno now available for treating many presentations. Unfortunately, the difference between “physiologic cents who have acute hepatitis or natal liver disease is as high as 1 in following toxin exposure. Early recognition hyperbilirubinemia” and hyperbiliru binemia indicative of severe liver seen in older children who have is particularly important in neonates cholestasis, may manifest as irrita and infants because a delay in diag disease often is unappreciated. No matter what the nosis may have a negative effect on presentation, a stepwise analysis of the prognosis. For example, it is umented several factors contributing to late referral of infants who have historical data, clinical findings, and well recognized that when biliary laboratory values allows initiation of atresia is diagnosed after 2 months liver disease (Table 1). Reasons for a among females of normal weight, denly develops jaundice with ele Delay in Referral of Infants and the rate of intrafamilial recur vated aminotransferase values in the Who Have Liver Disease rence approaches zero. Also, an absence of other known hepatotoxic associated polysplenia syndrome exposures. Hepatitis A is often anic Lack of follow-up of neonatal favors a diagnosis of biliary atresia. Gram-negative bacteria to widespread screening (1992) can (unconjugated (eg, Escherichia coli) causing uri suggest hepatitis C infection. Teen hyperbilirubinemia) nary tract infections are especially agers who become jaundiced always False security due to a fall in common. Unfortunately, of which recently has been shown to jaundice is not recognized in infants be associated with hepatitis C (shar until the first health supervision ing of glass paraphernalia) and pos the most appropriate and cost visit, which leaves little time for sibly hepatitis B infection. If the effective strategy to diagnose and diagnosis and surgical correction of course of a documented hepatitis B treat the underlying condition. History and Signs of Liver wise approach to rule out biliary Male homosexuals are at an Disease atresia in an infant presenting with increased risk to develop viral cholestasis before 2 months of age. In the presence of extra or hepatotoxic medications, including hyperbilirubinemia) or may be intrahepatic obstruction, little or no isoniazid, nitrofurantoin, sulfon breastfeeding, it is important not to bilirubin is excreted into the intes amides, and nonsteroidal anti attribute jaundice in an infant older tine, resulting in no color to the neo inflammatory agents, such as acet than 14 days to one of these causes. If an Jaundice in any infant after 2 weeks some pigment may be present in the overdose or an intoxication is the of age should raise the suspicion of stools of neonates who have biliary cause of liver dysfunction, children liver disease and prompt appropriate obstruction because of desquamation can present with altered mental sta evaluation. Confusion and provide clues about the existence stool, these stools usually are much coma suggest liver failure or meta and type of liver disease. For exam lighter than those found in healthy bolic disease leading to hyperam ple, the onset of liver disease associ infants. Furthermore, breaking the monemia, hypoglycemia, or a com ated with dietary changes may sug stool into pieces will show that the bination of both. Female teenagers gest an inborn error of carbohydrate pigment is only superficial, with the who develop jaundice and have his metabolism, such as an inability to internal part exhibiting a clay color tories of acne, intermittent arthritis, metabolize galactose or fructose. In older children, a history docu Patients who have immunodefi A recurrent clinical phenotype menting anorexia, fever, vomiting, ciencies and become jaundiced may within a family suggests an inherited abdominal pain, darkening of the have an infection with cytomegalo disorder such as tyrosinemia or urine, especially following ingestion virus, Epstein-Barr virus, or retrovi Byler syndrome (progressive famil of crustaceans or shellfish of dubi rus. In contrast, bili disease in any child who has a his rant colicky pain and nausea (espe Pediatrics in Review Vol. Signs and symptoms of transferase concentrations (especially ticularly dark and foamy urine. In neonates who suffer early in the congenital infections, associated fea course of liver tures often include microcephaly, disease. If the chorioretinitis, purpura, low birth spleen is weight, and generalized organ fail enlarged, one ure. Dysmorphic features may be of the many characteristic of certain chromo causes of portal somal disorders. Patients who have hypertension or Alagille syndrome usually have a storage disease characteristic facies (beaked nose, should be sus high forehead), butterfly vertebrae, a pected. Nor murmur on cardiovascular ausculta mally, the liver tion due to peripheral pulmonic ste edge is round nosis, and a posterior embryotoxon and soft and on ophthalmologic examination. The onset of symp the presence of toms (such as vomiting) following fibrosis or cir the introduction of a new food con rhosis. The taining galactose or fructose could latter condition suggest galactosemia or hereditary also often is fructose intolerance. Palpation of Infants who have cholestasis often the liver in the suffer from intense pruritus, which are detergent molecules that lower epigastrium signifies either the pres is characteristic of obstructive liver the superficial tension of solutions, ence of cirrhosis or Riedel lobe disease, that primarily is manifested thereby creating visible foaminess. Among edema that is responsible for the the laboratory findings of liver this plethora of physical findings, perceived pain localized to the liver.
Overcoming these challenges requires mastering new techniques in caring for one’s airways medicine daughter lyrics generic meldonium 250 mg on line, dealing with life long side efects of radiation and other treatments symptoms 3 months pregnant buy meldonium with mastercard, living with the results of surgeries medications used to treat depression purchase 500 mg meldonium fast delivery, facing uncertainties about the future medications of the same type are known as purchase generic meldonium on line, and struggling with psychological, social, medical and dental issues. This cancer and its treatment afect some of the most basic human functions, communication, nutrition, and social interaction. As I gradually learned to cope with my life as a laryngectomee, I realized that the solutions to many problems are not only based on medicine and science but also on experience in addition to trial and error. Because each person’s medical history, anatomy and personality are diferent, so are some of the solutions. I was fortunate to beneft from my physicians, speech and language pathologists, and other laryngetomees as I learned how to care for myself and overcome the myriad of daily challenges. This practical guide is based on my Website and is aimed at Diagnosis and treatment of laryngeal providing useful information that can assist laryngectomees and their cancer caregivers in dealing with medical, dental and psychological issues. The guide contains information about the side efects of radiation and chemotherapy; the methods of speaking afer laryngectomy; how to care for the airway, stoma, heat and moisture exchange flter, and voice Overview prosthesis. In addition I address eating and swallowing issues, medical, dental and psychological concerns, respiration and anesthesia, and Laryngeal cancer afects the voice box. Although the discussion below addresses laryngeal cancer, it is also generally applicable to hypopharyngeal cancer. The larynx contains the vocal cords (or folds) which, by vibrating, generate sounds that create audible voice when the vibrations echo through the throat, mouth, and nose. The larynx is divided into three anatomical regions: the glottis (in the middle of the larynx, includes the vocal cords); the supraglottis (in the top part, includes the epiglottis, arytenoids and aryepiglottic folds, and false cords); and the subglottis (the bottom of the larynx). While cancer can develop in any part of the larynx most laryngeal cancers originate in the glottis. Supraglottic cancers are less common, and subglottic tumors are the least frequent. Diagnosis Symptoms and signs of laryngeal cancer include: • Abnormal (high-pitched) breathing sounds • Chronic cough (with and without blood) • Difculty swallowing • A sensation of a lump in the throat Figure 1: Anatomy before and afer laryngectomy • Hoarseness that does not get better in 1 2 weeks Laryngeal and hypopharyngeal cancer may spread by direct • Neck and ear pain extension to adjacent structures, by metastasis to regional cervical lymph nodes, or more distantly, through the blood stream to other locations in • Sore throat that does not get better in 1 2 weeks, even with the body. Later symptoms may include difculty in swallowing, Cancer Statistics Review of the National Cancer Institute, an estimated ear pain, chronic and sometimes bloody cough, and hoarseness. The number of new laryngectomees has been declining mainly airway obstruction or palpable metastatic lymph nodes. A contrast material such as an injected or swollen dye difculty in breathing on exertion. Many tests are magnet and radio waves to generate a series of detailed pictures required to determine if a person has cancer or if another condition of areas inside the body. Efective diagnostic testing is used to confrm or eliminate the Barium swallow: A procedure to examine the esophagus and presence of cancer, monitor its progress, and plan for and evaluate stomach in which the patient drinks a barium solution that coats the efectiveness of treatment. In some instances, it is necessary to the esophagus and stomach, and x-rays are obtained. Diagnostic procedures for cancer may include imaging, can be viewed under a microscope to check for cancer. The potential for recovery from laryngeal cancer depends on the The following tests and procedures may be used to help diagnose following: and stage laryngeal cancer which infuences the choice of treatment: • The extent the cancer has spread (the “stage”) Physical examination of the throat and neck: this enables the doctor to feel for swollen lymph nodes in the neck and to view • The appearance of the cancer cells (the “grade”) the throat by using a small, long-handled mirror to check for abnormalities. Patients with laryngeal cancer who continue to smoke and drink are less likely to be cured and Laryngoscopy: A procedure to examine the larynx with a mirror more likely to develop a second tumor. This may include • Maintaining the patient’s ability to talk, eat, and breathe as surgery and a combination of radiation therapy and chemotherapy, normally as possible generally given at the same time. Targeted therapy is another therapeutic option specifcally • Whether the cancer has returned directed at advanced laryngeal cancer. Targeted cancer therapies are administered by using drugs or other substances that block the growth The medical team describes the available treatment choices to the and spread of cancer by interfering with specifc molecules involved in patient and what are the expected results, as well as the possible side tumor growth and progression. Patients should carefully consider the available options and The choice of treatment depends mainly on the patient’s general understand how these treatments may afect their ability to eat, swallow, health, the location of the tumor, and whether the cancer has spread to and talk, and whether these treatments will alter their appearance other sites. The patient and his/her health care team can work together to develop a treatment plan that fts the patient’s A team of medical specialists generally collaborate in planning the needs and expectations. Supportive care for control of pain and other symptoms that can Tese can include: relieve potential side efects and ease emotional concerns should be available before, during, and afer cancer treatment. If necessary, obtaining a second medical and/or surgical opinion is • General head and neck surgeons helpful. Having a patient advocate (family member or friend) attend the discussions with the medical team is desirable as they can assist the • Medical oncologists patient in making the best choice. Having surgery: types of laryngectomy, • What are the chances of being able to eat normally. Types of laryngectomy • What is the estimated cost of the treatment and will insurance Treatment of laryngeal cancer ofen includes surgery. Laser surgery is performed using a device that generates an intense beam of light that cuts or destroys tissues. Tere are two types of surgery for removal of laryngeal cancer: • Is a research study (clinical trial) a good option. Removal of part of the larynx: The surgeon takes out only the part of the larynx harboring the tumor. Removal of the entire larynx: The surgeon removes the whole larynx and some adjacent tissues. Lymph nodes that are close or drain the cancerous site may also be taken out during either type of surgery. The patient may need to undergo reconstructive or plastic surgery to rebuild the afected tissues. The surgeon may obtain tissues from other parts of the body to repair the site of the surgery in the throat and/ or neck. The reconstructive or plastic surgery sometimes takes place at the same time when the cancer is removed, or it can be performed later. Surgery’s outcome The main results of the surgery can include all or some of the following: Preparing for surgery • Troat and neck swelling Prior to surgery it is important to thoroughly discuss with the surgeon all available therapeutic and surgical options and their short and • Local pain long term outcomes. It is therefore important to have a patient • Tiredness advocate (such as a family member or friend) also attend the meetings with the surgeon. It is important to freely ask and discuss any concerns • Increased mucus production and request clarifcations. It may be necessary to repeatedly listen to explanations until they are fully understood. It is useful to prepare • Changes in physical appearance questions to ask the surgeon prior to the meeting and write down the information obtained. However, not all such efects are permanent, as discussed later in the guide (see chapters • Radiation oncologist 6 and 11). Tose who lose their ability to talk afer surgery may fnd it useful to communicate by writing on a notepad, writing board (such as • Medical oncologist a magic slate), cell phone, or computer. Prior to the surgery it may be helpful to make a recording for one’s answering machine or voicemail • Anesthetist to inform callers about one’s speaking difculties. Generally, the delay in initiating treatment • Social worker or mental health counselor will not make the eventual treatment less efective. One can request a referral to another specialist from the primary doctor, It is also very useful to meet other individuals who have already a local or state medical society, a nearby hospital, or a medical school. They can guide the patient about future Even though patients with cancer are ofen in a rush to get treated and speech options, share some of their experiences, and provide emotional remove the cancer as soon as possible, waiting for another opinion may support. Getng a second opinion Pain management afer surgery When facing a new medical diagnosis that requires making a choice The degree of pain experienced afer laryngecomy (or any other head between several therapeutic options, including surgery, it is important and neck surgery) is very subjective, but, as a general rule, the more to get a second opinion. Tere may be diferent medical and surgical extensive the surgery, the more likely the patient will experience pain. Certain types of reconstructive procedures, where tissue is transferred Getting such an opinion from physicians experienced in the issues at (a fap) from the chest muscles, forearm, thigh, jejunum, or a stomach hand is judicious. Tere are many situations when treatment cannot be pull up are more likely to be associated with increased or prolonged reversed. Tose who have a radical neck dissection as part of the surgery Some individuals may be reluctant to ask for a referral to see may experience additional pain. Some may be afraid that this “modifed radical neck dissection” when the spinal accessory nerve is will be interpreted as lack of confdence in their primary physician or not removed.