American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. Implementing evidence based antiemetic guidelines in the oncology setting: results of a 4-month prospective intervention study Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline. Recommendations for clinical trials of off-label drugs used to treat advanced-stage cancer. Assessment of the relationship between adherence with antiemetic drug therapy and control of nausea and vomiting in breast cancer patients receiving anthracycline-based chemotherapy. Guideline for the prevention of acute nausea and vomiting due to antineoplastic medication in pediatric cancer patients. Recommendations for the Use of White Blood Cell Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer. Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials. Pharmaceutical care for patients with breast and ovarian cancer A prospective observational trial on emesis in radiotherapy: analysis of 1020 patients recruited in 45 Italian radiation oncology centres. Views of American oncologists about the purposes of clinical trials. EAU guidelines on renal cell carcinoma: the 2010 update. American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guidelines in the adjuvant setting. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. American Society of Clinical Oncology 2008 clinical practice guideline update: use of chemotherapy and radiation therapy protectants. Who enrolls onto clinical oncology trials? A radiation Patterns Of Care Study analysis.
PURPOSE To up date the 1999 American Society of Clinical Oncology guideline for antiemetics in oncology . UP DATE METHODOLOGY The Up date Committee completed a review and analysis of data published from 1998 thru February 2006 . The literature review focused on published r and omized controlled trials , and systematic review s and meta-analyses of published phase II and phase III r and omized controlled trials . RECOMMENDATIONS The three-drug combination of a 5-hydroxytryptamine-3 ( 5-HT(3 ) ) serotonin receptor antagonist , dexamethasone , and aprepitant is recommended before chemotherapy of high emetic risk . For persons receiving chemotherapy of high emetic risk , there is no group of patients for whom agents of lower therapeutic index are appropriate first-choice antiemetics . These agents should be reserved for patients intolerant of or refractory to 5-HT3 serotonin receptor antagonists , neurokinin-1 receptor antagonists , and dexamethasone . The three-drug combination of a 5-HT3 receptor serotonin antagonist , dexamethasone , and aprepitant is recommended for patients receiving an anthracycline and cyclophosphamide . For patients receiving other chemotherapy of moderate emetic risk , the Up date Committee continues to recommend the two-drug combination of a 5-HT3 receptor serotonin antagonist and dexamethasone . In all patients receiving cisplatin and all other agents of high emetic risk , the two-drug combination of dexamethasone and aprepitant is recommended for the prevention of delayed emesis . The Up date Committee no longer recommends the combination of a 5-HT3 serotonin receptor antagonist and dexamethasone for the prevention of delayed emesis after chemotherapeutic agents of high emetic risk . CONCLUSION The Up date Committee recommends that clinicians administer antiemetics while considering patients ' emetic risk categories and other characteristics Abstract . There is a considerable gap between obtaining results in r and omized trials and implementing them into practice . This is particularly relevant with the high-cost 5HT3 antiemetics , which include ondansetron , dolasetron and granisetron . R and omized trial data suggests that they should be used as a single daily dose during only the first 24 h of chemotherapy because they offer little benefit over less costly agents beyond this period . In this study , six intervention methods ( i.e. multifaceted approach ) were combined to change physicians ' 5HT3 prescribing patterns to comply with evidence -based antiemetic guidelines . A six-step implementation process was adopted , consisting of guideline dissemination , the use of opinion leaders , interactive educational workshops , therapeutic reminders in the form of preprinted orders , clinical interventions by pharmacists for the event of inappropriate antiemetic orders , and physician audit and feedback . Once implemented , the control of emesis was collected in all patients who were enrolled in the intervention program . Multivariable regression analysis was then used to assess whether prescribing within antiemetic guidelines compromised patient care . A total of 195 in patients were enrolled in the study over the 4-month intervention period . Overall , 88.7 % of granisetron prescriptions fulfilled the guidelines with respect to appropriate indication , dosage , and duration of therapy . The multivariable analysis suggested that granisetron prescribing within guidelines did not compromise the control of acute and delayed emesis . In addition , patients who received evidence -based antiemetic therapy experienced a significant reduction in the severity of acute nausea [ risk ratio ( RR ) = 0.69 ; P=0.03 ] . The results of this guideline implementation study revealed that a pharmacist-driven multifaceted intervention program for such high-cost agents as 5HT3 antiemetics can promote their use in a clinical ly appropriate manner and can save unnecessary drug costs without compromising the quality of patient care PURPOSE To provide evidence -based recommendations to oncologists and others for treatment of patients with locally advanced , unresectable pancreatic cancer . METHODS American Society of Clinical Oncology convened an Expert Panel of medical oncology , radiation oncology , surgical oncology , gastroenterology , palliative care , and advocacy experts and conducted a systematic review of the literature from January 2002 to June 2015 . Outcomes included overall survival , disease-free survival , progression-free survival , and adverse events . RESULTS Twenty-six r and omized controlled trials met the systematic review criteria . RECOMMENDATIONS A multiphase computed tomography scan of the chest , abdomen , and pelvis should be performed . Baseline performance status and comorbidity profile should be evaluated . The goals of care , patient preferences , psychological status , support systems , and symptoms should guide decisions for treatments . A palliative care referral should occur at first visit . Initial systemic chemotherapy ( 6 months ) with a combination regimen is recommended for most patients ( for some patients radiation therapy may be offered up front ) with Eastern Cooperative Oncology Group performance status 0 or 1 and a favorable comorbidity profile . There is no clear evidence to support one regimen over another . The gemcitabine-based combinations and treatments recommended in the metastatic setting ( eg , fluorouracil , leucovorin , irinotecan , and oxaliplatin and gemcitabine plus nanoparticle albumin-bound paclitaxel ) have not been evaluated in r and omized controlled trials involving locally advanced , unresectable pancreatic cancer . If there is local disease progression after induction chemotherapy , without metastasis , then radiation therapy or stereotactic body radiotherapy may be offered also with an Eastern Cooperative Oncology Group performance status ≤ 2 and an adequate comorbidity profile . If there is stable disease after 6 months of induction chemotherapy but unacceptable toxicities , radiation therapy may be offered as an alternative . Patients with disease progression should be offered treatment per the ASCO Metastatic Pancreatic Cancer Treatment Guideline . Follow-up visits every 3 to 4 months are recommended . Additional information is available at www.asco.org/ guidelines /LAPC and www.asco.org/ guidelines /MetPC and www.asco.org/ guidelines wiki PURPOSE To provide recommendations to trialists and sponsors that guide the design and implementation of prospect i ve postapproval clinical trials for oncology drugs used outside US Food and Drug Administration-labeled indications for treatment of late-stage cancers . METHODS A meeting was hosted by the Center for Medical Technology Policy in Baltimore , MD , on November 12 , 2009 . Discussion s during the meeting and key informant interviews were conducted before and after this stakeholder meeting . Peer review by multidisciplinary stakeholders was followed by a public comment period . Input was received from patient advocacy groups , medical oncologists , pharmaceutical companies , the US Food and Drug Administration , Centers for Medicare and Medicaid Services , the National Cancer Institute , foreign government agencies involved in health technology assessment , public and private payers , drug compendia , clinical research entities , statisticians , academics , and the American Society of Clinical Oncology . RESULTS To address the needs of patients and their clinical providers , compendia , payers , and policy makers , recommendations are proposed to guide the design of future prospect i ve trials for off-label use of oncology drugs across four areas : trial design and data analysis , patient and site recruitment , comparators , and outcomes . CONCLUSION The US Food and Drug Administration provides guidance to the pharmaceutical industry and others design ing r and omized clinical trials for regulatory approval . However , a gap exists for postregulatory decision makers , including patients , prescribers , and payers , because regulatory trials do not answer the questions most relevant to them . Therefore , guidance is needed for trials performed in the postapproval environment for these postapproval decision makers BACKGROUND There are little prevalence data in the literature on nonadherence to outpatient antiemetic regimens for prophylaxis of chemotherapy-induced nausea and vomiting ( CINV ) . It is unclear whether adherence with outpatient antiemetic regimens is associated with better CINV control . Our previous survey research supports the work of clinical pharmacists in collaborative practice with medical oncologists in improving adherence with antiemetic therapy in women undergoing highly emetic chemotherapy for breast cancer . OBJECTIVES To ( a ) evaluate the impact of adherence to delayed antiemetics ( days 2 - 4 following anthracycline-based chemotherapy ) on CINV control in breast cancer patients after anthracycline-based chemotherapy and ( b ) identify patient-related factors associated with nonadherence to delayed antiemetics . METHODS A single-center , prospect i ve , observational study was conducted from December 2006 to January 2011 in breast cancer patients receiving anthracycline-based chemotherapy ( doxorubicin or epirubicin ) and antiemetics at the National Cancer Centre Singapore ( NCCS ) , the largest ambulatory cancer center in Singapore . Included patients were aged 21 years or older with confirmed diagnoses of breast cancer and receiving anthracycline-containing chemotherapy with antiemetics . Patients were excluded if they ( a ) were diagnosed with intestinal obstruction or received concurrent radiotherapy that predisposed them to nausea and vomiting , ( b ) had vomited in the 24 hours preceding chemotherapy , or ( c ) had brain metastases that would impair their judgment . Patients documented in a st and ardized diary their emesis events , severity of nausea , use of rescue therapy with metoclopramide , and compliance with dose instructions for antiemetic drug therapy for 5 days : day 1 was the day of chemotherapy and first day of antiemetic therapy , and day 5 was the day after completion of delayed antiemetic therapy ( days 2 - 4 ) . Three definitions were used to describe the CINV outcomes : ( a ) complete response ( no emetic episodes and no rescue therapy ) ; ( b ) complete protection ( no emetic episodes , no rescue therapy , and no significant nausea [ Likert score 2 or less ] ) ; and ( c ) complete control ( no emetic episodes , no rescue therapy , and no nausea ) . The delayed ( days 2 - 5 post-chemotherapy ) phase of these endpoints was analyzed . Nonadherence was defined as missing at least 1 dose of the delayed antiemetics from the prescribed regimen . Pearson chi-square or Fisher 's exact tests and multiple logistic regression analysis were used to assess the relationship between adherence and CINV outcomes . RESULTS Of 519 eligible patients , 88 ( 17.0 % ) patients declined participation ; 35 ( 6.7 % ) were lost to follow-up ; and another 35 ( 6.7 % ) were excluded due to the absence of therapy with delayed antiemetics according to guideline protocol . Of the 361 ( 69.6 % ) patients included in the final analysis , the mean ( SD ) age was 50.0 ( 8.9 ) ; the majority was Chinese ( 80.1 % ) and diagnosed with stage 2 or higher breast cancer ( 88.1 % ) . A total of 152 patients ( 42.1 % ) self-reported nonadherent use of delayed antiemetics .  Among all the nonadherent patients ( n=152 ) , 16.4 % ( n=25 ) achieved complete control ; 34.2 % ( n=52 ) achieved complete protection ; and 58.6 % ( n=89 ) achieved complete response , compared with rates of 26.8 % ( n=56 ) , 39.7 % ( n=83 ) , and 62.7 % ( n=131 ) , respectively , for adherent patients ( n=209 ) . The rate of adherence to dexamethasone  , which was prescribed for all study patients , was low ( 62.6 % ) . After adjusting for potential confounders ( ethnicity , educational level , and disease stage ) , adherent patients were more likely to achieve complete control of CINV ( adjusted odds ratio=1.74 , 95 % CI=1.01 - 3.01 , P=0.048 ) . Among the demographic and CINV risk-factor variables , higher education , alcohol consumption , and prior exposure to other ( nonanthracycline-based ) chemotherapy regimens were associated with nonadherence ( P < 0.05 ) . CONCLUSIONS Although 42 % of breast cancer patients receiving anthracycline-based chemotherapy  were nonadherent with the dose administration protocol for post-chemotherapy antiemetic therapy , there was no significant difference in control of CINV compared with adherent patients except for the category of complete CINV control , defined as no nausea , no emesis , and no use of the rescue medication metoclopramide This guideline provides an approach to the prevention of acute antineoplastic-induced nausea and vomiting ( AINV ) in children . It was developed by an international , inter-professional panel using AGREE and CAN-IMPLEMENT methods . Evidence -based interventions that provide optimal AINV control in children receiving antineoplastic agents of high , moderate , low , and minimal emetogenicity are recommended . Recommendations are also made regarding selection of antiemetic agents for children who are unable to receive corticosteroids for AINV control , the role of aprepitant and optimal doses of antiemetic agents . Gaps in the evidence used to support the recommendations were identified . The contribution of this guideline to AINV control in children requires prospect i ve evaluation Purpose To up date the 2006 American Society of Clinical Oncology guideline on the use of hematopoietic colony-stimulating factors ( CSFs ) . Methods The American Society of Clinical Oncology convened an Up date Committee and conducted a systematic review of r and omized clinical trials , meta-analyses , and systematic review s from October 2005 through September 2014 . Guideline recommendations were based on the review of the evidence by the Up date Committee . Results Changes to previous recommendations include the addition of tbo-filgrastim and filgrastim-sndz , moderation of the recommendation regarding routine use of CSFs in older patients with diffuse aggressive lymphoma , and addition of recommendations against routine dose-dense chemotherapy in lymphoma and in favor of high – dose-intensity chemotherapy in urothelial cancer . The Up date Committee did not address recommendations regarding use of CSFs in acute myeloid leukemia or myelodysplastic syndromes in adults . Recommendations Prophylactic use of CSFs to reduce the risk of febrile neutropenia is warranted when the risk of febrile neutropenia is approximately 20 % or higher and no other equally effective and safe regimen that does not require CSFs is available . Primary prophylaxis is recommended for the prevention of febrile neutropenia in patients who are at high risk on the basis of age , medical history , disease characteristics , and myelotoxicity of the chemotherapy regimen . Dose-dense regimens that require CSFs should only be used within an appropriately design ed clinical trial or if supported by convincing efficacy data . Current recommendations for the management of patients exposed to lethal doses of total-body radiotherapy , but not doses high enough to lead to certain death as a result of injury to other organs , include the prompt administration of CSFs . J Clin Oncol 33:3199 - 3212 . © 2015 by American Society of Clinical The purpose of this article is to provide up date d recommendations for the treatment of patients with stage IV non-small-cell lung cancer . A literature search identified relevant r and omized trials published since 2002 . The scope of the guideline was narrowed to chemotherapy and biologic therapy . An Up date Committee review ed the literature and made up date d recommendations . One hundred sixty-two publications met the inclusion criteria . Recommendations were based on treatment strategies that improve overall survival . Treatments that improve only progression-free survival prompted scrutiny of toxicity and quality of life . For first-line therapy in patients with performance status of 0 or 1 , a platinum-based two-drug combination of cytotoxic drugs is recommended . Nonplatinum cytotoxic doublets are acceptable for patients with contraindications to platinum therapy . For patients with performance status of 2 , a single cytotoxic drug is sufficient . Stop first-line cytotoxic chemotherapy at disease progression or after four cycles in patients who are not responding to treatment . Stop two-drug cytotoxic chemotherapy at six cycles even in patients who are responding to therapy . The first-line use of gefitinib may be recommended for patients with known epidermal growth factor receptor ( EGFR ) mutation ; for negative or unknown EGFR mutation status , cytotoxic chemotherapy is preferred . Bevacizumab is recommended with carboplatin-paclitaxel , except for patients with certain clinical characteristics . Cetuximab is recommended with cisplatin-vinorelbine for patients with EGFR-positive tumors by immunohistochemistry . Docetaxel , erlotinib , gefitinib , or pemetrexed is recommended as second-line therapy . Erlotinib is recommended as third-line therapy for patients who have not received prior erlotinib or gefitinib . Data are insufficient to recommend the routine third-line use of cytotoxic drugs . Data are insufficient to recommend routine use of molecular markers to select chemotherapy PURPOSE Oncologists prescribe anticancer drugs based on results of phase III r and omized clinical trials ( RCTs ) , but some safety concerns appear only later in up date d drug labels . Here , we analyze adverse drug reactions ( ADRs ) of targeted anticancer agents from up date d drug labels and their reporting in corresponding pivotal RCTs . METHODS We search ed the US Food and Drug Administration ( FDA ) Web site for approved targeted anticancer drugs with up date s of their labels related to safety in 2008 and 2009 and at least one RCT referenced in the up date d drug label . For each drug , serious ADRs , including potentially fatal ADRs , were identified from the up date d label . Published reports of RCTs referenced in the label were search ed to determine whether they described these ADRs . RESULTS We identified 12 eligible targeted anticancer agents with 36 corresponding RCTs referenced in up date d drug labels . There were 76 serious ADRs reported in up date d drug labels , and 50 % ( n = 38 ) were potentially fatal . Of these , 39 % ( n = 30 ) of all serious ADRs and 39 % ( n = 15 ) of potentially fatal ADRs were not described in any published report of RCTs , whereas 49 % and 58 % , respectively , were not described in initial drug labels . After a median 4.3 years between initial approval and up date of drug labels , 42 % ( n = 5 ) of targeted cancer agents acquired one or more boxed warnings ( the highest level of FDA alert ) . CONCLUSION Published reports of pivotal RCTs and initial drug labels contain limited information about serious ADRs of targeted anticancer agents . Rare but serious ADRs may be important causes of morbidity and mortality in general oncologic practice Purpose Individualized patient care may help reduce the incidence of adverse drug events in systemic cancer therapy . This study was conducted to explore the feasibility and potential of additional pharmaceutical care for breast and ovarian cancer patients . Methods The study was design ed as a prospect i ve , multicentered cohort study with a control group . Ninety-eight breast or ovarian cancer patients were recruited from outpatient oncology clinics and primary care oncologists : initially into the control group receiving st and ard care and after implementation of pharmaceutical care into the intervention group consisting of additional patient counseling on the management of treatment-associated adverse events and optimization of supportive medication . Primary outcome was the complete response to the antiemetic prophylaxis . Secondary endpoints were the severity of nausea , frequency of emesis , health-related quality of life , and patient satisfaction with information on cancer treatment education . Results Forty-eight patients were included in the control group and 50 in the intervention group . Of the patients , 35.4 % in the control group and 76.0 % in the intervention group ( p < 0.001 ) had a complete response to the antiemetic prophylaxis . The severity of acute and delayed nausea was not reduced . The global health scale and two symptom scales ( nausea and vomiting , appetite loss ) of the EORTC QLQ-C30 question naire were positively affected by pharmaceutical care . Patient satisfaction with information was significantly higher in the intervention group . Conclusions Patients with breast and ovarian cancer seem to benefit from pharmaceutical care , as suggested by improved patient-reported outcomes such as emetic episodes , quality of life , and patient satisfaction after implementation PURPOSE A prospect i ve observational multicentre trial was carried out to assess the incidence , pattern , and prognostic factors of  radiation-induced emesis ( RIE )  , and to evaluate the use of antiemetic drugs  in patients treated with radiotherapy or concomitant radio-chemotherapy .  The application in clinical practice of the Multinational Association of Supportive Care in Cancer guidelines was also studied . MATERIAL S AND METHODS Forty-five Italian radiation oncology centres took part in this trial . The accrual lasted for 3 consecutive weeks and only patients starting radiotherapy or concomitant radio-chemotherapy in this period were enrolled . Evaluation was based on diary card filled in daily by patients during treatment and one week after stopping it . Diary card recorded the intensity of nausea/vomiting and prophylactic/symptomatic antiemetic drug prescriptions .  RESULTS A total of 1020 patients entered into the trial , and 1004 were evaluable .  Vomiting and nausea occurred in 11.0 % and 27.1 % of patients , respectively , and 27.9 % patients had both vomiting and nausea . In multifactorial analysis , the only statistically significant patient-related risk factors were concomitant chemotherapy and previous experience of vomiting induced by chemotherapy . Moreover , two radiotherapy-related factors were significant risk factors for RIE , the irradiated site ( upper abdomen ) and field size ( > 400 cm(2 ) ) . An  antiemetic drug  was given only to a minority ( 17 % ) of patients receiving RT , and the prescriptions were prophylactic in 12.4 % and symptomatic in 4.6 % . Different compounds and a wide range of doses and schedules were used . CONCLUSIONS These data were similar to those registered in our previous observational trial , and the radiation oncologists ' attitude in underestimating RIE and under prescribing antiemetics was confirmed BACKGROUND Many research subjects believe incorrectly that the primary purpose of clinical trials is to benefit the participants rather than to improve therapy for future patients . However , few data are available about how physicians view trials . METHODS We mailed surveys to a stratified r and om sample ( n = 1120 ) of U.S. medical , pediatric , and other oncology specialists who were selected from the American Society of Clinical Oncology Membership Directory . Respondents were asked to select , from a list of options , their reasons for enrolling individual patients in trials  and what they thought the main societal purpose s of clinical trials are . We used logistic regression models to evaluate which demographic and clinical practice characteristics were associated with responses to these questions . All statistical tests were two-sided . RESULTS Of the 547 physicians ( 48.8 % ) who responded , 40.5 % of the medical oncologists , 32.3 % of the pediatric oncologists , and 62.6 % of the other oncology subspecialists reported enrolling individual patients in clinical trials to improve future therapy . Most of the other respondents reported enrolling patients to ensure that they received state-of-the-art treatment . When asked about the main societal purpose of clinical trials , 72.7 % of the medical oncologists , 59.4 % of the pediatric oncologists , and 81.9 % of the other oncology subspecialists cited  improving future therapy ;  most of the other respondents cited ensuring state-of-the-art treatment for participants . In multivariable analysis , medical oncologists ( odds ratio [ OR ] = 0.6 , 95 % confidence interval [ CI ] = 0.3 to 0.9 ) and pediatric oncologists ( OR = 0.3 , 95 % CI = 0.2 to 0.5 ) were less likely than other oncologists to identify improving future therapy as the main societal purpose of clinical trials , whereas industry physicians ( OR = 4.6 , 95 % CI = 1.1 to 20.5 ) chose this option more often than physicians who did not work for industry . CONCLUSIONS Many respondents viewed the main societal purpose of clinical trials as benefiting the participants rather than as creating generalizable knowledge to advance future therapy . This view , which was more prevalent among specialists such as pediatric oncologists that enrolled greater proportions of patients in trials , conflicts with established principles of research ethics CONTEXT AND OBJECTIVES The European Association of Urology Guideline Group for renal cell carcinoma ( RCC ) has prepared these guidelines to help clinicians assess the current evidence -based management of RCC and to incorporate the present recommendations into daily clinical practice . EVIDENCE ACQUISITION The recommendations provided in the current up date d guidelines are based on a thorough review of available RCC guidelines and review articles combined with a systematic literature search using Medline and the Cochrane Central Register of Controlled Trials . EVIDENCE SYNTHESIS A number of recent prospect i ve r and omised studies concerning RCC are now available with a high level of evidence , whereas earlier publications were based on retrospective analyses , including some larger multicentre validation studies , meta-analyses , and well- design ed controlled studies . CONCLUSIONS These guidelines contain information for the treatment of an individual patient according to a current st and ardised general approach . Up date d recommendations concerning diagnosis , treatment , and follow-up can improve the clinical h and ling of patients with RCC PURPOSE To up date the 1999 American Society of Clinical Oncology ( ASCO ) guideline on breast cancer follow-up and management in the adjuvant setting . METHODS An ASCO Expert Panel review ed pertinent information from the literature through March 2006 . More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a r and omized design . RESULTS The evidence supports regular history , physical examination , and mammography as the cornerstone of appropriate breast cancer follow-up . All patients should have a careful history and physical examination performed by a physician experienced in the surveillance of cancer patients and in breast examination . Examinations should be performed every 3 to 6 months for the first 3 years , every 6 to 12 months for years 4 and 5 , and annually thereafter . For those who have undergone breast-conserving surgery , a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy . Thereafter , unless otherwise indicated , a yearly mammographic evaluation should be performed . Patients at high risk for familial breast cancer syndromes should be referred for genetic counseling . The use of CBCs , chemistry panels , bone scans , chest radiographs , liver ultrasounds , computed tomography scans , [18F]fluorodeoxyglucose-positron emission tomography scanning , magnetic resonance imaging , or tumor markers ( carcinoembryonic antigen , CA 15 - 3 , and CA 27.29 ) is not recommended for routine breast cancer follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination . CONCLUSION Careful history taking , physical examination , and regular mammography are recommended for appropriate detection of breast cancer recurrence Purpose To provide evidence -based recommendations to up date the American Society of Clinical Oncology guideline on systemic therapy for stage IV non – small-cell lung cancer ( NSCLC ) . Methods An Up date Committee of the American Society of Clinical Oncology NSCLC Expert Panel based recommendations on a systematic review of r and omized controlled trials from January 2007 to February 2014 . Results This guideline up date reflects changes in evidence since the previous guideline . Recommendations There is no cure for patients with stage IV NSCLC . For patients with performance status ( PS ) 0 to 1 ( and appropriate patient cases with PS 2 ) and without an EGFR-sensitizing mutation or ALK gene rearrangement , combination cytotoxic chemotherapy is recommended , guided by histology , with early concurrent palliative care . Recommendations for patients in the first-line setting include platinum-doublet therapy for those with PS 0 to 1 ( bevacizumab may be added to carboplatin plus paclitaxel if no contraindications ) ; combination or single-agent chemotherapy or palliative care alone for those with PS 2 ; afatinib , erlotinib , or gefitinib for those with sensitizing EGFR mutations ; crizotinib for those with ALK or ROS1 gene rearrangement ; and following first-line recommendations or using platinum plus etoposide for those with large-cell neuroendocrine carcinoma . Maintenance therapy includes pemetrexed continuation for patients with stable disease or response to first-line pemetrexed-containing regimens , alternative chemotherapy , or a chemotherapy break . In the second-line setting , recommendations include docetaxel , erlotinib , gefitinib , or pemetrexed for patients with nonsquamous cell carcinoma ; docetaxel , erlotinib , or gefitinib for those with squamous cell carcinoma ; and chemotherapy or ceritinib for those with ALK rearrangement who experience progression after crizotinib . In the third-line setting , for patients who have not received erlotinib or gefitinib , treatment with erlotinib is recommended . There are insufficient data to recommend routine third-line cytotoxic therapy . Decisions regarding systemic therapy should not be made based on age alone . Additional information can be found at http://www.asco.org/ guidelines /nsclc and http://www.asco.org/ guidelines wiki . J Clin Oncol 33:3488 - 3515 . © 2015 by American Society of Clinical PURPOSE To up date a clinical practice guideline on the use of chemotherapy and radiation therapy protectants for patients with cancer . METHODS An up date committee review ed literature published since the last guideline up date in 2002 . RESULTS Thirty-nine reports met the inclusion criteria : palifermin and dexrazoxane , three reports ( two studies ) each ; amifostine , 33 reports ( 31 studies ) ; and mesna , no published r and omized trials identified since 2002 . RECOMMENDATIONS Dexrazoxane is not recommended for routine use in breast cancer ( BC ) in adjuvant setting , or metastatic setting with initial doxorubicin-based chemotherapy . Consider use with metastatic BC and other malignancies , for patients who have received more than 300 mg/m(2 ) doxorubicin  who may benefit from continued doxorubicin-containing therapy . Cardiac monitoring should continue in patients receiving doxorubicin . Amifostine may be considered for prevention of cisplatin-associated nephrotoxicity , reduction of grade 3 to 4 neutropenia ( alternative strategies are reasonable ) , and to decrease acute and late xerostomia with fractionated radiation therapy alone for head and neck cancer . It is not recommended for protection against thrombocytopenia , prevention of platinum-associated neurotoxicity or ototoxicity or paclitaxel-associated neuropathy , prevention of radiation therapy-associated mucositis in head and neck cancer , or prevention of esophagitis during concurrent chemoradiotherapy for non-small-cell lung cancer . Palifermin is recommended to decrease severe mucositis in autologous stem-cell transplantation ( SCT ) for hematologic malignancies with total-body irradiation ( TBI ) conditioning regimens , and considered for patients undergoing myeloablative allogeneic SCT with TBI-based conditioning regimens . Data are insufficient to recommend use in the non-SCT setting PURPOSE To identify factors significantly influencing accrual to clinical protocol s by analyzing radiation Patterns of Care Study ( PCS ) surveys of 3,047 r and omly selected radiotherapy ( RT ) patients . METHODS AND MATERIAL S Patterns of Care Study surveys from disease sites studied for the periods 1992 - 1994 and 1996 - 1999 ( breast cancer , n = 1,080 ; prostate cancer , n = 1,149 ; esophageal cancer , n = 818 ) were analyzed . The PCS is a National Cancer Institute-funded national survey of r and omly selected RT institutions in the United States . Patients with nonmetastatic disease who received RT as definitive or adjuvant therapy were r and omly selected from eligible patients at each institution . To determine national estimates , individual patient records were weighted by the relative contribution of each institution and patients within each institution . Data regarding participation in clinical trials were recorded . The factors age , gender , race , type of insurance , and practice type of treating institution ( academic or not ) were studied by univariate and multivariate analyses . RESULTS Overall , only 2.7 % of all patients were accrued to clinical protocol s. Of these , 57 % were enrolled on institutional review board-approved institutional trials , and 43 % on National Cancer Institute collaborative group studies . On multivariate analysis , patients treated at academic facilities ( p = 0.0001 ) and white patients ( vs. African Americans , p = 0.0002 ) were significantly more likely to participate in clinical oncology trials . Age , gender , type of cancer , and type of insurance were not predictive . CONCLUSIONS Practice type and race significantly influence enrollment onto clinical oncology trials . This suggests that increased communication and education regarding protocol s , particularly focusing on physicians in nonacademic setting s and minority patients , will be essential to enhance accrual
For persons receiving chemotherapy of high emetic risk , there is no group of patients for whom agents of lower therapeutic index are appropriate first-choice antiemetics .
In all patients receiving cisplatin and all other agents of high emetic risk , the two-drug combination of dexamethasone and aprepitant is recommended for the prevention of delayed emesis .
The Up date Committee no longer recommends the combination of a 5-HT3 serotonin receptor antagonist and dexamethasone for the prevention of delayed emesis after chemotherapeutic agents of high emetic risk .
PURPOSE To up date the 1999 American Society of Clinical Oncology guideline for antiemetics in oncology .