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RESUMO Introducao A aspiracao manual de trombos durante a intervencao coronaria percutânea primaria foi muito utilizada no fim da decada passada, mas, a partir de resultados de publicacoes recentes, houve queda em seu grau de recomendacao. O objetivo deste trabalho foi avaliar o uso desta tecnica no Brasil. Metodos Utilizando dados da Central Nacional de Intervencoes Cardiovasculares (CENIC) do periodo de 2008 a 2016, avaliamos pacientes submetidos a intervencao coronaria percutânea primaria que realizaram tromboaspiracao manual. Dividimos a analise em [...]

Background Cangrelor, an intravenous, reversible P2Y12 antagonist, is approved for use in patients undergoing percutaneous coronary intervention (PCI). Objectives This study sought to evaluate the efficacy and safety of cangrelor compared with clopidogrel in subgroups that did and did not receive glycoprotein IIb/IIIa inhibitors (GPIs). Methods This pooled, patient-level analysis of the 3 CHAMPION (Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition) trials analyzed all randomized patients who underwent PCI and received the study drug (n = 24,902). Only bailout/rescue GPI use was permitted, except in CHAMPION PCI, in which routine or bailout/rescue GPI use was at the site investigator’s discretion. The primary efficacy endpoint was the composite of all-cause mortality, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 h after randomization. Results Overall, 3,173 patients (12.7%) received a GPI, most commonly eptifibatide (69.4%). Despite variation in indications for GPIs, baseline characteristics were well balanced between the cangrelor and clopidogrel arms in subsets receiving and not receiving GPIs. Rates of the primary composite endpoint were lower with cangrelor compared with clopidogrel in patients who did (4.9% vs. 6.5%; odds ratio [OR]: 0.74; 95% confidence interval [CI]: 0.55 to 1.01) or did not receive a GPI (3.6% vs. 4.4%; OR: 0.82; 95% CI: 0.72 to 0.94; Pint = 0.55). Cangrelor did not increase the primary safety endpoint, GUSTO-defined severe/life-threatening bleeding, in patients who did (0.4% vs. 0.5%; OR: 0.71; 95% CI: 0.25 to 1.99) or did not receive GPIs (0.2% vs. 0.1%; OR: 1.56; 95% CI: 0.80 to 3.04; Pint = 0.21). GPI use was associated with increased risk of bleeding in both treatment arms. Conclusions Cangrelor’s efficacy in reducing ischemic complications in patients undergoing PCI was maintained irrespective of GPI administration. GPI use was associated with substantially higher bleeding rates, regardless of the randomization to cangrelor or clopidogrel. (A Clinical Trial to Demonstrate the Efficacy of Cangrelor [PCI]: NCT00305162 ; Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition [PLATFORM]: NCT00385138 ; A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI] [CHAMPION PHOENIX] [CHAMPION]: NCT01156571 )

Background End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin's efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Objective The overall objective of this protocol is to (1) evaluate aspirin's safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin's efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups. Methods We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed. Results The randomized clinical trial will be performed after approval by the ethical committee of the participating center and registration at ClinicalTrials.gov. Conclusions We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events. Registered report identifier RR1-10.2196/10516.

BackgroundDoor-to-balloon time (DBT) has become a measure of performance and is the focus in quality of care improvement initiatives. This study aimed to evaluate the association between DBT and its impact on hospital costs.MethodsPatients treated with primary percutaneous coronary intervention between 2008 and 2013 were divided according to the DBT < or ≥ 90minutes. All costs recorded at hospital discharge were adjusted by the Medical-Hospital Cost Variation Index.ResultsA total of 141 patients were included, grouped as DBT < 90minutes (n = 77) and DBT ≥ 90minutes (n = 64). DBT was 64.0 ± 14.1minutes and 133.8 ± 35.2minutes, respectively. There were no differences in clinical outcomes between the groups. The costs were R$ 34,883.24 ± 27,749.46, with the mean cost for DBT < 90minutes being R$ 33,194.24 ± 27,387.61 and the cost for DBT ≥ 90minutes R$ 36,947.58 ± 28,267.80 (p = 0.43). The costs, according to the culprit artery, were R$ 29,588.53 ± 16,358.85 for the right coronary artery; R$ 48,494.62 ± 44,015.04 for the left circumflex artery; and R$ 34,016.96 ± 26,503.94 for the left anterior descending artery. There was a difference between the costs of procedures related to the left circumflex artery when compared to the right coronary or left anterior descending arteries (p = 0.01), but there was no difference between the costs related to the right coronary, when compared to the left anterior descending artery (p = 0.68).ConclusionsThere was no difference in hospital costs regarding the private health insurance, when the groups were divided according to the DBT. Clinical outcomes were similar and a difference in costs was found for patients with the circumflex artery as the culprit vessel.

RESUMOIntroduçãoO tempo porta‐balão (TPB) tornou‐se uma medida de desempenho e é foco de iniciativas de melhoria da qualidade assistencial. Este estudo teve como objetivo avaliar a relação entre o TPB e seu impacto nos custos de internação hospitalar.MétodosPacientes tratados com intervenção coronária percutânea primária, entre 2008 e 2013, foram divididos de acordo com o TPB < ou ≥ 90 minutos. Todos os custos registrados na alta hospitalar foram ajustados por meio do Índice de Variação de Custos Médico‐Hospitalares.ResultadosForam incluídos 141 pacientes, agrupados em TPB < 90 minutos (n=77) e TPB ≥ 90 minutos (n=64). Os TPB foram 64,0 ± 14,1 minutos e 133,8 ± 35,2 minutos, respectivamente. Não foram observadas diferenças nos desfechos clínicos entre os grupos. Os custos foram de R$ 34.883,24 ± 27.749,46, sendo o custo médio para TPB < 90 minutos de R$ 33.194,24 ± 27.387,61, e para TPB ≥ 90 minutos, de R$ 36.947,58 ± 28.267,80 (p=0,43). Os custos, segundo a artéria culpada, foram de R$ 29.588,53 ± 16.358,85 para a coronária direita; R$ 48.494,62 ± 44.015,04 para a circunflexa; e de R$ 34.016,96 ± 26.503,94 para a descendente anterior. Houve diferença entre os custos dos procedimentos relativos à artéria circunflexa comparados aos da coronária direita ou da descendente anterior (p=0,01), mas não houve diferença entre os custos relativos à coronária direita, comparados à descendente anterior (p=0,68).ConclusõesNão houve diferença nos custos hospitalares, no âmbito da saúde suplementar, quando os grupos foram divididos de acordo com o TPB. Os desfechos clínicos foram semelhantes, e foi encontrada uma diferença de custos em pacientes com a artéria circunflexa culpada.ABSTRACTBackgroundDoor‐to‐balloon time (DBT) has become a measure of performance and is the focus in quality of care improvement initiatives. This study aimed to evaluate the association between DBT and its impact on hospital costs.MethodsPatients treated with primary percutaneous coronary intervention between 2008 and 2013 were divided according to the DBT < or ≥ 90minutes. All costs recorded at hospital discharge were adjusted by the Medical‐Hospital Cost Variation Index.ResultsA total of 141 patients were included, grouped as DBT < 90minutes (n=77) and DBT ≥ 90minutes (n=64). DBT was 64.0 ± 14.1minutes and 133.8 ± 35.2minutes, respectively. There were no differences in clinical outcomes between the groups. The costs were R$ 34,883.24 ± 27,749.46, with the mean cost for DBT < 90minutes being R$ 33,194.24 ± 27,387.61 and the cost for DBT ≥ 90minutes R$ 36,947.58 ± 28,267.80 (p=0.43). The costs, according to the culprit artery, were R$ 29,588.53 ± 16,358.85 for the right coronary artery; R$ 48,494.62 ± 44,015.04 for the left circumflex artery; and R$ 34,016.96 ± 26,503.94 for the left anterior descending artery. There was a difference between the costs of procedures related to the left circumflex artery when compared to the right coronary or left anterior descending arteries (p=0.01), but there was no difference between the costs related to the right coronary, when compared to the left anterior descending artery (p=0.68).ConclusionsThere was no difference in hospital costs regarding the private health insurance, when the groups were divided according to the DBT. Clinical outcomes were similar and a difference in costs was found for patients with the circumflex artery as the culprit vessel.

Introduction: The time interval between symptom onset and coronary artery reperfusion for ST-elevation myocardial infarction is directly related to patient morbidity and mortality. The guidelines stipulate that door-to-balloon time, i.e., the time spent between hospital arrival and percutaneous coronary intervention (PCI), must not exceed 90 minutes. Few hospitals achieve this goal. Thus, the objective of the present study was to assess the efficacy of the implementation of hospital work processes with respect to reducing the door-to-balloon time. Methods: Two [...]

The management of stage I seminoma has evolved over the past 20 years. Contemporary management options after orchiectomy include adjuvant radiation, adjuvant chemotherapy, and observation. This analysis defines the experience at Kaiser Permanente Southern California from 1990 to 2010. We examined outcomes for stage I seminoma patients and reviewed prognostic factors for recurrence in those managed with observation.This is a retrospective study of 502 stage I seminoma patients who underwent orchiectomy from 1990 to 2010. Outcomes examined were relapse-free survival (RFS), overall survival (OS), and cause-specific survival (CSS). Risk factors for recurrence evaluated were age, preoperative hCG elevation, preoperative LDH elevation, tumor size, lymphovascular invasion, rete testis invasion, epididymis invasion, and invasion through the tunica albuginea.Among radiation patients, 5-year RFS was 97.2%, OS was 98.0%, and CSS was 99.3%. Among chemotherapy patients, 2-year RFS was 98.3% and OS and CSS were 100%. Among observation patients, 5-year RFS was 89.2%, OS was 98.8%, and CSS was 100%. There was no difference in OS or CSS among the groups. RFS was significantly lower for observation patients. Among observation patients, univariate analysis identified tumor size, lymphovascular invasion, and rete testis invasion as risk factors for relapse. No factors were significant on multivariate analysis.Our data show that adjuvant radiation and chemotherapy yield similar outcomes in the management of stage I seminoma. Observation results in a lower RFS, but patients who relapse can be salvaged; OS and CSS are not affected.

FUNDAMENTO: O transplante cardíaco continua sendo o tratamento de escolha para a insuficiência cardíaca refratária ao tratamento otimizado. Dois métodos diagnósticos apresentam elevada sensibilidade no diagnóstico de episódios de rejeição ao enxerto e Doença Vascular do Enxerto (DVE), causas importantes de mortalidade no pós-transplante. OBJETIVO: Avaliar a relação entre os resultados do ultrassom intracoronariano (USIV) e os laudos das biópsias endomiocárdicas (BX) no seguimento de pacientes submetidos a transplante cardíaco em um serviço de referência brasileiro. MÉTODOS: Foi realizado um ensaio epidemiológico retrospectivo observacional, com pacientes submetidos a transplante cardíaco ortotópico, no período de 2000 a 2009. Foram analisados os prontuários desses pacientes e os resultados dos USIV e BX realizados rotineiramente no seguimento clínico pós-transplante e terapêutica em uso. RESULTADOS: Dos 77 pacientes analisados, 63,63% são do sexo masculino, nas faixas etárias de 22 a 69 anos. Quanto aos resultados dos USIV, 33,96% foram classificados em Stanford classe I, e 32,08%, como Stanford IV. Dos 143 laudos das biópsias, 51,08% tiveram resultado 1R, 3R em 0,69% dos laudos, e 14,48% apresentaram a descrição de efeito Quilty. Todos usaram antiproliferativos, 80,51% usaram inibidores da calcineurina e 19,48% usaram inibidores do sinal de proliferação (ISP). CONCLUSÃO: A avaliação dos pacientes pós-transplante cardíaco por meio do USIV incorpora informações detalhadas para o diagnóstico precoce e sensível da DVE, que são complementadas pelas informações histológicas fornecidas pelas BX, estabelecendo uma possível relação causal entre a DVE e os episódios de rejeição humoral. BACKGROUND: Cardiac transplantation continues to be the treatment of choice for heart failure refractory to optimized treatment. Two methods have high sensitivity for diagnosing allograft rejection episodes and cardiac allograft vasculopathy (CAV), important causes of mortality after transplantation. OBJECTIVE: To assess the relationship between intravascular ultrasound (IVUS) results and endomyocardial biopsy (BX) reports in the follow-up of patients undergoing cardiac transplantation in a Brazilian reference service. METHODS: A retrospective epidemiological observational study was carried out with patients undergoing orthotopic cardiac transplantation from 2000 to 2009. The study assessed the medical records of those patients and the results of the IVUS and BX routinely performed in the clinical post-transplant follow-up, as well as the therapy used. RESULTS: Of the 77 patients assessed, 63.63% were males, their ages ranging from 22 to 69 years. Regarding the IVUS results, 33.96% of the patients were classified as Stanford class I, and 32.08%, as Stanford class IV. Of the 143 BX reports, 51.08% were 1R, and 0.69%, 3R. The Quilty effect was described in 14.48% of the BX reports. All patients used antiproliferative agents, 80.51% used calcineurin inhibitors, and 19.48% used proliferation signal inhibitors. CONCLUSION: The assessment of cardiac transplant patients by use of IVUS provides detailed information for the early and sensitive diagnosis of CAV, which is complemented by histological data derived from BX, establishing a possible causal relationship between CAV and humoral rejection episodes.

Paciente do sexo masculino, 43 anos, assintomatico, portador de hipertensao arterial sistemica, diabetes melito e insuficiencia renal cronica dialitica. Submetido a ecodopplercardiograma transtoracico para avaliacao da funcao ventricular esquerda, sendo visualizada massa proxima ao ventriculo direito, em sua face diafragmatica. Ressonância magnetica mostrou tratar-se de aneurisma da arteria coronaria direita, localizado em terco distal, com 3,9 x 3,5 cm de diâmetro em seus maiores eixos, revestido por trombo mural circunferencial excentrico (). Foi indicada coronariografia, que evidenciou dilatacao difusa de [...]

Introduction: Cardiac allograft vasculopathy (CAV) is a major limitation for long-term survival of patients undergoing heart transplantation (HT). Some immunosuppressants can reduce the risk of CAV. Objectives: The primary objective was to evaluate the variation in the volumetric growth of the intimal layer measured by intracoronary ultrasound (IVUS) after 1 year in patients who received basiliximab compared with that in a control group. Methods: Thirteen patients treated at a single center between 2007 and 2009 were analyzed retrospectively. Evaluations were performed with IVUS, measuring the volume of a coronary segment within the first 30 days and 1 year after HT. Vasculopathy was characterized by the volume of the intima of the vessel. Results: Thirteen patients included (7 in the basiliximab group and 6 in the control group). On IVUS assessment, the control group was found to have greater vessel volume (120–185.43 mm3 vs. 127.77–131.32 mm3; p = 0.051). Intimal layer growth (i.e., CAV) was also higher in the control group (27.30–49.15 mm3 [∆80%] vs. 20.23–26.69 mm3 [∆33%]; p = 0.015). Univariate regression analysis revealed that plaque volume and prior atherosclerosis of the donor were not related to intima growth (r = 0.15, p = 0.96), whereas positive remodeling was directly proportional to the volumetric growth of the intima (r = 0.85, p < 0.001). Conclusion: Routine induction therapy with basiliximab was associated with reduced growth of the intima of the vessel during the first year after HT. Resumo Fundamento: A doença vascular do enxerto (DVE) constitui uma grande limitação de sobrevida a longo prazo de pacientes submetidos a transplante cardíaco (TxC). Alguns imunossupressores diminuem o aparecimento da DVE. Objetivos: O principal objetivo foi avaliar, através de ultrassonografia intracoronária (USIC), a variação do crescimento volumétrico da camada íntima e comparar, após um ano, o grupo que recebeu basiliximab com um grupo de controle. Métodos: Treze pacientes de um único centro foram analisados retrospectivamente de 2007 a 2009. As análises foram feitas através de USIC, medindo-se o volume de um segmento coronariano nos primeiros 30 dias e um ano após o TxC. A vasculopatia foi caracterizada pelo volume da camada íntima do vaso. Resultados: O estudo incluiu 13 pacientes (7 no grupo com o basiliximab e 6 no grupo de controle). A análise por USIC revelou que o grupo de controle apresentou maior crescimento volumétrico do vaso (131,32 a 127,77 mm3 x 120 a 185,43 mm3 p = 0,051). O crescimento da camada íntima (CCI) também foi maior no grupo de controle [Basiliximab: 20,23 a 26,69 mm3 (∆ 33%); Controle: 27,30 a 49,15 mm3 (∆ 80% p = 0,015)]. De acordo com a regressão univariada, o volume da placa aterosclerótica prévia do doador não teve relação com o crescimento da íntima (r = 0,15, p = 0,96), enquanto que o remodelamento positivo do vaso foi diretamente proporcional ao crescimento da íntima (r = 0,85, p < 0,001). Conclusão: A terapia de indução de rotina com basiliximab está associada à redução do crescimento da camada íntima do vaso no primeiro ano após o transplante cardíaco.

Background: The recommendations in guidelines are based on evidence; however, there is a gap between recommendations and clinical practice. Objective: To describe the practice of prescribing evidence-based treatments for patients with acute coronary syndrome in Brazil. Methods: This study carried out a subanalysis of the ACCEPT registry, assessing epidemiological data and the prescription rate of acetylsalicylic acid, p2y12 inhibitors, antithrombotic drugs, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (IAT1RB), and statins. In addition, the quality of myocardial reperfusion in ST-segment elevation myocardial infarction was evaluated. Results: This study assessed 2,453 patients. The prescription rates of acetylsalicylic acid, p2y12 inhibitors, antithrombotic drugs, beta-blockers, angiotensin-converting enzyme inhibitors/IAT1RB, and statins were as follows: in 24 hours - 97.6%, 89.5%, 89.1%, 80.2%, 67.9% and 90.6%; and at six months - 89.3%, 53.6%, 0%, 74.4%, 57.6% and 85.4%, respectively. Regarding ST-segment elevation myocardial infarction, only 35.9% and 25.3% of the patients underwent primary angioplasty and thrombolysis, respectively, within the recommended times. Conclusion: This registry showed high initial prescription rates of antiplatelet drugs, antithrombotic drugs, and statins, and lower prescription rates of beta-blockers and angiotensin-converting enzyme inhibitors/IAT1RB. Independently of the class, the use of all drugs decreased by six months. Most patients with ST-segment elevation myocardial infarction did not undergo myocardial reperfusion within the time recommended.

We describe a typical case of apical ballooning syndrome in an octogenarian female patient with left ventricular wall motion abnormality on electrocardiography, whose ventricular function returned to normal. The patient has allergic rhinitis and had used nasal decongestant excessively a few hours prior to the episode of pain.

Purpose To report our experience in treating T3 and T4 anal carcinoma with combined external beam (EBRT) and chemotherapy, followed by interstitial 192Ir implant boost. Methods and Materials From 1990 to 2000, 31 patients with T3 and T4 anal carcinoma were treated with: 30 Gy EBRT (2 Gy fractions, 5 days/week) + 5-fluorouracil + mitomycin-C. Median implant dose was 31.3 Gy at 0.5 cm, delivered at a mean rate of 0.52 Gy/h. Results Six patients had local persistence and 4 eventually developed local-regional recurrence. Eight underwent abdomino-perineal resection (APR). With the addition of APR in selected cases, the ultimate local-regional control after initial treatment was 84%. Distant metastases occurred in 10. Of the initial cohort, 55% is still alive and NED. Eight had radiation proctitis and 7 developed postimplant ulceration. Only 1 required surgical intervention. Conclusions Treatment of T3 and T4 anal cancer with combined chemotherapy and EBRT, followed by interstitial implant results in an ultimate local-regional control of 84%, after the inclusion of selected APR. It is well tolerated, with acceptable toxicity.

Purpose Management of squamous cell carcinoma of undetermined primary tumors in the head and neck region is controversial. Here we report the Southern California Kaiser Permanente experience with these patients. Methods and Materials From January 1969 through December 1994, 106 patients were eligible for this retrospective analysis. Distribution of nodal staging was as follows: 14 N1, 27 N2A, 39 N2B, 2 N2C, and 24 N3. Initial treatment included excisional biopsy alone in 12, radical neck dissection alone in 29, radiotherapy alone in 24, excisional biopsy followed by radiotherapy in 15, and radical neck dissection plus postoperative radiation in 26 patients. Results Except for two patients, all patients have had a minimum follow-up of 5 years. Overall, 57 patients (54%) have had recurrences. Only two patients (3%) who had received radiotherapy as part of their initial treatment had an appearance of a potential primary site inside the irradiated field vs 13 patients (32%) who had not received radiotherapy (p = .006). Combined modality therapy resulted in fewer neck relapses, particularly in patients with advanced neck disease. Including salvage, surgery alone as the initial treatment resulted in 81% ultimate tumor control above the clavicle for patients with N1 and N2a disease without extracapsular extension. The 5-year survival for the entire population was 53%. Radiotherapy alone resulted in poor survival in patients with advanced/unresectable neck disease. No significant difference in survival based on the initial treatment was found. The statistically significant adverse factors in determining survival included advanced nodal stage and the presence of extracapsular extension. Conclusions Radiotherapy is very effective in reducing the rate of appearance of a potential primary site. However, in the absence of advanced neck disease (N1 and N2A without extracapsular extension), radiotherapy can be reserved for salvage. Radiotherapy alone results in poor outcomes in patients with advanced/unresectable neck disease, and incorporation of concurrent chemotherapy and cytoprotective agents should be investigated. © 2002 Wiley Periodicals, Inc. Head Neck 24: 236–246, 2002; DOI 10.1002/hed.10017

18526 Background: We have previously shown that Subcutaneous amifostine (SQ A) was safe and effective in decreasing the early and late complications of patients (PTS) treated with radiotherapy (RT) or chemoradiotherapy (CRT) for head and neck cancer (HNC). We have further observed that the QOL is better for many PTS treated with SQ A compared with historical controls (HC). Although we believe we cannot put a price on QOL, we hypothesized that the use of SQ A could result in cost savings to our institution because of the observed decrease in treatment-related complications. Methods: From May 2001 to October 2004, we treated 52 consecutive HNC PTS with RT or CRT and daily SQ A. PTS treated in our SQ A protocol received 500 mg of SQ A at least 30 minutes prior to daily RT. In order to be included in our present study, SQ A PTS had to have completed at least 80% of the prescribed SQ A dose. These PTS were then matched with HC based on age, sex, stage, primary site, smoking status, co-morbidiites, and treatment (RT or CRT). Fourteen PTS treated with SQ A (SQ A Group) were successfully matched with HC (Control Group). The entire costs of these 28 PTS to our institution (including the cost of SQ A) was obtained using our Management Accounting and Analysis database. Cost data was obtained at 6 months and 12 months after the completion of treatment. The median follow-up is 18 months (range 12–31). The economical impact of SQ A on xerostomia and dental care were not addressed in this study. Results: Ten PTS received RT and 18 received CRT. At 6 months of follow-up, the total cost for the Control Group was $196,789 versus $211,711 for the SQ A Group (p= 0.59). At 12 months, the total cost in the Control Group and SQ A Group were $287,594 and $275,654 respectively (p = 0.51). Within the SQ A Group, the cost was lowest in PTS who had never smoked or had a remote (>5 years) smoking history (p < 0.01). Conclusions: This study primarily addresses one of SQ A’s cytoprotective properties, mucositis. Our analysis suggests that we were able to offset the cost of SQ A in most PTS because of fewer complications observed in this group. The cost benefit of SQ A appears to be greater at 12 months vs. 6 months after treatment, suggesting continued cytoprotection. QOL is better in the SQ A Group. We plan to continue to follow these PTS and accrue new ones in a prospective fashion. [Table: see text]

5609 Background: Traditional tx for locally advanced squamous cell carcinoma [SCC] of oropharynx [OPX] has been oncologic resection + adjuvant RT. In recent years, organ preserving therapy with che...

8154 BACKGROUND: We have previously reported that SQ A. was safe and effective in 24 patients (pts) receiving chemoradiation (CR) for SCCA of the H & N (SCCHN). Our expanded experience includes 19 ...

Objectives: 1) To determine feasibility and outcome of treating patients with advanced SCCHN using concurrent low- dose weekly Paclitaxel and radiation therapy; 2) To study the role of SQ Amifostine as a radiation protectant. Methods: Previously untreated patients with stage III and IV SCCHN were eligible. From Oct 1998 to June 2001, 38 patients were treated with 30 mg/m2 of Paclitaxel given weekly over 1 hour with concurrent once a day radiation (2Gy/day;total dose 70 Gy), with no planned breaks. There were 32 patients with stage IV disease. Primary tumor sites included oropharynx (23), larynx (7), hypopharynx (7) and parotid (1). SQ Amifostine was added to the protocol in early 2001; 7 patients have received this drug. Results: At the end of the planned treatment the Response Rate (CR + PR) was 100%; 25 pts(66%) achieved a CR at both neck and primary. Nine pts(24%) had residual lymphadenopathy, underwent neck dissections and are now NED. The ultimate locoregional control rate is 89%; 3 pts died of progressive disease, one died of intercurrent disease. With a median followup of 24 months, 34 pts(89%) are alive and NED. Organ preservation was achieved in 100%. Thirty(79%) finished the radiotherapy dose as planned, 64% received all 7 cycles of Paclitaxel. Grade 3 mucositis was observed in 36% pts and these were the only pts who required a treatment break. Eight pts(21%) required a PEG tube for feeding; median weight loss was 10%. There were no complications durng the administration of SQ Amifostine. Conclusion: This treatment is feasible and highly active in the treatment of locally advanced SCCHN. Although the followup for patients treated with Amifostine is short, it appears that the addition of this drug in our protocol resulted in reduced early and late toxicity.