Switching from imatinib to nilotinib plus pegylated interferon-α2b in chronic phase CML failing to achieve deep molecular response: clinical and immunological effects.

In order to improve molecular response for a discontinuation attempt in chronic myeloid leukemia (CML) patients in chronic phase, who had not achieved at least a molecular response <0.01% BCR-ABL1IS (MR4.0) after at least 2 years of imatinib therapy, we prospectively evaluated whether they could attain MR4.0 after a switch to a combination of nilotinib and 9 months of pegylated interferon-α2b (PegIFN). The primary endpoint of confirmed MR4.0 at month 12 (a BCR-ABL1IS level ≤ 0.01% both at 12 and 15 months) was reached by 44% (7/16 patients, 95% confidence interval (CI): 23- 67%) of patients, with 81% (13/16 patients, 95% CI: 57-93%) of patients achieving an unconfirmed MR4.0. The scheduled combination was completed by 56% of the patients, with premature discontinuations, mainly due to mood disturbances after the introduction of PegIFN, questioning the feasibility of the combination of nilotinib and PegIFN for this patient population and treatment goal. A comprehensive clinical substudy program was implemented to characterize the impact of the treatment changes on the immunological profile. This trial was registered at www.clinicaltrials.gov as #NCT01866553.

Neuroinvasive West Nile virus infection in solid organ transplant recipients.

BACKGROUND: Literature on the natural course of neuroinvasive West Nile virus (WNV) infection in solid organ transplant (SOT) recipients is sparse. In the setting of a 2021 WNV outbreak in Arizona, we reviewed our institution's experience with neuroinvasive WNV infection in patients with SOT. METHODS: We retrospectively identified SOT recipients treated for neuroinvasive WNV at Mayo Clinic in Arizona from 2007 through 2021. Clinical manifestations, disease course, and outcomes were analyzed. RESULTS: Among 24 SOT recipients with WNV infection identified during the study period, 13 infections occurred in 2021. Most patients had gastrointestinal tract symptoms and fever at disease presentation. Five patients had cognitive impairment, and 14 initially or eventually had acute flaccid paralysis. Clinically significant deterioration occurred at a median of 4 (range, 1-11) days after hospital admission. Seventeen patients (71%) were transferred to the intensive care unit, with 15 requiring mechanical ventilation. Initial cerebrospinal fluid analysis mainly demonstrated a neutrophil-predominant pleocytosis. Almost all patients (n = 23) were treated with intravenous immunoglobulin alone or in combination with interferon alfa-2b. Sixteen patients had clinical improvement, 4 of whom recovered completely. Six patients died during hospitalization due to complications of neuroinvasive WNV infection. Two patients were discharged to hospice without clinical recovery. The overall 30-day mortality rate was 36%. CONCLUSION: Despite advances in supportive care, neuroinvasive WNV infection is associated with substantial morbidity and mortality in SOT recipients. Flaccid paralysis is an indicator of poor prognosis.

Vanishing Bone Disease of the Thoracic Cage: Challenges in the Management of a Rare Entity.

Background/Objective: Vanishing bone disease (VBD) is a rare entity, characterized by massive osteolysis and lymphovascular proliferation. Our objective was to report the case of a 22-year-old man who presented with VBD of the ribs and the challenges involved with its management in this location. Case Report: A 22-year-old man presented with left-sided chest and back pain. An x-ray revealed that the fourth to sixth ribs on the left side of the chest were missing. The erythrocyte sedimentation rate was normal (5 mm/h; normal value, <10 mm/h), ruling out overt infectious and inflammatory pathology. A positron emission tomography-computed tomography scan excluded an underlying malignancy. Findings of serum protein electrophoresis did not show an M band. Normal levels of calcium (9.0 mg/dL; normal range, 8.3-10.4 mg/dL) and parathyroid hormone (38 pg/mL; normal range, 8-74 pg/mL) excluded primary hyperparathyroidism as a cause for osteolysis. A computed tomography scan of the chest revealed only lytic destruction and resorption of the fourth to sixth ribs on the left side. A diagnosis of VBD was made. A biopsy was deferred owing to the location of the disease involving the thoracic cage that could cause permanent lymphatic leakage. He was administered parenteral zoledronate 4 mg monthly for 3 months and subsequently once every 3 months for the next 2 years with subcutaneous interferon alfa-2b 6 MIU thrice weekly initially, then twice a week, and subsequently tapered to once every 10 days. On the follow-up at 3 years, he remained stable, with no further osteolysis or radiographic progression of the disease. Discussion/Conclusion: VBD may present diagnostic and therapeutic challenges; the abovementioned patient was diagnosed with VBD after excluding secondary causes of osteolysis. Although a high index of suspicion is required to diagnose VBD, it also mandates close monitoring and follow-up.

Carcinoma epidermoide de piel tratado con HeberFERON®

RESUMEN Introducción: en la literatura biomédica son escasos los reportes sobre el uso de los interferones como tratamiento en el carcinoma epidermoide. En una unidad de atención primaria, en Colón, Matanzas, se implementó el HeberFERON® en este tipo de tumor, con experiencias favorables. Objetivo: describir la efectividad del HeberFERON® en el carcinoma epidermoide. Materiales y métodos: se realizó un estudio observacional, descriptivo en 33 lesiones de carcinoma epidermoide en 29 pacientes. La dosis fue de 7,0 y 10,5 MUI de actividad antiviral, infiltrada de forma perilesional tres veces por semana durante tres semanas. Se realizó el seguimiento clínico de los pacientes antes del tratamiento y a las 16 semanas del inicio del mismo. Las variables fueron: edad, sexo, fototipo de piel, procedencia, localización, tipo clínico, estadio y respuesta clínica al tratamiento. Se consideraron cuatro categorías de respuesta: completa, parcial, enfermedad estable y progresiva. Se incluyó la respuesta objetiva (completa más parcial). Se recogieron los datos en una historia clínica. Se utilizaron los programas Microsoft Excel y SPSS para el procesamiento estadístico. Resultados: el 65,5 % de los pacientes correspondió al sexo masculino. Un 58,6 % son fototipo II y de procedencia urbana. Predominaron las edades entre 61 y 80 años (55,2 %). Hubo respuesta objetiva en 57,6 % (cinco completas y 14 parciales). Las mejores respuestas la mostraron el carcinoma epidermoide queratósico superficial y el noduloulceroso. Conclusiones: la mezcla de interferones fue efectiva en el carcinoma epidermoide en todos los subtipos clínicos, aunque los autores sugieren un segundo ciclo de HeberFERON® o asociarlo con quimioterapia cuando la respuesta no sea completa.

ABSTRACT Introduction: there are few reports in the literature on the use of interferon in the treatment of the squamous cell carcinoma. In a primary care unit in Colon, Matanzas, HeberFERON® was implemented in this type of tumor with favorable experiences. Objective: to describe the effectiveness of HeberFERON® in epidermoid carcinoma. Materials and methods: an observational, descriptive study was conducted in 33 epidermoid carcinoma lesions in 29 patients. The doses were 7.0 and 10.5 MUI of antiviral activity, perilesionally infiltrated three times a week for three weeks. Clinical follow-up of patients was performed before the treatment and at 16 weeks from the beginning of the treatment. The variables were: age, sex, skin phototype, origin; location, clinical type, stage and clinical response to treatment. Four categories of response were considered: complete, partial, stable and progressive disease. The objective response (complete plus partial) was included. Data were collected in a clinical record. The Microsoft Excel and SPSS programs were used for statistical processing. Results: 65.5 % of patients were male. 58.6 % are phototype II and of urban origin. Ages ranging from 61 to 80 years (55.2 %) predominated. There was objective response in 57.6 % (five complete and 14 partials). The superficial keratotic squamous cell carcinoma and the nodular ulcerative one showed the best responses. Conclusions: interferon mixing was effective in all clinical subtypes of epidermoid carcinoma, although the authors suggest a second cycle of HeberFERON® or to associate it with chemotherapy when the response is not complete.

Efficacy and safety of pegylated interferon alfa-2b in moderate COVID-19: A phase II, randomized, controlled, open-label study.

OBJECTIVE: To evaluate the efficacy and safety of pegylated interferon alfa-2b (PEG IFN-α2b) along with the standard of care (SOC) in subjects with moderate COVID-19. METHODS: In this phase 2, randomized, open-label study, adult subjects aged ≥18 years with RT-PCR confirmed COVID-19 with moderate symptoms were randomized in a 1:1 to receive PEG IFN-α2b plus SOC, or SOC alone. The primary endpoint was improvement in clinical status on day 15, measured by the WHO 7-point ordinal scale. RESULTS: Forty subjects were randomized to PEG IFN-α2b plus SOC (n = 20) and SOC (n = 20). Overall, 19 (95.00%) subjects in PEG IFN-α2b plus SOC had achieved clinical improvement on day 15 compared to 13 (68.42%) subjects in SOC (p < 0.05). Overall, 80% and 95% of subjects in the PEG IFN-α2b plus SOC group had a negative RT-PCR result on day 7 and day 14, respectively, compared to 63% and 68% in the SOC group. Adverse events (AEs) were reported for eleven subjects in the PEG IFN-α2b plus SOC group and eight subjects in the SOC group. All reported AEs were mild. CONCLUSION: The significant improvement in clinical status on day 15 is likely due to faster viral reduction compared to SOC with the PEG IFN-α2b treated moderate COVID-19 subjects showing a difference as early as day seven and becoming significant by day 14.

Clinical cure and liver fibrosis reversal after postoperative antiviral combination therapy in hepatitis B-associated non-cirrhotic hepatocellular carcinoma: A case report.

BACKGROUND: The incidence of hepatocellular carcinoma (HCC) is high in China, and approximately 15%-20% of HCC cases occur in the absence of cirrhosis. Compared with patients with cirrhotic HCC, those with non-cirrhotic HCC have longer postoperative tumor-free survival. However, the overall survival time is not significantly increased, and the risk of postoperative recurrence remains. Strategies to improve the postoperative survival rate in these patients are currently required. CASE SUMMARY: A 47-year-old man with a family history of HCC was found to have hepatitis B virus (HBV) infection 25 years ago. In 2000, he was administered lamivudine for 2 years, and entecavir (ETV 0.5 mg) was administered in 2006. In October 2016, magnetic resonance imaging revealed a tumor in the liver (5.3 cm × 5 cm × 5 cm); no intraoperative hepatic and portal vein and bile duct tumor thrombi were found; and postoperative pathological examination confirmed a grade II HCC with no nodular cirrhosis (G1S3). ETV was continued, and no significant changes were observed on imaging. After receiving pegylated interferon alfa-2b (PEG IFNα-2b) (180 µg) + ETV in February 2019, the HBsAg titer decreased significantly within 12 wk. After receiving hepatitis B vaccine (60 µg) in 12 wk, HBsAg serological conversion was realized at 48 wk. During the treatment, no obvious adverse reactions were observed, except for early alanine aminotransferase flares. The reexamination results of liver pathology were G2S1, and reversal of liver fibrosis was achieved. CONCLUSION: The therapeutic regimen of ETV+ PEG IFNα-2b + hepatitis B vaccine for patients with HBV-associated non-cirrhotic HCC following hepatectomy can achieve an HBV clinical cure and prolong the recurrence-free survival.

The treatment of recurrent conjunctival and corneal intraepithelial neoplasia with interferon alfa-2b and retinoic acid: ~9 years' follow-up on tumor control.

PURPOSE: To evaluate the long-term follow-up of recurrent conjunctival and corneal intraepithelial neoplasia (CCIN) treated with combination topical interferon alfa-2b and retinoic acid (I/RA). METHODS: Our study represents a retrospective observational interventional series of 82 eyes from 82 patients from a single institution, reviewed for CCIN. All were administered topical interferon alfa-2b 1 million IU/mL QID and retinoic acid 0.01% every other day. Patients had been diagnosed by biopsy. A Kaplan-Meier survival analysis, Wilcoxon signed-rank test and a multivariate logistic regression were statistical tests used to correlate recurrence with patient and tumor variables. RESULTS: 79 eyes assessed for CCIN diagnoses and treated with I/RA achieved tumor resolution. The median tumor-free follow-up was ~109.1 months with a median time to resolution being ~2.8 months. Our median treatment duration was ~11.3 months. The greatest difference in the mean total residual tumor size was identified between Months 0-1 [-7.63 mm2]. The difference in mean total residual tumor size remained significant till 36-months. A statistically significant correlation with recurrence was identified for biopsy type [OR 0.138]. 6 patients experienced papillary conjunctivitis which resolved with dosage reduction. CONCLUSIONS: Combination I/RA was effective in treating CCIN lesions with few transient side effects. The combination of retinoids and interferons may represent a viable topical therapeutic agent with an extended tumor-free follow-up and a large proportion of our study's patients achieving >10 year's tumor-free follow-up. Our treatment duration is long, but by cost-comparing surgical against medical interventions, topical I/RA may serve as a safe and effective alternative.

Interferon Alfa 2b for Ocular Surface Squamous Neoplasia: Factors Influencing the Treatment Response.

PURPOSE: To study the factors influencing the response to treatment with interferon alfa 2b (IFN) in ocular surface squamous neoplasia (OSSN)Methods: Retrospective study of 91 patientsResults: The mean age at presentation of patients with OSSN was 58 years (median, 60 years; range, 21 to 83 years). The mean number of clock hours of conjunctiva/cornea/limbus involvement by the tumor was 6 (median, 6; range, 1 to 12). The mean duration of topical IFN was 3 months (median, 3 months; range, 1 to 6 months) and the mean number of subconjunctival injections of IFN was 2 (median, 2; range, 0 to 6), till complete tumor regression or initiation of alternate treatment. Of 91 OSSN cases treated with IFN, 72 (79%) patients showed complete response to treatment, while 19 (21%) showed partial response displaying mean % tumor reduction of 34% (median, 20%; range, 5% to 90%). Patient demographics, immune status, disease chronicity, tumor location, or morphological pattern were not predictive of tumor response to IFN. The only factor predictive of incomplete response of OSSN to IFN was more than 6 clock hour involvement of ocular surface by OSSN (p = .04). Of 31 (34%) cases with OSSN >6 clock hours, 23 (74%) patients showed complete tumor regression with IFN alone, while 8 (26%) patients displayed incomplete response; and of 60 (66%) cases with OSSN ≤6 clock hours, 49 (82%) patients showed complete tumor regression with IFN alone, while 11 (18%) patients displayed incomplete response. Tumor recurrence was noted in 3% cases and one case had corneal perforation secondary to infective keratitis over a mean follow-up period of 14 months (median, 8 months; range, 3 to 58 months). CONCLUSION: Clock hour involvement of ocular surface by OSSN determines the response to IFN. Interferon alfa 2b is an effective immunotherapy agent for tumors ≤6 clock hours of ocular surface in 82% cases and serves as an immunoreducing agent for larger tumors involving >6 clock hours of ocular surface in 26% cases.

Conjunctival papillomatosis in children treated with co-adjuvant topical interferon alpha-2b. / Papilomatosis conjuntival en niños tratada con interferón alfa-2b tópico coadyuvante.

A series of paediatric patients is presented in whom topical interferon alpha-2b was used as a co-adjuvant treatment for conjunctival papilloma. This condition is frequently associated with human papillomavirus infection. There is little information on the pediatric population with the use of interferon for the treatment of these lesions. In this case series, adjuvant treatment with topical interferon alpha-2b in paediatric patients showed no recurrence and good tolerance.

Episcleritis in a patient with mucosal melanoma treated with interferon alfa-2b and radiotherapy: a case report.

BACKGROUND: Mucosal melanoma of the head and neck is a rare malignant tumor associated with a poor prognosis. Surgery, chemotherapy, radiotherapy, and biotherapy are common strategies for treating mucosal melanoma of the head and neck. Episcleritis is an idiopathic, immune-mediated disease, and is classified into two types: simple episcleritis and nodular episcleritis. CASE PRESENTATION: In this case report we describe ocular changes involving simple episcleritis in a 65-year-old Chinese man with mucosal melanoma of the head and neck after treatment with interferon alfa-2b and radiotherapy. On the third day of interferon alfa-2b treatment, he began to develop simple episcleritis in his left eye. Moreover, the percentage of CD3+ T cells in lymphocytes from blood was increased after interferon alfa-2b treatment. After approximately 6 days, the symptoms of eye pain, hyperemia, and edema disappeared gradually. Then, after radiotherapy was performed three times, he again developed episcleritis in his left eye. The same symptoms of hyperemia and edema occurred again; CD3+ T cell frequency was also at a higher level. After approximately a week, all the symptoms disappeared completely. Simple treatment involving topical ofloxacin and phenylephrine was administered during the two periods of episcleritis. CONCLUSION: Episcleritis in this patient might have been due to the treatment with interferon alfa-2b and radiotherapy, leading to an increase in the level of CD3+ T cells and activation of immune system cells, which provides the guide for clinical clinicians.

Resolution of conjunctival melanoma with topical interferon alpha 2b in a patient with mitomycin C intolerance. / Resolución de un melanoma conjuntival con interferón tópico alfa 2b en un paciente con intolerancia a la mitomicina C.

OBJECTIVE: To describe the clinical and histological resolution of a case of an inexcisable conjunctival melanoma using topical interferon alpha 2b (INFα2b) in a patient with mitomycin C (MMC) intolerance. CASE REPORT: Conjunctival melanoma is a rare, but potentially sight- and life-threatening, tumour. In cases of multiple lesions, or when surgical excision is not possible, topical combination chemotherapy with MMC and INFα2b has been described as first line therapy. The case is presented of a 77 year-old woman with a multifocal conjunctival in situ melanoma, who was intolerant to initial treatment with MMC and was switched to long-term INFα2b therapy, with a good outcome. CONCLUSIONS: When topical MMC is given as chemotherapy treatment for primary acquired melanosis with atypia or in situ melanoma is not well tolerated, switching to INFα2b seems to be a good option. This approach could replace surgical management of pigmented tumours, especially the larger ones, with potential benefits that include less dependence on surgical margins. This report prompts a need for prospective studies designed to examine the role of INFα2b as primary treatment for heavily pigmented conjunctival tumours avoiding the ocular surface toxicity caused by MMC.

Management of Mastocytosis in Pregnancy: A Review.

In this article, the authors present a case of pregnancy complicated by the need for management of indolent systemic mastocytosis. The diagnosis of mastocytosis is reviewed, as well as subtypes of mastocytosis and management options particularly in pregnancy. A table of pregnancy/lactaction categories for common medications used in mastocytosis is presented.

Giant conjunctival squamous cell carcinoma. Treatment with surgery following topical interferon alpha-2b.

CASE REPORT: A 50-year-old man presented with a giant and invasive mass at the nasal limbus in his right eye. A surgical excision without safety margins was promptly performed, followed by interferon alpha-2b (IFNα2b) eye drops. After monitoring the patient for two years and after performing a number of biopsies, he remains free from any signs of disease. DISCUSSION: For cases of giant and invasive squamous cell carcinoma, to reverse the order of treatment, by first performing an early tumour excision, followed by the application of topical IFNα2b, may prove useful to achieve total remission of the tumour.

Coincidence of Inflamed Conjunctival Carcinoma in situ and Primary Pterygium.

BACKGROUND: We report a rare case of carcinoma in situ (CIS) in conjunction with a primary pterygium that exhibited characteristic angiographic and histopathological findings. CASE: A 78-year-old man presented with a pterygium and a whitish tumor adjacent to the pterygium in his right eye. Indocyanine green angiography displayed that feeder vessels within the primary pterygium spread to the whitish tumor. The tumor and pterygial tissues were surgically removed. Histologically, the resected tissue contained CIS as well as squamous metaplasia. There was a marked inflammatory cell infiltration within the tumor and beneath the epithelium. Topical interferon alfa-2b was given 4 times per day for 2 months. The patient has been well without local recurrence of tumor or distal metastases to 54 follow-up months after surgery. CONCLUSIONS: Because CIS can occur adjacent to pterygial tissues, long-term follow-up is necessary in patients with pterygia.

The Effect of Duration of Penile Traction Therapy in Patients Undergoing Intralesional Injection Therapy for Peyronie's Disease.

PURPOSE: The concomitant use of penile traction therapy with interferon α-2b has been previously described. We present an update on our clinical experience to assess the benefit and duration of daily traction. MATERIALS AND METHODS: A retrospective review of patients who underwent interferon α-2b therapy between 2001 and 2012 was performed. Charts were reviewed and data collected regarding various patient demographics, vascular parameters, objective length and curvature measurements, and use of penile traction therapy. Penile traction therapy was further stratified according to duration of daily use. RESULTS: A total of 112 patients underwent a median of 12 interferon α-2b injections (range 6 to 24). Daily use of penile traction therapy was reported by 31% of patients. There were no differences in patient demographics, initial vascular status, pretreatment stretched penile length, erect circumference and curvature between patients who followed a penile traction therapy regimen and those who did not. Overall, the use of penile traction therapy did not effect change in penile circumference (with therapy +3.2 mm [SD 6.5] vs no therapy +2.1 mm [SD 7.4], p=0.45), change in curvature (with therapy -8.1 degrees [SD 16.0] vs no therapy -9.9 degrees [SD 11.8], p=0.49) or change in stretched penile length (with therapy +2.4 mm [SD 0.9] vs no therapy +1.3 mm [SD 0.8], p=0.56). Men who used penile traction therapy 3 or more hours per day gained significantly greater stretched penile length compared to those who did not use penile traction therapy (4.4 mm [SD 0.5] vs 1.3 mm [SD 0.8], p=0.04). CONCLUSIONS: Routine penile traction therapy during intralesional injection with interferon α-2b for Peyronie's disease may result in a small but subjectively meaningful improvement in stretched penile length, without affecting curvature, if used for at least 3 hours a day.

Conjunctival intraepithelial neoplasia. Interferon as a rescue therapy after failure of mitomycin C.

CLINICAL CASE: The case of a 60 year-old male with a conjunctival lesion diagnosed as conjunctival intraepithelial neoplasia (CIN), who was treated with mitomycin-C for 3 weeks with minimal improvement. The therapy was change to interferon 2B. Six month later, and after a complete remission of the lesion, the treatment was suspended, with no signs of relapse. DISCUSSION: The treatment of these lesions is currently made with chemotherapy and immunotherapy agents, such as mitomycin-C, 5-fluorouracil, and interferon alfa 2B. The latter, even although is the least used, gives excellent results with fewer secondary effects than mitomycin-C, resulting in an optimal therapy for the non-invasive treatment of CIN lesions.

Pityriasis rosea associated with pegylated interferon alfa and ribavirin treatment in a patient with chronic hepatitis C.

BACKGROUND: Pityriasis rosea is an acute inflamatory skin disease that the etiology is unknown but some viral agents like human herpes virus-6 and 7 and drugs are suspected. CASE REPORT: A-58-year-old man with chronic hepatitis C was being followed up in our hospital. Pegylated interferon (PEG-IFN) alfa-2b (100 µg per week) and ribavirin (1000 mg/day) was started. In the third month of this treatment, the patient was diagnosed with pityriasis rosea (PR), which was confirmed by skin biopsy. PEG-IFN alfa-2b treatment for chronic hepatitis C was maintained and no therapy was given for PR. The lesions spontaneously improved within 5 weeks. CONCLUSION: Interferon and ribavirin have several cutaneous side effects. Our case is the first case of PR, emerged in a patient with chronic hepatitis C while receiving PEG-IFN alfa 2b and ribavirin.

Efeitos colaterais do tratamento da hepatite C no polo aplicador do ABC / Side effects of the hepatitis C treatment at the ABC application center

OBJETIVO: Analisar e comparar os efeitos colaterais do tratamento da hepatite C com interferon peguilado e ribavirina no Centro de Referência de Imunobiológicos Especiais (CRIE) do Hospital Mário Covas (Santo André), de 23/02/2011 a 05/05/2011. MÉTODOS: Estudo do tipo transversal, por questionário, com amostra não probabilística composta por 340 pacientes que receberam pelo menos uma dose da medicação. RESULTADOS: Os efeitos colaterais apresentados foram cansaço (82,9%), artralgia e/ou mialgia (76,8%), emagrecimento (71,8%), cefaleia (67,6%), desânimo (65,9%), depressão e/ou irritabilidade (64,4%), prurido (60,6%), febre (59,1%), alopecia (51,5%), tosse seca (34,1%), náuseas (11,7%), inapetência (11,7%) e tontura (7,9%). Foram relatados até 19 sintomas durante o tratamento. Apenas quatro pacientes (1,2%) não apresentaram efeitos colaterais. Ao comparar os interferons, observamos que o uso do alfa-2b causou uma média de 8,01 sintomas por paciente, enquanto o do alfa-2a foi responsável por uma média de 7,50. Os pacientes em uso do interferon alfa-2b apresentaram mais febre, emagrecimento, cefaleia, artralgia e/ou mialgia, cansaço, desânimo, depressão e/ou irritabilidade e tosse seca do que os pacientes em uso do alfa-2a, que, por sua vez, tiveram mais alopecia e prurido. CONCLUSÃO: O estudo mostra uma grande morbidade relacionada ao tratamento, já que apenas 1,2% dos pacientes não apresentaram efeitos colaterais. Na amostra, o interferon peguilado alfa-2b foi responsável por maior prevalência de febre e emagrecimento quando comparado ao alfa-2a, sendo essa relação estatisticamente significante (p < 0,05).

OBJECTIVE: To review and compare side effects of hepatitis C treatment with pegylated interferon and ribavirin at the CRIE of the Hospital Mário Covas (Santo André), São Paulo, Brazil, from February 23 to May 5, 2011. METHODS: Cross-sectional study through questionnaire, with a non-probability sample comprised of 340 patients that had received at least one dose of the medication. RESULTS: Side effects presented were fatigue (82.9%), arthralgia and/or myalgia (76.8%), weight loss (71.8%), headache (67.6%), listlessness (65.9%), depression and/or irritability (64.4%), itching (60.6%), fever (59.1%), alopecia (51.5%), dry cough (34.1%), nausea (11.7%), inappetence (11.7%), and dizziness (7.9%). Up to 19 symptoms were reported during treatment. Only four patients (1.2%) did not present side effects. When comparing the types of interferon, it was observed that alpha-2b caused an average of 8.01 symptoms per patient, while alpha-2a was responsible for an average of 7.50 symptoms. Patients using interferon alpha-2b showed more fever, weight loss, headache, arthralgia and/or myalgia, fatigue, listlessness, depression and/or irritability, and dry cough than patients using alpha-2a, who had more alopecia and itching. CONCLUSION: The study shows a high morbidity related to the treatment, as only 1.2% of the patients showed no side effects. In the sample, the pegylated interferon alpha-2b was responsible for higher prevalence of fever and weight loss when compared to alpha-2a, and this was a statistically significant relation (p < 0.05).

Quimioprofilaxis en la recidiva tumoral vesical / Chemoprophylaxis in the vesical tumoral recurrence

Los tumores vesicales superficiales se caracterizan por una alta tasa de recidiva, que ocurre especialmente dentro de los dos primeros años, y que es aun mayor en los grupos de alto riesgo. Existe consenso en la utilidad del uso del Bacilo de Calmette-Guerin para disminuir la recurrencia tumoral. La quimioterapia intravesical con otros medicamentos han demostrado su utilidad o no en disminuir la recurrencia de estos tumores vesicales. Entre los años 1999 y 2008 se estudian y tratan 110 pacientes (96 hombres y 14 mujeres), con una edad promedio de 63 años, divididos en tres grupos para tratamiento de la recidiva tumoral después de resección transuretral o cistectomía parcial, con tres diferentes agentes quimioprofilácticos e inmunomoduladores (Thio-Tepa, BCG+factor de transferencia, doxorrubicina+interferón alfa 2b). El objetivo de esta investigación fue presentar la experiencia en el tratamiento de estos pacientes, donde se observa mejores resultados en 5 años, con el grupo tratado con doxorrubicina+interferón alfa 2b, seguido del grupo tratado con BCG+factor de transferencia, con una marcada disminución de las recurrencias y una limitación en la progresión de la enfermedad a largo plazo.

The superficial bladder tumors are characterized by a high rate of recurrence taking place especially within the first two years that is even higher in the high risk groups. There is an agreement in the usefulness of the Calmette-Guerin Bacillus (CGB) to diminish the tumoral recurrence. The intravesical chemotherapy with other medications have demonstrated its profit or not in decreasing the recurrence of these bladder tumors. Between 1999 and 2008 we studied and treated 110 patients (96 men and 14 women), aged in average 63 years old. They were divided into three groups for the treatment of the tumoral recidivism after the transurethral resection or partial cystectomy, using three different chemoprophylactic agents and inmunomodulators (Thio-Tepa, BCG+Transference Factor, Doxorubicin +Interferon Alpha 2b). The objective of this research was presenting our experience in the treatment of these patients during five years, obtaining better results in the group treated with doxorubicin + interferon alpha 2b, followed by the group treated by means of BCG + transference factor, with a remarked decrease of the recurrence and a limitation in the long term progression of the disease.

Retrospective US database analysis of drug utilization patterns, health care resource use, and costs associated with adjuvant interferon alfa-2b therapy for treatment of malignant melanoma following surgery.

BACKGROUND: The purpose of this study was to identify a real-world US population having undergone surgery for malignant melanoma and describe treatment patterns, health care resource utilization, and costs for patients who subsequently received interferon alfa-2b (IFN) therapy or other standard of care chemotherapies. METHODS: A retrospective cohort study was conducted using administrative claims from MarketScan(®) databases among melanoma patients diagnosed between 2004 and 2008 who had surgery and were subsequently treated with IFN or other chemotherapies. Health care resource utilization and costs of services (converted to 2009 dollars) were evaluated. Cost refers to the amount paid to providers associated with the health service. RESULTS: Of 18,075 subjects with melanoma surgery claims, 1525 (8.4%) were treated with IFN and 1194 (6.6%) with other chemotherapies. Median duration (days) and number of doses of IFN therapy were 29 and 20, respectively. Approximately half of patients who received IFN discontinued therapy within or after the one-month induction phase. For IFN therapy patients, average total cost per patient for the last melanoma-related surgery prior to start of therapy, including costs of the surgery itself, pathology, anesthesia, and hospital care, was $2219. The average total cost per patient related to IFN therapy was $1188; this included costs for drug, office visits, blood work, and infusions. Other chemotherapy costs ranged from $146 to $2678. CONCLUSION: There is an unmet treatment need, considering that this study observed that melanoma patients on IFN therapy post-surgery do not complete the recommended one-year course of treatment which may compromise its full therapeutic benefits. Further study to investigate reasons for discontinuation may be warranted. In addition, costs associated with adjuvant IFN therapy in post-surgical treatment of disease are likely acceptable.