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Background: Idiopathic Granulomatous Mastitis (IGM) is a chronic inflammatory disease of the breast. Although most of the studies have reported IGM as a rare disease, recent studies have shown an increase in the prevalence, especially in developing countries. The most important challenge is about the appropriate treatment of this disease that is not established yet. The aim of this cross-sectional study was to review the definite cases of IGM in terms of clinical characteristics and the result of treatment at Motamed Cancer Institute (MCI). Methods and Materials: This retrospective study was conducted on 383 women who were referred to Motamed Cancer Research Institute with a confirmed diagnosis of IGM for a two-year period from March 2015 to February 2018. The demographic and clinical characteristics and the result of treatment options were extracted from the patients’ medical records. The data was statistically analyzed using SPSS version 22. Results: Among 383 pathologically proven cases with IGM, the mean age was 35.6+7.593 years, 97% of them had a history of pregnancy and 95.2% had breastfed. The most common symptoms of the disease were palpable mass, pain, fistula to the skin and inflammation respectively. In response to the prescribed treatments, among 241 patients with available follow-up, the most commonly used treatment was Corticosteroids + Methotrexate (70.1%), the highest complete remission was in the group receiving Corticosteroid (100%) and Methotrexate (97%) respectively and the highest partial remission belonged to Corticosteroid+ Methotrexate with the frequency of 21.3%. The shortest time to complete remission belonged to Methotrexate regimen with a mean duration of 5.83 months and the highest recurrence rate was seen in the group receiving Corticosteroids alone (16.7%). Conclusion: According to the results of this study, among the prescribed treatments, the highest rate of complete remission with the lowest duration and recurrence rate belongs to Methotrexate regimen. Corticosteroids were associated with the high rate of complete remission but high rate of recurrence yet. Given the autoimmune nature of IGM, such results seem expectable and Methotrexate could be recommended especially in moderate to severe forms and as an additional treatment to taper Corticosteroids. Implementation of clinical trials regarding the best treatment options for IGM is recommended.

Summary Background The investigation was designed to assess the effects of synbiotic supplementation on glycemic profile, insulin-like growth factor-1 (IGF-1) and sex hormones in overweight and obese postmenopausal breast cancer survivors (BCSs) who had hormone-receptor-positive breast cancer. Methods This randomized, triple-blind, placebo-controlled trial was conducted on 76 overweight and obese BCSs aged 57.43 (5.82) years. All participants were given a specified low calorie diet and were randomly assigned into two groups to intake 109 CFU/day of synbiotic supplement (n = 38) or placebo (n = 38) for 8 weeks. Body composition, physical activity, glycemic profile, IGF-1, estradiol, testosterone and dehydroepiandrosterone sulfate (DHEA-S) were measured at baseline and after 8 weeks. Results A significant reduction in serum insulin (median change (Q1, Q3) from baseline of −1.05 (−2.36, 0.32) μIU/mL; P = 0.006) and insulin resistance (HOMA-IR) (mean change (SD) from baseline of −4.0 (0.9); P = 0.007) were seen over the 8 weeks in the synbiotic group. However, no significant changes were observed in serum insulin, fasting plasma glucose, HbA1c, HOMA-IR, IGF-1, estradiol, testosterone, DHEA-S and sex hormone binding globulin between-groups at the end of the intervention. Conclusions Overall, as the 8-week synbiotic consumption compared with placebo had insignificant-reducing effects on glycemic profile, IGF-1 and sex hormones among overweight and obese postmenopausal BCSs, synbiotics may exert considerable beneficial consequences, which need to be further assessed in future clinical trials. Trial registration IRCT, IRCT2015090223861N1. Registered 02 February 2017, http://www.irct.ir : IRCT2015090223861N1.

Adipokines and inflammatory factors can affect breast cancer (BC) prognosis and recurrence among breast cancer survivors (BCSs). This study was to evaluate the effects of synbiotic supplementation along with a low-calorie diet on some recurrence-related factors such as adiponectin, tumor necrosis factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP) among obese and overweight BCSs. We performed a randomized, triple-blind, placebo-controlled clinical trial among 76 overweight or obese postmenopausal women with a history of hormone-receptor-positive BC. Participants were randomly divided into 2 groups to intake either 109 CFU/day synbiotic supplement or placebo (n = 38 each group) for 8 weeks. All participants were given a low-calorie diet program. The primary outcome was serum concentration of adiponectin which was measured at baseline and after 8 weeks. Compared with the placebo, synbiotic intake significantly increased adiponectin (+ 13.58 (10.08, 18.17) vs. − 0.42 (− 2.90, 1.98) μg/ml; P < 0.001). In addition, synbiotic supplementation resulted in significant reduction in TNF-α levels (− 17.09 (− 32.05, − 13.60) vs. 0.20 (− 3.97, 2.00) ng/L; P < 0.001) and hs-CRP levels (− 1.14 (− 1.90, − 0.88 vs. − 0.06 (− 0.38, 0.15) mg/L; P < 0.001) compared with the placebo. In conclusion, 8-week synbiotic consumption by overweight and obese postmenopausal BCSs had beneficial effects on adiponectin, TNF-α, and hs-CRP. IRCT, IRCT20091114002709N49. Registered 18 May 2018, http://www.irct.ir : IRCT20091114002709N49

Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of some chemotherapy regimens. Lithium has been suggested for CIPN in some animal studies. We aimed to study lithium’s preventive effect on CIPN in breast cancer patients treated with taxanes and platinum-based medications. Method A double-blind placebo-controlled randomized clinical trial (RCT) was implemented on 36 breast cancer patients in two equal-size groups by block randomization. Participants in both groups consumed daily tablets, either placebo or lithium (300 mg), for 5 days in each course of chemotherapy. The tablets were prescribed 1 day before the start of chemotherapy. The electromyography (EMG) and nerve-conduction-velocity (NCV) tests were achieved before the first chemotherapy, 3 and 9 months after the treatment. The changes and signs or symptoms of CIPN, such as numbness, tingling, freezing, sensitivity to touch, muscle weakness, fibrillation, and knee and elbow reflex disorders, were recorded by examination. The trend of outcome changes was compared between two groups during the 9 months of study. Results In both groups, neurologic signs and symptoms were exacerbated during the first 3 months and improved up to the ninth month of study. Results showed significant changes of all EMG-NCV variables during the 9 months of research in each group (P P P=0.352). No side effect was found during the study. Conclusion The study showed that 300 mg lithium prescription once daily for 5 days might not effectively prevent CIPN in breast cancer patients. Evaluation of lithium effect on CIPN on different cancers in future studies is suggested. Trial registration Iranian Registry of Clinical Trials IRCT20160813029327N10. Registration date: May 16, 2018.

Background: As an essential principle, the collective life of human beings can constitute a human society only when human rights are respected. Demanding and respecting the rights of patients, as an inevitable part of human society, requires familiarity with patient-involved individuals. The present study aimed to determine the awareness level of Ahvaz Jundishapur University of Medical Sciences (AJUMS) students about the Charter of Patients’ Rights (CPR). Methods: This descriptive-analytical study was conducted on 200 senior university students who had been in contact with patients during their undergraduate program. They were invited from different faculties of the university. The data collection tool was a two-section questionnaire. The first section covered the demographic information, and the second included 29 questions about the 5 principles of the CPR. The obtained data were analyzed in SPSS by descriptive statistics, and analytical tests, including Independent Samples t-test, Analysis of Variance (ANOVA), and Spearman’s correlation coefficient. Results: From the 200 study participants, 103 (51%) were female. The Mean±SD of students’ awareness was 14.50±2.3. The highest and lowest mean scores belonged to the areas of access to services and confidentiality. There was no statistically significant difference between the awareness score of students from different faculties (P=0.359). Conclusion: This study results suggested that the awareness level of the medical students about the CPR was unsatisfactory. Instituting ethical codes among students and providing them knowledge of their professional lives is an essential part of the university’s responsibilities.

Aim of the study The present study showed the clinicopathological characteristics and survival of early breast cancer (BC) patients. Material and methods A total of 236 patients were included in the study. The mean follow-up time was 59.5 months (range: 12-204 months). The inclusion criteria consisted of female patients aged > 20 years and early BC patients (stages I and IIA). Results The mean age at diagnosis was 51.2 years (range, 23-83 years), and 55.9% of patients were aged ≥ 50 years. Most patients (92.8%) did not have lymph node metastasis, and luminal B had the highest prevalence (54.2%) in patients. The eight-year overall survival (OS) and disease-free survival (DFS) rates were 98.3% and 92.3%, respectively. Stage IIA and Ki67 index ≥ 14% were more prevalent in the patients with tumour size of 2 ≤ T ≤ 5 cm compared to another tumour size group and Ki67 index. Conclusions The mean age at diagnosis in this study was in agreement with other studies reported in various areas, but with a higher percentage for elderly patients compared to some previous studies. In addition, the survival rate in the present study was higher than the results of previous studies. Future studies need to investigate these factors in a higher number of patients and in different areas and should select similar stages for early BC.

Background: The objective of this study was to compare the efficacy and side effects of to evaluate the efficacy and safety of a single dose (Peg-Filgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial.Methods: In this randomized clinical trial, 80 patients recruited and allocated randomly in two equal arms. In one group, a single subcutaneous dose of 6 mg of PDL was injected the day after receiving a chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of 300 micrograms per day for six consecutive days in each course of treatment. Side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight courses of chemotherapy.Results: hematologic parameters showed no significant difference in each course of treatment between two groups of study. The comparison of the WBC (p=0.527), Hgb (p=0.075), Platelet (p=0.819), Neutrophil (p=0.575), Lymphocyte (p=705) and ANC (p=0.675) changes during eight courses of treatment identified no statistically significant difference between two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs.Conclusion: Regarding our results, PDL is completely non- inferior in efficacy and also less toxic compared to PDG. Prescribing in single-dose and lower expenses of PDL introduces it as a cost-effective drug in the treatment of chemotherapy-induced neutropenia. Trial registration number, date of registration: IRCT20190504043465N1, May 2019https://www.irct.ir/search/result?query=IRCT20190504043465N1

Adipokines and inflammatory factors can affect breast cancer (BC) prognosis and recurrence among breast cancer survivors (BCSs). This study was to evaluate the effects of synbiotic supplementation along with a low-calorie diet on some recurrence-related factors such as adiponectin, tumor necrosis factor-alpha (TNF-α), and high-sensitivity C-reactive protein (hs-CRP) among obese and overweight BCSs.We performed a randomized, triple-blind, placebo-controlled clinical trial among 76 overweight or obese postmenopausal women with a history of hormone-receptor-positive BC. Participants were randomly divided into 2 groups to intake either 10Compared with the placebo, synbiotic intake significantly increased adiponectin (+ 13.58 (10.08, 18.17) vs. - 0.42 (- 2.90, 1.98) μg/ml; P0.001). In addition, synbiotic supplementation resulted in significant reduction in TNF-α levels (- 17.09 (- 32.05, - 13.60) vs. 0.20 (- 3.97, 2.00) ng/L; P0.001) and hs-CRP levels (- 1.14 (- 1.90, - 0.88 vs. - 0.06 (- 0.38, 0.15) mg/L; P0.001) compared with the placebo.In conclusion, 8-week synbiotic consumption by overweight and obese postmenopausal BCSs had beneficial effects on adiponectin, TNF-α, and hs-CRP.IRCT, IRCT20091114002709N49. Registered 18 May 2018, http://www.irct.ir : IRCT20091114002709N49.

To evaluate hormone receptor status on survival and recurrence of the human epidermal growth factor receptor 2-positive breast cancer treated with Trastuzumab in the adjuvant setting.The retrospective study was conducted in 2017 at the Breast Cancer Research Centre, Tehran University of Medical Sciences, Tehran, Iran, and comprised data of women aged20 years with stage I-III of human epidermal growth factor receptor 2-positive breast cancer who were treated with Trastuzumab from 2008 to 2017. The patients were divided into two groups. Group P had patients who were triple positive for human epidermal growth factor receptor 2, oestrogen receptor and progesterone receptor. Group N had patients positive for only human epidermal growth factor receptor 2. All patients in group P were treated with hormone therapy. Overall survival, disease-free survival, and distant metastasis rates were measured. SPSS 22 was used for data analysis.Of the 263 patients, 169(%) were in group P with a mean age of 46.86 ± 10.92 years, and 94(%) were in group N with a mean age of 48.53±12.33 years (p0.05). There were no unfavourable predictors for overall survival and disease-free survival except for stage (p0.05). The difference on both counts between the groups was not significant (p0.05 each).The impact of hormone receptor positivity on survival and progression of human epidermal growth fac tor receptor 2-positive breast cancer remains an area of debate.

Objective Some hormonal and targeted treatment options are available in the first line of metastatic HR+ & HER2- breast cancer. This study aimed to quantify the preferences of Iranian breast cancer patients regarding the levels of attributes of hypothetical treatment options. Methods The discrete choice experiment included 16 orthogonally designed scenarios. A novel method (named “the World Cup”) was used to offer the scenarios to the respondents. Each choice task had 2 hypothetical treatments. A conditional logit regression model was used to obtain preference estimates, based on an expected utility model without interactions between attributes. Results A total of 78 patients with breast cancer participated in the survey. The effectiveness was the main concern of the patient, which was followed by monthly cost. Participant patients significantly preferred to avoid adverse events; preference dummy-coded estimates were reported. Conclusion Followed by the effectiveness and cost, the risk of neutropenia, stomatitis, and arthralgia was least prioritized by the respondents. The estimation for the levels of the attribute “administration mode” is not significant (P = .690). Patients with breast cancer were willing to pay significant amounts to gain the benefit of the treatments and showed a significant willingness to accept to avoid the adverse events of the treatments.

Aim of the study This study aimed to assess the efficacy of anthracycline-based (AB) and non-anthracycline-based (nAB) adjuvant therapies in the human epidermal growth factor receptor 2 (HER2)-positive non-metastatic BC (nMBC) patients. Material and methods This retrospective study included women with HER2-positive BCs (stage I-III) treated with trastuzumab from 2008 to 2017. The patients were divided into two groups, including 196 patients in group AB and 67 in group nAB. Results Cox's proportional hazard regression analysis showed no unfavourable predictors for five-year overall survival (OS) and disease-free survival (DFS) except for stage and hormone therapy. The OS rate was 67.9% in group AB and 80.6% in group nAB (p = 0.630). The DFS rate was 61.6% in group AB compared with 67.1% in group nAB (p = 0.447). Conclusions The results showed no difference between the efficacies of AB and nAB regimens in HER2-positive nMBCs in adjuvant setting. Therefore, selecting the nAB regimen can reduce the serious damage caused by the AB regimen.

Purpose The purpose of this study was to compare the efficacy and safety of a proposed bevacizumab biosimilar to those of the reference product in patients with metastatic colorectal cancer (mCRC). Methods This Phase III, multicenter, randomized, double-blind (patient- and assessor-blind), active-controlled, 2-armed, parallel-group, noninferiority trial was conducted in patients with histologically verified colorectal cancer with evidence of at least 1 metastasis. Patients with mCRC were randomized 2:1 to receive 5 mg/kg IV of either study drug plus FOLFIRI-3 (with repeated irinotecan 100 mg/m2 60-min infusion on day 3) or the reference drug plus FOLFIRI-3 every 2 weeks for 1 year. Progression-free survival (PFS) was the primary end point, and overall survival, objective response rate, and time to treatment failure as well as safety and immunogenicity were secondary end points. The population assessable for PFS was per protocol, and the intention-to-treat population was used for sensitivity analysis. Safety was assessed based on reports of adverse events, laboratory test results, and vital sign measurements. Findings A total of 126 patients were enrolled; PFS values in the biosimilar and reference arms were 232 days (7.7 months) and 210 days (7 months), respectively (P = 0.47). The hazard ratio of the biosimilar arm versus the reference arm was 0.79 in the per-protocol population (90% CI, 0.46–1.35; P = 0.47). The upper limit for the 2-sided 90% CI was lower than the margin of 1.44, indicating that the biosimilar drug was noninferior to the reference drug. The hazard ratio for overall survival in the intent-to-treat population was 0.99 (95% CI, 0.55–1.80; P = 0.99). The difference between other efficacy end points among the groups was not statistically significant. No significant difference was observed in the comparison of the two arms for safety. The antidrug antibody was positive in 1 patient in each arm. Implications The proposed biosimilar BE1040V was noninferior to the reference product in terms of efficacy in the treatment of mCRC, and tolerability was comparable between the 2 drugs. ClinicalTrials.gov identifier: NCT03288987.

Gastrointestinal (GI) side effects caused by chemotherapy in women with breast cancer are common but poorly understood which might be controlled by nutritional intervention. Thus, the major aim of this study was to assess the effect of dietary intervention along with nutritional education on reducing these side effects. The present study is a single-center, single-controlled, and randomized trial. A total of 150 patients with breast cancer undergoing chemotherapy were randomly assigned into intervention group to receive dietary intervention and nutritional education (n = 73) or control group (n = 67) for 10 weeks, after their three sessions of chemotherapy. The primary endpoint was the GI symptoms after each session of chemotherapy that were measured by a designed questionnaire based on ROMIII questionnaire. The severity of GI side effects in the dietary intervention along with nutritional education was decreased significantly in the third session of chemotherapy compared to the first session, which include reflux disorder (P = 0.05), anorexia (P

Patients with breast cancer (PsBC) usually face with chemotherapy induced nausea and vomiting (CINV). The aim of this study was to assess the impact of nutritional counseling on CINV and quality of life (QoL) of PsBC. 150 PsBC were randomly assigned for receiving a personalized diet, which contained 1.2-1.5 g/kg of protein, 30% of energy from fat and 55-60% of energy from carbohydrate, a face to face nutrition education, and a pamphlet which contained beneficial nutrition information to reduce the severity of CINV before each chemotherapy session for three times (n = 75) or regular care (n = 75). CINV, QoL, and dietary intake were evaluated after each chemotherapy session. Nausea rating index, overall nausea index, and visual analog scale (P 0.001) were dramatically lower in the intervention group. Global health status/QoL as well as physical functioning, role functioning, emotional functioning, and cognitive functioning (P 0.001) were significantly better in the intervention group. Patients in the control group experienced more fatigue, nausea and vomiting, pain, dyspnea, loss of appetite, constipation, and diarrhea (P 0.001). Nutrition counseling during adjuvant chemotherapy among PsBC reduced the occurrence of CINV and led to significant improvements in the QoL.

Background: Neoadjuvant chemotherapy is the standard treatment for patients with locally advanced breast cancer which was recently introduced for operable breast cancer especially to achieve negative margins in breast conservation. Several studies have shown that Pathologic complete response (pCR) after neoadjuvant chemotherapy increases survival rate. The aim of this study therefore, was to evaluate the rate of pathologic complete response and its effective factors in breast cancer research center (BCRC). Methods: During a cross-sectional study, 179 patients with stage I to III breast cancer, who received neoadjuvant chemotherapy in breast cancer research center from 1997 to 2014, were included. Cases with pathologic complete response were defined as no tumor residue in the breast tissue and axillary region. This group of patients was compared with patients who had residual tumor at pathology. Data were analyzed by descriptive and inferential statistics using SPSS 19. Results: The mean age of patients was 45.4 years. Thirty-four patients (19%) were identified in the pathological complete response group (pCR). There was no significant difference between the pCR and non-pCR groups with respect to Age, Menopausal status, Family history of breast cancer, Tumor size, Histological type, Hormone receptors, Her-2neu and Phenotypic subtypes. However, ki67 index was significantly different between the two groups of patients, indicating that in patients with Ki67 of more than 40, pCR was the most observed (P = 0.01). Conclusions: This study showed that among the demographic, clinical, pathological and therapeutic factors, Ki67 can be a predicting factor for pathologic complete response after neoadjuvant chemotherapy.

Background: Non-Hodgkin’s lymphoma (NHL) is the fifth most frequently diagnosed cancer whose incidence has risen by at least 100 percent over the past five decades especially in the West. Objectives: The aim of this study is to investigate Clinicopathology figures, overall survival (OS) and Progression-free survival (PFS) in patients with NHL in Iran. Methods: In a descriptive study, 143 patients referred to Clinic of Hematology in two centers between 2005 and 2014. We checked age, sex, types and subtypes of NHL; recurrence, Ki-67, organomegaly, lymphadenopathy, radiotherapy, OS and PFS in the patients. The mean follow-up was 49 months. All patients received R-CHOP regimen for 6 to 8 cycles. Results: The mean age at diagnosis for the patients was 46 years (range, 16 - 82) and 76.9% had age < 60 years and 62.2% were male. 58% patients had primary nodal NHL and out of 139 patients, 88.5% were aggressive NHL. Organomegaly and lymphadenopathy were in 12 patients (8.4%) and 80 (55.9%), respectively. Of all patients, 106 patients (74.1%) were treated with radiotherapy. 2-year OS rate was 91.5% and 5-year OS rate was 85%.2-and 5-year PFS rates were 79.6% and 63.3%, respectively. Conclusions: Percentage of NHL in males is more than females and the median age is around 45 years. Also, the prevalence of nodal is more compared with extranodal in NHL patients.

Aim of the study: The aim of this trial was to compare overall survival (OS), disease-free survival (DFS), and toxicity of two adjuvant regimens in triple negative patients with Iranian ethnicity. Material and methods: In a phase II trial, patients with previously untreated triple negative breaststroke cancer were randomly assigned by using docetaxel 70 mg/m 2 and carboplatin AUC = 7 every three weeks with granulocyte colony-stimulating factor for sin courses (arm A) or doxorubicin hydrochloride 60 mg/m 2 and cyclophosphamide 600 mg/m 2 every three weeks with G-CSF for four courses followed by docetaxel 70 mg/m 2 and carboplatin AUC = 7 every three weeks with G-CSF for four courses (arm B). Results : A total of 119 patients were randomly enrolled in our study (60 patients in Arm A and 59 patients in Arm B) between 2011 and 2016. The mean follow-up was 40 months at the time of treatment analysis. The 2-year and 5-year DFS rates for Arm A were 92.7% vs. 85% and for Arm B were 82.6% vs. 64.4%. The 2-year and 5-year OS rates for Arm A were 96.5% vs. 91.7% and for Arm B were 90.5% vs. 81.3%. There was a significant correlation for DFS and OS in the two arms. There was no significant difference between adverse events with the two regimens. Conclusions : In our research, less progression was found with Arm A as compared to Arm B. Adding of anthracyclines such as doxorubicin hydrochloride did not increase OS and DFS in triple negative breast cancer (TNBC) patients.

Chemotherapy-induced nausea and vomiting (CINV) places a significant burden on the patient. Herbal agents are the most commonly complementary therapies used among the public. This study was done to determine the effect of ginger and chamomile capsules on nausea and vomiting in cases undergoing chemotherapy for breast cancer (BC).In a randomized, double-blind and clinical trial study, 65 women with BC undergoing chemotherapy were referred to Breast Cancer Research Center, Tehran, Iran, between May 2013 to June 2014. Regimen for ginger group for 5 days before and 5 days after chemotherapy was: 2 times a day and 500 mg capsules of powdered ginger root in addition to a routine antiemetic regimen consisting of dexamethasone, metoclopramide and aprepitant (DMA) capsules. Chamomile group similarly was: 2 times a day and 500 mg capsules of Matricaria chamomilla extract in addition to a routine antiemetic regimen consisting of DMA capsules. Control group, routine antiemetic regimen consisting of DMA capsules.There were no significant differences between the ginger, chamomile and control groups regarding age. Drugs used for chemotherapy were identical and duration of disease was also matched (1-4 months). Ginger and chamomile were both significantly effective for reducing the frequency of vomiting, there being no significant difference between the ginger and chamomile groups. Moreover, unlike the chamomile, ginger significantly influenced the frequency of nausea.According to the findings of this study, it should be declared that taking ginger capsules (1 g/day) might relieve CINV safely. Nurses dealing directly with cancer patients should be responsible for providing educational programs for patients and their families about how to deal with their drug regimens and associated side effects.

Background: A combination of rituximab to cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is one of the most effective front-line therapies to treat B-cell non-Hodgkin's lymphoma (NHL). The aim of this trial was to evaluate overall survival (OS), progression free survival (PFS) and toxicity of R-CHOP-14 compared to R-CHOP-21 in untreated stage III and IV B-cell NHL patients with Iranian ethnicity. Materials and Methods: In a phase III trial, patients with previously untreated stage III and IV indolent and aggressive B-cell NHL were randomly assigned by using a minimization method to receive six to eight cycles of either R-CHOP-21 (administered every 21 days) or R-CHOP-14 (administered every 14 days with granulocyte colony-stimulating factor). Results: A total of 143 patients were randomly enrolled in our study (66 patients in R-CHOP-14 group and 77 patients in R-CHOP-21), between 2011 and 2014. The mean follow-up was 45 months at the time of treatment analysis. The 2-year and 5-year PFS rates for the R-CHOP-14 group were 83.6% vs 73.6% and for R-CHOP-21 group were 75% vs 54%. The 2-year and 5-year OS rates for R-CHOP-14 group were 98% vs 89% and for R-CHOP-21 group were 84.4% vs 67.5%. There was a significant correlation for PFS and OS in the two arms. There was no significant difference between adverse events with the two regimens. Conclusions: In our research improved survival was found with CHOP-14 as compared to CHOP-21. It is possible that drug metabolism in different races/ethnicities may be one important factor.

Background: Mapping from non-performance-based measures onto generic performance-based measures provides an appropriate solution to derive utilities to be used in economic evaluations. Objectives: This study aimed to create a model through which EQ-5D utilities for cataracts can be obtained from scores on the diseasespecific Catquest measure. Patients and Methods: One hundred ninety-nine observations from 103 patients who self-administered the EQ-5D, the Catquest and questions on demographic and clinical characteristics were included in the analysis. Data was divided into estimation and validation datasets. To predict EQ-5D utilities, multiple regression analysis, using the Ordinary Least Square (OLS) and the censored least absolute deviation (CLAD), was performed. Catquest scores, age, gender, and performing surgery were included as explanatory variables. An estimation dataset was used to derive the coefficients, and these coefficients were then validated using a validation dataset. Based on the explanatory power, the consistency, the simplicity, the mean absolute error (MAE) and the correlations between observed and fitted utilities, the most appropriate model was selected. Results: The mean EQ-5D and Catquest scores of the total sample were 0.631 and 15.8, respectively. Age and surgery showed no significant effect for either method. Removing age and surgery, model II was built and given an R 2 of 0.697, an MAE of 0.1176 for the OLS and an R 2 of 0.614, and an MAE of 0.1153 for the CLAD method. In the validation stage, the CLAD revealed better prediction ability, with an MAE of 0.198 versus an MAE of 0.209 for the OLS. ICC and Bland-Altman analysis put the CLAD as a preferred method with the following equation: Utilities (EQ-5D) = 0.988 - 0.0281 × Catquest (PD) + 0.102 × gender (male = 1). Conclusions: Based on these results, a mapping function was obtained which appears to be valuable in predicting EQ-5D utilities from Catquest scores. This function gives an appropriate solution to estimate utilities when primary EQ-5D data is not available. Although the model represents good consistency and predictive ability, further examination of obtained function is required with large samples.

Background: Utility values are a key component of a cost-utility analysis. The EQ-5D and SF-6D are two commonly used measures for deriving utilities. Of particular importance is assessing the performance of these instruments in terms of validity. Objectives: This study aimed to compare the performance of the EQ-5D and the SF-6D in different states of breast cancer. Patients and Methods: This was a cross-sectional study of 163 patients with breast cancer who attended the breast cancer subspecialty clinic affiliated with the breast cancer research center (BCRC) at ACECR, in Tehran, Iran, and were consecutively recruited. Patients completed several questionnaires, including the EQ-5D, SF-36, and general questions regarding their demographic characteristics. Utility values for different states of breast cancer were obtained using predetermined algorithms for the EQ-5D and SF-6D. The distribution of the utility values and the differences between the different states for both instruments were statistically assessed. Furthermore, the agreement between the two instruments was evaluated using intra-class correlation coefficients and Bland-Altman plots. Results: The mean and median EQ-5D utility scores for the total sample were 0.685 and 0.761, respectively. The mean SF-6D utility score for the total sample was 0.653, and the median utility score was 0.640. The mean utility values of the EQ-5D for “state P,” “state R,” “state S,” and “state M” were estimated as 0.674, 0.718, 0.730, and 0.552, respectively. The SF-6D provided mean utility values of 0.638, 0.677, 0.681, and 0.587 for those states. Both instruments assigned statistically significant (P < 0.01) scores for different states. The intra-class correlation for the two measures was 0.677 (95% confidence interval (CI): 0.558 - 0.764). The Bland-Altman plot indicated a better agreement on the higher values and that at higher values, the EQ-5D yields a higher score than the SF-6D; this relationship was reversed at lower values. Conclusions: Although the two instruments were able to discriminate between various states, the values derived from these instruments were quite different. This distinction could have influenced the conclusions of an economic evaluation. Further research is required to determine which instrument should be used in economic evaluations.

Objective The objective of our study was to show the impact of different chemotherapy regimens on the incidence of amenorrhea (chemotherapy-induced amenorrhea [CIA]) in premenopausal women of various ages with breast cancer. Methods This is a follow-up study of 226 premenopausal women with breast cancer who had received one of three chemotherapy regimens: conventional (cyclophosphamide/methotrexate/5-fluorouracil), anthracycline based, and anthracycline-taxane based. They were evaluated for the incidence of CIA in the follow-up clinic of the Iranian Center for Breast Cancer. A statistical analysis using SPSS software was performed, and logistic regression and Cox regression model were used to determine the risk factors for CIA. Results Of the 226 women with a median age of 40 years (range, 26-56 y) who participated in this study, 154 (68.1%) developed CIA. In 101 (65.6%) of these women, CIA was established. CIA was present in 52.5% of the women who had been treated with conventional regimens (cyclophosphamide/methotrexate/5-fluorouracil), 66.7% of the women who had been treated with anthracycline, and 78.7% of the women who had been treated with anthracycline-taxane. Therefore, the frequency of CIA was significantly higher in the taxane-based chemotherapy group than in the other groups (P = 0.015). Although a slightly higher incidence of CIA in women with hormone-insensitive tumors (estrogen receptor negative and progesterone receptor negative) versus hormone-sensitive tumors (estrogen receptor positive and progesterone receptor positive) who had been treated with combination regimens was observed, no statistically significant difference was found (P = 0.629). Of all of the risk factors that were evaluated in the study, anthracycline-taxane-based regimens (odds ratio, 4.059; 95% CI, 1.6-9.8) and age older than 40 years (odds ratio, 3.5; 95% CI, 1.9-6.6) were the most important factors in the development of CIA. Conclusions The type of chemotherapy and the age of the woman at the onset of breast cancer are the most important risk factors in CIA. Taxane-based regimens induced more CIA than did other regimens.

Background: Although transcatheter arterial chemoembolization (TACE) has been widely used as a palliative treatment for unresectable hepatocellular carcinoma (HCC), its actual efficacy and prognostic usefulness have not been clarified in past studies. Objectives: The aim of the study is to investigate the efficacy, complications, and prognostic factors of the TACE in unresectable HCC patients. Patients and Methods: Thirty-two patients with unresectable HCC were treated with TACE. The procedure was performed with a combination of Lipiodol, doxorubicin, and cytomycin followed by gelatin-sponge particles embolization. CT-scan imaging and liver function tests (AST, ALT, ALP, BIL, and PT) were performed before and after the TACE. All patients were followed-up for 6-months. Results: Of all patients, 1 and 11 patients respectively, exhibited a complete response (CR) and a partial response (PR) (response rate, CR+PR, 44%). Data have shown that tumor size, number of lesions and number of involved segments are significantly reduced after the TACE performance (P < 0.05). No significant clinical adverse effect was observed in patients after the intervention. Also, liver function tests including AST, ALT, ALP, BIL, and PT did not significantly differ before and after the intervention (P > 0.05). The 6-month cumulative survival rates of the 32 patients were 78.1 %, respectively. Univariate analysis showed that survival correlated significantly with the following factors: tumor size; ≥ 8 cm versus < 8 cm (P < 0.010), serum ALP level; < 300 versus ≥ 300 (P < 0.043), and number of liver involved segments; < 2 versus ≥ 2 (P < 0.020). Conclusions: We showed that in treatment of patients with unresectable hepatocellular carcinoma, TACE significantly improved the disease and the overall survival rate. Also, we introduce the tumor size, serum ALP level, and number of liver involved segments as prognostic factors of the procedure. Finally, TACE can be recommended as the initial treatment for unresectable HCC patients.

To determine the prevalence of gluten sensitive enteropathy (GSE) in a large group of patients with iron deficiency anemia (IDA) of obscure origin.In this cross-sectional study, patients with IDA of obscure origin were screened for GSE. Anti-endomysial antibody (EMA) and tissue transglutaminase antibody (tTG) levels were evaluated and duodenal biopsies were taken and scored according to the Marsh classification. The diagnosis of GSE was based on a positive serological test and abnormal duodenal histology. Gluten free diet (GFD) was advised for all the GSE patients.Of the 4120 IDA patients referred to our Hematology departments, 206 (95 male) patients were found to have IDA of obscure origin. Thirty out of 206 patients (14.6%) had GSE. The mean age of GSE patients was 34.6 +/- 17.03 (range 10-72 years). The female to male ratio was 1.3:1. Sixteen patients had Marsh 3, 12 had Marsh 2, and 2 had Marsh 1 lesions. The severity of anemia was in parallel with the severity of duodenal lesions. Twenty-two GSE patients (73.3%) had no gastrointestinal symptoms. Fourteen GSE patients who adhered to GFD without receiving iron supplementation agreed to undergo follow up visits. After 6 mo of GFD, their mean hemoglobin levels (Hb) increased from 9.9 +/- 1.6 to 12.8 +/- 1.0 g/dL (P0.01). Interestingly, in 6 out of 14 patients who had Marsh 1/2 lesions (e.g. no villous atrophy) on duodenal biopsy, mean Hb increased from 11.0 +/- 1.1 to 13.1 +/- 1.0 g/dL (P0.01) while they did not receive any iron supplementation.There is a high prevalence (e.g. 14.6%) of GSE in patients with IDA of obscure origin. Gluten free diet can improve anemia in GSE patients who have mild duodenal lesions without villous atrophy.