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Background Breast cancer is the most frequently diagnosed cancer and the leading reason for cancer-related death among women. Neoadjuvant treatment with dual-HER2 (human epidermal growth factor receptor 2) blockade has shown promising effects in this regard. The present study aimed to compare the efficacy and safety of a proposed pertuzumab biosimilar with the reference pertuzumab. Methods This randomized, phase III, multicenter, equivalency clinical trial was conducted on chemotherapy-naive women with HER2-positive breast cancer. Patients were randomly assigned (1:1) to receive six cycles of either P013 (CinnaGen, Iran) or the originator product (Perjeta, Roche, Switzerland) along with trastuzumab, carboplatin, and docetaxel every 3 weeks. Patients were stratified by cancer type (operable, locally advanced, inflammatory) and hormone receptor status. The primary endpoint was breast pathologic complete response (bpCR). Secondary endpoints included comparisons of total pCR, overall response rate (ORR), breast-conserving surgery (BCS), safety, and immunogenicity. Results Two hundred fourteen patients were randomized to treatment groups. bpCR rate in the per-protocol population was 67.62% in the P013 and 71.57% in the reference drug groups. Based on bpCR, P013 was equivalent to the reference pertuzumab with a mean difference of − 0.04 (95% CI: − 0.16, 0.09). Secondary endpoints were also comparable between the two groups. Conclusions The proposed biosimilar P013 was equivalent to the reference product in terms of efficacy. The safety of both medications was also comparable.

Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim 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 were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of 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 the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

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.

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.

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.

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.

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.

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.

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.