Efficacy and safety of diphereline 11.25 mg, microrelin 11.25 mg, and microrelin 3.75 mg in premenopausal patients with breast cancer: a non-inferiority randomized clinical trial.

BACKGROUND: Diphereline is a Gonadotropin-Releasing Hormone agonist commonly used in patients with breast cancer. This study aimed to compare the efficacy and safety of one-month and three-month Microrelin injections produced by Homa Pharmed Company with three-month Diphereline injections manufactured by IPSEN, France. METHODS: The study was a non-inferiority randomized clinical trial conducted between 2019 and 2023 on premenopausal women candidates for endocrine therapy. The participants were randomly assigned in blocks of six to one of three groups named A (Diphereline 11.25 mg), B (Microrelin 11.25 mg), and C (Microrelin 3.75 mg). The participants' menopausal symptoms, estradiol, and FSH serum levels were recorded in three-month intervals for one year. The efficacy of each medication and its side effects were compared among the three groups by statistical analysis during the one-year follow-up. RESULTS: The study included 133 patients with breast cancer. A decreasing trend in the serum levels of FSH and estradiol and an increasing trend of menopausal symptoms were recorded during the study. No specific side effects leading to drug disruption, hospitalization, or exclusion from the study were observed. Adjusting the effect of study group and time showed no significant changes in estradiol levels between groups B (p = 0.506) and C (p = 0.607) and group A. Also, serum FSH changes between groups B (p = 0.132) and C (p = 0.104) compared to group A were not significant. Moreover, the menopausal symptoms during the one-year follow-up did not significantly increase in group B (p = 0.108) and C (p = 0.113) compared to group A. CONCLUSIONS: It can be concluded that injections of both Microrelin 11.25 mg and 3.75 mg, produced by Homa Pharmed, Iran, are non-inferior in terms of effectiveness and incidence of menopausal symptoms compared to Diphereline, manufactured by IPSEN, France. TRIAL REGISTRATION: IRCT.ir, IRCT20201227049847N1; Registered on 09/01/2021.

Refractory and Recurrent Idiopathic Granulomatous Mastitis Treatment: Adaptive, Randomized Clinical Trial.

BACKGROUND: Idiopathic granulomatous mastitis (IGM) is mostly described as an autoimmune disease with higher prevalence among Middle Eastern childbearing-age women. This study aimed to evaluate the best treatment of choice in patients with resistant or recurrent IGM. STUDY DESIGN: Patients with established recurrent or resistant IGM who were referred to the Breast Cancer Research Center from 2017 to 2020 were randomly assigned to either one of the following treatment groups: A (best supportive care), B (corticosteroids: prednisolone), and C (methotrexate and low-dose corticosteroids). This adaptive clinical trial evaluated radiological and clinical responses, as well as the potential side effects, on a regular basis in each group, with patients followed up for a minimum of 2 years. RESULTS: A total of 318 participants, with a mean age of 33.52 ± 6.77 years, were divided into groups A (10 patients), B (78 patients), and C (230 patients). In group A, no therapeutic response was observed; group B exhibited a mixed response, with 14.1% experiencing complete or partial responses, 7.7% maintaining stability, and 78.2% experiencing disease progression. Accordingly, groups A and B were terminated due to inadequate response. In group C, 94.3% achieved complete response, 3% showed partial remission, and 2.7% had no response to therapy. Among the entire patient cohort, 11.6% tested positive for antinuclear antibodies, 3.5% for angiotensin-converting enzyme, and 12.3% for erythema nodosum. Notably, hypothyroidism was a prevalent condition among the patients, affecting 7.2% of the cohort. The incidence of common side effects was consistent across all groups. CONCLUSIONS: The most effective treatment option for patients with recurrent or resistant IGM is a combination therapy involving steroids and disease-modifying antirheumatic drugs such as methotrexate.

A micropillar array-based microfluidic chip for label-free separation of circulating tumor cells: The best micropillar geometry?

INTRODUCTION: The information derived from the number and characteristics of circulating tumor cells (CTCs), is crucial to ensure appropriate cancer treatment monitoring. Currently, diverse microfluidic platforms have been developed for isolating CTCs from blood, but it remains a challenge to develop a low-cost, practical, and efficient strategy. OBJECTIVES: This study aimed to isolate CTCs from the blood of cancer patients via introducing a new and efficient micropillar array-based microfluidic chip (MPA-Chip), as well as providing prognostic information and monitoring the treatment efficacy in cancer patients. METHODS: We fabricated a microfluidic chip (MPA-Chip) containing arrays of micropillars with different geometries (lozenge, rectangle, circle, and triangle). We conducted numerical simulations to compare velocity and pressure profiles inside the micropillar arrays. Also, we experimentally evaluated the capture efficiency and purity of the geometries using breast and prostate cancer cell lines as well as a blood sample. Moreover, the device's performance was validated on 12 patients with breast cancer (BC) in different states. RESULTS: The lozenge geometry was selected as the most effective and optimized micropillar design for CTCs isolation, providing high capture efficiency (>85 %), purity (>90 %), and viability (97 %). Furthermore, the lozenge MPA-chip was successfully validated by the detection of CTCs from 12 breast cancer (BC) patients, with non-metastatic (median number of 6 CTCs) and metastatic (median number of 25 CTCs) diseases, showing different prognoses. Also, increasing the chemotherapy period resulted in a decrease in the number of captured CTCs from 23 to 7 for the metastatic patient. The MPA-Chip size was only 0.25 cm2 and the throughput of a single chip was 0.5 ml/h, which can be increased by multiple MPA-Chips in parallel. CONCLUSION: The lozenge MPA-Chip presented a novel micropillar geometry for on-chip CTC isolation, detection, and staining, and in the future, the possibilities can be extended to the culture of the CTCs.

Long-term Survival and Prognostic Factors of Breast Cancer.

BACKGROUND: Breast cancer survival rate is an important index for assessment of treatment effect in reducing the mortality. Weaimed to determine the fifteen-year survival rate for breast cancer at a referral center in Iran and its correlated factors. METHODS: This survival study enrolled patients with breast cancer who referred to Motamed Cancer Institute (MCI) from 1998 to2016. The survival rate was calculated using the Kaplan-Meier method. The relationship of demographic, clinical and therapeuticfactors with overall survival (OS) was studied using Cox's proportional hazard model. RESULTS: Totally, 3443 patients were studied. Their mean age and follow-up period were 47.7 (±11.43) years and 61.66 (±52.1)months, respectively. The median follow-up time was 48.4 months (range: 1-413 months), 49.7% of the patients had high schoolor higher education, and 71.3% presented in the early stage of the disease. Death occurred in 505 (14.7%) of the patients. Theoverall 2-, 5-, 7-, 10- and 15-year survival rates were 93%, 82%, 78%, 74%, and 66%, respectively. Lymph node involvement(HR=2.07; 95% CI: 1.38-3.09), tumor size≥5 cm (HR=2.83; 95% CI: 1.59-2.04), being single/divorced/widowed (HR=1.65;95% CI: 1.13-2.4), and education level

Breast cancer risk factors in Iranian women: a systematic review and meta-analysis of matched case-control studies.

BACKGROUND: Identifying breast cancer risk factors is a critical component of preventative strategies for this disease. This study aims to identify modifiable and non-modifiable risk factors of breast cancer in Iranian women. METHODS: We used international databases (PubMed/Medline, Scopus, Web of Knowledge, and Embase) and national databases (SID, Magiran, and ISC) to retrieve relevant studies until November 13, 2022. The odds ratio (OR) with a 95% confidence interval using the random-effect model was used to estimate the pooled effect. The publication bias was assessed by the Egger and Begg test. A sensitivity analysis was conducted to evaluate the effect of each included study on the final measurement. RESULTS: Of the 30,351 retrieved articles, 24 matched case-control records were included with 12,460 participants (5675 newly diagnosed cases of breast cancer and 6785 control). This meta-analysis showed that of the known modifiable risk factors for breast cancer, obesity (vs normal weight) had the highest risk (OR = 2.17, 95% CI 1.47 to 3.21; I2 = 85.7) followed by age at marriage (25-29 vs < 18 years old) (OR = 2.00, 95% CI 1.53 to 2.61; I2 = 0), second-hand smoking (OR = 1.86, 95% CI 1.58 to 2.19; I2 = 0), smoking (OR = 1.83, 95% CI 1.41 to 2.38; I2 = 18.9), abortion history (OR = 1.44, 95% CI 1.02 to 2.05; I2 = 66.3), oral contraceptive use (OR = 1.35, 95% CI 1.11 to 1.63; I2 = 74.1), age at marriage (18-24 vs < 18 years old) (OR: 1.22, 95% CI 1.02 to 1.47; I2 = 0). Of non-modifiable risk factors, history of radiation exposure (OR = 3.48, 95% CI 2.17 to 5.59; I2 = 0), family history of breast cancer (OR = 2.47, 95% CI 1.83 to 3.33; I2 = 73), and age at menarche (12-13 vs ≥ 14 years old) (OR = 1.67, 95% CI 1.31-2.13; I2 = 25.4) significantly increased the risk of breast cancer. CONCLUSIONS: Since most risk factors related to breast cancer incidence are modifiable, promoting healthy lifestyles can play an influential role in preventing breast cancer. In women with younger menarche age, a family history of breast cancer, or a history of radiation exposure, screening at short intervals is recommended.

Breast conserving surgery versus mastectomy: cancer practice by general surgeons in Iran.

BACKGROUND: There appear to be geographical differences in decisions to perform mastectomy or breast conserving surgery for early-stage breast cancer. This study was carried out to evaluate general surgeons' preferences in breast cancer surgery and to assess the factors predicting cancer practice in Iran. METHODS: A structured questionnaire was mailed to 235 general surgeons chosen from the address list of the Iranian Medical Council. The questionnaire elicited information about the general surgeons' characteristics and about their work experience, posts they have held, number of breast cancer operations performed per year, preferences for mastectomy or breast conserving surgery, and the reasons for these preferences. RESULTS: In all, 83 surgeons returned the completed questionnaire. The results indicated that only 19% of the surgeons routinely performed breast conserving surgery (BCS) and this was significantly associated with their breast cancer case load (P < 0.01). There were no associations between BCS practice and the other variables studied. The most frequent reasons for not performing BCS were uncertainty about conservative therapy results (46%), uncertainty about the quality of available radiotherapy services (32%), and the probability of patients' non-compliance in radiotherapy (32%). CONCLUSION: The findings indicate that Iranian surgeons do not routinely perform BCS as the first and the best treatment modality. Further research is recommended to evaluate patients' outcomes after BCS treatment in Iran, with regard to available radiotherapy facilities and cultural factors (patients' compliance).

Evaluation of factors impacting cosmetic outcome of breast conservative surgery--a study in Iran.

BACKGROUND: Breast conservative surgery (BCS) followed by radiotherapy is the standard approach in management of stage I-II breast cancer. Several factors can affect cosmetic outcomes. The aim of this study was to evaluate the cosmetic results of BCS and influencing factors in the Iranian Breast Cancer Research Center. MATERIALS AND METHODS: Patients who had undergone BCS were included. Photographs were taken of both breasts of the patients in three aspects and were evaluated by three specialists. The cosmetic scores were calculated based on a standard questionnaire. The data were analyzed using univariate and multivariate regression for relationships between cosmetic scores and clinical data. RESULTS: A total number of 103 patients were included in the study. Mean age and BMI of the patients were 46.8±8.9 and 28.1±3.9, respectively. Breast cup sizes C and D accounted for 74.7% of the study group. The mean cosmetic score obtained from three referees was 5.72+2.06, consisting of 35.9% excellent-good, 35% moderate, and 29.1% unsatisfactory results. Patient BMI, volume of the resected tissue and breast cup size (D) showed significant correlation with the cosmetic score. On multivariate regression analysis, cosmetic score and BMI (p=0.022,) as well as breast cup size (p=0.040), remained significant. CONCLUSIONS: Immediate or delayed symmetrization of the breasts is suggested during breast conservative surgery, meanwhile performing oncoplastic techniques to improve the results significantly. Also it is suggested to discuss anticipation of less satisfactory results with patients having higher BMI and large breast cup size.

Seroma formation after surgery for breast cancer.

BACKGROUND: Seroma formation is the most frequent postoperative complication after breast cancer surgery. We carried out a study to investigate the effect of various demographic, clinical and therapeutic variables on seroma formation. PATIENTS AND METHODS: A retrospective cross sectional study of patients who underwent surgical therapy for breast cancer with either modified radical mastectomy (MRM) or breast preservation (BP) was carried out. The demographic data and clinical information were extracted from case records. Seroma formation was studied in relation to age, type of surgery, tumor size, nodal involvement, preoperative chemotherapy, surgical instrument (electrocautery or scalpel), use of pressure garment, and duration of drainage. The multiple logistic regression analysis was performed to estimate odds ratios. RESULTS: A total of 158 patients with breast cancer were studied. The mean age of the patients was 46.3 years (SD +/- 11.9). Seventy-three percent underwent modified radical mastectomy and the remaining 27% received breast preservation surgery. Seroma occurred in 35% of patients. In multivariate logistic regression analysis an association of postoperative seroma formation was noted with modified radical mastectomy (OR = 2.83, 95% CI 1.01-7.90, P = 0.04). No other factor studied was found to significantly effect the seroma formation after breast cancer surgery. CONCLUSION: The findings suggest that the type of surgery is a predicting factor for seroma formation in breast cancer patients.