Combination of immune checkpoint inhibitors and radiotherapy in locally advanced esophagogastric junction adenocarcinoma: A review.

Esophagogastric adenocarcinoma (EGJ-AC) poses a significant global health burden, characterized by high incidence rates and poor prognosis. Despite advancements in treatment modalities, including surgery, chemotherapy, and radiation therapy (RT), locally advanced EGJ-AC management remains challenging. Various preclinical and clinical studies have provided insights into the synergistic effects of combining immune checkpoint inhibitors (ICIs) with RT, further supporting the combination therapy in EGJ-AC. Immunotherapy, particularly ICIs, has emerged as a promising therapeutic approach in various malignancies, including EGJ-AC. This narrative review aims to critically examine the rationale behind combining ICIs with standard treatment modalities, including RT or chemoradiotherapy, in the preoperative setting for locally advanced EGJ-AC. A comprehensive literature search identified eight phase 2 randomized clinical trials evaluating the safety profile and oncologic outcomes of adding ICI agents to neoadjuvant chemoradiotherapy in this population. The results of enrolled trials show that the combination of ICIs with standard treatment modalities is a promising approach for improving survival and pathological response in patients with locally advanced EGJ-AC. This combination treatment was associated with mostly grade 1-2 immune-related toxicities, indicating its safety and tolerability. There were higher rates of complete or major pathologic responses compared to historical controls. Further studies, including large-scale randomized controlled trials, are needed to address remaining questions regarding the efficacy, safety, and long-term outcomes of combination therapy in this population.

Hospital and post-discharge mortality in COVID-19 patients with a preexisting cancer diagnosis in Iran.

BACKGROUND: Despite the severe impact of COVID-19 on cancer patients, data on COVID-19 outcomes in cancer patients from low- and middle-income countries is limited. We conducted a large study about the mortality rate of COVID-19 in cancer patients in Iran. METHODS: We analyzed data from 1,079 cancer (average age: 58.2 years) and 5,514 non-cancer patients (average age: 57.2 years) who were admitted for COVID-19 in two referral hospitals between March 2019 and August 2021. Patients were followed up until death or 31st August 2021. Multiple logistic regression models estimated the odds ratio (OR) and 95% confidence intervals (CI) of factors associated with ICU admission and intubation. The Cox regression model estimated hazard ratios (HRs) and 95% CI of factors associated with hospital and post-discharge 60-day mortalities. RESULTS: The cancer patients had higher ICU admission (OR = 1.65, 95% CI: 1.42-1.91; P-value 0.03) and intubation (OR = 3.13, 95% CI = 2.63-3.73, P-value < 0.001) than non-cancer patients. Moreover, hospital mortality was significantly higher in cancer patients than in non-cancer patients (HR = 2.12, 95% CI: 1.89-2.41, P-value < 0.001). HR for the post-discharge mortality was higher in these patients (HR = 2.79, 95% CI: 2.49-3.11, < 0.001). The hospital, comorbidities, low oxygen saturation, being on active treatment, and non-solid tumor were significantly associated with ICU admission (P-value < 0.05) in cancer patients, while only low oxygen saturation was associated with intubation. In addition, we found that old age, females, low oxygen saturation level, active treatment, and having a metastatic tumor were associated with death due to COVID-19 (P-value < 0.05). Only lung cancer patients had a significantly higher risk of death compared to other cancer types (HR = 1.50, 95% CI: 1.06-2.10, P-value = 0.02). CONCLUSION: Cancer patients are at a higher risk of ICU admission, intubation, and death due to COVID-19 than non-cancer patients. Therefore, cancer patients who are infected with COVID-19 require intensive care in the hospital and active monitoring after their discharge from the hospital.

PErspective and current status of Radiotherapy Service in IRan (PERSIR)-1 study: assessment of current external beam radiotherapy facilities, staff and techniques compared to the international guidelines.

BACKGROUND AND PURPOSE: Radiotherapy (RT) is an essential treatment modality against cancer and becoming even more in demand due to the anticipated increase in cancer incidence. Due to the rapid development of RT technologies amid financial challenges, we aimed to assess the available RT facilities and the issues with achieving health equity based on current equipment compared to the previous reports from Iran. MATERIALS AND METHODS: A survey arranged by the Iran Cancer Institute's Radiation Oncology Research Center (RORC) was sent to all of the country's radiotherapy centers in 2022. Four components were retrieved: the reimbursement type, equipment, human resources, and patient load. To calculate the radiotherapy utilization rate (RUR), the Lancet Commission was used. The findings were compared with the previous national data. RESULTS: Seventy-six active radiotherapy centers with 123 Linear accelerators (LINACs) were identified. The centers have been directed in three ways. 10 (20 LINACs), 36 (50 LINACs), and 30 centers (53 LINACs) were charity-, private-, and public-based, respectively. Four provinces had no centers. There was no active intraoperative radiotherapy machine despite its availability in 4 centers. One orthovoltage X-ray machine was active and 14 brachytherapy devices were treating patients. There were 344, 252, and 419 active radiation oncologists, medical physicists, and radiation therapy technologists, respectively. The ratio of LINAC and radiation oncologists to one million populations was 1.68 and 4.10, respectively. Since 2017, 35±5 radiation oncology residents have been trained each year. CONCLUSION: There has been a notable growth in RT facilities since the previous reports and Iran's situation is currently acceptable among LMICs. However, there is an urgent need to improve the distribution of the RT infrastructure and provide more facilities that can deliver advanced techniques.

Duloxetine to prevent neuropathy in breast cancer patients under paclitaxel chemotherapy (a double-blind randomized trial).

PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the major side effects and main reasons for affecting quality of life and dose reduction or even discontinuation of treatment in breast cancer patients. One of the most widely prescribed chemotherapies is the "taxanes." Considering that duloxetine has been used in treating neuropathies in recent years, this study aimed to investigate its effectiveness in preventing taxane-related neuropathy. MATERIAL AND METHODS: This is a randomized controlled trial on 47 patients: 24 received a placebo and 23 received duloxetine at 30 mg daily in the first week following the injection of paclitaxel and 60 mg during the second week in each chemotherapy cycle. Patients objective (nerve conduction velocity (NCV) values) and subjective symptoms (visual analog scale including; neuropathy, paresthesia, pain, cold sensitivity, and numbness), the grades of the patients' neuropathy (calculated according to Common Terminology Criteria for Adverse Events (CTCAE) v.5), and the presence of complications, before and after each chemotherapy cycle, were recorded. RESULTS: The placebo group experienced significantly higher occurrences of new neuropathy (8/23 in duloxetine vs 16/24 in placebo, P = 0.029) in NCV by tibial nerve latency (- 0.28% vs 19.87%, P = 0.006), tibial amplitude (4.40% vs - 10.88%, P = 0.049), and median nerve latency (8.72% vs 31.16%, P = 0.039); administration of duloxetine significantly reduced the scores of neuropathies (P < 0.001), pain (P = 0.027), during chemotherapy, and 6 weeks later; however, no significant effect was observed on paresthesia, numbness, cold sensitivity, and other NCV measurements. CONCLUSIONS: Paclitaxel can cause neuropathy, lasting for a long time. Our study showed duloxetine is potentially an effective medication that can prevent subjective and objective neuropathy.

Dos and don'ts in designing a computerized oral and lip squamous cell cancer registry.

BACKGROUND: In the last ten years, many countries have started to develop constructive systems for registering common diseases and cancers. In this research, we intended to determine and identify the minimum data set (MDS) required for the design of the oral and lip squamous cell cancer registration system in Iran. METHODS AND MATERIAL: At first, primary information elements related to disease registries were extracted using scientific papers published in reliable databases. After reviewing the books, related main guidelines, and 42 valid articles, the initial draft of a researcher-made questionnaire was compiled. To validate the questionnaire, two focus group meetings were held with 29 expert panel members. The final version of this questionnaire was prepared by extracting different questions and categories and receiving numerous pieces of feedback from specialists. Lastly, a final survey was conducted by the experts who were present at the previous stage. RESULTS: Out of 29 experts participating in the study, 17 (58.62%) were men and 12 (40.37%) were women. The age range of experts varies from 34 to 58 years. One hundred-fourteen items, which are divided into ten main parts, were considered the main information elements of the registry design. The main minimum data sets have pertained to the demographic and clinical information of the patient, information related to the consumed drugs, initial diagnostic evaluations of the patient, biopsy, tumor staging at the time of diagnosis, clinical characteristics of the tumor, surgery, histopathological characteristics of the tumor, pathologic stage classification, radiotherapy details, follow-up information, and disease registry capabilities. The distinctive characteristics of the oral and lip squamous cell cancer registry systems, such as the title of the disease registration programme, the population being studied, the geographic extent of the registration, its primary goals, the definition of the condition, the technique of diagnosis, and the kind of registration, are all included in a model. CONCLUSION: The benefits of designing and implementing disease registries can include timely access to medical records, registration of information related to patient care and follow-up of patients, the existence of standard forms and the existence of standard information elements, and the existence of an integrated information system at the country level.

Efficacy of gabapentin for the prevention of paclitaxel induced peripheral neuropathy: A randomized placebo controlled clinical trial.

Neuropathy is a dose limiting side effect of taxanes which may impact the quality of life and treatment outcomes. This randomized placebo-controlled double-blinded clinical trial was carried out to assess the efficacy of gabapentin in preventing chemotherapy induced neuropathy. Women with breast cancer were randomized into two groups of paclitaxel chemotherapy with gabapentin 300 mg/three times a day orally or placebo for 2 weeks started at day 1 of each paclitaxel cycle. Two groups were compared based on the relative frequency of neuropathy and change in nerve conducting velocity (NCV). Twenty women were assigned to each study arm. The majority of the neuropathy in gabapentin group was grade 1 in all of the four cycles with no event of ≥grade 3 neuropathy in this group. Compared to the placebo, the rate of 2nd and 3rd grade neuropathy was significantly lower in the gabapentin group (P = 0.000). The change in NCV after four cycles of paclitaxel was significantly lower in the gabapentin group compared to the placebo group (17.7% vs 61.0% decline in NCV for sural and 21.9% vs 62.5% declines in NCV for peroneal nerve). Gabapentin given with paclitaxel is effective in the prevention of intermediate and high grade neuropathies both objectively and subjectively.

State of the neoadjuvant therapy for glioblastoma multiforme-Where do we stand?

Glioblastoma multiforme (GBM) is the most common malignant primary brain tumor in adults. Despite several investigations in this field, maximal safe resection followed by chemoradiotherapy and adjuvant temozolomide with or without tumor-treating fields remains the standard of care with poor survival outcomes. Many endeavors have failed to make a dramatic change in the outcomes of GBM patients. This study aimed to review the available strategies for newly diagnosed GBM in the neoadjuvant setting, which have been mainly neglected in contrast to other solid tumors.

Examining the impact of the device used for contouring in saving time and increasing the ease of contouring patients in radiotherapy treatment.

INTRODUCTION/BACKGROUND: This study was designed to investigate the amount of time saved and the degree of contour difficulty between the two methods of contouring, mouse/keyboard, versus touch screen/stylus in radiotherapy. METHODS: Each of 94 patients consisting of 26 breast cancer cases, 24 lymph nodes cases, 25 rectal cancer cases, and 19 heart cases has been contoured twice. One with a mouse/keyboard, and the next one with the touch screen/stylus. Three radiation oncologists participated in this study. Contouring information including measured time, estimated time spent, volume of contour performed and organ contoured are recorded. To evaluate the differences between the contouring methods, the results regarding target volume and time to completion were analyzed using two-way robust ANOVA. Ease of use and contouring difficulty were compared for differences in distribution of the response choices between the groups using Pearson chi-square test. RESULTS: In this study, 94 clinical cases were studied. The average time required for contouring with the touch screen/stylus method was half the time needed for contouring patients with the mouse/keyboard method. The reduction in the time in breast cancer cases was the highest (48.2%) and the lowest in head and neck cancer cases (32.4%). In comparing the contoured volumes, no significant difference was observed between the two methods. the mean estimated time reported by the radiation oncologist in the mouse/keyboard method was 5.6 minutes longer and, in the touch screen/stylus method, was 3.9 minutes less than the actual measured time. CONCLUSIONS: All the measured and analyzed variables show the superiority of contouring with the touch screen/stylus method and reduced the time required for patient contouring by an average of 50%.

Role of Oxaliplatin in the Neoadjuvant Concurrent Chemoradiotherapy in Locally Advanced Rectal Cancer: a Review of Evidence.

The treatment of locally advanced rectal cancer (LARC) is a challenging situation for radiation oncologists and colorectal surgeons. Most current approaches recommend neoadjuvant fluorouracil or capecitabine-based chemoradiotherapy followed by surgery as a standard of care. Intensification of concurrent chemotherapy by adding oxaliplatin to fluorouracil or capecitabine backbone to get better outcomes is the matter that has remained unresolved. In this review, we searched Medline and Google Scholar databases and selected 28 prospective phase II and III clinical trials that addressed this question. We discussed the potential advantages and drawbacks of incorporating oxaliplatin into concurrent chemoradiation therapy. We tried to define whether adding oxaliplatin to concurrent chemoradiation with excellent performance and high-risk features benefits some subpopulations. The available literature suggests that by adding oxaliplatin there are some benefits in enhancing response to neoadjuvant chemoradiotherapy, however, without any translated improvements in long-term outcomes including overall and disease-free survival.

The role of histology on the outcome of sinonasal carcinomas treated with radiotherapy: a single institution experience.

PURPOSE: Sinonasal malignancies are a rare group of head and neck cancers. We aimed to report the oncological outcomes based on histological types in patients who underwent radiotherapy. MATERIALS AND METHODS: In this single-institution study, we retrospectively retrieved and analyzed data of patients with sinonasal carcinomas who underwent radiotherapy during 2011-2016 as part of their treatment. The 3-year rate of local, regional, and distant recurrences, and overall survival were evaluated according to the histological type. RESULTS: A total of 28 patients were evaluated in this study, the majority of whom were male (60%). Squamous cell carcinoma (SCC), adenoid cystic carcinoma (ACC), and adenocarcinoma (ADC) were found in 15 patients (53.5%), 8 (28.5%), and 5 (18%), respectively. The highest rates of local and regional recurrences were observed in ACC and SCC, respectively. Distant recurrences were numerically more common in ADC. The 3-year OS was 48%, 50%, and 73% in SCC, ADC, and ACC, respectively. CONCLUSION: Different histopathologies of sinonasal cancer seem to have different patterns of failure, and this may be considered in the treatment approach.

The clinical application of ctDNA to predict response to neoadjuvant chemoradiotherapy in patients with locally-advanced rectal cancer.

Colorectal cancer is a major cause of cancer-related deaths worldwide. A third of colorectal cancers reside in the rectum. Many patients with rectal cancer present in the locally-advanced stage which needs multi-modality therapy usually starting with neoadjuvant chemo-radiotherapy followed by surgery and adjuvant systemic chemotherapy. Total neoadjuvant therapy, defined as the preoperative administration of both neoadjuvant chemoradiotherapy and systemic chemotherapy is also an evolving treatment that can be delivered if indications for preoperative chemotherapy exist. Identifying biomarkers to predict response to neoadjuvant therapy, can improve patient selection for a non-surgical, active surveillance approach. Circulating tumor DNA (ctDNA) can be detected in about 75% of patients with locally-advanced rectal cancer (LARC) at the baseline and in about 15-20% of patients in the post-neoadjuvant, or postoperative setting. ctDNA clearance rate after delivering neoadjuvant chemoradiotherapy, or integrating baseline ctDNA with other conventional markers of clinical response can be a promising marker to select and monitor patients on the "watch and wait" approach. In this article, we aimed to integrate the recent findings and provide a unique insight into the utilization of preoperative ctDNA to predict clinical response in patients with LARC. We also sought to highlight the potential areas for future research in this field. Further studies with a larger number of participants from diverse populations and settings are needed to increase external validity of such investigations and determine the role of ctDNA in guiding clinical decisions and management of patients with LARC.

The role of external beam radiation therapy in the management of thyroid carcinomas: A retrospective study in Iran Cancer Institute.

BACKGROUND: Thyroid cancers are histologically classified into three types; differentiated thyroid carcinoma (DTC), medullary thyroid carcinoma (MTC), and anaplastic thyroid carcinoma (ATC). Among the several therapeutic strategies for treatment and management of thyroid cancer, surgical resection in combination with radioactive iodine therapy (RAI) is indicated for moderate to high-risk differentiated thyroid cancer (DTC) patients- according to current guidelines. However, external radiation therapy (EBRT) can be a viable alternative treatment option for these patients and scarce evidence is available regarding the efficacy and effectiveness of EBRT on thyroid cancer. AIM: This study aims at evaluating the role of EBRT in the management of thyroid carcinomas. METHODS AND RESULTS: In this retrospective cohort study, the records of 59 patients with thyroid cancer were accessed who were treated by EBRT from 2008 to 2016. The indications for EBRT included unresectable primary (definitive) or loco-regional recurrences (salvage) not suitable for RAI, palliation for local disease or metastatic foci (palliative), and the adjuvant treatment for suspected residual disease following resection. Progression-free survival (PFS) and overall survival (OS) were calculated for different types of cancer. PFS was measured from the start of EBRT to the last uneventful follow-up, recurrence, or death. Kaplan-Meier model was used for the survival analysis. Fifty-nine patients were evaluated. The histopathology of the tumors was differentiated and poorly-differentiated, medullary and anaplastic thyroid carcinomas in 22 and 6, 15 and 16 patients, respectively. Twenty-seven patients received external beam radiotherapy (EBRT) as adjuvant therapy and 18 of the cases as palliative therapy while the remaining received salvage or definitive primary EBRT. The stage of patients' cancer was as follows: stage II in 3 and III in 1, IVA in 18 and IVB in 18 and IVC in 19. Stage-based median overall survival was 26 months for IVA, 44 for IVB, and 29 for IVC. The median PFS was 18, 22 and 21 months for stages IVA, IVB and IVC, respectively. CONCLUSION: Based on our findings, EBRT may still play a role in the management of patients with thyroid carcinoma and should be considered in the armamentarium against thyroid cancers.

Complication and response assessment of high-dose-rate endorectal brachytherapy boost in neo-adjuvant chemoradiotherapy of locally advanced rectal cancer with long-term outcomes.

Purpose: To identify efficacy, complication, and pathologic response of high-dose-rate endorectal brachytherapy (HDR-BRT) boost in neo-adjuvant chemoradiotherapy (nCRT) of locally advanced rectal cancer. Material and methods: Forty-four patients who met eligibility criteria were included in this non-randomized comparative study. Control group was recruited retrospectively. nCRT (50.40 Gy/28 fr. plus capecitabine 825 mg/m2 twice daily) was administered to both groups before surgery. In the case group, HDR-BRT (8 Gy/2 fr.) was supplemented after chemoradiation. Surgery was done 6-8 weeks after completion of neo-adjuvant therapy. Pathologic complete response (pCR) was the study's primary endpoint. Results: From 44 patients in the case and control groups, pCR was 11 (50%) and 8 (36.4%), respectively (p = 0.27). According to Ryan's grading system, tumor regression grade (TRG) TRG1, TRG2, and TRG3 were 16 (72.7%), 2 (9.1%), and 4 (18.2%) in the case, and 10 (45.5%), 7 (31.8%), and 5 (22.7%) in the control group (p = 0.118). T down-staging was found in 19 (86.4%) and 13 (59.1%) patients in the case and control groups, respectively. No grade > 2 toxicity was identified in both the groups. Organ preservation was achieved in 42.8% and 15.3% in the case and control arm (p = 0.192). In the case group, 8-year overall survival (OS) and disease-free survival (DFS) were 89% (95% CI: 73-100%) and 78% (95% CI: 58-98%), respectively. Our study did not reach median OS and median DFS. Conclusions: Treatment schedule was well-tolerated, and neo-adjuvant HDR-BRT could achieve better T down-staging as a boost comparing with nCRT, without significant complication. However, the optimal dose and fractions in the context of HDR-BRT boost needs further studies.

Frequency of HER2 Expression, MMR Deficiency, and PI3KCA Mutation in Pretreated Surgical Specimens of Patients with Esophageal Squamous Cell Carcinoma in Iran Cancer Institute.

Background & Objective: Iran is located in the esophageal cancer geographical belt. As multiple genetic alterations are responsible for the molecular pathogenesis of esophageal squamous cell cancer (ESCC), the role and frequency of HER2 expression, MMR deficiency, and PI3KCA mutation are not well defined. Methods: We carried out HER2/neu expression, dMMR/MSI high, and PI3KCA mutation analysis in specimens of patients with ESCC. We accessed archival tissue blocks related to specimens of 68 ESCC cases at the time of surgery following neoadjuvant chemoradiation. These patients underwent surgery during 2013-2018 at the Cancer Institute of Iran affiliated with the Tehran University of Medical Sciences in Tehran. Results: None of the patients showed HER2 expression, dMMR/MSI high, or PI3K mutations. Conclusion: dMMR/MSI-H and PI3KCA mutation and HER2 expression may not be reliable andfrequent targets for systemic therapy in patients with esophageal SCC.

Investigation of the effect of Low-Level Laser Therapy on arm lymphedema in breast cancer patients: A noninvasive treatment for an intractable morbidity.

Purpose: This article aims to study the effect of Low-Level Laser Therapy (LLLT) on arm lymphedema in patients who have breast cancer. Methods and Materials: Twenty-three patients were selected in a nonrandomized phase-2 clinical trial. After measuring the circumference of the affected and unaffected limbs at 6-points, the volume of the limbs, the degree of mental symptoms on visual analog scale by the patient upon entering the study, and performing an ultrasound on the patient's axilla to locate the fibrotic areas, a low-level laser device at a therapeutic dose of 2 J/cm2 was used to treat the patients three times a week for 4 weeks, and after an 8-week gap, for another similar period. Measurement of circumference and volume of affected and unaffected limbs and mental symptoms were carried out at the end of the 4th week, the beginning of the 12th week, and the end of the 16th week, and the obtained results were compared with those before the treatment. Results: We noted that the average reductions in the circumference and volume of the affected limb, as compared with the unaffected limb, were about 16% and 21.7%, respectively, and improvement in the patient's mental symptoms was about 32%. Another notable observation was the great enthusiasm of most patients to continue their treatment, particularly from the second cycle onward. Conclusions: LLLT can, at least in association with current standard methods, be used for arm lymphedema to introduce further reductions in pain and volume.

Remote Monitoring of Colorectal Cancer Survivors Using a Smartphone App and Internet of Things-Based Device: Development and Usability Study.

BACKGROUND: Patients with colorectal cancer who undergo surgery face many postoperative problems. These problems include the risk of relapse, side effects, and long-term complications. OBJECTIVE: This study sought to design and develop a remote monitoring system as a technological solution for the postdischarge care of these patients. METHODS: This research was conducted in 3 main steps: system feature extraction, system design, and evaluation. After feature extraction from a systematic review, the necessary features were defined by 18 clinical experts in Iran. In the next step, the architecture of the system was designed based on the requirements; the software and hardware parts of the system were embedded in the architecture, then the software system components were drawn using the unified modeling language diagrams, and the details of software system implementation were identified. Regarding the hardware design, different accessible hardware modules were evaluated, and suitable ones were selected. Finally, the usability of the system was evaluated by demonstrating it over a Skype virtual meeting session and using Nilsen's usability principles. RESULTS: A total of 21 mandatory features in 5 main categories, including patient information registration, periodic monitoring of health parameters, education, reminders, and assessments, were defined and validated for the system. The software was developed using an ASP.Net core backend, a Microsoft SQL Server database, and an Ionic frontend alongside the Angular framework, to build an Android app. The user roles of the system included 3 roles: physicians, patients, and the system administrator. The hardware was designed to contain an Esp8266 as the Internet of Things module, an MLX90614 infrared temperature sensor, and the Maxim Integrated MAX30101 sensor for sensing the heartbeat. The hardware was designed in the shape of a wristband device using SolidWorks 2020 and printed using a 3D printer. The firmware of the hardware was developed in Arduino with the capability of firmware over the air. In evaluating the software system from the perspective of usability, the system received an average score of 3.8 out of 5 from 4 evaluators. CONCLUSIONS: Sensor-based telemonitoring systems for patients with colorectal cancer after surgery are possible solutions that can make the process automatic for patients and caregivers. The apps for remote colorectal patient monitoring could be designed to be useful; however, more research regarding the developed system's implementation in clinic settings and hospitals is required to understand the probable barriers and limitations.

Assessment of Tolerability, Response and Complications of Concurrent Chemoradiation With Capecitabine and Cisplatin in Muscle-Invasive Bladder Cancer; A Single Arm Study.

PURPOSE: To evaluate the feasibility, tolerance and efficacy of cisplatin+capecitabine as a proposed combination in concurrent chemoradiotherapy for patients with muscle-invasive bladder cancer (MIBC). METHODS: MIBC patients with stage T2-T4aN0M0 participated in this single-arm clinical trial. After maximal TURBT, 66Gy/33 daily fractions of radiation were administered with concurrent chemotherapy of cisplatin (35 mg/m2) and capecitabine (625 mg/m2). The primary endpoint was treatment tolerability, defined as receiving capecitabine+cisplatin combination for at least 5 weeks during radiation therapy. The secondary endpoints included complete response (CR) and acute toxicity rates. RESULTS: This study included 19 MIBC patients from 2018 to 2019. Eighteen patients (94.7%, 95%CI: 75.4-99.0) completed the planned treatment course. Only one patient (5.26%, 95%CI: 0.9-24.6) discontinued the treatment due to grade-3 GI toxicity. Among those who completed the treatment, CR was seen in 12 patients (66.7%, 95% CI = 44.4-88.9) with no grade ≥ 3 toxicities. The most common grade-2 side effects during therapy were renal complications (57.9%), and the only grade-2 complication after therapy was urinary-related (11.1%). The median follow-up was 31 months and the median overall survival (OS) was 31 months. The 2-year OS was 78% (95% CI 58.4-97.6), Cystectomy-free survival was 61% (95% CI: 37.5-84.5), and the median OS after recurrence was 13 months. Distant metastases were the first type of recurrence in most patients with a recurrence, which occurred in 7 (36.8%) patients. Median metastasis-free survival (MFS) was 30 months, and 2-year MFS was 66% (95% CI:45-87). CONCLUSION: The promising tolerability rate seen with concurrent cisplatin+capecitabine in this study was comparable to the available literature. Thus, this combination concurrently with radiation warrants further studies in the context of chemoradiotherapy of MIBC.

Duloxetine for the Prevention of Oxaliplatin Induced Peripheral Neuropathy: A Randomized, Placebo-Controlled, Double-blind Clinical Trial.

PURPOSE: Peripheral neuropathy is a dose-limiting adverse effect of oxaliplatin. The aim of this study was to evaluate the efficacy and safety of duloxetine in the prevention of oxaliplatin-induced peripheral neuropathy (OIPN). METHOD: Cancer patients receiving oxaliplatin based chemotherapy were randomized into two arms. Duloxetine 60 mg capsule was given in the first 14 days of each chemotherapy cycle to one arm and placebo was similarly given to another. We compared the two arms based on the incidence of neuropathy and the results of the nerve conduction study (NCS). Grade of complained neuropathy was recorded according to Common Terminology Criteria for Adverse Events (CTCAE). RESULTS: Thirty-two patients mostly rectal cancer (90.6%) were randomized to duloxetine and placebo arms. Highest grade of neuropathy in each cycle was not significantly different between the two groups. Six weeks after treatment incidence of neuropathy of any grade was 52.9 in duloxetine arm compared to 76.9% in placebo arm (P: 0.26). Patients in the duloxetine arm had a lower percentage of chemotherapy cycles (mean) in which they reported distal paresthesia (51% vs. 84%, P = 0.01) and throat discomfort (37% vs. 69%, P = 0.01). Results of NCS were mostly comparable between the two arms except for the velocity in two of the examined nerve which was significantly higher in duloxetine group. Duloxetine was safe and well-tolerated. CONCLUSION: Although a definite conclusion might be difficult to draw but administering duloxetine for 14 days in each chemotherapy cycle could not decrease the incidence of acute OIPN based on CTCAE grading system.

Necessity of Pelvic Lymph Node Irradiation in Patients with Recurrent Prostate Cancer after Radical Prostatectomy in the PSMA PET/CT Era: A Narrative Review.

The main prostate cancer (PCa) treatments include surgery or radiotherapy (with or without ADT). However, none of the suggested treatments eliminates the risk of lymph node metastases. Conventional imaging methods, including MRI and CT scanning, are not sensitive enough for the diagnosis of lymph node metastases; however, the novel imaging method, PSMA PET/CT scanning, has provided valuable information about the pelvic LN involvement in patients with recurrent PCa (RPCa) after radical prostatectomy. The high sensitivity and negative predictive value enable accurate N staging in PCa patients. In this narrative review, we summarize the evidence on the treatment and extent of radiation in prostate-only or whole-pelvis radiation in patients with positive and negative LN involvement on PSMA PET/CT scans.

The Performance of SARS-CoV-2 Serology Testing in the Diagnosis of COVID-19.

BACKGROUND & OBJECTIVE: COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) has been a reference test for diagnosing a disease since the very beginning of the pandemic. COVID-19 serology tests have also been developed and used to estimate the prevalence of individuals who have already been infected. We aimed to evaluate the performance of serology tests for the diagnosis of patients who had been referred to medical centers with acute symptoms. METHODS: In this cross-sectional study, 80 individuals suspected of COVID-19 who had been referred to Imam Khomeini Hospital Complex, Tehran, Iran, were examined. Upper respiratory tract specimens for RT-PCR and blood samples for COVID-19 IgM and IgG antibody level tests were collected and the results were compared. RESULTS: The overall proportion in agreement, the agreement between positive results, and the agreement between negative results when comparing RT-PCR and IgM serology test were 40% (kappa = -0.006, P = 0.9), 32%, and 66.6%, respectively, and when comparing RT-PCR and IgG serology test were 46% (kappa = -0.006, P = 0.94), 43.5%, and 55.5%, respectively. CONCLUSION: The absence of a gold standard method for the diagnosis of COVID-19 makes it very challenging to determine the true sensitivity and specificity of different methods. The study results revealed no agreement between the two methods; so the RT-PCR test for upper respiratory tract specimen cannot be replaced with COVID-19 serology test for the diagnosis of patients with acute symptoms.