1.Efficacy and Feasibility of Adding Induction Chemotherapy to Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer: A Phase II Clinical Trial
Hamid NASROLAHI ; Sepideh MIRZAEI ; Mohammad MOHAMMADIANPANAH ; Ali Mohammad BANANZADEH ; Maral MOKHTARI ; Mohammad Reza SASANI ; Ahmad MOSALAEI ; Shapour OMIDVARI ; Mansour ANSARI ; Niloofar AHMADLOO ; Seyed Hasan HAMEDI ; Nezhat KHANJANI
Annals of Coloproctology 2019;35(5):242-248
PURPOSE: Currently, neoadjuvant chemoradiation (CRT) followed by total mesorectal resection is considered the standard of care for treating locally advanced rectal cancer. This study aimed to investigate the efficacy and feasibility of adding induction chemotherapy to neoadjuvant CRT in locally advanced rectal cancer. METHODS: This phase-II clinical trial included 54 patients with newly diagnosed, locally advanced (clinical T3–4 and/or N1–2, M0) rectal cancer. All patients were treated with 3 cycles of preoperative chemotherapy using the XELOX (capecitabine + oxaliplatin) regimen before and after a concurrent standard long course of CRT (45–50.4 Gy) followed by standard radical surgery. Pathologic complete response (PCR) rate and toxicity were the primary and secondary end-points, respectively. RESULTS: The study participants included 37 males and 17 females, with a median age of 59 years (range, 20–80 years). Twenty-nine patients (54%) had clinical stage-II disease, and 25 patients (46%) had clinical stage-III disease. Larger tumor size (P = 0.006) and distal rectal location (P = 0.009) showed lower PCR compared to smaller tumor size and upper rectal location. Pathologic examinations showed significant tumor regression (6.1 ± 2.7 cm vs. 1.9 ± 1.8 cm, P < 0.001) with 10 PCRs (18.5%) compared to before the intervention. The surgical margin was free of cancer in 52 patients (96.3%). Treatment-related toxicities were easily tolerated, and all patients completed their planned treatment without interruption. Grade III and IV toxicities were infrequent. CONCLUSION: The addition of induction chemotherapy to neoadjuvant CRT is an effective and well-tolerated treatment approach in patients with rectal cancer.
Drug Therapy
;
Female
;
Humans
;
Induction Chemotherapy
;
Male
;
Neoadjuvant Therapy
;
Polymerase Chain Reaction
;
Rectal Neoplasms
;
Standard of Care
2.Efficacy and Safety of Low-Dose-Rate Endorectal Brachytherapy as a Boost to Neoadjuvant Chemoradiation in the Treatment of Locally Advanced Distal Rectal Cancer: A Phase-II Clinical Trial.
Shapour OMIDVARI ; Shadi ZOHOURINIA ; Mansour ANSARI ; Leila GHAHRAMANI ; Mohammad ZARE-BANDAMIRI ; Ahmad MOSALAEI ; Niloofar AHMADLOO ; Saeedeh POURAHMAD ; Hamid NASROLAHI ; Sayed Hasan HAMEDI ; Mohammad MOHAMMADIANPANAH
Annals of Coloproctology 2015;31(4):123-130
PURPOSE: Despite advances in rectal cancer treatment over the last decade, local control and risk of late side effects due to external beam radiation therapy (EBRT) remain as concerns. The present study aimed to investigate the efficacy and the safety of low-dose-rate endorectal brachytherapy (LDRBT) as a boost to neoadjuvant chemoradiation for use in treating locally advanced distal rectal adenocarcinomas. METHODS: This phase-II clinical trial included 34 patients (as the study arm) with newly diagnosed, locally advanced (clinical T3-T4 and/or N1/N2, M0) lower rectal cancer. For comparative analysis, 102 matched patients (as the historical control arm) with rectal cancer were also selected. All the patients were treated with LDRBT (15 Gy in 3 fractions) and concurrent chemoradiation (45-50.4 Gy). Concurrent chemotherapy consisted of oxaliplatin 130 mg/m2 intravenously on day 1 plus oral capecitabine 825 mg/m2 twice daily during LDRBT and EBRT. RESULTS: The study results revealed a significant differences between the study arm and the control arm in terms in the pathologic tumor size (2.1 cm vs. 3.6 cm, P = 0.001), the pathologic tumor stage (35% T3-4 vs. 65% T3-4, P = 0.003), and the pathologic complete response (29.4% vs. 11.7%, P < 0.028). Moreover, a significantly higher dose of EBRT (P = 0.041) was found in the control arm, and a longer time to surgery was observed in the study arm (P < 0.001). The higher rate of treatment-related toxicities, such as mild proctitis and anemia, in the study arm was tolerable and easily manageable. CONCLUSION: A boost of LDRBT can optimize the pathologic complete response, with acceptable toxicities, in patients with distal rectal cancer.
Adenocarcinoma
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Anemia
;
Arm
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Brachytherapy*
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Drug Therapy
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Humans
;
Neoadjuvant Therapy
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Proctitis
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Rectal Neoplasms*
;
Capecitabine
3.Efficacy and safety of sequential neoadjuvant chemotherapy and short-course radiation therapy followed by delayed surgery in locally advanced rectal cancer: a single-arm phase II clinical trial with subgroup analysis between the older and young patients
Alimohammad BANANZADEH ; Ali Akbar HAFEZI ; NamPhong NGUYEN ; Shapour OMIDVARI ; Ahmad MOSALAEI ; Niloofar AHMADLOO ; Mansour ANSARI ; Mohammad MOHAMMADIANPANAH
Radiation Oncology Journal 2021;39(4):270-278
Purpose:
This study was performed to investigate the efficacy and safety of short-course radiation therapy (SCRT) and sequential chemotherapy followed by delayed surgery in locally advancer rectal cancer with subgroup analysis between the older and young patients.
Materials and Methods:
In this single-arm phase II clinical trial, eligible patients with locally advanced rectal cancer (T3–4 and/or N1–2) were enrolled. All the patients received a median three sequential cycles of neoadjuvant CAPEOX (capecitabine + oxaliplatin) chemotherapy. A total dose of 25 Gy in five fractions during 1 week was prescribed to the gross tumor and regional lymph nodes. Surgery was performed about 8 weeks following radiotherapy. Pathologic complete response rate (pCR) and grade 3–4 toxicity were compared between older patients (≥65 years) and younger patients (<65 years).
Results:
Ninety-six patients with locally advanced rectal cancer were enrolled. There were 32 older patients and 64 younger patients. Overall pCR was 20.8% for all the patients. Older patients achieved similar pCR rate (18.7% vs. 21.8; p = 0.795) compared to younger patients. There was no statistically significance in terms of the tumor and the node downstaging or treatment-related toxicity between older patients and younger ones; however, the rate of sphincter-saving surgery was significantly more frequent in younger patients (73% vs. 53%; p=0.047) compared to older ones. All treatment-related toxicities were manageable and tolerable among older patients.
Conclusion
Neoadjuvant SCRT and sequential chemotherapy followed by delayed surgery was safe and effective in older patients compared to young patients with locally advanced rectal cancer.
4.Serum Cytokine Profile in Patients with Chronic Rhinosinusitis with Nasal Polyposis Infected by Aspergillus flavus.
Gargi RAI ; Mohammad Ahmad ANSARI ; Sajad Ahmad DAR ; Shyama DATT ; Neelima GUPTA ; Sonal SHARMA ; Shafiul HAQUE ; Vishnampettai Ganapathysubramanian RAMACHANDRAN ; Arpeeta MAZUMDAR ; Shivprakash RUDRAMURTHY ; Arunaloke CHAKRABARTI ; Shukla DAS
Annals of Laboratory Medicine 2018;38(2):125-131
BACKGROUND: Fungi, especially Aspergillus flavus, can cause chronic rhinosinusitis with nasal polyposis and modulate host innate immune components. The objective of this study was to examine the serum levels of T helper (Th) cell subset Th1, Th2, and Th17 cytokines and total IgE in patients having chronic rhinosinusitis with nasal polyposis and Aspergillus flavus infection. METHODS: A case-control study including 40 patients with chronic rhinosinusitis with nasal polyposis and 20 healthy controls was conducted. Aspergillus flavus infection was confirmed by standard potassium hydroxide (KOH) testing, culture, and PCR. Serum samples of all patients and controls were analyzed for various cytokines (interleukins [IL]-1β, IL-2, IL-4, IL-6, IL-17, IL-21, IL-27, TGF-β) and total IgE by ELISA. Data from patients with Aspergillus flavus infection and healthy volunteers were compared using the independent t-test and non-parametric Mann-Whitney U test. RESULTS: Aspergillus flavus infection was found in 31 (77.5%) patients with chronic rhinosinusitis with nasal polyposis. IL-1β, IL-17, IL-21, and TGF-β serum levels were significantly higher in these patients than in controls; however, IL-2, IL-4, IL-6, and IL-27 levels were lower. Compared with nine (22.5%) patients without Aspergillus flavus infection, IL-17 level was higher while IL-2 level was lower in patients with Aspergillus flavus infection. Total IgE was significantly higher in patients with Aspergillus flavus infection than in controls. CONCLUSIONS: High levels of IL-17 and its regulatory cytokines in patients with chronic rhinosinusitis with nasal polyposis infected by Aspergillus flavus raise a concern about effective disease management and therapeutic recovery. Surgical removal of the nasal polyp being the chief management option, the choice of post-operative drugs may differ in eosinophilic vs. non-eosinophilic nasal polyposis. The prognosis is likely poor, warranting extended care.
Aspergillus flavus*
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Aspergillus*
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Case-Control Studies
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Cytokines
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Disease Management
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Enzyme-Linked Immunosorbent Assay
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Eosinophils
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Fungi
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Healthy Volunteers
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Humans
;
Immunoglobulin E
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Interleukin-17
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Interleukin-2
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Interleukin-27
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Interleukin-4
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Interleukin-6
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Nasal Polyps
;
Polymerase Chain Reaction
;
Potassium
;
Prognosis
5.Relationship between using cell phone and the risk of accident with motor vehicles: An analytical cross-sectional study.
Mohammad KOGANI ; Seyed Ahmad ALMASI ; Alireza ANSARI-MOGADDAM ; Sahar DALVAND ; Hassan OKATI-ALIABAD ; Seyed Mehdi TABATABAEE ; Seyedeh Zeinab ALMASI
Chinese Journal of Traumatology 2020;23(6):319-323
PURPOSE:
Traffic accidents are one of the major health problems in the world, being the first cause of burden of illness and the second leading cause of death in Iran. The Sistan-Baluchestan province is one of the most accidental provinces of Iran with the highest rate of accidents-caused deaths. This study was conducted to determine the risk factors associated with traffic accidents in Zahedan through 2013 to 2016.
METHODS:
This analytical cross-sectional study was carried out on 223 drivers from Zahedan who were traumatized by traffic accident and sent to Zahedan hospitals. The data were obtained through interviews taken by the trained interviewers via refereeing to the medical records and collected in the researcher-made checklist. Census was obtained from the study subjects. For data analysis, independent t-test, one-way ANOVA, Chi-square and logistic regression were used with the Stata software version 11.0.
RESULTS:
In this study, 223 male subjects with the mean age of (32.54 ± 12.95) years, 39.8% single and 60.2% married, entered for investigation. Most accidents (38.8%) occurred between 12:00 to 17:59. While driving, 47.1% of the study subjects were using cell phones, 89.1% had manual use of mobile phones, 21.9% had a habit of sending short message service (SMS) and 23.4% had sent SMS within 10 min before the accident. The one way analysis of variance showed that the mean age of individuals with marital status, driving experience, education and accident with motorcycle were significantly different (p < 0.05). Also, the multivariate logistic regression test indicated a significant relationship of smoking, ethnicity, insurance and SMS typing while driving with motorcycle accident (p < 0.05).
CONCLUSION
In this study, SMS and smoking while driving had the highest risk among the variables studied in the motorcycle accidents. Therefore, effective education attempting to enhance people's awareness about the consequences of using cell phone and smoking during driving to reduce traffic accidents seems necessary.
Accidents, Traffic/statistics & numerical data*
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Adolescent
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Adult
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Aged
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Aged, 80 and over
;
Automobile Driving
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Cause of Death
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Cell Phone Use/adverse effects*
;
Cross-Sectional Studies
;
Female
;
Health Education
;
Humans
;
Iran/epidemiology*
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Male
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Marital Status
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Middle Aged
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Risk
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Smoking/adverse effects*
;
Young Adult