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

Mohammad Mohammadianpanah,Shapour Omidvari,Shadi Zohourinia,Mansour Ansari,Leila Ghahramani,Mohammad Zare-Bandamiri,Ahmad Mosalaei,Niloofar Ahmadloo,Saeedeh Pourahmad,Hamid Nasrolahi,Sayed Hasan Hamed 대한대장항문학회 2015 Annals of Coloproctolgy Vol.31 No.4

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.

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

Ali Mohammad Bananzadeh,Ali Akbar Hafezi,NamPhong Nguyen,Shapour Omidvari,Ahmad Mosalaei,Niloofar Ahmadloo,Mansour Ansari,Mohammad Mohammadianpanah 대한방사선종양학회 2021 Radiation Oncology Journal Vol.39 No.4

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.

Factors Affecting Survival in Patients with Colorectal Cancer in Shiraz, Iran

Zare-Bandamiri, Mohammad,Khanjani, Narges,Jahani, Yunes,Mohammadianpanah, Mohammad Asian Pacific Journal of Cancer Prevention 2016 Asian Pacific journal of cancer prevention Vol.17 No.1

Background: Colorectal cancer (CRC) is the third most common cancer in the world, and the fourth in Iran in both genders. The aim of this study was to find predictive factors for CRC survival. Materials and Methods: Medical records of 570 patients referred to the radiotherapy oncology department of Shiraz Namazi hospital from 2005 to 2010 were retrospectively analysed. Data were collected by reviewing medical records, and by telephone interviews with patients. Survival analysis was performed using the Cox's regression model with survival probability estimated with Kaplan-Meier curve. The log-rank test was used to compare survival between strata. Data was analyzed with Stata 12. Results: The five-year survival rate and the mean survival time after cancer diagnosis were 58.5% and $67{\pm}4months$. On multivariate analysis, age of diagnosis, disease stage and primary tumor site, lymphovascular invasion and type of treatment (in colon cancer) were significant factors for survival. Conclusions: Age of diagnosis and type of treatment (adjuvant therapy in patients with colon cancer) were two modifiable factors related to survival of CRC patients. Therefore earlier diagnosis might help increase survival.

Prognostic Significance of Mucinous Histologic Subtype on Oncologic Outcomes in Patients With Colorectal Cancer

Sare Hosseini,Ali Mohammad Bananzadeh,Roham Salek,Mohammad Zare-Bandamiri,Ali Taghizadeh Kermani,Mohammad Mohammadianpanah 대한대장항문학회 2017 Annals of Coloproctolgy Vol.33 No.2

Purpose: Mucinous adenocarcinomas account for about 10% of all colorectal cancers. This study aimed to investigate the prognostic impact of mucinous histologic subtype on oncologic outcomes in patients with colorectal cancer. Methods: This retrospective study was performed at two large tertiary university hospitals. We analyzed the characteristics, prognostic factors, and survival of patients with colorectal cancer who were treated and followed up between 2000 and 2013. Results: Totally, 144 of 1,268 patients with a colorectal adenocarcinoma (11.4%) had mucinous histologic subtype. Statistically significant results found in this research are as follows: Mucinous histologic subtype tended to present in younger patients and to have larger tumor size, higher histologic grade, higher node stage, larger number of positive nodes, and higher rate of perineural invasion compared to nonmucinous histologic subtype. On the univariate analysis, mucinous subtype was a prognostic factor for disease-free and overall survival. On the multivariate analysis, primary tumor location, node stage and lymphatic-vascular invasion were independent prognostic factors for the local control rate. Rectal tumor location, higher disease stage, tumor grade II, and presence of lymphatic-vascular invasion had negative influences on disease-free survival, as did rectal tumor location, higher disease stage and presence of lymphatic-vascular invasion on overall survival. Conclusion: Mucinous histologic subtype was associated with some adverse pathologic features in patients with colorectal cancer; however, it was not an independent prognostic factor for oncologic outcome.

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 Hamed 대한대장항문학회 2019 Annals of Coloproctolgy Vol.35 No.5

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 endpoints, 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.

Colorectal Cancer Staging Using Three Clustering Methods Based on Preoperative Clinical Findings

Pourahmad, Saeedeh,Pourhashemi, Soudabeh,Mohammadianpanah, Mohammad Asian Pacific Journal of Cancer Prevention 2016 Asian Pacific journal of cancer prevention Vol.17 No.2

Determination of the colorectal cancer stage is possible only after surgery based on pathology results. However, sometimes this may prove impossible. The aim of the present study was to determine colorectal cancer stage using three clustering methods based on preoperative clinical findings. All patients referred to the Colorectal Research Center of Shiraz University of Medical Sciences for colorectal cancer surgery during 2006 to 2014 were enrolled in the study. Accordingly, 117 cases participated. Three clustering algorithms were utilized including k-means, hierarchical and fuzzy c-means clustering methods. External validity measures such as sensitivity, specificity and accuracy were used for evaluation of the methods. The results revealed maximum accuracy and sensitivity values for the hierarchical and a maximum specificity value for the fuzzy c-means clustering methods. Furthermore, according to the internal validity measures for the present data set, the optimal number of clusters was two (silhouette coefficient) and the fuzzy c-means algorithm was more appropriate than the k-means clustering approach by increasing the number of clusters.

Prognostic significance of adjuvant radiation therapy in adenocarcinoma of the cecum

Sare Hosseini,Ali Mohammad Bananzadeh,Mohammad Mohammadianpanah,Roham Salek,Ali Taghizadeh-Kermani 대한방사선종양학회 2018 Radiation Oncology Journal Vol.36 No.1

Purpose: Local recurrence is a common failure pattern in adenocarcinoma of the cecum. This study aimed to investigate the potential role of adjuvant radiation therapy on oncologic outcomes of patients with adenocarcinoma of the cecum. Materials and Methods: This retrospective study was carried out at three large tertiary university hospitals. We analyzed the characteristics, prognostic factors, and survival of 162 patients with adenocarcinoma of the cecum that were treated and followed up between 2000 and 2013. All the patients had undergone a right hemicolectomy and received chemotherapy with (n = 48) or without (n = 114) adjuvant radiation therapy. Results: The subjects were 65 females and 97 males with a median age of 56 years (range, 17 to 90 years) at diagnosis. The 5-year local control (LC), disease free survival (DFS), and overall survival (OS) rates were 72.7%, 57.2%, and 62.6% respectively. In a multivariate analysis, age, tumor stage, node stage, and adjuvant radiation therapy were determined to be independent prognostic factors. Age more than 55 years (hazard ratio [HR] = 1.0; 95% confidence interval [CI], 0.06–0.32; p = 0.003), T4 stage (HR = 6.8; 95% CI, 3.07–15.36; p < 0.001), node positive disease (HR = 4.2; 95% CI, 1.94–9.13; p < 0.001), and the absence of adjuvant radiation therapy (HR = 3.0; 95% CI, 1.39–6.46; p = 0.005) had a negative influence on OS. Conclusion: Adjuvant radiation therapy significantly improves DFS and OS in patients with adenocarcinoma of the cecum.

Efficacy of Ginger in Control of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients Receiving Doxorubicin-Based Chemotherapy

Ansari, Mansour,Porouhan, Pezhman,Mohammadianpanah, Mohammad,Omidvari, Shapour,Mosalaei, Ahmad,Ahmadloo, Niloofar,Nasrollahi, Hamid,Hamedi, Seyed Hasan Asian Pacific Journal of Cancer Prevention 2016 Asian Pacific journal of cancer prevention Vol.17 No.8

Nausea and vomiting are among the most serious side effects of chemotherapy, in some cases leading to treatment interruption or chemotherapy dose reduction. Ginger has long been known as an antiemetic drug, used for conditions such as motion sickness, nausea-vomiting in pregnancy, and post-operation side effects. One hundred and fifty female patients with breast cancer entered this prospective study and were randomized to receive ginger (500 mg ginger powder, twice a day for 3 days) or placebo. One hundred and nineteen patients completed the study: 57 of them received ginger and 62 received ginger for the first 3 chemotherapy cycles. Mean age in all patients was 48.6 (25-79) years. After 1st chemotherapy, mean nausea in the ginger and control arms were 1.36 (${\pm}1.31$) and 1.46 (${\pm}1.28$) with no statistically significant difference. After the $2^{nd}$ chemotherapy session, nausea score was slightly more in the ginger group (1.36 versus 1.32). After $3^{rd}$ chemotherapy, mean nausea severity in control group was less than ginger group [1.37 (${\pm}1.14$), versus 1.42 (${\pm}1.30$)]. Considering all patients, nausea was slightly more severe in ginger arm. In ginger arm mean nausea score was 1.42 (${\pm}0.96$) and in control arm it was 1.40 (${\pm}0.92$). Mean vomiting scores after chemotherapy in ginger arm were 0.719 (${\pm}1.03$), 0.68 (${\pm}1.00$) and 0.77 (${\pm}1.18$). In control arm, mean vomiting was 0.983 (${\pm}1.23$), 1.03 (${\pm}1.22$) and 1.15 (${\pm}1.27$). In all sessions, ginger decreased vomiting severity from 1.4 (${\pm}1.04$) to 0.71 (${\pm}0.86$). None of the differences were significant. In those patients who received the AC regimen, vomiting was less severe ($0.64{\pm}0.87$) comparing to those who received placebo ($1.13{\pm}1.12$), which was statistically significant (p-Value <0.05). Further and larger studies are needed to draw conclusions.

Prognostic significance of adjuvant radiation therapy in adenocarcinoma of the cecum

Hosseini, Sare,Bananzadeh, Ali Mohammad,Mohammadianpanah, Mohammad,Salek, Roham,Taghizadeh-Kermani, Ali The Korean Society for Radiation Oncology 2018 Radiation Oncology Journal Vol.36 No.1

Purpose: Local recurrence is a common failure pattern in adenocarcinoma of the cecum. This study aimed to investigate the potential role of adjuvant radiation therapy on oncologic outcomes of patients with adenocarcinoma of the cecum. Materials and Methods: This retrospective study was carried out at three large tertiary university hospitals. We analyzed the characteristics, prognostic factors, and survival of 162 patients with adenocarcinoma of the cecum that were treated and followed up between 2000 and 2013. All the patients had undergone a right hemicolectomy and received chemotherapy with (n = 48) or without (n = 114) adjuvant radiation therapy. Results: The subjects were 65 females and 97 males with a median age of 56 years (range, 17 to 90 years) at diagnosis. The 5-year local control (LC), disease free survival (DFS), and overall survival (OS) rates were 72.7%, 57.2%, and 62.6% respectively. In a multivariate analysis, age, tumor stage, node stage, and adjuvant radiation therapy were determined to be independent prognostic factors. Age more than 55 years (hazard ratio [HR] = 1.0; 95% confidence interval [CI], 0.06-0.32; p = 0.003), T4 stage (HR = 6.8; 95% CI, 3.07-15.36; p < 0.001), node positive disease (HR = 4.2; 95% CI, 1.94-9.13; p < 0.001), and the absence of adjuvant radiation therapy (HR = 3.0; 95% CI, 1.39-6.46; p = 0.005) had a negative influence on OS. Conclusion: Adjuvant radiation therapy significantly improves DFS and OS in patients with adenocarcinoma of the cecum.

Cost-Utility of "Doxorubicin and Cyclophosphamide" versus "Gemcitabine and Paclitaxel" for Treatment of Patients with Breast Cancer in Iran

Hatam, Nahid,Askarian, Mehrdad,Javan-Noghabi, Javad,Ahmadloo, Niloofar,Mohammadianpanah, Mohammad Asian Pacific Journal of Cancer Prevention 2015 Asian Pacific journal of cancer prevention Vol.16 No.18

Purpose: A cost-utility analysis was performed to assess the cost-utility of neoadjuvant chemotherapy regimens containing doxorubicin and cyclophosphamide (AC) versus paclitaxel and gemcitabine (PG) for locally advanced breast cancer patients in Iran. Materials and Methods: This cross-sectional study in Namazi hospital in Shiraz, in the south of Iran covered 64 breast cancer patients. According to the random numbers, the patients were divided into two groups, 32 receiving AC and 32 PG. Costs were identified and measured from a community perspective. These items included medical and non-medical direct and indirect costs. In this study, a data collection form was used. To assess the utility of the two regimens, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30) was applied. Using a decision tree, we calculated the expected costs and quality adjusted life years (QALYs) for both methods; also, the incremental cost-effectiveness ratio was assessed. Results: The results of the decision tree showed that in the AC arm, the expected cost was 39,170 US$ and the expected QALY was 3.39 and in the PG arm, the expected cost was 43,336 dollars and the expected QALY was 2.64. Sensitivity analysis showed the cost effectiveness of the AC and ICER=-5535 US$. Conclusions: Overall, the results showed that AC to be superior to PG in treatment of patients with breast cancer, being less costly and more effective.