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

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.

Efficacy and Feasibility of Adding Induction Chemotherapy to Neoadjuvant Chemoradiation in Locally Advanced Rectal Cancer: A Phase II Clinical Trial

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.

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

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.

Treatment results and prognostic indicators in thymic epithelial tumors: a clinicopathological analysis of 45 patients

Background: Thymomas are rare epithelial tumors arising from thymus gland. This study aims at investigating the clinical presentation, prognostic factors and treatment outcome of forty five patients with thymoma and thymic carcinoma

Methods: Forty-five patients being histologically diagnosed with thymoma or thymic carcinoma that were treated and followed-up at a tertiary academic hospital during January 1987 and December 2008 were selected for the present study. Twelve patients were solely treated with surgery, 14 with surgery followed by adjuvant radiotherapy, 12 with sequential combined treatment of surgery, radiotherapy and/or chemotherapy and 7 with non-surgical approach including radiotherapy and/or chemotherapy. Tumors were classified based on the new World Health Organization [WHO] histological classification

Results: T here were 18 women and 27 men with a median age of 43 years. Twelve patients [26.7%] had stage I, 7 [17.8%] had stage II, 23 [51%] had stage III and 2 [4.5%] had stage IV disease. Tumors types were categorized as type A [n=4], type AB [n=10], type B1 [n=9], type B2 [n=10], type B3 [n=5] and type C [n=7]. In univariate analysis for overall survival, disease stage [P=0.001], tumor size [P=0.017] and the extent of surgical resection [P<0.001] were prognostic factors. Regarding the multivariate analysis, only the extent of the surgical resection [P<0.001] was the independent prognostic factor and nonsurgical treatment had a negative influence on the survival. The 5-year and 10-year overall survival rates were 70.8% and 62.9%, respectively

Conclusion: Complete surgical resection is the most important prognostic factor in patients with thymic epithelial tumors

Efficacy of topical alpha ointment [containing natural henna] compared to topical hydrocortisone [1%] in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial

Background: This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream [1%] in the healing of radiation-induced dermatitis in breast cancer patients

Methods: The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer [treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]] and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment [study arm, n=30] or topical hydrocortisone cream [1%] [control arm, n=30] immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy

Results: The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm[2] in the control arm and 17.02 cm[2] in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream [1%] [P=0.001]. This effect was significant in the second week [P=0.007]. In addition, Alpha ointment decreased the patients' complaints such as pain [P<0.001], pruritus [P=0.009], and discharge [P=0.010] effectively and meaningfully

Conclusion: Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream [1%] in our patients with breast cancer

Very late relapse in breast cancer survivors: a report of 6 cases

Breast cancer is the most common cancer and the leading cause of cancer death among the women worldwide. The risk of local and distant recurrence is the highest during the first two years following the initial treatment. Very late relapse [after 12 years] is uncommon in breast cancer survivors. Herein, we report the characteristics and outcomes of 6 such cases of breast cancer. The mean age of the patients was 40.1 years [range 30-57] and the mean disease free survival was 19.6 years. Late relapse is not so common in breast cancer but can occur in any stage. Therefore, we suggest life-time follow up for every patient with breast cancer

Effect of oral zinc sulphate in prevention of radiation induced oropharyngeal mucositis during and after radiotherapy in patients with head and neck cancers

Mucositis is a disturbing side effect of radiotherapy treatment for head and neck cancer. To date, no effective modality for its prophylaxis and treatment has been found. We performed this study to evaluate the efficacy of oral zinc sulphate in delaying the onset of oral and pharyngeal mucositis and decreasing their severity. A total of 58 patients who were treated for head and neck squamous cell carcinoma with radiotherapy or chemoradiotherapy were randomly assigned to receive oral zinc sulphate [220 mg] or an oral placebo 3 times a day during their radiotherapy course. Total radiation dose was 6000 cGy to 7000 cGy by conventional radiotherapy. Seventy nine percent of the patients also received concurrent chemotherapy. Oral and pharyngeal mucositis were scored according to an RTOG protocol. Time to onset of mucositis did not vary between the two groups. However, oral mucositis scores were less severe in the zinc group in weeks 4 to 6. The difference was statistically significant and the P values for weeks 4, 5 and 6 were 0.02, 0.007, and 0.012, respectively. Treatment interruptions in both groups were the same [four cases each] and all were due to dysphagia [pharyngeal mucositis]. Our results suggest that zinc is effective in reducing the severity of oral mucositis but not pharyngeal mucositis. Treatment interruptions were more frequently caused by pharyngeal mucositis which presented as dysphagia, rather than oral pain that was a manifestation of oral mucositis