BackgroundCurrent standard for most of the locally advanced rectal cancers is preoperative chemoradiotherapy, and, variably per institution, postoperative adjuvant chemotherapy. Short-course preoperative radiation with delayed surgery has been shown to induce tumour down-staging in both randomized and observational studies. The concept of neo-adjuvant chemotherapy has been proven successful in gastric cancer, hepatic metastases from colorectal cancer and is currently tested in primary colon cancer.Methods and designPatients with rectal cancer with high risk features for local or systemic failure on magnetic resonance imaging are randomized to either a standard arm or an experimental arm. The standard arm consists of chemoradiation (1.8 Gy x 25 or 2 Gy x 25 with capecitabine) preoperatively, followed by selective postoperative adjuvant chemotherapy. Postoperative chemotherapy is optional and may be omitted by participating institutions. The experimental arm includes short-course radiotherapy (5 Gy x 5) followed by full-dose chemotherapy (capecitabine and oxaliplatin) in 6 cycles before surgery. In the experimental arm, no postoperative chemotherapy is prescribed. Surgery is performed according to TME principles in both study arms. The hypothesis is that short-course radiotherapy with neo-adjuvant chemotherapy increases disease-free and overall survival without compromising local control. Primary end-point is disease-free survival at 3 years. Secondary endpoints include overall survival, local control, toxicity profile, and treatment completion rate, rate of pathological complete response and microscopically radical resection, and quality of life.DiscussionFollowing the advances in rectal cancer management, increased focus on survival rather than only on local control is now justified. In an experimental arm, short-course radiotherapy is combined with full-dose chemotherapy preoperatively, an alternative that offers advantages compared to concomitant chemoradiotherapy with or without postoperative chemotherapy. In a multi-centre setting this regimen is compared to current standard with the aim of improving survival for patients with locally advanced rectal cancer.Trial registrationClinicalTrials.gov NCT01558921
Squamous cell carcinoma of the anus (SCCA) is a rare cancer but its incidence is increasing throughout the world, and is particularly high in the human immunodeficiency virus positive (HIV+) population. A multidisciplinary approach is mandatory (involving radiation therapists, medical oncologists, surgeons, radiologists and pathologists). SCCA usually spreads in a loco-regional manner within and outside the anal canal. Lymph node involvement at diagnosis is observed in 30-40% of cases while systemic spread is uncommon with distant extrapelvic metastases recorded in 5-8% at onset, and rates of metastatic progression after primary treatment between 10% and 20%. SCCA is strongly associated with human papilloma virus (HPV, types 16-18) infection. The primary aim of treatment is to achieve cure with loco-regional control and preservation of anal function, with the best possible quality of life. Treatment dramatically differs from adenocarcinomas of the lower rectum. Combinations of 5FU-based chemoradiation and other cytotoxic agents (mitomycin C) have been established as the standard of care, leading to complete tumour regression in 80-90% of patients with locoregional failures in the region of 15%. There is an accepted role for surgical salvage. Assessment and treatment should be carried out in specialised centres treating a high number of patients as early as possible in the clinical diagnosis. To date, the limited evidence from only 6 randomised trials [1,2,3,4,5,6,7], the rarity of the cancer, and the different behaviour/natural history depending on the predominant site of origin, (the anal margin, anal canal or above the dentate line) provide scanty direction for any individual oncologist. Here we aim to provide guidelines which can assist medical, radiation and surgical oncologists in the practical management of this unusual cancer.
Background: In the management of isolated locoregional failure after (chemo)radiation therapy for anal epidermoid cancer, salvage abdominoperineal resection (APR) is the treatment of choice. The results of a 15-year consecutive population-based series are reviewed.Methods: Details of all patients with anal epidermoid cancer treated from 1985 to 2000 in the Stockholm Health Care Region were recorded prospectively. Among 308 patients with biopsy-proven anal epidermoid cancer, there have been 39 isolated locoregional failures after sphincter-preserving therapy. Thirty-®ve patients have undergone salvage APR. The medical records of these 35 patients were reviewed retrospectively with regard to surgical and oncological results.Results: There were no postoperative deaths. There was considerable morbidity related to the perineal wound, with postoperative perineal infections in 13 patients and delayed healing beyond 3 months in 23 patients. Complications unrelated to the perineal wound were found in 13 patients. The crude 5-year survival rate for the 35 patients was 52 per cent (median follow-up 33 months). Patients with persistent disease fared signi®cantly worse than those with locoregional recurrence (crude 5-year survival rate 33 versus 82 per cent; P < 0´05, log rank test).Conclusion: Salvage APR in anal epidermoid cancer is associated with a high complication rate but may result in long-term survival.
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