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254. A novel chemoradiotherapy regimen for squamous-cell anal cancer
ABSTRACTS 95% CI 0.11-0.43; OR rectosigmoid/rectum versus colon 0.65: 95% CI 0.46-0.90). Crude 5-year overall survival was higher in the group of patients who underwent additional surgical resection as compared to patients who underwent polypectomy only (82% versus 75%, p¼0.002). Also after adjusting for patient and tumour characteristics, patients who underwent additional surgical resection had a decreased risk of death as compared to patients who underwent polypectomy only (HR 0.68: 95% CI 0.500.93). Conclusions: Elderly with a tumour located in the rectosigmoid or rectum were less likely to undergo additional surgical resection. Given that additional surgical resection was independently associated with improved overall survival, this might imply that all pT1 CRC patients should receive additional surgical resection after initial polypectomy. No conflict of interest. http://dx.doi.org/10.1016/j.ejso.2014.08.244
253. Hypofractionated chemoradiotherapy with local hyperthermia and metronidazole for fixed or tethered T4 rectal cancer S. Gordeyev1, Y.U.A. Barsukov1, S.I. Tkachev2 1 Blokhin Cancer Research Center, Proctology, Moscow, Russian Federation 2 Blokhin Cancer Research Center, Radiational Oncology, Moscow, Russian Federation Background: Preclinical studies support additive effect of hypofractionated radiotherapy, local hyperthermia and metronidazole. The aim of this study was to prospectively evaluate the safety and efficacy of neoadjuvant chemoradiotherapy with local hyperthermia and metronidazole for fixed T4 rectal cancer. Methods: Patients received radiation therapy 40 Gy in 10 fractions thrice a week. Chemotherapy consisted of Capecitabine 650 mg/m2 bid per os on days 1-22, oxaliplatin 50 mg/m2 intravenously on days 3, 10, 17. Local hyperthermia 41-45 C, 60 minutes was performed on days 8, 10, 15, 17. Metronidazole 10 g/m2 per rectum was used on days 8, 15. Surgery was carried out within 6-8 weeks after neoadjuvant treatment. Primary endpoint was R0 rate. Secondary endpoints included toxicity, tumor regression, 2-year OS and DFS, local recurrence rate. Results: Between Sept.2007 and Jan.2011, a total of 116 consecutive patients were enrolled (median age 57 years; 72 male, 44 female; median tumor diameter 8 cm). R0 resection rate was 90,5%. 5(4,3%) patients remained inoperable, 6(5,2%) had R1 resection. 26(22,4%) patients experienced G3-G5 toxicity (23 Grade 3/4 and 3 Grade 5). There was no postoperative mortality. 48(41,4%) patients had near-complete and 10(8,6%) patients - complete response. Median follow-up was 21.9 months. 2-year OS was 82.6%, 2-year DFS was 70.9%. 30(25.9%) patients had disease progression. 13(11.2%) patients had local recurrences, 22(19%) patients developed metastatic disease. Conclusion: High R0 resection rate in fixed or tethered rectal cancer in our study warrants further investigation of the proposed treatment scheme in a randomized setting. No conflict of interest. http://dx.doi.org/10.1016/j.ejso.2014.08.245
254. A novel chemoradiotherapy regimen for squamous-cell anal cancer A. Malikhov1, U.A. Barsukov1, A.V. Nikolaev1, D.F. Kim1, U.M. Timofeev1 1 Blokhin’s Russian Cancer Research Center, Coloproctology, Moscow, Russian Federation The aim of this trial was to investigate safety and efficacy of anal cancer chemoradiotherapy with cisplatin, bleomycin and local hyperthermia.
S103 Methods: This retrospective trial included 157 consecutive patients, who underwent chemoradiotherapy for squamous-cell anal cancer during 1998-2011. All patients received 36-48 Gy radiotherapy in 2 Gy fractions followed by a boost (after 2 week gap) till a total dose of 64-70 Gy was achieved. Chemotherapy included intravenous cisplatin 20 mg/m2 days 1,3 weeks 1-4, intramuscular bleomycin days 2,4, weeks 1-4. 5 sessions of local 41-45 C hyperthermia were carried out during the radiotherapy course. Results: Complete clinical response was achieved in 126 (80,3%) patients, 31 (19,7%) patients underwent abdominoperineal resection. Median followup was 30 months. 24 (16,9%) patients died from disease progression, including 10 (7,0%) patients with local recurrence. 5-year survival rate was 73,7 %. Conclusion: Anal cancer chemoradiotherapy with cisplatin, bleomycin and local hyperthermia seems a feasible alternative to standard treatment, the efficacy of this regimen needs to be validated in prospective trials. No conflict of interest. http://dx.doi.org/10.1016/j.ejso.2014.08.246
255. Rectal cancer treatment and complications in IBD patients S.J. Van Rooijen1, S.L. Bosch2, H.J.W. Braam1, G.M.J. B€okkerink1, I.D. Nagtegaal2, J.H.W. De Wilt1 1 Radboud University Medical Center, Surgery, Nijmegen, Netherlands 2 Radboud University Medical Center, Pathology, Nijmegen, Netherlands Background: IBD patients have an increased risk of developing colorectal cancer(CRC). For sporadic rectal cancer (RC), neoadjuvant therapy followed by total mesorectal excision (TME), is standard of care. Data on the effects of this treatment for IBD related RC are rare, since IBD patients are usually excluded from neo-adjuvant trials. Materials and methods: All IBD patients of the Netherlands with RC between 1990 and 2010 were selected using a nationwide search in the Dutch Pathology Database (PALGA). Clinical data were collected from detailed medical record review in each hospital. All histopathological slides were reviewed to confirm both diagnoses. Surgical complications were scored according to the Clavien-Dindo scale (Grade 1 to 5). Results from IBD patients with RC were compared with data from the Dutch surgical colorectal audit containing all CRC patients treated in the Netherlands. Results: 173 patients from 40 hospitals were identified (89 Ulcerative Colitis (UC), 70 Crohn’s Disease (CD), 14 indeterminate colitis). 112 (64.7%) were males and 61 (35.3%) females with mean age of RC diagnosis of 60.7 years (28.2e92.4). The mean duration of IBD before development of RC was 17.4 years (0e50.9). Neoadjuvant therapy was used in 63 (36.4%) patients, 29 (17.9%) received short course radiotherapy (RT), 13(8.3%) long course RT, 21 (13.1%) chemoradiation therapy (CRT). 154 (89.1%) patients underwent resection of the tumor. Diagnosis of RC was known preoperatively in 145 (83.8%) patients (CD 72.7% and UC 90.9%; p¼0.022). Stage distribution was: 1 patient stage 0 (0.9%), 27 stage I (23.9%), 41 stage II (36.3%), 30 stage III (26.5%), and 14 stage IV (12.4%). 42% of the patients developed one or several complications after rectal surgery. Complication grade 2 was reported most, 26 (27,4%) times, as a presacral or intra-abdominal abscess (15.8%), perineal or abdominal wound (26.3%) or urologic (20%) cause. 48 grade 3+ complications were reported in 41 (24.4%) patients. No more complications were seen with neoadjuvant therapy usage nor immunosuppressive. Local recurrence was seen in 14 (8,1%) patients. Conclusions: Rectal cancer is often not recognized in patients with IBD who undergo surgery. This leads to a high number of R1 resections and an increased local recurrence rate, especially in patients with CD. The complication rate after TME surgery in IBD patients seems comparable with sporadic RC patients. No conflict of interest. http://dx.doi.org/10.1016/j.ejso.2014.08.247
253. Hypofractionated chemoradiotherapy with local hyperthermia and metronidazole for fixed or tethered T4 rectal cancer S. Gordeyev1, Y.U.A. Barsukov1, S.I. Tkachev2 1 Blokhin Cancer Research Center, Proctology, Moscow, Russian Federation 2 Blokhin Cancer Research Center, Radiational Oncology, Moscow, Russian Federation Background: Preclinical studies support additive effect of hypofractionated radiotherapy, local hyperthermia and metronidazole. The aim of this study was to prospectively evaluate the safety and efficacy of neoadjuvant chemoradiotherapy with local hyperthermia and metronidazole for fixed T4 rectal cancer. Methods: Patients received radiation therapy 40 Gy in 10 fractions thrice a week. Chemotherapy consisted of Capecitabine 650 mg/m2 bid per os on days 1-22, oxaliplatin 50 mg/m2 intravenously on days 3, 10, 17. Local hyperthermia 41-45 C, 60 minutes was performed on days 8, 10, 15, 17. Metronidazole 10 g/m2 per rectum was used on days 8, 15. Surgery was carried out within 6-8 weeks after neoadjuvant treatment. Primary endpoint was R0 rate. Secondary endpoints included toxicity, tumor regression, 2-year OS and DFS, local recurrence rate. Results: Between Sept.2007 and Jan.2011, a total of 116 consecutive patients were enrolled (median age 57 years; 72 male, 44 female; median tumor diameter 8 cm). R0 resection rate was 90,5%. 5(4,3%) patients remained inoperable, 6(5,2%) had R1 resection. 26(22,4%) patients experienced G3-G5 toxicity (23 Grade 3/4 and 3 Grade 5). There was no postoperative mortality. 48(41,4%) patients had near-complete and 10(8,6%) patients - complete response. Median follow-up was 21.9 months. 2-year OS was 82.6%, 2-year DFS was 70.9%. 30(25.9%) patients had disease progression. 13(11.2%) patients had local recurrences, 22(19%) patients developed metastatic disease. Conclusion: High R0 resection rate in fixed or tethered rectal cancer in our study warrants further investigation of the proposed treatment scheme in a randomized setting. No conflict of interest. http://dx.doi.org/10.1016/j.ejso.2014.08.245
254. A novel chemoradiotherapy regimen for squamous-cell anal cancer A. Malikhov1, U.A. Barsukov1, A.V. Nikolaev1, D.F. Kim1, U.M. Timofeev1 1 Blokhin’s Russian Cancer Research Center, Coloproctology, Moscow, Russian Federation The aim of this trial was to investigate safety and efficacy of anal cancer chemoradiotherapy with cisplatin, bleomycin and local hyperthermia.
S103 Methods: This retrospective trial included 157 consecutive patients, who underwent chemoradiotherapy for squamous-cell anal cancer during 1998-2011. All patients received 36-48 Gy radiotherapy in 2 Gy fractions followed by a boost (after 2 week gap) till a total dose of 64-70 Gy was achieved. Chemotherapy included intravenous cisplatin 20 mg/m2 days 1,3 weeks 1-4, intramuscular bleomycin days 2,4, weeks 1-4. 5 sessions of local 41-45 C hyperthermia were carried out during the radiotherapy course. Results: Complete clinical response was achieved in 126 (80,3%) patients, 31 (19,7%) patients underwent abdominoperineal resection. Median followup was 30 months. 24 (16,9%) patients died from disease progression, including 10 (7,0%) patients with local recurrence. 5-year survival rate was 73,7 %. Conclusion: Anal cancer chemoradiotherapy with cisplatin, bleomycin and local hyperthermia seems a feasible alternative to standard treatment, the efficacy of this regimen needs to be validated in prospective trials. No conflict of interest. http://dx.doi.org/10.1016/j.ejso.2014.08.246
255. Rectal cancer treatment and complications in IBD patients S.J. Van Rooijen1, S.L. Bosch2, H.J.W. Braam1, G.M.J. B€okkerink1, I.D. Nagtegaal2, J.H.W. De Wilt1 1 Radboud University Medical Center, Surgery, Nijmegen, Netherlands 2 Radboud University Medical Center, Pathology, Nijmegen, Netherlands Background: IBD patients have an increased risk of developing colorectal cancer(CRC). For sporadic rectal cancer (RC), neoadjuvant therapy followed by total mesorectal excision (TME), is standard of care. Data on the effects of this treatment for IBD related RC are rare, since IBD patients are usually excluded from neo-adjuvant trials. Materials and methods: All IBD patients of the Netherlands with RC between 1990 and 2010 were selected using a nationwide search in the Dutch Pathology Database (PALGA). Clinical data were collected from detailed medical record review in each hospital. All histopathological slides were reviewed to confirm both diagnoses. Surgical complications were scored according to the Clavien-Dindo scale (Grade 1 to 5). Results from IBD patients with RC were compared with data from the Dutch surgical colorectal audit containing all CRC patients treated in the Netherlands. Results: 173 patients from 40 hospitals were identified (89 Ulcerative Colitis (UC), 70 Crohn’s Disease (CD), 14 indeterminate colitis). 112 (64.7%) were males and 61 (35.3%) females with mean age of RC diagnosis of 60.7 years (28.2e92.4). The mean duration of IBD before development of RC was 17.4 years (0e50.9). Neoadjuvant therapy was used in 63 (36.4%) patients, 29 (17.9%) received short course radiotherapy (RT), 13(8.3%) long course RT, 21 (13.1%) chemoradiation therapy (CRT). 154 (89.1%) patients underwent resection of the tumor. Diagnosis of RC was known preoperatively in 145 (83.8%) patients (CD 72.7% and UC 90.9%; p¼0.022). Stage distribution was: 1 patient stage 0 (0.9%), 27 stage I (23.9%), 41 stage II (36.3%), 30 stage III (26.5%), and 14 stage IV (12.4%). 42% of the patients developed one or several complications after rectal surgery. Complication grade 2 was reported most, 26 (27,4%) times, as a presacral or intra-abdominal abscess (15.8%), perineal or abdominal wound (26.3%) or urologic (20%) cause. 48 grade 3+ complications were reported in 41 (24.4%) patients. No more complications were seen with neoadjuvant therapy usage nor immunosuppressive. Local recurrence was seen in 14 (8,1%) patients. Conclusions: Rectal cancer is often not recognized in patients with IBD who undergo surgery. This leads to a high number of R1 resections and an increased local recurrence rate, especially in patients with CD. The complication rate after TME surgery in IBD patients seems comparable with sporadic RC patients. No conflict of interest. http://dx.doi.org/10.1016/j.ejso.2014.08.247