Background. The need for preoperative chemoradiation or short-course radiation in all T3 rectal tumors is a controversial issue. A multicenter phase II trial was undertaken to evaluate the efficacy and safety of neoadjuvant capecitabine and oxaliplatin combined with bevacizumab in patients with intermediate-risk rectal adenocarcinoma. Methods. We recruited 46 patients with T3 rectal adenocarcinoma selected by magnetic resonance imaging (MRI) who were candidates for (R0) resection located in the middle third with clear mesorectal fascia and who were selected by pelvic MRI. Patients received four cycles of neoadjuvant capecitabine and oxaliplatin combined with bevacizumab (final cycle without bevacizumab) before total mesorectal excision (TME). In case of progression, preoperative chemoradiation was planned. The primary endpoint was overall response rate (ORR). Results. On an intent-to-treat analysis, the ORR was 78% (n 5 36; 95% confidence interval [CI]: 63%-89%) and no progression was detected. Pathologic complete response was observed in nine patients (20%; 95% CI: 9-33), and T downstaging was observed in 48%. Forty-four patients proceeded to TME, and all had R0 resection. During preoperative therapy, two deaths occurred as a result of pulmonary embolism and diarrhea, respectively, and one patient died after surgery as a result of peritonitis secondary to an anastomotic leak (AL). A 13% rate of AL was higher than expected. The 24-month disease-free survival rate was 75%
We present a case of the rare occurrence of a mucus-secreting adenocarcinoma originating in an anal gland. A 37-year-old diabetic man had an anal fistulotomy 16 years before. He had four ischiorectal abscesses in a 6-month period. A seton was inserted in a complex fistula tract in the left anterior lateral aspect. Due to delayed healing, a new surgical exploration was carried out; pathological analysis of the curetted mucinous tissue revealed a mucoid adenocarcinoma. Surgical resection is the first choice of curative treatment, and additional treatments include chemotherapy, radiotherapy and brachytherapy.
3586 Background: Retrospective data suggest that RT might not be needed in all patients with stage II/III RC. Modern systemic therapy might have local efficacy similar to chemoradiation (CRT). Methods: A multicenter phase II trial was undertaken to evaluate safety and efficacy of neoadjuvant CAPOX-B in patients with T3 middle third rectal adenocarcinoma. Eligible patients (pts) had measurable disease at the baseline and candidate for R0 total mesorectal escision (TME) with intermediate-risk defined by pelvic MR a) T3 with distal border of tumor > 5 cm from the anal verge and below the sacral promontory. b) tumor ≥2 mm from the mesorectal fascia. Pts received 4 cycles of Cap 2000 mg/m2 (d1-14), Ox 130 mg/m2 (d1) and B 7.5 mg/kg (d1) every 3 weeks (last cycle without B). Pts undergo re-staging with MR. One radiologist reviewed all pre- and post-treatment MR scans independently. Pts without progression proceed to TME 4-6 weeks from the last cycle. If progression, pts were to be referred for pre-op cap/RT followed by TME. 1º Endpoint: Tumor Response (RECIST). Design: Simon 2-stage; 28 pts 1st stage and 46 pts 2nd stage. We report data on the planned analysis of pts included for 1st stage. Results: 28 eligible pts (10F/18M) were enrolled from 7/09-5/11. Tumor response, compliance and toxicity details are shown in table below. Two pN2 pts received postop Cap/RT. Conclusions: Neoadjuvant CAPOX-B is active and safe. Early parameters of efficacy are encouraging and seem similar to those observed with CRT. [Table: see text]
4044 Background: The aim of this phase II trial was to assess the impact of preoperative external radiation therapy combined with Capecitabine and Oxaliplatin on pathologic tumor response, sphincter preservation and tumor control in patients with locally advanced rectal carcinoma. Methods: Sixty-seven patients with locally advanced rectal carcinoma (T3/T4 or N+) received radiotherapy (50.4 Gy/28 fractions) and chemotherapy with Capecitabine 825 mg/m2/12 hours on days 1–5 + Oxaliplatin 50 mg/m2 on day 1 every week (weeks 1–6). Surgery with TME was performed 6–7 weeks after the end of the treatment. Adjuvant chemotherapy was administered after surgery according investigator‘s crtiteria. Results: Patients have been recruited between February 2005 and June 2006. 47 male/20 female. Median age 67 years (range 38–79). Performance status (ECOG) 0 in 45 patients. Clinical stage (determined by EUS+CT or RMI): cT2 3p/cT3 58p/cT4 6p/cN+ 47p. Tumor location (from anal verge): = 5 cm in 27p. Median CEA level 3,69 ng/ml (0,7–391). Surgery (performed in 65 patients) consisted of low anterior resection in 37p, abdominal perineal resection in 28p. Tumor downstaging was observed in 52p (78%), 50 (76,9%) had negative lymph nodes, including 13p with complete pathological response (19,4%) and ten with only microfoci of tumor remaining (14,9%). 80% of the patients received adjuvant chemotherapy. Main adverse effects (NCI-CTC): diarrhea G3/4 25%, sensitive peripheral neurotoxicity G1 60%, skin G2 9%, skin G3 3%, nausea/vomiting G2 7.5%, fatigue G2 50%, fatigue G3 4%, neutropenia G3/4 4%. Conclusions: Those results show that preoperative chemoradiotherapy with capecitabine and oxaliplatin is a well tolerated regimen for locally advanced operable rectal cancer leading to a high probability of tumor downstaging. No significant financial relationships to disclose.
13543 Background: Preoperative chemoradiotherapy has shown to improve local control and sphincter preservation with decreased acute toxicity compared with postoperative treatment in locally advanced rectal carcinoma. The primary endpoint of this phase II trial was pathologic tumor response. Secondary endpoints were sphincter preservation and toxicity. Methods: Inclusion criteria: rectal adenocarcinoma <12 cms from anal verge, clinical stage T3–4 and/or N+, adequate renal, hematological and liver function. Planned sample for this trial was 43 patients. Treatment scheme: pelvic radiotherapy (50.4 Gy/28 fractions) and chemotherapy: Capecitabine 825 mg/m2/12 hours on days 1–5 + Oxaliplatin 50 mg/m2 on day 1 every week (weeks 1–6). Surgery with TME was performed between 6–8 weeks after the end of the treatment. Adjuvant chemotherapy was administered after surgery according each center criteria. Results: 37 patients have been recruited between February and December 2005. 26 male/11 female. Median age 70 years (range 38–79). Clinical stage (determined by EUS+CT or RMI): cT2 1p/cT3 33p/cT4 3p/cN+ 27p. Tumor location (from anal verge): ≤ 5 cm in 15p, >5 cm in 22p. Surgery (performed in 26 patients) consisted of low anterior resection in 13p and abdominal-perineal resection in 13p. Tumor downstaging was observed in 17p (65%), 20 (77%) had negative lymph nodes, including 6p with complete pathological response (23%) and four with only microfoci of tumor remaining (15%). Main adverse effects (NCI-CTC): diarrhea G3–4 19%, sensitive peripheral neurotoxicity G1 38%, skin G2 11%, nausea/vomiting G2 11%, fatigue/malaise G3 4%, neutropenia G3 7%. Conclusions: Preliminary results show that preoperative chemoradiotherapy with capecitabine and oxaliplatin is a well tolerated regimen for locally advanced operable rectal cancer leading to a high probability of tumor downstaging. No significant financial relationships to disclose.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.