Abstract
PurposeNeoadjuvant chemoradiation has become the standard treatment in locally advanced rectal cancer (LARC) and improves local control. This study explored the feasibility of an intensified chemoradiation treatment followed by one cycle of capecitabine before surgery for LARC.Methods and materialsPatients with histologically confirmed, newly diagnosed, locally advanced rectal adenocarcinoma (cT3-T4 and/or cN+) located within 12 cm of the anal verge were included in this study. Patients received intensity-modulated radiation therapy (IMRT) to the pelvis (total dose 44 Gy in 20 fractions), as well as concurrent oxaliplatin (50 mg/m2 d1 weekly) and capecitabine (625 mg/m2 b.i.d. d1–5 weekly). One cycle of capecitabine (1000 mg/m2 b.i.d. d1–14) was given two weeks after the completion of concomitant chemoradiation, and radical surgery was scheduled six weeks after chemoradiation.ResultsBetween October 2007 and November 2008, a total of 42 patients were enrolled in the study (median age 51 years; 31 male). Of these, 38 underwent surgical resection and 4 refused radical surgery because of almost complete primary tumor regression and complete symptom relief after neoadjuvant therapy. Fifteen patients underwent sphincter-sparing lower anterior resection. Six patients had a pathological complete response (pCR). The incidence of grade 3 hematologic, gastro-intestinal, and skin toxicities were 4.7%, 14.3%, and 26.2%, respectively. Grade 4 toxicity was not observed. Surgical complications (incisional infection within 2–3 weeks after surgery) were observed in 5 patients. Good responders (defined as TRG 3–4) had a significant difference in DFS (81.6% vs. 16.8%, respectively; p = 0.000) and OS (83.9% vs. 40.7%, respectively; p = 0.007) compared to those who were evaluated as TRG 1–2.ConclusionsOur study indicates that neoadjuvant chemoradiation followed by one cycle of capecitabine before surgery has a good treatment efficacy, with only mild toxicities associated with chemoradiation and acceptable surgical complications. Treatment response was an early surrogate marker and correlated to oncologic prognosis.
Highlights
Neoadjuvant chemoradiation (CRT) followed by total mesorectal excision is the standard of care for patients with locally advanced rectal cancer (LARC)
Good responders had a significant difference in disease-free survival (DFS) (81.6% vs. 16.8%, respectively; p = 0.000) and overall survival (OS) (83.9% vs. 40.7%, respectively; p = 0.007) compared to those who were evaluated as Tumor regression grading (TRG) 1–2
Our study indicates that neoadjuvant chemoradiation followed by one cycle of capecitabine before surgery has a good treatment efficacy, with only mild toxicities associated with chemoradiation and acceptable surgical complications
Summary
Neoadjuvant chemoradiation (CRT) followed by total mesorectal excision is the standard of care for patients with locally advanced rectal cancer (LARC). In an Italian retrospective study of 566 pCR patients, the 5-year rate of disease-free survival (DFS), overall survival (OS) and cancer-specific survival after neoadjuvant therapy increased to 85%, 90% and 94%, respectively [2]. Compared with results from other studies in stage II/III rectal cancer patients, these reports are encouraging and indicate that pCR may be considered an important potential prognostic factor in neoadjuvant CRT. In a retrospective analysis of 3,157 patients enrolled in seven randomized Phase III trials and 45 Phase II trials, the use of continuous infusion 5-FU, a second drug based on 5-FU and a higher radiation dose was associated with higher rates of pCR [3]. Based on four reported randomized clinical trials, there was a conflict whether patients could benefit from additional oxaliplatin in the neoadjuvant CRT [4,5,6,7]. Applied advanced radiation technology with intensified treatment may maintain this balance
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