A Phase II Study of Additional Four-Week Chemotherapy With Capecitabine During the Resting Periods After Six-Week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

Abstract

PurposeThe aim of this study is to evaluate the efficacy and the safety of additional 4-week chemotherapy with capecitabine during the resting periods after a 6-week neoadjuvant chemoradiotherapy (NCRT) in patients with locally advanced rectal cancer.MethodsRadiotherapy was delivered to the whole pelvis at a total dose of 50.4 Gy for 6 weeks. Oral capecitabine was administered at a dose of 825 mg/m2 twice daily for 10 weeks. Surgery was performed 2-4 weeks following the completion of chemotherapy.ResultsBetween January 2010 and September 2011, 44 patients were enrolled. Forty-three patients underwent surgery, and 41 patients completed the scheduled treatment. Pathologic complete remission (pCR) was noted in 9 patients (20.9%). T down-staging and N down-staging were observed in 32 patients (74.4%) and 33 patients (76.7%), respectively. Grade 3 to 5 toxicity was noted in 5 patients (11.4%). The pCR rate was similar with the pCR rates obtained after conventional NCRT at our institute and at other institutes.ConclusionThis study showed that additional 4-week chemotherapy with capecitabine during the resting periods after 6-week NCRT was safe, but it was no more effective than conventional NCRT.

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

“…In a previous study, Lee et al [ 35 ] showed that 4 additional weeks of neoadjuvant chemotherapy with capecitabine was safe during the resting periods before the surgery, but it did not improve the tumor response rate compared to conventional chemoradiation. A standard period of conventional neoadjuvant therapy consists of 5-6 weeks of concurrent chemoradiation, followed by a 6- to 8-week recovery window and then by a surgical resection.…”

Additional Chemotherapy During Resting Periods After Preoperative Chemoradiotherapy in Patients With Rectal Cancer

“…In this article, authors report that they tried an additional four weeks of chemotherapy with capecitabine during resting periods. They did not obtain a visibly better result; nonetheless, this article bears prospective meanings [ 1 ].…”