| Background:Colorectal cancer (CRC) is one of the most common cancers, and one of the leading causes of cancer death worldwide. According to the Chinese Cancer Registry Annual Report2012, colorectal cancer (CRC) is the3rd most frequently diagnosed cancer and the5th leading cause of cancer death.75%of newly diagnosed patients can attempt the curative surgery. However, although the curative surgery has been performed, half of patients would round into incurable recurrences, which makes the5-year survival rate only50%. Therefore, additional therapies are quested for improving therapeutic effectiveness. Adjuvant chemotherapy has been thoroughly studied for several decades. Fluorouracil-based adjuvant chemotherapies have been confirmed to bring a profit to reduce the incidence of recurrence and prolong survival, especially for stage Ⅲ patients. With oxaliplatin, capecitabine listed, there are some new progresses in adjuvant chemotherapy for colon cancer emerging. The Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) and National Surgical Adjuvant Breast and Bowel Project (NSABP) C-07trials both indicated that adding oxaliplatin to infusional or bolus FU/LV significantly improves disease free survival (DFS) when treating stage Ⅱ/Ⅲ colon cancer patients as adjuvant therapy. According to the results of MOSAIC and (NSABP) C-07trials, FOLFOX (FU/LV/oxaliplatin) and FLOX (bolus FU/LV/oxaliplatin) have been confirmed as the novel standard adjuvant chemotherapy for stage II and Ⅲ colon cancer instead of FU/LV recently. Capecitabine (xeloda; F.Hoffmann-La Roche, Basel, Switzerland) as an oral fluoropyrimidine has been proved to be highly effective in the first-line treatment of metastatic colorectal cancer, and also in the adjuvant therapy as an alternative to bolus FU/LV. In order to estimate the efficacy and the feasibility of capecitabine combine with oxaliplatin, NO16968(XELOX in Adjuvant Colon Cancer Treatment [XELOXA]) was designed to compare XELOX with bolus FU/FA (Mayo Clinic [MC] or Roswell Park[RP] regimens) in patients with stage Ⅲ colon cancer, showing that XELOX improved DFS for stage Ⅲ colon cancer, which led to the approval of XELOX as a standard adjuvant treatment for stage Ⅲ colon cancer after a curative surgery. Nevertheless, the standard regimen used in NO16968is bolus FU/FA, which is proved to be inferior to FOLFOX, we found that there is no head-to-head comparison of FOLFOX vs. XELOX.Therefore, this research is more instructive for the selection of the adjuvant therapy regimens. Clinicians can make better chemotherapy choices according to the patients’tolerance and compliance.Objective:To compare the efficacy and safety of capecitabine and oxaliplatin (XELOX) with5-fluorouracil/leucovorin and oxaliplatin (FOLFOX) as adjuvant treatment for stage Ⅱand Ⅲ colon cancer patients.Methods:The stage Ⅱ (T3-4N0M0) and Ⅲ (T1-4N1-2M0) colon cancer patients who underwent complete resection and received either XELOX (capecitabine1,000mg/m2bid, days1to14plus oxaliplatin130mg/m2days1, repeated every3weeks) or FOLFOX (oxaliplatin85mg/m2followed by leucovorin400mg/m2plus5-FU400mg/m2bolus with a22h infusion of5-FU600mg/m2on days1and2, repeated every2weeks) between January1,2005and October31,2010in our hospital were retrospectively collected and analyzed. The patients enrolled into this study should meet the established inclusion and exclusion criteria strictly. The primary endpoint was disease-free survival. Secondary end points included the rate of disease-free survival at3years, overall survival and safety.Result:A total of215colon cancer patients were treated with XELOX (n=112) or FOLFOX (n=103). No statistically significant difference was observed between the XELOX group and the FOLFOX group in the DFS (log-rank P=0.19) and OS (log-rank P>0.05). However, the FOLFOX group was associated with a trend towards the superior3-year DFS rates (77.7%vs.71.4%) than XELOX (P=0.29). After adjustment for all covariables, the result of the effects on the DFS (HR,1.474;95%CI:0.858to2.532, P-0.16) and OS (HR,1.144;95%CI:0.624to2.096, P=0.66) was not changed. Following the multivariate analysis, age(P=0.015), nodal stage(P<0.001), histological appearance(P<0.001), time from surgery to treatment(P <0.001), the duration of adjuvant treatment(P=0.002) were independent prognostic factors for DFS. XELOX was associated with significantly less grade3/4stomatitis (0%vs.3.9%; P=0.035) and neutropenia (9.8%vs.28.2%; P=0.001), but more hand-foot syndrome than FOLFOX group (4.5%vs.0%; P=0.030). The costs of XELOX group were higher than FOLFOX group. But the costs for treating adverse drug reactions were different, which could not been assessed accurately because of the different adverse drug reactions between the two groups.ConclusionNo difference in survival between XELOX and FOLFOX regimens, but less toxicities in XELOX regimen were observed. And also capecitabine has the advantage of convenient administration, less utilization of the medical resources and avoiding complications related to intravenous chemotherapy, but the costs are higher. Clinicians should make better chemotherapy choices according to the patients’tolerance, compliance and economic situations for stage Ⅱ and Ⅲ colon cancer in the adjuvant treatment. |
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