Background: Standard therapy for locally advanced rectal cancer (LARC) is concurrent neo-adjuvant chemo-radiation using infusional 5-fluorouracil (CIV-5-FU). Capecitabine (CAP) offers a convenient oral replacement for CIV-5-FU. There is no randomized trial comparing infusional 5-FU to capecitabine. We retrospectively compared the safety and efficacy of CAP-based regimens with well-established CIV-5-FU-based regimens in LARC.
Materials and methods: We collected published data on 542 patients treated on either CIV-5-FU (197) or CAP (345) with concurrent radiation (external radiation treatment, XRT) for LARC. This included Phase I or II studies published or available from Pubmed. Safety was assessed by determining proportion of patients who experienced grade III/IV adverse effects. Efficacy was assessed by determining pathological complete response (pCR). Chi-square tests were used to compare the two regimens. A P value less than 0.05 was considered statistically significant. Statistical tests were further corrected for multiplicity using the method of Benjamini and Yekutieli (Ann Stat, 29(4):1165-1188, 2001).
Results: pCR was significantly higher in patients getting CAP vs CIV-5-FU (25 vs 13%; P = 0.008,.P adj = 0.034). Both regimens were generally well tolerated. There was no grade IV toxicity reported. Grade III hand foot syndrome was more common in the CAP group, and grade III diarrhea was more common in the CIV group.
Conclusions: CAP when compared to CIV seems to have superior efficacy with reasonable toxicities. It is reasonable to treat LARC with CAP + XRT.