Abstract
Despite lack of a true comparative study, the folfox (5-fluorouracil-leucovorin-oxaliplatin) and capox (capecitabine-oxaliplatin) regimens are believed to be similar in their efficacy and tolerability in the treatment of stage iii colorectal cancer. However, that belief has been disputed, because real-life data suggest that the capox regimen is more toxic, leading to more frequent reductions in the delivered dose intensity-thus raising questions about the effect of dose intensity on clinical outcomes. A retrospective data review for two Canadian institutions, the Segal Cancer Centre and the Tom Baker Cancer Centre, considered patients diagnosed with stage iii colorectal cancer during 2006-2013. Primary endpoints were dose intensity and toxicity, with a secondary endpoint of disease-free survival. The study enrolled 180 eligible patients (80 at the Segal Cancer Centre, 100 at the Tom Baker Cancer Centre). Of those 180 patients, 75 received capox, and 105 received mfolfox6. In the capox group, a significant dose reduction was identified for capecitabine compared with 5-fluorouracil in mfolfox6 group (p = 0.0014). Similarly, a significant dose reduction was observed for oxaliplatin in mfolfox6 compared with oxaliplatin in capox (p = 0.0001). Compared with the patients receiving capox, those receiving mfolfox6 were twice as likely to experience a treatment delay of more than 1 cycle-length (p = 0.03855). Toxicity was more frequent in patients receiving mfolfox6 (nausea: 30% vs. 18%; diarrhea: 47% vs. 24%; peripheral sensory neuropathy: 32% vs. 3%). At a median follow-up of 40 months, preliminary data showed no difference in disease-free survival (p = 0.598). Pooled data from both institutions were also separately analyzed, and no significant differences were found. Our results support the use of capox despite a lack of head-to-head randomized trial data.
Highlights
Fluoropyrimidines—and in particular 5-fluorouracil (5fu)—have largely been the backbone of chemotherapy for colon cancer in the adjuvant setting[1]
A significant dose reduction was identified for capecitabine compared with 5-fluorouracil in mfolfox[6] group (p = 0.0014)
Consensus on the toxicity profiles of the capecitabine arms compared with the 5fu–lv infusion arms has been somewhat variable, but in general, grade 3 occurrences of diarrhea, hand–foot syndrome, and thrombocytopenia have been significantly higher with the capox regimens, and grade 3 neutropenia and febrile neutropenia seem to occur significantly more often with the folfox regimens[6]
Summary
Fluoropyrimidines—and in particular 5-fluorouracil (5fu)—have largely been the backbone of chemotherapy for colon cancer in the adjuvant setting[1]. Randomized clinical trials have consistently shown that, compared with 5fu and leucovorin (lv) alone, the addition of oxaliplatin (folfox) results in superior response rates and time to disease progression, as exemplified by the North Central. Cancer Treatment Group trial N9741 and the mosaic studies in stage iii patients[2,3]. Almost all studies comparing capecitabine monotherapy with bolus 5fu–lv regimens resulted in CAPOX AND mFOLFOX6 DOSE INTENSITY AND CLINICAL OUTCOMES IN STAGE III CRC, Mamo et al. Despite lack of a true comparative study, the folfox (5-fluorouracil–leucovorin–oxaliplatin) and capox (capecitabine–oxaliplatin) regimens are believed to be similar in their efficacy and tolerability in the treatment of stage iii colorectal cancer. That belief has been disputed, because real-life data suggest that the capox regimen is more toxic, leading to more frequent reductions in the delivered dose intensity— raising questions about the effect of dose intensity on clinical outcomes
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