In Reply We thank McCaw and colleagues for their observations and interesting suggestions about the end point of our Three or Six Colon Adjuvant (TOSCA) stage II subgroup analysis recently published in JAMA Oncology.1 We concluded that, despite not reaching the noninferiority significance, the clinical nonsignificance of the overall results (in particular the 1% difference in 5-year relapse-free survival) with 3-month capecitabine plus oxaliplatin (XELOX) treatment may reasonably lead to suggest that this schedule may be preferable in terms of efficacy and toxicity for these patients. We agree that future studies should look to composite end points (that couple efficacy and toxicity) and that these need to be prospectively evaluated in large randomized studies. McCaw and colleagues suggest a reanalysis of our data as a function of both outcome and toxicity outcomes for stratification purposes. This is a useful compromise coupling outcome and adverse events. Unfortunately, our trial did not include a quality-of-life evaluation. In a similar study, the Short Course Oncology Therapy (SCOT) trial,2 shorter chemotherapy duration showed similar survival with a better quality of life, and the authors identified the 3-month duration as the reference standard in these stages.
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Zaniboni A, Petrelli F, Labianca R. Risk-Benefit Comparisons Between Shorter and Longer Durations of Adjuvant Chemotherapy in High-Risk Stage II Colorectal Cancer—Reply. JAMA Oncol. Published online June 25, 2020. doi:10.1001/jamaoncol.2020.2262
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