Comments on the CAIRO4 Trial Secondary Outcomes Report—Reply

Van der Kruijssen et al thank Hammett et al for their interest in their study. They acknowledge that publishing results of the primary CAIRO4 outcome before publishing data on 60-day mortality could have been considered preferable to put these results into context. However, because the early mortality data of their study were available and in the light of recent publications on the topic, they decided data on 60-day mortality would be a valuable and necessary contribution to the debate. Furthermore, the presented data will not change after reaching the primary end point of the study. Sixty-day mortality is frequently used as an outcome measure in studies concerning the safety of systemic therapy. Although data on both short-term and long-term survival are important for the consideration of whether systemic therapy only or primary tumor resection followed by systemic therapy is provided to patients, previous reports on randomized clinical trials investigating these interventions did not include 60-day mortality.