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QoL is a cool tool

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We read the manuscript by Dr. Schuurhuizen and colleagues, questioning the validity of the global Quality of Life (QoL) measurements in metastatic colorectal cancer (mCRC) [1].

Over the last decade, an increasing number of published studies reported QoL outcomes, and regulatory agencies have emphasized the relevance of patient-reported outcomes (PROs) in the balanced evaluation of benefits and risks associated with new treatments. Nevertheless, measuring QoL poses more challenges than traditional endpoints. The need for improving QoL analyses is crucial and several efforts are underway, such as the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative [2].

Schuurhuizen and colleagues lay the basis of their work on the question “does severe toxicity affect global QoL?”. Here arises the confusion: side effects description and QoL measurement give complementary, but very different information. QoL is a complex and multidimensional concept that refers to patients’ subjective perception of the effect of their disease and treatment on physical, psychological and social aspects of daily life [2].

The need for exploring the correlation between toxicity, survival and QoL in mCRC is not new. Back in 2006, De Kort and colleagues [3] already reported that out of 17 trials where toxicity was significantly higher in the experimental arm, QoL was negatively affected in only two. The authors judiciously concluded that toxicity and QoL are two different, independent variables that cannot be exchanged with or neutralized each other. In the context of palliative treatments, the goal is defined as prolonging life with preservation of QoL. Indeed, we doubt that metastatic setting, where treatment may cause both side effects and control of tumour-related symptoms, is the good one for exploring the correlation between toxicity and QoL. Even in other solid tumors, there are many examples of trials that compared treatments associated with definitely different toxicity, without demonstrating a significant difference in global QoL. For instance, in patients with advanced non-small-cell lung cancer, a platinum-based combination was associated with a relevant increase in toxicity compared to a platinum-free doublet, but without difference in global QoL, suggesting that the magnitude of symptom control can be at least as important as treatment toxicity in modifying global QoL [GEMVIN]. On the contrary, when a treatment is clearly better in terms of disease control, the difference in global QoL can be quite clear [TORCH].

Two additional points weaken the analysis presented by Schuurhuizen. Results are presented without distinguishing specific side effects. How would the authors argument towards the potential biases of trials with anti-EGFRs (whose dermatological toxicity is correlated to treatment efficacy[4]) or with oxaliplatin (causing cumulative neuropathy, which increases with duration of treatment, potentially implying higher toxicity in responding patients)?

Schuurhuizen and colleagues concluded that “the use of global QoL for comparing treatment arms in RCTs for patients with mCRC does not provide information of clinical relevance”. Based on the above reported

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observations, we found rather hasty and disputable this statement. It poses the risk of throwing the baby out with the bathwater.

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