Pulmonary metastasectomy in colorectal cancer: health utility scores by EQ-5D-3L in a randomized controlled trial show no benefit from lung metastasectomy.

AIM: The aim was to assess the health utility of lung metastasectomy in the treatment of patients with colorectal cancer (CRC) using the EQ-5D-3L questionnaire. METHODS: Multidisciplinary CRC teams at 14 sites recruited patients to a two-arm randomized controlled trial-Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC). Remote randomization was used, stratified by site and with minimization for seven known confounders. Participants completed the EQ-5D-3L questionnaire together with other patient reported outcome measures at randomization and then again at 3, 6, 12 and 24 months. These were returned by post to the coordinating centre. RESULTS: Between December 2010 and December 2016, 93 participants were randomized, 91 of whom returned questionnaires. Survival and patient reported quality of life have been published previously, revealing no significant differences between the trial arms. Described here are patient reported data from the five dimensions of the EQ-5D-3L and the visual analogue scale (VAS) health state. No significant difference was seen at any time point. The estimated difference between control and metastasectomy patients was -0.23 (95% CI -0.113, 0.066) for the composite 0 to 1 index scale based on the descriptive system and 0.123 (95% CI -7.24, 7.49) for the 0 to 100 VAS scale. CONCLUSIONS: Following lung metastasectomy for CRC, no benefit was demonstrated for health utility, which alongside a lack of a survival or quality of life benefit calls into question the widespread use of the procedure

Pulmonary metastasectomy in colorectal cancer: health utility scores by EQ-5D-3L in a randomized controlled trial show no benefit from lung metastasectomy.

Aims: To assess the Health Utility of lung metastasectomy in the treatment of patients with colorectal cancer using the EQ-5D-3L questionnaire. Methods: Multidisciplinary colorectal cancer teams at 14 sites recruited patients to a 2-arm randomised controlled trial—Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC). Remote randomisation was used, stratified by site and with minimisation for seven known confounders. Participants completed the EQ-5D-3L questionnaire together with other patient reported outcome measures at randomisation and then again at 3, 6, 12 and 24 months. These were returned by post to the co-ordinating centre. Results: Between December 2010 and December 2016, 93 participants were randomised 91 of whom returned questionnaires. Survival and patient reported Quality of Life has been published previously, revealing no significant differences between the trial arms. Described here are patient reported data from the five dimensions of the EQ-5D-3L and the visual analogue scale (VAS) Health State. No significant difference was seen at any time point. The estimated difference between control and metastasectomy patients was -0.23 (95%CI-0.113,0.066) for the composite 0 to 1 index scale based on the descriptive system and 0.123(95%CI-7.24,7.49) for the 0 to 100 VAS scale. Conclusions: Following lung metastasectomy for colorectal cancer, no benefit was demonstrated for Health Utility, which alongside a lack of a survival or QoL benefit, calls into question the widespread use of the procedure

Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) randomised controlled trial: a systematic review of published responses

OBJECTIVES: The objective of this review was to assess the nature and tone of the published responses to the Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) randomized controlled trial. METHODS: Published articles that cited the PulMiCC trial were identified from Clarivate Web of Science (©. Duplicates and self-citations were excluded and relevant text extracted. Four independent researchers rated the extracts independently using agreed scales for the representativeness of trial data and the textual tone. The ratings were aggregated and summarized. Two PulMiCC authors carried out a thematic analysis of the extracts. RESULTS: Sixty-four citations were identified and relevant text was extracted and examined. The consensus rating for data inclusion was a median of 0.25 out of 6 (range 0 to 5.25, IQR 0-1.5) and for textual tone the median rating was 1.87 out of 6 (range 0 to 5.75, IQR 1-3.5). The majority of citations did not provide adequate representation of the PulMiCC data and the overall the textual tone was dismissive. Although some were supportive, many discounted the findings because the trial closed early and was underpowered to show non-inferiority. Two misinterpreted the authors' conclusions but there was acceptance that five-year survival was much higher than widely assumed. CONCLUSIONS: Published comments reveal a widespread reluctance to consider seriously the results of a carefully conducted randomized trial. This may be because the results challenge accepted practice because of 'motivated reasoning'. But there is a widespread misunderstanding of the fact that though PulMiCC with 93 patients was underpowered to test non-inferiority, it still provides reliable evidence to undermine the widespread belief in a major survival benefit from metastasectomy