RESUMO
The European Study Group for Pancreatic Cancer (ESPAC-1) study is the largest study of adjuvant treatment for pancreatic ductal adenocarcinoma to date and confirmed a survival advantage for adjuvant chemotherapy but not for chemoradiation. The importance of parallel evaluation of survival and quality of life (QoL) has been recognized as fundamental and the aim was to assess QoL and quality adjusted survival. A longitudinal QoL study on a subset of ESPAC-1 patients who prospectively completed the EORTC QLQ C-30 questionnaire during treatment and follow-up. An integrated quality-survival product method was used to adjust any treatment effect on survival by a function of measured QoL, calculated over a restricted 24-month-period (QALM-24). Three hundred and sixteen patients completed 1,201 questionnaires. There were no differences between treatment groups in dimension scores at baseline (randomization). For the chemotherapy group, the mean Quality Adjusted Life Months over 24 months (QALM-24) was 9.6 (95% CI: 8.7, 11.2) months compared with the mean QALM-24 of 8.6 (95% CI: 7.6, 10.5) months for the no chemotherapy group. For the chemoradiation group, the mean QALM-24 was 7.1 (95% CI: 6.0, 9.0) months compared with the mean QALM-24 of 8.1 (95% CI: 7.0, 10.0) months for the no chemoradiation group. The previously reported survival advantage supporting the use of adjuvant chemotherapy is maintained when adjusted using quality adjusted survival methodology. Chemotherapy provided on average an additional 1.0 quality-adjusted life months within a restricted 2-year time period from the time of resection.