Early palliative care (EPC) seems to ameliorate Quality of Life (QoL) of advanced cancer patients but the optimal timing for activating EPC has to be defined.
Four ESMO Designated Centres of Integrated Oncology & Palliative Care (ESMO-DC) randomized pts to receive Standard Oncologic Care (SOC) alone (control arm - C) or integrated with EPC (sperimental arm - S). Eligible pts had diagnosis, within the previous eight weeks, of advanced NSCLC, gastric, pancreatic and biliary cancers; first line chemotherapy; ECOG PS 0-2. QoL was assessed at baseline (T0) and at 12 weeks (T1) with the FACT-G scale. Primary endpoint was the change in the QoL scores from T0 and T1.
Between December 2014 and March 2016 we randomized 281 pts. No differences were found between the characteristics of the two groups. The FACT-G questionnaires evaluable at T1 were 103 (74%) and 111 (78%), respectively, for C and S arm. The mean FACT-G score at T1 were 67.9 (SD 15.4) and 68.5 (SD 15.3) respectively, for C and S arm (T-test p= 0.77). At 12 weeks (T1) the mean difference in change score for FACT-G between C (3.5 points; SD 14.5) and S (4.1 points; SD 13.9) arm was not statistically significant (T-test P= 0.75).
In this trial, EPC did not improve QoL at 12 weeks, measured with FACT-G, in NSCLC, gastric, pancreatic and biliary cancer pts. The study can not rule out the value of EPC because the profile of ESMO-DC and the eterogeneity of the tumor sites could have reduced the effect of the EPC. Future studies shoud be focused on single tumours, using instruments for measuring QoL-specific cancer. Further analyses are in progress to study the phenomenological complexity and identify clusters of patients in whom the EPC could be effective. (Funded by “Programma di Ricerca Regione Emilia Romagna-Università 2013 – Area 2”, Project code E35E13000030002).
Clinical trial identification
Funded by “Programma di Ricerca Regione Emilia Romagna-Università 2013 – Area 2”, Project code E35E13000030002
Legal entity responsible for the study
Regione Emilia Romagna
Regione Emilia Romagna
All authors have declared no conflicts of interest.
|Variable||SOC 139 pts||EPC 142 pts|
|NSCLC||81 (59%)||82 (58%)|
|Pancreatic||29 (20%)||31 (22%)|
|Gastric||26 (19%)||18 (12%)|
|Biliary||3 (2%)||11 (8%)|
|Female||53 (38%)||45 (32%)|
|0||43 (31%)||48 (34%)|
|1||88 (63%)||86 (61%)|
|2||8 (6%)||8 (5%)|
|Metastatic||126 (91%)||130 (92%)|
|Evaluable||139 (100%)||142 (100%)|
|FACT-G SCORE mean (SD)||71.3 (14.3)||72.6 (12.7)|