Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Supportive and palliative care

3298 - Evaluation of effects of early palliative care on quality of life of advanced cancer patients. A multicenter controlled randomised clinical trial


08 Oct 2016


Supportive and palliative care


Vittorio Franciosi


Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435


V. Franciosi1, G. Caruso1, G. Maglietta2, C. Degli Esposti3, L. Cavanna4, R. Bertè5, G. Bacchini1, L. Bocchi1, E. Piva6, M. Monfredo4, V. Scafuri6, P. Di Cesare4, B. Melotti3, M. Sequino2, A. Rimanti1, C. Binovi1, F. Ghisoni7, C. Caminiti2

Author affiliations

  • 1 Medical Oncology Unit, University Hospital, 43123 - Parma/IT
  • 2 Research And Innovation Unit, University Hospital, Parma/IT
  • 3 Medical Oncology Unit, University Hospital, Bologna/IT
  • 4 Medical Oncology Unit, General Hospital, Piacenza/IT
  • 5 Palliative Care Unit, General Hospital, Piacenza/IT
  • 6 Medical Oncology Unit, University Hospital, Ferrara/IT
  • 7 Palliative Care Unit, General Hospital, Fidenza/IT


Abstract 3298


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
AGE (median) 68 68
 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)

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings