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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

Date

08 Oct 2016

Session

Supportive and palliative care

Presenters

Vittorio Franciosi

Citation

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

Authors

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
More

Resources

Abstract 3298

Background

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.

Methods

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.

Results

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).

Conclusions

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

Funding

Regione Emilia Romagna

Disclosure

All authors have declared no conflicts of interest.

Variable SOC 139 pts EPC 142 pts
AGE (median) 68 68
PRIMARY SITE
 NSCLC 81 (59%) 82 (58%)
 Pancreatic 29 (20%) 31 (22%)
 Gastric 26 (19%) 18 (12%)
 Biliary 3 (2%) 11 (8%)
SEX
 Female 53 (38%) 45 (32%)
ECOG
 0 43 (31%) 48 (34%)
 1 88 (63%) 86 (61%)
 2 8 (6%) 8 (5%)
STAGE
 Metastatic 126 (91%) 130 (92%)
BASELINE FACT-G
 Evaluable 139 (100%) 142 (100%)
 FACT-G SCORE mean (SD) 71.3 (14.3) 72.6 (12.7)

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