Abstract 1452P
Background
Early phase clinical trials usually include patients (pts) with advanced disease who have failed to standard therapies. Early palliative care (EPC) for these pts has shown to improve quality of life and even survival. Pallia 10 score (from 1 to 10) is a tool developed by the French Palliative Care Society to identify the best time to introduce palliative care.
Methods
We assessed the Pallia 10 score and other prognostic factors (age, ECOG, Royal Marsden Hospital (RMH) score, LDH and albumin levels, number (nb) of prior systemic treatments and metastatic sites) in pts enrolled in phase I trials (P1CT) prospectively during 2 periods of time (cohort 1 (C1) and 2 (C2)). A double-blind assessment of the Pallia 10 score was done during 15 days by a member of the palliative care unit in C2. A Pallia 10 > 3 motivated a dedicated palliative care consultation.
Results
From 01/07/2018 to 01/11/2018 (C1) and from 01/12/2020 to 16/04/2021 (C2), a total of 85 pts were assessed in C1 and 302 in C2. Gastro-intestinal (23%), hematological (14%) and lung (11%) cancer were the most frequent tumor types. Pallia 10 score and prognostic factors were similar between both cohorts (Table). On C1 and C2, 12% and 4% of pts had a dedicated palliative consultation with median time of referral of 18 and 2 months (m) after the P1CT onset (p=0.003), with a median Pallia 10 score of 1.5 and 2 (p=0.65), respectively. Overall, 75% and 76% of pts in C1 and C2 were still alive beyond 3m after discontinuation of the P1CT (p=0.91), followed by at least one subsequent treatment in 56% and 54% of pts. In C2, assessment of Pallia 10 score was significantly different between palliative care physician (median 5, range 3-8), phase I physician (median 1, range 1 -6) and phase I nurse (median 3, range 1-8) (p<0.001). Table: 1452P
| Cohort 1 (C1), median (range) | Cohort 2 (C2), median (range) | p | |
| Age | 61 (28-83) | 60 (19-93) | 0.36 |
| Prior lines of therapy | 3 (1-9) | 3 (0-20) | 0.14 |
| Pallia 10 | 1 (1-5) | 1 (1-8) | 0.06 |
| ECOG | 1 (0-2) | 1 (0-2) | 0.85 |
| RMH score | 1 (0-3) | 1 (0-3) | 0.53 |
| LDH level | 197 (106-1318) | 224 (102-2644) | 0.37 |
| Albumin level | 40 (30-48) | 44 (29-52) | <0.001 |
| Nb of metastatic sites | 1 (0-4) | 2 (0-5) | <0.001 |
Conclusions
Only a few patients included in P1CT were referred to the palliative care unit. Median Pallia 10 score was low when assessed by the phase I physician which suggests the need for a better tool to implement EPC in clinical practice and trials.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Gustave Roussy Cancer Center.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.