290MO - Patient controlled analgesia (PCA) versus non-pca intravenous hydromorphone for severe cancer pain: Update from a multi-center, phase III randomized trial, HMORCT09-1

Background

HMORCT09-1 trial was submitted in ASCO 2020 as a poster. The result confirmed that PCA titration of IV hydromorphone provides quicker analgesic effect, higher patients satisfaction, and a similar tolerability as compared to non-PCA administration among patients with severe cancer pain. We present the change of cancer symptoms with Edmonton Symptom Assessment System (ESAS) after 24 hrs IV titration of PCA or non-PCA.

Methods

Patients with persistent severe cancer pain (NRS ≥7/10 at rest) were randomized into PCA or non-PCA arm. For both arms, the dosage was 10-20% of the total equianalgesic of the last 24h with opioid tolerance patients and, 0.5 mg among opioid naïve patients. The PCA mode was set at 15 minutes intervals without continuous dose. For non-PCA arm, the hydromorphone was administrated IV by clinicians/nurses at 15 minutes interval. Reassess pain at 15 minutes for all patients. The dose of hydromorphone was increased by 50%-100% if pain unchanged or increased; continuing the same dosage if NRS was 4-6, or continue at current dose as needed if NRS≤3. The primary endpoint was the time to successful titration (TST) – time from start to the time of pain controlled at NRS ≤ 3 in two consecutive evaluation with 15-min intervals. The ESAS scores were assessed at baseline and 24 hrs.

Results

Among 214 patients (PCA=106; non-PCA=108), median TST was 0.50h (PCA) and 0.79h (non-PCA) (HR 1.64, 95% CI 1.23, 2.17, P=0.001). At baseline, median [IQR] overall ESAS score was 36 [34, 38] in the PCA arm and 37 [34, 39] in the non-PCA arm (P=0.154). At hour 24, PCA arm was 25 [16, 29]) and non-PCA arm was 26 [19, 35], P=0.096. After 24h titration, overall ESAS scores significantly decreased in both arms. At baseline, pain items of ESAS were not statistically significant different between PCA and non-PCA arm (median [IQR] was 8 [7, 8] vs 8 [7, 8], p=0.419). At hour 24, there is a trend toward significant decline in pain scores for the PCA vs non-PCA arm (median [IQR] 2 [2, 2] vs 2 [2, 5], p=0.060).

Conclusions

IV hydromorphone titration can improve symptoms of patients with severe cancer pain regardless of PCA or non-PCA administration.

Clinical trial identification

NCT03375515.

Editorial acknowledgement

Legal entity responsible for the study

Rongbo Lin.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.