Abstract 401TiP
Background
As reported in our previous study (Lin, JNCCN 2021) intravenous (i.v.) opioid titration with PCA provides earlier analgesia and higher patient satisfaction for pain control compared with conventional titration administrated by medical staff. After successful opioid titration, it is appropriate to maintain analgesia with regularly scheduled medication plus supplemental doses for breakthrough cancer pain (BTcP). Compared with regularly scheduled doses, continuous infusion using a PCA pump can confer a more stable and effective plasma concentration to control background pain. An on-demand bolus dose allows patients to voluntarily control BTcP. Therefore, continuous infusion plus an on-demand bolus dose may maximize the benefits of i.v. PCA (IPCA) for maintenance therapy. Our previous phase II study (Lin, JNCCN 2022) reported that IPCA was superior to oral administration as maintenance analgesia for severe cancer pain. IPCA with continuous infusion vs. without continuous infusion (bolus-only) may not be different in terms of pain control. IPCA without continuous infusion may consume less opioid. Therefore, in this study we aim to confirm these findings in a phase III study with a larger sample size.
Trial design
This is a multicenter open-label randomized controlled phase III trial. Eligibility criteria include: patients who are diagnosed with a malignant solid tumor by pathology or cytology and who have had persistent severe cancer-related pain (≥7 at rest on the 11-point Numeric Pain Rating Scale [NRS]); age 18 to 80 years; and ECOG PS≤3. Patients were randomly assigned in a 2:2:1 ratio to 1 of 3 arms: (A1) IPCA hydromorphone with bolus-only dose as needed (PRN); (A2) IPCA hydromorphone with continuous infusion for background pain plus bolus for BTcP; or (B) oral extended-release morphine around the clock for background pain and normal-release morphine PRN for BTcP. The primary endpoint was average NRS over days 1-3 (sum of previous 24-hour average pain scores for days 1–3 divided by 3). Enrollment is ongoing.
Clinical trial identification
NCT04785768.
Legal entity responsible for the study
The authors.
Funding
Guiding Project of Fujian Province (No.2023Y0057).
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
62P - Combination of chemotherapy with endocrinal therapy as upfront treatment of metastatic breast cancer in hormone receptor- positive, HER2 -negative disease: A phase II randomised clinical trial
Presenter: Mariam Saleh
Session: Poster Display
Resources:
Abstract
63P - Efficacy and safety of eribulin plus carboplatin combination for HER2-negative metastatic breast cancer
Presenter: Mengqian Ni
Session: Poster Display
Resources:
Abstract
64P - Unmet needs following metastatic breast cancer in a middle-income Asian country
Presenter: Nirmala Bhoo-Pathy
Session: Poster Display
Resources:
Abstract
66P - Utidelone-based therapy in metastatic solid tumors after failure of standard therapies: A prospective, multicenter, single-arm trial
Presenter: Jianjun Zhang
Session: Poster Display
Resources:
Abstract
67P - Efficacy and safety of trastuzumab biosimilar in HER2+ve metastatic breast cancer: A multicenter phase III study
Presenter: krishna Mohan
Session: Poster Display
Resources:
Abstract
68P - Neratinib in combination with fulvestrant and or palbociclib can overcome endocrine resistance in HER2-low/ ER+ breast cancer
Presenter: Maryam Arshad
Session: Poster Display
Resources:
Abstract
69P - A multicenter, retrospective, real-world study of inetetamab combined with pyrotinib and vinorelbine as treatment for HER2-positive metastatic breast cancer
Presenter: Nan Jin
Session: Poster Display
Resources:
Abstract
70P - Overall survival of eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: A phase II, single-arm clinical trial
Presenter: Kenichi Inoue
Session: Poster Display
Resources:
Abstract
71P - Efficacy and safety of disitamab vedotin after trastuzumab for HER2 -positive breast cancer: A real-world data of retrospective study
Presenter: Chao Li
Session: Poster Display
Resources:
Abstract
72P - Real-world data on the efficacy of T-DM1 biosimilar for the treatment of HER2-positive metastatic breast cancer patients: Outcomes from a single center retrospective study in India
Presenter: Kaushal Patel
Session: Poster Display
Resources:
Abstract