Abstract
The safety and efficacy of diclofenac sodium suppository as adjunctive opioids in the treatment of cancer pain: A prospective, multi-center, real-world study.
Author
person
Jianping He
Division of Abdominal Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, China
info_outline
Jianping He, Yan Zhang, Yaogui Wu, Huarong Zhao, Jinqi Yang, Zhenhua Zhang, Hongmei Qiao, Yufeng Cao, Zhenhua Yan, Yang Wang, Guoyi Ji, Shudong Zhan, Yarui Zhang, Yu Sun, Peng Meng, Xiuliang Zhang, Xiang Wang, Zhifeng Guo, Shoulei Ren, Wentian Zhang
Full text
Authors
person
Jianping He
Division of Abdominal Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, China
info_outline
Jianping He, Yan Zhang, Yaogui Wu, Huarong Zhao, Jinqi Yang, Zhenhua Zhang, Hongmei Qiao, Yufeng Cao, Zhenhua Yan, Yang Wang, Guoyi Ji, Shudong Zhan, Yarui Zhang, Yu Sun, Peng Meng, Xiuliang Zhang, Xiang Wang, Zhifeng Guo, Shoulei Ren, Wentian Zhang
Organizations
Division of Abdominal Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, China, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing, China, The Renmin Hospital of Wuhan University, Wuhan, China, People's Hospital of Hejiang County, Luzhou, China, Yanggu People's Hospital, Liaocheng, China, People's Hospital of NingGuo, Anhui, Ningguo, China, Baoji High-Tech Hospital, Baoji, China, Qingdao Hiser Hospital Affiliated of Qingdao University, Qingdao, China, Ruzhou Hospital of Traditional Chinese Medicine, Ruzhou, China, Tieli Medical Service Community Central Hospital, Tieli, China, The First People's Hospital of SiPing, Siping, China, Gaoyou Hospital of Traditional Chinese Medicine, Yangzhou, China, Tianjin Union Medical Center, Tianjin, China, Anqiu City People's Hospital, Anqiu, China, Yantai Hospital of Traditional Chinese Medicine, Yantai, China, People's Hospital of Pingyi County, Linyi, China, Xiangxiang People's Hospital of Hunan Province, Xaingxiang, China, Chifeng City Hospital, Chifeng, China, Sunshine Union Hospital, Weifang, China, Lingshou County Hospital of Integrated Traditional Chinese and Western Medicine, Shi Jia Zhuang, China
Abstract Disclosures
Research Funding
No funding sources reported
Background:
Cancer pain is one of the most common and unbearable symptoms for cancer patients (pts), seriously affecting their quality of life. Diclofenac sodium is a potent third-generation non-steroidal anti-inflammatory drug known for its significant analgesic, anti-inflammatory, and antipyretic effects. It is commonly used to treat different types of cancer pain. The objective of this study was to assess the safety and effectiveness of diclofenac sodium suppository when used alongside opioids for managing cancer pain in pts with solid tumors.
Methods:
In this prospective, multi-center, real-world study, we enrolled pts diagnosed with malignancy, Eastern Cooperative Oncology Group (ECOG) performance status of 0-3, numeric rating scale (NRS) score ≥ 3, and sustained cancer pain, who required additional analgesic medication were enrolled. Diclofenac sodium suppository is an anal administration suppository, prescribed once a day at a dosage of 50 mg. This study was conducted across 20 centers to observe the clinical characteristics of pain relief in pts with cancer pain . The primary endpoint of the study was to assess the safety of the medication. The secondary endpoints included evaluating the incidence of breakthrough pain (BP), NRS score, and Brief Pain Inventory (BPI) score on the second and sixth days of medication.
Results:
Of the 506 pts that were screened, 437 pts met the inclusion criteria. This included 10 pts who did not receive planned treatment and 2 pts who did not undergo post-baseline efficacy evaluation. Among the 425 pts in the full analysis set (FAS), 261 were man, and 169 (39.8%) had baseline BP. The mean age was 63.0±11.3 years old. Among 425 response-evaluable pts, compared to the baseline, the incidence of BP was reduced on the second (20.0% vs 39.8%), and sixth days (14.8% vs 39.8%) of medication and the difference was statistically significant ( P < 0.001, P < 0.001). For pts with baseline BP, 56.2% and 66.9% pts achieved BP relief on the second and sixth days of medication, respectively. From the baseline evaluation, the mean NRS scores for the three visits (baseline, second day, sixth day) were 5.28 ± 1.71, 3.73 ± 1.71, and 2.91 ± 1.88, respectively. The mean pain intensity at each visit was decreased compared to the baseline, and the difference was statistically significant ( P < 0.001, P < 0.001). 427 pts were included for safety analysis and 5 pts experienced any grade treatment emergent adverse events (TEAEs). All TEAEs were grade 1-2. TEAE leading to treatment discontinuation was occurred in one pt.
Conclusions:
This study demonstrated that diclofenac sodium suppository was an effective treatment option for managing breakthrough pain in patients with persistent cancer pain who required additional analgesic therapy. Moreover, diclofenac sodium suppository was found to be well tolerated when administered anally.
18 organizations
1 drug
2 targets
Target
COX-2Target
COX-1Organization
The Renmin Hospital of Wuhan UniversityOrganization
People's Hospital of Hejiang CountyOrganization
Yanggu People's HospitalOrganization
People's Hospital of NingGuoOrganization
Baoji High-Tech HospitalOrganization
Ruzhou Hospital of Traditional Chinese MedicineOrganization
Tieli Medical Service Community Central HospitalOrganization
The First People's Hospital of SiPingOrganization
Gaoyou Hospital of Traditional Chinese MedicineOrganization
Anqiu City People's HospitalOrganization
Yantai Hospital of Traditional Chinese MedicineOrganization
People's Hospital of Pingyi CountyOrganization
Xiangxiang People's Hospital of Hunan ProvinceOrganization
Chifeng City HospitalOrganization
Sunshine Union Hospital