Journal of the National Comprehensive Cancer Network : JNCCN · 2026
Intravenous Patient-Controlled Analgesia Versus Oral Opioids to Maintain Analgesia for Severe Cancer Pain: A Randomized Phase III Trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Lin Rongbo, He Lang, Lu Mingqian, Zhuang Li, Lu Wei, Chen Yunfang, Liu Junli, Lin Shaowei, Zhao Shen, Su Liyu, Lv Xia, Zhong Jincai, Zhang Zhichun, Gong Liyan, Luo Yushuang, Ren Tao, Cao Lei, Liu Jiang, Zou Huichao, Shang Chunxiang, Cui Lichun, Chen Shaojun, Wu Shuqiang, Yang Shanlan, Zhang Xiaojuan, Chen Pengtao, Deng Hong, Zhao Yongsheng, Fu Feng, Zhu Bisheng, Wu Xiaodong, Bi Yiming, An Hanxiang, Sun Tao, Gao Hong, Huo Zhongchao, Liang Jun, Chen Ying, Huang Cheng
Аннотация
BACKGROUND: Effective management of severe cancer pain remains challenging. Our phase II study suggested that intravenous patient-controlled analgesia with hydromorphone (IPCA-HM), delivered either as bolus-only or continuous infusion, is superior to oral morphine for patients with severe cancer pain, with bolus-only potentially providing comparable efficacy to infusion while resulting in a lower rate of morphine equivalent dose (MED) escalation. This phase III study aimed to validate these findings.
PATIENTS AND METHODS: Patients with solid tumors and severe cancer pain (≥7 at rest on an 11-point Numeric Rating Scale [NRS]) who achieved successful 24-hour IPCA-HM dose-finding were randomized (2:2:1) to bolus-only IPCA-HM (bolus), continuous infusion IPCA-HM (infusion), or oral morphine (oral) for 6 days. The primary outcome was average NRS score over days 1-3 (3DNRS).
RESULTS: Of 1,349 patients from 48 oncology centers, 542 received bolus, 540 infusion, and 267 oral. Mean [SD] 3DNRS scores were 2.36 [0.89], 2.26 [0.87], and 2.94 [1.16], respectively. Both IPCA-HM arms were statistically significantly better than the oral arm in 3DNRS scores (bolus vs oral: mean difference, 0.58 [95% CI, 0.42 to 0.74]; infusion vs oral: 0.68 [95% CI, 0.52 to 0.84]; both P<.001). Bolus was noninferior to infusion (mean difference, 0.10 [95% CI, -0.01 to 0.20]; predefined noninferiority margin, 0.3; P<.001), achieving noninferiority in opioid-naïve, but not opioid-tolerant, patients. Median (IQR) total MEDs over days 1-6 were 400 (260-692) mg, 643 (380-1,117) mg, and 867 (540-1,313) mg for the bolus, infusion, and oral arms, respectively. Opioid-related adverse events (all grade 1 or 2) were comparable between the bolus (20.1%) and infusion (23.0%) arms, and both were lower than in the oral arm (33.7%).
CONCLUSIONS: For severe cancer pain, both IPCA-HM regimens provided statistically significantly better pain relief compared with oral morphine. The bolus regimen achieved noninferior efficacy compared with infusion while requiring lower opioid doses, providing a safe and effective analgesic option.
PATIENTS AND METHODS: Patients with solid tumors and severe cancer pain (≥7 at rest on an 11-point Numeric Rating Scale [NRS]) who achieved successful 24-hour IPCA-HM dose-finding were randomized (2:2:1) to bolus-only IPCA-HM (bolus), continuous infusion IPCA-HM (infusion), or oral morphine (oral) for 6 days. The primary outcome was average NRS score over days 1-3 (3DNRS).
RESULTS: Of 1,349 patients from 48 oncology centers, 542 received bolus, 540 infusion, and 267 oral. Mean [SD] 3DNRS scores were 2.36 [0.89], 2.26 [0.87], and 2.94 [1.16], respectively. Both IPCA-HM arms were statistically significantly better than the oral arm in 3DNRS scores (bolus vs oral: mean difference, 0.58 [95% CI, 0.42 to 0.74]; infusion vs oral: 0.68 [95% CI, 0.52 to 0.84]; both P<.001). Bolus was noninferior to infusion (mean difference, 0.10 [95% CI, -0.01 to 0.20]; predefined noninferiority margin, 0.3; P<.001), achieving noninferiority in opioid-naïve, but not opioid-tolerant, patients. Median (IQR) total MEDs over days 1-6 were 400 (260-692) mg, 643 (380-1,117) mg, and 867 (540-1,313) mg for the bolus, infusion, and oral arms, respectively. Opioid-related adverse events (all grade 1 or 2) were comparable between the bolus (20.1%) and infusion (23.0%) arms, and both were lower than in the oral arm (33.7%).
CONCLUSIONS: For severe cancer pain, both IPCA-HM regimens provided statistically significantly better pain relief compared with oral morphine. The bolus regimen achieved noninferior efficacy compared with infusion while requiring lower opioid doses, providing a safe and effective analgesic option.