Cancer Research and Treatment

Original Article

A Prospective, Single-Cohort, Open, Multi-center, Observational Study of Sublingual Fentanyl for Breakthrough Cancer Pain: Effectiveness, Safety, and Tolerability in Korean Cancer Patients: Youn Seon Choi, Su-Jin Koh, Woo Kyun Bae, Se Hyung Kim, Seong Hoon Shin, So Yeon Oh, Sang Byung Bae, Yaewon Yang, Eun-Kee Song, Yoon Young Cho, Pyung Bok Lee, Ho-Suk Oh, MinYoung Lee, Jin Seok Ahn; Received June 13, 2024 Accepted December 24, 2024 Published online December 26, 2024; DOI: https://doi.org/10.4143/crt.2024.557 [Epub ahead of print]

Abstract PDF PubReader ePub: Purpose
Fentanyl, a highly lipophilic opioid, was developed as a sublingual fentanyl tablet (SFT) for the management of breakthrough cancer pain (BTcP), and its efficacy and safety were confirmed in a randomized, controlled study. We investigated the effectiveness and safety of SFT administered to alleviate BTcP in a real-world setting.
Materials and Methods
In this prospective, open, single-cohort study, conducted in 13 referral hospitals in South Korea, opioid-tolerant cancer patients receiving around-the-clock opioids for persistent cancer pain were enrolled if the individual had BTcP ≥ 1 episode/day during the preceding week. The primary outcome was the SFT titration success rate.
Results
Among 113 patients evaluated for effectiveness, 103 patients (91.2%) had a successful titration of SFT, with an effective dose range between 100 μg and 400 μg. The most frequent dose was 100 μg, administered to 65.0%, 72.1%, and 81.8% of the patients at week 1, 4, and 12, respectively. The proportion of patients achieving the personalized pain goal assessed in the first week was 75.2%. The mean change in pain intensity measured with a numeric rating scale at 30 and 60 minutes after taking SFT was –2.57 and –3.62, respectively (p < 0.001 for both). The incidence rate of adverse events related to SFT among 133 patients included for safety evaluation was 9.0% (12/133), which included vomiting (3.0%), nausea (2.3%), and headache (1.5%).
Conclusion
In a real-world setting, SFT provides rapid and effective analgesia in BTcP, even at the lowest dose (100 μg), and the safety profile was acceptable.

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Special Article

Management of Physical Symptoms in Patients with Advanced Cancer during the Last Weeks and Days of Life: Ahsan Azhar, David Hui; Cancer Res Treat. 2022;54(3):661-670. Published online June 30, 2022; DOI: https://doi.org/10.4143/crt.2022.143

Abstract PDF PubReader ePub

Patients with advanced cancer are faced with many devastating symptoms in the last weeks and days of life, such as pain, delirium, dyspnea, bronchial hypersecretions (death rattle) and intractable seizures. Symptom management in the last weeks of life can be particularly challenging because of the high prevalence of delirium complicating symptom assessment, high symptom expression secondary to psychosocial and spiritual factors, limited life-expectancy requiring special considerations for prognosis-based decision-making, and distressed caregivers. There is a paucity of research involving patients in the last weeks of life, contributing to substantial variations in clinical practice. In this narrative review, we shall review the existing literature and provide a practical approach to in-patient management of several of the most distressing physical symptoms in the last weeks to days of life.

Citations

Citations to this article as recorded by

Nursing Practice for Patients with Cancer Pain with Predicted Prognosis of Months or Weeks: A Multicenter Cross-Sectional Study in Japan
Miharu Morikawa, Masamitsu Kobayashi, Kohei Kajiwara, Kimiko Nakano, Yusuke Kanno, Yoshinobu Matsuda, Jun Kako
Palliative Medicine Reports.2025; 6(1): 129. CrossRef
Comparing the use of aggressive end-of life care among frail and non-frail patients with cancer using a claims-based frailty index
Rishi Sachdev, Galen Shearn-Nance, Long Vu, Wyatt P. Bensken, Sara L. Douglas, Siran M. Koroukian, Johnie Rose
Journal of Geriatric Oncology.2024; 15(2): 101706. CrossRef

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Original Article

Randomized Controlled Open Labelled, Phase III Trials, Comparing the Efficacy between Fentas(R) and Durogesic(R) Patches in Controlling Cancer Pain: Multicenter Trial: Myung Ju Ahn, Tae June Jung, Jung Hye Choi, Mi Ran Oh, Hwi Joong Yoon, Jun Suk Kim, Chul Won Choi, Kyung Wook Hur, Dae Sik Hong, Hee Sook Park, Sung Kyu Park, Jung Ae Lee, Young Suk Park, Hyonggi Jung; Cancer Res Treat. 2002;34(3):165-169. Published online June 30, 2002; DOI: https://doi.org/10.4143/crt.2002.34.3.165

Abstract PDF: PURPOSE
Fentanyl is a synthetic opioid and transdermal therapeutic system (TTS), designed to release the drug into the skin at a constant rate, ranging from 25 to 100 microgram/hr, for up to 3 days. For the control of chronic cancer pain, Durogesic(R) patches (Janssen Co., USA) are now widely used. Recently, the Hana Company in Korea developed a new fentanyl patch, Fentas(R) using a different method. To compare the efficacy, and safety, of the fentanyl patch manufactured in Korea (Hana Pharm. Co. Ltd), with the Durogesic(R) patch, in controlling cancer pain, we performed randomized controlled, open labelled, phase III studies. MATERIALS AND METGODS: From January 2000 to April 2001, 85 patients were enrolled, 69 of whom (42 in D arm and 43 in F arm) completed the study, and were therefore assessable for per protocol (PP) analyses.
RESULTS
There were no significant differences between the two groups in baseline characteristics, with the exception of age. The primary end point was to show the therapeutic equivalence of the two patches. In these clinical trials, the confidence interval of difference, between the test drug (Fentas(R)) and the control (Durogesic(R)), was 0.027~ +0.124 by intention to treat (ITT) analysis. Even if the upper confidence interval exceeds + 0.1, the test drug is not superior to the control drug, because the confidence interval includes 0. However, by PP analysis, the confidence interval lies exactly within +/- 0.1. Therefore, we could conclude the two patches are therapeutically equivalent. The second endpoint was the difference of visual analog scale (VAS) between the baseline and the average of three measurements after treatment. The difference in VAS was 50.44+/-10.28 for the F arm, and 44.69+/-11.00 for the D arm. By PP analysis the test drug was superior to the control (p=0.028). The rescue morphine amount was 81.21+/-124.76 for F arm and 66.19+/-115.9 for D arm, and there was no significant difference between the two groups (p=0.6063). The most common adverse effects of both fentanyl patches were nausea or vomiting (55.3%), somnolence (50.0%), constipation (39.5%), gastrointestinal discomfort (57.9%) and headaches (25.0%). In general there was no significant difference in side effects or laboratory data between the two groups.
CONCLUSION
These findings suggest that Fentas(R) patches, administered every 3 days, are effective, safe, and well tolerated for the treatment of most patients with cancer pain and is as effective or better than Durogesic(R).

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