Breakthrough pain management using fentanyl buccal tablet (FBT) in combination with around-the-clock (ATC) opioids based on the efficacy and safety of FBT, and its relationship with ATC opioids: results from an open-label, multi-center study in Japanese cancer patients with detailed evaluation.
OBJECTIVE
Rapid analgesic onset opioids, particularly fentanyl buccal tablet, is preferable for managing breakthrough pain. The efficacy and safety of fentanyl buccal tablet and its association with around-the-clock opioids needs to be explored with an option of dose adjustments, more closely reflecting administration in clinical practice. The aim of the study was to assess the safety and efficacy of fentanyl buccal tablet in breakthrough pain management in combination with around-the-clock opioids with the dose adjustment option, and explore the dose adjustment's influence on breakthrough pain management using detailed evaluation.


METHODS
The 12-week open-label, multi-center study was conducted throughout Japan. Cancer patients aged 20 years or older, experiencing persistent pain controlled with around-the-clock opioids and breakthrough pain with supplemental medications were enrolled. Fentanyl buccal tablet and around-the-clock opioid doses could be adjusted under protocol-specified conditions. Efficacy variables were assessed at each fentanyl buccal tablet administration. Safety was assessed mainly by adverse events.


RESULTS
All efficacy variables showed sustained analgesic effect. Nearly half the patients stayed on the same dose; most fentanyl buccal tablet administrations did not require additional supplemental medications. Dose increase of fentanyl buccal tablet and around-the-clock opioids seemed to improve breakthrough pain intensity and frequency, respectively. Fentanyl buccal tablet and around-the-clock opioid doses were not strongly associated. Treatment-related adverse events were all common with opioid treatment and did not increase over time.


CONCLUSIONS
Fentanyl buccal tablet can stably and safely manage breakthrough pain in cancer patients with independent dose adjustment based on detailed evaluation of each patient's condition. Breakthrough pain management using fentanyl buccal tablet with around-the-clock opioids at optimal doses may be an important factor in palliative care for cancer patients with breakthrough pain.
Department of Palliative Medicine, KKR Sapporo Medical Center, Sapporo chizuko-takigawa@kkr-smc.com.
Chizuko
C
Takigawa
International University of Health and Welfare Hospital, Nasushiobara.
Fumio
F
Goto
Department of Medical Oncology, Tohoku Rosai Hospital, Sendai.
Shigeru
S
Tanda
Department of Palliative Medicine, Tsukuba Medical Center Hospital, Tsukuba.
Yasuo
Y
Shima
Department of Palliative Care, Saitama Cancer Center, Kitaadachi-gun.
Kinomi
K
Yomiya
Department of Palliative Medicine, Aomori Prefectural Central Hospital, Aomori.
Motohiro
M
Matoba
Division of Palliative Medicine, Shizuoka Cancer Center, Sunto-gun.
Isamu
I
Adachi
Department of Palliative and Supportive Care, Chukyo Hospital, Nagoya.
Tetsusuke
T
Yoshimoto
Department of Internal Medicine and Medical Oncology, Teikyo University School of Medicine, Itabashi-ku, Japan.
Kenji
K
Eguchi
D000278:Administration, Buccal; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D059390:Breakthrough Pain / Q000188:drug therapy* / Q000209:etiology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D013607:Tablets; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D013607:Tablets; D005283:Fentanyl
breakthrough pain; cancer pain; fentanyl buccal tablet; pain management; rapid-onset opioids