Tapentadol in the management of cancer pain: current evidence and future perspectives

Figures & data

Table 1 Key elements from randomized controlled clinical trials on tapentadol PR in the treatment of cancer pain

Study	Design	Patients randomized	Tapentadol PR median modal daily dosea	Duration study treatment	Efficacy on pain (primary endpoint)	Safety
Imanaka et al^Citation22	Randomized, double-blind, active-controlled (oxycodone CR), multicenter phase III study. Rescue medication: morphine IR 5 mg as needed	Asia: 343 opioid-naive patients with moderate-to-severe, chronic malignant tumor-related pain	TDD: 50.0 mg Allowed dose range: 25–200 mg twice daily	Median: 28 days	Mean difference in the change in pain intensity (baseline vs 3 last days of treatment, tapendatol PR vs oxycodone CR): −0.06 (95% CI: −0.506−0.383)b	Patients with at least one TEAE: Tapentadol PR 87.5% vs oxycodone CR 90.1% Patients with at least one gastrointestinal TEAE: Tapentadol PR 55.4% vs oxycodone CR 67.4%
Kress et al^Citation23	Randomized withdrawal, parallel group, active (morphine CR) and placebo-controlled, double-blind, multicenter phase III study. Rescue medication: Morphine IR 10 mg as needed	Europe: 496 opioid-pretreated or opioid-naive patients with moderate-to-severe, chronic malignant tumor-related pain. 2/3 with neuropathic pain component	TDD: 300 mg Allowed dose range: 100–250 mg twice daily	Median: 14 days of titration period, followed by re-randomization for another 28-day maintenance period	Responder rate at the end of titration: tapentadol PR 76.0%, morphine CR 83.0% (P=0.001 for non-inferiority) Adjusted responder rate during maintenance (primary endpoint): 64.3% with tapentadol, 47.1% with placebo (P=0.02)	During titration: incidence of TEAEs: 50.0% with tapentadol, 63.9% with morphine. Incidence of nausea, vomiting, and dry mouth significantly lower with tapentadol PR than with morphine CR (P<0.0039) During maintenance: incidences of TEAEs were 56.3% with placebo, 62.3% (66/106) with tapentadol PR, and 62.4% (68/109) with morphine CR

Note:

a Median modal daily dose = most frequently used daily dose.

b Non-inferiority.

Abbreviations: CR, controlled release; IR, immediate release; PR, prolonged release; TDD, total daily dose; TEAE, treatment-emergent adverse events.

ImanakaKTominagaYEtropolskiMEfficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related painCurr Med Res Opin201329101399140923937387

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KressHGKochEDKosturskiHTapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related painPain Physician201417432934325054392

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