Saif, M.W., Syrigos, K., Kaley, K., & Isufi, I. (2010). Role of pregabalin in treatment of oxaliplatin-induced sensory neuropathy. Anticancer Research, 30, 2927–2933.

The study goal was to assess the efficacy of pregabalin in the treatment of oxaliplatin-induced neurotoxicity.

Patients receiving oxaliplatin with grade 2 and 3 sensory neuropathy were treated with pregabalin up to a target dose of 150 mg orally three times a day. Neurologic symptoms were serially evaluated before treatment initiation with pregabalin and every two weeks thereafter, recording intensity and duration of the symptom. Interference with activities of daily living (ADLs) were evaluated. Patients started pregabalin at 50 mg three times per day. If tolerated, the dose was increased by 50 mg increments until symptoms improved to a max of 150 mg three times per day.

• The sample consisted of 23 patients (14 men, 9 women) with gastrointestinal cancer.
• Age range of the participants was 50–71 years.
• Patients had grade 2 or 3 oxaliplatin-induced sensory neuropathy based on National Cancer Institute common toxicity criteria.
• Patients were excluded if they had preexisting neuropathy from diabetes, alcoholism, CNS disease, or neurotoxic chemotherapy.

The study was conducted at an outpatient university setting in the United States.

The study had a prospective trial design.

National Cancer Institute common toxicity criteria

Five of the 23 participants were escalated to 150 mg of pregabalin with benefit and tolerance. Seven of the 23 escalated to 100 mg with benefit and tolerance. Four stopped due to no benefit, five could not be increased above 50 mg three times daily, two continued at this dose, and three stopped because of CNS side effects. Onset of benefit observed in 2–6 weeks. Three patients' neuropathy improved from grade 3 to grade 2, two patients improved from grade 3 to grade 1, and six patients improved from grade 2 to grade 1. No patients remained at grade 3 and five remained stable at grade 2. The five most common toxicities of pregabalin were dizziness, headache, somnolence, dry mouth, ataxia, and tremor.

Pregabalin at a dose of 100 mg–150 mg three times daily appears to decrease sensory neuropathy in some patients receiving oxaliplatin. Pregabalin was associated with side effects that limited the ability to tolerate the medication or dose escalation.

• The study had a small sample size (less than 30).
• The study also lacked a comparison or control group.
• The NCI toxicity criteria may not be valid to measure neuropathy.
• Results may be difficult to generalize to other groups of patients with cancer.

Pregabalin may be another alternative in treating chemotherapy-induced neuropathy for some patients. Findings suggest that pregabalin is not effective for everyone. In addition, the drug is expensive and is a controlled substance, which can limit the use. Pregabalin has side effects that need to be considered, including CNS side effects that required drug discontinuation. Patients receiving this agent need to be monitored appropriately for both effectiveness and potential side effects.