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Gabapentin no better than standard therapy for prevention of delayed CINV
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The anticonvulsant and analgesic agent gabapentin did not significantly improve delayed chemotherapy-induced nausea and vomiting compared with standard therapy, according to results of a phase 2, double blind, placebo-controlled study.
More than 50% of patients who undergo moderately or highly emetogenic chemotherapy experience delayed nausea, and anywhere from one-third to one-half of patients experience delayed vomiting. Standard treatment consists of corticosteroids and 5HT3 receptor antagonists, but more effective treatments are needed, according to researchers.
Debra L. Barton
Debra L. Barton, RN, PhD, associate professor of oncology at Mayo Clinic in Rochester, Minn., and colleagues assessed gabapentin (Neurontin, Pfizer) vs. standard therapy for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) in 437 patients who underwent highly emetogenic chemotherapy.
All patients received prophylactic treatment with 20 mg dexamethasone and a 5HT3 receptor antagonist on the day of chemotherapy. Researchers randomly assigned 207 patients to receive subsequent dexamethasone plus 300 mg twice-daily gabapentin after chemotherapy. The other 206 patients received post-chemotherapy dexamethasone plus placebo.
Complete response — defined as no vomiting and no rescue medications on days 2 through 6 of each chemotherapy cycle — served as the primary endpoint.
Secondary endpoints included adverse effects and tolerability, as well as outcomes measured by the Functional Living Index-Emesis, a self-reported scale that evaluates the impact vomiting and nausea have on patients’ daily functions. Patients also recorded daily rankings of treatment satisfaction and distress by answering a series of questions linked to a 10-point scale.
Results showed 47% of patients assigned gabapentin and 41% assigned placebo achieved complete response (P=.23).
Patient-reported satisfaction with regard to CINV control exceeded 8 points on the 10-point scale in both study arms, and researchers reported no significant differences in side effects between cohorts.
Nausea-associated distress levels were low and did not significantly differ between arms. However, researchers observed a trend toward less distress among patients assigned gabapentin (P=.06).
“Overall, despite lower-than-expected complete response rates, the number of emetic events was low and nausea severity was mild,” Barton and colleagues wrote. “Patients were quite satisfied with the control of their nausea and vomiting irrespective of arm.”
Disclosure: The researchers report grants from NCI and advisory board roles with Genentech.
Perspective
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Christine A. Zawistowski, MD
The prospect of a relatively inexpensive medication with a good safety profile and few drug interactions is exciting to any physician, regardless of what you will be treating with it. The idea that gabapentin could have yet another application — to treat delayed chemotherapy-induced nausea and vomiting (CINV) — in addition to treating seizures, neuropathic pain and a smattering of other conditions was intriguing to me. This study was based on a sound physiologic hypothesis, as well as convincing pilot study data. It was well designed. But, alas, it didn’t pan out. And that provides us with just as much valuable information as if it had shown gabapentin to be a new “wonder drug” for CINV. This study demonstrated that we already have very good prophylactic guidelines to combat CINV. Perhaps we just need to stick to them. As for the 25% of patients who are symptomatic despite receiving guideline-directed therapy for CINV, this study provides a starting point to investigate whether gabapentin could be their “wonder drug” for this distressing and burdensome symptom.
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