March 1, 2005Clinical Cancer Research

A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial of Recombinant Human Leukemia Inhibitory Factor (rhuLIF, Emfilermin, AM424) to Prevent Chemotherapy-Induced Peripheral Neuropathy

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Why the study?

Does recombinant human leukemia inhibitory factor prevent chemotherapy-induced peripheral neuropathy in patients with solid tumors receiving carboplatin and paclitaxel?

Population

117 patients with solid tumors eligible for treatment with carboplatin and paclitaxel

Comparison

Recombinant human leukemia inhibitory factor… vs Placebo

Design

RCT, Randomized, Double-blind

Follow-up

After four cycles of chemotherapy

Authors

IDIan D. DavisEastern Health LKLynette KiersThe Royal Melbourne Hospital LMLachlan MacGregorRoche (Switzerland)

Discussion

Member takes

Implication

rhuLIF does not prevent CIPN with carboplatin-paclitaxel; challenges preclinical promise and closes this neuroprotective avenue.

Structured PICO

Does recombinant human leukemia inhibitory factor prevent chemotherapy-induced peripheral neuropathy in patients with solid tumors receiving carboplatin and paclitaxel?

Population

117 patients with solid tumors eligible for treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m2 over 3 hours)

Intervention

Recombinant human leukemia inhibitory factor (rhuLIF, emfilermin) given subcutaneously daily for 7 days starting the day before chemotherapy, at low-dose (2 microg/kg) or high-dose (4 microg/kg)

Comparator

Placebo

Outcome

Standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapysurrogate

Recombinant human leukemia inhibitory factor (rhuLIF) does not prevent chemotherapy-induced peripheral neuropathy in patients receiving carboplatin and paclitaxel.

Cite This Study

Davis et al. (2005) studied this question.

synapsesocial.com/papers/6a8a984d0f137e402b339d74 https://doi.org/10.1158/1078-0432.ccr-04-1655

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A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial of Recombinant Human Leukemia Inhibitory Factor (rhuLIF, Emfilermin, AM424) to Prevent Chemotherapy-Induced Peripheral Neuropathy

Discussion

Member takes

Implication

Structured PICO

Cite This Study

A Randomized, Double-Blinded, Placebo-Controlled Phase II Trial of Recombinant Human Leukemia Inhibitory Factor (rhuLIF, Emfilermin, AM424) to Prevent Chemotherapy-Induced Peripheral Neuropathy

Discussion

Member takes

Implication

Structured PICO

Cite This Study

Also Consider

Also Consider