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A phase I study of cetuximab/paclitaxel in patients with advanced-stage breast cancer
Shanu Modi1, Gabriella D'Andrea, Larry Norton
1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
Background:
The epidermal growth factor receptor (EGFR) is part of the ErbB family of receptor tyrosine kinases and is known to be variably expressed in breast cancers. Cetuximab is a humanized monoclonal antibody directed against the EGFR that works by blocking the downstream signaling function of this protein and thereby interfering with cancer cell proliferation. Preclinical studies have indicated a synergistic effect for the combination of anti-EGFR therapy plus paclitaxel in breast cancer models.
Patients And Methods:
Hence, we conducted a dose-escalation phase I trial using cetuximab/paclitaxel in patients with metastatic breast cancer to evaluate the feasibility of this combination. Patients with EGFR-positive metastatic breast cancer treated with
Results:
Twelve patients were enrolled to 3 treatment cohorts. Two of 6 patients on the second cohort (cetuximab 100 mg/m2) developed dose-limiting toxicities, presenting as grade 3 rash. The third cohort was amended to allow the same cetuximab dose but to modify the paclitaxel to a weekly schedule. Despite this, 1 of 3 patients in this group also developed grade 3 skin toxicity as a dose-limiting toxicity; thus, the trial was stopped. Ten of the 12 patients were evaluable for response, and of these, 2 patients experienced stable disease, and 8 patients experienced disease progression.
Conclusion:
Because of prohibitive dermatologic toxicity and disappointing preliminary efficacy, the combination of paclitaxel/cetuximab was not considered promising in this population, although further study of this regimen might be warranted.
Insights
This phase I trial combined cetuximab (anti-EGFR therapy) with paclitaxel for metastatic breast cancer. The combination showed significant skin toxicity and limited efficacy, halting further investigation.
Area of Science:
- Oncology
- Pharmacology
Background:
- Epidermal growth factor receptor (EGFR) is variably expressed in breast cancers.
- Cetuximab, an anti-EGFR monoclonal antibody, inhibits cancer cell proliferation.
- Preclinical models suggest synergy between anti-EGFR therapy and paclitaxel.
Purpose of the Study:
- Evaluate the feasibility of combining cetuximab and paclitaxel in metastatic breast cancer.
- Determine the maximum tolerated dose of cetuximab in combination with paclitaxel.
Main Methods:
- A dose-escalation phase I trial was conducted.
- Eligible patients had EGFR-positive metastatic breast cancer with limited prior therapy.
- Treatment involved weekly cetuximab and tri-weekly paclitaxel, with dose escalation.
Main Results:
- Dose-limiting grade 3 rash occurred in 2/6 patients at cetuximab 100 mg/m2.
- Modifications to the paclitaxel schedule did not prevent further grade 3 skin toxicity.
- Only 2/10 evaluable patients showed stable disease; 8/10 experienced progression.
Conclusions:
- The combination of paclitaxel and cetuximab demonstrated prohibitive dermatologic toxicity.
- Preliminary efficacy was disappointing in this patient population.
- Further study of this specific regimen is not recommended at this time.
