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Phase II study on lapatinib in advanced EGFR-positive chordoma
S Stacchiotti1, E Tamborini2, S Lo Vullo3
1Sarcoma Unit, Departments of Cancer Medicine.
Background:
To report on a prospective, investigator-driven, phase II study on lapatinib in epidermal growth factor receptor (EGFR)-positive advanced chordoma patients.
Patients And Methods:
From December 2009 to January 2012, 18 advanced progressing chordoma patients entered this study (median age: 61 years; disease extent: metastatic 72% and locally advanced 28%). Epidermal growth factor receptor (EGFR) expression and activation were evaluated by immunohistochemistry and/or phospho-arrays, real-time polimerase chain reaction, fluorescence immunostaining. Fluorescence in situ hybridization analysis was also carried out. Patients received lapatinib 1500 mg/day (mean dose intensity = 1282 mg/day), until progression or toxicity. The primary study end point was response rate (RR) as per Choi criteria. Secondary end points were RR by Response Evaluation Criteria in Solid Tumor (RECIST), overall survival, progression-free survival (PFS) and clinical benefit rate (CBR; RECIST complete response + partial response (PR) + stable disease (SD) ≥ 6 months).
Results:
All patients were evaluable for response. Six (33.3%) patients had PR and 7 (38.9%) SD, as their best Choi responses, corresponding to RECIST SD in all cases. Median PFS by Choi was 6 [interquartile (IQ) range 3-8] months. Median PFS by RECIST was 8 (IQ range 4-12) months, with a 22% CBR.
Conclusions:
This phase II study showed a modest antitumor activity of lapatinib in chordoma. The clinical exploitation of EGFR targeting in chordoma needs to be further investigated, both clinically and preclinically. Clinical trial Registration No: EU Clinical Trials Register trial no. 2009-014456-29.
Insights
Lapatinib showed modest antitumor activity in advanced chordoma patients with epidermal growth factor receptor (EGFR) positivity. Further research is needed to explore EGFR targeting in chordoma treatment.
Area of Science:
- Oncology
- Molecular targeted therapy
- Chordoma research
Background:
- Chordoma is a rare bone tumor.
- Epidermal growth factor receptor (EGFR) is a potential therapeutic target in chordoma.
Purpose of the Study:
- To evaluate the efficacy and safety of lapatinib in patients with advanced chordoma.
- To assess the response rate and survival outcomes in this patient population.
Main Methods:
- A prospective, investigator-driven, phase II study.
- 18 patients with advanced chordoma received lapatinib.
- EGFR expression and activation were assessed.
- Response was evaluated using Choi criteria and RECIST.
Main Results:
- A response rate of 33.3% (partial response) and 38.9% (stable disease) by Choi criteria was observed.
- Median progression-free survival was 6 months (Choi) and 8 months (RECIST).
- A clinical benefit rate of 22% was reported.
Conclusions:
- Lapatinib demonstrated modest antitumor activity in advanced chordoma.
- EGFR targeting warrants further clinical and preclinical investigation in chordoma.
- This study provides valuable data for future chordoma treatment strategies.
