In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 16544-16544
Abstract:
16544 Background: Concurrent chemoradiation is considered the optimal treatment for advanced HNSCC, including post-resected status. Erlotinib is an oral EGFR TKI, with activity in recurrent and metastatic HNSCC.The Spanish Group of Clinical Research in Radiation Oncology (GICOR) leads a phase I/II study to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of adding erlotinib (e) to chemoradiation to patients (p) with surgically resected locally advanced HNSCC Methods: p had surgically resected advanced HNSCC, with a least one of the following criteria: T3 or T4 primary lesion (except T3N0 with negative resection margins), pathologic N2-N3 disease, and poor prognostic findings (i.e. extranodal spread, positive resection margins, perineural or perivascular involvement). Additional eligibility criteria included: age 18–70 y; life expectancy = 12 w; PS 0–1; no evidence of metastasis; adequate organic function; and written informed consent. Dose-escalating phase I study consisted on 3 cohorts of 3–6 p each, with increasing doses of erlotinib (100–150 mg po qd) and cisplatin (30–40 mg/m 2 , iv, d 1) for 7 w. Radiotherapy was delivered as a fixed standard regimen of daily 1.8 Gy (5 fractions/w) to a total dose of 63 Gy in high risk areas along 7 w. Results: By the time of this analysis, 7 p have entered the phase I component of the study. Median age: 52 y; male 100%. Complete data for 4 pats included in cohort 1 (e 100 mg/d, c 30 mg/m 2 ) are available. One p withdrew prematurely the study due to a grade 2 toxicity (not considered DLT) and was considered unevaluable by the Scientific Committee. Among evaluable p, 2 developed mucositis (1g.3), vomiting (g.1) and nausea (g.1). All p developed skin rash (mild in all the cases). Haematological toxicities were single cases of anaemia, leukopenia and thrombocytopenia (g.1). All 3 p completed 7 weeks of treatment and no dose reduction was required. No DLT as per protocol has been described and study went subsequently further to cohort 2. Conclusions: This study demonstrates the safe addition of erlotinib to chemoradiotherapy in the treatment of this p population. Full data from the phase I study will be presented. No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2007.25.18_suppl.16544
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2007
detail.hit.zdb_id:
2005181-5
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