Phase II trial of gefitinib in patients with incurable salivary gland cancer
May 26th, 2008 by admin
B. S. Glisson, G. Blumenschein, M. Francisco, J. Erasmus, R. Zinner and M. Kies
UT MD
5532
Background: Conventional chemotherapy agents offer little efficacy for patients with incurable salivary gland cancer. EGFR (her1) overexpression has been identifed in > 90% of salivary gland cancers in recent series. Thus, EGFR-targeted therapy with gefitinib offers promise in treatment of this disease. Methods: From 6/04 to 12/04 28 patients with incurable salivary gland cancer were accrued to a phase II trial of gefitinib (250 mg po daily). Eligibility: ECOG PS 0–2, measurable disease, no prior EGFR inhiibitors. Patients were accrued in two cohorts: (1) adenoid cystic and (2) other histologies. Primary endpoint was response rate based on RECIST criteria and imaging every 2 months. Analysis of EGFR and her2 expression (IHC) on archival tumor was a secondary endpoint. Results: Patient characteristics, number(%): PS 1 26(93), M 19(68), prior chemotherapy 6(21), adenoid cystic 19(68), adenocarcinoma 3(11), salivary duct 3(11), mucoepidermoid 2(7), and undifferentiated 1(3). Twenty-six patients received 71 courses. Two are in their first course. Toxicity (26 pts), number (%): grade 1 diarrhea 20(77), grade 1/2 rash 14(54), grade 1/2 anorexia 8(31), grade 1/2 fatigue 14(54), grade 1 nausea 4(15), grade 1 mucositis 4(15), grade 1 nail change 2(8). No grade 3–4 effects observed. Three patients discontinued therapy due to grade1–2 effects that were felt treatment-related in only 1/3. Response (21 pts), number(%): CR/PR 0(0), SD 14 (67), PD 7(33). 13/14 pts with SD have adenoid cystic cancer. Median duration of SD: 13 wks (4–19). One pt is dead of disease, two have died from other causes. Accrual to the adenoid cystic cohort is complete unless a reponse is observed. Accrual to the other cohort is ongoing. Conclusions: Gefitinib was well-tolerated and led to a high rate of SD in adenoid cystic cancer. Given the frequent indolent nature of salivary gland cancer, interpretation of the value of SD requires further f/u. This will be updated and expression of EGFR and her2 will be presented.
No significant financial relationships to disclose.
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