scholarly journals Phase II Study of Lapatinib in Recurrent or Metastatic Epidermal Growth Factor Receptor and/or erbB2 Expressing Adenoid Cystic Carcinoma and Non–Adenoid Cystic Carcinoma Malignant Tumors of the Salivary Glands

2007 ◽  
Vol 25 (25) ◽  
pp. 3978-3984 ◽  
Author(s):  
Mark Agulnik ◽  
Ezra W.E. Cohen ◽  
Roger B. Cohen ◽  
Eric X. Chen ◽  
Everett E. Vokes ◽  
...  
Keyword(s):  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Adenoid Cystic Carcinoma ◽  
Phase Ii ◽  
Progressive Disease ◽  
Phase Ii Study ◽  
Growth Factor Receptor ◽  
Adenoid Cystic ◽  
Epidermal Growth

PurposeExpression of erbB2 and/or epidermal growth factor receptor (EGFR) is associated with biologic aggressiveness and poor prognosis in malignant salivary gland tumors (MSGTs). This phase II study was conducted to determine the antitumor activity of lapatinib, a dual inhibitor of EGFR and erbB2 tyrosine kinase activity, in MSGTs.Patients and MethodsPatients with progressive, recurrent, or metastatic adenoid cystic carcinoma (ACC) immunohistochemically expressing at least 1+ EGFR and/or 2+ erbB2 were treated with lapatinib 1,500 mg daily, in a two-stage cohort. Patients with non-ACC MSGTs were treated as a separate single-stage cohort.ResultsOf 62 patients screened, 29 of 33 (88%) ACC and 28 of 29 (97%) non-ACC patients expressed EGFR and/or erbB2. Forty patients with progressive disease were enrolled onto the study. Among 19 assessable ACC patients, there were no objective responses, 15 patients (79%) had stable disease (SD), nine patients (47%) had SD ≥ 6 months, and four patients (21%) had progressive disease (PD). For 17 assessable non-ACC patients, there were no objective responses, eight patients (47%) had SD, four patients (24%) had SD ≥ 6 months, and nine patients (53%) had PD. The most frequent adverse events were grade 1 to 2 diarrhea, fatigue, and rash. Eight paired tumor biopsies for correlative studies were procured; results did not correlate with clinical outcome.ConclusionAlthough no responses were observed, lapatinib was well tolerated, with prolonged tumor stabilization of ≥ 6 months in 36% (95% CI, 21% to 54%) of assessable patients. The antitumor effects of lapatinib in MGSTs appear mainly cytostatic, hence evaluation of other molecular targeted agents, or combinations with lapatinib, may be considered. Continued efforts should be made to gain better understanding into the biology of this heterogeneous group of malignancies.

Phase II study of cetuximab in patients with unresectable or metastatic hepatocellular carcinoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14096-14096 ◽  
Author(s):  
A. X. Zhu ◽  
L. Blaszkowsky ◽  
P. C. Enzinger ◽  
P. Bhargava ◽  
D. P. Ryan ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Growth Factor Receptor ◽  
Advanced Hepatocellular Carcinoma ◽  
Egfr Expression ◽  
Epidermal Growth

14096 Background: Patients with advanced hepatocellular carcinoma (HCC) have a poor prognosis with no established systemic treatment regimen. Epidermal growth factor receptor/human epidermal growth factor receptor 1 (EGFR/HER1) and ligand expression is frequently seen in HCC. Recent studies suggest that erlotinib, an EGFR/HER1 tyrosine kinase inhibitor, may have benefit in stabilizing HCC. We performed a phase II study with cetuximab, a chimeric monoclonal antibody that binds selectively to EGFR, in advanced HCC. Methods: Eligibility criteria include unresectable or metastatic measurable HCC, up to two prior systemic regimens, performance status ≤ 2, CLIP score ≤ 3, and adequate organ functions. The initial dose of cetuximab is 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 IV over 60 minutes. Each cycle is defined as 6 consecutive weekly treatments. EGFR expression was assayed by immunohistochemistry and trough serum concentrations of cetuximab were determined during the first cycle. The primary endpoint of the study was progression free survival (PFS). Results: The planned 30 patients have been enrolled: median age = 58 (33–82), M/F = 23/7, ECOG 0/1/2 = 16/12/2, CLIP 0/1/2/3=2/9/14/5. No responses were seen. Five patients had stable disease. The median number of cycles on study per patient was 1 (range, 1–3). 16 patients developed progressive disease following one cycle of treatment. Only one patient remains on study. The median PFS and OS were 41 days (95% CI, 36 to 79) and 157 days (95% CI, 112 to not available), respectively. The treatment was generally well tolerated. No treatment related deaths occurred. Treatment related grade 1–2 toxicities included rash (83%), fatigue (47%), hypomagnesemia (27%), nausea (20%), anemia (13%), diarrhea (13%), anorexia (13%), and elevation of SGOT/SGPT (10%). Grade 3 SGOT, hypomagnesemia, and fever without neutropenia were seen in one patient (3%) each. Conclusions: Cetuximab has no activity in HCC in this phase II study. It can be safely given with tolerable toxicity profiles in HCC patients. Updated information on toxicity, efficacy, EGFR expression and pharmacokinetics will be presented at the meeting. Supported by Bristol-Myers Squibb. [Table: see text]

scholarly journals Randomized Phase II Study of the Anti–Epidermal Growth Factor Receptor Monoclonal Antibody Cetuximab With Cisplatin Versus Cisplatin Alone in Patients With Metastatic Triple-Negative Breast Cancer

2013 ◽  
Vol 31 (20) ◽  
pp. 2586-2592 ◽  
Author(s):  
José Baselga ◽  
Patricia Gómez ◽  
Richard Greil ◽  
Sofia Braga ◽  
Miguel A. Climent ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Phase Ii ◽  
Triple Negative ◽  
Phase Ii Study ◽  
Growth Factor Receptor ◽  
Randomized Phase Ii ◽  
Epidermal Growth

Purpose Epidermal growth factor receptor is overexpressed in metastatic triple-negative breast cancers (mTNBCs), an aggressive subtype of breast cancer. Our randomized phase II study investigated cisplatin with or without cetuximab in this setting. Patients and Methods Patients who had received no more than one previous chemotherapy regimen were randomly assigned on a 2:1 schedule to receive no more than six cycles of cisplatin plus cetuximab or cisplatin alone. Patients receiving cisplatin alone could switch to cisplatin plus cetuximab or cetuximab alone on disease progression. The primary end point was overall response rate (ORR). Secondary end points studied included progression-free survival (PFS), overall survival (OS), and safety profiles. Analyses included a significance level of α = .10 with no adjustments for multiplicity. Results The full analysis set comprised 115 patients receiving cisplatin plus cetuximab and 58 receiving cisplatin alone; 31 patients whose disease progressed on cisplatin alone switched to cetuximab-containing therapy. The ORR was 20% (95% CI, 13 to 29) with cisplatin plus cetuximab and 10% (95% CI, 4 to 21) with cisplatin alone (odds ratio, 2.13; 95% CI, 0.81 to 5.59; P = .11). Cisplatin plus cetuximab resulted in longer PFS compared with cisplatin alone (median, 3.7 v 1.5 months; hazard ratio [HR], 0.67; 95% CI, 0.47 to 0.97; P = .032). Corresponding median OS was 12.9 versus 9.4 months (HR, 0.82; 95% CI, 0.56 to 1.20; P = .31). Common grade 3/4 adverse events included acne-like rash, neutropenia, and fatigue. Conclusion While the primary study end point was not met, adding cetuximab to cisplatin doubled the ORR and appeared to prolong PFS and OS, warranting further investigation in mTNBC.

Primary adenoid cystic carcinoma of the liver: A case report

2017 ◽  
Vol 2 (1) ◽  
pp. 20
Author(s):  
Padmaj S. Kulkarni ◽  
Girish Phadke ◽  
Mahesh M. Mandolkar ◽  
Sujit Nilegaonkar ◽  
Sonali Deshmukh
Keyword(s):  
Epidermal Growth Factor Receptor ◽  
Case Report ◽  
Targeted Therapy ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Adenoid Cystic Carcinoma ◽  
Rare Case ◽  
Growth Factor Receptor ◽  
Adenoid Cystic ◽  
Epidermal Growth

<p><span>Adenoid cystic carcinoma (ACC) is primarily found in the salivary glands and rarely at other organs but never reported as liver primary. This is a very rare case of primary ACC of the liver which was not resectable and managed with chemotherapy and targeted therapy. The patient progressed on imatinib (c-kit positive) while responded to chemotherapy and gefitinib (epidermal growth factor receptor mutation absent).</span></p>

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