Dataset Information

Cetuximab and platinum-based chemoradio- or chemotherapy of patients with epidermal growth factor receptor expressing adenoid cystic carcinoma: a phase II trial.

ABSTRACT:

Background

Epidermal growth factor receptor (EGFR) is highly expressed in adenoid cystic carcinoma (ACC). The efficacy and toxicity of cetuximab with concomitant platinum-based chemoradio- or chemotherapy in patients with locally advanced or metastatic ACC, respectively, was evaluated.

Methods

Eligible patients (9 with locally advanced tumour and 12 with metastases) had positive tumour EGFR expression. The cetuximab loading dose (400 mg m⁻²) was followed by 250 mg m⁻² per week. Locally advanced tumours were irradiated (mean dose 65 Gy) and treated with concomitant cisplatin (75 mg m⁻², intravenously). Patients with metastases received concomitant cisplatin and 5-fluorouracil (4 × 1000 mg m⁻²).

Results

For patients with locally advanced disease (median follow-up: 52 months), the median progression-free survival (PFS) was 64 months and the 2-year overall survival (OS) rate was 100%. For patients with metastases (median follow-up: 72 months), the median PFS and OS were 13 and 24 months, respectively. In both groups the objective response rate was >40%. Skin rash, in-field dermatitis, mucositis and vomiting were the most frequent grade 3/4 adverse events.

Conclusion

In this single-arm study, the efficacy of cetuximab plus chemoradio- or chemotherapy appeared favourable as compared with historical controls. All side effects were manageable and did not hamper the treatment.

SUBMITTER: Hitre E

PROVIDER: S-EPMC3778310 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Publications

Cetuximab and platinum-based chemoradio- or chemotherapy of patients with epidermal growth factor receptor expressing adenoid cystic carcinoma: a phase II trial.

Hitre E E Budai B B Takácsi-Nagy Z Z Rubovszky G G Tóth E E Remenár É É Polgár C C Láng I I

British journal of cancer 20130813 5

<h4>Background</h4>Epidermal growth factor receptor (EGFR) is highly expressed in adenoid cystic carcinoma (ACC). The efficacy and toxicity of cetuximab with concomitant platinum-based chemoradio- or chemotherapy in patients with locally advanced or metastatic ACC, respectively, was evaluated.<h4>Methods</h4>Eligible patients (9 with locally advanced tumour and 12 with metastases) had positive tumour EGFR expression. The cetuximab loading dose (400 mg m⁻²) was followed by 250 mg m⁻² per week. Lo ...[more]

PMID: 23942070

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Project description:BackgroundRecurrent/metastatic adenoid cystic carcinoma (ACC) is an incurable disease with no standard treatments. The majority of ACCs express the oncogenic transcription factor MYB (also c-myb), often in the context of a MYB gene rearrangement. This phase II trial of the tyrosine kinase inhibitor (TKI) axitinib (Pfizer) tested the hypothesis that targeting pathways activated by MYB can be therapeutically effective for ACC.Patients and methodsThis is a minimax two-stage, phase II trial that enrolled patients with incurable ACC of any primary site. Progressive or symptomatic disease was required. Patients were treated with axitinib 5 mg oral twice daily; dose escalation was allowed. The primary end point was best overall response (BOR). An exploratory analysis correlating biomarkers to drug benefit was conducted, including next-generation sequencing (NGS) in 11 patients.ResultsThirty-three patients were registered and evaluable for response. Fifteen patients had the axitinib dose increased. Tumor shrinkage was achieved in 22 (66.7%); 3 (9.1%) had confirmed partial responses. Twenty-five (75.8%) patients had stable disease, 10 of whom had disease stability for >6 months. The median progression-free survival (PFS) was 5.7 months (range 0.92-21.8 months). Grade 3 axitinib-related toxicities included hypertension, oral pain and fatigue. A trend toward superior PFS was noted with the MYB/NFIB rearrangement, although this was not statistically significant. NGS revealed three tumors with 4q12 amplification, producing increased copies of axitinib-targeted genes PDGFR/KDR/KIT. Two 4q12 amplified patients achieved stable disease for >6 months, including one with significant tumor reduction and the longest PFS on study (21.8 months).ConclusionsAlthough the primary end point was not met, axitinib exhibited clinical activity with tumor shrinkage achieved in the majority of patients with progressive disease before trial enrollment. Analysis of MYB biomarkers and genomic profiling suggests the hypothesis that 4q12 amplified ACCs are a disease subset that benefit from TKI therapy.

Project description:BackgroundCervical adenoid cystic carcinoma (ACC) and adenoid basal carcinoma (ABC) are rare cervical cancer types and have unclarified clinicopathological features and survival outcomes. This retrospective study focused on predicting the value of radiotherapy or/and chemotherapy for cervical ACC and ABC patients.MethodsThe clinical data of cervical ACC and ABC patients in the Surveillance, Epidemiology, and End Results (SEER) database from 1973 and 2013 were included. The clinicopathological features, Kaplan-Meier curves, and overall survival (OS) of patients were evaluated. The prognostic nomogram was established based on the multivariate Cox models. To validate the nomogram prediction, Harrell's Concordance index (C-index) was calculated and receiver operating characteristic (ROC) curves were generated.ResultsA total of 84 cervical ACC and 82 ABC patients were identified, and ABC patients had better 10-year OS than ACC patients (60.81% vs. 36.94%, P=0.001). Age, ACC, surgery, radiotherapy, chemotherapy, and regional node involvement were significantly correlated with patient prognosis. In the multivariate analysis, only age >80 years (HR =5.945, 95% CI: 1.912-18.485, P=0.002) and age 70-80 years (HR =4.803, 95% CI: 1.626-14.188, P=0.005) were independent predictors of patient prognosis. In subgroup analysis, patients who underwent surgery (HR =2.199, 95% CI: 1.085-4.455, P=0.029) and the ABC subgroup (HR =4.233, 95% CI: 1.532-11.696, P=0.005) received radiotherapy, chemotherapy, or chemoradiotherapy with a poor prognosis. Patients received radiotherapy (HR =1.936, 95% CI: 1.208-3.105, P=0.006) was associated with a poor prognosis, while surgical patients had a better prognosis (HR =0.535, 95% CI: 0.344-0.832, P=0.006).ConclusionsCervical ABC patients had a better survival time than cervical ACC patients. We found that increased age was potentially an independent risk factor for poor prognosis, surgical patients had a better prognosis, and radiotherapy, or chemotherapy combination treatment had an unfavorable tendency to prognosis.

Dataset Information

Cetuximab and platinum-based chemoradio- or chemotherapy of patients with epidermal growth factor receptor expressing adenoid cystic carcinoma: a phase II trial.

Background

Methods

Results

Conclusion

Publications

Cetuximab and platinum-based chemoradio- or chemotherapy of patients with epidermal growth factor receptor expressing adenoid cystic carcinoma: a phase II trial.

Similar Datasets

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