Reference Detail

Ref Type Journal Article
PMID (29301831)
Authors Hui EP, Ma BBY, Loong HHF, Mo F, Li L, King AD, Wang K, Ahuja AT, Chan CML, Hui CWC, Wong CH, Chan ATC
Title Efficacy, Safety, and Pharmacokinetics of Axitinib in Nasopharyngeal Carcinoma: A Preclinical and Phase II Correlative Study.
Journal Clinical cancer research : an official journal of the American Association for Cancer Research
Vol
Issue
Date 2018 Jan 04
URL
Abstract Text Purpose: We hypothesized that axitinib is active with an improved safety profile in nasopharyngeal carcinoma (NPC).Experimental Design:We evaluated axitinib in preclinical models of NPC and studied its efficacy in a phase II clinical trial in recurrent or metastatic NPC patients who progressed after at least one line of prior platinum-based chemotherapy. We excluded patients with local recurrence or vascular invasion. Axitinib was started at 5 mg twice daily in continuous 4-week cycles. Primary endpoint was clinical benefit rate (CBR), defined as the percentage of patients achieving complete response, partial response, or stable disease by RECIST criteria for more than 3 months.Results:We recruited 40 patients, who received a median of 3 lines of prior chemotherapy. Axitinib was administered for a mean of 5.6 cycles, with 16 patients (40%) receiving ≥6 cycles. Of 37 patients evaluable for response, CBR was 78.4% (95% CI, 65.6%-91.2%) at 3 months and 43.2% (30.4%-56.1%) at 6 months. Grade 3/4 toxicities were uncommon, including hypertension (8%), diarrhea (5%), weight loss (5%), and pain (5%). All hemorrhagic events were grade 1 (15%) or grade 2 (3%). Elevated diastolic blood pressure during the first 3 months of axitinib treatment was significantly associated with improved overall survival (HR, 0.29; 95% CI, 0.13-0.64,P= 0.0012). Patient-reported fatigue symptom was associated with hypothyroidism (P= 0.039). Axitinib PK parameters (Cmaxand AUC(0-t)) were significantly correlated with tumor response, toxicity, and serum thyroid-stimulating hormone changes.Conclusions:Axitinib achieved durable disease control with a favorable safety profile in heavily pretreated NPC patients.Clin Cancer Res; 1-8. ©2018 AACR.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Therapy Description
Drug Name Trade Name Synonyms Drug Classes Drug Description
Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown nasopharynx carcinoma not applicable Axitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Inlyta (axitinib) inhibited growth of nasopharyngeal carcinoma cell lines in culture, and inhibited tumor growth, decreased microvessel density, and increased tumor necrosis in a nasopharyngeal carcinoma xenograft model (PMID: 29301831). 29301831
Unknown unknown nasopharynx carcinoma not applicable Axitinib Clinical Study Actionable In a clinical trial, treatment with Inlyta (axitinib) resulted in a 3-month clinical benefit rate (CBR) of 78.4% (29/37; 1 confirmed partial response (PR), 6 unconfirmed PR, 22 stable disease for greater than 3 months) and 6-month CBR of 43.2%, a median progression-free survival of 5.0 months, and median overall survival of 10.4 months in patients with nasopharyngeal carcinoma (PMID: 29301831). 29301831