BACKGROUND: Second-line treatment options in advanced hepatocellular carcinoma (HCC) are limited. Axitinib, a selective potent tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor VEGF) receptors 1, 2, and 3, merits exploration in HCC. METHODS: This was a single-arm phase II trial of axitinib in advanced HCC. Eligible patients were Child-Pugh A/B7, with measurable progressive disease after TKIs/antiangiogenic drugs. Axitinib was started at 5 mg twice daily orally, titrated from 2 to 10 mg twice daily as tolerated. The primary end point was tumor control at 16 weeks by RECIST1.1; secondary end points were response rate, comparing response by RECIST1.1 to Choi and modified RECIST, exploring dynamic contrast-enhanced imaging models, safety, progression-free (PFS), and overall survival (OS). RESULTS: Thirty patients were treated. Of 26 patients evaluable for response, there were 3 partial responses (PR) per RECIST1.1; 13 PR by Choi, 6 PR and 1 complete response by modified RECIST. Tumor control rate at 16 weeks was 42.3%. Two-week perfusion changes were noted on functional imaging. Of 21 patients with evaluable a-fetoprotein response, 43% had >50% decrease from baseline. Most common axitinib-related grade 3/4 adverse events (AEs) were hypertension, thrombocytopenia and diarrhea. Of 11 patients with any grade hypertension, 7 had disease control >36wks. Four patients discontinued treatment due to AEs. Median PFS was 3.6months. Median OS was 7.1months. CONCLUSIONS: With 42.3% tumor control at 16weeks, primary endpoint was met. Axitinib has shown encouraging tolerable clinical activity in VEGF-pretreated HCC patients but further study should be in a selected population incorporating potential biomarkers of response. Cancer 2015;121:1620-7.
Magnetic resonance (MR) imaging is becoming the cross-sectional imaging modality of choice for follow-up of patients with previous rectal cancer to diagnose pelvic recurrence and plan for surgery. The authors conducted a retrospective review of MR imaging examinations performed at their institution for evaluation of local recurrence of rectal cancer in 42 patients. Twenty-six patients had undergone rectal anastomosis and 16 had undergone abdominoperineal resection. The mean interval between initial surgery and recurrence was 2.5 years. Recurrence sites were axial (involving the anastomosis) (n = 19); lateral (sidewall) (n = 6); anterior (prostate or seminal vesicle [n = 2], bladder [n = 4], ureter [n = 3], vagina or uterus [n = 5]); or posterior (presacral fascia [n = 11], sacrum [n = 2]). Other recurrence sites included the pelvic floor (n = 7), sciatic nerve (n = 2), obturator nerve (n = 1), perineum (n = 1), abdominal wall (n = 1), or adnexa (n = 1). Recurrence was confirmed at surgery or by evidence of tumor growth at follow-up imaging. Recurrence patterns, signal intensity characteristics, findings of unresectability, potential MR imaging pitfalls, and the role of MR imaging versus other modalities in evaluating recurrent rectal carcinoma are discussed. Supplemental material available at http://radiographics.rsna.org/lookup/suppl/doi:10.1148/rg335115170/-/DC1.
Waterfall plots are subject to substantial variability in criteria used to define them and are influenced by measurement errors; they should be generated by trained radiologists. Caution should be exercised when interpreting results of waterfall plots in the context of clinical trials.
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