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- Title
Multicenter Phase II Trial of Axitinib Monotherapy for Gemcitabine‐Based Chemotherapy Refractory Advanced Biliary Tract Cancer (AX‐BC Study).
- Authors
Okano, Naohiro; Furuse, Junji; Ueno, Makoto; Morizane, Chigusa; Yamanaka, Takeharu; Ojima, Hidenori; Ozaka, Masato; Sasaki, Mitsuhito; Takahara, Naminatsu; Nakai, Yousuke; Kobayashi, Satoshi; Morimoto, Manabu; Hosoi, Hiroko; Maeno, Satoko; Nagashima, Fumio; Ikeda, Masafumi; Okusaka, Takuji
- Abstract
Lessons Learned: Axitinib exhibited marginal activity against gemcitabine‐refractory unselected biliary tract cancer.Pretreated soluble vascular endothelial growth factor receptor‐2 may be a useful biomarker for axitinib treatment outcome.Ascites should be carefully monitored in patients receiving anti–vascular endothelial growth factor receptor therapy including axitinib in advanced biliary tract cancer. Background: There are no clear options for second‐line treatment in patients with gemcitabine (GEM)‐refractory biliary tract cancer (BTC). We conducted a multicenter, single‐arm, phase II trial to confirm the efficacy and safety of axitinib, a potent selective inhibitor of vascular endothelial growth factor receptor (VEGFR)‐1/2/3, in patients with GEM‐refractory BTC. Methods: Patients refractory or intolerant to GEM‐based chemotherapy were enrolled. Axitinib was administered orally at an initial dose of 5 mg twice daily. The primary endpoint was progression‐free survival (PFS), and the threshold and expected values were set at 2 and 3 months, respectively. The target sample size was 32 patients. Results: Nineteen patients were enrolled. The trial was interrupted for a total of 13 months for the evaluation of adverse events. Thirteen patients were previously treated with ≥2 regimens. The median PFS was 2.8 months (95% confidence interval [CI]: 2.1–4.1). The median overall survival was 5.8 months (95% CI: 3.3–9.7). The response rate was 5.3% (95% CI: 0.0–15.3). Grade 3 ascites occurred in two patients. Baseline soluble VEGFR‐2 levels were significantly associated with PFS. Conclusion: Axitinib exhibited marginal activity against GEM‐refractory BTC. Ascites should be carefully monitored in axitinib‐treated patients with advanced BTC.
- Subjects
THERAPEUTIC use of antineoplastic agents; THERAPEUTIC use of antimetabolites; ANTINEOPLASTIC agents; ASCITES; BENZAMIDE; CANCER chemotherapy; CANCER patients; CELL receptors; CLINICAL trials; CONFIDENCE intervals; DRUG resistance in cancer cells; DRUG efficacy; MEDICAL cooperation; ORAL drug administration; RESEARCH; SURVIVAL analysis (Biometry); TUMOR markers; BILE duct tumors; PROTEIN-tyrosine kinase inhibitors; ENDOTHELIAL growth factors; DESCRIPTIVE statistics; EVALUATION
- Publication
Oncologist, 2021, Vol 26, Issue 2, p97
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1002/onco.13547