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Phase II Study of Ramucirumab in Advanced Biliary Tract Cancer Previously Treated By Gemcitabine-Based Chemotherapy.
Lee, Sunyoung; Shroff, Rachna T; Makawita, Shalini; Xiao, Lianchun; Danner De Armas, Anaemy; Bhosale, Priya; Reddy, Kavitha; Shalaby, Ahmed; Raghav, Kanwal; Pant, Shubham; Wolff, Robert A; Javle, Milind.
Afiliación
  • Lee S; Division of Cancer Medicine, Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Shroff RT; Division of Hematology and Oncology, Department of Medicine, University of Arizona College of Medicine, Tucson, Arizona.
  • Makawita S; Division of Hematology and Oncology, Department of Medicine, Baylor College of Medicine, Houston, Texas.
  • Xiao L; Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Danner De Armas A; Division of Cancer Medicine, Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Bhosale P; Division of Diagnostic Imaging, Department of Abdominal Imaging, University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Reddy K; Division of Cancer Medicine, Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Shalaby A; Department of Diagnostic Radiology, University of Mississippi, Oxford, Mississippi.
  • Raghav K; Division of Cancer Medicine, Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Pant S; Division of Cancer Medicine, Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Wolff RA; Division of Cancer Medicine, Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
  • Javle M; Division of Cancer Medicine, Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Clin Cancer Res ; 28(11): 2229-2236, 2022 06 01.
Article en En | MEDLINE | ID: mdl-35312753
PURPOSE: VEGF receptor-2 (VEGFR-2)-mediated angiogenesis contributes to pathogenesis of biliary tract cancers (BTC). We investigated ramucirumab, a mAb targeting VEGFR-2 for treatment of advanced, chemorefractory BTC. PATIENTS AND METHODS: This is a phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC with ECOG 0/1, adequate liver, renal, and marrow functions. Ramucirumab was administered at 8 mg/kg, 2 weekly with restaging performed 8 weekly. Primary endpoint was progression-free survival (PFS). Secondary endpoints were overall response rate (ORR), disease control rate (DCR), overall survival (OS), and toxicity. Exploratory endpoints included correlation of tumor mutational status with PFS and OS. RESULTS: 61 patients were enrolled: the median age was 58.5 years; 59 with stage IV disease; 62%, intrahepatic cholangiocarcinoma; 22%, gallbladder cancer; and 16%, extrahepatic cholangiocarcinoma. All received prior chemotherapy: 52% had 1 prior, and rest ≥2 prior lines. Median treatment duration was 10.1 weeks (range, 2.1-86). Median PFS was 3.2 months [95% confidence interval (CI), 2.1-4.8]; median OS, 9.5 months (95% CI, 5.8-13.6). One (1.7%) patient achieved partial response; 26 (43.3%), stable disease; and 25 (41.7%), disease progression; DCR, 45%. Median 6-month PFS and OS rates were 32% (95% CI, 0.22-0.46) and 58% (95% CI, 0.47-0.72). The majority of toxicities were grade 1 or 2; grade 3 proteinuria (1, 2%), hypertension (13, 22%), and pulmonary embolism (1, 2%), and grade 4 gastrointestinal bleeding (1, 2%) occurred. CONCLUSIONS: Ramucirumab was well tolerated and resulted in PFS similar to that achieved with other chemotherapy regimens used historically for chemorefractory BTC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de los Conductos Biliares / Neoplasias del Sistema Biliar / Colangiocarcinoma Límite: Humans / Middle aged Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de los Conductos Biliares / Neoplasias del Sistema Biliar / Colangiocarcinoma Límite: Humans / Middle aged Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos