title: Adjuvant sunitinib following chemoradiotherapy and surgery for locally advanced esophageal cancer: a phase II trial.
abstract: The prognosis for locally advanced esophageal cancer is poor despite the use of trimodality therapy. In this phase II study, we report the feasibility, tolerability and efficacy of adjuvant sunitinib. Included were patients with stage IIa, IIB or III cancer of the thoracic esophagus or gastroesophageal junction. Neoadjuvant therapy involved Irinotecan (65 mg/m2) + Cisplatin (30 mg/m2) on weeks 1 and 2, 4 and 5, 7 and 8 with concurrent radiation (50Gy/25 fractions) on weeks 4-8. Sunitinib was commenced 4-13 weeks after surgery and continued for one year. Sixty-one patients were included in the final analysis, 36 patients commenced adjuvant sunitinib. Fourteen patients discontinued sunitinib due to disease recurrence (39%) within the 12-month period, 12 (33%) discontinued due to toxicity, and 3 (8%) requested cessation of therapy. In the overall population, median survival was 26 months with a 2 and 3-year survival rate of 52% and 35%, respectively. The median survival for the 36 patients treated with sunitinib was 35 months and 2-year survival probability of 68%. In a historical control, a prior phase II study with the same trimodality therapy (n = 43), median survival was 36 months, with a 2-year survival of 67%. Initiation of adjuvant sunitinib is feasible, but poorly tolerated, with no signal of additional benefit over trimodality therapy for locally advanced esophageal cancer.
authors.affiliation: Department of Medical Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: A M
authors.initials: AM
authors.lastname: Horgan
authors.affiliation: Department of Surgical Oncology, Division of Thoracic Surgery, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: G
authors.initials: G
authors.lastname: Darling
authors.affiliation: Department of Radiation Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Wong
authors.affiliation: Department of Pathology and Laboratory Medicine, Cedars Sinai Medical Center, Los Angeles, California, USA.
authors.forename: M
authors.initials: M
authors.lastname: Guindi
authors.affiliation: Department of Medical Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: G
authors.initials: G
authors.lastname: Liu
authors.affiliation: Department of Medical Oncology, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: D J
authors.initials: DJ
authors.lastname: Jonker
authors.affiliation: Department of Surgical Oncology, Division of Thoracic Surgery, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Lister
authors.affiliation: Department of Biostatistics, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: W
authors.initials: W
authors.lastname: Xu
authors.affiliation: Department of Medical Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: H M
authors.initials: HM
authors.lastname: MacKay
authors.affiliation: Department of Radiation Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Dinniwell
authors.affiliation: Department of Radiation Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Kim
authors.affiliation: Department of Surgical Oncology, Division of Thoracic Surgery, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Pierre
authors.affiliation: Division of Thoracic Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Y
authors.initials: Y
authors.lastname: Shargall
authors.affiliation: Department of Medical Oncology, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: T R
authors.initials: TR
authors.lastname: Asmis
authors.affiliation: Department of Thoracic Surgery, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: O
authors.initials: O
authors.lastname: Agboola
authors.affiliation: Department of Pathology, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: A J
authors.initials: AJ
authors.lastname: Seely
authors.affiliation: Department of Radiation Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Ringash
authors.affiliation: Department of Radiation Oncology, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Wells
authors.affiliation: Department of Pathology, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: E C
authors.initials: EC
authors.lastname: Marginean
authors.affiliation: Department of Medical Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Haider
authors.affiliation: Department of Medical Oncology, Princess Margaret and Toronto General Hospitals, University Health Network, Toronto, Ontario, Canada.
authors.forename: J J
authors.initials: JJ
authors.lastname: Knox
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D059248:Chemoradiotherapy; D017024:Chemotherapy, Adjuvant / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D004938:Esophageal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016629:Esophagectomy; D004943:Esophagogastric Junction / Q000473:pathology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000401:mortality; D009367:Neoplasm Staging; D011184:Postoperative Period; D011758:Pyrroles / Q000008:administration & dosage* / Q000009:adverse effects; D000077210:Sunitinib; D015996:Survival Rate; D028761:Withholding Treatment / Q000706:statistics & numerical data
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D002945:Cisplatin; D000077210:Sunitinib
keywords: esophageal cancer; sunitinib; trimodality