title: Sunitinib plus paclitaxel in patients with advanced esophageal cancer: a phase II study from the Hoosier Oncology Group.
abstract: The combination of sunitinb (37.5 mg orally daily) + paclitaxel (90 mg/m intravenously on days 1, 8, 15 every 4 weeks) was examined in patients with advanced esophageal or gastroesophageal junction cancer, and progression-free survival (PFS) was compared to that of historical controls. The end points included response rate, overall survival, and toxicities. Twenty-eight patients were enrolled at six centers. Median age was 59.5 years. The 24-week PFS rate was 25% (90% confidence interval [CI], 12-42%). Three (11%) of 23 evaluable patients had a response (1 complete response and 2 partial response) (90% CI, 3-25%). Median overall survival was 228 days (90% CI, 140-283 days). Grade 3/4 toxicities included leukopenia/neutropenia (25%), anemia (18%), fatigue (11%), and hemorrhage (11%). There were four grade 5 toxicities including upper gastrointestinal hemorrhage (n = 2), gastrointestinal/esophageal fistula (n = 1), and unexplained death (n = 1). In our study, we found that sunitinib + paclitaxel in patients with advanced esophageal or gastroesophageal junction cancer had a 24-week PFS no better than the PFS of historical controls. The combination also had a high rate of serious toxicities and will not be pursued.
authors.affiliation: Indiana University Simon Cancer Center, Indianapolis, IN, USA. jmw8@iupui.edu
authors.forename: Jordan M
authors.initials: JM
authors.lastname: Schmitt
authors.forename: Scott R
authors.initials: SR
authors.lastname: Sommers
authors.forename: William
authors.initials: W
authors.lastname: Fisher
authors.forename: Rafat
authors.initials: R
authors.lastname: Ansari
authors.forename: Erwin
authors.initials: E
authors.lastname: Robin
authors.forename: Karuna
authors.initials: K
authors.lastname: Koneru
authors.forename: John
authors.initials: J
authors.lastname: McClean
authors.forename: Ziyue
authors.initials: Z
authors.lastname: Liu
authors.forename: Yan
authors.initials: Y
authors.lastname: Tong
authors.forename: Nasser
authors.initials: N
authors.lastname: Hanna
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011758:Pyrroles / Q000008:administration & dosage / Q000009:adverse effects; D000077210:Sunitinib
chemical_list: D007211:Indoles; D011758:Pyrroles; D017239:Paclitaxel; D000077210:Sunitinib