title: A phase II trial of modified FOLFOX6 as first-line therapy for adenocarcinoma of an unknown primary site.
abstract: OBJECTIVE
  The aim of the study was to assess the clinical activity and toxicity of oxaliplatin and leucovorin in combination with bolus and continuous infusional 5-fluorouracil administered every 2 weeks (modified FOLFOX-6 regimen) to patients with adenocarcinoma of an unknown primary site (ACUP).
  
  
  METHODS
  Previously untreated ACUP patients were treated with oxaliplatin (100 mg/m(2)) and leucovorin (200 mg/m(2)) as a 2-h infusion followed by bolus administration of 5-fluorouracil (400 mg/m(2)) and continuous infusion of 5-fluorouracil (2400 mg/m(2)) every 2 weeks.
  
  
  RESULTS
  A total of 23 patients were enrolled and treated with a modified FOLFOX-6 regimen between May 2009 and November 2014. This trial was terminated before the scheduled enrollment due to poor accrual. A total of 134 cycles of mFOLFOX-6 were administered to 23 patients. The median number of cycles of mFOLFOX-6 was 5 (range 1-12). Among 20 patients whose tumor responses were evaluable, seven patients showed a partial response (no complete response), with an objective response rate of 35.0%. The median duration of response was 3.9 months (range 3.0-19.8). The median progression-free survival and overall survival were 3.0 and 9.5 months, respectively (95% confidence interval 1.4-6.7 months and 4.8-26.4 months, respectively). Treatment-related toxicity was manageable.
  
  
  CONCLUSIONS
  mFOLFOX-6 showed modest activity in treatment-naïve patients with ACUP. A future, prospective large-scale study incorporating a parallel molecular prediction marker study is warranted.
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, 75 Nowon-gil, Nowon-gu, Seoul, 139-706, Republic of Korea.
authors.forename: Dong-Yeop
authors.initials: DY
authors.lastname: Shin
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Dongnam Institute of Radiological and Medical Sciences, Busan, Republic of Korea.
authors.forename: Yoon Hee
authors.initials: YH
authors.lastname: Choi
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, 75 Nowon-gil, Nowon-gu, Seoul, 139-706, Republic of Korea.
authors.forename: Hyo-Rak
authors.initials: HR
authors.lastname: Lee
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, 75 Nowon-gil, Nowon-gu, Seoul, 139-706, Republic of Korea.
authors.forename: Im Il
authors.initials: II
authors.lastname: Na
authors.affiliation: Department of Internal Medicine, Sanggye Paik Hospital, College of Medicine, Inje University, Seoul, Republic of Korea.
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Yuh
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, VHS Medical Center, Seoul, Republic of Korea.
authors.forename: Bong-Seog
authors.initials: BS
authors.lastname: Kim
authors.affiliation: Division of Hematology/Medical Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun-Gun, Republic of Korea.
authors.forename: Ik Joo
authors.initials: IJ
authors.lastname: Chung
authors.affiliation: Division of Hematology/Medical Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun-Gun, Republic of Korea.
authors.forename: Woo-Kyun
authors.initials: WK
authors.lastname: Bae
authors.affiliation: Division of Hematology/Medical Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun-Gun, Republic of Korea.
authors.forename: Hyun-Jeong
authors.initials: HJ
authors.lastname: Shim
authors.affiliation: Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Republic of Korea.
authors.forename: Eun-Kee
authors.initials: EK
authors.lastname: Song
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, 75 Nowon-gil, Nowon-gu, Seoul, 139-706, Republic of Korea.
authors.forename: Sung Hyun
authors.initials: SH
authors.lastname: Yang
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, 75 Nowon-gil, Nowon-gu, Seoul, 139-706, Republic of Korea. hyejin@kirams.re.kr.
authors.forename: Hye Jin
authors.initials: HJ
authors.lastname: Kang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009382:Neoplasms, Unknown Primary / Q000188:drug therapy* / Q000473:pathology; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil
keywords: Adenocarcinoma of unknown primary; FOLFOX; Oxaliplatin; Phase II trial