title: Preoperative gemcitabine and cisplatin followed by gemcitabine-based chemoradiation for resectable adenocarcinoma of the pancreatic head.
abstract: OBJECTIVE
  We conducted a phase II trial of preoperative gemcitabine and cisplatin chemotherapy in addition to chemoradiation (Gem-Cis-XRT) and pancreaticoduodenectomy (PD) for patients with stage I/II pancreatic adenocarcinoma.
  
  
  METHODS
  Chemotherapy consisted of gemcitabine (750 mg/m(2)) and cisplatin (30 mg/m(2)) given every 2 weeks for four doses. Chemoradiation consisted of four weekly infusions of gemcitabine (400 mg/m(2)) combined with radiation therapy (30 Gy in 10 fractions administered over 2 weeks) delivered 5 days per week. Patients underwent restaging 4 to 6 weeks after completion of chemoradiation and, in the absence of disease progression, were taken to surgery.
  
  
  RESULTS
  The study enrolled 90 patients; 79 patients (88%) completed chemo-chemoradiation. Sixty-two (78%) of 79 patients were taken to surgery and 52 (66%) of 79 underwent PD. The median overall survival of all 90 patients was 17.4 months. Median survival for the 79 patients who completed chemo-chemoradiation was 18.7 months, with a median survival of 31 months for the 52 patients who underwent PD and 10.5 months for the 27 patients who did not undergo surgical resection of their primary tumor (P < .001).
  
  
  CONCLUSIONS
  Preoperative Gem-Cis-XRT did not improve survival beyond that achieved with preoperative gemcitabine-based chemoradiation (Gem-XRT) alone. The longer preoperative interval required more durable biliary decompression (metal stents) but was not associated with local tumor progression. The gemcitabine-based chemoradiation platform is a reasonable foundation on which to build future phase II multimodality trials for stage I/II pancreatic cancer incorporating emerging systemic therapies.
authors.affiliation: Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 426, Houston, TX 77030, USA. gvaradha@mdanderson.org
authors.forename: Gauri R
authors.initials: GR
authors.lastname: Varadhachary
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wolff
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Crane
authors.forename: Charlotte C
authors.initials: CC
authors.lastname: Sun
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: Lee
authors.forename: Peter W T
authors.initials: PW
authors.lastname: Pisters
authors.forename: Jean-Nicolas
authors.initials: JN
authors.lastname: Vauthey
authors.forename: Eddie
authors.initials: E
authors.lastname: Abdalla
authors.forename: Huamin
authors.initials: H
authors.lastname: Wang
authors.forename: Gregg A
authors.initials: GA
authors.lastname: Staerkel
authors.forename: Jeffrey H
authors.initials: JH
authors.lastname: Lee
authors.forename: William A
authors.initials: WA
authors.lastname: Ross
authors.forename: Eric P
authors.initials: EP
authors.lastname: Tamm
authors.forename: Priya R
authors.initials: PR
authors.lastname: Bhosale
authors.forename: Sunil
authors.initials: S
authors.lastname: Krishnan
authors.forename: Prajnan
authors.initials: P
authors.lastname: Das
authors.forename: Linus
authors.initials: L
authors.lastname: Ho
authors.forename: Henry
authors.initials: H
authors.lastname: Xiong
authors.forename: James L
authors.initials: JL
authors.lastname: Abbruzzese
authors.forename: Douglas B
authors.initials: DB
authors.lastname: Evans
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016577:Pancreaticoduodenectomy; D011300:Preoperative Care / Q000379:methods*; D011878:Radiotherapy / Q000009:adverse effects; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine