title: A pilot study of preoperative continuous infusion 5-fluorouracil, external microwave hyperthermia, and external beam radiotherapy for treatment of locally advanced, unresectable, or recurrent rectal cancer.
abstract: OBJECTIVE
  To determine the feasibility of combining external beam radiotherapy, continuous infusion 5-fluorouracil (5-FU), and external microwave hyperthermia in patients with locally advanced, unresectable, or recurrent adenocarcinoma of the rectum.
  
  
  METHODS
  From 7/95 through 2/99, 15 patients were enrolled in the study. The treatment regimen consisted of continuous infusion 5-FU 250 mg/m(2)/d 7 days/week beginning on day 1, external beam radiotherapy to the pelvis, 4500 cGy, 180 cGy/d 5 days/week using a 3 or 4-field technique, and external microwave hyperthermia on days 3, 8, 15, 22, and 29. Chemotherapy was stopped on the last day of radiotherapy. Surgical resection, if feasible, was scheduled 3-6 weeks after completing thermochemoradiotherapy. For this regimen to be considered feasible, no more than 2 of the 15 patients should fail to complete therapy due to life-threatening toxicity. Toxicity was scored using National Cancer Institute Criteria.
  
  
  RESULTS
  All patients completed the chemoradiotherapy portion of the protocol. Eleven of the 15 patients completed all 5 hyperthermia treatments. Of the 4 patients who did not receive the full course of hyperthermia, only 1 patient had treatment stopped due to life-threatening toxicity. The other 3 patients did not complete hyperthermia due to scheduling errors (n = 2) or patient request (n = 1). Five of 15 patients required a treatment interruption due to toxicity > or = Grade 3. Seven patients experienced lesser degrees of toxicity which did not require treatment interruption. Three patients experienced no side effects. The most common toxicities were dermatitis and diarrhea. Of the 14 patients in whom surgery was planned, 11 (79%) were resectable. There was one pathologic complete response.
  
  
  CONCLUSIONS
  It is feasible to deliver thermochemoradiotherapy, as prescribed in this study, to patients with locally advanced, unresectable, or recurrent rectal cancer. The therapy is moderately toxic, with one-third of patients requiring temporary treatment interruptions. The regimen appears active against rectal cancer, and appears to warrant further consideration as a treatment option for this patient population.
authors.affiliation: Department of Radiation Oncology, Duke Comprehensive Cancer Center, Duke University Medical Center, Durham, NC 27710, USA. anscher@radonc.duke.edu
authors.forename: M S
authors.initials: MS
authors.lastname: Anscher
authors.forename: C
authors.initials: C
authors.lastname: Lee
authors.forename: H
authors.initials: H
authors.lastname: Hurwitz
authors.forename: D
authors.initials: D
authors.lastname: Tyler
authors.forename: L R
authors.initials: LR
authors.lastname: Prosnitz
authors.forename: P
authors.initials: P
authors.lastname: Jowell
authors.forename: G
authors.initials: G
authors.lastname: Rosner
authors.forename: T
authors.initials: T
authors.lastname: Samulski
authors.forename: M W
authors.initials: MW
authors.lastname: Dewhirst
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D008297:Male; D008872:Microwaves / Q000627:therapeutic use*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*; D010865:Pilot Projects; D011878:Radiotherapy / Q000379:methods; D012004:Rectal Neoplasms / Q000473:pathology / Q000532:radiotherapy / Q000628:therapy*
chemical_list: D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil