title: Perioperative chemotherapy in patients with oral cancer.
abstract: In the final report of a prospective, randomized controlled clinical trial, we report the results of using adjuvant perioperative chemotherapy in patients with oral cancer. Our study is based on the hypothesis of Goldie and Coldman. A total of 135 patients with alveolobuccal carcinoma, classified as clinically stage III and IV, were entered on the protocol. After a curative resection, they were randomized. The patients in the test arm of the study received methotrexate 50 mg/m2 on the 3rd, 10th, and 17th postoperative days. The patients in the control arm underwent observation. This analysis at 24 months showed a disease-free survival rate of 61% in the test arm versus 37% in the control arm, which is statistically highly significant (P < 0.01). Analysis of the recurrence pattern showed that recurrence at the primary site was dramatically reduced during the first 6 postoperative months (P = 0.002). Our study provided further clinical evidence in support of the concepts of Goldie and Coldman that the timing of chemotherapeutic drugs is critical for a successful end result.
authors.affiliation: Department of Head and Neck Surgery, Tata Memorial Hospital, Parel, Bombay, India.
authors.forename: R S
authors.initials: RS
authors.lastname: Rao
authors.forename: D M
authors.initials: DM
authors.lastname: Parikh
authors.forename: H K
authors.initials: HK
authors.lastname: Parikh
authors.forename: M B
authors.initials: MB
authors.lastname: Bhansali
authors.forename: V H
authors.initials: VH
authors.lastname: Deshmane
authors.forename: A R
authors.initials: AR
authors.lastname: Fakih
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D011446:Prospective Studies
chemical_list: D008727:Methotrexate