title: Tolerance and toxicity of neoadjuvant docetaxel, cisplatin and 5 fluorouracil regimen in technically unresectable oral cancer in resource limited rural based tertiary cancer center.
abstract: BACKGROUND
  Recent studies indicate neoadjuvant chemotherapy (NACT) can result in R0 resection in a substantial proportion of patients with technically unresectable oral cavity cancers. However, data regarding the efficacy and safety of docetaxel, cisplatin and 5 fluorouracil (TPF) NACT in our setting is lacking. The present audit was proposed to evaluate the toxicities encountered during administration of this regimen. It was hypothesized that TPF NACT would be considered feasible for routine administration if an average relative dose intensity (ARDI) of ≥0.90 or more in at least 70% of the patients.
  
  
  METHODS
  Technically unresectable oral cancers with Eastern Cooperative Oncology Group PS 0-2, with biopsy proven squamous cell carcinoma underwent two cycles of NACT with TPF regimen. Toxicity and response rates were noted following the CTCAE 4.03 and RECIST criteria. Descriptive analysis of completion rates (completing 2 cycles of planned chemotherapy with ARDI of 0.85 or more), reason for delay, toxicity, and response are presented.
  
  
  RESULTS
  The NACT was completed by all patients. The number of subjects who completed all planned cycles of chemotherapy are with the ARDI of the delivered chemotherapy been equal to or >0.85 was 11 (91.67%). All toxicity inclusive Grade 3-5 toxicity was seen in 11 patients (91.67%). The response rate of chemotherapy was 83.33%. There were three complete response, seven partial response, and two stable disease seen post NACT in this study.
  
  
  CONCLUSIONS
  Docetaxel, cisplatin and 5 fluorouracil regimen can be routinely administered at our center with the supportive care methods and precautionary methods used in our study.
authors.affiliation: Department of Clinical Hematology and Medical Oncology, Malabar Cancer Center, Thalassery, Kannur, Kerala, India.
authors.forename: V M
authors.initials: VM
authors.lastname: Patil
authors.forename: S
authors.initials: S
authors.lastname: Chakraborty
authors.forename: P K
authors.initials: PK
authors.lastname: Shenoy
authors.forename: A
authors.initials: A
authors.lastname: Manuprasad
authors.forename: T P
authors.initials: TP
authors.lastname: Sajith Babu
authors.forename: T
authors.initials: T
authors.lastname: Shivkumar
authors.forename: S
authors.initials: S
authors.lastname: Babu
authors.forename: A
authors.initials: A
authors.lastname: Bhatterjee
authors.forename: S
authors.initials: S
authors.lastname: Balasubramanian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000191:economics / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006295:Health Resources / Q000191:economics*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000191:economics / Q000473:pathology; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D012074:Remission Induction; D012424:Rural Population; D043823:Taxoids / Q000008:administration & dosage; D062606:Tertiary Care Centers; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil