title: Metronomic chemotherapy in platinum-insensitive failures and/or early failures postmultimodality management in oral cancers.
abstract: OBJECTIVE
  Oral cancer patients with platinum-resistant disease and or early failures have limited treatment options. This analysis was planned to study the efficacy of metronomic chemotherapy in this group of patients.
  
  
  METHODS
  This was a retrospective analysis of oral cancer patients who had squamous cell carcinoma and had an early failure and/or platinum-insensitive failure. Early failure was defined as a failure either within 1-month of adjuvant radiotherapy or within 6 months of chemoradiation (CTRT). A sample size of 100 patients was selected for this study. If ≥39 of 100 patients would have survived at 6 months with metronomic chemotherapy, then additional studies would be warranted.
  
  
  RESULTS
  The ECOG PS was 0-1 in 92 patients and 2 in 8 patients. The subsite of primary was buccal mucosa in 38 patients (38%), anterior two-third tongue (oral tongue) in 51 patients (51%), and alveolus in 11 patients (11%). The median estimated overall survival was 110 days (95% confidence interval [CI]: 85-134 days). The proportion of patients surviving at 6 months was 26.4% (95% CI: 17.9-35.6).
  
  
  CONCLUSIONS
  Metronomic combination of methotrexate and celecoxib failed to meet its prespecified efficacy limit and should not be used in these patients as routine.
authors: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors: Vijay M
authors: VM
authors: Patil
authors: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors: Vanita
authors: V
authors: Noronha
authors: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors: Amit
authors: A
authors: Joshi
authors: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors: Rakesh
authors: R
authors: Pinninti
authors: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors: Sachin
authors: S
authors: Dhumal
authors: Division of Clinical Research and Biostatistics, Malabar Cancer Centre, Kerala, India.
authors: Atanu
authors: A
authors: Bhattacharjee
authors: Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
authors: Kumar
authors: K
authors: Prabhash
keywords: Head and neck cancer; metronomic; oral cancer; palliative chemotherapy; platinum refractory; platinum-insensitive; platinum-resistant