title: Health-related quality of life in patients with metastatic, relapsed, or inoperable squamous cell carcinoma of the head and neck in India.
abstract: OBJECTIVE
  The objective of this study was to evaluate changes in health related quality of life (HRQoL) in patients with metastatic head and neck (H&N) cancer randomized to receive metronomic (methotrexate and celecoxib) or cisplatin chemotherapy.
  
  
  METHODS
  Patients older than 18 years, with a Karnofsky Performance score of ≥70, and diagnosed with metastatic, locally advanced inoperable or recurrent head and neck (H&N) cancer not amenable to surgery or radiation were randomized (1:1) to receive metronomic or cisplatin chemotherapy. All patients were recruited from the Tata Memorial Hospital, Mumbai, India. In addition to demographic and baseline clinical characteristics, patients were asked to rate their HRQoL using the EORTC QLQ-C30 and the EORTC QLQ-H&N35 questionnaires (Indian versions) at baseline and at the end of each chemo cycle (every 3 weeks) till the end of study or early termination.
  
  
  RESULTS
  Of the 110 patients screened, 87 agreed to participate in the study. Mean age of the study population was 47.5 years (S.D. ±10.04) for the metronomic group and 47.2 years (S.D. ±9.89) for the cisplatin group. Overall quality of life was not significantly different between the two treatment groups from baseline to end of treatment. However, there was a statistically significant improvement in Pain QLQ-C30 score from baseline to week 3 (OR = 3.14, p = 0.036) and week 6 (OR = 3.33, p = 0.034) in the metronomic arm compared with the cisplatin arm.
  
  
  CONCLUSIONS
  In addition to improvements in survival, understanding the impact of treatment options on changes in HRQoL is important as it can aid physicians in making treatment and rehabilitation decisions for patients with advanced inoperable H&N cancer.
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Room no-304, Parel, Mumbai, 400012, India.
authors.forename: Vanita
authors.initials: V
authors.lastname: Noronha
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Room no-304, Parel, Mumbai, 400012, India.
authors.forename: Amit
authors.initials: A
authors.lastname: Joshi
authors.affiliation: pharmEDGE, Mumbai, India.
authors.forename: Shalaka
authors.initials: S
authors.lastname: Marfatia
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Room no-304, Parel, Mumbai, 400012, India.
authors.forename: Vijay
authors.initials: V
authors.lastname: Patil
authors.affiliation: Department of Radiology, Tata Memorial Hospital, Mumbai, India.
authors.forename: Shashikant
authors.initials: S
authors.lastname: Juvekar
authors.affiliation: Department of Radiology, Tata Memorial Hospital, Mumbai, India.
authors.forename: Supreeta
authors.initials: S
authors.lastname: Arya
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Room no-304, Parel, Mumbai, 400012, India.
authors.forename: Shripad
authors.initials: S
authors.lastname: Banavali
authors.affiliation: Department of Medical Oncology, Tata Memorial Hospital, Room no-304, Parel, Mumbai, 400012, India. kumarprabhashtmh@gmail.com.
authors.forename: Kumar
authors.initials: K
authors.lastname: Prabhash
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology*; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011788:Quality of Life; D000077195:Squamous Cell Carcinoma of Head and Neck
chemical_list: D000970:Antineoplastic Agents
keywords: EORTC QLQ-C30; EORTC QLQ-H&N35; Head and neck cancer; Health-related quality of life; Outcome assessments; Validation