title: Chemotherapy alone vs. chemotherapy plus high dose multiple antioxidants in patients with advanced non small cell lung cancer.
abstract: OBJECTIVE
  In vitro and animal studies suggest that antitumor effect of chemotherapeutic agents may be enhanced by antioxidants. Therefore, we initiated a clinical study to test the efficacy of high-dose multiple antioxidants (vitamins C, E and beta carotene) as an adjunct to chemotherapy (paclitaxel and carboplatin) in non-small-cell lung cancer.
  
  
  METHODS
  136 patients of stage IIIb and stage IV NSCLC were randomized to receive chemotherapy (paclitaxel and carboplatin) alone (chemotherapy arm, n = 72) or chemotherapy in combination with ascorbic acid 6100 mg/day, dl-alpha-tocopherol (vitamin E) 1050 mg/day and beta-carotene 60 mg/day (combination arm, n = 64). Survival were calculated by the Kaplan-Meier method and compared using the log-rank test.
  
  
  RESULTS
  An overall response rate (RR) of 33% was observed in chemotherapy arm with 24 patients showing a partial response (PR) and none showing a complete response (CR). In combination arm the overall RR was 37% with 24 patients showing PR and two showing CR. The median survival times in chemotherapy arm and combination arm were nine and 11 months respectively. The overall survival (OS) rates in chemotherapy arm and combination arm at one year were 32.9% and 39.1%, and at two years, 11.1% and 15.6% respectively. None of these differences were statistically significant (p = 0.20). Toxicity profiles were similar in both arms.
  
  
  CONCLUSIONS
  These results do not support the concern that antioxidants might protect cancer cells from the free radical damage induced by chemotherapy. Larger trials are needed to demonstrate whether high-dose multiple antioxidants in conjunction with chemotherapy increase the response rates and/or survival time in advanced lung cancer.
authors.affiliation: Department of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110 029, INDIA.
authors.forename: Ashutosh K
authors.initials: AK
authors.lastname: Pathak
authors.forename: Manisha
authors.initials: M
authors.lastname: Bhutani
authors.forename: Randeep
authors.initials: R
authors.lastname: Guleria
authors.forename: Sabyasachi
authors.initials: S
authors.lastname: Bal
authors.forename: Anant
authors.initials: A
authors.lastname: Mohan
authors.forename: Bidhu K
authors.initials: BK
authors.lastname: Mohanti
authors.forename: Atul
authors.initials: A
authors.lastname: Sharma
authors.forename: Raminder
authors.initials: R
authors.lastname: Pathak
authors.forename: Narendra K
authors.initials: NK
authors.lastname: Bhardwaj
authors.forename: Kedar N
authors.initials: KN
authors.lastname: Prasad
authors.forename: Vinod
authors.initials: V
authors.lastname: Kochupillai
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D000975:Antioxidants / Q000008:administration & dosage / Q000627:therapeutic use*; D001205:Ascorbic Acid / Q000008:administration & dosage / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D004357:Drug Synergism; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D014810:Vitamin E / Q000008:administration & dosage / Q000627:therapeutic use; D019207:beta Carotene / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D000975:Antioxidants; D019207:beta Carotene; D014810:Vitamin E; D001205:Ascorbic Acid