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Chemotherapy alone vs. chemotherapy plus high dose multiple antioxidants in patients with advanced non small cell lung cancer.

AbstractOBJECTIVE:
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.
AuthorsAshutosh K Pathak, Manisha Bhutani, Randeep Guleria, Sabyasachi Bal, Anant Mohan, Bidhu K Mohanti, Atul Sharma, Raminder Pathak, Narendra K Bhardwaj, Kedar N Prasad, Vinod Kochupillai
JournalJournal of the American College of Nutrition (J Am Coll Nutr) Vol. 24 Issue 1 Pg. 16-21 (Feb 2005) ISSN: 0731-5724 [Print] United States
PMID15670980 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antineoplastic Agents
  • Antioxidants
  • beta Carotene
  • Vitamin E
  • Ascorbic Acid
Topics
  • Adult
  • Aged
  • Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
  • Antineoplastic Combined Chemotherapy Protocols
  • Antioxidants (administration & dosage, therapeutic use)
  • Ascorbic Acid (administration & dosage, therapeutic use)
  • Carcinoma, Non-Small-Cell Lung (drug therapy, mortality)
  • Drug Synergism
  • Female
  • Humans
  • Lung Neoplasms (drug therapy, mortality)
  • Male
  • Middle Aged
  • Survival Analysis
  • Vitamin E (administration & dosage, therapeutic use)
  • beta Carotene (administration & dosage, therapeutic use)

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