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Background: In 2012,ASCO Identified opportunities to improve the quality and value of cancer care by reducing inappropriate and/or prolonged use of chemotherapy The NCCN compendium is recognized as an authoritative reference for insurance coverage for drug indications without FDA approval.We evaluated FDA-approved,compendia and unapproved use of chemotherapy.Methods: We useddata from the SEER-Medicare database to identify patients with metastatic cancer who received chemotherapy.For each tumor,drugs with >3 claims were identified.Each drug was classified as having an FDA-approved indication,an indication based on NCCN compendia guidelines or neither of these.The number of claims for each drug was calculated.Logistic regression was used to assess the factors that Results: Between 1998-2007,37,351 subjects were identified as having received chemotherapy; of these,24,876(66.6%)received only FDA approved drugs,and 12,475(33.4%)received at least one unapproved drug.Of those who received an unapproved drug,8,669(69%)received a drug with a compendia listing.Therefore,of the total population,10%received a drug that was neither FDA nor compendia approved.The mean number of unapproved claims was 10.3(SD=15.2)and the mean number of drugs was 1.3.Unapproved use was highest in subjects with prostate and lowest in patients with colon cancer.In a multivariate analysis,unapproved use decreased with increasing age and >2 comorbid conditions.Compared to prostate cancer,the odds of having an unapproved drug was lower for breast(OR=0.27),colon(OR=0.08),lung(OR=0.65),ovary(OR=0.38),uterus(OR=0.49)and myeloma(OR=0.60).No patients with colon or prostate cancer received compendia-approved drugs.Over 90%of unapproved use for breast,ovary and lung cancer were compendia-approved.Costs associated with unapproved/compendia use will be presented.Conclusions: A large fraction of patients who use chemotherapy receive FDA-unapproved drugs; however,the majority of those drugs are acknowledged by NCCN.A better understanding of the costs and benefits of compendia-approved drugs is warranted to reduce the costs of cancer care.