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J Clin Oncol. 2014 Nov 10;32(32):3634-42. doi: 10.1200/JCO.2014.55.8437. Epub 2014 Sep 29.

Risk of incremental toxicities and associated costs of new anticancer drugs: a meta-analysis.

Author information

1
Saroj Niraula, CancerCare Manitoba and University of Manitoba, Winnipeg, Manitoba; Eitan Amir, Francisco Vera-Badillo, and Ian F. Tannock, Princess Margaret Hospital and University of Toronto, Toronto, Ontario, Canada; Bostjan Seruga, Institute of Oncology Ljubljana, Ljubljana, Slovenia; and Alberto Ocana, Albacete University Hospital, Albacete, Spain. saroj.niraula@cancercare.mb.ca.
2
Saroj Niraula, CancerCare Manitoba and University of Manitoba, Winnipeg, Manitoba; Eitan Amir, Francisco Vera-Badillo, and Ian F. Tannock, Princess Margaret Hospital and University of Toronto, Toronto, Ontario, Canada; Bostjan Seruga, Institute of Oncology Ljubljana, Ljubljana, Slovenia; and Alberto Ocana, Albacete University Hospital, Albacete, Spain.

Abstract

PURPOSE:

There are increasing reports of rare but serious toxicities caused by new anticancer drugs, and there are costs associated with their management.

METHODS:

We identified anticancer drugs approved by the U.S. Food and Drug Administration from 2000 to 2011 and pivotal trials supporting their registration. Twelve frequent grade 3 to 4 adverse event (AEs) were weighted and pooled in a meta-analysis. Estimates of incremental drug prices and incremental costs for management of AEs were calculated according to type of new agent based on target specificity.

RESULTS:

We identified 41 studies comprising 27,539 patients and evaluating 19 experimental drugs. Agents directed against a specific molecular target on cancer cells had a lower incidence of grade 3 to 4 toxicities compared with controls (median risk ratio [RR], 0.67; P = .22), whereas less-specific targeted agents, including angiogenesis inhibitors (median RR, 3.39; P < .001) and chemotherapeutic agents (median RR, 1.73; P < .001), were more toxic. Risk was increased regardless of whether the control arm contained active treatment (RR, 2.11; P < .001) or not (RR, 3.02; P < .001). Median incremental drug price for experimental agents was $6,000 per patient per month. Median cost of managing toxicity was low compared with drug costs but higher than controls for treatment with less-specific targeted agents and chemotherapies.

CONCLUSION:

Newly approved anticancer drugs are associated with increased toxicity, except for agents with a specific molecular target on cancer cells. Management of toxicity leads to a small increase in overall cost of treatment. Frequency of toxicity and associated costs are likely higher in less-selected patients treated in general oncologic practice. Development of biomarker-driven agents should be encouraged.

PMID:
25267757
DOI:
10.1200/JCO.2014.55.8437
[Indexed for MEDLINE]

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