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Evaluation of Adverse Events Experienced by Older Patients Participating in Studies of Molecularly Targeted Agents Alone or in Combination

Authors' Affiliation: Princess Margaret Hospital Phase II Consortium, Ontario, Canada

Requests for reprints: Lillian L. Siu, Princess Margaret Hospital, University Health Network, 610 University Avenue, Suite 5-210, Toronto, Ontario, M5G 2M9, Canada. Phone: 416-946-2911; Fax: 416-946-6546; E-mail: lillian.siu{at}uhn.on.ca.

Background: The tolerability of molecularly targeted agents in older patients has not been specifically examined. Adverse event data from clinical trials in the Princess Margaret Hospital Phase II Consortium database were analyzed to address this question.

Methods: The Consortium database collects trial information on all patients treated with either a molecularly targeted agent alone or in combination since 2001. The frequency of adverse events was determined and analyzed by two different age groups, <65 years and 65 years. Toxicity indices (TI) and frequencies of dose-limiting toxicities (DLT), based on adverse events of all causalities (TI_ALL and DLT_ALL), and on adverse events that were at least possibly related to the molecularly targeted agent (TI_MTA and DLT_MTA), were calculated for both age groups.

Results: Four hundred and one patients who received 1,252 treatment cycles were analyzed from 19 different studies. Baseline performance status was similar between both age groups, but fewer older patients have had multiple prior regimens of chemotherapy or prior radiation therapy. A comparison of the proportions of younger and older patients experiencing DLT_ALL and DLT_MTA showed similar results. The TI_MTA values were comparable between the two age groups in both single agent (3.25 versus 3.00, for <65 versus 65 years) and multi-agent (3.65 versus 3.00, for <65 versus 65 years) trials.

Conclusions: Older patients seem to tolerate molecularly targeted therapies either alone or in combination with chemotherapy as well as younger patients. Age alone should not be a barrier in the administration of targeted agents.

Commentary

Cancer Treatment and the Older Patient

Edward L. Trimble and Michaele C. Christian
Clin. Cancer Res. 2006 12: 1956-1957. [Full Text] [PDF]

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