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

Abstract

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 z65 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 z65 years) and multi-agent (3.65 versus 3.00, for <65 versus z65 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.

Safety and Efficacy of Sorafenib in Elderly Patients Treated in the North American Advanced Renal Cell Carcinoma Sorafenib Expanded Access Program

“…However, evidence is growing that many elderly patients are able to tolerate targeted therapy as well as younger patients [20]. In a study investigating the toxicity of targeted therapies either alone or in combination with chemotherapy in various cancer types, toxicity was similar in older (≥65 years) and younger (<65 years) patients [22]. Growing evidence suggests that the efficacy and tolerability of sorafenib in advanced RCC is generally independent of age, and the results from this study add further evidence to support these findings [4,20].…”

Use of a simplified geriatric evaluation in thoracic oncology

“…Several studies [15][16][17][18][19] failed to detect any influence of age on the response to chemotherapy in bronchial cancer. Other studies have demonstrated that a large proportion of elderly patients are capable of receiving anti-cancer chemotherapy, even more modern compounds, of being treated by radiotherapy and of undergoing surgical pulmonary excision [14,20]. The management of cancer patients ≥75 years of age should therefore be decided according to the oncological reference system, taking into account information provided by geriatric evaluation [6,[21][22][23].…”

Le problème difficile du choix des traitements en cancérologie chez le sujet âgé: qualité ou quantité de vie?

“…Si les études publiées de phase I à III tendent à montrer la capacité des sujets âgés à tolérer les traitements médicaux de la même manière que les sujets plus jeunes et à en tirer un bénéfice identique [15,29], elles sont souvent conduites chez des sujets âgés sélectionnés sur les mêmes critères que des sujets plus jeunes. Or, ces sujets âgés aux fonctions vitales satisfaisantes, appelés « fit elderly » par les AngloSaxons, reflètent très imparfaitement la population âgée globale, non nécessairement retrouvée en milieu urbain ou universitaire.…”