Drug Utilization, Safety and Effectiveness of Anti-Cancer Drugs for Solid Tumors: A Focus on Special Populations

Dear Colleagues,

In the last decade, the pharmacological treatment of most parts of advanced/metastatic solid tumors has been revolutionized by the approval of novel anti-cancer pharmacotherapies such as target therapies and immunotherapies. However, the marketing authorizations of anti-cancer therapies are usually based on the results of randomized controlled trials with a low number of patients, with a short duration of exposure and with stringent selection criteria. Special populations such as women, children, elderly, pregnant women, racial/ethnic minorities and patients with concurrent diseases are absent or underrepresented in clinical trials concerning cancer. Safety and effectiveness, as well as drug utilization of anti-cancer drugs in clinical practice, may be different than expected. Pharmacoepidemiology and pharmacovigilance studies can help improving this lack of knowledge. On the one hand, the use of routinely collected electronical healthcare data to conduct pharmacoepidemiology studies has advantages in terms of the inclusion of a large number of patients underrepresented in clinical trials. On the other hand, data coming from spontaneous reporting systems are fundamental to observe the safety profile of anticancer drugs and to detect safety signals in the broad population. The present Special Issue aims to fill the knowledge gap on the use, the safety and the effectiveness of anti-cancer drugs used in the treatment of solid tumors in clinical practice. Articles that focus on special populations will be prioritized for inclusion in this Special Issue. Original research articles such as pharmacoepidemiologic studies and pharmacovigilance studies, as well as reviews and meta-analysis, will be welcome.

Bullet points:

1) Safety of target-therapies and immunotherapies in pediatric patients with solid tumors;

2) Effectiveness of target-therapies and immunotherapies in pediatric patients with solid tumors;

3) Safety of immunotherapy in women and men with solid tumors;

4) Effectiveness of immunotherapy in women and men with solid tumors;

5) Sex difference in terms of drug utilization of anti-neoplastic drugs;

6) Drug utilization of anti-neoplastic drugs among elderly patients and in those with concomitant diseases.

Dr. Andrea Spini
Dr. Sandra Donnini
Guest Editors

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