CEO Message 2005: The Role of Maintenance Therapy.

It is a very exciting time for cancer research with over 500 products in development and one-third of the pharmaceutical industry’s research budget allotted toward new cancer drug development. Despite all of the current excitement over new drug development, unanswered questions remain regarding the best use of the approved compendium, including:

• What is the treatment duration?
• What is the dose and the frequency of dosing?
• What is the optimal effectiveness in combination therapy?

An area of particular interest to the Pharmatech Research Network is maintenance therapy/chronic treatment and response. One Pharmatech study utilizes Gemzar as response consolidation in the treatment of NSCLC (non-small cell lung cancer). The study involves four cycles of Carboplatin and Gemzar as induction therapy. Patients that have not
progressed are randomized to supportive care or to additional cycles of Gemzar. Although this Phase III protocol was initiated three years ago, the question it addresses is even more relevant today.

The challenge for this trial and other maintenance trials is to measure the length of remission (or survival) while trying to determine symptom-free survival and quality-of-life during the maintenance phase. Intuitively, the industry believes that chronic therapy will prolong survival, however, these long-term clinical trials must be completed in a timely fashion. Patient enrollment in maintenance trials needs to happen as soon as possible in order to answer the aforementioned questions.

If your practice and your patients are interested in the role of maintenance therapy in advanced NSCLC, please contact us to become a participant in this study. In order to reach a target of 600 patients enrolled in the study to present results at ASCO 2007, we need 10-20 additional investigators to enroll 5-10 patients each in the next 12 months. The data from the Gemzar study will help us understand the affects of continued chemotherapy after initial disease response in regards to disease progression and patient outcomes. As always, we appreciate your contributions to research.

Matthew B. Wiener, PharmD