CME CREDIT INFORMATION

Sessions can be individually reviewed for credit. You can participate in as few or as many as you desire.

Before the symposium begins, a pre-activity educational assessment consisting of approximately six to ten patient care treatment-strategy questions with multiple-choice answers will be conducted with the learners to determine how they currently treat their patients with lung cancer or head and neck cancer in order to determine a baseline of current medical oncologists' practices.

The format of the symposium is that most of its sessions will contain at least one major patient case study with multiple-choice treatment ARS questions for the learners (which will show the results from the live activity), and one Point-CounterPoint debate. The faculty has been instructed to begin each didactic presentation with a patient case study or a few clinical questions and ARS for providing additional learner involvement with the faculty at this symposium. This approach utilizing case studies and clinical questions to start each didactic presentation was initially used by the OLC at the Second Annual Symposium on Personalized Therapies and Best Clinical Practices for Breast Cancer that we conducted in January 2009 as a beta test, and it was highly successful.

Each session of the symposium will conclude with a 15-minute consensus period with a Q & A and panel discussion, which were recorded from the live activity, during which the following three questions are asked of the session's faculty regarding the particular session's content to help ensure that the content can be applied to clinical practice today: 1) Is this a new standard of care? 2) Should it be discussed with your patients? 3) How can you use it today in your practice? Further opportunities for learners' questions are provided during these consensus periods. And, including these novel consensus periods in our symposia has, indeed, helped ensure that knowledge and competence that is useful today is presented, rather than data that is not ready for the clinic.

The clinical applications of predictive and prognostic molecular biomarkers, including histology, gene mutations and other factors are becoming critically important for the selection of and usage of chemotherapies for NSCLC. Thus, there is a practice gap and a need to educate oncologists on how to actually apply these predictive and prognostic tests for developing personalized treatment strategies for patients with NSCLC. The clinical applications of chemotherapy for NSCLC have heretofore often been based on established and empirically derived first-line, second-line and third-line therapies. However, there is new data to show that the expression of specific cellular proteins such as ERCC-1, RRM1, Beta tubulin, and others may predict patient response to specific chemotherapy agents including taxanes, platinums and antimetabolites, and, also predict patient prognosis.

There is also data that shows that tumor histology can be predictive of response to some chemotherapy agents. It is quite clear that NSCLC patients with adenocarcinoma or large cell histological sub types respond better to certain drugs. These histology-based response differences were further corroborated by data presented at the 2009 ASCO meeting with results from a randomized Phase III trial of best supportive care (BSC) versus pemetrexed. Moreover, this clinical trial revealed an important new role for this chemotherapeutic agent, that of maintenance therapy for NSCLC until disease progression. Pemetrexed maintenance therapy offered Progression-Free Survival (PFS) and Overall Survival (OS) that was significantly superior to BSC. There is a gap that exists with some oncologists' understanding of how to optimally incorporate this chemotherapy agent into maintenance therapy of NSCLC.

The clinical applications of targeted therapies for many patients with NSCLC are critically important for improved survival and quality of life. Although the use of anti-angiogenesis therapy is now standard in patients with non-squamous histology, there remain some questions-in-practice regarding its use. These have included, “what is the optimum dose and duration of anti-angiogenesis therapy?” and “should anti-angiogenesis therapy be continued as maintenance therapy after the patient has progressed from first-line therapy?” How an anti-angiogenesis approach can be optimized in a multi-modality approach to NSCLC treatment is yet another question in-practice. Final results from the AVAil trial were presented at the 2009 ASCO meeting that further demonstrated the efficacy of bevacizumab in combination with platinumbased chemotherapy in the treatment of advanced NSCLC. And final safety data on AVAil confirmed the well-established and manageable safety profile of bevacizumab based therapy in patients with advanced NSCLC. Results from a randomized, double blind, placebo controlled, Phase IIIb, clinical trial (ATLAS) were presented at the 2009 ASCO meeting. These data showed that the addition of the anti-antiogenic agent, bevacizumab, plus the anti-EGFR agent, erlotinib, significantly prolonged the PFS of patients with NSCLC in the maintenance setting following first-line combination systemic therapy. Thus, a physician practice gap exists regarding the use of antiangiogenesis therapy in the treatment of NSCLC.

Therapies that target the EGFR pathway are also increasingly important for many patients with NSCLC. There have been several scientific advancements that may change how anti-EGFR therapy can be optimally applied in a personalized approach to NSCLC treatment. Factors such as EGFR expression and mutation status have been shown to be important for response to anti-EGFR therapy. Positive results from two clinical trials presented at the 2009 ASCO meeting were revealed that showed the efficacy of gefitinib as a single-agent therapy in patients with an EGFR mutation. One was a randomized, open-label, Phase III trial in selected patients with advanced NSCLC (IPASS) revealing the significant efficacy of single-agent gefitinib therapy in patients with an EGFR mutation, and showing that EGFR mutation status was a strong predictor of response to this agent. The other was of a similar design, but as of May 2009 there has only been the announcement at the 2009 ASCO meeting of a planned preliminary analysis for PFS. No results were released at the 2009 ASCO meeting. Also presented at the 2009 ASCO meeting regarding anti-EGFR therapy for patients with advanced NSCLC were the results from the SATURN trial, a double-blind, randomized, Phase III study of maintenance erlotinib. The SATURN trial met both its primary and co-primary endpoints with high statistical significance. Erlotinib in the maintenance setting significantly improves disease control and delays disease progression.

Some clinical studies have also shown that the mutation status of the Kras oncogene may also be another predictive factor for response to anti-EGFR therapy. However, results from one trial presented at the 2009 ASCO meeting showed that the updated clinical data from the FLEX trial (presented in 2008) did not support the previously raised hypothesis that the Kras mutation is predictive of cetuximab efficacy when combined with first-line chemotherapy for advanced NSCLC, whereas an early acne-like rash of any grade appears to be associated with a better outcome in patients treated with platinum-based chemotherapy plus cetuximab in this setting. An analysis of the SATURN trial data showed that the efficacy of erlotinib was similar in both the wild type and mutant Kras patients. Thus, the optimal roles of anti-EGFR therapy and the optimal selection of anti-EGFR patients and regimens for treating advanced NSCLC are areas that are evolving. Therefore, another goal of the Second Annual Symposium on Personalized Therapies and Best Clinical Practices for Lung Cancer and Head & Neck Cancer is to close these physician practice gaps regarding anti-EGFR treatment strategies.

Regarding recent developments in second-line therapy for patients with advanced NSCLC, results from a Phase III trial (ZODIAC) were presented at the 2009 ASCO meeting. The ZODIAC trial was the first study to show a significant clinical benefit of adding a targeted therapy to a chemotherapy agent for advanced NSCLC. In this trial, vandetanib, a small molecule inhibitor of VEGFR, EGFR and RET, in combination with docetaxel, met its primary endpoint of prolonging PFS versus docetaxel alone.

According to various sources, including www.clinical trials.gov, pharmaceutical company press releases, and, pharmaceutical company Web sites, as of June 2009 there are at least ten investigational drugs for lung cancer in Phase III trials and five in Phase II trials. These investigational agents include targeted therapies and chemotherapies. They include IGF-1R agents, various tyrosine kinase inhbitors including multiple and dual pathway inhibitors, vaccines, anti-EGFR and anti-VEGF monoclonal antibodies, a platinum agent, and an anthracyclinne.

The Oncology Learning Center designates this educational activity for a maximum of 8 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

All faculty and OLC staff participating in the content, planning or implementation of an educational CME activity are required to disclose to the audience of the educational activity any relevant financial relationships or interests and to assist in the resolution of any conflict of interest that may arise from the relationship(s) or interest(s). It is also the policy of the OLC to require all faculty presenters to make a meaningful disclosure to the audience of their discussions of unlabeled or FDA unapproved drugs, products, tests or devices. This information will be available as part of the educational activity and related material.

The following faculty and OLC staff have reported real or potential relevant conflicts of interest and these conflicts have been resolved, prior to this educational activity through a peer-review process by two medical oncologists who have had no affiliation with this educational activity other than the peer review process.  This is documented on this page immediately following the financial disclosures below.

Sincere appreciation is extended to the following companies for their generous support of this educational meeting: