Taught by the top academic experts in lung cancer and head and neck cancer this is the thoracic CME symposium that you should attend this year.  It consists of the topics and sessions that are of the highest relevance to oncologists and hematologist/oncologists and other clinicians treating lung cancer and/or head and neck cancer patients.  And this symposium's faculty are the true world experts in their field.  The data to be presented at this symposium also contains the highlights from the June 2009 ASCO and from the August 2009 World Lung Cancer Congress (WLCC). So this symposium's content is the most up-to-date and relevant. You get the benefit of the best of ASCO and the best of WLCC for treating your lung cancer and head and neck cancer patients....all in a one-day CME meeting.

Several improvements have been made to this symposium that will help make it even better than last year's highly successful symposium. These include the following:

1. The symposium is more interactive between the audience and faculty.  The format is heavily case-study based with numerous patient treatment decision questions asked of the audience.  Each presentation will begin with either a patient case study with several therapy-related questions for the audience, or one clinical question for the audience.  And within three of the four symposium sessions there are additional patient case studies where the audience again is questioned and selects treatments.
2. There are three Point-CounterPoint debates on important controversial topics, and the audience votes before and after each debate. These debates have been rated very highly by past participants who have requested more case studies and more debates.
3. For further involvement with the faculty, during the meeting, the audience will be able to "tweet" via Twitter to ask questions or make comments. This will require the use of your own computers with your own portable, wireless internet access card, or "smart cell phones" with Twitter installed....most Blackerry's, iPhones, and most other newer cell phones can be easily Twitter enabled.
4. To ensure that the data presented by the faculty can be put into clinical practice today, after each session, a fifteen-minute "consensus period" will be conducted where the faculty asks each other the following three questions: 1) Is this a new standard of care? 2) Should it be discussed with your patients? and 3) How can you use it today in your practice?
5. A "Lunch with Professors" session has been added providing additional opportunities to interact with the faculty.  Each of the thirteen faculty will sit at a separate lunch table.  The audience decides which faculty with whom they wish to have lunch. This also provides an extra hour of CME credit.
6. A new presentation has been added to help community-based, non-academic clinicians fully understand how to utilize and interpret all of the various molecular and genetic tests needed for personalizing treatments for their patients with lung cancer and/or head and neck cancer. This new presentation will be given by one of the world's leading authorities on this subject, Dr. Mark Ladanyi, a lung pathologist, the Chief of Molecular Diagnostics Service at Memorial Sloan-Kettering Cancer Center.  Dr. Ladanyi was selected because he is an expert and a great teacher.
7. A special new 20-minute panel discussion has been added which will be lead by Dr. Paul Bunn. The audience will be able to ask questions of the panel regarding the value and clinical applications of any commercially available NSCLC and Head & Neck Cancer diagnostic tests that may or may not be yet validated with a prospective clinical trial.
8. The symposium was moved to downtown Philadelphia from Chicago.
9. The symposium has been shortened to one day, allowing for personal time with your spouse or significant other during the weekend.

Advancements in molecular biomarker technology have been evolving quite significantly during the past year and have helped lead to new clinical applications of these predictive and prognostic factors. These molecular biomarkers have helped researchers find more effective clinical roles for established chemotherapies, and also for targeted therapies for treating NSCLC.  As revealed from our direct measurements and from the references in the literature and other data sources, these technological advancements are evolving and emerging so rapidly that many oncologists are not able to remain current with all of the applications of this new information, and so this represents a major practice gap for the treatment of NSCLC. Thus, a comprehensive understanding of both the science and of the practical aspects, or “how to use” the state-of-the-art molecular biomarker technology is clearly needed. One goal of the Second Annual Symposium on Personalized Therapies and Best Clinical Practices for Lung Cancer and Head & Neck Cancer is to close this practice gap resulting from the rapid advancement of biomarker technology.

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 been based on established and empirically derived first-line, second-line and third-line therapies.  However, now there is data to show that the expression of specific cellular proteins such as ERCC-1, RRM1, Beta tubulin, SPARC and others may predict patient response to specific chemotherapy agents including taxanes, platinums and antimetabolites, and, also predict patient prognosis. There is also recent data that shows that tumor histology can be predictive of response to specific chemotherapy agents. It is quite clear that NSCLC patients with adenocarcinoma or large cell histological sub types respond better to certain drugs, such as pemetrexed. 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 many 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 remains 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 platinum-based 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 anti-angiogenesis 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 of 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. And a retrospective analysis from another clinical trial using an anti-EGFR approach for NSCLC presented at ASCO 2009 (BMS099) showed that there was no significant correlation between patient response to cetuximab and any molecular marker evaluated to date (including Kras mutation, EGFR mutation, EGFR by IHC, and EGFR by FISH). Moreover, 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 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 anthracycline.

Head & Neck Cancer

The treatment of Head and Neck Cancer (HNC) in patients with locally-advanced, recurrent, or metastatic disease remains quite challenging. Long-term survival varies from 10% to 50%, depending upon the site, stage and resectability of the tumor. Surgical intervention is potentially curative in resectable patients. However, preservation of organ structure and function is a major concern. Chemotherapy before definitive surgery and radiation therapy has been demonstrated to increase response in both localized disease and disease with lymph node metastasis. At the 2009 ASCO annual meeting, data from a Phase III clinical trial (Hitt) stated that for unresectable, locally-advanced HNC, induction chemotherapy with docetaxel, cisplatin and 5-FU should now be considered a standard of care.  How chemotherapy can be optimally applied in a personalized approach to the treatment of HNC is a current question-in-practice and practice gap.

Improved results have been observed with the clinical applications of targeted therapies for HNC. The optimal roles of targeted therapies such as anti-EGFR strategies in the treatment of HNC are areas that are rapidly evolving and, thus, represent an identifiable physician practice gap. At the ASCO 2009 meeting, proteomics helped provide further support for using anti-EGFR monotherapy with either erlotinib, gefitinib or cetuximab for squamous cell HNC. Thus, there is a practice gap and an educational need to review and evaluate the most up-to-date data regarding the clinical application of anti-EGFR other targeted therapies for the treatment of patients with HNC. Preliminary results from one Phase II trial reported at the 2009 ASCO meeting suggested that sorafenib may be a useful agent in treating patients with thyroid cancer.

These educational activities are designed to meet the educational needs of medical oncologists, hematologist/oncologists, radiation oncologists, surgical oncologists, pathologists, nurse practitioners/nurses, pharmacists, fellows and other health care professionals who are involved in the treatment or management of patients with lung cancer or head and neck cancer.  These thoracic malignancies are treated optimally by a multi-disciplinary approach of clinicians and, thus, they are all targeted for invitation to these educational activities.

Based on the data identified in the Needs Assessment and Physician Practice Gap Analysis, the following Educational Objectives have been developed for these CME activities:

1. Evaluate the roles of predictive and prognostic molecular biomarkers for the treatment of thoracic malignancies.
2. Devise strategies to apply predictive and prognostic tests in the clinic in order to help develop personalized systemic therapy regimens for optimal treatment of patients with thoracic malignancies.
3. Evaluate the roles of histology in the development of optimal treatment strategies for systemic therapy of thoracic malignancies.
4. Evaluate the roles of gene mutations in the development of optimal treatment strategies for systemic therapy of thoracic malignancies.
5. Analyze the large amount of new clinical data revealed in 2009 for personalization of treatments for patients with thoracic malignancies receiving first-line therapy and for those who are refractory to prior treatment, and, for NSCLC patients receiving maintenance therapy.
6. Determine the optimal roles of chemotherapies, including anti-metabolites, multi-targeted antifolates, taxanes and platinums for the personalized treatment of patients with thoracic malignancies.
7. Determine the newest applications of targeted therapies, including combinations of anti-angiogenesis agents and combinations of anti-EGFR agents in the first-line and maintenance settings, single-agent anti-EGFR therapy in the first-line setting, and other targeted approaches for the treatment of patients with thoracic malignancies.
8. For maintenance or consolidation therapy of NSCLC, devise the best clinical practice treatment strategies using chemotherapy, including multi-targeted antifolates, and also using targeted therapy, including anti-EGFR and anti-angiogenesis approaches, to increase PFS.
9. Devise strategies to optimize multi-modality approaches for the personalized treatment of HNC with best clinical practices: the use of HPV and p16 molecular biomarkers for improved prognosis, and the use of blood-based testing to select HNC populations to receive anti-EGFR monotherapy.
10. Evaluate clinical data revealing a new standard of care using induction chemotherapy with a taxane and a platinum followed by consolidation RT for locally advanced HNC.
11. Compare and contrast the clinical efficacy of the numerous investigational new drugs in late-stage development for treating lung cancer.

The Oncology Learning Center is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Oncology Learning Center designates this educational activity for a maximum of 9 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

During the live course, learners will have ample time to interact with the faculty via the numerous Q & A sessions and with microphones to communicate directly with the faculty.  Through numerous case studies the learners will use their ARS handsets to select treatment strategies, and the learners will also answer other clinical and scientific questions that the faculty will ask during their didactic presentations.  Point-CounterPoint debates and Consensus Periods are yet additional opportunities for learner involvement with the faculty, again, using ARS.