Performance Improvement Strategies in Non-Small Cell Lung Cancer Audioconference - April 22, 2010

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1 Performance Improvement Strategies in Non-Small Cell Lung Cancer Audioconference - April 22, 2010 OLIVIA FRITZ: Welcome to the Non-Small Cell Lung Cancer Community of Practice Audioconference with expert faculty, Dr. Fred Hirsch and Dr. Robert Jotte. I m Olivia Fritz, your moderator for today s discussion. During this evening s call, you will have an opportunity to discuss evidence-based strategies for improving practice performance and enhancing the care of your patients with nonsmall cell lung cancer (NSCLC). You are invited to voice questions or comments during live discussion for immediate faculty feedback. This activity has been developed as part of the American Medical Association (AMA)-standardized CME initiative, Performance Improvement Strategies in Non-Small Cell Lung Cancer, for which Drs. Hirsch and Jotte have served as faculty experts. This performance improvement series is sponsored by Med-IQ and provided in collaboration with Oncology Today TM, the CME subsidiary of US Oncology. Additional details about this initiative will be discussed during this evening s audioconference. I am pleased to now introduce the faculty co-chairs of this activity: Dr. Fred Hirsch is a Professor of Medicine and Pathology at the University of Colorado Cancer Center. Dr. Hirsch has worked with clinical translational research in lung cancer for more than 25 years. His current interest is in the use of biomarkers for early detection, chemoprevention, and treatment of lung cancer. We are also joined by Dr. Robert Jotte, Medical Oncologist with the Rocky Mountain Cancer Center and Developmental Cochair of the US Oncology Lung Committee. Dr. Jotte specializes in thoracic oncology and head and neck cancer; his clinical research is focused on the identification of pivotal new treatments and therapies for patients with all

2 stages of lung cancer. He also serves as Medical Director of the Lung Cancer Center of the Rockies and Assistant Clinical Professor of Medicine in the Division of Medical Oncology at the University of Colorado Health Sciences Center. Dr. Hirsch? FRED R. HIRSCH, MD, PhD: Dear colleagues, good evening and welcome to this community of practice audioconference for NSCLC. The goal of this audioconference is to bring together specialists who are interested in NSCLC to discuss advances in the care of patients with this disease, with a special focus on processes or systems of care. Before we open the discussion to your questions, we first want to share some of the reasons why programs such as this performance improvement initiative are so important and provide you with a bit of insight about the current state of NSCLC care. For those of you who may not be familiar with our performance improvement, or PI program, this is an AMAapproved CME format in which clinicians work on improving their individual performance by completing stages of retrospective patient data and implementing a plan for improvement into practice. This particular PI activity focuses on three general areas of care for NSCLC, namely evaluation and staging, the application of evidence-based surveillance and supportive care, and the application of evidence-based treatment. To our knowledge, this activity is the only PI initiative focused solely on the care of patients with NSCLC. Dr. Jotte? ROBERT M. JOTTE, MD, PhD: Thank you, Dr. Hirsch. In this program there are three phases to the process, and 5 CME credits are available for each step, with an additional 5 credits available to clinicians who complete the entire activity. In the first step, or Stage A, participants perform a retrospective analysis of 10 patient charts by completing a short patient data form for each chart. This can be done either by the participating clinician or by a designee. Our pilot study has indicated that the time required to complete each form is approximately 5 to 10 minutes if the data are being pulled from an electronic medical record, or EMR, and about 15 minutes per form if paper charts are used. Once the chart review has been completed, participants receive a summary of their practice patterns relative to those of their peers enrolled in the program, as well as national standards.

3 In the next step, or Stage B of the program, participants review these results and design a process-based improvement strategy specific to the needs of their own practice. To help develop a plan to improve care, clinicians may read a complementary, certified CME implementation guide that outlines the current evidence and treatment guidelines and provides practical tools and resources. Clinicians who participate in this activity receive an additional 1.5 CME credits beyond the 5 available for this stage of the program. We recommend that participants implement their improvement plan for at least 30 days before returning to review an additional 10 patient charts in the final step, or Stage C of the program. The charts selected for this stage of the program should be for patients who are seen after the clinician started the program and ideally include patients who were initially diagnosed after the clinician put his or her improvement strategy into place. Once again, a patient data form is completed for each chart, and this step may also be completed by a designee. At the conclusion of Stage C, participants receive a summary of their current practice patterns relative to their earlier practice patterns, as well as those of their peers and national standards. Data collected through this PI activity can be used to complete the American Board of Internal Medicine (ABIM) Self-Directed Practice Improvement Module and satisfy the Practice Performance Improvement requirement for maintenance of certification. DR. HIRSCH: Now that we have discussed the framework of Performance Improvement CME, I would like to take a moment to highlight some key recent advances in the field of NSCLC that affect patient care. Beginning this year, many oncologists are expected to use staging criteria based on the 7 th edition of the International Association for the Study of Lung Cancer Staging Manual, which are considerably different than the widely used criteria of the 6 th edition. This new staging system creates more homogenous and distinct stage groupings with respect to survival. It provides improved prognostic information and enables clinicians to more accurately group patients for future clinical trials. NSCLC is not a single entity, but a number of diseases that can be further categorized by histology and molecular criteria. Ongoing research will determine whether genetic mutations or genomic signatures can supplement clinical and

4 pathological features for prognosis and prediction of patient outcomes. Furthermore, scientists are enthusiastically attempting to identify molecular abnormalities within tumors that can be targeted by small molecules and monoclonal antibodies. A multitude of new agents have been developed to target these markers, and many have favorable toxicity profiles. These molecular targets include epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF), among others. A final topic of great interest is the role of maintenance therapy in patients with advanced NSCLC. Several trials investigating the efficacy and safety of maintenance regimens in this population are either ongoing or recently completed. Although the best application of this treatment strategy in clinical practice has not yet been determined, significant progress has been made in defining optimal treatment in NSCLC over the past several years. These advances have the potential to change the way that medical oncologists construct therapeutic plans and will move the field closer to personalized treatment regimens. As these advances emerge and guideline recommendations change, clinicians need to stay abreast of and understand this important update to optimally treat their patients with NSCLC. DR. JOTTE: Dr. Hirsch and I would now like to open it up to any comments and questions about challenges facing NSCLC and/or strategies for improving the management of these patients. We ll begin with one or two of the questions we received in advance by , but by all means, please feel free to let the operator know if you have a question you would like to address this evening. MS. FRITZ: Thank you, Dr. Jotte. At this time, we will begin the question and answer session. To ask a live question, please press 0 followed by a 1 on your touchtone phone. Questions will be answered in the order they are received. Again, if you would like to ask a question, please press 0 followed by a 1 now. Med-IQ received several questions in advance for this audioconference. At this time, Dr. Allison Gardener will share a question that was submitted by one of your colleagues. Dr. Gardener? DR. ALLISON GARDENER: Thank you. A question submitted by one of the participants who registered for this call asks about immunoperoxidase stains. The question is, which immunoperoxidase stains do your pathologists use to classify NSCLC as either squamous cell carcinoma or adenocarcinoma?

5 Dr. Jotte? DR. JOTTE: Well, I m going to defer in part to Dr. Hirsch since he s one of our pathologists on the call. Before Dr. Hirsch goes into the details of the types of immunostains that are used in defining the difference between squamous cell carcinoma and adenocarcinoma, I d like to point out that we will often receive biopsy results that simply state it is a poorly differentiated carcinoma, or at times it is simply listed as a non-small cell lung carcinoma or lung cancer. We re moving into a time when that s no longer adequate. We certainly need to further define the actual histology so that we can make therapeutic choices about the different cytotoxic agents or target agents that we may be using. But, Dr. Hirsch, I d like to open it to you to perhaps comment specifically on the types of stains that we will often use when we have difficulty identifying adenocarcinoma versus some other form of NSCLC histology. DR. HIRSCH: Thank you, Dr. Jotte. I think I will take a step back first and spend a few words on the importance of histologic subtyping. This might be evident for everyone some of the agents approved for the routine care of patients with advanced NSCLC are restricted to histological subtypes. Bevacizumab is labeled for non-squamous carcinomas mainly because of the toxicity seen in squamous carcinomas in early clinical development, which stopped the development in squamous and focused on non-squamous carcinomas. And later we had pemetrexed, which was restricted to non-squamous carcinomas because of efficacy; the efficacy was much greater in non-squamous, but there was an opposite effect in squamous carcinoma. The specific histology plays a significant role in the decision of first-line therapy for advanced NSCLC. And how are we dealing with this in routine clinical practice? Dr. Jotte mentioned that the quality or the size of the specimens might affect the capability of making this distinction, and that is definitely true. The grade of differentiation in the tumors also influences decisions. For high-grade, well-differentiated squamous cell carcinomas and adenocarcinomas, it is not usually a problem for the pathologist to distinguish between those two main subtypes just based on conventional light microscopy and H&E stain. However, the less differentiated the tumor is and particularly if you have smaller size biopsies, we need to move to special immunostains. Several markers can help us in this distinction. For adenocarcinoma, we have TTF-1,

6 cytokeratin 7, and mucin stain. All of those markers support the diagnosis of adenocarcinoma. For squamous cell carcinoma, we have a couple of markers: p63, and cytokeratin 5 and 6. These markers support the diagnosis of squamous cell carcinoma. Immunohistochemistry provides stronger evidence for one or the other subtypes of histology. DR. GARDENER: Great. So continuing in a somewhat similar vein, Dr. Hirsch, in your opening remarks you mentioned a lot of progress occurring currently in the field regarding the use of biomarkers in making treatment decisions in NSCLC. Could you comment on the status of biomarkers and treatment decisions for this disease? DR. HIRSCH: Yes. That is based on recent data we have received within the last year. We know today that EGFR mutation seems to play a significant role in association with EGFR tyrosine kinase inhibitor (TKI) drugs like erlotinib and gefitinib. This evidence comes mainly from Asia. Several Asian studies (among them the landmark study IPASS) have shown that patients who have EGFR mutations in the tumor experienced better responses and outcomes with an EGFR-TKI alone compared to chemotherapy. In wild-type patients in the IPASS study, however, the chemotherapy group had better outcomes than the EGFR-TKI group. So this study, other studies in Asia, and a couple of studies in Western Europe all point to the same conclusion: patients who have a tumor harboring EGFR mutation do better with an EGFR-TKI alone. That is the paradigm change that happened within the last year. We have also learned new data based on a presentation at ASCO It was a remarkable Phase I study with an ALK inhibitor; the remarkable thing here was that patients who had this ALK fusion rearrangement in the tumor had an almost dramatic response to this particular targeted drug. So, even if this ALK rearrangement occurs only in 3% of unselected NSCLC patients, I personally believe that for those 3%, it is important to know because of this remarkable response. A large Phase III trial is currently evaluating this ALK factor, and although we haven t seen results from this trial yet, people are already talking about making ALK fusion assessment on patients primary tumors. So at this stage, there are certainly indications for looking into biomarkers before deciding first-line therapy. DR. JOTTE: Dr. Hirsch, I would also like to chime in about the

7 current biomarkers that you re alluding to in terms of EGFR mutations, as well as the ALK-1 fusion mutation. For those physicians out in the community, where can that testing be done? Here in Denver, we certainly have the opportunity of having you in town, and your pathology department has the capability of doing these tests. However, for other physicians that are out in the community, there is a flurry of different companies now making available these different types of tests, namely checking for EFGR expression as well as FISH test for EGFR looking for those mutations. They are also offering the ALK-1 mutation analysis. They are also offering several other tests such as ERCC1, which, of course, relies on data that was presented by Simon and Bepler suggesting that individual tumor ERCC1 status may predict response to platinum versus non-platinum regimens. In addition, they ll check for KRAS, even though the EGFR data are much more convincing and predictive of who may respond to the TKIs as opposed to those who have wild-type KRAS. These data are coming at us faster than we can figure out how to therapeutically put into practice; however, I think the two pieces that are the most important are those that you ve already mentioned. There are data from very provocative trials suggesting clear therapeutic benefit to those patients who are identified as having either the EGFR plate mutations or the exon deletions as well as ALK-1 mutations. Again, those trials attempting to validate these data are currently ongoing. DR. HIRSCH: I agree with that, Dr. Jotte. I think all these new markers might raise some frustrations in the communities. My personal view, which I believe is also a kind of consensus in the scientific community, is that the EGFR mutation seems to be very well validated on this stage. The ALK story is extremely encouraging and, of course, there is a big Phase III study going on so we will see, but I m pretty confident that these will be validated and verified. All the other markers you mentioned are, in my opinion, not fully validated yet and not ready for prime time in clinical practice. A few words about KRAS mutation: KRAS mutation plays a significant role in colorectal cancer in terms of using an EGFR TKI. We don t think it plays the same role in lung cancer, although, you are right that the response rate in KRAS-mutation positive patients with lung cancer is low with EGFR TKI. It is not clear whether that translates into a shorter progression-free survival or overall survival. So, I

8 think that is the current status of biomarkers. MS. FRITZ: Thank you Gentlemen. And again, as a reminder to our participants, if you would like to ask a question please press 0 followed by a 1 on your touchtone phone. While our system compiles each of your responses, we will turn back to Dr. Gardener for another presubmitted question. DR. GARDENER: Another subject that was mentioned in the opening remarks was that of the use of maintenance therapy for treatment of patients with advanced disease. So would you mind commenting on the best use of these types of treatment regimens and where you see them falling into clinical practice? DR. JOTTE: I think that this is certainly an exploding area in the management of NSCLC. I think that first we need to actually define what maintenance therapy is, and at this point, we haven t really come to any clear consensus as to the definition of maintenance therapy. John Schiller tried to put some parameters onto this definition last year at ASCO in Orlando, but there really has not been any generalized consensus as to what actually constitutes maintenance therapy. In my own opinion, maintenance therapy can be whatever drug you want to use that is attempting to maintain a particular patient s disease state. You can envision using a drug that was initially a component of a patient s firstline therapy, and then continuing that single agent; this is similar to Alan Sandler s use of bevacizumab in ECOG 4599 where bevacizumab was used in combination with paclitaxel and carboplatin, and then continued as a single agent after six cycles of the three-drug regimen. Similarly, you could look at the JMBD study where pemetrexed was initiated immediately after first-line therapy with a platinum-based doublet therapy, and similarly in the SATURN study where erlotinib was added on immediately afterward in terms of standard chemotherapy regimen. The definition of maintenance therapy remains to be clearly defined in terms of those different features, where they re incorporated, and how they re incorporated. From those several different studies that I ve just alluded to, clear data now demonstrates that maintenance therapy appears to improve overall survival as well as primary progression-free survival when used immediately upon the completion of what we have historically termed platinum-based doublet cytotoxic chemotherapy. I think this brings up a lot of new questions regarding how

9 we manage these patients. The paradigm previously was to undergo four to six cycles of doublet chemotherapy, at which point you would take a break from chemotherapy. Then upon noting progression, we would have turned to second-line chemotherapy. Now we re either incorporating this drug that was used in the very beginning as part of their initial therapy or as a new drug as a part of this maintenance therapy; it will certainly change the way we initially speak with patients about how we re going to manage their disease. It is truly changing how we treat patients as they walk into our clinics. This past week the FDA approved the use of erlotinib as a maintenance therapy immediately upon completion of front-line chemotherapy. Once we identify something that appears to add a component to overall survival, it oftentimes asks more questions than it answers. So now we are starting to ask questions of how we incorporate these biomarkers inside a genetic analysis ahead of time, as well as incorporating those particular drugs either as a component of the front-line therapy or as a single agent in the maintenance regimen. This clearly is changing our field, but it s still a developing field. I do think that maintenance therapy is something that we now need to discuss with patients, whereas two years ago, this was a topic that rarely would have been brought up in our clinics. DR. HIRSCH: I agree with Dr. Jotte. The piece we are missing at this stage is a comparison between maintenance therapy and second-line therapy, meaning either using continuous therapy or discontinuing and then initiating second-line therapy at progression. We don t have these data those would be good to have in the whole discussion. I do agree with Dr. Jotte that with the approval of pemetrexed and erlotinib as maintenance therapy, we need to address this with our patients; I think maintenance therapy in one or another way will be a part of clinical care in the future. DR. JOTTE: I do think you bring up an excellent point with regards to immediate maintenance therapy versus second-line therapy, however you want to term that. In one of the TAX studies where docetaxel was examined (either immediately initiating docetaxel second-line therapy prior to progression versus waiting until progression of disease and then initiating docetaxel), we found that immediate docetaxel appeared to provide a survival benefit. The second-line therapy group was followed very closely and monitored for disease progression, at which point they would be offered second-line therapy. The truth of the matter, however, was that many of those patients

10 often progressed in such a rapid fashion that their performance status declined to the level where second-line therapy was not an option. In fact, almost half of those patients never actually went on to receive second-line therapy. I do think that is a very important issue to address, but that particular study suggested that perhaps one of the advantages of maintenance therapy is getting the drug into the patient as opposed to waiting until they progress, at which point it may be too late for many patients. DR. HIRSCH: Right. I agree. MS. FRITZ: Thank you, Gentlemen. This concludes this evening s Non-Small Cell Lung Cancer Community of Practice Audioconference, which has been sponsored by Med-IQ, provided in collaboration with Oncology Today, and supported by an educational grant from Lilly USA, LLC. This activity is part of the complimentary, AMA standardized, certified three-stage performance improvement CME series, Performance Improvement Strategies in Non-Small Cell Lung Cancer. More than 100 specialists have enrolled in this PI initiative to assess their current NSCLC practice patterns and improve their practices of care. To learn more about Performance Improvement Strategies in Non-Small Cell Lung Cancer or to enroll today, please visit Thank you for your time and commitment to improving NSCLC patient care. Thank you. [END 4_22_LC_AUDIO.MP3]

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