ASCO Education

Victoria Lai is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center with a clinical and research focus on small cell lung cancer and other pulmonary neuroendocrine tumors.  She conducts clinical trials that aim to elucidate the underlying biology of small cell lung cancer in order to develop new biomarkers and treatments options to improve patient outcomes.   TRANSCRIPT [MUSIC PLAYING] Welcome to the recent approvals episode of the ASCO University weekly podcast. My name is Victoria Lai. I am an assistant attending physician in a thoracic oncology service at Memorial Sloan Kettering Cancer Center. Today, we will discuss the approval of nivolumab for the treatment of patients with metastatic small cell lung cancer in the third-line setting. As a background to today's discussion, we know that FDA approved therapies for small cell lung cancer are extremely limited and remain a large, unmet need. Immune checkpoint inhibitors, including nivolumab, are active therapies in several different tumor types. Nivolumab is a monoclonal antibody against PD-1 and has previously been shown to be effective in non-small cell lung cancer. More recently, the role of immune checkpoint inhibitors in the treatment of small cell lung cancer has been explored in an effort to develop more effective treatment options for these patients. On August 16 2018, nivolumab was granted an accelerated approval by the FDA for the treatment of patients with metastatic small cell lung cancer with disease progression after prior platinum-based chemotherapy and at least one other line of treatment regardless of PD-L1 expression of the tumor. This approval of nivolumab in the third-line setting in small cell lung cancer was based on results from the CheckMate 032 study that was initially published in The Lancet in 2016 and has since reported updated results. CheckMate 032 was a multi-center open-label trial in patients with metastatic solid tumors. The study included a subgroup of 109 patients with metastatic small cell lung cancer who experienced disease progression after platinum-based therapy and at least one other line of therapy regardless of tumor PD-L1 status. All patients received nivolumab 3 milligrams per kilogram by intravenous infusion over 60 minutes every two weeks. The primary endpoint of this study was the objective response rate. The overall response rate was 12% with a 95% confidence interval between 6.5 to 19.5% with responses seen in 13 out of 109 patients. Responses were durable for six months or longer in 77% of patients, 12 months or longer in 62% of patients, and 18 months or longer in 39% of patients. PD-L1 tumor status did not appear to be predictive of response. Of all the patients who received at least one dose of nivolumab, the most common side effects were fatigue, decreased appetite, musculoskeletal pain, dyspnea, nausea, diarrhea, constipation, and cough. Serious adverse reactions occurred in 45% of patients and included pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration. The recommended dosing schedule of nivolumab for this approved indication is 240 milligrams every two weeks over 30 minutes. The approval of nivolumab as subsequent line therapy marks a significant advancement in the treatment of patients with metastatic small cell lung cancer. Prior to this, topotecan was the only other agent approved by the FDA for treatment in this setting, which did not yield durable responses. Although the response to nivolumab was modest, the majority of patients responded to treatment were able to achieve durable responses of greater than 12 months with over 1/3 of patients achieving a durable response of greater than 18 months. Further more, responses to nivolumab were seen regardless of the patient's prior response to chemotherapy. Given that topotecan yields a response rate in the single digits as subsequent line therapy for chemo-resistant disease, nivolumab adds an especially valuable treatment option for these patients whose disease did not previously respond to chemotherapy. Nivolumab adds an especially valuable treatment option for these patients whose disease did not previously respond to chemotherapy. Responses to nivolumab were also seen in patients who had exceeded three prior lines of therapy indicating that nivolumab can still be effective in heavily pre-treated patients. With 45% of patients in this study having developed a serious adverse reaction, patients undergoing treatment with nivolumab should be monitored closely. Finally, this study did not show any correlation or responses to nivolumab with PD-L1 expression, suggesting that the role of PD-L1 as a predictive biomarker in small cell lung cancer remains unclear. Thank you for listening to this week's episode of the ASCO University weekly podcast. For more information on immunotherapy and the treatment of small cell lung cancer, please visit the comprehensive eLearning center at university.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Shadia Jalal, MD, Assistant Professor of Clinical Medicine in the Department of Medicine, Division of Hematology/Oncology at Indiana University School of Medicine discusses updated guideline for palliative care in the global setting. TRANSCRIPT Welcome to the ASCO Guidelines episode of the ASCO University weekly podcast. My name is Alexander Drilon, and I am the clinical director of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and editorial board member for ASCO University. Today, we feature an ASCO Guideline published in the Journal of Clinical Oncology. The episode you are about to hear was originally aired on the ASCO Guidelines podcast series. The ASCO Guidelines podcast series features interviews with panelists of recently-published ASCO clinical practice guidelines products, highlighting recommendations and noteworthy qualifying statements made by the expert panel. [MUSIC PLAYING] Hello, and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernan, and today, I'm interviewing Dr. Nahla Gaffer, from the Radiation S Isotope Center in Sudan, an author on palliative care in the global setting, American Society of Clinical Oncology resource-stratified practice guideline. Thank you for being here today Dr. Gaffer. Good morning. Thank you, so much, Mrs. Shannon for this opportunity. First, can you give us a general overview of what this guideline covers, and what it means to be a resource-stratified practice guideline? Yes. These guidelines outline and they cover the recommended set of palliative care integration concerning personnel needed, training needed for this staff, structure, and availability of medicines at different resource levels. And by a resource-stratified guideline, we mean that it's suitable for different levels of development. Yes. For example, if you are speaking about a community level, you are speaking of primary care centers, or if we are speaking about in a different setting, like a regional hospital and also, the highest level might be the oncology center. And at every level, there should be a better structure and better training and availability of palliative care. But at all of these levels, we should have palliative care. What are the key recommendations of this guideline? Yes. The key recommendations, as I mentioned, is that we should have a coordinated system, where the patient's palliative care needs are identified and met at every level and from the moment of diagnosis. So we are speaking about, at the basic level, we should have at least a volunteer or community worker or better even, a nurse trained in palliative care. And these people have got the job to facilitate identification of patients who need palliative care at the community level. Another level is the limited level, and here, we should have at least one doctor and a nurse trained in basic palliative care, and they work with the people working in the community. And they address minor issues, prescribing basic medicines, referring patients, and they also have the ability to support the patient and the family in [INAUDIBLE]. At another enhanced level, and we are speaking here about setting like a regional hospital, there should be a team, at least of three personnel-- doctor, nurse, pharmacist. Of course, if there is a psychologist or religious chaplain, it's OK, but at least these three personnel should be trained about palliative care, so a minimum of six weeks training. And they can provide palliative care, and they can offer as outpatient service in this regional hospital. The best setting or the maximum setting is when we are speaking about a bigger hospital or an oncology center. And we are speaking that no oncology center or any facility for palliative care patients, like hospices, should exist without a well-developed palliative care team. And having personnel and all personnel working in that center should receive basic training in palliative care. The main treating doctors, for example, the oncologists, should have secondary training in palliative care, so it's a higher level of training in palliative care. And we need for palliative care physicians to supervise and develop the service. At such a setting, we should have psychologists, we should have chaplains all integrated in the service. Another recommendation is that palliative care should be given and provided at all levels ideally, at the moment of diagnosis of the patient, but especially for patients who are coming with overwhelming symptoms, whether physical, psychological, or spiritual or patients who have metastasis or patients who cannot receive active treatment for curative intent, for example, for comorbidities or age or patients with a disease with a known short life expectancy. All these patients should receive palliative care from the moment of diagnosis. Why is this guideline so important, and how will it change practice? Yes, it is very important because palliative care is important to be given to all patients at every setting. It is not expensive. It doesn't require special equipment. It can be given. It not only should be given, but it can also be given. It's not difficult to change. And this guideline is very important, because sometimes people don't hear other colleagues or junior doctors. They hear high recommendations, like from the ASCO guidelines. And finally, how will these guideline recommendations affect patients? Yes. We hope the directors of hospitals, people or personnel at administerial levels, our fellow colleagues, they embrace these recommendations more and more. As I mentioned, sometimes it needs to come from higher up, and for that, we thank the American Society of Clinical Oncology for taking this task. Once we are caring for our patients holistically, which includes social, spiritual, psychological dimensions, in addition to physical, it leads to a better quality of life, affecting not only the patient and the family in all dimensions but even leading to a better survival, and here, I mean both in time and quality. Great. Thank you for your time today, Dr. Gaffer. Thanks. Thanks a lot. And thank you to all of our listeners for tuning into the ASCO Guidelines podcast series. If you've enjoyed what you've heard today, please rate and review the podcast and refer this show to a colleague. [MUSIC PLAYING] The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

2018 Annual Meeting raised the curtain on a new session type: ASCO Voices. These noncompete session feature presentations no longer than 7 minutes each and bring a variety of perspectives to the stage to share stories on oncology, medicine, and the world. From big ideas to personal passions, ASCO Voices present stories that differ significantly from the remainder of session types available at Annual Meeting. Dr. Trevor Bayliss is an oncologist in Pittsfield, Massachusetts and is affiliated with Berkshire Medical Center. He received his medical degree from Albany Medical College and has been in practice between 6-10 years. He is one of 6 doctors at Berkshire Medical Center who specialize in Oncology. In his ASCO Voices presentation, Dr. Bayliss shares his personal story of overcoming cancer and how it lead him to a career in oncology.  

Rachel Freedman, MD, MPH- Assistant Professor, Medicine, Harvard Medical School, Dana-Farber Cancer Institute presents a self-assessment question from an ASCO University course focusing on the treatment breast cancer.  AUDIO TRANSCRIPT Welcome to the self-evaluation episode of the ASCO University weekly podcast. My name is Rachel Friedman, and I'm a medical oncologist and clinical researcher in the Breast Oncology Center at Dana-Farber Cancer Institute. Today, we feature a self-evaluation question on the treatment of early stage breast cancer. We begin by reading the question stem. A 75-year-old woman with a past medical history of coronary artery disease and diabetes, with an ECOG performance status of 2, has been seen in the medical oncology office following a partial mastectomy for a 1 centimeter invasive breast cancer. The margins were clear and hormone receptors are reported as positive. The HER2/neu status is reported as negative. An Oncotype recurrence score is reported as 5. Which of the following is the best adjuvant therapy for this patient? Choice A, doxorubicin, cyclophosphamide, and weekly paclitaxel, followed by an aromatase inhibitor. B, docetaxel and cyclophosphamide for four cycles, followed by an aromatase inhibitor for five years with radiation therapy to the breast. C, radiation therapy to the breast and axilla, followed by an aromatase inhibitor. D, aromatase inhibitor. E, tamoxifen. The correct answer to this question is D, aromatase inhibitor. This patient has a poor performance status and high co-morbidity burden, with a higher likelihood of non-breast cancer deaths over breast cancer death, over time. The cancer is low risk, with a low likelihood for local and distant recurrence. Radiation and chemotherapy are unlikely to improve her outcome and will increase her toxicity risk. Further, we have multiple randomized trials to support safe omission of radiation and the setting of older age and stage 1 hormone receptor positive disease. Briefly, the benefit of adjuvant chemotherapy is anticipated to be negligible, and even harmful, in the setting of her low risk disease, advanced co-morbidity, poor functional status, and Oncotype score of 5. Chemotherapy should be avoided in this setting, making answers A and B incorrect. Although radiation should be considered and administered in most patients with invasive breast cancer, undergoing breast conservation, as mentioned earlier, we have prospective randomized controlled trial data, supporting omission of radiation in this clinical scenario, making option C also incorrect for this reason. Further, there is no indication for radiation to the axilla in a low risk breast cancer, such as the one described here, making option C incorrect for that reason as well. Option E, tamoxifen, is also a treatment option here, but may be less appealing in an older patient who lives a more sedentary lifestyle who may be at more risk for adverse events on tamoxifen, such as thrombosis, and where the use of aromatase inhibitors may be of a small incremental benefit over tamoxifen, with regard to risk for recurrences over time. Thank you for listening to this week's episode of the ASCO University weekly podcast. For more information on the treatment of breast cancer, including opportunities for self-evaluation and for a review, please visit the comprehensive eLearning center at university.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.

Karen M. Winkfield, MD, PhD, Associate Professor of Radiation Oncology, Comprehensive Cancer Center at Wake Forest Baptist Health discusses identifying factors associated with prognosis and staging in a MALT lymphoma and how to identify factors predicting local failure following H Pylori eradication therapy. 

2018 Annual Meeting raised the curtain on a new session type: ASCO Voices. These noncompete session feature presentations no longer than 7 minutes each and bring a variety of perspectives to the stage to share stories on oncology, medicine, and the world. From big ideas to personal passions, ASCO Voices present stories that differ significantly from the remainder of session types available at Annual Meeting. Dr. Loehrer is director of the Indiana University Melvin and Bren Simon Cancer Center, an IU Distinguished Professor, H.H. Gregg Professor of Oncology and associate dean for cancer research at Indiana University School of Medicine.   In his ASCO Voices presentation, Dr. Loehrer shares a personal story about coping with cancer diagnosis of a close colleague and friend.  

Dr. Jonathan Strosberg, section chief of the Neuroendocrine Tumor Division of the Moffitt Cancer Center, discusses the recent FDA approval of Lutetium Lu 177 dotatate for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

An interview with Dr. Paul Hesketh from Lahey Hospital and Medical Center on the antiemetics guideline update published in 2017. The guideline update expands the recommendations to include olanzapine and neurokinin 1 receptor antagonists. Read the full guideline at www.asco.org/supportive-care-guidelines

Rachel Freedman, MD, MPH- Assistant Professor, Medicine, Harvard Medical School, Dana-Farber Cancer Institute, presents a self-assessment question from an ASCO University course focusing on the treatment breast cancer.   

Rami Manochakian, M.D., a thoracic clinical oncologist at the Mayo Clinic in Florida, presents information on the recently approved drug in oncology, durvalumab for patients with stage III Non-Small Cell Lung Cancers (NSCLC) after the completion of radiation therapy.