ESMO 2018: Nivolumab Alone or in Combination with Ipilimumab in Patients with Platinum-Pretreated Metastatic Urothelial Carcinoma, including the Expansion from CheckMate 032

Munich, Germany (UroToday.com) Jonathan E. Rosenberg, MD presented the preliminary results of the study analyzing the effects of Nivolumab alone or in combination with Ipilimumab in patients with platinum-pretreated metastatic urothelial carcinoma. This study is an expansion of the Checkmate 032 trial.

ESMO 2018: Invited Discussant - Nivolumab Alone or in Combination with Ipilimumab in Patients with Platinum-Pretreated Metastatic Urothelial Carcinoma, from CheckMate 032

Munich, Germany ( UroToday.com) Cora Sternberg, MD discussed the Checkmate 032 study presented earlier by Dr. Rosenberg on Nivolumab monotherapy, Nivolumab 3 mg/kg (Nivo3) + Ipilimumab 1 mg/kg (IPI1), and Nivolumab 1 mg/kg (Nivo1) + Ipilimumab 3 mg/kg (IPI3) in previously treated metastatic urothelial carcinoma patients.

ESMO 2018: Pillars of an Effective Healthcare System in Europe Key Components of a Well-Functioning Healthcare System

Munich, Germany (UroToday.com) Wilm Quentin, MD kicked off this session with a focus on defining what the key components to a well-functional healthcare system are – though he was the first to admit that this is difficult to do and there are many definitions out there, each with its own flaws. However, he started out by focusing on the progress to this point and what components he thinks should be included.

ESMO 2018: Prevention and Management in Long-Term Chronic Cancer Care: Pain Within the Cancer Trajectory

Munich, Germany (UroToday.com) Augusto Caraceni, MD gave a talk on the important, and sometimes overlooked topic of pain in the cancer patient. This is an important issue that cancer patients deal with on a daily basis, and the medical system is not always attentive enough to this critically debilitating issue to patients.

ESMO 2018: PD-L1 Status and Clinical Outcomes to Cabozantinib, Sunitinib and Everolimus in Patients with Metastatic Clear-Cell RCC Treated on CABOSUN and METEOR Trials

Munich, Germany (UroToday.com) Cabozantinib, a multiple receptor tyrosine kinase inhibitor (RTK) that inhibits c-Met, VEGFR2, AXL, and RET, is an agent that has now been established in 2 separate randomized controlled trials as effective 2nd line therapy for metastatic RCC (METEOR trial, Choueiri NEJM 2015) and as 1st line therapy for intermediate/poor risk mRCC patients (CABOSUN trial, Choueiri NEJM 2017). In METEOR, it had a 5-month median OS benefit compared to everolimus, while in CABOSUN it demonstrated a 3-month median PFS benefit in poor/intermediate risk patients compared to sunitinib.

ESMO 2018: Brain Metastases Response to Nivolumab in Patients with Renal Cell Carcinoma: Prospective Analysis from the GETUG-AFU 26 (NIVOREN) Trial

Munich, Germany (UroToday.com) The cumulative incidence of brain metastases after a patient has been diagnosed with renal cell carcinoma (RCC) is 10% at 5 years1. In a cohort of 138 patients with metastatic renal cell carcinoma (mRCC) who underwent treatment for their brain metastases, median overall survival was 10.7 months and 5 year overall survival was 12%2. In another cohort of patients from Europe, median survival was 7 months, with negative prognostic factors being lack of nephrectomy, left side and temporal location of brain metastases, the presence of fever or weight loss, ESR > 50 mm/hr, and time from initial diagnosis to brain metastases ≤ 18 months3. Because RCC may be resistant to radiation, these patients often have poor prognosis.  

ESMO 2018: Molecular Correlates Differentiate Response to Atezolizumab plus Bevacizumab vs Sunitinib: Results From a Phase III Study IMmotion151 in Untreated mRCC

Munich, Germany (UroToday.com) In this abstract, the authors of ImMotion151, which assesses the immune checkpoint combination of atezolizumab and prior immunotherapy bevacizumab against the traditional standard of sunitinib for patients with untreated metastatic renal cell carcinoma (mRCC), focus on the molecular correlates utilized and their preliminary results. InMotion151 is a phase III study and has previously reported at ASCO – it was first randomized Phase III trial of a PD-L1/PD-1 pathway inhibitor combined with an anti-VEGF agent in 1L mRCC. In the primary results, the median PFS HR for atezo + bev (AB) vs sunitinib (SUN) was 0.74 (95% CI 0.57, 0.96) in PD-L1+ pts and 0.83 (95% CI 0.70, 0.97) in ITT pts.

ESMO 2018: Nivolumab Alone or in Combination With Ipilimumab in Patients with Platinum-Pretreated Metastatic Urothelial Carcinoma

Munich, Germany (UroToday.com) Immune checkpoint inhibitors have been established as a preferred second-line treatment of choice for patients with metastatic urothelial carcinoma who progress on platinum chemotherapy. Several phase II and phase III clinical trials have been supportive of this treatment paradigm including Keynote-045(pembrolizumab – phase III), IMvigor2112(atezolizumab – phase III), CheckMate 275(nivolumab – phase II), JAVELIN Solid Tumor(avelumab – phase I), and NCT01693562 (durvalumab – phase I/II)5.

ESMO 2018: Invited Discussant - Pembrolizumab for High-Risk Non–Muscle Invasive Bladder Cancer Unresponsive to BCG: Phase 2 Keynote-057 Trial

Munich, Germany (UroToday.com) Dr. Shariat discussed and summarized the key feature of the Keynote 057 study, presented earlier by Dr. Ronald De Wit. Intravesical Bacille Calmette Guerin (BCG) is the standard therapy for high risk non-muscle invasive bladder cancer (NMIBC).  There are approximately 1.2 million doses of BCG used globally for bladder cancer.  The initial response rate after BCG therapy for carcinoma in situ (CIS) disease is around 80%, and the tumor-free rate of papillary tumors is 70%. However, for some patients, this treatment is not effective, and over time tumors can relapse.

ESMO 2018: Nivolumab in Combination with Iipilimumab Shows Promising Results in Patients with Advanced Form of Bladder Cancer

San Francisco, CA USA (UroToday.com) -- Follow-up data evaluating Opdivo (nivolumab) monotherapy and Opdivo in combination with Yervoy (ipilimumab) in patients with platinum-pretreated metastatic urothelial carcinoma (mUC) to be presented at ESMO 2018. Results from the Phase 1/2 CheckMate -032 trial showed that patients who received the combination of Opdivo 1 mg/kg plus Yervoy 3 mg/kg (O1:Y3) experienced a higher objective response rate (ORR) compared to those who received Opdivo 3 mg/kg plus Yervoy 1 mg/kg (O3:Y1) or Opdivo alone. Patients in the study were heavily pretreated, with most receiving at least two prior treatment regimens.

ESMO 2018: Axitinib vs. Placebo in Patients at High Risk of Recurrent Renal Cell Carcinoma (RCC): ATLAS Trial Results

Munich, Germany (UroToday.com) The concept of adjuvant therapy for high-risk advanced localized renal cell carcinoma (RCC) has been appealing, yet the results to date have been mixed to say the least. Knowing that up to 40% of patients with RCC will develop metastases, and that high-risk patients have a 5-year recurrence rate of 60%, adjuvant therapy is an unmet need for a relatively younger healthier patient population. However, at this time, surveillance remains a standard of care.

ESMO 2018: Civic Participation: How Citizens Shape the Society they Live In

Munich, Germany (UroToday.com) In this talk, Dr. Giovanni Moro, a professor of political sociology in Rome, gave a talk on civic participation and its impact on healthcare. He began by giving a background of his own research and his involvement in citizen’s rights movements in both Italy and Europe. Unfortunately, most of his powerpoint presentation was not available and not loaded, so he was unable to provide details for much of his discussion. Below are his primary take-home points.

ESMO 2018: Pembrolizumab for High-Risk Non–Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to BCG: Phase 2 Keynote-057 Trial

Munich, Germany (UroToday.com) Ronald de Wit, MD, Ph.D. presented preliminary results of the Keynote-057 trial of Pembrolizumab for high risk non-muscle invasive bladder cancer (NMIBC) patients who were unresponsive to Bacillus Calmette-Guerin (BCG) therapy. This was a single arm open-label phase 2 study. Dr. de Wit began with an introduction and review of BCG unresponsive high-risk NMIBC. Adequate BCG therapy is defined as at least 5-6 instillations of induction BCG + at least 2 of 3 doses of maintenance therapy or 2 of 6 doses of a second induction course.

ESMO 2018: When is a Cancer Patient Cured?

Munich, Germany (UroToday.com) With time progressing, the number of people living after been diagnosed with cancer is rising significantly. In the US these constitute 15 million people, and in Italy, they are 3.5 million (6% of the entire population). Dr. Dal Maso believes that we need to better categorize these patients, to bring survivorship into precision medicine era.

ESMO 2018: The Right to be Forgotten - Access to Loan-Related Insurance for French Cancer Survivors

Munich, Germany (UroToday.com) It is known that insurance is required to obtain a loan and requesting home loans is quite common. Approximately 27% of the European population live in an owner-occupied home with and outstanding loan. Mortgage loans enable the bank to repossess the house to pay off the loan. It is seldom used in France, like other European countries – Italy, Germany, as opposed to England. The insurance is important because the loan is not protected by the property.

ESMO 2018: Immunotherapy in Renal and Bladder Cancers

Munich, Germany (UroToday.com) Cora Sternberg, MD gave an overview of the contemporary role of immunotherapy in renal and bladder cancer. Immunotherapy in renal cancer began with the introduction of high dose IL-2 therapy in a total of 7 clinical trials including 255 patients.1 IL-2 was FDA approved in 1992 demonstrating 15% risk reduction with durable responses in a small percentage of patients. However, this treatment caused significant toxicity and had considerable cost.

ESMO 2018: Immune Therapies Going Adjuvant: Benefits Versus Risks: How Long Should We Treat Patients?

Munich, Germany (UroToday.com) In this session, Dr. John Haanen discusses the rationale for adjuvant therapy. First, the basis for adjuvant therapy with IO’s (immune-oncology, or immune checkpoint inhibitors) has long been there with other therapeutic agents – chemotherapy, Her2 targeting agents, antihormonal therapies). However, all these agents targeted the tumor directly – IO’s target the immune system directly and the tumor indirectly, so it is unclear if the concept of adjuvant therapy holds true.

ESMO 2018: Immune Therapies Going Adjuvant: Benefits Versus Risks: Side Effects

Munich, Germany (UroToday.com) Dr. James Larkin finished off the patient advocacy session with talking about side effects. This was a broad discussion.  First, as these agents work on the immune system, the breadth of side effects can be vast – an overactive immune system can affect any organ system. A brief list based on the system is as follows:

ESMO 2018: Immune Therapies Going Adjuvant: Benefits Versus Risks: Introduction

Munich, Germany (UroToday.com) This was the start of a session focused on patient advocacy. Dr. Bettina Ryll, while trained as a medical oncologist with a focus on melanoma, was the wife of a patient who developed melanoma in 2011 and died of the disease. She has since been a strong advocate of patient education and involvement. In this session, she and her colleagues highlighted the key concepts in the adjuvant therapy of cancer with immune checkpoint inhibitors.
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