ASH Clinical News | Page 40

Hematology Link Continued from page 16 What are unique issues of palliative care for patients with hematologic disorders? Obviously, the need for transfusions in this patient population can be profound, but what was once a lifeline for patients for so long can become ineffective and burdensome. This can raise difficult issues for patients where collaboration between our providers can be rich and effective. For example, in a patient requiring transfusions for a hematologic condition, we can review the patient’s overall trajectory to predict his or her likely outcome. That includes asking each other: implications on the patient’s life. In this case, one component of the “total pain” management plan, then, is reducing that physical pain, but also thinking about alternative ways the patient can access his or her faith. This would involve asking questions like, “Can your pastor come to your home? Is there a television program that would equate to going to Mass?” Similarly, there are critical questions that can provide us with more insight beyond a numerical rating of pain: “How would your life be different without the pain? What do you think is causing the pain? To what degree can your pain be relieved? What does that pain mean to you?” These questions can help us better understand the individual patient’s pain experience. Relative to the hematologist’s practice and clinic workflow, pain assessments may be initiated as part of an intake questionnaire conducted by a medical assistant or a nurse colleague at the beginning the patient’s visit – asking about the intensity, severity, duration, location, and what makes the pain better • Are transfusions being required more often? or worse. Gathering those data can help guide the hematologist, when necessary, toward conducting a more thorough pain assessment during a clinical visit. When does a patient transition from cancer treatment plus palliative care to only palliative care? What makes determining that point difficult? It is different for every patient. One important thing I find helpful is to explore and identify the patient’s values and goals. We need that individualized, personalized N O W AVA I L A B L E • Is the efficacy of the transfusions lessening? Is the patient responding as robustly to the transfusions? F O R T H E T R E A T M E N T O F P h - N E G A T I V E R E L A P S E D / R E F R A C T O RY B - C E L L A C U T E LY M P H O B L A S T I C L E U K E M I A ( A L L ) • What is the patient’s functionality or performance status? Are transfusions helping the patient’s energy level now as they previously did? • How does the patient’s overall status compare to month ago? Three months ago? Six and 12 months ago? • Would we be surprised if the patient would be alive in six months? In one year? Why or why not? Together we can look at global indices of a patient’s well-being. As hematologists know, with many hematologic disorders – unlike solid tumor oncology – you can’t always measure the size of a tumor or the impingement upon an organ and come to conclusions about the trajectory of the illness. You have to rely on longitudinal information. A dual approach can take the aggregate care and interpretation of the illness to the next level - examining where the patient’s been, where the patient is now, and where we would forecast the patient to be in the future. What kinds of questions should hematologists be asking their patients to assess pain? Pain can be thought of as “the fifth vital sign.” For anyone providing pain management, it is important to assess how all the different domains – physical, psychosocial, quality-oflife, spiritual – are being impacted. For example, a patient’s physical pain may prevent him or her from attending church, which may then contribute to feelings of spiritual pain from losing that connection with his or her congregation and God. So, that physical pain is having broader 48 ASH Clinical News Discover the first and only FDA-approved Bispecific CD19-directed CD3 T-cell Engager In a phase 2, open-label, multicenter, single-arm clinical trial: • The primary endpoint was the complete remission/complete remission with partial hematological recovery (CR/CRh*) rate within 2 cycles of treatment with BLINCYTO™. • Eligible patients were ≥ 18 years of age with Philadelphia chromosome-negative relapsed or refractory B-precursor ALL. • Relapsed or refractory was defined as relapsed with first remission duration of ≤ 12 months in first salvage or relapsed or refractory after first salvage therapy or relapsed within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT), and had ≥ 10% blasts in bone marrow. 75.3% 41.6% (95% CI: 34.4-49.1) of R/R ALL evaluable patients achieved a CR/CRh* (n=77/185)1 (95% CI: 64.2-84.4) with CR/CRh* also had an MRD response (defined as MRD by PCR < 1 x 10-4) (n=58/77)1 39% of patients who achieved CR/CRh* went on to receive allogeneic transplant (n=30/77)1 INDICATION BLINCYTO™ is indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials. IMPORTANT SAFETY INFORMATION WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended. • Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO™. Interrupt or discontinue BLINCYTO™ as recommended. Contraindications BLINCYTO™ is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation. Warnings and Precautions • Cytokine Release Syndrome (CRS): Life-threatening or fatal CRS occurred in patients receiving BLINCYTO™. Infusion reactions have occurred and may be clinically indistinguishable from manifestations of CRS. Closely monitor patients for signs and symptoms of serious events such as pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Interrupt or discontinue BLINCYTO™ as outlined in the Prescribing Information (PI).