Edward P. Ambinder

Principles of Safe Practice Using an Oncology EHR System for Chemotherapy Ordering, Preparation, and Administration, Part 1 of 2

An outline of broad principles that should be considered when integrating an electronic health record, and in particular, a chemotherapy ordering module, into practice.

Template for reporting results of biomarker testing of specimens from patients with carcinoma of the colon and rectum.

The College of American Pathologists offers these templates to assist pathologists in providing clinically useful and relevant information when reporting results of biomarker testing. The College regards the reporting elements in the templates as important elements of the biomarker test report, but the manner in which these elements are reported is at the discretion of each specific pathologist, taking into account clinician preferences, institutional policies, and individual practice.

Combination chemotherapy with high-dose methotrexate, bleomycin, and cisplatin in management of head and neck squamous cell carcinoma

Fifty-nine patients with stage IV head and neck squamous cell cancer were treated with an intensive induction chemotherapy consisting of high-dose methotrexate-leucovorin, bleomycin, and cisplatin. Forty-five patients had recurrent disease following surgery and/or radiation therapy. The response rate in this group was 22%, with a median response duration of 10 weeks and a median survival of 19 weeks. The median survival in responders was 20 weeks and in nonresponders 18 weeks. Fourteen previously untreated patients (13 T4 and one T2) received identical chemotherapy followed by radiation and/or surgery. The response to chemotherapy in previously untreated patients was impressively higher (93%). These patients had a median survival of 48 weeks, and 30% survived 2 years. The initial chemotherapy did not compromise the succeeding radiation therapy or surgery. Toxicities were frequent, but generally well tolerated. It is concluded that prior surgery and/or radiation therapy compromises the efficacy of subsequent chemotherapy in head and neck cancer. Responses to intensive chemotherapy prior to surgery and/or radiation therapy are excellent in patients with T4 tumors and provides a basis for further intensive treatment in attempts to augment cure rates.

Development, implementation, and initial evaluation of a foundational open interoperability standard for oncology treatment planning and summarization

OBJECTIVE Develop and evaluate a foundational oncology-specific standard for the communication and coordination of care throughout the cancer journey, with early-stage breast cancer as the use case. MATERIALS AND METHODS Owing to broad uptake of the Health Level Seven (HL7) Consolidated Clinical Document Architecture (C-CDA) by health information exchanges and large provider organizations, we developed an implementation guide in congruence with C-CDA. The resultant product was balloted through the HL7 process and subsequently implemented by two groups: the Health Story Project (Health Story) and the Athena Breast Health Network (Athena). RESULTS The HL7 Implementation Guide for CDA, Release 2: Clinical Oncology Treatment Plan and Summary, DSTU Release 1 (eCOTPS) was successfully balloted and published as a Draft Standard for Trial Use (DSTU) in October 2013. Health Story successfully implemented the eCOTPS the 2014 meeting of the Healthcare Information and Management Systems Society (HIMSS) in a clinical vignette. During the evaluation and implementation of eCOPS, Athena identified two practical concerns: (1) the need for additional CDA templates specific to their use case; (2) the many-to-many mapping of Athena-defined data elements to eCOTPS. DISCUSSION Early implementation of eCOTPS has demonstrated successful vendor-agnostic transmission of oncology-specific data. The modularity enabled by the C-CDA framework ensures the relatively straightforward expansion of the eCOTPS to include other cancer subtypes. Lessons learned during the process will strengthen future versions of the standard. CONCLUSION eCOTPS is the first oncology-specific CDA standard to achieve HL7 DSTU status. Oncology standards will improve care throughout the cancer journey by allowing the efficient transmission of reliable, meaningful, and current clinical data between the many involved stakeholders.

Number of helper T cells and phytohemagglutinin stimulation correlate in cancer patients.

SummaryMononuclear cells from 12 normal controls (co), 10 advanced untreated (c1), and 6 advanced treated cancer patients (c2) have been isolated. The numbers of mononuclear cells bearing Leu1, Leu2, Leu3, Leu2/HLA-DR and LeuM3 were measured with a fluorescence-activated cell sorter. Only the quantity of helper T cells (Leu3) was decreased in cancer patients (co: 0.89, c1: 0.32, c2: 0.44 × 109/1). Expression of all other markers, including activated suppressor T cells (Leu2/HLA-DR), did not differ significantly from the control. The proliferation of the lymphocytes was determined in a phytohemagglutininculture assay. The cancer groups showed a significantly decreased response (co: 95.8 × 109, cl: 28.7 × 109, c2: 25.7 × 109 cpm). These values correlated with the number of helper T cells but not with the suppressor T cells. Monocytes of cancer patients adsorbed significantly more immunoglobulins than the monocytes of controls. The addition of indomethacin or isoprinosine to phytohemagglutinin-culture assay increased the proliferation of lymphocytes from both the cancer patients and normal controls.

Role of opsonins in clinical response to granulocyte transfusion in granulocytopenic patients

Fifty febrile severely granulocytopenic patients were given four daily transfusions of 2.2 X 10(10) normal donor granulocytes. Twenty-three (46 percent) responded clinically, although both responders and nonresponders were similar in clinical characteristics at the outset. This study examines the relation between serum opsonic activity before initiation of granulocyte administration and clinical response. Opsonic activity to three test organisms (Escherichia coli 286 and ON 2, and Staphylococcus aureus) and to 15 blood stream isolates from 14 patients was measured as serum-dependent uptake of heat-killed 14C-labeled bacteria by normal donor leukopheresis granulocytes in an in vitro assay and compared with results obtained with a standard normal serum in each assay. At a concentration of 8 percent serum, all patient groups were equivalent to standard (90 to 102 percent) for the three test organisms. When rate-limiting concentrations of serum (1 to 2 percent) were employed, opsonic activity remained similar to standard for S. aureus in all patient groups and for the two E. coli strains in responders (82 to 98 percent). In contrast, opsonins for E. coli decreased to 41 to 50 percent of standard in nonresponders (p less than 0.01). When patients with proved infection were separately analyzed, opsonin activity for E. coli 286 and ON 2 was significantly greater in responders than nonresponders (73.6 versus 34.9 percent and 124.8 versus 58.1 percent, respectively for the two strains) (p less than 0.01). Patients with opsonin activity of 50 percent or greater of standard had a greater response rate (73 versus 19 percent and 45 versus 0 percent for the two E. coli strains) (p less than 0.005 and p = 0.08, respectively). Eight of 10 patients with 75 percent or greater of standard for opsonic activity against their own blood stream isolates also responded, whereas zero of four with opsonins less than 75 percent of standard had a favorable outcome. These results indicate that serum opsonic activity may be a determinant of clinical response to granulocyte transfusion in infected granulocytopenic patients and may be predictive of outcome. We conclude that opsonic activity should be assessed in such patients before granulocyte administration and suggest a trial of plasma infusion in opsonin-deficient patients.

HIGH DOSE METHOTREXATE FOLLOWED BY CITROVORUM FACTOR REVERSAL IN PATIENTS WITH ADVANCED CANCER

High dose methotrexate followed by citrovorum factor reversal has been utilized in twenty‐six patients with advanced cancer. Four of 10 patients with head and neck cancer had an objective response. One of 7 patients with metastatic osteosarcoma to the lungs had stabilization with twenty treatments over 23 months. One patient with acute lymphocytic leukemia developed marrow aplasia but did not attain remission. The regimen was well tolerated when meticulous attention was paid to hydration, urine alkalinization, renal function and third space fluid accumulation. Life‐threatening or lethal toxicity was encountered when these phenomena were not scrupulously observed.

Hyperleukocytosis in Adult Leukemia

Patients with leukemia and hyperleukocytosis are at risk of developing leukostasis [1]. Patients with acute myeloid leukemia (AML) will tend to develop symptoms of leukostasis at a white blood count (WBC) of 100000/μl. Patients with chronic myelocytic leukemia (CML) will tend to develop symptoms of leukostasis at a higher WBC of over 200000/μL Patients with acute lymphocytic leukemia (ALL) and hyperleukocytosis have a poorer prognosis than patients with a lower WBC but leukostasis is not a common finding. Patients with chronic lymphocytic leukemia (CLL) very rarely develop symptoms from hyperleukocytosis unless the WBC is extremely elevated e.g. 400000/μl. Leukostasis was reported by us in a single patient with hairy cell leukemia and a WBC of 1 million/μl [2].

Identifying Health Information Technology Needs of Oncologists to Facilitate the Adoption of Genomic Medicine: Recommendations From the 2016 American Society of Clinical Oncology Omics and Precision Oncology Workshop

At the ASCO Data Standards and Interoperability Summit held in May 2016, it was unanimously decided that four areas of current oncology clinical practice have serious, unmet health information technology needs. The following areas of need were identified: 1) omics and precision oncology, 2) advancing interoperability, 3) patient engagement, and 4) value-based oncology. To begin to address these issues, ASCO convened two complementary workshops: the Omics and Precision Oncology Workshop in October 2016 and the Advancing Interoperability Workshop in December 2016. A common goal was to address the complexity, enormity, and rapidly changing nature of genomic information, which existing electronic health records are ill equipped to manage. The subject matter experts invited to the Omics and Precision Oncology Workgroup were tasked with the responsibility of determining a specific, limited need that could be addressed by a software application (app) in the short-term future, using currently available genomic knowledge bases. Hence, the scope of this workshop was to determine the basic functionality of one app that could serve as a test case for app development. The goal of the second workshop, described separately, was to identify the specifications for such an app. This approach was chosen both to facilitate the development of a useful app and to help ASCO and oncologists better understand the mechanics, difficulties, and gaps in genomic clinical decision support tool development. In this article, we discuss the key challenges and recommendations identified by the workshop participants. Our hope is to narrow the gap between the practicing oncologist and ongoing national efforts to provide precision oncology and value-based care to cancer patients.

Advancing High-Quality Cancer Care: Cancer Biomedical Informatics Grid Supports Personalized Medicine and the Electronic Health Record

T he electronic collection of cancer-related information and data is an important subject for oncologists. It’s highly likely to be integral to the delivery of quality personalized cancer care. Two areas that address the collection and processing of electronic information for research, quality initiatives, and best-practice patient care are the cancer Biomedical Informatics Grid (caBIGTM), led by the National Cancer Institute’s (NCI) Center for Biomedical Informatics and Information Technology, and electronic health record (EHR) systems.