Off-label use of immune checkpoint inhibitors for the treatment of solid tumors: analysis of a nationwide patient sample.

PURPOSE: Immune checkpoint inhibitors (ICIs) have become an indispensable part of clinical practice; however, off-label use of these agents is unknown. We aimed to define the patterns of off-label use of ICIs in a nationwide sample of patients. METHODS: The online database (Reçetem) was retrospectively searched for off-label use cases related to ICIs approved during a 6-month period. Adult patients with metastatic solid tumors were included. Ethics approval was obtained. Reasons for off-label use were recorded in eight categories and cases were assessed for adherence to current guidelines. Statistical analysis was performed with GNU PSPP version 1.5.3. RESULTS: Five hundred seventy-seven reasons for use were recorded for 538 cases related to 527 patients (67.5% male). Non-small-cell lung cancer (NSCLC) (35.9%) was the most common cancer type. Nivolumab (49%), pembrolizumab (25.5%), and atezolizumab (25%) were commonly used. The top reason for off-label use was lack of approval for the cancer type (37.1%), followed by use beyond the approved treatment line (21%). Nivolumab was more frequently used than atezolizumab and/or pembrolizumab in patients with malignant melanoma, kidney cancer, head and neck cancer, and hepatocellular carcinoma (Chi-square goodness-of-fit test, p < 0.001). The guideline adherence rate was 60.5%. CONCLUSION: Off-label use of ICIs was primarily related to (NSCLC), and most patients were treatment-naïve in contrast to the acceptance that off-label use results from exhausted treatment options. Lack of approval is a significant reason for the off-label use of ICIs.

Review of novel and supplemental approvals of the targeted cancer drugs by the Food and Drug Administration in 2021.

OBJECTIVE: This review aims to present the most recent results from clinical trials of targeted cancer drugs that led to the Food and Drug Administration approval in 2021 and reflect the changing treatment landscape of solid malignancies. DATA SOURCES: Novel approvals and supplemental approvals in 2021 were retrieved from the official web page of the Food and Drug Administration (Drugs@FDA). This review did not include approvals for generics, biosimilars, imaging, and diagnostics agents. DATA SUMMARY: This review included 10 novel drugs approved for 11 indications and 10 already-approved drugs approved for 21 indications by the Food and Drug Administration in 2021. Novel approvals mainly were related to treating an orphan disease. In addition, one-third of the supplemental approvals were given for neoadjuvant or adjuvant treatment, while the number of indications for each tumor site was as follows: gastrointestinal (7), genitourinary (5), skin (3), lung (2), breast (2), thyroid (1), and cervix (1). CONCLUSIONS: Targeted cancer treatments are gaining more importance than ever in treating malignant diseases. As the approval of targeted cancer drugs provides a possibility for patients and this trend is expected to continue in the future, it remains vital for healthcare providers to stay up-to-date with newer therapeutic options.

International society of oncology pharmacy practitioners (ISOPP) position statement: The role of oncology pharmacy practitioners in immunotherapy treatment with immune checkpoint inhibitors for malignant conditions.

Oncology pharmacists, pharmacy technicians and assistants are key members of the multidisciplinary health care team (MHT) caring for patients receiving immunotherapy with immune checkpoint inhibitors. The International Society of Oncology Pharmacy Practitioners (ISOPP) developed this position statement to provide guidance on the role of oncology pharmacy practitioners in caring for patients receiving immune checkpoint inhibitors.Four key recommendations were identified: 1) participation as an integrated, collaborative member of the MHT;2) provision of education and training for patients, students, residents, fellows and other members of the MHT;3) involvement in clinical governance to optimise the use of immune checkpoint inhibitors and4) involvement in research and development in the field of immunotherapy.In summary, oncology pharmacy practitioners play essential roles within the MHT in caring for patients receiving immune checkpoint inhibitors.

Oncologists' attitudes towards prophylaxis of cancer associated venous thromboembolism: A prospective, descriptive study.

INTRODUCTION: Cancer-associated venous thromboembolism creates a big burden on both patients and healthcare systems. Clinical guidelines have a consensus on the initiation of prophylactic treatment for hospitalised patients, however a debate still exists for ambulatory cancer patients. Therefore, this study aimed to identify attitudes and practices of medical oncologists on cancer-associated venous thromboembolism management. METHODS: An online survey consisting of 22 questions was developed by researchers in the view of previous studies and delivered to 100 medical oncologists registered to the national society of medical oncology by e-mail between September and October 2018. Descriptive and statistical analyses were performed using Statistical Package for Social Science (SPSS) version 23.0 (ICM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp). RESULTS: A total of 62 medical oncologists (75.8% male) responded to the survey (response rate of 62%). The most critical three risk factors considered for initiating prophylaxis were prior venous thromboembolism history, immobilisation and tumour/cancer type for inpatients and outpatients (χ2 test, p < 0.001). The first choice of drug for prophylaxis was mostly low molecular weight heparins (n = 60, 96.8%). In the absence of contraindications, physicians initiate prophylaxis 'usually' for inpatients (n = 25, 40.3%) and outpatients (n = 5, 8.1%). However routine use of the Khorana score is not incorporated into the risk assessment process of cancer patients. CONCLUSION: Attitudes of oncologists towards thromboprophylaxis in cancer patients are consistent with previous studies in the literature. The respondents are aware of the venous thromboembolism risk of cancer patients, however raising awareness on both cancer-associated venous thromboembolism and current guideline recommendations is needed.

International Society of Oncology Pharmacy Practitioners (ISOPP) position statement: Role of the oncology pharmacy team in cancer care.

The Oncology Pharmacy Team (OPT), consisting of specialty-trained pharmacists and/or pharmacy technicians, is an integral component of the multidisciplinary healthcare team (MHT) involved with all aspects of cancer patient care. The OPT fosters quality patient care, safety, and local regulatory compliance. The International Society of Oncology Pharmacy Practitioners (ISOPP) developed this position statement to provide guidance on five key areas: 1) oncology pharmacy practice as a pharmacy specialty; 2) contributions to patient care; 3) oncology pharmacy practice management; 4) education and training; and 5) contributions to oncology research and quality initiatives to involve the OPT. This position statement advocates that: 1) the OPT be fully incorporated into the MHT to optimize patient care; 2) educational and healthcare institutions develop programs to continually educate OPT members; and 3) regulatory authorities develop certification programs to recognize the unique contributions of the OPT in cancer patient care.

Assessment of adherence to cancer-associated venous thromboembolism guideline and pharmacist's impact on anticoagulant therapy.

PURPOSE: Cancer-associated venous thromboembolism (VTE) can cause many unfavorable health outcomes. Many institutions have published guidelines, but implementation of these guidelines in cancer clinics is still under investigation. This study aimed to evaluate the guideline adherence and identify potential gaps between the recommendations and their implications in clinics. METHODS: A prospective study was conducted between September and December 2018 at oncology inpatient and ambulatory settings. The guideline adherence rate was assessed for inpatients during hospital stay by using 8 criteria developed based on the National Comprehensive Cancer Network (NCCN) Guideline on Cancer Associated Venous Thromboembolic Disease Version 1.2018. Guideline-based recommendations were proposed to the consultant physician in case of non-adherence. Khorana risk scores were calculated for each patient at outpatient clinics. In cases where the score was found to be ≥ 3, the consultant physician was informed. RESULTS: A total of 100 inpatients and 200 ambulatory patients were included in the study. The guideline adherence rates ranged between 59 and 100% for 5 out of 8 pre-defined criteria, whereas the rate for others remained at 0-1%. A significant increase was observed in the adherence rates for initiation of prophylaxis at admission and determination of correct dose of an anticoagulant after recommendations being implemented (p < 0.001, McNemar test). Eleven patients were identified as at high-risk of VTE at ambulatory setting; however, an initiation of an anticoagulant was not considered by the consultant physicians. CONCLUSION: There are potential problems in implementation of guideline recommendations, which leads to low adherence rate. Therefore, liason with pharmacists and consultants for individual risk assessment and monitoring of patients will help to increase guideline adherence rates.