4.5 Review

A practical guide to the handling and administration of talimogene laherparepvec in Europe

期刊

ONCOTARGETS AND THERAPY
卷 10, 期 -, 页码 3867-3880

出版社

DOVE MEDICAL PRESS LTD
DOI: 10.2147/OTT.S133699

关键词

herpes simplex virus; intralesional injection; melanoma; oncolytic immunotherapy; practical considerations; talimogene laherparepvec

资金

  1. Amgen [Europe] GmbH, Zug, Switzerland
  2. ICR/RM NIHR Biomedical Research Centre
  3. National Institute for Health Research [NF-SI-0515-10101] Funding Source: researchfish
  4. Rosetrees Trust [M236-F1-CD1, M236-CD1] Funding Source: researchfish

向作者/读者索取更多资源

Talimogene laherparepvec is a herpes simplex virus-1-based intralesional oncolytic immunotherapy and is the first oncolytic virus to be approved in Europe. It is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage IIIB, IIIC, and IVM1a) with no bone, brain, lung, or other visceral disease. Talimogene laherparepvec is a genetically modified viral therapy, and its handling needs special attention due to its deep freeze, cold-chain requirements, its potential for viral shedding, and its administration by direct intralesional injection. This review provides a practical overview of handling, storage, and administration procedures for this agent in Europe. Talimogene laherparepvec vials should be transported/stored frozen at a temperature of -90 degrees C to -70 degrees C, and once thawed, vials must not be refrozen. Universal precautions for preparation, administration, and handling should be followed to avoid accidental exposure. Health care providers should wear personal protective equipment, and materials that come into contact with talimogene laherparepvec should be disposed of in accordance with local institutional procedures. Individuals who are immunocompromised or pregnant should not prepare or administer this agent. Talimogene laherparepvec is administered by intralesional injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound. Treatment should be continued for >= 6 months. As with other immunotherapies, patients may experience an increase in the size of existing lesion(s) or the appearance of new lesions (ie, progression) prior to achieving a response (pseudo-progression). As several health care professionals (eg, physicians [dermatologists, surgeons, oncologists, radiologists], pharmacists, nurses) are involved in different stages of the process, there is a need for good interdisciplinary collaboration when using talimogene laherparepvec. Although there are specific requirements for this agent's storage, handling, administration, and disposal, these can be effectively managed in a real-world clinical setting through the implementation of training programs and straightforward standard operating procedures.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.5
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

Review Oncology

Systematic review and meta-analysis of occult contralateral nodal metastases in patients with oropharyngeal squamous carcinoma undergoing elective neck dissection

Akshat Malik, John C. Hardman, Yadsan Devabalan, Christopher Nutting, Shreerang Bhide, Kevin Harrington, Clare Schilling, Vinidh Paleri

Summary: A systematic review and meta-analysis was conducted to evaluate occult contralateral nodal metastases (OCM) in patients undergoing bilateral neck dissection for surgically treated oropharyngeal squamous cell carcinoma (OPSCC). The study found that OCM were seen in 9.8% of patients, with a higher rate in cN positive necks compared to cN0 necks. This highlights the importance of considering contralateral neck involvement in the surgical treatment of OPSCC.
Article Oncology

Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study

Kevin J. Harrington, Barbara Burtness, Richard Greil, Denis Soulieres, Makoto Tahara, Gilberto de Castro Jr, Amanda Psyrri, Irene Brana, Neus Baste, Prakash Neupane, Ase Bratland, Thorsten Fuereder, Brett G. M. Hughes, Ricard Mesia, Nuttapong Ngamphaiboon, Tamara Rordorf, Wan Zamaniah Wan Ishak, Jianxin Lin, Burak Gumuscu, Ramona F. Swaby, Danny Rischin

Summary: The study presents a post hoc analysis of the long-term efficacy and progression-free survival in recurrent/metastatic head and neck squamous cell carcinoma patients treated with pembrolizumab and pembrolizumab-chemotherapy as next-line therapy. The results demonstrate favorable clinical efficacy and progression-free survival with pembrolizumab and pembrolizumab-chemotherapy in patients with programmed death ligand 1 (PD-L1) combined positive score (CPS) >= 20, CPS >= 1, and total populations. Subsequent treatments after pembrolizumab-based therapy also showed good efficacy.

JOURNAL OF CLINICAL ONCOLOGY (2023)

Article Oncology

Durvalumab with or without tremelimumab versus the EXTREME regimen as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck: KESTREL, a randomized, open-label, phase III study

A. Psyrri, J. Fayette, K. Harrington, M. Gillison, M. -J. Ahn, S. Takahashi, J. Weiss, J. -P. Machiels, S. Baxi, A. Vasilyev, A. Karpenko, M. Dvorkin, C. -Y. Hsieh, S. C. Thungappa, P. P. Segura, I. Vynnychenko, R. Haddad, S. Kasper, P. -S. Mauz, V. Baker, P. He, B. Evans, S. Wildsmith, R. F. Olsson, A. Yovine, J. F. Kurland, N. Morsli, T. Y. Seiwert

Summary: The study compared the efficacy of durvalumab with or without tremelimumab versus the EXTREME regimen in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The results showed that in patients with high PD-L1 expression, durvalumab had comparable overall survival with the EXTREME regimen. However, durvalumab alone and in combination with tremelimumab showed durable responses and reduced treatment-related adverse events compared to the EXTREME regimen.

ANNALS OF ONCOLOGY (2023)

Article Oncology

Phase 1, open-label, dose-escalation study on the safety, pharmacokinetics, and preliminary efficacy of intravenous Coxsackievirus A21 (V937), with or without pembrolizumab, in patients with advanced solid tumors

Charles M. Rudin, Hardev S. Pandha, Matthew Zibelman, Wallace L. Akerley, Kevin J. Harrington, Daphne Day, Andrew G. Hill, Steven J. O'Day, Timothy D. Clay, Gavin M. Wright, Ross R. Jennens, David E. Gerber, Jonathan E. Rosenberg, Christy Ralph, David C. Campbell, Brendan D. Curti, Jaime R. Merchan, Yixin Ren, Emmett Schmidt, Lisa Guttman, Sumati Gupta

Summary: This study evaluated the efficacy and safety of V937 combined with pembrolizumab in patients with advanced solid tumors. The results showed that the combination therapy had a manageable safety profile, but did not achieve greater efficacy than pembrolizumab monotherapy in non-small cell lung cancer and urothelial cancer.

JOURNAL FOR IMMUNOTHERAPY OF CANCER (2023)

Article Oncology

Deep and lasting response and acquired resistance to BRAFV600E targeting in a low-grade ovarian cancer patient

Sandro Anchisi, Anita Wolfer, Bettina Bisig, Edoardo Missiglia, Amine Tiab, Ehab Mohamed Kamel, Olivier Michielin, George Coukos, Krisztian Homicsko

Summary: The treatment of BRAFV600E mutant melanoma has been revolutionized by BRAF inhibitors, and BRAF/MEK combination has shown further improvements. BRAF inhibitor use has also been proposed in low-grade ovarian tumors.

CANCER BIOLOGY & THERAPY (2023)

Review Oncology

Managing cisplatin-ineligible patients with resected, high-risk, locally advanced squamous cell carcinoma of the head and neck: Is there a standard of care?

Robert I. Haddad, Kevin Harrington, Makoto Tahara, Petr Szturz, Christophe Le Tourneau, Satu Salmio, Marcis Bajars, Nancy Y. Lee

Summary: For the last 20 years, cisplatin-based chemoradiotherapy has been the standard treatment for locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) patients at high risk of recurrence. However, many patients are ineligible for this treatment due to various reasons. The criteria for cisplatin ineligibility, including age and renal impairment, are still debated. The proportion of cisplatin ineligible patients with resected LA SCCHN remains unclear. This review discusses cisplatin ineligibility considerations, limited clinical evidence, and ongoing clinical trials for alternative treatment options.

CANCER TREATMENT REVIEWS (2023)

Article Biochemistry & Molecular Biology

Response and Resistance to Trametinib in MAP2K1-Mutant Triple-Negative Melanoma

Fanny Seraphine Krebs, Bianca Moura, Edoardo Missiaglia, Veronica Aedo-Lopez, Olivier Michielin, Petros Tsantoulis, Bettina Bisig, Mounir Trimech, Vincent Zoete, Krisztian Homicsko

Summary: The development of targeted therapies for non-BRAF p.Val600-mutant melanomas remains challenging as Triple wildtype (TWT) melanomas lacking BRAF, NRAS, or NF1 mutations are heterogeneous in their genomic drivers. MAP2K1 mutations are enriched in BRAF-mutant melanomas and function as resistance mechanisms to BRAF inhibition. This case study illustrates the difficulties in combining MEK1 and CDK4/6 inhibitors in the presence of resistance to MEK inhibitor monotherapy.

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES (2023)

Article Oncology

Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck The Phase 2 CheckMate 714 Randomized Clinical Trial

Kevin J. Harrington, Robert L. Ferris, Maura Gillison, Makoto Tahara, Athanasios Argiris, Jerome Fayette, Michael Schenker, Ase Bratland, John W. T. Walker, Peter Grell, Caroline Even, Christine H. Chung, Rebecca Redman, Alexandre Coutte, Sebastien Salas, Cliona Grant, Sergio de Azevedo, Denis Soulieres, Aaron R. Hansen, Li Wei, Tariq Aziz Khan, Karen Miller-Moslin, Mustimbo Roberts, Robert Haddad

Summary: The clinical benefit of first-line nivolumab plus ipilimumab was evaluated in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The study found that nivolumab plus ipilimumab did not improve clinical outcomes compared to nivolumab alone in these patients. Further research is needed to identify subpopulations of R/M SCCHN patients who would benefit from nivolumab plus ipilimumab therapy.

JAMA ONCOLOGY (2023)

Article Oncology

Predicting Response to Radical Chemoradiotherapy with Circulating HPV DNA (cHPV-DNA) in Locally Advanced Uterine Cervix Cancer

Susan Lalondrelle, Jen Lee, Rosalind J. Cutts, Isaac Garcia Murillas, Nik Matthews, Nicholas Turner, Kevin Harrington, Katherine Vroobel, Emily Moretti, Shreerang A. Bhide

Summary: Human papilloma virus (HPV) is a major cause of cervical cancer, and there is currently no reliable method to predict early relapse. We have developed a blood test that can accurately detect HPV-DNA fragments in the blood, which can be used to assess treatment response and monitor relapse.

CANCERS (2023)

Article Oncology

COVID-19 in cancer patients: update from the joint analysis of the ESMO-CoCARE, BSMO, and PSMO international databases

P. Martin, Z. Tsourti, J. Ribeiro, L. Castelo-Branco, E. de Azambuja, S. Gennatas, J. Rogado, M. Sekacheva, S. Susnjal, D. Vinal, R. Lee, S. Khallaf, G. Dimopoulou, S. Pradervand, J. Whisenant, T. K. Choueiri, D. Arnold, K. Harrington, K. Punie, J. Oliveira, O. Michielin, U. Dafni, S. Peters, G. Pentheroudakis, E. Romano

Summary: This paragraph summarizes the results of a study analyzing COVID-19 patients, which found that factors such as symptomatic patients, males, older age, ethnicity other than Asian/Caucasian, Eastern Cooperative Oncology Group performance status >2, body mass index <25, hematological malignancy, progressive disease versus no evident disease, and advanced cancer stage significantly affect COVID-19 outcomes.

ESMO OPEN (2023)

Article Oncology

Cell-type-specific tumour sensitivity identified with a bromodomain targeting PROTAC in adenoid cystic carcinoma

Alexandra J. Rose, Mercedes M. Fleming, Jeffrey C. Francis, Jian Ning, Anton Patrikeev, Ritika Chauhan, Kevin J. Harrington, Amanda Swain

Summary: This study established patient-derived xenograft (PDX) lines and tumor organoid models for salivary gland adenoid cystic carcinoma (ACC), and demonstrated the inhibitory effect of dBET6 on ACC cells. Molecular studies revealed a decrease in BRD4 and MYB protein levels and target gene expression with dBET6 treatment. In vivo experiments showed that dBET6 altered the relative composition of ACC cell types and inhibited their progenitor function.

JOURNAL OF PATHOLOGY (2023)

Review Oncology

The Role of Mucin Expression in the Diagnosis of Oesophago-Gastric Cancer: A Systematic Literature Review

Nikhil Manish Patel, Georgios Geropoulos, Pranav Harshad Patel, Ricky Harminder Bhogal, Kevin Joseph Harrington, Aran Singanayagam, Sacheen Kumar

Summary: Diagnosis of oesophago-gastric cancer is challenging, but non-invasive risk stratification can identify susceptible patients with pre-malignant or benign diseases. Early oesophago-gastric cancer can be treated sooner following diagnostic confirmation through endoscopic biopsy. Mucins, transmembrane glycoproteins implicated in oesophago-gastric cancer, have the potential to be used as biomarkers for malignant transformation. This systematic review examines the role of mucins in the diagnosis of oesophago-gastric cancer.

CANCERS (2023)

Meeting Abstract Oncology

Safety, Efficacy, and Biomarker Assessment of RP1 in Combination With Nivolumab in Patients with Advanced Skin Cancers

Georgia M. Beasley, Ari M. VanderWalde, Tawnya L. Bowles, Joseph J. Sacco, Jiaxin Niu, Katy K. Tsai, Jason A. Chesney, Bartosz Chmielowski, Adel Samson, Terence Duane Rhodes, Gino K. In, Anna C. Pavlick, Trisha M. Wise-Draper, Miguel F. Sanmamed, Jeannie Hou, Mark R. Middleton, Kevin Harrington, Celeste Lebbe, Judith Michels, Mohammed M. Milhem

ANNALS OF SURGICAL ONCOLOGY (2023)

Article Dentistry, Oral Surgery & Medicine

Head and neck mucosal melanoma: radiological considerations and UK imaging guidelines

Ashwin Algudkar, Kevin Harrington, Cyrus Kerawala, Izhar Bagwan, Derfel Ap Dafydd

Summary: This study summarizes the imaging recommendations and characteristics of head and neck mucosal melanoma (HNMM), and provides revised guidelines to guide the investigation and management of this rare and aggressive cancer.

ORAL AND MAXILLOFACIAL SURGERY-HEIDELBERG (2023)

Article Oncology

Pembrolizumab versus methotrexate, docetaxel, or cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040) : Subgroup analysis by pattern of disease recurrence

K. J. Harrington, E. E. W. Cohen, D. Soulieres, J. Dinis, L. Licitra, M. -j. Ahn, A. Soria, J. -p. Machiels, N. Mach, R. Mehra, B. Burtness, R. F. Swaby, J. Lin, J. Ge, N. Lerman, C. Le Tourneau

Summary: Through a study on patients with HNSCC, it was found that pembrolizumab provided longer overall survival and durable responses in all subgroups of recurrence patterns, regardless of previous treatment.

ORAL ONCOLOGY (2023)

暂无数据