Result card

  • ORG2: What kind of staff, training and other human resources are required when the tests (uPA/PAI-1/ Oncotype DX/ MammaPrint) are used to support treatment choice?
English

What kind of staff, training and other human resources are required when the tests (uPA/PAI-1/ Oncotype DX/ MammaPrint) are used to support treatment choice?

Authors: Jennifer Butt, Marco Marchetti, Angelica Carletto, Americo Cicchetti, Chiara Filippi

Internal reviewers: Paolo Giorgi Rossi, Claudia Wild, Anne Lee, Antonio Migliore, Stefan Mathis-Endenhofer, Cari Almazan

Analysis of selected studies extracted from the basic literature search. Two articles were found to be relevant to this question.

MammaPrint

MammaPrint must be analysed exclusively by the manufacturer’s laboratory so no special staff, training or other human resources are needed within the centres, other than pathologists for the specimen preparation. Sample isolation and preparation must be performed by pathologists in the proper way, following the instructions of the manufacturer. Specimen preparation requires either fresh, fresh-frozen or FFPE tissue. {RC-TEC2, RC-TEC3, RC-TEC4}

In the logistics pilot study preceding the MINDACT trial {5} training activities were performed before introducing the 70-gene prognosis-signature into daily clinical practice. The study coordinator organised on-site instruction meetings in each participating hospital. These instruction meetings were attended by a multidisciplinary team, i.e. breast surgeons, medical oncologists, pathologists, data managers and research nurses. During this instruction visit, the logistical scheme was discussed and incorporated into the local standard procedures. Additionally, all study-specific standard procedures were explained in detail in a manual of operations and were summarised on provided pocket summaries, to support standardised procedures for tissue collection, freezing and shipment. The authors highlighted that training and repetition are very important to avoid sample failure and to achieve the balance between a sufficient amount of tumour cells and a limited amount of stromal tissue. {5}

Oncotype DX

Oncotype DX must be analysed exclusively by the manufacturer’s laboratory so no special staff, training or other human resources are needed within the centres, other than pathologists for the specimen preparation. Sample isolation and preparation must be performed by pathologists in the proper way, following the instructions of the manufacturer. The pathologist must be able to select the appropriate tumour block for Oncotype DX, given that results should reflect the invasive component of the tumour. Specimen preparation requires FFPE tissue. {6, RC-TEC4}

uPA/PAI-1 and FEMTELLE

If FEMTELLE is analysed in the centre’s own laboratory, the staff must be trained to an appropriate level (see RC-TEC13 or RC-ORG5 for more details). If the samples are sent to a laboratory recommended by the manufacturer, no special staff, training or other human resources are needed within the centres, other than pathologists for the specimen preparation. In both cases sample isolation and preparation must be performed by pathologists in the proper way, following the instructions of the manufacturer. Specimen preparation requires fresh-frozen tissue. {RC-TEC2}

No information was found about the staff, training or human resources requirements of using a generic (“home brew”) uPA/PAI-1 test.

If one particular tissue collection and preservation system (such as FFPE) is normally used in the clinical setting, use of a test which requires a different system (such as fresh-frozen) will have an impact on staff, training and human resource needs.

Important
Completely
Butt J et al. Result Card ORG2 In: Butt J et al. Organisational aspects In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 2 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113

References