NICE, the UK HMO, Publishes full Guidance on the Diagnosis and Management of Metastatic Malignant Disease of Unknown Primary Origin

NICE, the UK HMO, Publishes full Guidance on the Diagnosis and Management of Metastatic Malignant Disease of Unknown Primary Origin.

Full Text here

Every hospital with a cancer centre or unit should establish a carcinoma of unknown primary (CUP) team, and ensure that patients have access to the team when malignancy of undefined primary origin (MUO) is diagnosed. The team should:
− consist of an oncologist, a palliative care physician and a CUP specialist nurse or key worker as a minimum
− have administrative support and sufficient designated time in their job plans for this specialist role and
− have a named lead clinician.

Every hospital with a cancer centre or unit should assign a CUP specialist nurse or key worker to patients diagnosed with MUO or CUP. The CUP specialist nurse or key worker should:
− take a major role in coordinating the patient’s care in line with this guideline
− liaise with the patient’s GP and other community support services
− ensure that the patient and their carers can get information, advice and support about diagnosis, treatment, palliative care, spiritual and psychosocial concerns
− meet with the patient in the early stages of the pathway and keep in close contact with the patient regularly by mutual agreement and
− be an advocate for the patient at CUP team meetings.

Refer outpatients with MUO to the CUP team immediately using the rapid referral pathway for cancer, so that all patients are assessed within 2 weeks of referral. A member of the CUP team should assess inpatients with MUO by the end of the next working day after referral. The CUP team should take responsibility for ensuring that a management plan exists which includes:
− appropriate investigations
− symptom control
− access to psychological support and
− providing information.

A CUP network multidisciplinary team (MDT) should be set up to review the treatment and are of patients with confirmed CUP, or with MUO or provisional CUP and complex diagnostic or treatment issues. This team should carry out established specialist MDT responsibilities.

Every cancer network should establish a network site-specific group to define and oversee policies for managing CUP. The group should:
− ensure that every CUP team in the network is properly set up (see recommendation on page 15)
− ensure that the local care pathway for diagnosing and managing CUP is in line with this guideline
− be aware of the variety of routes by which newly diagnosed patients present
− advise the cancer network on all matters related to CUP, recognising that many healthcare professionals have limited experience of CUP

maintain a network-wide audit of the incidence of CUP, its timely management, and patient outcomes
− arrange and hold regular meetings for the group to report patient outcomes and review the local care pathway.

Offer the following investigations to patients with MUO, as clinically appropriate, guided by the patient’s symptoms:
− comprehensive history and physical examination including breast, nodal areas, skin, genital, rectal and pelvic examination
− full blood count; urea, electrolytes and creatinine; liver function tests; calcium; urinalysis; lactate dehydrogenase
− chest X-ray
− myeloma screen (when there are isolated or multiple lytic bone lesions)
− symptom-directed endoscopy
− computed tomography (CT) scan of the chest, abdomen and pelvis
− prostate-specific antigen (PSA) in men (see recommendation on page 24)
− cancer antigen 125 (CA125) in women with peritoneal malignancy or ascites (see recommendation on page 24)
− alpha-fetoprotein (AFP) and human chorionic gonadotrophin (hCG) (particularly in the presence of midline nodal disease) (see recommendation on page 24)
− testicular ultrasound in men with presentations compatible with germ-cell tumours
− biopsy and standard histological examination, with immunohistochemistry where necessary, to distinguish carcinoma from other malignant diagnoses.

Do not use gene-expression-based profiling to identify primary tumours in patients with provisional CUP

Perform investigations only if:
− the results are likely to affect a treatment decision
− the patient understands why the investigations are being carried out
− the patient understands the potential benefits and risks of investigation and treatment and
− the patient is prepared to accept treatment.

Include the patient’s prognostic factors in decision aids and other information for patients and their relatives or carers about treatment options.

If chemotherapy is being considered for patients with confirmed CUP, with no clinical features suggesting a specific treatable syndrome, inform patients about the potential
benefits and risks of treatment.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.


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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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