STEP 4: Treatment

Step 4 describes the optimal treatments for keratinocyte cancer, the training and experience required of the treating clinicians and the health service characteristics required for optimal cancer care.

All health services must have clinical governance systems that meet the following integral requirements:

  • identifying safety and quality measures
  • monitoring and reporting on performance and outcomes
  • identifying areas for improvement in safety and quality (ACSQHC 2020).

Step 4 outlines the treatment options for keratinocyte cancer. For detailed clinical information on treatment options refer to this resource:

The intent of treatment can be defined as one of the following:

  • curative (most keratinocyte cancer patients will be cured with simple excision or radiotherapy)
  • palliative.

The treatment intent should be documented in the patient’s medical record, particularly when there is a deviation from standard care.

The potential benefits need to be balanced against the morbidity and risks of treatment.

The lead clinician should discuss the advantages and disadvantages of each treatment and associated potential side effects with the patient and their carer or family before treatment consent is obtained and begins so the patient can make an informed decision. Supportive care services should also be considered during this decision-making process. Patients should be asked about their use of (current or intended) complementary therapies (see Appendix D).

Timeframes for starting treatment should be informed by evidence-based guidelines where they exist. The treatment team should recognise that shorter timeframes for appropriate consultations and treatment can promote a better experience for patients.

Initiate advance care planning discussions with patients before treatment begins (this could include appointing a substitute decision-maker and completing an advance care directive). Formally involving a palliative care team/service may benefit any patient, so it is important to know and respect each person’s preference (AHMAC 2011).

The definitive treatment of primary keratinocyte cancer involves complete excision of the skin and subcutaneous tissue – usually fat. Margin-control surgery may be offered to some patients for removing keratinocyte cancers with a high risk of recurrence or metastasis, or to maximise skin preservation (e.g. around the lips, nose or eyes). Curettage and diathermy may be an option for some keratinocyte cancers. Referral to a specialist plastic surgeon may be required.

Most clinically favourable BCCs can be excised with a margin of 2–3 mm, with a very high chance of achieving complete excision and long-term control. While a margin of 0.5 mm may be adequate for a well-defined (nodular) BCC, an aggressive form of BCC would require a wider margin of 3–5 mm.

The recommended surgical margin of excision for SCC varies from 2 mm to 10 mm. For SCCs with poor prognostic features, even wider margins may be necessary (Cancer Council Australia Keratinocyte Cancers Guideline Working Party 2019). If there is any concern about margins, consider a discussion with a pathologist and referring for adjuvant radiotherapy if re-excision is not possible.

Timeframe for starting treatment

Patients will be prioritised depending on their particular tumour type and extent but will usually be having active treatment within a three-month period.

Training and experience required of the surgeon

Surgeons must have training and experience of this standard:

  • Fellow of the Royal Australian College of Surgeons or Fellow of the Australasian College of Dermatologists (or equivalent) with adequate training and experience that enables institutional credentialing and agreed scope of practice in keratinocyte cancer
  • adequate training and experience that enables institutional credentialing and agreed scope of practice within this area (ACSQHC 2015).

Documented evidence of the surgeon’s training and experience, including their specific (subspecialty) experience with keratinocyte cancer and procedures to be undertaken, should be available.

Health service characteristics

To provide safe and quality care for patients having surgery, health services should have adequate equipment and staff availability appropriate to the complexity of surgery being performed. Critical care support may be required.

Definitive radiation therapy should be recommended for primary keratinocyte cancer in patients who have declined or have contraindications for conventional surgery, and for cases of persistent, recurrent or advanced keratinocyte cancer where adjuvant radiation can complement surgery to improve control rates (Cancer Council Australia Keratinocyte Cancers Guideline Working Party 2019). Radiation therapy is also an important local modality in the palliative setting. Radiation therapy may also be the primary treatment for appropriate histologically proven tumours, usually where other treatment modalities are less appropriate.

For lesions that will be treated by radiotherapy alone, a confirmatory biopsy is advisable.

Clinical scenarios where patients with keratinocyte cancer may benefit from radiation therapy include the following.

Definitive radiation therapy:

  • patients unsuitable for surgery
  • where surgery creates significant functional and/or aesthetic morbidity that is unacceptable to the patient (e.g. near the lip, eyes or nose).

Adjuvant radiation therapy:

  • patients with incompletely excised keratinocyte cancer where re-excision would result in significant morbidity; adjuvant radiation therapy provides comparable control rates to re-excision and may be a good alternative in these scenarios (Cancer Council Australia Keratinocyte Cancers Guideline Working Party 2019)
  • patients with locally advanced or node-positive disease
  • patients with neurotropic or recurrent lesions.

Symptom palliation:

  • bleeding, fungating, rapidly growing or painful skin lesions.

If the excision specimen shows evidence of perineural invasion (PNI) in more than one nerve, in nerves larger than 0.1 mm or evidence of PNI extending away from the main tumour mass, the patient should be referred for an opinion about postoperative radiotherapy because these patients are at higher risk of local recurrence.

Timeframe for starting treatment

Adjuvant radiation therapy should start as soon as possible once the surgical wounds have healed, usually within four to six weeks of surgery.

Training and experience required of the appropriate specialists

The appropriate specialist should be a radiation oncologist (FRANZCR) with adequate training and experience, institutional credentialing and agreed scope of practice in keratinocyte cancer.

The training and experience of the radiation oncologist should be documented.

Health service unit characteristics

To provide safe and quality care for patients having radiation therapy, health services should have these features:

  • linear accelerator (LINAC) capable of image-guided radiation therapy (IGRT)
  • dedicated CT planning
  • access to MRI and PET imaging
  • automatic record-verify of all radiation treatments delivered
  • a treatment planning system
  • trained medical physicists, radiation therapists and nurses with radiation therapy experience
  • coordination for combined therapy with systemic therapy, especially where facilities are not co-located
  • participation in Australian Clinical Dosimetry Service audits
  • an incident management system linked with a quality management system.

The following treatments may be used for SCC in situ (Bowen’s disease or intraepithelial squamous cell carcinoma) and early-stage keratinocyte cancer when surgery is not suitable. The following treatments should be compared with surgery when discussing the likelihood of cure with the patient:

  • curettage (with collection of a sample for histopathology) and electrocautery for well-defined, superficial or small nodular primary BCCs, SCC in situ and for selected low-risk SCCs where excision is not feasible
  • cryotherapy for SCC in situ and early-stage superficial BCCs
  • 5-fluorouracil cream for multiple solar keratoses and SCC in situ
  • imiquimod cream for biopsy-proven superficial BCCs, multiple solar keratoses and SCC in situ
  • photodynamic therapy for multiple solar keratoses, SCC in situ and selected cases of superficial BCC
  • oral acitretin as an antiproliferative agent as chemoprophylaxis for post–solid organ patients with multiple previous SCCs.

Timeframes for starting treatment

Treatment should start as soon as diagnosis and staging has occurred, and the treatment modality becomes available, ideally within four weeks of the MDM.

For patients with locally advanced or a metastatic BCC, hedgehog pathway inhibitors (vismodegib and sonidegib) are currently available targeted treatment options.

Training and experience required of the appropriate specialists

Medical oncologists must have training and experience of this standard:

  • Fellow of the Royal Australian College of Physicians (or equivalent)
  • adequate training and experience that enables institutional credentialing and agreed scope of practice within this area (ACSQHC 2015).

Cancer nurses should have accredited training in these areas:

  • anti-cancer treatment administration
  • specialised nursing care for patients undergoing cancer treatments, including side effects and symptom management
  • the handling and disposal of cytotoxic waste (ACSQHC 2020).

Systemic therapy should be prepared by a pharmacist whose background includes this experience:

  • adequate training in systemic therapy medication, including dosing calculations according to protocols, formulations and/or preparation.

In a setting where no medical oncologist is locally available (e.g. regional or remote areas), some components of less complex therapies may be delivered by a general practitioner or nurse with training and experience that enables credentialing and agreed scope of practice within this area. This should be in accordance with a detailed treatment plan or agreed protocol, and with communication as agreed with the medical oncologist or as clinically required.

The training and experience of the appropriate specialist should be documented.

Health service characteristics

To provide safe and quality care for patients having systemic therapy, health services should have these features:

  • a clearly defined path to emergency care and advice after hours
  • access to diagnostic pathology including basic haematology and biochemistry, and imaging
  • cytotoxic drugs prepared in a pharmacy with appropriate facilities
  • occupational health and safety guidelines regarding handling of cytotoxic drugs, including preparation, waste procedures and spill kits (eviQ 2019)
  • guidelines and protocols to deliver treatment safely (including dealing with extravasation of drugs)
  • coordination for combined therapy with radiation therapy, especially where facilities are not co-located
  • appropriate molecular pathology access.

Immune checkpoint inhibitors (PD-1 inhibitors) and targeted EGFR inhibitors have shown promise in treating locally advanced and metastatic SCC (Australian Cancer Society 2019; Chen et al. 2019). This is best done through a multidisciplinary team.

The key principle for precision medicine is prompt and clinically oriented communication and coordination with an accredited laboratory and pathologist. Tissue analysis is integral for access to emerging therapies and, as such, tissue specimens should be treated carefully to enable additional histopathological or molecular diagnostic tests in certain scenarios.

Early referral to palliative care can improve the quality of life for people with cancer and in some cases may be associated with survival benefits (Haines 2011; Temel at al. 2010; Zimmermann et al. 2014). This is particularly true for cancers with poor prognosis.

The lead clinician should ensure patients receive timely and appropriate referral to palliative care services. Referral should be based on need rather than prognosis. Emphasise the value of palliative care in improving symptom management and quality of life to patients and their carers.

The ‘Dying to Talk’ resource may help health professionals when initiating discussions with patients about future care needs (see ‘More information’). Ensure that carers and families receive information, support and guidance about their role in palliative care (Palliative Care Australia 2018).

Patients, with support from their family or carer and treating team, should be encouraged to consider appointing a substitute decision-maker and to complete an advance care directive.

Refer to Step 6 for a more detailed description of managing patients with recurrent, residual or metastatic disease.

More information

These online resources are useful:

The team should support the patient to participate in research or clinical trials where available and appropriate. Many emerging treatments are only available on clinical trials that may require referral to certain trial centres.

For more information visit the Cancer Australia website.

See validated screening tools mentioned in Principle 4 ‘Supportive care’.

A number of specific challenges and needs may arise for patients at this time:

  • assistance for dealing with emotional and psychological issues, including body image concerns, fatigue, quitting smoking, traumatic experiences, existential anxiety, treatment phobias, anxiety/depression, interpersonal problems and sexuality concerns
  • potential isolation from normal support networks, particularly for rural patients who are staying away from home for treatment
  • management of physical symptoms such as pain and paraesthesia
  • disfigurement and scarring from appearance-altering treatment (and possible need for a prosthetic), which may require referral to a specialist plastic surgeon, psychologist, psychiatrist or social worker
  • possible wound complications following surgery require appropriate care by the practitioner who performed the surgery and/or the patient’s general practitioner, or a plastic and reconstructive surgeon
  • lymphoedema, which may require referral to a trained lymphoedema practitioner
  • decline in mobility or functional status as a result of treatment
  • assistance with beginning or resuming regular exercise with referral to an exercise physiologist or physiotherapist (COSA 2018; Hayes et al. 2019).

Early involvement of general practitioners may lead to improved cancer survivorship care following acute treatment. General practitioners can address many supportive care needs through good communication and clear guidance from the specialist team (Emery 2014).

Patients, carers and families may have these additional issues and needs:

  • financial issues related to loss of income (through reduced capacity to work or loss of work) and additional expenses as a result of illness or treatment
  • advance care planning, which may involve appointing a substitute decision-maker and completing an advance care directive
  • legal issues (completing a will, care of dependent children) or making an insurance, superannuation or social security claim on the basis of terminal illness or permanent disability.

Cancer Council’s 13 11 20 information and support line can assist with information and referral to local support services.

For more information on supportive care and needs that may arise for different population groups, see Appendices A and B, and special population groups.

Rehabilitation may be required at any point of the care pathway. If it is required before treatment, it is referred to as prehabilitation (see section 3.6.1).

All members of the multidisciplinary team have an important role in promoting rehabilitation. Team members may include occupational therapists, speech pathologists, dietitians, social workers, psychologists, physiotherapists, exercise physiologists and rehabilitation specialists.

To maximise the safety and therapeutic effect of exercise for people with cancer, all team members should recommend that people with cancer work towards achieving, and then maintaining, recommended levels of exercise and physical activity as per relevant guidelines. Exercise should be prescribed and delivered under the direction of an accredited exercise physiologist or physiotherapist with experience in cancer care (Vardy et al. 2019). The focus of intervention from these health professionals is tailoring evidence-based exercise recommendations to the individual patient’s needs and abilities, with a focus on the patient transitioning to ongoing self-managed exercise.

Other issues that may need to be dealt with include managing cancer-related fatigue, improving physical endurance, achieving independence in daily tasks, optimising nutritional intake, returning to work and ongoing adjustment to cancer and its sequels. Referrals to dietitians, psychosocial support, return-to-work programs and community support organisations can help in managing these issues.

The lead or nominated clinician should take responsibility for these tasks:

  • discussing treatment options with patients and carers, including the treatment intent and expected outcomes, and providing a written version of the plan and any referrals
  • providing patients and carers with information about the possible side effects of treatment, managing symptoms between active treatments, how to access care, self-management strategies and emergency contacts
  • encouraging patients to use question prompt lists and audio recordings, and to have a support person present to aid informed decision making
  • initiating a discussion about advance care planning and involving carers or family if the patient wishes.

The general practitioner plays an important role in coordinating care for patients, including helping to manage side effects and other comorbidities, and offering support when patients have questions or worries. For most patients, simultaneous care provided by their general practitioner is very important.

The lead clinician is often the general practitioner for keratinocyte cancer. If this is not the case, the lead clinician, in discussion with the patient’s general practitioner, should consider these points:

  • the general practitioner’s role in symptom management, supportive care and referral to local services
  • using a chronic disease management plan and mental health care management plan
  • how to ensure regular and timely two-way communication about:
    • the treatment plan, including intent and potential side effects
    • supportive and palliative care requirements
    • the patient’s prognosis and their understanding of this
    • enrolment in research or clinical trials
    • changes in treatment or medications
    • the presence of an advance care directive or appointment of a substitute decision-maker
    • recommendations from the multidisciplinary team.
More information

Refer to Principle 6 ‘Communication’ for communication skills training programs and resources.