A treatment protocol provides details of the cancer therapy including chemotherapy, monoclonal antibodies, targeted therapy and related medicines to be administered on each day of the treatment cycle. A protocol also specifies guidelines and recommendations for administration, dose calculations, supportive therapy, monitoring parameters and criteria for dose modification.
Treatment protocols for cancer chemotherapy support safe, evidence-based and cost-effective cancer treatment for all cancer patients. The use of detailed treatment protocols reduces non-evidence-based variation and standardises care, both of which are fundamental principles for optimising quality and safety in patient care.
For purposes of this section the term "protocols" refers to all aspects of a treatment protocol including chemotherapy, biological therapy, targeted therapy and supportive medication.
The use of pre-documented protocols have been shown to reduce errors in prescribing. Misinterpretations of published articles and errors occurring in original papers have led to fatal outcomes where the article has been used as a direct source for writing a chemotherapy order.
The protocol should come from an evidence-based, published source or validated standard reference source such as the Australian government’s eviQ Cancer Treatments online resource (Cancer Institute NSW) or Children’s Oncology Group (COG) wherever possible. The use of an abstract, which does not represent full results/analysis, should be discouraged as a direct source for writing a chemotherapy order unless an exceptional case arises (Carrington et al, 2010).
There should be a formalised process of initial review by a multidisciplinary team before a protocol is implemented into clinical practice (Carrington et al, 2010). The responsibilities of each member of the team in verifying the content of a protocol should be clearly defined.
Protocols agreed within an institution should be incorporated into an electronic program (e.g. an oncology information system or computerised prescribing system). A fully validated electronic prescribing system should be utilised for the prescribing of chemotherapy wherever available (National Chemotherapy Advisory Group, 2009). Where an electronic system is not available pre-printed prescriptions should be used.
Investigational medications, doses and administration schedules must be verified against a study protocol that has been approved by all relevant regulatory agencies and study sponsors. Any protocol amendments should be distributed immediately and an up-to-date copy of the study protocol should be readily available for reference (Goldspiel et al, 2015).
Requirements associated with the delivery of the protocol at a local level should be considered including availability of supportive services (e.g. pathology and the ability to manage expected adverse effects or events) (Carrington et al, 2010).
Protocols should be reviewed on a regular basis for currency and changes in practice (Carrington et al, 2010).
The format of the protocol should be: (Carrington et al, 2010)
The use of out-of-date protocols can compromise patient safety. Superseded protocols should be archived (not deleted) and only be accessible to a limited number of senior staff. It is recognised that older protocols may be useful as a reference source or for educational purposes.
Facilities should consider convening a regular review meeting where current and proposed protocols can be discussed in a multidisciplinary format.
Variation from standard practice outlined within a treatment protocol including individual drug dose variations may be clinically appropriate for individual patients, and reasons for such variation and discussion with the patient and/or carer should be clearly documented. Monitoring and analysis of protocol and dose variations at an institutional level should be possible with local agreement on methods and frequency of auditing such variations being in place.
Key annual scientific meetings (e.g. American Society of Clinical Oncology, San Antonio Breast Symposium and The American Society of Hematology) often report on study data that may have practice changing implications for protocols. It is useful to convene a protocol review meeting after conferences to consider any major changes required.
Table 2: Suggested content of the chemotherapy protocol
|1|| Protocol name and reference number (if applicable)
Care should be taken to distinguish protocols with similar names (e.g. CHOP/CHOP14, FOLFOX4/ FOLFOX6).
|2|| Indication (e.g. tumour group and stage) and treatment intent
Multi-tumour protocols can lead to confusion over diagnosis and treatment intent and should not be used (e.g. weekly paclitaxel for lung/breast).
|3|| Other treatment modalities that may accompany the protocol
For example: Concurrent or sequential chemo radiation, surgery following neo-chemotherapy.
|4|| Special precautions and contraindications to treatment
|5|| Pre-treatment investigations for first and subsequent cycles including suggested scheduling of investigations during treatment
For example: Blood tests, ECHO, tumour markers.
|6|| All medications that are part of the protocol including individual dosing parameters. Chemotherapy, targeted therapy and supportive therapy must be included.
For oral chemotherapy: 
|7||Route of administration of all medication|
|9|| Cycle frequency, the number of cycles and the total length of a treatment cycle or course
Protocol should specify the interval between repeated doses, the days on which each dose is to be given within a treatment cycle or course, and the total length of a treatment cycle or course.
|10|| Medication vehicle and volume (where appropriate)
For example: Cyclophosphamide in sodium chloride 0.9%, 500 mL.
|11|| Rate and duration of administration
|12|| Adverse effects/regimen-specific complications that may occur during infusion/administration
|13|| Supportive therapy and concurrent medication
|14|| Laboratory tests/investigations required to monitor toxicities and side effects
Parameters for initiating the next cycle of chemotherapy should be defined (e.g. neutrophil count > 1 x 109 /L for cycle to proceed).
|15|| Dose modifications for each agent in the protocol
This should be stated according to laboratory results (including blood and organ function tests) and side effects of treatment.
|16||Potential interactions and medicines/agents/foods to be avoided|
|17||Expected side effects/toxicities, likelihood of onset and their management|
|18|| Reference sources that support the use of the protocol in clinical practice and an assessment of the strength of evidence
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