Table 1 Definitions of key terms.

Anti-cancer agent

A (bio)pharmaceutical product used for the treatment of malignant disease, including—but not limited to—cytotoxic, endocrine, targeted, immunotherapy (including vaccine and cell and gene therapy) and radiopharmaceuticals (e.g. radioisotopes, radio-labelled monoclonal antibodies, radioactive microspheres) that has been approved by the FDA and/or the EMA for treatment of any cancer.

Note: (1) An anti-cancer agent in clinical development not yet approved by the FDA and/or EMA for treatment of any cancer (as on date of starting such therapy) should be termed an ‘experimental anti-cancer agent’; (2) Supportive therapy (e.g. haematopoietics, drugs for preventing skeletal related events, etc) should not be considered as an anti-cancer agent.

Anti-cancer modality

The type of therapy used to remove, kill or suppress cancer cells, including:

• Surgery (therapeutic and including, but not limited to, open surgery, laparoscopic surgery, video-assisted thoracic surgery, robot-assisted surgery, etc.), but excluding diagnostic biopsy;

• Radiotherapy (including, but not limited to, external beam radiation, brachytherapy, proton beam, stereotactic radiosurgery) but excluding radiopharmaceuticals (e.g. radioisotopes, radio-labelled monoclonal antibodies, radioactive microspheres);

• Systemic anti-cancer therapy (SACT; see definition below);

• Other (including, but not limited to, high-intensity focused ultrasound, cryotherapy, thermal ablation, photodynamic therapy, hyperthermia, vascular embolisation and anti-cancer agents not meeting the definition of SACT).

Clinical progression of disease (cPD)

The clear worsening of the patient’s clinical status or prognosis in the opinion of the treating clinician, taking into consideration clinical findings, imaging (including, but not limited to, objective imaging response criteria) and laboratory test results.

Clinical setting

The maximum extent of cancer spread experienced by the patient to date, denoted as

A: Early setting (operable, without known distant metastasis);

B: Locally advanced setting (inoperable, without known distant metastasis);

C. Metastatic setting (operable/inoperable, with known distant metastases)

Note: Operable implies that in the opinion of the clinician all known cancer can be completely removed surgically; Inoperable implies that in the opinion of the clinician all known cancer cannot be completely removed surgically.

Line of therapy (LoT)

A serial chronological number assigned to each systemic anti-cancer therapy (SACT) and experimental SACT administered to a patient and denotes a discrete attempt to treat the cancer.

Note: LoT is reported in the format LoT N (CLoT + PLoT); CLoT is the number of SACT administered with curative intent and/or in the early setting (i.e. operable, without known distant metastasis); PLoT is the number of SACT given with palliative (i.e. non-curative/life-extending) intent and/or in the advanced setting (i.e. inoperable and/or with known distant metastases); N is the sum of CLoT and PLoT.

Systemic anti-cancer therapy (SACT)

SACT has the following features:

• It consists of one or more anti-cancer agents or experimental anti-cancer agents, which can be administered alone or in combination or sequence (which might include alternating, hybrid, continuation maintenance therapy and/or switch-maintenance therapy);

• It is prospectively planned;

• It is usually (but not necessarily) administered in repeating cycles;

• It is administered systemically, or via local/regional routes but with the intention of systemic effect or significant reduction of overall tumour burden in the opinion of the clinician;

• It is given at a clinically relevant dose for a duration that is expected to exert systemic anti-cancer effect.

Note: (1) If the SACT is composed exclusively of experimental anti-cancer agent(s), the prefix ‘Experimental’ should be added to such SACT; (2) A patient participating in a study where the control arm consists only of a placebo should not be considered to have received a SACT in that trial unless unblinded information is available; (3) If an FDA/EMA-approved anti-cancer agent is used with the intention of providing supportive/symptomatic care (e.g. dexamethasone is approved for multiple myeloma, but might also be used to treat nausea and vomiting in patients with other cancers), it should not be considered as an SACT.

Treatment intent

Treatment intent, in the opinion of the treating clinician, can be curative or palliative (i.e. non-curative/life-extending)

(A) Curative therapy aims at complete elimination of cancer and preventing its recurrence;

(B) Palliative therapy aims at improving the quality and/or quantity of life but without the expectation of cure.