IDEA4RC FHIR Implementation Guide
0.1.0 - CI Build 150

IDEA4RC FHIR Implementation Guide, published by IDEA4RC Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/idea4rc/ and changes regularly. See the Directory of published versions

Logical Model: SystemicTreatmentI4RC - Detailed Descriptions

Draft as of 2025-07-25

Definitions for the SystemicTreatment logical model.

Guidance on how to interpret the contents of this table can be foundhere

0. SystemicTreatment
Definition

Systemic Treatment Maturity Level: 0 Draft

ShortSystemic Treatment
Control0..*
Is Modifierfalse
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. SystemicTreatment.diagnosisReference
Definition

Diagnosis reference in case the treatment was done for baseline

ShortDiagnosis reference (M)
Control1..*
Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Diagnosis
Obligations
    ObligationsActor
    SHALL:handleHead and Neck
    SHALL:handleSarcoma
    4. SystemicTreatment.episodeEvent
    Definition

    EpisodeEvent element containing the data regarding the patient's cancer

    ShortEpisode Event reference (M)
    Control1..*
    Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/EpisodeEvent
    Obligations
      ObligationsActor
      SHALL:handleHead and Neck
      SHALL:handleSarcoma
      6. SystemicTreatment.systemicTreatmentHospital
      Definition

      In which hospital was the SystemicTreatment performed

      ShortSystemicTreatment Hospital (M)
      Control1..*
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Obligations
        ObligationsActor
        SHALL:handleHead and Neck
        SHALL:handleSarcoma
        8. SystemicTreatment.typeOfSystemicTreatment
        Definition

        Select the type of systemic treatment administered. It is possible to directly select the single treatment as appropriate.

        Shorttype of systemic treatment (M)
        Comments

        Chemotherapy - 4273629 Immunotherapy - 40310107 Targeted therapy - 912065

        Control1..*
        TypeCodeableConcept
        Obligations
          ObligationsActor
          SHALL:handleHead and Neck
          SHALL:handleSarcoma
          10. SystemicTreatment.intent
          Definition

          Clarifies the reasons why systemic therapy is administered • Curative chemotherapy is chemotherapy administered with the goal of achieving a complete remission and preventing the recurrence of cancer. • Palliative chemotherapy refers to any chemotherapy administration that is not curative but administered simply to decrease tumor load and increase life expectancy. It has been defined also as “…treatment in circumstances where the impact of intervention is insufficient to result in major survival advantage, but does affect improvement in terms of tumor‐related symptoms…”

          ShortIntent (O)
          Comments

          Palliative - 4179711 Curative procedure intent - 4162591

          Control0..*
          TypeCodeableConcept
          Obligations
            ObligationsActor
            SHALL:handleHead and Neck
            12. SystemicTreatment.setting
            Definition

            Clarifies the context / how the therapy was administered alone or in conjunction with other treatments • Neoadjuvant: treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy. • Adjuvant: additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy. • Concomitant/concurrent: A treatment that is given at the same time as another (es. Chemotherapy and radiotherapy).

            ShortSetting (O)
            Comments

            Neo-adjuvant - 44808409 Concomitant - 2000100028 Adjuvant - 44804498 Systemic treatment alone - 2000100029

            Control0..*
            TypeCodeableConcept
            Obligations
              ObligationsActor
              SHALL:handleHead and Neck
              14. SystemicTreatment.chemotherapyInfo
              Definition

              Information for chemotherapy

              ShortChemotherapy info (O)
              Comments

              Preoperative - 4119031 Postoperative period - 4118656 Hyperthermic intraperitoneal chemotherapy - 3184898 Therapeutic - 4133895

              Control0..*
              TypeCodeableConcept
              Obligations
                ObligationsActor
                SHALL:handleSarcoma
                16. SystemicTreatment.startDateSystemicTreatment
                Definition

                Specifies when systemic treatment begins

                ShortStart date systemic treatment (M)
                Control1..*
                Typedate
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Obligations
                  ObligationsActor
                  SHALL:handleHead and Neck
                  SHALL:handleSarcoma
                  18. SystemicTreatment.endDateSystemicTreatment
                  Definition

                  Specifies when systemic treatment ends

                  ShortEnd date systemic treatment (M)
                  Control1..*
                  Typedate
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Obligations
                    ObligationsActor
                    SHALL:handleHead and Neck
                    SHALL:handleSarcoma
                    20. SystemicTreatment.numberOfCycles
                    Definition

                    Clarifies how many times the treatment was administered. A cycle of treatment is a period of treatment followed by a period of rest (no treatment). For example, treatment given for one week followed by three weeks of rest is one cycle of treatment. A cycle can be repeated multiple times.

                    ShortNumber of cycles/ administrations (O)
                    Control0..*
                    TypeQuantity
                    Obligations
                      ObligationsActor
                      SHALL:handleHead and Neck
                      SHALL:handleSarcoma
                      22. SystemicTreatment.regimen
                      Definition

                      The regimen applied to the patient. If this is not present, or the specific regimen is not listed here, use the DrugsForTreatments entity.

                      ShortRegimen (O)
                      Comments

                      Doxorubicin and Ifosfamide - 35806965 Ifosfamide and Paclitaxel - 35805248 doxorubicin and vincristine - 2000100054 Epirubicin monotherapy - 35804228 Etoposide monotherapy - 35803691 Gemcitabine monotherapy - 35804135 Ifosfamide and Gemcitabine - 35806435 gemcitabine and vincristine - 2000100055 high dose cisplatin - 2000100056 Ifosfamide monotherapy - 35804542 ifosfamide and etoposide - 2000100057 Irinotecan liposomal monotherapy - 35805368 Lenvatinib monotherapy - 35805795 Methotrexate monotherapy - 35804095 Nivolumab monotherapy - 35803677 ADT (other androgen deprivation therapy) - 35806821 Oxaliplatin monotherapy - 35805078 Paclitaxel monotherapy - 35804166 Gemcitabine and Paclitaxel - 35804158 Ifosfamide and Paclitaxel - 35805248 Paclitaxel and Trastuzumab (TH) - 35804201 Paclitaxel and Vinorelbine - 35101452 Pembrolizumab monotherapy - 35803678 Sorafenib monotherapy - 35803487 Trastuzumab emtansine monotherapy (TDM1) - 35805230 Trastuzumab monotherapy - 35804222 Vinorelbine monotherapy - 35804241 weekly carboplatin - 2000100058 weekly cisplatin - 2000100059

                      Epirubicin and Ifosfamide - 35806948 Vincristine and Doxorubicin and Ifosfamide - 2000100060 Vincristine, Actinomycin D, Ifosfamide ( VAI) - 35805452 Docetaxel and Gemcitabine - 35803577 Dacarbazine and Doxorubicin - 35806964 Methotrexate and Doxorubicin and Cisplatin - 2000100061 Methotrexate and Doxorubicin and Ifosfamide - 2000100062 Doxorubicin and Cisplatin and Ifosfamide - 2000100063 Cisplatin and Doxorubicin - 35804819 Methotrexate and Vinorelbine - 2000100064 Ifosfamide and Etoposide (IE) - 35805454 Vincristine and Doxorubicin and Cyclophosphamide - 2000100065 Cyclophosphamide and Etoposide - 35806476 Doxorubicin and Ifosfamide and Dacarbazine - 2000100066 Dacarbazine and Gemcitabine - 35806969 Cyclophosphamide and Topotecan - 35805453 Irinotecan and Vincristine - 2000100067 Irinotecan and Temozolomide - 35805455 Busulfan and Melphalan - 35804000 TNF and Melphalan - 2000100068 Cyclophosphamide and Vinorelbine - 2000100069 Vincristine, Ifosfamide, Doxorubicin, Etoposide (VIDE) - 35805451 Pazopanib monotherapy - 35805690 Regorafenib monotherapy - 35804569 high dose Ifosfamide - 2000100070

                      Control0..*
                      TypeCodeableConcept
                      Obligations
                        ObligationsActor
                        SHALL:handleHead and Neck
                        SHALL:handleSarcoma
                        24. SystemicTreatment.startDateRegimenChanged
                        Definition

                        Specifies when the new systemic treatment begins, if a combination please specify the start of the first drug

                        ShortStart date regimen changed (M)
                        Control1..*
                        Typedate
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Obligations
                          ObligationsActor
                          SHALL:handleHead and Neck
                          26. SystemicTreatment.endDateRegimenChanged
                          Definition

                          Specifies when the new systemic treatment ends,if a combination please specify the end of the last drug

                          ShortEnd date regimen changed (M)
                          Control1..*
                          Typedate
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Obligations
                            ObligationsActor
                            SHALL:handleHead and Neck
                            28. SystemicTreatment.reasonForEndOfTreatment
                            Definition

                            Clarifies the reasons why the treatment ended or was interrupted

                            ShortReason for end of treatment (M)
                            Comments

                            Completed successfully - 44788181 Chemotherapy changed acute chemotherapy toxicity - 4162594 Treatment ended due to comorbidity - 2000100030 Intolerance to drug - 4240582 Procedure discontinued by patient - 37017062 Death - 4306655

                            Control1..*
                            TypeCodeableConcept
                            Obligations
                              ObligationsActor
                              SHALL:handleHead and Neck
                              SHALL:handleSarcoma
                              30. SystemicTreatment.treatmentResponse
                              Definition

                              Measures how well a cancer patient responds to treatment. RECIST criteria should not be applied. The definition of Complete response; Partial response; Stable disease; Progression, should be based on the clinical judgement based on imaging. Only when setting=neoadiuvant or palliative

                              ShortTreatment response (based on imaging alone; no recist or other criteria) (M)
                              Comments

                              Complete Remission - 32946 Partial Remission - 32947 Stable Disease - 32948 Progression - 32949 Not applicable - 4294169 (Not usable in OMOP)

                              Control1..*
                              TypeCodeableConcept
                              Obligations
                                ObligationsActor
                                SHALL:handleHead and Neck
                                SHALL:handleSarcoma

                                Guidance on how to interpret the contents of this table can be foundhere

                                0. SystemicTreatment
                                Definition

                                Systemic Treatment Maturity Level: 0 Draft

                                ShortSystemic Treatment
                                Logical ModelInstances of this logical model are not marked to be the target of a Reference
                                2. SystemicTreatment.diagnosisReference
                                Definition

                                Diagnosis reference in case the treatment was done for baseline

                                ShortDiagnosis reference (M)
                                Control1..*
                                Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Diagnosis
                                Obligations
                                  ObligationsActor
                                  SHALL:handleHead and Neck
                                  SHALL:handleSarcoma
                                  4. SystemicTreatment.episodeEvent
                                  Definition

                                  EpisodeEvent element containing the data regarding the patient's cancer

                                  ShortEpisode Event reference (M)
                                  Control1..*
                                  Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/EpisodeEvent
                                  Obligations
                                    ObligationsActor
                                    SHALL:handleHead and Neck
                                    SHALL:handleSarcoma
                                    6. SystemicTreatment.systemicTreatmentHospital
                                    Definition

                                    In which hospital was the SystemicTreatment performed

                                    ShortSystemicTreatment Hospital (M)
                                    Control1..*
                                    Typestring
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Obligations
                                      ObligationsActor
                                      SHALL:handleHead and Neck
                                      SHALL:handleSarcoma
                                      8. SystemicTreatment.typeOfSystemicTreatment
                                      Definition

                                      Select the type of systemic treatment administered. It is possible to directly select the single treatment as appropriate.

                                      Shorttype of systemic treatment (M)
                                      Comments

                                      Chemotherapy - 4273629 Immunotherapy - 40310107 Targeted therapy - 912065

                                      Control1..*
                                      TypeCodeableConcept
                                      Obligations
                                        ObligationsActor
                                        SHALL:handleHead and Neck
                                        SHALL:handleSarcoma
                                        10. SystemicTreatment.intent
                                        Definition

                                        Clarifies the reasons why systemic therapy is administered • Curative chemotherapy is chemotherapy administered with the goal of achieving a complete remission and preventing the recurrence of cancer. • Palliative chemotherapy refers to any chemotherapy administration that is not curative but administered simply to decrease tumor load and increase life expectancy. It has been defined also as “…treatment in circumstances where the impact of intervention is insufficient to result in major survival advantage, but does affect improvement in terms of tumor‐related symptoms…”

                                        ShortIntent (O)
                                        Comments

                                        Palliative - 4179711 Curative procedure intent - 4162591

                                        Control0..*
                                        TypeCodeableConcept
                                        Obligations
                                          ObligationsActor
                                          SHALL:handleHead and Neck
                                          12. SystemicTreatment.setting
                                          Definition

                                          Clarifies the context / how the therapy was administered alone or in conjunction with other treatments • Neoadjuvant: treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy. • Adjuvant: additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy. • Concomitant/concurrent: A treatment that is given at the same time as another (es. Chemotherapy and radiotherapy).

                                          ShortSetting (O)
                                          Comments

                                          Neo-adjuvant - 44808409 Concomitant - 2000100028 Adjuvant - 44804498 Systemic treatment alone - 2000100029

                                          Control0..*
                                          TypeCodeableConcept
                                          Obligations
                                            ObligationsActor
                                            SHALL:handleHead and Neck
                                            14. SystemicTreatment.chemotherapyInfo
                                            Definition

                                            Information for chemotherapy

                                            ShortChemotherapy info (O)
                                            Comments

                                            Preoperative - 4119031 Postoperative period - 4118656 Hyperthermic intraperitoneal chemotherapy - 3184898 Therapeutic - 4133895

                                            Control0..*
                                            TypeCodeableConcept
                                            Obligations
                                              ObligationsActor
                                              SHALL:handleSarcoma
                                              16. SystemicTreatment.startDateSystemicTreatment
                                              Definition

                                              Specifies when systemic treatment begins

                                              ShortStart date systemic treatment (M)
                                              Control1..*
                                              Typedate
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Obligations
                                                ObligationsActor
                                                SHALL:handleHead and Neck
                                                SHALL:handleSarcoma
                                                18. SystemicTreatment.endDateSystemicTreatment
                                                Definition

                                                Specifies when systemic treatment ends

                                                ShortEnd date systemic treatment (M)
                                                Control1..*
                                                Typedate
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Obligations
                                                  ObligationsActor
                                                  SHALL:handleHead and Neck
                                                  SHALL:handleSarcoma
                                                  20. SystemicTreatment.numberOfCycles
                                                  Definition

                                                  Clarifies how many times the treatment was administered. A cycle of treatment is a period of treatment followed by a period of rest (no treatment). For example, treatment given for one week followed by three weeks of rest is one cycle of treatment. A cycle can be repeated multiple times.

                                                  ShortNumber of cycles/ administrations (O)
                                                  Control0..*
                                                  TypeQuantity
                                                  Obligations
                                                    ObligationsActor
                                                    SHALL:handleHead and Neck
                                                    SHALL:handleSarcoma
                                                    22. SystemicTreatment.regimen
                                                    Definition

                                                    The regimen applied to the patient. If this is not present, or the specific regimen is not listed here, use the DrugsForTreatments entity.

                                                    ShortRegimen (O)
                                                    Comments

                                                    Doxorubicin and Ifosfamide - 35806965 Ifosfamide and Paclitaxel - 35805248 doxorubicin and vincristine - 2000100054 Epirubicin monotherapy - 35804228 Etoposide monotherapy - 35803691 Gemcitabine monotherapy - 35804135 Ifosfamide and Gemcitabine - 35806435 gemcitabine and vincristine - 2000100055 high dose cisplatin - 2000100056 Ifosfamide monotherapy - 35804542 ifosfamide and etoposide - 2000100057 Irinotecan liposomal monotherapy - 35805368 Lenvatinib monotherapy - 35805795 Methotrexate monotherapy - 35804095 Nivolumab monotherapy - 35803677 ADT (other androgen deprivation therapy) - 35806821 Oxaliplatin monotherapy - 35805078 Paclitaxel monotherapy - 35804166 Gemcitabine and Paclitaxel - 35804158 Ifosfamide and Paclitaxel - 35805248 Paclitaxel and Trastuzumab (TH) - 35804201 Paclitaxel and Vinorelbine - 35101452 Pembrolizumab monotherapy - 35803678 Sorafenib monotherapy - 35803487 Trastuzumab emtansine monotherapy (TDM1) - 35805230 Trastuzumab monotherapy - 35804222 Vinorelbine monotherapy - 35804241 weekly carboplatin - 2000100058 weekly cisplatin - 2000100059

                                                    Epirubicin and Ifosfamide - 35806948 Vincristine and Doxorubicin and Ifosfamide - 2000100060 Vincristine, Actinomycin D, Ifosfamide ( VAI) - 35805452 Docetaxel and Gemcitabine - 35803577 Dacarbazine and Doxorubicin - 35806964 Methotrexate and Doxorubicin and Cisplatin - 2000100061 Methotrexate and Doxorubicin and Ifosfamide - 2000100062 Doxorubicin and Cisplatin and Ifosfamide - 2000100063 Cisplatin and Doxorubicin - 35804819 Methotrexate and Vinorelbine - 2000100064 Ifosfamide and Etoposide (IE) - 35805454 Vincristine and Doxorubicin and Cyclophosphamide - 2000100065 Cyclophosphamide and Etoposide - 35806476 Doxorubicin and Ifosfamide and Dacarbazine - 2000100066 Dacarbazine and Gemcitabine - 35806969 Cyclophosphamide and Topotecan - 35805453 Irinotecan and Vincristine - 2000100067 Irinotecan and Temozolomide - 35805455 Busulfan and Melphalan - 35804000 TNF and Melphalan - 2000100068 Cyclophosphamide and Vinorelbine - 2000100069 Vincristine, Ifosfamide, Doxorubicin, Etoposide (VIDE) - 35805451 Pazopanib monotherapy - 35805690 Regorafenib monotherapy - 35804569 high dose Ifosfamide - 2000100070

                                                    Control0..*
                                                    TypeCodeableConcept
                                                    Obligations
                                                      ObligationsActor
                                                      SHALL:handleHead and Neck
                                                      SHALL:handleSarcoma
                                                      24. SystemicTreatment.startDateRegimenChanged
                                                      Definition

                                                      Specifies when the new systemic treatment begins, if a combination please specify the start of the first drug

                                                      ShortStart date regimen changed (M)
                                                      Control1..*
                                                      Typedate
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Obligations
                                                        ObligationsActor
                                                        SHALL:handleHead and Neck
                                                        26. SystemicTreatment.endDateRegimenChanged
                                                        Definition

                                                        Specifies when the new systemic treatment ends,if a combination please specify the end of the last drug

                                                        ShortEnd date regimen changed (M)
                                                        Control1..*
                                                        Typedate
                                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                        Obligations
                                                          ObligationsActor
                                                          SHALL:handleHead and Neck
                                                          28. SystemicTreatment.reasonForEndOfTreatment
                                                          Definition

                                                          Clarifies the reasons why the treatment ended or was interrupted

                                                          ShortReason for end of treatment (M)
                                                          Comments

                                                          Completed successfully - 44788181 Chemotherapy changed acute chemotherapy toxicity - 4162594 Treatment ended due to comorbidity - 2000100030 Intolerance to drug - 4240582 Procedure discontinued by patient - 37017062 Death - 4306655

                                                          Control1..*
                                                          TypeCodeableConcept
                                                          Obligations
                                                            ObligationsActor
                                                            SHALL:handleHead and Neck
                                                            SHALL:handleSarcoma
                                                            30. SystemicTreatment.treatmentResponse
                                                            Definition

                                                            Measures how well a cancer patient responds to treatment. RECIST criteria should not be applied. The definition of Complete response; Partial response; Stable disease; Progression, should be based on the clinical judgement based on imaging. Only when setting=neoadiuvant or palliative

                                                            ShortTreatment response (based on imaging alone; no recist or other criteria) (M)
                                                            Comments

                                                            Complete Remission - 32946 Partial Remission - 32947 Stable Disease - 32948 Progression - 32949 Not applicable - 4294169 (Not usable in OMOP)

                                                            Control1..*
                                                            TypeCodeableConcept
                                                            Obligations
                                                              ObligationsActor
                                                              SHALL:handleHead and Neck
                                                              SHALL:handleSarcoma

                                                              Guidance on how to interpret the contents of this table can be foundhere

                                                              0. SystemicTreatment
                                                              Definition

                                                              Systemic Treatment Maturity Level: 0 Draft

                                                              ShortSystemic Treatment
                                                              Control0..*
                                                              Is Modifierfalse
                                                              Logical ModelInstances of this logical model are not marked to be the target of a Reference
                                                              2. SystemicTreatment.diagnosisReference
                                                              Definition

                                                              Diagnosis reference in case the treatment was done for baseline

                                                              ShortDiagnosis reference (M)
                                                              Control1..*
                                                              Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Diagnosis
                                                              Obligations
                                                                ObligationsActor
                                                                SHALL:handleHead and Neck
                                                                SHALL:handleSarcoma
                                                                4. SystemicTreatment.episodeEvent
                                                                Definition

                                                                EpisodeEvent element containing the data regarding the patient's cancer

                                                                ShortEpisode Event reference (M)
                                                                Control1..*
                                                                Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/EpisodeEvent
                                                                Obligations
                                                                  ObligationsActor
                                                                  SHALL:handleHead and Neck
                                                                  SHALL:handleSarcoma
                                                                  6. SystemicTreatment.systemicTreatmentHospital
                                                                  Definition

                                                                  In which hospital was the SystemicTreatment performed

                                                                  ShortSystemicTreatment Hospital (M)
                                                                  Control1..*
                                                                  Typestring
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Obligations
                                                                    ObligationsActor
                                                                    SHALL:handleHead and Neck
                                                                    SHALL:handleSarcoma
                                                                    8. SystemicTreatment.typeOfSystemicTreatment
                                                                    Definition

                                                                    Select the type of systemic treatment administered. It is possible to directly select the single treatment as appropriate.

                                                                    Shorttype of systemic treatment (M)
                                                                    Comments

                                                                    Chemotherapy - 4273629 Immunotherapy - 40310107 Targeted therapy - 912065

                                                                    Control1..*
                                                                    TypeCodeableConcept
                                                                    Obligations
                                                                      ObligationsActor
                                                                      SHALL:handleHead and Neck
                                                                      SHALL:handleSarcoma
                                                                      10. SystemicTreatment.intent
                                                                      Definition

                                                                      Clarifies the reasons why systemic therapy is administered • Curative chemotherapy is chemotherapy administered with the goal of achieving a complete remission and preventing the recurrence of cancer. • Palliative chemotherapy refers to any chemotherapy administration that is not curative but administered simply to decrease tumor load and increase life expectancy. It has been defined also as “…treatment in circumstances where the impact of intervention is insufficient to result in major survival advantage, but does affect improvement in terms of tumor‐related symptoms…”

                                                                      ShortIntent (O)
                                                                      Comments

                                                                      Palliative - 4179711 Curative procedure intent - 4162591

                                                                      Control0..*
                                                                      TypeCodeableConcept
                                                                      Obligations
                                                                        ObligationsActor
                                                                        SHALL:handleHead and Neck
                                                                        12. SystemicTreatment.setting
                                                                        Definition

                                                                        Clarifies the context / how the therapy was administered alone or in conjunction with other treatments • Neoadjuvant: treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy. • Adjuvant: additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy. • Concomitant/concurrent: A treatment that is given at the same time as another (es. Chemotherapy and radiotherapy).

                                                                        ShortSetting (O)
                                                                        Comments

                                                                        Neo-adjuvant - 44808409 Concomitant - 2000100028 Adjuvant - 44804498 Systemic treatment alone - 2000100029

                                                                        Control0..*
                                                                        TypeCodeableConcept
                                                                        Obligations
                                                                          ObligationsActor
                                                                          SHALL:handleHead and Neck
                                                                          14. SystemicTreatment.chemotherapyInfo
                                                                          Definition

                                                                          Information for chemotherapy

                                                                          ShortChemotherapy info (O)
                                                                          Comments

                                                                          Preoperative - 4119031 Postoperative period - 4118656 Hyperthermic intraperitoneal chemotherapy - 3184898 Therapeutic - 4133895

                                                                          Control0..*
                                                                          TypeCodeableConcept
                                                                          Obligations
                                                                            ObligationsActor
                                                                            SHALL:handleSarcoma
                                                                            16. SystemicTreatment.startDateSystemicTreatment
                                                                            Definition

                                                                            Specifies when systemic treatment begins

                                                                            ShortStart date systemic treatment (M)
                                                                            Control1..*
                                                                            Typedate
                                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                            Obligations
                                                                              ObligationsActor
                                                                              SHALL:handleHead and Neck
                                                                              SHALL:handleSarcoma
                                                                              18. SystemicTreatment.endDateSystemicTreatment
                                                                              Definition

                                                                              Specifies when systemic treatment ends

                                                                              ShortEnd date systemic treatment (M)
                                                                              Control1..*
                                                                              Typedate
                                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                              Obligations
                                                                                ObligationsActor
                                                                                SHALL:handleHead and Neck
                                                                                SHALL:handleSarcoma
                                                                                20. SystemicTreatment.numberOfCycles
                                                                                Definition

                                                                                Clarifies how many times the treatment was administered. A cycle of treatment is a period of treatment followed by a period of rest (no treatment). For example, treatment given for one week followed by three weeks of rest is one cycle of treatment. A cycle can be repeated multiple times.

                                                                                ShortNumber of cycles/ administrations (O)
                                                                                Control0..*
                                                                                TypeQuantity
                                                                                Obligations
                                                                                  ObligationsActor
                                                                                  SHALL:handleHead and Neck
                                                                                  SHALL:handleSarcoma
                                                                                  22. SystemicTreatment.regimen
                                                                                  Definition

                                                                                  The regimen applied to the patient. If this is not present, or the specific regimen is not listed here, use the DrugsForTreatments entity.

                                                                                  ShortRegimen (O)
                                                                                  Comments

                                                                                  Doxorubicin and Ifosfamide - 35806965 Ifosfamide and Paclitaxel - 35805248 doxorubicin and vincristine - 2000100054 Epirubicin monotherapy - 35804228 Etoposide monotherapy - 35803691 Gemcitabine monotherapy - 35804135 Ifosfamide and Gemcitabine - 35806435 gemcitabine and vincristine - 2000100055 high dose cisplatin - 2000100056 Ifosfamide monotherapy - 35804542 ifosfamide and etoposide - 2000100057 Irinotecan liposomal monotherapy - 35805368 Lenvatinib monotherapy - 35805795 Methotrexate monotherapy - 35804095 Nivolumab monotherapy - 35803677 ADT (other androgen deprivation therapy) - 35806821 Oxaliplatin monotherapy - 35805078 Paclitaxel monotherapy - 35804166 Gemcitabine and Paclitaxel - 35804158 Ifosfamide and Paclitaxel - 35805248 Paclitaxel and Trastuzumab (TH) - 35804201 Paclitaxel and Vinorelbine - 35101452 Pembrolizumab monotherapy - 35803678 Sorafenib monotherapy - 35803487 Trastuzumab emtansine monotherapy (TDM1) - 35805230 Trastuzumab monotherapy - 35804222 Vinorelbine monotherapy - 35804241 weekly carboplatin - 2000100058 weekly cisplatin - 2000100059

                                                                                  Epirubicin and Ifosfamide - 35806948 Vincristine and Doxorubicin and Ifosfamide - 2000100060 Vincristine, Actinomycin D, Ifosfamide ( VAI) - 35805452 Docetaxel and Gemcitabine - 35803577 Dacarbazine and Doxorubicin - 35806964 Methotrexate and Doxorubicin and Cisplatin - 2000100061 Methotrexate and Doxorubicin and Ifosfamide - 2000100062 Doxorubicin and Cisplatin and Ifosfamide - 2000100063 Cisplatin and Doxorubicin - 35804819 Methotrexate and Vinorelbine - 2000100064 Ifosfamide and Etoposide (IE) - 35805454 Vincristine and Doxorubicin and Cyclophosphamide - 2000100065 Cyclophosphamide and Etoposide - 35806476 Doxorubicin and Ifosfamide and Dacarbazine - 2000100066 Dacarbazine and Gemcitabine - 35806969 Cyclophosphamide and Topotecan - 35805453 Irinotecan and Vincristine - 2000100067 Irinotecan and Temozolomide - 35805455 Busulfan and Melphalan - 35804000 TNF and Melphalan - 2000100068 Cyclophosphamide and Vinorelbine - 2000100069 Vincristine, Ifosfamide, Doxorubicin, Etoposide (VIDE) - 35805451 Pazopanib monotherapy - 35805690 Regorafenib monotherapy - 35804569 high dose Ifosfamide - 2000100070

                                                                                  Control0..*
                                                                                  TypeCodeableConcept
                                                                                  Obligations
                                                                                    ObligationsActor
                                                                                    SHALL:handleHead and Neck
                                                                                    SHALL:handleSarcoma
                                                                                    24. SystemicTreatment.startDateRegimenChanged
                                                                                    Definition

                                                                                    Specifies when the new systemic treatment begins, if a combination please specify the start of the first drug

                                                                                    ShortStart date regimen changed (M)
                                                                                    Control1..*
                                                                                    Typedate
                                                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                    Obligations
                                                                                      ObligationsActor
                                                                                      SHALL:handleHead and Neck
                                                                                      26. SystemicTreatment.endDateRegimenChanged
                                                                                      Definition

                                                                                      Specifies when the new systemic treatment ends,if a combination please specify the end of the last drug

                                                                                      ShortEnd date regimen changed (M)
                                                                                      Control1..*
                                                                                      Typedate
                                                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                                      Obligations
                                                                                        ObligationsActor
                                                                                        SHALL:handleHead and Neck
                                                                                        28. SystemicTreatment.reasonForEndOfTreatment
                                                                                        Definition

                                                                                        Clarifies the reasons why the treatment ended or was interrupted

                                                                                        ShortReason for end of treatment (M)
                                                                                        Comments

                                                                                        Completed successfully - 44788181 Chemotherapy changed acute chemotherapy toxicity - 4162594 Treatment ended due to comorbidity - 2000100030 Intolerance to drug - 4240582 Procedure discontinued by patient - 37017062 Death - 4306655

                                                                                        Control1..*
                                                                                        TypeCodeableConcept
                                                                                        Obligations
                                                                                          ObligationsActor
                                                                                          SHALL:handleHead and Neck
                                                                                          SHALL:handleSarcoma
                                                                                          30. SystemicTreatment.treatmentResponse
                                                                                          Definition

                                                                                          Measures how well a cancer patient responds to treatment. RECIST criteria should not be applied. The definition of Complete response; Partial response; Stable disease; Progression, should be based on the clinical judgement based on imaging. Only when setting=neoadiuvant or palliative

                                                                                          ShortTreatment response (based on imaging alone; no recist or other criteria) (M)
                                                                                          Comments

                                                                                          Complete Remission - 32946 Partial Remission - 32947 Stable Disease - 32948 Progression - 32949 Not applicable - 4294169 (Not usable in OMOP)

                                                                                          Control1..*
                                                                                          TypeCodeableConcept
                                                                                          Obligations
                                                                                            ObligationsActor
                                                                                            SHALL:handleHead and Neck
                                                                                            SHALL:handleSarcoma