Oral Anti-Cancer Medicines

The information contained in these regimens is a statement of consensus of NCCP and ISMO or IHS professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. The treatment regimen to be used should take into account factors such as histology, molecular pathology, age, performance status, co-morbidities and the patient’s preference. Each treatment regimen has advantages and disadvantages, and there may be more than one good option.  In addition, treatment choices can change over time as more evidence becomes available. Use of these documents is the responsibility of the prescribing clinician and is subject to the HSE.ie terms of use.

Please email any comments or feedback on these regimens to oncologydrugs@cancercontrol.ie

 Oral Anti-Cancer Medicines (OAM) Regimens                           

Regimen Name Indication

Afatinib Monotherapy

Regimen

00221a

Treatment of Epidermal Growth Factor Receptor (EGFR) TKI- naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).

Alectinib Monotherapy

Regimen

00401a

Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib

00401b

 As monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)

Anastrozole Monotherapy

Regimen

00254a

Treatment of hormone receptor positive locally advanced or metastatic breast cancer in post-menopausal women. 

00254b

Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer

00254c

Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.

Axitinib Monotherapy

Regimen

00104a

Treatment of adult patients with advanced renal cell carcinoma (RCC) after failure, on a previous line of therapy, i.e. treatment with SUNItinib, or a cytokine

Bicalutamide Therapy

Regimen

00482a

Treatment of advanced prostate cancer in combination with luteinizing-hormone releasing hormone (LHRH) analogue therapy or surgical castration

Bortezomib , Melphalan and Prednisolone

Regimen

00275a

Treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.

Bortezomib + Dexamethasone +Thalidomide (VTD) Induction Therapy

Regimen

00274a

Bortezomib, thalidomide and dexamethasone for induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation

Bortezomib, Lenalidomide and Dexamethasone (RVD) Therapy- 21 day

Regimen

00416a

Treatment of newly diagnosed myeloma in adult patients with high risk features

00416b

Treatment of relapsed or refractory myeloma that has received prior therapy in adult patients with high risk features

Bortezomide, Cyclophosphamide and Dexamethasone -21 day Therapy

Regimen

00273a

Treatment of newly diagnosed symptomatic multiple myeloma. 

00273b

Treatment of relapsed/refractory multiple myeloma

Bosutinib Monotherapy

Regimen

00224a

Treatment of adult patients with chronic phase (CP), accelerate phase (AP), and blast phase (BP) Philadelphia choromosome positive chronic myelogenous leukaemia (Ph+CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotonib and dasatinib are not considered appropriate treatment options

Cabozantanib Therapy

Regimen

00518a

Treatment of advanced renal cell carcinoma (RCC) in adults following prior VEGF targeted therapy

Capecitabine Monotherapy

Regimen

00216a

Treatment of patients with locally advanced or metastatic breast cancer

00216b

Treatment of metastatic colorectal cancer. 

00216c

Adjuvant treatment of patients following surgery of stage III colon cancer 

00216d

Adjuvant treatment of patients following surgery of stage II colon cancer. 

00216e

Adjuvant treatment of patients with metastatic colorectal cancer following complete resection 

Capecitabine and RT – 7 day

Regimen

00523a

Locally advanced pancreatic cancer after induction chemotherapy

Capecitabine/Oxaliplatin (XELOX) Therapy

Regimen

00321a

Adjuvant treatment of stage III (Dukes C) colon cancer after complete resection of the primary tumour.

00321b

Treatment of advanced or metastatic colorectal cancer

00321c

Adjuvant Stage II/III gastric adenocarcinoma post D2 gastrectomy.

Capecitabine 825mg/m2 and RT–7 day

Regimen

00586a

Locally advanced rectal cancer

CARBOplatin and Oral Etoposide Therapy-21 days

Regimen

00319a

Small cell lung cancer (SCLC) extensive disease

Carfilzomib, Lenalidomide and Dexamethasone (KRd) Therapy -  28 day 

Regimen

00405a

Carfilzomib,  lenalidomide and dexamethasone therapy is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy

Ceritinib Monotherapy

Regimen

00340a

Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib

Chlorambucil10mg/m2 Therapy

Regimen

00411a

Treatment of patients with low grade lymphoma. 

00411b

Treatment of patients with Chronic Lymphocytic Leukaemia

CISplatin and Capecitabine Adjuvant Chemoradiation Therapy

Regimen

00473a

Adjuvant treatment of adult patients with resected gastric cancer stage IIA or higher and no distant metastases

CISplatin and Teysuno-28 day cycle

Regimen

00235a

Treatment of advanced gastric cancer when given in combination with CISplatin.

Crizotinib Monotherapy

Regimen

00243a

Treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

00243b

The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)

00243c

First-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)

Cylophosphamide (Oral)  Methotrexate and 5-Fluorouracil (CMF) Therapy

Regimen

00377a

Adjuvant treatment for breast carcinoma in patients who are considered unsuitable for anthracycline therapy

00377b

Metastatic breast carcinoma

Dabrafenib Monotherapy

Regimen

00237a

Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation

Dacomitinib Monotherapy

Regimen

00565a

Monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations

Dexamethasone, riTUXimab and Cyclophosphamide
(DRC)Therapy

Regimen

00532a

Treatment of Symptomatic treatment naive or relapsed/refractory
Waldenstrom’s macroglobulinaemia

Encorafenib and Binimetinib Therapy

Regimen

00563a

Treatment of adult patients with advanced unresectable or metastatic)
melanoma with a BRAF V600 mutation.

Enzalutamide Monotherapy

Regimen

00233a

Treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after DOCEtaxel therapy.

00233b

Treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

00233c

The treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC)

epiRUBicin, CISplatin and Capecitabine (ECX) Therapy

Regimen

00380a

Perioperative treatment of resectable gastric adenocarcinoma

00380b

Perioperative treatment of resectable gastroesophageal junction adenocarcinoma

00380c

Perioperative treatment of resectable lower oesophagus adenocarcinoma

00380d

Palliative therapy for metastatic or locally advanced gastric adenocarcinoma

00380e

Palliative therapy for metastatic or locally advanced oesphagogastric adenocarcinoma 

epiRUBicin, Oxaliplatin and Capecitabine (EOX) Therapy 

Regimen

00239a

Locally advanced or metastatic gastric carcinoma

00239b

Locally advanced or metastatic oesophageal carcinoma

00239c

Locally advanced or metastatic gastroesophageal carcinoma

Erlotinib Monotherapy

Regimen

00219a

First-line treatment of patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with EGFR activating mutations.

00219b

Switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy

00219c

Treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Escalated Dose BEACOPP 21 day Therapy

Regimen

00354a

Treatment of patients with high risk, advanced stage Hodgkin Lymphoma (IPS ≥ 3)

00354b

Escalation of treatment of patients with Hodgkin Lymphoma after failure to reach complete metabolic response post 2 cycles of ABVD

Everolimus Monotherapy

Regimen

00320a

Treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy

00320b

Treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. 

00320c

The treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal origin in adults with progressive disease

Exemestane Monotherapy

Regimen

00376a

Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer

00376b

Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior adjuvant endocrine therapy.

00376c

Advanced breast cancer after relapse or disease porgression in women with natural or artificially induced post menopausal endocrine status

Everolimus and Exemestane Therapy

Regimen

00322a

Treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

Fludarabine, Cyclophosphamide and riTUXimab (FC Oral+R) Therapy

Regimen

00410a

Treatment of B-cell chronic lymphocytic leukaemia (CLL)

Gefitinib Monotherapy

Regimen

00220a

Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK

Gemcitabine (1000mg/m2) and Capecitabine (830mg/m2) Therapy - 28 days

Regimen

00524a

Adjuvant treatment of pancreatic adenocarcinoma after macroscopic complete resection

Gemcitabine + Capecitabine Therapy

Regimen

00384a

Locally advanced or metastatic pancreatic carcinoma

00384b

Locally advanced bilary tree carcinoma

Ibrutinib Therapy (CLL/ Waldenstrom's Macroglobulinaemia)

Regimen

00296a

As a single agent for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy

00296b

As a single agent for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy

00296c

As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy

Ibrutinib Therapy (Mantly Cell Lymphoma)

Regimen

00297a

As a single agent for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)

Idelalisib and Ofatumumab Therapy

Regimen

00390a

In combination with Ofatumumab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy

00390b

In combination with Ofatumumab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies

Idelalisib and riTUXimab Therapy

Regimen

00389a

In combination with riTUXimab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy

00389b

In combination with riTUXimab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies

Idelalisib Monotherapy

Regimen

00291a

Monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment. 

Imatinib Therpay-GIST

Regimen

00335a

Treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).

00335b

Adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST

Ixazomib, Lenalidomide and Dexamethasone Therapy - 28 day

Regimen

00516a

Ixazomib in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy

Lapatinib and Capecitabine

Regimen

00217a

Treatment of adult patients with breast cancer, whose tumours over express HER2 in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which should have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting

LEAM Autologous Transplant Conditioning Protocol (Lomustine, etoposide, cytarabine, melphalan)

Regimen

00468a

Autologous conditioning in non-Hodgkins Lymphoma (NHL)

00468b

Autologous conditioning in Hodgkins lymphoma

Lenalidomide 25mg and Dexamethasone Therapy -  28 day 

Regimen

00218a

Treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant

00218b

Treatment of multiple myeloma in adult patients who have received at least one prior therapy

Lenvatinib DTC Therapy

Regimen

00295a

Treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine.

Letrozole Monotherapy

Regimen

00371a

Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer

00371b

Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women  who have received prior adjuvant endocrine therapy for 5 years.

00371c

Advanced breast cancer after relapse or disease progression in women with natural or artificially induced post menopausal endocrine status

00371d

Neo-adjuvant treatment of postmenopausal women with hormone receptor positive breast cancer

Modified CyBorD/ Bortezomib, Cylophosphamide and Dexamethasone –Weekly Therapy

Regimen

00299a

Treatment of newly diagnosed symptomatic multiple myeloma

00299b

Treatment of relapsed/refractory multiple myeloma

Nindetanib Therapy

Regimen

00372a

Treatment of adult patients with locally advanced, metastatic of stage IIIB or IV, or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy

Obinutuzumab and Chlorambucil Therapy

Regimen

00286a

Treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.

Olaparib Monotherapy

Regimen

00341a

Maintenance treatment of adult patients with platinum -sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian cancer who are in response (complete response or partial response) to platinum-based chemotherapy

00341b

Maintenance treatment of adult patients with platinum -sensitive relapsed BRCA-mutated (germline and/or somatic) fallopian tube cancer who are in response (complete response or partial response) to platinum-based chemotherapy

00341c

Maintenance treatment of adult patients with platinum -sensitive relapsed BRCA-mutated (germline and/or somatic) primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy

Oral Etoposide Therapy 

Regimen

00388a

Small cell lung cancer (SCLC) extensive disease in patients unsuitable for intravenous or combination chemotherapy 

Oral Vinorelbine Monotherapy-7days

Regimen

00259a

Advanced breast cancer

00259b

 Non small cell lung cancer  (NSLC)  

Palbociclib Therapy-28 day

Regimen

00414a

Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor

00414b

Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy

Pazopanib Therapy

Regimen

00445a

First line treatment of advanced Renal Cell Carcinoma (RCC) in adults and for patients who have received prior cytokine therapy for advanced disease.

00445b

Treatment of adult patients with selective subtypes of advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. 

Pomalidomide and Dexamethasone

Regimen

00245a

Treatment in combination with dexamethasone of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Ponatinib Therapy

Regimen

00302a

Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation 

00302b

Treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. 

Procarbazine Lomustine and VinCRIStine (PCV) Therapy

Regimen

00379a

Adjuvant treatment of Grade II glioma administered after radiotherapy 

00379b

Palliative treatment for recurrent high grade gliomas 

RiTUXimab, Cyclophosphamide, Etoposide, Vincristine Prednisolone (R-CEOP) Therapy – 21 days

Regimen

00510a

Treatment of Non Hodgkin CD20 positive Lymphoma for patients not

Regorafenib Monotherapy

Regimen

00244a

Treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy. 

00244b

Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib

Ribociclib Therapy-28 day

Regimen

00525a

Treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine-based therapy in combination with an aromatase inhibitor.

00525b

Treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine based therapy or in women who have received prior endocrine therapy.

In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.

Ruxolitinib Monotherapy

Regimen

00229a

Treatment of disease related splenmegaly or symptoms in adult patients with primary myelofibrosis (chronic idiopathic myelofibrosis)

00229b

Post polycythaemia vera myelofibrosis

00229c

Post essential thrombocythaemia myelofibrosis

Sorafenib Therapy

Regimen

00294a

Treatment of hepatocellular carcinoma (HCC).

00294b

Treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

00294c

Treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine.

SUNitnib 37.5mg Therapy

Regimen

00327a

Treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults 

SUNitinib 50mg Therapy

Regimen

00325a

Treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. 

00325b

Treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults 

Tamoxifen Monotherapy

Regimen

00253a

Adjuvant treatment of oestrogen receptor positive breast cancer in pre- or post-menopausal women.

00253b

Treatment of oestrogen receptor positive advanced breast cancer in pre- or post-menopausal women 

Temozolomide Recurrent Therapy

Regimen

00342a

Adult patients with Grade III or IV malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma,showing recurrence or progression after standard therapy.

Temozolomide with Radiotherapy (RT) and Adjuvant Therapy-Patients greater than 65 years

Regimen

00461a

Adult patients greater than 65 years with newly-diagnosed glioblastoma multiforme not suitable for the standard radiotherapy regimen in combination with temozolomide. 

Temozolomide with RT and Adjuvant Therapy

Regimen

00334a

Adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) followed by adjuvant treatment commencing 4 weeks after completion of chemoradiation.

TivozanibTherapy

Regimen

00564a

Tivozanib for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC

Topotecan Oral Monotherapy

Regimen

00587a

Treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first –line regimen is not considered appropriate

Tretinoin (ATRA) with Arsenic Trioxide (ATO) Induction Therapy 

Regimen

00356a

Treatment of patients with newly diagnosed low to intermediate risk Acute Promyelocytic Leukaemia (APL)

Tretinoin (ATRA) with Arsenic Trioxide (ATO) Consolidation Therapy 

Regimen

00357a

Treatment of patients with low to intermediate risk Acute Promyelocytic Leukaemia (APL) with haematological complete remission (CR) after induction treatment with tretinoin (ATRA) and arsenic trioxide (Ref NCCP Protocol 00356

Tretinoin (ATRA)/Idarubicin (PETHEMA  AIDA) Induction Therapy 

Regimen

00366a

Treatment of patients with newly diagnosed Acute Promyelocytic Leukaemia (APL)

Trifluridine and Tipiracil (Lonsurf®) Therapy

Regimen

00382a

Treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine, oxaliplatin and irinotecan based therapies, anti-VEGF and anti-EGFR agents. 

Vandetanib Monotherapy

Regimen

00242a

Treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.

Vemurafenib Monotherapy

Regimen

00102a

Treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Venetoclax Monotherapy

Regimen

00400a

Treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor

00400b

Treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor

Vismodegib Monotherapy

Regimen

00236a

Treatment of adult patients with symptomatic metastatic basal cell carcinoma (MBCC)

00236b

Treatment of adult patients with local advanced basal cell carcinoma inappropriate for surgery or radiotherapy.