Gastrointestinal SACT Regimens

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.

NCCP Guidance on bevacizumab rapid infusion rate

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

For information on open clinical trials please refer to the Cancer Trials Ireland website and also to basket trials.

Gastrointestinal Chemotherapy Regimens

Regimen Name	Indication
Aflibercept and FOLFIRI Therapy -14 day Regimen	00238a Aflibercept is indicated as second line therapy in combination with irinotecan/5-fluorouracil/folinic acid (FOLFIRI) chemotherapy in adults with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after an oxaliplatin-containing regimen.
Atezolizumab and Bevacizumab Therapy Regimen	00831a Atezolizumab in combination with bevacizumab for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Bevacizumab 10 mg/kg –14 days Regimen	00212a In combination with fluoropyrimidine-based chemotherapy for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Bevacizumab 7.5 mg/kg –21 days Regimen	00214a In combination with fluoropyrimidine-based chemotherapy for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Bevacizumab 15 mg/kg –21 days Regimen	00215d In combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Bevacizumab 5mg/kg and FOLFIRI Therapy-14 day Regimen	00449a Treatment of adult patients with metastatic carcinoma of the colon or rectum.
Bevacizumab 5mg/kg and modified FOLFOX-6 Therapy-14 day Regimen	00446a Treatment of adult patients with metastatic carcinoma of the colon or rectum.
Bevacizumab 5mg/kg and FOLFOXIRI -14 day Regimen	00783a Treatment of metastatic colorectal cancer
Bevacizumab 7.5mg/kg and Capecitabine 1250mg/m2 Therapy- 21 day Regimen	00623a Treatment of metastatic or unresectable colorectal cancer in patients not suitable for combination chemotherapy with irinotecan or oxaliplatin.
Capecitabine Monotherapy Regimen	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 825mg/m² and RT–7 day Regimen	00586a Locally advanced rectal cancer
Capecitabine and RT–7 day Regimen	00523a Locally advanced pancreatic cancer after induction chemotherapy.
Capecitabine and Temozolomide Therapy* Regimen	00505a Treatment of patients with locally advanced or metastatic neuroendocrine tumours of the pancreas.
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.
CARBOplatin (AUC 2) Weekly and PACLitaxel (50mg/m²) Weekly with Radiotherapy (RT) -5 weeks Regimen	00422a Preoperative chemoradiation treatment of oesophageal and gastro-oesophageal junction carcinomas.
Cetuximab Therapy- 7 days Regimen	00207a Treatment of patients with epidermal growth factor receptor (EGFR)-expressing RAS wild-type metastatic colorectal cancer (mCRC)
Cetuximab Therapy- 14 days* Regimen	00732a As monotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing RAS wild-type metastatic colorectal cancer (mCRC) in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan
Cetuximab (7days) and Irinotecan (14 days ) Therapy Regimen	00330a Second line therapy for metastatic colorectal cancer with non-mutated (wild type) RAS after failure of or contraindication to oxaliplatin based therapy.
Cetuximab (14 days) and Irinotecan (14 days ) Therapy* Regimen	00331a Second line therapy for metastatic colorectal cancer with non-mutated (wild type) RAS after failure of or contraindication to oxaliplatin based therapy.
Cetuximab and FOLFOX-4 Therapy Regimen	00692a Treatment of patients with RAS wild type metastatic colorectal cancer
Cetuximab (14 days) and FOLFIRI (14 days) Therapy Regimen	00585a Treatment of patients with RAS wild type metastatic colorectal cancer.
Cetuximab and FOLFOX-6 (modified) Therapy* Regimen	00733a Treatment of patients with KRAS wild type metastatic colorectal cancer.
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 75mg/m² and 5-Fluorouracil Chemoradiation Therapy-Herskovic Regimen Regimen	00460a Locally advanced squamous or adenocarcinoma of the oesophagus not suitable for surgery.
CISplatin, 5-Fluorouracil and Radiation Therapy Regimen	00594a Treatment of anal canal carcinoma.
CISplatin and Teysuno^®-28 day cycle Regimen	00235a Treatment of advanced gastric cancer when given in combination with cisplatin.
DOCEtaxel Monotherapy 75mg/m² – 21 day cycle Regimen	00203d Advanced or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction in patients who have progressed during or within 6 months after treatment with a platinum-fluoropyrimidine combination.
DOXOrubicin 60mg/m² Therapy Regimen	00386a Treatment of unresectable or metastatic hepatocellular carcinoma not suitable for treatment with regional therapies.
epiRUBicin, CISplatin and 5-FU (ECF) Therapy Regimen	00240a Metastatic or locally advanced (unresectable) gastric adenocarcinoma. 00240b Metastatic or locally advanced (unresectable) esophagogastric junction adenocarcinoma. 00240c Metastatic or locally advanced (unresectable) oesophageal adenocarcinoma. 00240d Perioperative treatment of resectable gastric adenocarcinoma. 00240e Perioperative treatment of resectable gastroesophageal junction adenocarcinoma. 00240f Perioperative treatment of resectable lower oesophagus adenocarcinoma.
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 5-FU (EOF) -21 day Regimen	00429a Locally advanced or metastatic gastric carcinoma 00429b Locally advanced or metastatic oesophageal carcinoma 00429c Locally advanced or metastatic gastroesophageal carcinoma
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.
Everolimus Monotherapy Regimen	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
FLOT Therapy-14 day Regimen	00344a Treatment of locally advanced (≥T2) and/or nodal positive (N+) resectable gastric adenocarcinoma 00344b Treatment of locally advanced ((≥T2) and/or nodal positive (N+) resectable adenocarcinoma of the oesophagogastreal junction
FLOX Therapy Regimen	00486a Adjuvant treatment of stage II or III colon cancer after complete resection of primary tumour
FOLFIRI Therapy-14 day Regimen	00227a Treatment of patients with advanced colorectal cancer. 00227b Treatment of patients with metastatic oesophageal carcinoma. 00227c Second line treatment of patients with locally advanced metastatic pancreatic carcinoma
FOLFIRI (14 days) and cetuximab (7 days) therapy Regimen	00328a Treatment of patients with RAS wild type metastatic colorectal cancer.
FOLFOX- 4 Therapy-14 day Regimen	00210a Adjuvant treatment of stage II and stage III colon cancer after complete resection of primary tumour. 00210b Metastatic colorectal carcinoma
FOLFOX- 6 Modified Therapy-14 day Regimen	00209a Adjuvant treatment of stage II or III colon cancer after complete resection of primary tumour 00209b Metastatic colorectal carcinoma 00209c Advanced or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction
FOLFOX-6 Modified Chemoradiation Therapy-14 day Regimen	00509a Definitive squamous cell carcinoma (SCC) or adenocarcinoma of the oesophagus in combination in patients for whom a CISplatin based regimen is contraindicated.
FOLFOXIRI Therapy Regimen	00555a Treatment of metastatic colorectal cancer
FOLFIRINOX Therapy Regimen	00329a Metastatic pancreatic cancer.
FOLFIRINOX-Modified Therapy Regimen	00515a Adjuvant treatment of pancreatic ductal adenocarcinoma 00515b Metastatic pancreatic cancer.
FOLFIRINOX Therapy - (Rectal Carcinoma) Regimen	00691a Neoadjuvant chemotherapy for locally advanced rectal cancer
5-Fluorouracil and Folinic Acid Therapy-14 day Regimen	00660a Adjuvant treatment of colorectal carcinoma 00660b Locally advanced, locally recurrent or metastatic colorectal adenocarcinoma not curable with surgery or radiation
5-Fluorouracil (4 day) and mitoMYcin Chemoradiation Therapy Regimen	00451a Treatment of anal canal carcinoma.
5-fluorouracil 225mg/m²/day and Radiotherapy (RT)-Continuous infusion (7day) Regimen	00421a Treatment of locally advanced rectal cancer.
Gemcitabine 1000mg/m²Monotherapy-28 day Regimen	00284a Adjuvant chemotherapy for pancreatic adenocarcinoma.
Gemcitabine 1000mg/m²Monotherapy- 56 day Regimen	00283a Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas.
Gemcitabine (400mg/m²) and RT therapy Regimen	00522a Resectable Adenocarcinoma of the head of Pancreas.
Gemcitabine (600mg/m²) and RT Therapy – 7day Regimen	00559a Treatment of patients with localized unresectable adenocarcinoma of the pancreas.
Gemcitabine (1000mg/m²) and RT therapy Regimen	00521a Non-metastatic, locally advanced pancreatic cancer.
Gemcitabine (1000mg/m²) and Capecitabine (650mg/m²) Therapy- 21 day Regimen	00384a Locally advanced or metastatic pancreatic carcinoma. 00384b Locally advanced biliary tree carcinoma.
Gemcitabine (1000mg/m²) and Capecitabine (830mg/m²) Therapy- 28 day Regimen	00524a Adjuvant treatment of pancreatic adenocarcinoma after macroscopic complete resection.
Gemcitabine (1000mg/m²) and CISplatin (25mg/m²)Therapy-21 day Regimen	00383a Locally advanced or metastatic pancreatic carcinoma 00383b Locally advanced or metastatic biliary tree carcinoma.
Irinotecan Monotherapy - 21days Regimen	00213a Treatment of patients with advanced colorectal cancer as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.
Irinotecan 150mg/m2 Monotherapy – 28 days Regimen	00654a Second line therapy for advanced gastric cancer refractory to treatment with fluoropyrimidine plus platinum.
Lenvatinib_HCC Therapy Regimen	00644a As monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
Lutetium (177Lu) oxodotreotide (Lutathera®) Therapy Regimen	00642a Treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive- gastroenteropancreatic neuroendocrine tumours (GEP- NETs) in adults.
mitoMYcin and Capecitabine Chemoradiation Therapy Regimen	00727 Treatment of anal canal carcinoma
nab-PACLitaxel and Gemcitabine -28 Days Regimen	00256a First-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Nivolumab and FOLFOX-6 Modified Therapy Regimen	00844a Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression ≥1%.
Nivolumab 480mg, CISplatin 80mg/m2 and 5-Fluorouracil infusional Therapy Regimen	00832a Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression ≥1%.
Nivolumab 240mg, CISplatin 80mg/m2 and 5-Fluorouracil infusional Therapy Regimen	00816a Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression ≥1%.
Nivolumab 3mg/kg with Ipilimumab 1mg/kg Therapy Regimen	00551c Nivolumab in combination with ipilimumab for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer (MSI-H mCRC) after prior fluoropyrimidine-based combination chemotherapy.
Nivolumab 240mg Monotherapy Regimen	00483g As monotherapy for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction (GEJ) cancer who have residual pathologic disease following prior neo-adjuvant chemo-radiotherapy.
Nivolumab 480mg Monotherapy- 28 days Regimen	00484g As monotherapy for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction (GEJ) cancer who have residual pathologic disease following prior neo-adjuvant chemo-radiotherapy.
PACLitaxel 80mg/m2 Day 1, 8 and 15 Monotherapy-28 Day Regimen	00621a Second line chemotherapy for advanced or recurrent gastric cancer.
Panitumumab 6mg/kg Therapy Regimen	00225c Treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) As monotherapy after failure of fluorpyridine, oxaliplatin, and irinotecan containing chemotherapy regimens
Panitumumab 6mg/kg and FOLFIRI Therapy-14 day Regimen	00448a First line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC) 00448b Second line treatment of adult patients with wild-type RAS mCRC who have received first-line fluorpyridine–based chemotherapy (excluding irinotecan)
Panitumumab 6mg/kg and modified FOLFOX-6 Therapy-14 day Regimen	00447a First line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC)
Pembrolizumab 200mg Monotherapy Regimen	00455k First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults
Pembrolizumab 400mg Monotherapy Regimen	00558k First-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in adults
Pembrolizumab 200mg, CISplatin 80mg/m2 and 5- Fluorouracil Infusional Therapy Regimen	00739a Pembrolizumab in combination with platinum and fluoropyrimidinebased chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS≥10
Pembrolizumab and FOLFOX-6 Modified Therapy Regimen	00839a Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS≥10.
QUASAR (Modified) Flu Fluorouracil (370mg/m²) and Folinic Acid (50mg) weekly Regimen	00428a Treatment of metastatic colorectal cancer. 00428b Adjuvant treatment of colorectal cancer.
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.
Roswell Park Modified (Fluorouracil 500mg/m² and Folinic Acid 50mg weekly x 6) Regimen Regimen	00427a Treatment of metastatic colorectal cancer. 00427b Adjuvant treatment of colorectal cancer.
SORAfenib Therapy Regimen	00294a Treatment of hepatocellular carcinoma (HCC).
Trastuzumab 5 Fluorouracil and CISplatin Therapy-21days Regimen	00502a Treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Trastuzumab and FOLFOX-6 Modified Therapy-14 day Regimen	00704a Treatment of adult patients with HER2 positive metastatic gastric or gastroesophageal junction cancer
Trifluridine and Tipracil (Lonsurf^®)Therapy Regimen	00382a Treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

Regimen Name

Indication

Aflibercept and FOLFIRI Therapy -14 day