Upper GI. Oesophageal & Gastric Cancer. Tumour Group: Regimen name / acronym Cisplatin/5-FU with concomitant RT. Place in therapy

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1 Tumour Group: Upper GI Tumour Type: Oesophageal & Gastric Cancer Primary Cisplatin/5-FU with concomitant RT Alternative Regimen: Oxaliplatin/ 5FU with concomitant RT (FOLFOX6-RT) Cisplatin Carboplatin + concomitant RT Primary f localized squamous cell adenocarcinom a of the upper / middle third of the oesophagus, and f selected adenocarcinom a of the oesophagus where surgery is contraindicated As above, if Cisplatin is contra-indicated If fluopyrimidine s contraindicated 4 cycles Cycles 1&2: Chemo RT (weeks 1 and 5) Cycles 3&4: Chemo only (weeks 8 and 11) befe chemort in selected patients 6 cycles FOLFOX, to be given weeks 1, 3, and 5 of chemort and befe/after RT at clinician discretion. No dose modification during RT. Carboplatin AUC 2 weekly + RT, Cisplatin 75mg/m2 weeks 1, 5 40mg/m2 weekly Neo-adjuvant + peri-operative Cisplatin /5-FU (OE02) Oesophageal and gastric Ca. when anthracyclines contra-indicated 2 cycles only (pre-op)

2 ECX Alternatives to ECX include: ECF, EOF,EOX, ECarboX, ECarboF practice Oesophageal & gastric s T3, N any, M 0 T any, N1-2, M0 (including squamous cell carcinoma of the lower third of the oesophagus. Repalcement of platinum and / Fluopyrimidin e as clinically indicated 3 cycles (pre-op) + 3 cycles (postop) 3 cycles (pre-op) + 3 cycles (postop) Adjuvant oesophago-gastric and gastric 5FU (modified MacDonald protocol) Capecitabine-RT Capecitabine and Oxaliplatin (CAPOX) Post-op Gastric GOJ (With RT in no pre-op OR no/ little response to Neoadj. Chemo OR with high risk facts f recurrence) Pre / post operative use in Pancreatic Alternative to cont. infusional 5FU in post-op gastric and post-op pancreatic As adjuvant f resected gastric where no neoadjuvant has been given and post-op chemadiation is CI Up to 12 weeks cont. infusion Weeks 1-4: Chemo only Weeks 5-9: Chemo RT Weeks 10-12: Chemo only. 200mg/m2 during RT, 300mg/m2 otherwise 5-6 weeks 8 cycles post-op

3 Palliative oesophago-gastric : 1 st Line EOX Alternative regimens to EOX include: EOF,ECX, ECF, ECarboX, ECarboF CAPOX FOLFOX Trastuzumab, ciplatin, capecitabine (TCX) Alternatives to TCX include: TCF, TCarboX, TCarboF Repalcement of platinum and / Fluopyrimidin e as clinically indicated where anthracycline CI where anthracycline / capecitabine CI HER+ metastatic gastric Repalcement of platinum and / Fluopyrimidin e as clinically indicated (Trastuzumab until progression) (Trastuzumab until progression) Palliative oesophago-gastric : 2nd Line EOX

4 Alternative regimens to EOX include: EOF,ECX, ECF, ECarboX, ECarboF CAPOX FOLFOX Trastuzumab, ciplatin, capecitabine(tcx) Alternatives to TCX include: TCF, TCarboX, TCarboF Repalcement of platinum and / Fluopyrimidin e as clinically indicated where anthracycline CI where anthracycline / capecitabine CI HER+ metastatic gastric Repalcement of platinum and / Fluopyrimidin e as clinically indicated 6-8 Cycles 12 cycles (Trastuzumab until progression) (Trastuzumab until progression) Tumour Type: Extrapulmonary Small Cell Carcinoma Adjuvant and Palliative Cisplatin Etoposide 1 st line Adjuvant and Palliative chemo in Extrapulmonary Small Cell Carcinoma 6 cycles

5 Carboplatin Etoposide 1 st line Adjuvant and Palliative chemo in Extrapulmonary Small Cell Carcinoma when Cisplatin is not a suitable treatment option 6 cycles Tumour Type: Gastrointestinal Stromal Tumours (GIST) Adjuvant Imatinib Adjuvant after resection of primary GIST, in high risk patients. 400mg OD Continuous f up to 3 years (CDF) until disease progression CDF Palliative Imatinib 1 st line f Kit (CD 117) positive unresectable and/ Metastatic. 1 st line, upfront high dose (800mg) treatment f specific mutational subtypes known to be less responsive to dose e.g. exon 9 mutations. 400mg ( 8oomg) OD Continuous until disease progression (400mg) CDF (800mg dose)

6 Sunitinib Treatment option in Unresectable and/ Metastatic Malignant Gastrointestinal Stromal Tumours (GIST) if Imatinib treatment has failed because of resistance intolerance 50mg OD ally f 4 weeks, then 2 weeks rest Until disease progression unacceptable Tumour Type: Pancreatic Cancer Adjuvant Gemcitabine single agent Modified de Gramont Adjuvant of resected Pancreatic Cancer Adjuvant of resected Pancreatic Cancer where Gemcitabine is contraindicated/ not tolerated 6 cycles 12 cycles Palliative FOLFIRINOX (Oxaliplatin & Irinotecan & 5FU) Gemcitabine single agent m FOLFOX (Oxaliplatin & 5FU) 1 st line Predominantly f PS st line treatment in advanced pancreatic f patients ineligible f a trial 2 nd line, following progression with Gemcitabine SA 12 cycles unacceptable 6 cycles 1 st cycle:weekly, f 7 consecutive weeks 2 nd cycle onwards: Weekly f 3 consecutive weeks out of every 4 weeks CDF CDF

7 Modified de Gramont Palliative treatment of Pancreatic Cancer where Gemcitabine is contraindicated not tolerated 6 cycles Tumour Type: Gallbladder & Bile Duct Cancer Palliative Therapy Gemcitabine GemCis GemCarbo (AUC 2) m FOLFOX (Oxaliplatin & 5FU) ECF Patients who are not fit f surgery with curative intent but who are willing and able to tolerate treatment with chemo Cholangiocarcin oma and other Biliary Tract tumours Alternative to GemCis in Advanced metastatic Cholangiocarcin omas and other Biliary tract tumours with renal impairment unable to tolerate Cisplatin 2 nd line, following progression with Gemcitabinecisplatin Patients with previously untreated biliary Until disease progression / unacceptable Max. 8 cycles Max. 8 cycles 6 8 cycles

8 Tumour Type: Hepatocellular Palliative Safenib 400mg bd Doxubicin 60mg/m 2 mfolfox Advanced disease- Patients not appropriate f radical resection, liver transplant locegional treatment e.g. Transcatheter arterial chemoembolisa tion (TACE), Radio frequency ablation (RFA) Selective Internal Radiation Therapy (SIRT), progressed following locegional treatment. (Childs Pugh A and selected Childs-Pugh B (B7) with good perfmance status) Patients with unresect able DISEAS E, 2 nd line. in patients where funding f Safenib is not available. Patients with advance d HCC, 2 nd line post safenib intolerant of anthracy clines Until disease progression / unacceptable Up to 6 cycles unacceptable Up to 12 cycles CDF

9 Tumour Type: Neuroendocrine Tumours Adjuvant Mitotane single agent Adjuvant adrenoctical carcinoma, following radical resection Start at 1g/day, (in 2 divided doses) increased progressively (e.g. at 2 week intervals) as tolerated, no me than 6-10g/day. GSTT KCH PR UH QEW QMS UHL NICE CDF Palliative Streptozocin & 5FU every 42 days Streptozocin & Capecitabine Etoposide (IV D1; PO, D2-3)/ Carboplatin Everolimus Sunitinib EDP-M Metastatic unresectable neuroendocrine tumours, predominantly of pancreatic igin Alternative to Streptozocin 5FU Metastatic unresectable high grade neuroendocrine carcinoma Unresectable metastatic, well moderately differentiated neuroendocrine tumours of pancreatic igin in adults with progressive disease. Unresectable metastatic pancreatic neuroendocrine tumours (excluding poly differentiated) with disease progression Unresectable metastatic adrenoctical 4 cycles GSTT KCH PR UH QEW QMS UHL NICE 6 cycles 4 cycles Until progression unacceptable Until progression unacceptable 6 cycles CDF CDF

10 Chemo & Immuno Regimens Tumour Group: UPPER GI Chemo regimens agreed by: Date Andrew Gaya David Landau Martin Leslie Nick Maisey Paul Ross 30/10/2012 Debashis Sarker Dr Ana Montes Chair of Drugs Expenditure Executive Dr Janine Mansi Chair Drugs and Therapeutics Advisy Committee 30/10/ /10/2012