Head and neck squamous cell cancer (HNSCC) SACT

TPF

Preferred first line

Docetaxel 75mgm² IV Day 1 

Cisplatin 75-100mg/m²   IV Day 1 

5FU 3750-4000mg/m² IV Day 1 over 4-5 days    

Every 21 days for 2-3 cycles

Cisplatin/Fluorouracil  

Cisplatin 75-100mg/m² IV Day 1  

5FU 3000-4000mg/m² IV Day 1 over 4-5 days 

Option to replace Fluorouracil with: 

Capecitabine 1000mg/m² BD PO D1-14 (if oral route assessed as appropriate route of administration) 

Every 21 days for 2-3 cycles

Carboplatin/Fluorouracil 

Carboplatin AUC 5 IV Day 1 

5FU 3000-4000mg/m² IV Day 1 over 4-5 days 

Option to replace Fluorouracil with: 

Capecitabine 1000mg/m² BD PO D1-14 (if oral route assessed as appropriate route of administration) 

Every 21 days for 2-3 cycles 

Refer to regional or local protocols for carboplatin prescribing advice

Carboplatin/Paclitaxel 

Carboplatin AUC 5 IV D1 

Paclitaxel 175mg/m² IV D1 

Every 21 days for 2-3 cycles 

Refer to regional or local protocols for carboplatin prescribing advice

Cisplatin 

Cisplatin 100mg/m² IV Week 1 then Week 4 or 5 of Radiotherapy 

For 2-3 cycles*

*For patients receiving 7 weeks of radiotherapy, a third cycle can also be considered on week 7 

(maximum dose of surface area (SA)=2.00/m²) 

Alternative regimen 

Cisplatin 40mg/m² IV Week 1 of radiotherapy then weekly during radiotherapy for 6-7 cycles 

Cetuximab

Loading dose 400mg/m² IV up to 1 week prior to radiotherapy start date then 250mg/m² IV weekly throughout radiotherapy. 

Consider in primary radiotherapy if cisplatin contraindicated due to co-morbidity or clinical factors 

Carboplatin

Carboplatin AUC5 IV Day 1 Week 1 then week 4 or 5 of radiotherapy   

For 2-3 cycles * 

*For patients receiving 7 weeks of radiotherapy a third cycle can also be considered on week 7 

Alternative regimen 

Carboplatin AUC 1.5 weekly for 6-7 cycles throughout radiotherapy 

Consider only if cisplatin contraindicated due to co-morbidity or clinical factors 

Refer to regional or local protocols for carboplatin prescribing advice  

There is no established role for adjuvant SACT after primary treatment with surgery or radiotherapy

For adjuvant radiotherapy in combination with SACT refer to the HNSCC Concurrent SACT with radiotherapy section and Radiotherapy page

SMC2257 Pembrolizumab as monotherapy or in combination with platinum and fluorouracil chemotherapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express programmed cell death ligand-1 (PD-L1) with a combined positive score (CPS)≥1. Pembrolizumab is subject to a two-year stopping rule.

Pembrolizumab/Cisplatin/Fluorouracil 

Pembrolizumab 200mg IV Day 1    

Cisplatin 75-100 mg/m² IV Day 1  

Fluorouracil 3000-4000 mg/m² IV Day 1 over 4-5 days  

Option to replace Fluorouracil with: 

Capecitabine 1000mg/m² BD PO D1-14 (if oral route assessed as appropriate route of administration) 

Every 21 days, for up to 6 cycles followed by  

Pembrolizumab monotherapy 200mg IV 3 weekly or 400mg IV 6 weekly for up to 2 years 

In patients where tumour PD-L1 CPS ≥1 

Pembrolizumab/Carboplatin/Fluorouracil 

Pembrolizumab 200mg IV Day 1    

Carboplatin AUC 5 IV Day 1  

Fluorouracil 3000-4000 mg/m² IV Day 1 over 4-5 days  

Option to replace Fluorouracil with: 

Capecitabine 1000mg/m² BD PO D1-14 (if oral route assessed as appropriate route of administration) 

 Every 21 days for up to 6 cycles followed by  

Pembrolizumab monotherapy 200mg IV 3 weekly or 400mg IV 6 weekly for up to 2 years 

In patients whose tumour express PD-L1 with a CPS ≥1 

Refer to regional or local protocols for carboplatin prescribing advice

Pembrolizumab Monotherapy 

Pembrolizumab 200mg IV every 3 weeks or  

400mg IV every 6 weeks, 

for up to 2 years 

In patients whose tumour express PD-L1 with a CPS ≥1 

Cisplatin/Fluorouracil  

Cisplatin 75-100mg/m² IV Day 1  

5FU 3000-4000mg/m² IV Day 1 Day 1 over 4-5 days 

Option to replace Fluorouracil with: 

Capecitabine 1000mg/m² BD PO D1-14 (if oral route assessed as appropriate route of administration) 

Every 21 days for 6 cycles 

Carboplatin/Fluorouracil 

Carboplatin AUC 5 IV Day 1  

5FU 3000-4000mg/m² IV Day 1 over 4 to 5 days  

Option to replace Fluorouracil with: 

Capecitabine 1000mg/m² BD PO D1-14 (if oral route assessed as appropriate route of administration) 

Every 21 days for 6 cycles 

Refer to regional or local protocols for carboplatin prescribing adviceCarboplatin/Paclitaxel

Carboplatin AUC 5 IV D1 

Paclitaxel 175mg/m² IV D1 

Every 21 days for 6 cycles 

Refer to regional or local protocols for carboplatin prescribing advice

Nivolumab

Nivolumab 240mg IV every 2 weeks or Nivolumab 480mg IV every 4 weeks for up to 2 years 

In patients who have not received prior immunotherapy treatment for HNSCC (PD-L1 status not required) 

SMC1261/17 Nivolumab as monotherapy, for the treatment of HNSCC in adults progressing on or after platinum-based therapy. Nivolumab is subject to a two-year stopping rule.

Re-challenge with first-line SACT, excluding pembrolizumab regimens Refer to the HNSCC First-line non-curative SACT section

Paclitaxel

Paclitaxel 

Paclitaxel 175mg/m² IV Day 1  

Every 21 days, for 4-6 cycles  

Alternative regimen 

Paclitaxel 80mg/m², IV, Day 1 

Every 7 days for 12-18 cycles

Methotrexate

Methotrexate 40mg/m² IV day 1 every 7 days until progression or unacceptable toxicity 

Cetuximab

Cetuximab Loading dose 400mg/m² IV then  

250mg/m² IV weekly until progression or unacceptable toxicity 

DocetaxelDocetaxel 75mg/m² IV every 21 days for up to 6 cycles  

Alternative regimen 

Docetaxel 30mg/m² IV every 7 days for up to 18 cycles

Vinorelbine

Vinorelbine 30mg/m² IV days 1, 8 and 15 every 21 days for up to 6 cycles or until progression or unacceptable toxicity 

Links to Regional Guidance/Protocols where available (access to local intranet may be required):

NCA

NHS Highland 

NHS Grampian

(For Tayside protocols refer to Chemocare)

SCAN

WoSCAN