SWAG Protocols Update May 2025 - New NICE TA and Protocols Progress
Stay informed with the latest updates on SWAG Protocols in May 2025, including progress on new protocols and comparison with previous reports. Explore the new NICE Technology Appraisals (TA) issued since the last report, covering a range of treatments for various cancers.
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SWAG Protocols update SWAG Protocols update May 2025 May 2025 Kate Gregory Lead Pharmacist for SWAG Protocols SWAG Cancer Alliance Divisional Lead Oncology Pharmacist UHBW
New Protocols New Protocols progress progress Protocols activity Oct 24 May 25 (and comparison with previous reports): Activity Oct 24 May 25 Mar 24 Oct 24 Oct 23-Mar 24 Nov 22-Sept 23 Nov 21-Oct 22 New protocols issued Protocols reviewed/amended 18 22 16 10 11 27 36 34 24 19 Protocols drafted (a/w review or sign off) 23 16 23 19 12 Total NICE protocol activity since Jan 2021: Activity Number Current status (May 25) Previous data (Oct 24) Total new NICE TA since Jan 2021 Protocols available Protocols in progress Protocols to be developed 139 112 N/A 81% 6% 13% N/A 77% 9% 14% 8 19
New NICE TA since last report New NICE TA since last report Progress NICE TA/Indication TBC - Tarlatamabfor previously treated advanced small-cell lung cancer 28th May 2025 TBC - Nivolumab plus ipilimumab for untreated unresectable or metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency Update existing protocol 21st May 2025 TBC - Durvalumab with platinum-based chemotherapy, then with our without olaparib for treating newly diagnosed advanced or recurrent endometrial 15th May 2025 TBC - Ribociclibwith an aromatase inhibitor can be used as an option for adjuvant treatment of hormone receptor-positive, HER2-negative, early breast 15th May 2025 TBC - Capivasertibwith fulvestrantfor treating hormone receptor-positive HER-2-negative advanced breast cancer after endocrine treatment. 12th May 2025 TBC - Erdafitinib for treating metastatic or unresectable FGFR-altered urothelial cancer 8th May 2025 TA1060 - Osimertinib with pemetrexed and platinum-based chemotherapy for untreated EGFR mutation-positive advanced non-small cell lung cancer 7th May 2025 TA1059 - Brentuximab vedotinin combination for untreated stage 3 or 4 CD30-positive Hodgkin lymphoma 16th April 2025 TA1055 - Rucaparib for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based 26th March 2025 TA1049 - Blinatumomab with chemotherapy for consolidation treatment of Philadelphia-chormosome-negative CD19-positive minimal residual 26th February 2025 TA1043 - Osimertinib for adjuvant treatment if stage 1b to 3a non-small-cell lung cancer (NSCLC) after complete tumour resectionin patients with EGFR exon Existing protocol updated 19th February 2025 TA1042 - Selpercatinibfor previosuly treated RET fusion-positive advanced non-small cell lung cancer 19th February 2025 TA1041 - Durvalumab with etoposide and either carboplatin or cisplatin for untreated extensive-stage small-cell lung cancer 12th February 2025 TA1040 - Olaparib for treating BRCA mutation-positive HER2-negative advanced breast cancer after chemotherapy 12th February 2025 TA1039 - Selpercatinibfor advanced thyroid cancer with RET alterations untreated with a targeted cancer drug in people 12 years and over 12th February 2025 TA1038 - Selpercatinib for advanced thyroid cancer with RET alterations after treatment with a targeted cancer drug in people 12 years and over 5th February 2025 TA1037 - Pembrolizumab for adjuvant treatment of resected non-small cell lung cancer 5th February 2025 TA1036 - Elacestrantfor treating oestrogen receptor-positive HER2-negative advanced breast cancer with an ESR1 mutation after endocrine treatment 15th January 2025 TA1030 - Durvalumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) for treating resectable non-small-cell lung cancer Needs draft 9th January 2025 TA1027 - Tebentafusp for treating advanced uveal melanoma 7th January 2025 TBC - Selpercatinibfor untreated RET fusion positive non-medullary or RET mutant medullary thyroid cancer 11th December 2024TA1023 - Elranatamabfor treating relapsed and refractory mutliple myeloma after 3 or more treatments 4th December 2024 TA1021 - Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer 20th November 2024TA1018 - Fedratinib for treating disease related splenomegaly or symptoms in myelofibrosis 20th November 2024TA1017 - Pembrolizumab plus chemotherapy for neo-adjuvant treatment and then continued as adjuvant monotherapy in adults with previously untreated 13th November 2024TA1015 - Teclistamabis recommended as an option for treating relapsed and refractory multiple myeloma in adults after 3 or more treatments (including an Published 13th November 2024TA1014 - Alectinib for adjuvant treatment of ALK-positive non-small-cell lung cancer 6th November 2024 TA1012 - Avapritinib for treating advanced systemic mastocytosis Progress Date TBC Protocol Status Drafted - out for review Needs draft Update existing protocol Drafted - out for review Needs draft Existing protocol updated Needs draft Published Need draft Existing protocol updated Needs draft Existing protocol updated Existing protocol updated Existing protocol updated Existing protocol updated Being drafted Published Existing protocol updated Published Existing protocol updated Published Needs draft Existing protocol updated Needs draft
Protocol work Protocol work Oct 24 Oct 24 May 25 May 25 Oncology Tumour site Breast New protocols issued Talazoparib Protocols reviewed/amended Olaparib (NICE TA) Protocols in development MMM Jakacki CNS Colorectal Germ Cell Gynae Bevacizumab & Lonsurf Rucaparib 3-weekly Cisplatin-RT Weekly Cisp-RT Treosulfan version update a/w references before final sign off Head & Neck Lung Osimertinib (NICE TA) Pembrolizumab (NICE TA) Crizotinib (NICE TA) Alectinib (NICE TA) Selpercatinib(NICE TA) Doxorubicin PLDH (Caelyx) Nivolumab, carboplatin & paclitaxel Tarlatamab PLDH & Ifosfamide Doxorubicin & Ifosfamide Ifosfamide Mifamurtide MAP Cabozantinib Cyclophosphamide & Prednisolone Denosumab GCT Ifosfamide (Ewing) Ifosfamide & Etoposide Irinotecan & Temozolomide Regorafenib Sunitinib Sirolimus Weekly paclitaxel IVADo VIT VC maintenance Sarcoma
Protocol work Protocol work Oct 24 Oct 24 May 25 cont d May 25 cont d Oncology cont d Tumour site Skin Thyroid New protocols issued Tebentafusp Protocols reviewed/amended Protocols in development Cabozantinib (brand change) Selpercatinib(NICE TA) Upper GI Urology Cabozantinib (brand change) Nivolumab & Cabozantinib (brand change) Cabozantinib(HCC) Tumour agnostic Larotrectinib Supportive meds Tumour site Supportive New protocols issued Protocols reviewed/amended Denosumab Protocols in development
Protocol work Protocol work Oct 24 Oct 24 May 25 cont d May 25 cont d Haematology Tumour site Leukaemia New protocols issued Ropeginterferon Momelotinib Fedratinib DA (AML induction) Quizartinib Sorafenib (AML) Protocols reviewed/amended Ruxolitinib Hydroxycarbamide Cladribine Protocols in development HD ARA-C (AML consolidation) Lymphoma Pola-R-CHP R-Pola-Benda Brentuximab vedotin A-CHP Epcoritamab Loncastuximabtesirine Teclistamab Myeloma Elranatamab(NICE TA) Carfilzomib/Len/Dex
Upcoming developments Upcoming developments Approval of SC Nivolumab SPC now available and some drafts of updated protocols. A/W full details from NHSE on eligibility. SC Pembrolizumab following later this year (FDA approved in March 2025) No update on timelines for release of any of the protocols as part of the national pilot 0.2 wte SWAG protocols pharmacist should be out to advert in next couple of weeks plan is for this to be haematology focussed
Reducing IV hydration for Cisplatin Reducing IV hydration for Cisplatin- -based regimens regimens based Kate Gregory Lead Pharmacist for SWAG Protocols SWAG Cancer Alliance Divisional Lead Oncology Pharmacist UHBW Based on slides provided by Dr Ella Daniels, ST5 Medical Oncology, RUH
Wales Cancer Network Guidance Wales Cancer Network Guidance Jan 2023 Jan 2023 Aimed to standardise hydration schedules based on available evidence and standard practice in centres across the UK Oral post-hydration proven to be as safe as IV in patients receiving Cisplatin < 60mg/m2 Puisset et al, 2019. 241 pts IV only vs 276 pts IV pre/oral post Grade 1 nephrotoxicity = 39.4% IV group vs 25.7% IV/PO group (p=0.001) No good evidence for use of diuretics, specifically mannitol Hypomagnesaemia should be carefully managed to reduce incidence of nephrotoxicity executive.nhs.wales/functions/networks-and-planning/cancer/clinical-hub/systemic-anti-cancer-therapies-sact/sact- accordion/wcn-guideline-for-management-of-hydration-during-systemic-anti-cancer-therapy-containing-cisplatin/
Cisplatin hydration recommendations Cisplatin hydration recommendations Before appointment: Inform patient to drink 2L of clear fluid over 24h prior to, and 24h after chemotherapy Supplement electrolytes (Mg/K+) Consider premedication in certain circumstances (heart failure) On arrival: Record weight Confirm complied with oral hydration and passing good volumes of urine Provide access to supply of drinking water During infusion: Monitor UO Weigh patient after end of IV fluids. If weight gain >2kg, give 20mg PO furosemide (build into SACT regimes) If does not PU within 30-60 mins, or symptoms of fluid overload, requires clinical review. Other networks have adopted the hydration schedules e.g. TVCN, others have cut IV hydration requirements for low dose cisplatin regimens e.g. Clatterbridge, Southampton
40mg/m2 2 Comparison with current practice Comparison with current practice 40mg/m Current practice weekly cisplatin/RT Practice following Wales hydration schedule Pre-hydration NaCl 0.9% 1L over 1 hr Pre-hydration NaCl 0.9% 500mL over 30 mins* Mannitol over 30 minutes No diuretic Cisplatin in 500mL over 1 hr Cisplatin in 1000mL over 1 hr Post-hydration NaCl 0.9% + 2g MgSO4 + 20mmol KCl 1L over 2 hrs Patient to drink 500mL before discharge** Total duration: 4.5 hrs (Total IV fluid 2.7-2.9L) Total duration: 2hrs (Total IV fluid 1.5L + 0.5L PO) *Plus patient to drink 2L clear fluid over 24 hr prior to chemotherapy and for 24 hr after **Monitor UO, weigh pt at end of IV fluids, if >2kg weight gain administer furosemide 20mg PO. If does not PU within 30-60 mins, or symptomatic of fluid overload, for clinical review
Benefits/Drawbacks of change Benefits/Drawbacks of change Potential to save 2-3 hours of chair time per patient on low-dose ( 40mg/m2) cisplatin regimens RUH audit predicts 416 hours per year of chair time saved Higher dose regimens would require +1hr infusion time as Mg given in pre-hydration which increases infusion time to 2hrs Patients need to be able to comply with oral hydration for those that can t they d need longer chair time which would potentially be difficult to accommodate if not booked in advance
Proposed change Proposed change Adopt reduced hydration schedules either as per Wales guidance or a 3-tier system as per TVCN (all doses over 61mg/m2 treated as per > 81mg/m2 Wales guidance) This reduces chair time for lower doses but increases chair time by 1hr for higher doses to allow for Mg replacement Host separate cisplatin hydration schedule on website that can be hyperlinked from specific protocols or update each protocol individually Happy to adopt for all protocols or only for OP single day regimens?
Pre Pre- -treatment blood test validity for treatment blood test validity for palliative regimens palliative regimens Kate Gregory Lead Pharmacist for SWAG Protocols SWAG Cancer Alliance Divisional Lead Oncology Pharmacist UHBW
Background Background Standard validity period for #1 on protocols is 14 days This is adjusted when drafting protocols as appropriate based on expertise of clinicians involved Many other network protocols do not include a validity period for bloods and only include go ahead parameters
Incident for discussion Incident for discussion Recent incident at a SWAG trust Patient due to start palliative SACT Prescription signed off with bloods from 14 days pre #1 Patient had bloods done at GP surgery closer to SACT treatment date which were deranged but not reviewed by cancer team (NB. out of area bloods so emailed through to secretaries with no prompt to check) Treatment went ahead but patient sadly died from toxicity No reports of similar issues from other SWAG trusts Do we feel this needs review of guidance in protocols?
