my mum did 3 yrs on ibrutinib but was stopped due to cardio toxicity.
She has been treatment free for 2 years but is now about to start V and R …. Originally it was Venetoclax plus obinutuzumab.
What is the difference, we have an appointment on the 18th to discuss but I just want to be clear.
Mum has been doing well but suddenly her spleen has slightly enlarged and her hemoglobin has dropped. She is slightly anemic. So treatment has been brought forward suddenly.
If anyone can help
thank you 🙏🏻
The key difference between Venetoclax with Obinutuzumab or Rituximab is that V+O is only approved for NHS use for first treatment while V+R is for relapsed treatment. Clearly the doctor forgot that your mum had prior treatment.
The difference for your mum will be the Ven of V+R is taken for 2 years while V+O is less than a year. There are 6 (7 if split first dose) IV of Rituximab, while Obinutuzumab has 9. The IV's will be a new experience but they will look after her.
This makes total sense as she has changed hospital. Playing catch up. Thanks for the reply. It’s scary and unknown …. Thank you for your help
Hello Mouseygirl, I would not assume your mum’s doctor made a mistake. I dont know how any of us good jump to that conclusion with such little info about your mum.
Rituximab and obinutuzumab are similar drugs, they are not only both monoclonal antibodies (mabs) but also both are CD 20 mabs. Cll cells have CD20 antigens on their surface and both rituximab and obinutuzumab target the CD 2O antigens to kill cll cells.
Rituximab is the older of the two mabs. In very simple terms, it’s an antibody made partly from mice. Obinutuzumab is the newer and more potent of the 2 mabs, it is called a humanized mab.
It sounds like your mum had problems tolerating ibrutinib. Since obinutuzumab is generally considered more harsh than rituximab, it might be that your mum’s doctor is opting for a slightly less potent mab that your mum might tolerate better.
Insofar as the different cycles for either drug, those are just guidelines. Doctors are free to adapt the program to the patient which may involve changing doses, skipping doses or whatever they think is best for their patient.
Your mum’s doctor is the best person to ask about why he chose one mab over the other. Venetoclax is a very effective drug all on its own, so your mum can do very well with either mab subbed in. Good luck.
Thank you Cajunjeff. This has all happened so suddenly. No assumptions about Dr’s, the new team are however catching up on my mum as she was only admitted to them 3 weeks ago.
Yes I’ve since read about the 2 mabs. Your reply is extremely helpful thank you. And yes she did have problems tolerating Ibrutinib!
We are all in a bit of a spin but trying to remain calm x
The NICE guidelines for NHS treatment are very specific. It's not a decision that a single doctor can change [1] as the hospital has to show that the patient met the criteria to recoup the drug costs from the Cancer Drugs Fund. The approval decision is based on evidence from trials, CLL14 for V+O was untreated CLL only, MURANO for VenR was for relapsed/refractory CLL only (mainly after CIT). UK NHS will have to wait for the outcome of ReVenGe trial in 2027 before V+O for relapsed CLL may be approved.
Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia
Technology appraisal guidance Reference number: TA663 Published: 09 December 2020
nice.org.uk/guidance/ta663/...
Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia
Technology appraisal guidance Reference number: TA561 Published: 27 February 2019
nice.org.uk/guidance/ta561/...
[1] when all approved options have been used and patient is R/R to all, the doctor can make a costed application with evidence for whatever they think the patient will respond to.
1) There is a reason that Nice publishes guidelines instead of rules. It is so that doctors can use their clinical judgment and experience to deviate from the guidelines when a patient presents as an exception to the guideline.
A guideline is similar to a rule, but are legally less binding as justified deviations are possible.
en.m.wikipedia.org/wiki/Gui...
Both of your links go to sites that make “recommendations” for treatment. By definition a recommendation is a suggestion, not a mandate. Surely you are not suggesting that if someone becomes neutropenic during V plus O that their doctor is unable to modify doses or pause infusions.
2) I am not an expert, you might be, I do not know. Even if you are an expert, I don’t see how you can declaratively state someone’s doctor made a mistake based on little info. It’s one thing to tell someone to seek clarification from their doctor or seek a second opinion and quite another to tell someone their doctor made a mistake. You seem to have ruled out the possibility that her doctor may have preferred rituximab over obinutuzumab for her for tolerance or other issues.
Doctors are free to make dose modifications as they see fit. Halting for more than 6 weeks beyond the expected 4-weekly cycle length requires approval to restart. There have been at least two people on HU this year that reacted so badly to first 100mg Obinutuzumab that treatment was discontinued. One then switched to relapsed treatment with VenR. The other switched from V+O to V+I, the doctor must have moved heaven and earth (or made an IFR) to get the use of another 1st line treatment approved after failure of 1st line.
They are not free to substitute Obinutuzumab for Rituximab for previously treated CLL.
They are not free to extend VenR past 2 years from first IV of Rituximab even if dose has been reduced.
They are not free to give more than 6 cycles of Rituximab.
NHS routine use of cancer drugs IS determined by the NICE appraisal. The "recommendation" within the "guidance" is just as strict as "Theory" is for science, no matter how loosely the public use the word.
england.nhs.uk/wp-content/u...
34. A modified appraisal process for cancer drugs was introduced on 1st April 2016 and now allows NICE to make one of three recommendations:
• Recommended for routine commissioning - ‘yes’ USE ALLOWED IN NHS. The doctor fills out a Blueteq submission form.
gilliankenny.com/blog/what-...
This, in turn, enables Clinical Commissioning Groups (CCGs) to monitor the use of expensive treatment, so that only treatments prescribed in line with local policy and National Institute for Health and Care Excellence (NICE) guidelines are reimbursed.
The hospital is reimbursed from the £15bn NHS England’s Specialised Commissioning budget. I'm not too sure who picks up the tab if treatment started before confirmation of funding, V+O ~£75, V+I ~£100k, cBTKi ~£50k/year for however long, it won't be the NHS patient, treatment won't be withdrawn and it looks like it's the hospital that doesn't get reimbursed.
hfma.org.uk/system/files/ho...
• Not recommended for routine commissioning - ‘no’ NOT NORMALLY AVAILABLE TO NHS, clinicians can make individual funding requests (or IFRs) to NHS England. Doesn't affect the use of drugs by private prescription or insurance. They just need marketing approval.
• Recommended for use within the CDF (new) FUNDING APPLICATION REQUIRED. An application is made to both Blueteq and the CDF. The CDF has a £340m fund to finance drugs that are not yet "Recommended for routine commissioning" but have the potential to be approved while they and the drug company collect data.
I had rituximab with ven in 2018 after a very bad reaction to BR in 2017. And so far it has given me 6 years of remission. Your doctor knows what they are doing.
Thanks emmiekay. I have no doubt the dr knows what he is doing. I myself was trying to understand all the different drug names. X
Venetoclax - hallucinations?
Bendamustine & Rituximab 
Help....
CLL 17p - Rituximab/Imbruvica then Rituximab/Venetoclax or enter in a clinical trial ?
