Zometa and Celebrex

[Mkeman]

A number of references have been made on this forum about the added survival time that results when Celebrex is added to Zometa. Is there anyone out there who has been or is on this regimen and, if so, what can you share with us?

[Tall_Allen]

Here's the trial

ascopubs.org/doi/10.1200/JC...

[Mkeman in reply to Tall_Allen]

Thanks. But I am curious if anyone is doing it. I have read that Celebrex can cause stomach bleeding which could be an even higher risk if you are taking prednisone with Zytiga. This Forum is fortunate to have you.

[Mkeman in reply to Mkeman]

As I read the study it says there is no advantage to combine the two.

[Tall_Allen in reply to Mkeman]

No - it says "Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 (95% CI, 0.62 to 0.98; P = .033) for SOC + ZA + Cel." That means that for men who have metastases, the combination of Zometa and Celebrex increased survival by 22%

[Tall_Allen in reply to Mkeman]

You have been misinformed - the whole purpose of this class of drugs was to AVOID the digestive tract issues caused by aspirin and NSAIDs. Celebrex is prescribed for people with arthritis who need a daily anti-inflammatory that won't cause stomach bleeding.

[dvcarola in reply to Tall_Allen]

Hi TA, may I ask if its better to switch from Xgeva to Zometa+Celebrex? Husband continues to have some bone pains so MO is suggesting a switch to Zometa after 6th month into Xgeva. Also what is the dosage of Celebrex when added to Zometa so I can discuss with MO as well. Thanks so much!

[Tall_Allen in reply to dvcarola]

400 mg twice a day

[Mkeman in reply to Tall_Allen]

I appreciate your comments. I am confused since the final summary of the study says the overall data suggests no benefit from adding Celebrex.

[Tall_Allen in reply to Mkeman]

What is confusing you is that this was a subgroup analysis of only men with metastases. if you throw in the men without metastases, there was no effect. Since Xometa is never prescribed for men without metastases, it doesn't matter.

[Mkeman in reply to Tall_Allen]

Yet there is an FDA black box warning on Celebrex calling attention to the higher risk for gastric events like bleeding. For patients taking prednisone with Zytiga or using blood thinners the risk gets higher.

[Tall_Allen in reply to Mkeman]

Look again. The black box warning is for ALL NSAIDs. The risk is actually lower for celebrex than for other NSAIDs (which is why it was developed). if you've had a coronary bypass graft, you may wish to avoid it however. On Table 1 of the prescribing info, you will see that all adverse events are less than Naproxen, Diclofenac, and Ibuprofen and not much higher than placebo:

labeling.pfizer.com/ShowLab...

The Zometa has much worse risk of serious side effects (jaw necrosis).

[Mkeman in reply to Tall_Allen]

True but Pfizer patient literature still

warns about the possibility of serious gastric problems. The bottom line is that Celebrex is a very potent drug and patients should rely on their physician’s advice.....not ours. Have a great holiday season. The readers of this Forum are fortunate to have you and your vast store of aPc knowledge to call on.

[Tall_Allen in reply to Mkeman]

It is only available by prescription, so it HAS to be by doctor's advice. All drugs have side effects - Celebrex has fewer than all other NSAIDs and aspirin.

[Mkeman in reply to Tall_Allen]

True ....but I would guess that the incidence of jaw problems with Zometa are less than the incidence of gastric problems with Celebrex.

[Tall_Allen in reply to Mkeman]

You don't have to guess. The table I cited shows dyspepsia affected 8.8% of those taking Celebrex (vs 6.6% of those on placebo, 12.8% of those taking ibuprofen, 12.2% of those taking naproxen, and 10.9% of those taking diclofenac. and 20-40% of those taking low-dose aspirin). So 8.8%-6.6% = 2.2% increase attributable to Celebrex. It is a low grade (1 or 2) side effect. Prilosec can prevent gastric problems.

Osteonecrosis of the jaw affects 2.1%. This sometimes requires surgery (Grade 3).

[Mkeman in reply to Tall_Allen]

I have read that it is difficult to determine what percentage of cases are caused by Zometa since steroids and chemo can also contribute to osteonecrosis due to their impact on the immune system and osteoporosis. Dental hygiene seems extremely important as many cases appear after an extraction.

[Tall_Allen in reply to Mkeman]

It's important to base decisions on reliable data like this:

medscape.com/viewarticle/80...

Chemo may contribute to it, but has never been found to be a cause, as far as I know.

[Mkeman in reply to Tall_Allen]

That study was for women with breast cancer who were likely taking other drugs. It is interesting that no one has joined in who has taken Zometa and Celebrex together...which is how this discussion began. I am awaiting my MO’s opinion on the subject. Will let you know what she says.

[Tall_Allen in reply to Mkeman]

This was a phase 3 trial - the women were exactly the same in both groups except for the fact that the treatment group took Zometa and experienced osteonecrosis, whereas the other group didn't. It PROVES that Zometa causes osteonecrosis. That's why we do randomized clinical trials. Don't see why you find it interesting - I have no idea what you can possibly hope to hear - that they lived longer?

[Mkeman in reply to Tall_Allen]

Since I take Zometa I would like to hear why the 2% got osteonecrosis and the 98% didn’t.

[Tall_Allen in reply to Mkeman]

Pre-existing dental problems and length of time taking the drug are pre-disposing factors.

[Mkeman in reply to Tall_Allen]

It would be interesting to study the breast Cancer group to see if any had tooth extractions during the study period. Extractions seem to precede osteonecrosis in many cases. There are other variables that could be studied such as gum disease, age, frequency of infusions and duration, as you mentioned. Just to say 2% got it and 98% didn’t doesn’t answer why...or how they did or didn’t.

[Tall_Allen in reply to Mkeman]

Actually, oncologists often have patients visit their dentists and have the extractions done and healed BEFORE starting on Zometa.

[Mkeman in reply to Tall_Allen]

I know that...I had it done three months before starting infusion. was recently told by endocrinologist to have teeth checked and cleaned twice a year because new evidence was surfacing that linked condition of gums to jaw necrosis. Have you had Zometa or do you have aPc. Just curious.

[Ldb01 in reply to Mkeman]

My husband had extreme pain two days after his zoledrinic acid injection. He had it along with chemo. Celebrex hekped quickly with the pain. MO also said it was a very good combination.

[Mkeman in reply to Ldb01]

Have them slow up the infusion to 45 minutes as that helps in some cases reported on this forum.