What do you do?

Pure

Tuesday I am back out at Duke to meet with my doc.

I am going to ask her for 2 things.

Zometa with chemo

Xeloba (spell?) Drug

Zometa we know the studies but there is a good study showing those who do it with chemo have a 100% response to chemo so I would like it with chemo in case that study works out to be true.

Xelboa also study being done in Finland for years and shows 45% decrease in chance of reoccurence in stage 3 women.

She is for Zometa but we have not discuss getting it with chemo.

I faxed her the Xeloba study so hopefully she has read it.

So anyway I am nervous she is going to say no. I am nervous to chat with her about these items.

What do you do if your doc says no? Find a new doc?

LavenderNLace

If I remember, aren't you already doing CFU?  The 'F' in that cocktail if 5-FU which is the IV form of Xeloda.  Xeloda metabolizes into 5-FU in the liver.

Q: How does XELODA work?
A: XELODA is a medicine you take by mouth (orally). XELODA is changed in the body to a substance called 5-fluorouracil ( 5-FU). In some patients with colon, rectum, or breast cancer, 5-FU stops cancer cells from growing and decreases the size of the tumor.

Xeloda FAQ

Pure

it does but it's different. Actually I posted the study somewhere.

Basically this is saying that using this drug with your chemo in patients with 3 or more nodes can cut recoccuerence further by 45%-but what is dangerous I guess is the side effects.

From Medscape Medical News

Capecitabine Added to Standard Chemotherapy Reduces Breast Cancer Recurrence

Roxanne Nelson

November 10, 2009 - Adding the oral drug capecitabine (Xeloda) to standard chemotherapy regimens appears to reduce the risk for recurrence in early breast cancer. Finnish researchers report that for patients with moderate- to high-risk early breast cancer, capecitabine combined with a regimen containing a taxane and an anthracycline was more effective in lowering the risk for disease recurrence than standard therapy.

The authors of the study, published online November 10 in the Lancet Oncology, note that the effect of adding capecitabine was "substantial," and "could be comparable to or greater than that achieved with the introduction of taxanes to adjuvant treatment of early breast cancer."

At a median follow-up of 35 months, recurrence-free survival was 93% for women in the capecitabine group and 89% for those in the standard-therapy group (hazard ratio [HR], 0.66; 95% confidence interval, 0.47 - 0.94; P = 0.20). Overall survival data are not yet mature because this study was a planned interim analysis. However, the authors note that the hazard ratio for overall survival was similar to that for recurrence-free survival.

They also point out that adding capecitabine to the treatment regimen was associated with frequent discontinuation of planned chemotherapy, although most patients were able to tolerate all of the scheduled cycles.

Lead author Heikki Joensuu, MD, PhD, from Helsinki University Central Hospital in Finland, believes that the study results are promising, and that "the benefits likely exceed the harms when the risk for breast cancer recurrence is considered substantial."

"I'm encouraged about the early efficacy, and find that this regimen can be selected for women who have moderate or high risk for breast cancer recurrence," he told Medscape Oncology. "The final results of the study are awaited with great interest."

Although these findings are not practice-changing, they are intriguing, and could merit further assessment in a larger trial, writes Ruth M. O'Regan, MD, from the Emory Winship Cancer Institute in Atlanta, Georgia, in an accompanying editorial. But the significant toxicity associated with the addition of capecitabine "dampens enthusiasm for further studies of this approach," she adds.

One Size Does Not Fit All

The study authors found that the addition of capecitabine seemed more effective in estrogen-receptor (ER)-positive than in ER-negative breast cancers, Dr. O'Regan points out.

"The positive findings in the capecitabine group could be explained by the fact that over three quarters of patients had ER-positive cancers," she writes. "There is currently no plausible mechanism to explain why capecitabine would be more effective in ER-positive disease, but this might warrant further study."

The editorialist also comments that this study represents yet another "one size fits all" approach to managing early-stage breast cancer. "More importantly, it is imperative that we take a more rational approach to the treatment of early-stage breast cancer by tailoring our treatment approaches to molecular phenotypes," Dr. O'Regan writes.

Capecitabine Improves Outcomes

Standard adjuvant chemotherapy regimens for women with moderate- to high-risk early breast cancer generally consist of a taxane, an anthracycline, and cyclophosphamide. In this study, Dr. Joensuu and colleagues investigated whether integrating capecitabine into a standard adjuvant regimen would enhance outcomes.

The study, conducted between January 27, 2004 and May 29, 2007, involved 1500 patients with moderate- to high-risk early breast cancer were who were randomized to 3 cycles of capecitabine and docetaxel followed by 3 cycles of cyclophosphamide, epirubicin, and capecitabine (n = 753), or to 3 cycles of docetaxel followed by 3 cycles of cyclophosphamide, epirubicin, and fluorouracil (n = 747).

The women were stratified by node status and HER2 status, and the primary end point was recurrence-free survival. Secondary end points were overall survival, defined as the time from randomization to death, and treatment safety.

At the 3-year planned interim analysis, recurrence-free survival was better with the capecitabine regimen than with the standard regimen (93% vs 89%). There were a total of 134 events (deaths, distant or local relapses) - 54 (7%) in the capecitabine group and 80 (11%) in the standard-therapy group.

Disease-free survival, including invasive contralateral breast cancers and second cancers, was longer in patients who received capecitabine than in those who received standard therapy (HR, 0.68; P = .020). In exploratory subgroup analyses, the researchers noted that recurrence-free survival was better in the capecitabine group, with the exception of patients with HER2-positive disease.

Exploratory Subgroup Analyses for Recurrence-Free Survival

<table><tbody><tr><td>Characteristics </td><td>Capecitabine,
Patients/Events </td><td>Standard Therapy,
Patients/Events </td><td>Hazard Ratio
(95% CI) </td></tr><tr><td>Positive Axillary Nodes      </td><td> </td><td> </td><td> </td></tr><tr><td>0-3</td><td>547/32</td><td>537/39</td><td>0·81 (0·51-1·29)</td></tr><tr><td>>3</td><td>204/22</td><td>208/41</td><td>0·52 (0·31-0·88)</td></tr><tr><td>Estrogen-Receptor Status </td><td> </td><td> </td><td> </td></tr><tr><td>Positive</td><td>580/28</td><td>563/45</td><td>0·60 (0·37-0·96)</td></tr><tr><td>Negative</td><td>171/26</td><td>182/35</td><td>0·77 (0·46-1·27)</td></tr><tr><td>HER2 Status </td><td> </td><td> </td><td> </td></tr><tr><td>Positive</td><td>146/20</td><td>139/13</td><td>1·56 (0·78-3·14)</td></tr><tr><td>Negative</td><td>605/34</td><td>606/67</td><td>0·49 (0·33-0·75)</td></tr></tbody></table>

More Adverse Events With Capecitabine

Patients receiving capecitabine had more cases of grade 3 or 4 diarrhea (6% vs 3%) and hand-foot syndrome (11% vs <1%) than those receiving the standard regimen. However, there were more occurrences of grade 3 or 4 neutropenia (98% vs 86%) and febrile neutropenia (9% vs 4%) among patients in the standard-therapy group. A greater number of patients also discontinued planned treatment in the capecitabine group than in the control group (24% vs 3%).

A total of 6 patients died from possible treatment-related causes - 4 in the capecitabine group (septic colitis, suicide, myocardial infarction, unknown cause [suspected cardiac arrhythmia]), and 2 in the control group (pulmonary arterial embolism, septicemia).

The authors note that most of the patients who interrupted capecitabine administration were able to continue treatment with other study agents and complete 6 cycles of chemotherapy.

The study was funded by Roche, Sanofi-Aventis, AstraZeneca, and the Cancer Society of Finland. Several of the authors report receiving honoraria or consulting fees from Roche and/or from Sanofi-Aventis.

Lancet Oncol. Published online November 10, 2009.

LavenderNLace

Yes, great article.  But you are already getting the IV form of this 5-FU which is the beneficial part.  You get it immediately instead of having to metabolize it.  I don't see anything in the article which says that the pill form is more effective than the IV form.  Maybe I missed it.  I think your onc has you on a very agressive treatment plan. 

YATCOMW

It would be good to know if they did a study against Xeloda vs. 5-FU......

I know MD Anderson (Dr. Hortogbagyi who runs the breast center) really believes in the 5FU.....in the older days people got FAC....and when the taxanes came along people switched to TAC....but at MD Anderson they give you the FAC with the 12 weeks of Taxol as Dr. H really believed in 5 FU.  When I went to see Dr. H he wanted to put me in this trial with the Xeloda but I turned it down since it was a blind study and my other oncologist had 5FU in another cocktail for me so I knew I would get it.

I think the million dollar question is what has been said......if you already had the 5FU is there a benefit to give you Xeloda as well?  Not sure we know the answer based on this study.

I will tell you that my oncologist is great about calling those that are running these trials and gets the answer......he has no ego to ask the necessary questions......I would ask your oncologist to do the same.....just a thought.

 Jacqueliine

Pure

it turns out this drug is a pro drug so I can still get even though I had 5fu. Meaning as a pro drug it enhances the drug your getting at the same time

The lady conducting the study is in Texas so my doc is going to call her to get her thoughts on giving to me.