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  #26  
Old Wed Jun 17, 2009, 06:37 PM
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e1905 Clinical Trial w/o MS-275 (Lab Results 6/17/09)

Today (6/17/09) was Ron's 22nd day of his 3rd Cycle of Vidaza (by injection) treatment on clinical trial e1905.

AWESOME LAB RESULTS TODAY !!!!

HGB 15.2, Hemacrit 43.6%, RBC 4.33, WBC 5.0, Neutrophils 56%, PLT 179

All counts have continued to increase, except the PLT did decrease some, but, still within the normal range. We're very pleased with Ron's WBCs!!!

We saw Ron's Doctor in the hallway and he smiled really BIG when he saw Ron's lab printout. Our doctor will be out of town next Wed when Ron begins Cycle#4 (Vidaza Injections), but, he said he wanted to set up an appt to discuss Ron's progress and future treatments. Ron's Clinical Trial coordinator said she just reported last week that Ron was doing exceptionally well on the 10-Day low dose regime... Not sure what this cycle will bring ... but, I'm thinking that perhaps Ron's BMB may come sooner than the clinical trial scheduled - month BMB...

NOTE: As far as "how Ron felt all week"..... He felt good all week, except for just one evening (2 nts ago). Ron said he didn't feel very good... that he felt weird. He mentioned his teeth/jaw hurt some and so did his back. He has had history with back/shoulder muscular/skeletal aches/pains, but, only recently teeth aching. He's been using the BIOTENE toothpaste the first 2 cycles, but, has now changed to "Sensidine" for sensitive teeth to see if that helps resolve anything... will let you now of future teeth problems/aches. The night he felt bad he said he had a headache too, so he took some tylenol. The next day he felt fine. Maybe it's MDS related.... treatment related, or just normal.... just felt bad one evening... it's hard to tell sometimes... I just mention these things for others to compare... etc.

Today we feel exceptionally Blessed.... And we continue to Praise God !!!

Cindy

Last edited by launch : Wed Jun 17, 2009 at 09:34 PM. Reason: Added "note" of how Ron felt all week....
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  #27  
Old Wed Jun 24, 2009, 08:02 PM
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e1905 Clinical Trial w/o MS-275 (Lab Results 6/24/09)

Today (6/24/09) was Ron's 1st Day - 4th Cycle of Vidaza.

LAB RESULTS:

HGB 15.9, Hemacrit 45.7%, RBC 4.57, WBC 4.0, Neutrophils 51%, PLT 170

HGB, Hemacrits, and RBCs overall continue to rise. WBC bounced back down a bit, but, we're still happy that they are at 4.0 and the Neutrophils remain above 50%. Ron remains on Antibiotics for now, PLTs dropped a bit more, but, still within range band.

We see the doctor next wed to discuss Ron's condition/progress. Seem the PA and the clinical coordinator were exceptionally pleased with results. We're happy because Ron is feeling "good".... it's nice having my "Guy" back...
We praise God for his progress and we pray Ron continues to be touched by God's Healing powers....

Cindy

Last edited by launch : Wed Jun 24, 2009 at 09:44 PM.
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  #28  
Old Thu Jun 25, 2009, 12:54 PM
Birgitta-A Birgitta-A is offline
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Vidaza

Congratulations once more to the good treatment results!
Kind regards
Birgitta-A
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  #29  
Old Thu Jun 25, 2009, 09:24 PM
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Thanks...

Birgitta,

Thanks for the continued encouragement you've provided over the past several months. I appreciate all of the members of marrowforums for their continued support.

You know, i continue to post Ron's progress, to encourage others... when we were trying to decide on treatments and learn about the e1905 clinical trial, seems I couldn't find a lot about it that was written in a way I could understand. I saw the flowerlady's post, asking if anyone is on it.... so, I thought, a continue posting under the clinical trial would be a good thing.

I am happy to be reporting the encouraging news that Ron's responding well... in hopes that this study provides more information for others... seems this low dose is perfect for Ron.... :-)

Hugs, Cindy

Last edited by launch : Thu Jun 25, 2009 at 09:25 PM. Reason: typo
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  #30  
Old Wed Jul 1, 2009, 05:58 PM
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e1905 Clinical Trial w/o MS-275 (Lab Results 7/01/09)

Today (7/01/09) was Ron's 8th Day of his 4th Cycle of Vidaza on this clinical trial. He's scheduled for at least 6 cycles, then, will have another BMB to check progress. Today I was hoping the doc would say he's ready for a BMB now and we could see progress, but, the doctor said the BMB will be after the completion of Cycle #6. He said, for now, a BMB is not necessary, that, the blood counts are showing definate response to treatment. Ron will stay on schedule for a 6th cycle BMB.

LAB RESULTS:

HGB 15.2, Hemacrit 43.9%, RBC 4.40, WBC 3.7, Neutrophils 42%, PLT 236

Overall everything down a little bit, except for Platelets, they've risen. I was concerned, but, the doctor said we should be very happy, as the numbers do bounce up and down for everyone.. with or without MDS... that there weren't significant drops on anything and these results still show overall progress from where we started. Of course, the HGB is normal range, so, that's not a big concern... I just want the WBCs to behave right now and continue to climb up into the "Normal Range"...

Today though, they took Ron off the daily antibiotic. They don't feel it's necessary at this point and don't want to over use it.

Will post Lab results again next week...
Take Care & Praise God in all things.
Cindy

Last edited by launch : Wed Jul 1, 2009 at 08:38 PM. Reason: re-wording to remove confusion about scheduled BMB.
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  #31  
Old Wed Jul 8, 2009, 07:38 PM
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Progress on Clinical Trial e1905 (Vidaza), but, in group Not receiving MS-275 pill

Today (7/08/09) was Ron's 15th day on his 4th cycle of treatment. His last Vidaza injection was last Friday (7/03/09) for this cycle, and he has 18 days off before he starts cycle # 5. Today was definately another Day to Praise God for Ron's Wonderful Lab Results!

HGB 15.8, Hemacrit 45.3%, RBC 4.56, WBC 4.4, Neutrophils 44%, PLT 203

Everything Looks Good, steady progress, Vidaza Treatment working Wonders! Ron has tremendous Energy! Taking nightly walks... not too much, but, enough to get in some exercise. Ron says he Feels Great! And, that is what really matters... is how you Feel....

I continue to Pray for everyone with this dreaded disease and for their caregivers... God Bless All of you! Cindy
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  #32  
Old Wed Jul 15, 2009, 07:47 PM
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e1905 Clinical Trial w/o MS-275 (Lab Results 7/15/09)

Today (7/15/09) was Ron's 22nd day of his 4th Cycle of Vidaza (by injection) treatment on clinical trial e1905. He begins Cycle 5 next wednesday. (NOTE: I've been posting each wednesday's Lab Results so other patients can follow Ron's progress on this particular clinical trial...

Wonderful Lab Results Today !!!

HGB 15.6, Hemacrit 45.2%, RBC 4.55, WBC 4.3, Neutrophils 53%, PLT 158

The Medical Staff continues to be pleased with Ron's progress. We continue to Praise God for his healing touch... Ron continues to feel wonderful... and I am thankful for that...

NOTE: On a side note, a gentleman we had met in this same clinical trial actually is receiving the MS-275 med along with the Vidaza. He just completed his 6th cycle of Vidaza & MS-275 and his BMB showed No Blasts. But, because the WBCs are not behaving like the Doctors want, they have decided to continue him on more cycles of Vidaza, at the same 10-Day cycle w/MS-275. This gentleman had very very low RBCs, WBCs, and PLTs when first starting this trial. Is WBCs have been as low as "zero". Hopefully they continue to increase with additional treatments. During the trial, the WBCs have gotten up to 2.2 I believe. He does feel really good though and he's walking 3 miles per day. Transfusion Free.

Last edited by launch : Thu Jul 16, 2009 at 09:42 AM. Reason: Correcting cycle Ron's on.
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  #33  
Old Thu Jul 23, 2009, 09:54 PM
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Clinical Trial e1905 w/o MS-275 (Cycle #5)

Today (7/23/09) was Ron's 2nd day of his 5th Cycle of Vidaza (by injection) treatment on clinical trial e1905.

Lab Results:
HGB 15.8, Hemacrit 45.3%, RBC 4.62, WBC 3.3, Neutrophils 39%, PLT 177

Today, Ron's numbers continue to look pretty good and he feels good. The only complaint he had the last two nights is that his teeth started hurting again. This has been happening off and on during the chemo treatments. (Tylenol quickly Relieves the pain)

We continue to Praise God for each day....

Cindy
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  #34  
Old Fri Jul 24, 2009, 05:18 AM
Birgitta-A Birgitta-A is offline
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Thumbs up Your trial

Hi Cindy,
Ron's counts are so good that I feel that I should ask my doctor if i could try a 10 days cure instead of a 5 days cure as they usually give i Sweden. My counts are still OK with watch and wait so we wait with Vidaza so far.

You know "your" study started 2006 and needed 63 paticipants. According to clin trials gov the study now is active but not recruiting participants - I think that means that they now are starting to analyse the results. Perhaps we will be informed about the results at the ASH conference in Dec 2009.
Kind regards
Birgitta-A
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  #35  
Old Fri Jul 24, 2009, 07:59 AM
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Birgitta,
It seems they're actually studying two different things in this trial... if I'm reading it right. The main study is for the Low-dose Vidaza for 10-Days with the added drug MS-275. But, the second control group (Which Ron's in), does not receive MS-275, but, does receive the lower dose (105mg) Vidaza for 10 Days each cycle. I believe they'll be able to see two things in this study... the effectiveness of low dose for 10-Days and the added MS-275, if that does anything to enchance effectiveness.

I know we're very happy with the minimal side effects (occassional teeth pain, but, quickly relieved with tylenol), and the increased counts. The most important thing is, Ron is feeling great!

The doctor did mention, after remission, Ron, of course, would continue on Vidaza. Initially he said, the 10-Days cycle would continue, but, then, he said, he would check the protocol, after remission on this type dose and see if he'd be able to slightly reduce the days of the injections. 10-Days is a lot each month to go to the hospital... but, if that's what it takes to keep Ron feeling wonderful.. then, we'll just take it easy for the 10-Days and we'll celebrate the 18-Days Free from treatment.

Talk later,
Have a nice Day! Cindy
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  #36  
Old Sat Jul 25, 2009, 12:16 PM
Birgitta-A Birgitta-A is offline
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Two studies

Hi Cindy,
Yes now I can see that there are two different studies of Vidaza with or without MS-275 called NCT00101179 and NCT00313586.

The first one (that is closed) is a dose-finding trial and the second one is a randomized Phase II study where 152 patients will participate. We hope to be able to read the results from the dose-finding study i Dec 2009.
Kind regards
Birgitta-A
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  #37  
Old Sun Jul 26, 2009, 08:35 AM
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Birgitta,
Ron & I both look forward to reveiwing the study results... and like you have said, seems the clinical study's lower dose for Ron seems to be perfect! If you decide on the same dose, i hope the same results for you. But, of course, the wait and see seems to be working for you right now... and I hope it continues :-) With Ron, he because so very weak and was sweating each night w/fever, etc... he needed some relief. I believe it was after the end of his 1st cycle & his last transfusion, the nightly sweats & Fevers stopped... and he started feeling "Normal" again...

God Bless,
Cindy
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  #38  
Old Wed Aug 5, 2009, 05:40 PM
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Smile Lab Results for 8th Day and 15th day of 5th Cycle Vidaza

I've not posted for 2 wks, so, today includes both 7/29/09 and 8/05/09 Lab Results. Ron continues to receive Vidaza by injection on clinical trial e-1905 (without MS-275 pill) for 10 Consective Days each cycle. (A complete cycle is 28 Days).

7/29/09:
HGB 15.7, Hemacrit 46.3%, RBC 4.68, WBC 2.5, Neutrophils 30%, PLT 226

8/05/09 (Today):
HGB 16.2, Hemacrit 45.4%, RBC 4.67, WBC 4.4, Neutrophils 49%, PLT 164

We saw the WBCs drop some during the end of the Chemo injection week, and then, 1 week later, we've seen significant improvement in the WBCs. We're Very Pleased and the Staff was too.

We Continue to Praise God Daily.... and are thankful for the "Good Days"... which, we're blessed to have had a lot of them over the pasts several months...

God Bless you All...
Cindy
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  #39  
Old Thu Aug 6, 2009, 10:25 AM
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Smile

Here are Ron's compiled Blood Results since Cycle. I thought it was easier to see the overall picture of response by aligning the the comparisons.... Ron is on Clinical Trial (Phase II) Vidaza by Injection (10-Days) w/o MS-275.

The first number, for example, 2-10, means Cycle 2, Day 10. Followed by Date of lab work....

2-10: 5/08/09 HGB 9.6, HCT 29.7%, RBC 3.06, WBC 1.9, NEU 29%, PLT 277

2-15: 5/13/09 HGB 10.4, HCT 31.3%, RBC 3.11, WBC 2.6, NEU 41%, PLT 239

2-22: 5/20/09 HGB 12.9, HCT 39.0%, RBC 3.73, WBC 3.0, NEU 45%, PLT 209

3- 1: 5/27/09 HGB 13.1, HCT 40.2%, RBC 3.86, WBC 3.0, NEU 42%, PLT 250

3- 8: 6/03/09 HGB 13.9, HCT 41.7%, RBC 4.04, WBC 2.2, NEU 14%, PLT 336

3-15: 6/10/09 HGB 14.5, HCT 42.6%, RBC 4.16, WBC 3.9, NEU 42%, PLT 226

3-22: 6/17/09 HGB 15.2, HCT 43.6%, RBC 4.33, WBC 5.0, NEU 56%, PLT 179

4- 1: 6/24/09 HGB 15.9, HCT 45.7%, RBC 4.57, WBC 4.0, NEU 51%, PLT 170

4- 8: 7/01/09 HGB 15.2, HCT 43.9%, RBC 4.40, WBC 3.7, NEU 42%, PLT 236

4-15: 7/08/09 HGB 15.8, HCT 45.3%, RBC 4.56, WBC 4.4, NEU 44%, PLT 203

4-22: 7/15/09 HGB 15.6, HCT 45.2%, RBC 4.55, WBC 4.3, NEU 53%, PLT 158

5- 2: 7/23/09 HGB 15.8, HCT 45.3%, RBC 4.62, WBC 3.3, NEU 39%, PLT 177

5-8: 7/29/09 HGB 15.7, HCT 46.3%, RBC 4.68, WBC 2.5, NEU 30%, PLT 226

5-15: 8/05/09 HGB 16.2, HCT 45.4%, RBC 4.67, WBC 4.4, NEU 49%, PLT 164

Last edited by launch : Thu Aug 6, 2009 at 12:21 PM. Reason: clarification of cycle/day
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  #40  
Old Thu Aug 6, 2009, 02:07 PM
Birgitta-A Birgitta-A is offline
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Ron's results

Hi Cindy,
The increase of the HGB is amazing and the WBC:s are now perfect !
Kind regards
Birgitta-A
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  #41  
Old Thu Aug 6, 2009, 07:26 PM
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Talking

Birgitta,
Thanks! After Ron was a bit bummed last week when his WBCs were 2.5 (equates to 2500), I decided to list it out like this to compare his progress... let's just say, I'm with you... his improved HGB and even WBCs are amazing. I may have to pull out his original blood counts, because, before treatment, he was down to .70 and 1.2 (equates to 700-1200) on his WBCs and his PLTs were 82 (equates to 82,000). His HGB was going down rapidly and he was obviously going to need transfusions every other week since first dx.

We're so fortunate for this Clinical Trial... Low dose Vidaza, although it's 10-Days in a row of injections... has little side effects for Ron. His teeth pain didn't occur at all last cycle, and the only thing Ron complains about is, approx 3 days after his chemo (Vidaza) treatment, he feels kind of wierd. He says he's not tired, but, that he feels a bit "Jittery" ... like his sugar is out of whack, but, he is not diabetic or anything....

Have a Wonderful Week! If you ever go on Vidaza... I hope you do as well as Ron's doing! This low dose treatment, as you've stated before, seems perfect for Ron!

Hugs, Cindy
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  #42  
Old Sat Sep 12, 2009, 11:33 AM
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Talking Update... Lab Results on Clinical Trial - Azacitidine Without MS-275

Just an update... I haven't posted any of Ron's weekly blood results since 8/06/09. Last lab posts were through Cycle 5, Day 15 (5-15). I've added all lab results since that post...

Just as a reminder, Ron is on Clinical Trial (Phase II) Vidaza by Injection (10-Days) w/o MS-275. The first number, means, for example, 5-22, means Cycle 5, Day 22. Followed by Date of lab work....


5-15: 8/05/09 HGB 16.2, HCT 45.4%, RBC 4.67, WBC 4.4, NEU 49%, PLT 164

5-22: 8/12/09 HGB 16.0, HCT 44.9%, RBC 4.62, WBC 4.2, NEU 54%, PLT 126

6- 1: 8/19/09 HGB 15.9, HCT 44.9%, RBC 4.66, WBC 3.5, NEU 37%, PLT 157

6-10: 8/26/09 HGB 16.1, HCT 45.4%, RBC 4.68, WBC 2.9, NEU 28%, PLT 224

6-15: 9/02/09 HGB 15.4, HCT 43.8%, RBC 4.53, WBC 4.3, NEU 48%, PLT 164

6-22: 9/09/09 HGB 15.7, HCT 45.2%, RBC 4.65, WBC 4.6, NEU 50%, PLT 130

All numbers continue to look good. PLT down just a bit, but, the doctor doesn't really seem worried about that. We're happy to see Ron's HGB and WBCs holding nicely. We Praise God Daily and we Enjoy/Celebrate each day that he's in Remission. Based on Blood work, the doctor did tell us Ron's in Remission, but, he's scheduled for BMB next wed (9/16/09). His last one was at the beginning of his clinical trial and he had 5-6 chromosomal aberations and blasts were <5%. All blood counts were down and Ron was requiring transfusions approx every other week since first dx (Feb'09).

We keep all MDS patients and Caregivers in our prayers...
Cindy
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  #43  
Old Sat Sep 12, 2009, 12:28 PM
Birgitta-A Birgitta-A is offline
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10/28 cycle

Hi Cindy,
Now Ron must be near 6 months of treatment and his counts are excellent! Hope the BMB will show remission too!
Kind regards
Birgitta-A
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  #44  
Old Sat Sep 12, 2009, 08:59 PM
helen c. helen c. is offline
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vidaza

my husband had his bmb the 13th we will get results wed. he responded so well last year and had remission thru dec.09hes on weekly transfusion his platletts are rarely above 50 he doesnt get platletts until they are around 10hes on dseferal for iron 3 times a week. hes on 3 different antibiotics. he is so tired and his hip and shoulders hurt all the time hes on pain meds. i am going to ask for a copy of the reprt wed. i would like to hear what others think so we can make a decsion on his next treatment plan helen
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  #45  
Old Sun Sep 13, 2009, 03:18 PM
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6 months

Birgitta,
You're right, this is Ron's 6th Month. I'll post again with the BMB results.

Helen,
I pray that your husband finds treatment to put him back into remission. I look forward to seeing his BMB results.

Prayers to all !!!
Cindy
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  #46  
Old Thu Sep 24, 2009, 10:44 PM
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6 month - BMB Results

Ron completed his full 28-Day of this 6th cycle of Vidaza on the clinical trial e1905 w/o MS-275 and received his BMB on the day he would have normally started his 7th cycle of treatment. We received notification yesterday that his BMB revealed good results, and he qualifies to remain on the clinical trial... But we meet with the Dr next Wed to discuss details of the BMB and the treatment. The Vidaza will begin again on Wed, Sep 30th. And we'll just continue on the same treatment protocol for now... unless Wed reveals something else....

Initially, Ron's BMB showed Blasts under 5%. I'm not exactly sure what the exact blasts were the first time. I have the BMB, but, it's difficult to interpret, but, I will ask on Wed. Right now, Ron's BMB shows 0.7% blasts, and the staff is very happy with that. We were hoping for no blasts, but, we'll wait for next results and continue to pray...

We were a bit disappointed that there were still some remaining blasts, but, I guess we need to be patient and at the same time, be thankful that Ron's feel wonderful and that we're able to get out and about some.

It's just depressing sometimes, as I'm sure all who read these posts know... I mean, you'll have something planned, like, we had tickets to the Tenn Vs Auburn Football game, and we're having to try to unload the tkts we bought. Everything would have been fine, as we had planned around the Chemo weeks, based on the schedule, prior to the BMB, and now, the treatment has shifted and we're having to miss the game and will probably have to cancel another trip we had planned the end of November... Argh...

I know, it's a "Pity Party"... but, every now and then, we're all entitled to one :-)

Sincerely,
Cindy
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  #47  
Old Fri Sep 25, 2009, 06:52 AM
Birgitta-A Birgitta-A is offline
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Blast cells are immature cells

Hi Cindy,
Good that Ron has so positive results!

You know as far as I understand blast cells are young or immature cells and the bone marrow always contains blast cells. You have to ask specially about the 0.7% blast cells.
http://www.oncologychannel.com/leuke...nemarrow.shtml
Kind regards
Birgitta-A
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  #48  
Old Mon Sep 28, 2009, 08:09 PM
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Thank you...

Birgitta,
Thanks again for your "up-lifting spirit"... I appreciate your references and your posts! Reading the article helps me to understand more about the blast cells and see that his results are, in fact, awesome! I also keep reminding Ron, and myself :-) that, it's better to be cancelling a trip due to a scheduling conflict vs a required transfusion, etc.... better to have MDS under control, even if it means we delay a trip or change up a week.... it's just nice that we can now plan... as compared to how it was back in Early Spring... So, we are Blessed, and we Thank God for Ron's response to Vidaza. He has a wonderful team of doctors...

Before Wednesday, I also have another question... I know, I know... don't quit a "Winning Team" ;-) But, I wondered, Ron could go on 5 Days vs 10 Days... it would be the same dosage for each day.... (105mg)... the only difference would be, he would only get 5 Days vs 10 Days. The change would require he come off the clinical trial. My concern is, are there any studies showing the 10 Days is much better than 5 Days? If not, then, I'm thinking, the less toxins (chemo/Vidaza) in the system, the better... BUT, only if the 5 Days is proven to do the same as 10 Days??? Any advice? Ron has decided, whatever the doctor tells him to do is what he'll do, and I'm with him, but, I do have concern about taking extra days of chemo if not a benefit...

on the Flip-Side though, as you stated in another post, MDS is many diseases with shared symptoms. So, who really knows if the 10 Days may have caused Ron to respond so nicely, where the 5 Days may not have? I thought the response percentage was approx 50% to Vidaza, but, I've learned it's actually less than 50%, so, we should be thankful... and think twice before changing things up.....

<Lots to Think About>
Cindy
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  #49  
Old Tue Sep 29, 2009, 01:58 PM
Birgitta-A Birgitta-A is offline
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Vidaza 10, 7 or 5 days

Hi Cindy,
You know I have never seen a report about 10 days treatment - they are beginning to report about Entinostat (MS-275) studies but not anything that is easy to understand and nothing about the control groups.

As I have written before my doctor, who is a specialist in MDS treatment, has told me that no one really knows the best doses of Vidaza.

Here is a report about 5 days treatment (56 % improved) that in this study was better than 5 + 0 + 0 + 2 days and 5 + 0 + 0 + 5 days treatment. All patients probably got more Vidaza than Ron has got.
http://www.oncolink.org/resources/ar...nth=3&id=16098
Kind regards
Birgitta-A
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  #50  
Old Tue Sep 29, 2009, 05:35 PM
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Thank you...

Birgitta,
Thank you! Ron begins Cycle #7 of Vidaza tomorrow... and so far, we're planning to continue on the 10-Day cycle on the clinical trial. I have some questions tomorrow for the doctor.

Will keep you advised... Ron will receive Labs tomorrow, and I'll post results.

Cindy
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