Ibrance (Palbociclib)
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Rabbit, Sondra, other ocean lovers - Have you seen any videos from the Monterey Bay Aquarium? I've been there in person 3 times. Their videos are excellent.
https://youtube.com/c/MMontereyBayAquarium
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Jensgotthis- FIVE YEARS!!!!!! Huzzah!!!!
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Hi all -
Jen- congratulations on 5 years! Amazing.
Tanya - 45 cycles is also amazing!
RRabbit - so happy to hear you are sleeping on your own, and sounds like you feel pretty rested. Decent sleep is so important to me and I don't function well when I don't sleep well. Your Pioneer Woman dishware and goblets sound really fun! I love the patterns and colors in Pioneer Woman dishware. For a hot second, I forgot this is MY second Christmas with MBC (DUH!). As I was dx 11/14/2019 last Thanksgiving (started Ibrance on that day) and last Christmas seem like a blur as I was terrified. I am happy to report that I am in a much better place (more hope, less daily terror about MBC).
Wandering and Lee64 - so sorry you are both dealing with ONJ.
Wandering - so happy to hear that your TM are coming down so treatment is going ok. I hope you like your new oncologist - I remember your previous oncologist abruptly left the medical center which is hard on us patients.SerenityStat - beautiful videos! I, too love the Monterey Bay Aquarium, have visited it a couple of times but not for at least 10 years.
Candy- been thinking about you this weekend and will be "in your pocket" for scans tomorrow. Please pop in and give us an update when you can.
I spent the entire day today baking - 4 pumpkin rolls, 4 dozen sugar cookies (rolled out and frosted), molasses crinkles and pecan puffs. Both of my kids helped which was fun. Last Christmas I baked pumpkin rolls but none of the cookies - just didnt have the energy plus had a broken wrist. It was a long day but really fun for me (kids are 23 and 21). We usually spend Christmas eve with a few other families and with covid, that isn't happening so I will drop off the Pumpkin Rolls as a holiday gift.
I have been thinking about all of you and wish you all a wonderful holiday season! Looking forward to 2021!
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Jen, good to hear from you. Yea! Great news on 5 years!
Lee, I also have ONJ. Mine is not infected so I just rinse daily with the medicated mouthwash. My Oral Surgeon said they are finding the best approach to dealing with early stages of ONJ is to let the body push the dead bone out, similar to a splinter. They can do surgery but there can be complications with the jaw healing which can cause more problems. It can take 1-2 years for the dead bone to work it's way out. I am not sure if you are on facebook, but there is a group that has quite a bit of info. Search for "Living with Osteonecrosis of Jaw". I hope this helps.
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Sounds painful. I’m sorry for those suffering with ONJ.
My ANC was 1.24 this month. I only wish I knew why it’s above 1.0 this month, but I wish I could bottle it. I go a few months above 1.0 and then it tanks. I’ll take it while it lasts. I also gained four pounds in a month. I haven’t been able to gain weight in two years. Who knows why. I’ll take that too.
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A new trial is underway for a drug that could come after CDK4/6 drugs fail. This one targets the same pathway plus another one and has been shown in mice to actually kill cancer cells rather than inhibit their growth. Has anyone heard more about this? Cure-ious, what do you think
NEWTOWN, Pa., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the filing of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for ON 123300, the Company's proprietary, differentiated, first-in-class multi-kinase inhibitor. The IND seeks permission to begin a Phase 1 trial with ON 123300 in relapsed/refractory advanced cancer including patients with HR+ HER 2- metastatic breast cancer with resistance to approved second-generation CDK4/6 inhibitors.
"We believe that ON 123300, based on its novel mechanism of action, presents an innovative approach to study advanced cancers including in HR+ HER 2- metastatic breast cancer that is or has become resistant to commercial CDK4/6 inhibitors. We are delighted to have filed our IND on schedule, and look forward to enrolling patients in the U.S. to complement the ongoing Phase 1 dose-escalation study underway in China by our partner HanX Biopharmaceuticals," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "The HanX Phase 1 ON 123300 study, which began in September 2020, has enrolled three patients to date and is expected to continue to enroll patients with advanced relapsed/refractory cancer at two sites until the recommended Phase 2 dose is identified. We believe that data from these two studies will generate important information to inform anticipated later-stage studies."
As currently envisioned, the Phase 1 trial in the U.S. will assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily or higher for consecutive 28-day cycles. The Phase 1 trial is planned for patients with relapsed/refractory advanced cancer, including but not limited to patients with HR+ HER 2- metastatic breast cancer with clinical resistance to the approved second-generation CDK4/6 inhibitors. Once the recommended Phase 2 dose is established, the Company's plan is to enroll additional HR+ HER 2- postmenopausal metastatic breast cancer patients refractory to approved second-generation CDK4/6 inhibitors, as well as patients diagnosed with advanced non-Hodgkin's lymphoma with a special interest in mantle cell lymphoma.
This trial design in the U.S. differs from the study in China because HanX is dosing patients daily for 21 days. Notably, of the three currently approved CDK4/6 inhibitors, two are approved for dosing in 21-day cycles and one is approved for dosing in a 28-day cycle. All three are blockbuster drugs marketed by well-known pharmaceutical companies, and all of these approved therapies require concomitant treatment with an aromatase inhibitor.
"Beyond metastatic breast cancer, we believe that ON 123300 may present an innovative approach to treating other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, advanced hepatocellular carcinoma, and inoperable glioblastoma based on preclinical studies suggesting ON 123300 crosses the blood-brain barrier," added Richard Woodman, M.D, Chief Medical Officer.
Commenting on the expected timetable and next steps with this program, Dr. Fruchtman added: "Once the FDA approves our IND, we will seek Institutional Review Board approval at the site where this Phase 1 trial will be conducted. We anticipate the first patient to be enrolled during the first half of 2021. With the ON 123300 program advancing, investigator-sponsored trials underway with our pipeline product rigosertib, and an active business development campaign to evaluate additional compounds, we look forward to an expanding portfolio of novel therapeutics for large, underserved oncology indications."
About ON 123300
Onconova's lead pipeline product is the novel small molecule ON 123300, a proprietary, first-in-class multi-kinase inhibitor targeting tumor-driving kinases including CDK4/6 and ARK5. ON 123300 is reported to simultaneously inhibit both cell cycle and cellular energy metabolism through CDK4/6 and ARK5, respectively, and in vitro has been shown to be cytotoxic to cancer cells (killing the cancer cells) rather than just cytostatic (inhibiting the growth of cancer cells), which is how the currently commercial CDK inhibitors are reported to work. With its differentiated mechanism of action, ON 123300 may present an innovative approach for treating solid tumors and hematologic malignancies that are refractory to or have become resistant to other CDK4/6 inhibitors.
Based on experiments in preclinical models, ON 123300 exhibits single-agent cytotoxicity, may have utility for certain types of cancers including breast cancer and non-Hodgkin's lymphoma, and may also have utility for mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, advanced hepatocellular carcinoma, and inoperable glioblastoma.
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Jens congratulations on 5 years and thank you for posting the information re this exciting new trial.
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April girl- Just about to start baking for this year, never tried pumpkin rolls! I am going to make sugar cookies and Good Earth seedy rolls and homemade mini-scones. Can you share the recipe? Ooh, are they like a cinnamon roll but with pumpkin? Cuz that would be awesome...
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serenity, yes!! The shark lagoon cam was my sleeping tv screen saver for a bit. They used to have a humungous ray in that tank that had the longest stinger I've ever seen, so big it would float in there towards the surface and since it liked to sleep on the ground often I'd just look for the floating stinger to find out where it was hiding among the faux coral. Havent seen that ray in the tank for a long while, wonder if it got moved. Was always curious if it was a boy or a girl and if they had named it. That place looks so neat. Jealous of those that have been there. I love aquariums. I've been to the Mystic Aquarium and Maritime Aquarium and many others as a kid. I love Aquariums.
I vote we all go over to April's with a pot of coffee, all that baking sounds awesome
I'm sorry for those dealing with ONJ but thank those for sharing their experiences with it and how your coping with it, all info I and many of us are keeping in back pocket.
Wandering, I think of you out in the remote quietness. The stars must be beautiful where you are.
Candy, thinking of you.
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Ooooohhh a pot of coffee with baked goodies sounds so yummy! I'm in!
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SInce I am taking I/L, I read several folks on this thread are leaning towards taking the Covid vaccine. The medical center where I'm employed received their first batch of Moderna today. Hence the facility started vaccinating today. My HR department sent me an email I can obtain the vaccine next week. I was hoping to wait a while but nervous if the facility doesn't receive another batch in the near future. SO do I roll the dice and wait, or just go for it. The potential side effects are concerning coupled with the lack of knowledge for cancer patients receiving the vaccine. Plus I guess where I am in my cycle plays a role when to receive it. I need to make a reservation, meaning a date /time. What decisions, my MO felt it was ok but she wasn't convincing... Any thoughts??? thanks.
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Simone80, thanks for your input on ONJ. My oral surgeon also told me that the body has to heal it on its own, that they have tried treatments and they usually fail. My MO talked like he wanted to get it resolved so I can get back on Xgeva. We'll see what happens; I am scheduled for a CT of my face on Jan. 14th.
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Wonderful news Jen! That trial you posted looks like a good option if the trials work out. 85 months sounds awesome
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Tinkerbell, Boy if anybody offered me a vaccine, I'd jump! I got the flu and shingles vaccine this fall (at the same time, which I would not recommend now) and am eager to take any of the FDA approved vaccines, altho I'm thinking the J&J one would be my preference assuming they make the grade when their trials end in January because their published data looks great. My sister and BIL are currently having an awful time with covid and first tested positive Dec.5, its a nasty virus. But of course many will choose to wait awhile longer. My brother is in the clinical trial for NovaVax and that vaccine is having remarkably few reports of any side effects, and he had none. We are also are waiting for that trial to end
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Signing off for a bit- somebody's gotta get those cookies started!
Merry Christmas, everybody, See you on the flip side...
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This is sliced pumpkin roll (with pumpkin pie !) It's a jelly roll filled with cream cheese frosting . Looks like a giant hoho before it's sliced
coffee is on!
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April-That looks amazing! I will be over in a flash. I love pumpkin-just when I think nothing could be better than pumpkin pie, that pumpkin cream cheese roll might be even better!
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Here is the pumpkin roll recipe! It's important that you roll it while it's pretty hot, so it doesn't crack. It is a serious crowd pleaser! I don't know why my recipe is so tiny - here is a link to a similar recipe from Libby's pumpkin - I personally would not include the nuts that are in the Libby's recipe. https://www.verybestbaking.com/libbys/recipes/libb...
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Cure-ious: Sorry to hear about your family with Covid. Hope they get well soon. thank you re your opinion with the Vaccine. I value your judgement.
Happy holidays everyone....
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Hi all.
Thanks for the thoughts on my appt yesterday (Monday).
I am still on Ibrance--- cycle 37-- and still continuing it. My MRI showed no new liver mets, just the same 4 shown 2 months ago. But they changed by 1-3mm each. Could be growth. Could be measurements by radiologist. But MO does not want to change treatments yet. I agree. Rescan in 3 months. She never mentioned the bone mets. Not really looking at that though with MRI of abdomen and CT of chest.
I did ask about the Covid vaccine. She said she wants to read CDC guidance for cancer patients on treatment and she hasn't seen that yet. I said I read (on here) that some on Ibrance would plan the vaccine on their week off when counts would be at their best. But I am on the 5/2 dosing. So I thought about a treatment vacation of a week when I was planning on getting my vaccine. She said that sounded good. I said I wanted my vaccine as soon as I could get it and she said "me too". So she hasn't had hers yet either. ????
I read that we- aged 16-74- with high risk health issues would be in Group 3. Group 2 is 75 and over, teachers, grocery workers, postal workers. And we are still in Group 1 with Healthcare workers and nursing home residents. Seems it is slow going. I do not expect to get it till Spring -- April or May my guess.
But... for now, I am still Ibrance Dancing.
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Thanks for the recipe April-I hope mine turns out as well as yours!
Candy-Sounds like a good plan-with those tiny changes it is hard to know if it was growth or not.
On a more discouraging note, according to an article I read yesterday in the Daily Mail, MBC will not qualify as a health condition that bumps us up the line. I thought since I had a damaged lung I might be getting the vaccine in January or February, but according to this article, since I am under 65, I will be in the general population group. Oh well, more patience is needed. So Tinkerbelle-If I were you, I would get the vaccine now. I have had the Shingrex and of course Flu vaccines since being on Ibrance. My oncologist never cared about what point in my cycle I got the vaccines, so I think I'll get the vaccine whenever it is offered without waiting for my off week unless I hear otherwise from my doctor.
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Good news, Candy. I’m happy you get to continue.
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Candy,
Good news on your visit yesterday. That all sounds positive, and I'm happy that you get to continue on Ibrance. I'm sure that it's a relief, and now that you are being followed on MRIs as well as CTs they will be able to keep a closer eye on your liver and those spots.
But your description of your visit on the other thread sure did sound like you were bouncing around like a ping pong ball all day. Hope you can get some well deserved rest today.
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April...That's what I thought you meant when you said pumpkin roll. That looks so good!
Candy...The measurement difference is so small. I think staying on Ibrance is a good thing. Overall you had a good appointment.
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BevJen- The cancer center says they do the scans and MO appt the same day for the patients that have to travel. 1 trip. But it does make for a long day. And then the pause in-between scans and MO appt so the radiologist can read the scans. By the time I had my Xgeva (the end of the day) the staff member said "Wow, you have had a long day". I agreed with her.
I am happy with the results. 3 more months of Ibrance and stable.
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Merry Christmas, Happy Holidays....bless each and everyone...may 2021 be a great year for all0
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Candy - awesome news for you! Glad that appointment turned out well (if a bit long) and you can at least get through the rest of the winter season with no need to change treatments.
Just to note - I believe the Johnson & Johnson vaccine is done with Phase 3 trials end of January, and will be seeking similar emergency approval. Early results show high efficacy (>95%), its one shot (not two) and likely safe for a range of groups, including immunocompromised:
https://www.verywellhealth.com/johnson-and-johnson...
What did Tom Petty sing? The waiting is the hardest part?
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april - That looks delicious! Beautiful plating. I love the serving size. 👍
Saw my MO on day 12 of Ibrance. I've had increased fatigue, hair thinning, and infrequent acid reflux since switching to tablets. My neutrophils are 0.89. High for me. I can take extra time off at the end of this cycle. My CA 15-3 dropped from 127 to 103. He approved getting the covid vaccine though unsure when it will be available. I'm one rung above the general population in terms of priority.
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Rabbit - I love aquariums, too. I never went as a kid, but I happily took my kids. When I was a child, I saw a dead seahorse on the beach. I had recently learned Santa wasn't real, so I figured something like a seahorse wasn't real either. Imagine my confusion when I saw that dead seahorse. One of the best aquarium exhibits is the one on seahorses. The leafy seadragon is incredible.
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