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Old 05-31-2017, 02:43 PM   #1
Billie
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Join Date: Dec 2014
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Dose Finding Study of Subcutaneous Pertuzumab

Hi all, I have the opportunity to participate in this trial. A phase 1 open label, two-part, multicentre Perjeta subcutaneous dose-funding study but wanted to ask the groups opinion on whether it is a good idea to do so. I was diagnosed Her2, epositive in 2013 and completed treatment in 2014. Since then all has been clear. Do you think there is any harm in completing this trial or would it be better to "leave well alone". Really appreciate your thoughts.

Billie. NZ
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Old 05-31-2017, 03:05 PM   #2
donocco
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Re: Dose Finding Study of Subcutaneous Pertuzumab

Billie

I should have done research before I try to answer you but my gut feeling is to leave well alone. My pharmacy education has always emphasized that IV dosage gives you the highest blood levels of a drug followed by IM or oral. I cant for the life of me see the purpose of subcutaneous Perjeta. Is it to save the insurance companies the cost of IVapparatus? As cynical as that sounds I cant think of any other reason. Maybe someone else on the board has some knowledge about subcutaneous Perjeta that I lack. I will research it for you. Im giving you a shoot from the hip response based on what I hane been taught.

Paul
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Old 05-31-2017, 03:17 PM   #3
donocco
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Re: Dose Finding Study of Subcutaneous Pertuzumab

Billie

I did some very quick research. They are starting to do the same thing with Herceptin ie giving it subcurtaneously combined with Hyaluronidase (probably to improve the relatively
poor subcutanous absorbtion). The reasoning behind these trials is that IV administration
is time consuming for the patient and health care system. As time is money as the old saying goes and health insurance companies are a major component of the health care system my cynical response might not be that far off. What they are trying to do is determine a subcutaneous dose that will give the same blood levels as the IV dose. The reasoning behind this is not to increase response but to save time and money. Im very conservative. My reasoning is "if it aint broke dont fix it. Personally Id avoid this. However talk with your Oncologist about it.

Paul
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Old 05-31-2017, 03:46 PM   #4
Juls
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Re: Dose Finding Study of Subcutaneous Pertuzumab

I had Perjeta for 2 1/2 years as a trial drug for stage 4 patients only.
Last year I progressed and was given subcut. Herceptin. It was much quicker but sometimes uncomfortable. Especially if given when too cold! Had injection for 13 months and now back to IV's. I have often wondered if the injection was the best way to have it!

Perjeta still a trial drug here ( Scotland) & always by IV.
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Old 05-31-2017, 09:22 PM   #5
Billie
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Re: Dose Finding Study of Subcutaneous Pertuzumab

Thank you so much for looking into this I never gave it a though that they might be looking at ways to save money. I though it might prove to be useful information for others so think I will leave well enough alone. Again thank you so much for taking the time to respond to my query, it is nice to be able to reach out to people who understand. Billie
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Old 06-01-2017, 12:31 AM   #6
Bunty
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Re: Dose Finding Study of Subcutaneous Pertuzumab

Hi Billie, I'm in Sydney and I started getting subcut Herceptin back in early 2016 (or maybe 2015). I had been having Herceptin via IV for the previous 8 years, and was excited for the subcut option. It's a standard dose for everyone, and I think that Paul is right in that it's a time and money saver for the health system. Herceptin, IV or subcut, is funded by the Government here, however, interestingly each time I had the subcut I had to pay $35 - not much, but I just didn't understand why. Anyway, I noticed the day after the injection I would feel 'flu-ey', which I had never felt before on IV, and wondered if the dose was too much for me........ Then after 9 years of no problems with Hereptin, my ejection fraction dropped significantly, and I had to stop Herceptin, and I'm still off it. I have a belief (based just on my experience) that the subcut Herceptin was too much for my heart. Mind you, they don't know for certain that the problem was caused by Herceptin - there are cases of late onset heart toxicity from Adriamycin which I had back in 2001 when first diagnosed.

My heart function is returning having been under a cardiologist and on Beta Blockers and Ace Inhibitors, and in fact my oncologist is happy to recommence Herceptin. I've decided to wait until I come back from a European holiday in July to start again, but the plan is definitely to go back to IV Herceptin, and to start with weekly doses, and continue to monitor heart function. I know this is not Perjeta, but I feel it might be better to have personalised dosing. Best wishes,
Marie
__________________
dx Dec 2000 dcis 2.5cm clear sentinel node, ER/PR- Her-2+
lumpectomy, 6 cycles AC, 6 weeks rads
October 2007 three x 2.5cm lung mets. 8 months Taxol, started Herceptin and continue. Significant reduction in lung mets.
June 2011 3cm x 4cm liver tumour. Started Abraxane and continue with Herceptin.
November 2011. Finished with Abraxane, continue with just Herceptin. Liver tumour now reduced to 15mm x 12mm. Lung tumour now 10mm x 0.5mm
February 2012. Scans show everything stable, and brain scan clear.
July 2012. PET/CT scans show I'm in remission - no active cancer!
]Dec CT brain cllear, lungs stable, liver tumour has increased to 20mm. PET scans showed active liver met and active lung thinglet, and possible bone met.
Jan 2013 recommence Abraxane, continue with Herceptin.
June 2013 finish Cycle 6 Abraxane, continue with Herceptin. 30% reduction in liver tumour, everything stable.
December 2013. CA15-3 on rise.
February 2014. PET and CT scans show single liver tumour has increased to 35mm. No other activity.
March 2014. Planned for SBRT for liver met, but couldn't have treatment as tumour too close to bowel. Continue Herceptin.
April 2014. Surgeon advises that I am a good candidate for liver resection, so will have operation early May (after camping holiday). Tumour now 44mm x 29mm.
May 7, 2014. Two liver tumours surgically removed. Third of liver removed, and gall bladder. Am I NED?May 2014. Pathology of tumour shows it's now ER+ (95% staining).
June 2014. CA15-3 has decreased to 18 from a pre-surgery reading of 59!
June 2014. Started Femara, continue with Herceptin.
July 2014. Stop Femara due to severe Osteoporosis. Commence Tamoxifen, continue Herceptin. Waiting to hear if I can have Aclasta infusion.
August 2014. CA15-3 has decreased further to 12 - YAY!
October 2014. Aclasta infusion for Osteoporosis. November 2014, CA15-3 decreased to 11. Scans of liver all clear, something new showing up on lung, but just watching at the moment.
November 2015. Started SBRT on solitary lung met.
November 2015. Bone density scan showed very good improvement so back on Femara - yay!
December 2016. 6 treatments of SBRT radiation on lung. Seems to have had some effect.
June 2016. CA15-3 still stable and low at 9.
June 2016. Started subcutaneous Herceptin replacing infusion.
Jan 2017. LVEF dropped to 46%. Stopped Herceptin.
Feb 2017. Started ACE Inhibitor and BETA Blocker. Still off Herceptin.
Aug 2017. Two new mets - Portacaval lymph node and mediastinal lymph node.
Aug 2017. Blood tests show extremely elevated liver enzyme levels. Many tests to investigate.
Sept 2017. Portacaval lymph node blocking liver bile duct causing liver enzyme and Bilirubin problems.
Oct 2017. 8cm stent inserted into liver bile duct. Procedure caused pancreatitis, and hospitalised for 3 days. Liver enzymes improving rapidly.
Nov 2017. Commenced 4 weeks of radiation on Portacaval lymph node. 5 week break before chemo.
Jan 2018. CT scan. 11 new small liver mets, and new superclavical lymph node med.
Jan 2018. Start Kadcyla. CA15-3 426.
Apr 2018. First scans since starting Kadcyla. All tumours reducing. CA15-3 dropped to 30 from 426.
Dec 2019. Still on Kadcyla, but two small brain mets have been treated in the past month with SRS. CA15-3 stable for 12 months at 11.
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Old 06-01-2017, 12:43 AM   #7
Pamelamary
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Posts: 494
Re: Dose Finding Study of Subcutaneous Pertuzumab

Marie,
Your experience is interesting. My oncologist hasn't been keen on my moving to subcut Herceptin - maybe now I can guess why. She has spoken about the "one size fits all" dosage and hasn't been happy with the available data. Hope you can get back on Herceptin without the heart problems. It is a relatively easy regime, though when I think about being due for cycle 82, my eyes roll.
Best wishes..... Pam
__________________
Diagnosed 2004: Lumpectomy - 2 tumours, both grade 1 infiltrating duct carcinoma, about 12mm. ER+,
C-erbB-2 status 3+.
Clear margins, no nodal involvement.
Radiotherapy, i year Tamoxifen, 4 years Arimidex.
Rediagnosed 2012: Multiple bone metastases.
3/12: began on Marianne trial - T-DM1 + Pertuzamab/Placebo.
5/12:Unexpected development of numerous bilateral liver mets. Came off trial.
Started Docetaxol/ Herceptin + Zometa.
8/12:Bones stable +major regression in liver (!)
9/12:Can't take any more Docetaxol! Start on Herceptin and Tamoxifen. Cross fingers!
Changed to Denosumab.
11/12: Scan shows stable - yay!
11/13: Still stable :-) !!!
1/16: All stable, but lowered calcium, so switched to Zometa 3 monthly.
2/19: Happily still stable on Herceptin, Letrozole and 3 monthly Zometa.
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