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  • Good News: Daily Oral Orgovyx Instead of Lupron, Etc.!

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    Old 01-07-2021, 12:23 PM   #1
    IADT3since2000
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    Lightbulb Good News: Daily Oral Orgovyx Instead of Lupron, Etc.!

    Here is some really good news: very recently (December 18) the FDA approved a fairly similar daily oral form of Lupron, Orgovyx® (relugolix), from Myovant Sciences. Here is a link to the FDA's announcement: https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-hormone-therapy-treating-advanced-prostate-cancer .

    Actually, Orgovyx is an LHRH-antagonist, as is degarelix, rather than an LHRH-agonist like Lupron and similar drugs, but the effects of the two sister classes of drugs are highly similar, with the significant exception that the "flare" phenomenon (brief surge in testosterone) does not occur with the antagonists and therefore does not need to be countered.

    Here is a link to the FDA statement of advice to doctors for Orgovyx: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214621s000lbl.pdf . I have looked at this PDF and it seems to me, as a long time veteran (December 1999-April 2014, intermittently) of androgen deprivation therapy (ADT, aka hormonal therapy) that the side effects of Orgovyx are remarkably similar to those of Lupron type drugs (but without the butt or stomach muscle injection area soreness, of course).

    I am also really impressed with its effectiveness in reducing testosterone: Table 4 in the FDA guide to physicians is a comparison to testosterone suppression between Orgovyx and Lupron; to me, the part of the table on the right, which addresses reduction of testosterone to < (less than) 20 ng/dL is really important! While many doctors consider adequate testosterone to be below 50 ng/dL, I, following the lead of doctors I consider experts, believe that testosterone should be < 20 ng/dL. Table 4 shows that Orgovyx reduced testosterone to < 20 ng/dL in 95% of the cases by Day 29 compared to a reduction in only 57% of the cases for Lupron, and, it reduced it more rapidly - less fuel for the cancer, and less fuel sooner than with Lupron!

    I suspect that one reason for the longer term superior performance of Orgoyvix in the trial is that, unlike Lupron, the dose is steady each day, rather than being higher at the beginning and then tailing off a bit before the next shot. Also, some men clear Lupron much more quickly than other men, meaning that there is a gap in the drug's dose before the next shot; that would not happen with daily dosing. There is also a calendar and convenience aspect: Lupron requires a visit to the doctor, and there may be a delay due to practical realities of getting an appointment that works for both the patient and doctor. It is likely that the impact of minor gaps would be minor against the cancer, in my layman's opinion.

    I am also thinking that there is an argument for using Orgovyx instead of degarelix, a fellow LHRH-antagonist drug that reduces testosterone more quickly, more deeply, and more safely (meaning no testosterone/PSA "flare") than Lupron. The major limitation of degarelix, to my patient's way of thinking, is that injection (into stomach muscle) is really painful, unless done with proper precautions: icing, slow administration, etc. It looks to me as if Orgovyx may reduce testosterone about as quickly and deeply as degarelix, though I have not looked at the specific data.

    It makes sense to me that patients whose doctors are prescribing Lupron, or a similar drug for them, should ask about Orgovyx. If the doctor is opposed, I would want to have a good reason. (One reason might be dementia, where the patient lacks the mental discipline to reliably take the drug every day.) Perhaps there are other reasons that will come to mind for others of us on the Board. I would really like to know what doctors are saying, and often the makers of the long existing drugs will be motivated to push back in order to protect market share. But at the moment, this looks like a really nice advance and preferable way to go!

    ….Jim

    - - - - - - - - - - - - - - - - - - - - - - - -
    21 years as a survivor. Doing well. Diagnosis Dec 1999 PSA 113.6 (first ever), age 56
    Gleason 4+3=7 (J. Epstein, JHU), all cores +, most 100%; "rock hard" prostate with ECE - stage 3, PNI, PSADT determined later 3-4 months; technetium bone scan and CT scan negative; prognosis 5 years.
    Later ProstaScint scan negative except for one suspicious small area in an unlikely location. ADT Lupron as first therapy, in Dec 1999, then + Casodex in March 2000, then + Proscar and Fosamax in Sep 2000. Rejected for surgery January 2000; offered radiation but told success odds were low; switched to ADT only vice radiation in May 2000, betting on holding the fort for improved technology; PSA gradual decline to <0.01 May 2002. Commenced intermittent ADT3 (IADT3) with first vacation from Lupron & Casodex. Negative advanced scans in 2011 (NaF18 PET/CT for bone) and 2012 (Feraheme USPIO for nodes and soft tissue). With improved technology, tried TomoTherapy RT, 39 sessions, in early 2013, plus ADT 3 in support for 18 months (fourth round of IADT3), ended April 2014. Continuing with Avodart as anti-recurrence shield. Current PSA remarkably low and stable at <0.01; apparently cured (Current PSA as of 12/2/2020). (Current T 93 12/2/2020.) Supportive diet/nutrition, exercise, supportive medications during this journey, as well as switches in antiandrogen, 5-ARI, and bone drugs. Barely noticeable side effects from radiation; continuing low T, likely do to long use of ADT, but good energy and adequate strength. I have a lot of School of Hard Knocks knowledge, and have followed research, which has made me an empowered and savvy patient, but I have had no enrolled medical education. What I experienced is not a guarantee for all but shows what is possible.

     
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    Old 01-07-2021, 03:11 PM   #2
    JWPMP
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    Re: Good News: Daily Oral Orgovyx Instead of Lupron, Etc.!

    Do you know how this new drug interacts with Abiraterone?
    Jim is scheduled to start that two weeks after his Lupron injection.

    Thank you
    Paula

     
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    Old 01-07-2021, 06:03 PM   #3
    IADT3since2000
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    Re: Good News: Daily Oral Orgovyx Instead of Lupron, Etc.!

    That's a good question for the doctor.

    I'm thinking, as a layman, that there would probably be no problem because there is no problem with other LHRH-agonist (like Lupron) and LHRH-antagonist drugs, but I really haven't heard any experts talk about this, write about this, and I could not find any research papers that addressed that combo.

    I'll bet doctors will be asking the same question. It's understandable that a doctor might not want to be the first to put this to the test, but I hope that some will and that it will work out fine. The trial was done with patients who had advanced cases, so something may already be known about combinations with abiraterone acetate and the advanced anti-androgens like enzalutamide.

    ….Jim

    - - - - - - - - - - - - - - - - - - - - - - - -
    21 years as a survivor. Doing well. Diagnosis Dec 1999 PSA 113.6 (first ever), age 56
    Gleason 4+3=7 (J. Epstein, JHU), all cores +, most 100%; "rock hard" prostate with ECE - stage 3, PNI, PSADT determined later 3-4 months; technetium bone scan and CT scan negative; prognosis 5 years.
    Later ProstaScint scan negative except for one suspicious small area in an unlikely location. ADT Lupron as first therapy, in Dec 1999, then + Casodex in March 2000, then + Proscar and Fosamax in Sep 2000. Rejected for surgery January 2000; offered radiation but told success odds were low; switched to ADT only vice radiation in May 2000, betting on holding the fort for improved technology; PSA gradual decline to <0.01 May 2002. Commenced intermittent ADT3 (IADT3) with first vacation from Lupron & Casodex. Negative advanced scans in 2011 (NaF18 PET/CT for bone) and 2012 (Feraheme USPIO for nodes and soft tissue). With improved technology, tried TomoTherapy RT, 39 sessions, in early 2013, plus ADT 3 in support for 18 months (fourth round of IADT3), ended April 2014. Continuing with Avodart as anti-recurrence shield. Current PSA remarkably low and stable at <0.01; apparently cured (Current PSA as of 12/2/2020). (Current T 93 12/2/2020.) Supportive diet/nutrition, exercise, supportive medications during this journey, as well as switches in antiandrogen, 5-ARI, and bone drugs. Barely noticeable side effects from radiation; continuing low T, likely do to long use of ADT, but good energy and adequate strength. I have a lot of School of Hard Knocks knowledge, and have followed research, which has made me an empowered and savvy patient, but I have had no enrolled medical education. What I experienced is not a guarantee for all but shows what is possible.

     
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    Old 01-07-2021, 06:10 PM   #4
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    Re: Good News: Daily Oral Orgovyx Instead of Lupron, Etc.!

    Thank you Jim.
    I am definitely asking her about this.
    Appreciate your time.
    Paula

     
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    Old 01-08-2021, 08:40 PM   #5
    JWPMP
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    Re: Good News: Daily Oral Orgovyx Instead of Lupron, Etc.!

    Quote:
    Originally Posted by IADT3since2000 View Post
    That's a good question for the doctor.

    I'm thinking, as a layman, that there would probably be no problem because there is no problem with other LHRH-agonist (like Lupron) and LHRH-antagonist drugs, but I really haven't heard any experts talk about this, write about this, and I could not find any research papers that addressed that combo.

    I'll bet doctors will be asking the same question. It's understandable that a doctor might not want to be the first to put this to the test, but I hope that some will and that it will work out fine. The trial was done with patients who had advanced cases, so something may already be known about combinations with abiraterone acetate and the advanced anti-androgens like enzalutamide.

    ….Jim

    - - - - - - - - - - - - - - - - - - - - - - - -
    21 years as a survivor. Doing well. Diagnosis Dec 1999 PSA 113.6 (first ever), age 56
    Gleason 4+3=7 (J. Epstein, JHU), all cores +, most 100%; "rock hard" prostate with ECE - stage 3, PNI, PSADT determined later 3-4 months; technetium bone scan and CT scan negative; prognosis 5 years.
    Later ProstaScint scan negative except for one suspicious small area in an unlikely location. ADT Lupron as first therapy, in Dec 1999, then + Casodex in March 2000, then + Proscar and Fosamax in Sep 2000. Rejected for surgery January 2000; offered radiation but told success odds were low; switched to ADT only vice radiation in May 2000, betting on holding the fort for improved technology; PSA gradual decline to <0.01 May 2002. Commenced intermittent ADT3 (IADT3) with first vacation from Lupron & Casodex. Negative advanced scans in 2011 (NaF18 PET/CT for bone) and 2012 (Feraheme USPIO for nodes and soft tissue). With improved technology, tried TomoTherapy RT, 39 sessions, in early 2013, plus ADT 3 in support for 18 months (fourth round of IADT3), ended April 2014. Continuing with Avodart as anti-recurrence shield. Current PSA remarkably low and stable at <0.01; apparently cured (Current PSA as of 12/2/2020). (Current T 93 12/2/2020.) Supportive diet/nutrition, exercise, supportive medications during this journey, as well as switches in antiandrogen, 5-ARI, and bone drugs. Barely noticeable side effects from radiation; continuing low T, likely do to long use of ADT, but good energy and adequate strength. I have a lot of School of Hard Knocks knowledge, and have followed research, which has made me an empowered and savvy patient, but I have had no enrolled medical education. What I experienced is not a guarantee for all but shows what is possible.
    Dr Borno just messaged.
    She said she will prescribe it for patients that are on hormone injections only, not patients on an oral regimen also.
    She said that they don't know enough about the interaction with the other meds, like Abiraterone and prednisone. Of course she was much more eloquent than I'm repeating lol.
    Paula

     
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    Old 01-09-2021, 08:35 AM   #6
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    Re: Good News: Daily Oral Orgovyx Instead of Lupron, Etc.!

    Thanks for relaying Dr. Borno's view. It makes sense at this point - kind of what I expected.

    I'm hoping the interactions issue will get resolved pretty soon, and I expect that it will be. I, as a savvy layman but with no enrolled medical education, believe there should be no problem switching from a Lupron or degarelix type drug to the new oral drug.

    ….Jim

    - - - - - - - - - - - - - - - - - - - - - - - -
    21 years as a survivor. Doing well. Diagnosis Dec 1999 PSA 113.6 (first ever), age 56
    Gleason 4+3=7 (J. Epstein, JHU), all cores +, most 100%; "rock hard" prostate with ECE - stage 3, PNI, PSADT determined later 3-4 months; technetium bone scan and CT scan negative; prognosis 5 years.
    Later ProstaScint scan negative except for one suspicious small area in an unlikely location. ADT Lupron as first therapy, in Dec 1999, then + Casodex in March 2000, then + Proscar and Fosamax in Sep 2000. Rejected for surgery January 2000; offered radiation but told success odds were low; switched to ADT only vice radiation in May 2000, betting on holding the fort for improved technology; PSA gradual decline to <0.01 May 2002. Commenced intermittent ADT3 (IADT3) with first vacation from Lupron & Casodex. Negative advanced scans in 2011 (NaF18 PET/CT for bone) and 2012 (Feraheme USPIO for nodes and soft tissue). With improved technology, tried TomoTherapy RT, 39 sessions, in early 2013, plus ADT 3 in support for 18 months (fourth round of IADT3), ended April 2014. Continuing with Avodart as anti-recurrence shield. Current PSA remarkably low and stable at <0.01; apparently cured (Current PSA as of 12/2/2020). (Current T 93 12/2/2020.) Supportive diet/nutrition, exercise, supportive medications during this journey, as well as switches in antiandrogen, 5-ARI, and bone drugs. Barely noticeable side effects from radiation; continuing low T, likely do to long use of ADT, but good energy and adequate strength. I have a lot of School of Hard Knocks knowledge, and have followed research, which has made me an empowered and savvy patient, but I have had no enrolled medical education. What I experienced is not a guarantee for all but shows what is possible.

     
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    Old 01-09-2021, 09:19 AM   #7
    JWPMP
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    Re: Good News: Daily Oral Orgovyx Instead of Lupron, Etc.!

    Quote:
    Originally Posted by IADT3since2000 View Post
    Thanks for relaying Dr. Borno's view. It makes sense at this point - kind of what I expected.

    I'm hoping the interactions issue will get resolved pretty soon, and I expect that it will be. I, as a savvy layman but with no enrolled medical education, believe there should be no problem switching from a Lupron or degarelix type drug to the new oral drug.

    ….Jim

    - - - - - - - - - - - - - - - - - - - - - - - -
    21 years as a survivor. Doing well. Diagnosis Dec 1999 PSA 113.6 (first ever), age 56
    Gleason 4+3=7 (J. Epstein, JHU), all cores +, most 100%; "rock hard" prostate with ECE - stage 3, PNI, PSADT determined later 3-4 months; technetium bone scan and CT scan negative; prognosis 5 years.
    Later ProstaScint scan negative except for one suspicious small area in an unlikely location. ADT Lupron as first therapy, in Dec 1999, then + Casodex in March 2000, then + Proscar and Fosamax in Sep 2000. Rejected for surgery January 2000; offered radiation but told success odds were low; switched to ADT only vice radiation in May 2000, betting on holding the fort for improved technology; PSA gradual decline to <0.01 May 2002. Commenced intermittent ADT3 (IADT3) with first vacation from Lupron & Casodex. Negative advanced scans in 2011 (NaF18 PET/CT for bone) and 2012 (Feraheme USPIO for nodes and soft tissue). With improved technology, tried TomoTherapy RT, 39 sessions, in early 2013, plus ADT 3 in support for 18 months (fourth round of IADT3), ended April 2014. Continuing with Avodart as anti-recurrence shield. Current PSA remarkably low and stable at <0.01; apparently cured (Current PSA as of 12/2/2020). (Current T 93 12/2/2020.) Supportive diet/nutrition, exercise, supportive medications during this journey, as well as switches in antiandrogen, 5-ARI, and bone drugs. Barely noticeable side effects from radiation; continuing low T, likely do to long use of ADT, but good energy and adequate strength. I have a lot of School of Hard Knocks knowledge, and have followed research, which has made me an empowered and savvy patient, but I have had no enrolled medical education. What I experienced is not a guarantee for all but shows what is possible.
    Seems to me (with no medical background whatsoever) that if Lupron doesn't interact, this new drug shouldn't either.
    They may be other doctors less hesitant.
    Thanks again Jim
    Paula

     
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