#gyncsm Community: maintenance therapies

Showing posts with label maintenance therapies. Show all posts

Wednesday, November 11, 2020

Nov 11,2020 Chat - PARPS and You : How Do You and Your Doctor Decide?

We were so happy to host Drs. Laura Havrilesky (@LHavrilesky), Shelby Reed (@ShelbyDReed) and Laura Fish (@laurafish4) to discuss the development of a shared-decision making tool for maintenance PARP inhibitors for women diagnosed with ovarian cancer. We had thirty-one participants join the chat. You may find the analytics here and the transcript here. Resources may be found at the bottom of the post.

Here are some highlights from the chat.

T1A: How have you gotten information about PARP inhibitors? Have you seen advertisements (print, TV, social media)?

T1A: research online, SGO conference 2019
T1A: first heard about PARPi’s from a friend in the pharma industry who accompanied me to my first visit with Gyn Onc
T1: I've seen more and more mention of PARPs on cancer nonprofit twitter accounts. Seems like more and more studies are coming up and the science is moving faster.
I started visiting SHARE, OCRA, FORCE websites to learn more about PARPi’s. Then read the Phase III clinical trial reports

T1B: How do social media sources (including online patient communities) play a role in your information gathering about possible treatments?

T1B Although I am not on a PARP I see lots of support and info sharing in Facebook Groups, @smart_patients and @teaminspire
T1B: Occasional use of closed patient groups to assess drug side effects or successful strategies to handle side effects

T2: Are PARP inhibitors a better fit for certain women than others?

T2 PARP inhibitors are FDA-approved for treatment of women with ovarian cancer in different categories, based on what is going on with the cancer right now and the woman’s or cancer’s genetic test status. The table below lists them. 1/4
T2 - 3 big studies came out October 2019, showing that PARP inhibitors given as maintenance therapy after a response to frontline chemotherapy can give a woman with ovarian cancer 6 extra months on average until the cancer begins to grow again. 2/4
T2 Women with BRCA mutations OR genetic changes called HRD, can gain about a year of extra cancer-free time with a PARP inhibitor, while women not having any of these genetic changes in their tumor may gain no extra time at all or up to 3 extra months. 3 /4
T2 Genetic testing and tumor testing can find BRCA and other mutations such as HRD to help determine the likelihood that taking a PARP inhibitor will have a positive impact. 4/4

T3: What are the pros and cons of maintenance therapy with PARP inhibitors?

T3 Common side effects of PARP inhibitors are fatigue, nausea, and low blood counts such as low platelets and anemia. When taking a PARP inhibitor, a woman will need to be seen frequently at first to check the lab values and adjust doses. 1/2
T3 This image from a presentation of the PRIMA randomized trial at the 2019 ESMO conference shows the specific side effects of niraparib (green) compared to an inactive placebo (pink). 2/2

T3: Pros for me it was very tolerable and civilized cancer care with just a pill and few side effects. Cons: Didn't work (slowed growth didn't stop or reverse). Eyepopping Costs (covered by insurance luckily.
T3: I didn’t see any drawbacks for myself. Weighed risks/possible benefits from the published lit. Only possible problem was $$$COST$$$

T4: Is there anything you wish you had known earlier about PARP inhibitors?

T4: When I tried Naraparib it was still pretty early on and very new for approval for maintenance for BRCA wt. I knew it was less likely to work, but still disappointing - for me it was an easy and tolerable therapy. I think there is more clarity now on best use.

T5: How do out of pocket expenses play a role in decisions you make about taking a PARP inhibitor? (and you can continue w/ tweets about anything you wish you knew about PARPs)

T5 Even though PARP inhibitors cost over $12,000 per month, insurance companies or Medicare usually foot most or all of the bill. Some women have no out of pocket expense or a very small one. However some women have monthly co-pays of over $1,000.
T5 Here are links to PARP patient assistance sites: olaparib / Lynparza: https://www.lynparzahcp.com/ovarian-cancer/olaparib-patient-support.html niraparib /Zejula: https://www.zejula.com/en/financial-support rubraca/ rucaparib: https://www.rubraca.com/ovarian-cancer/ 2/2
T5: Big decision! Medicare women aren’t eligible for manufacturer-sponsored financial assistance. Makes things difficult
T5: My gynonc nurses helped by submitting to the drugmaker to cover some costs. It effectively covered my OOP max on my insurance, and I was not billed for my costs. Very helpful.

T6: Are you aware of the current @ASCO guidelines about PARP inhibitor maintenance therapy?

T6 ASCO recommends that all women with advanced stage ovarian cancer who have a good response to initial chemotherapy be offered PARP inhibitor maintenance therapy and make a shared decision with her provider.
T6 Here is a link to the full ASCO guidelines on PARP inhibitors in ovarian cancer. https://t.co/wfU3gqhkSB
Here is a summary of the PARPi in Management of #ovca @ASCO guideline

I wonder how that’ll make a difference in clinical practice. My gyn Onc (and others, according to their patients) don’t see much benefit for those not BRCA+ or HRD+ and don’t like to prescribe them to those patients
I agree there is a very important distinction here-see the replies to T2 below for different levels benefit. Thats where the "shared decision" comes in -I agree that PARPi are not right for everyone.
Need to think about how that changes Survivorship and how pts may best cope with idea of continuing therapy instead of feeling “done”. Reinforces how important it is to understand ovarian cancer survivorship of continuum of many on and off therapy

We are so grateful for all Drs. Laura Havrilesky, Shelby Reed and Laura Fish do for patients and we look forward to the end result of their project - a Shared Decision Making Tool for women considering PARPs as maintenance therapy.

You can continue this PARP discussion at an “Ask the Experts” session on the online patient community Smart Patients (@smart_patients) starting Thursday at 1pmET. http://smartpatients.com/ovarian-cancer .

Please join us for our next #gyncsm chat Wednesday, December 9, 2020 at 9pmET as we discuss The Needs of Young Adult Gyn Cancer patients (#ayacsm).

Happy Thanksgiving!

Stay safe and see you next month!

Dee

RESOURCES

Efficacy | ZEJULA (niraparib) https://t.co/f9iMWl8Oce

@FacingOurRisk Maintenance Therapy for Ovarian Cancer https://www.facingourrisk.org/info/risk-management-and-treatment/by-cancer-type/fallopian-ovarian-peritoneal/maintenance-therapy

PARPs Frontline Maintenance Therapy Transforms Advanced Ovarian Cancer With PARP Inhibitors https://www.onclive.com/view/frontline-maintenance-therapy-transforms-advanced-ovarian-cancer-with-parp-inhibitors

Using PARP Inhibitors in Frontline Maintenance Therapy for Ovarian Cancer https://www.cancernetwork.com/view/using-parp-inhibitors-in-frontline-maintenance-therapy-for-ovarian-cancer

@SGO_org Practice statement: Frontline PARP inhibitor maintenance therapy in ovarian cancer: A Society of Gynecologic Oncology practice statement https://www.gynecologiconcology-online.net/article/S0090-8258(20)33747-1/fulltext

Tuesday, October 20, 2020

PARPS and You : How Do You and Your Doctor Decide? November 11, 2020 Chat

Recently Drs. Laura Havrilesky, Shelby Reed and Laura Fish reached out to our #gyncsm Twitter community to discuss the development of a shared decision aid for use by women with ovarian cancer who are considering PARPs as maintenance therapy. The first step involves finding out what ovarian cancer patients know and think about PARPs. We love their focus on shared decision making and asking patients! So we have invited them to be our guests for our Wednesday, November 11, 2020, 9pmET #GynCSM Twitter Chat.

We invite Ovarian Cancer patients, survivors and advocates to join us for this special discussion as we cover the following topics:

T1: How have you gotten information about PARP inhibitors? Have you seen advertisements (print, TV, social media)? How do social media sources play a role in your information gathering about possible treatments?

T2: Are PARP inhibitors a better fit for certain women than others?

T3: What are the pros and cons of maintenance therapy with PARP inhibitors?

T4: Is there anything you wish you had known earlier about PARP inhibitors?

T5: How do out of pocket expenses play a role in decisions you make about taking a PARP inhibitor?

T6: Are you aware of the current ASCO guidelines about PARP inhibitor maintenance therapy?

We look forward to seeing you all on November 11th!

Dee and Christina

#GYNcsm Co-Founders

Wednesday, July 10, 2019

Maintenance Therapies for Gyn Cancers - July 2019 Chat

This month's chat was a new but important topic for us to discuss - Maintenance Therapies for Gyn Cancers. Thank you to all our Twitter friends who promoted and joined in this chat.

We had 19 participants, including patients who have been on maintenance, advocates and physicians. You may find more analytics here and the transcript here. As always a list of resources can be found at the bottom of this page.

T1: What are maintenance therapies and why are they used?

@theNCI def: maintenance therapy is given to help keep cancer from coming back after it has disappeared following the initial therapy. It may include treatment with drugs, vaccines, or antibodies that kill cancer cells, and it may be given for a long time.
A1 Maintenance therapies are additional chemotherapy given beyond the standard chemotherapy. The philosophy is based on treatment for hematologic cancers and is now used for some solid tumors. The hope is that the additional treatment will prevent or delay recurrences.
The goal of maintenance therapy is to prevent recurrence or increase the time to next therapy with less side effects than chemotherapy
The downside of maintenance therapy is that patients may experience toxicity and a decriment in quality of life while on a maintenance program. Neuropathy was the reason that Taxol maintenance did not become a standard of care after 2 clinical trials in ovarian cancer. Also the initial benefit seen in survival was no longer apparent after patients were followed for longer time periods

T2A: What evidence was there to approve Avastin (Bevacizumab) for maintenance?

T2B: How long is Bev given? What side effects may women experience with maintenance Bev? Is Bev limited to women with a BRCA mutation?

Numerous clinical trials from American and European consortiums have demonstrated benefit of bevacizumab in the maintenance setting in Gyn cancers. (Gog252)
FDA Approval was based on GOG-0218 a multicenter, randomized, double-blind, placebo-controlled, three-arm study w/ addition of bev to carbo Taxol for patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
A2B in the US trial bevacizumab was given as maintenance for 15 cycles 3 weeks apart. Although an initial survival benefit was seen this was not sustained with longer followup. A similar trial was conducted in Europe with similar results.
In the maintenance phase, bevacizumab can be given up to an extra year of treatment. It is still unclear whether we should be giving this longer as no clinical trials have administered the drug longer than this. I have a personally treated patients for many years.#gyncsm
A2B Bevacizumab is generally well tolerated - some patients may have high blood pressure or kidney problems. More severe side effects are rare but possible.
Bevacizumab as maintenance is another therapy available for select women with #ovariancancer. Recommendations must be personalized to a specific patient (getting the right drug to the right patient at the right time
For anyone with gyn #sarcoma: Bevacizumab (Avastin) failed in a study of women with uterine #leiomyosarcoma, but some doctors are considering other combinations with it.

T3A: PARP inhibitors were approved for recurrent ovarian cancer and now for maintenance therapy for women with the BRCA mutation. What study results led to the FDA approval?

T3B How long is PARP given during maintenance? What side effects may women experience?

You can get an overview of PARP inhibitors for maintenance therapy of ovarian cancer via @FacingOurRisk site https://t.co/DNA0tsgoeN
T3A One study used was phase III SOLO1 trial (NCT01844986) assessed maintenance olaparib/placebo treatment following first-line platinum-based chemotherapy
T3A Frontline maintenance olaparib treatment was approved by the FDA in December 2018 for BRCAm carriers
T3B: PARP truly can be used until progression, or side effects make the patients want to stop. Biggest SE I see are GI and heme (bone marrow). Some recent eye changes...which is a new one!
T3B the length of parp maintenance will depend on the clinical scenario (up front or recurrent) as well as the patient's tolerance to the medications
Clinical trials proves a 21 month progression free survival for each of the PARP inhibitors: olaparib, rucaparib
The treatment is generally given until either the disease progresses where the patient cannot tolerate side effect. The side effects are different among each of the agents but generally fall into the realms of low blood counts, fatigue, nausea, in general malaise.
Some women with gyn #leiomyosarcoma use #trabectedin (#Yondelis) as maintenance therapy. They and women with endometrial stromal #sarcoma may use hormone therapy. (I took an aromatase inhibitor for about 5 years.)

T4: Are maintenance drugs given for other gyn cancers? Cervical, endometrial, etc?

No maintenance strategies are currently approved for endometrial cancer but a trial evaluated carboplatin and paclitaxel for six cycles with and without trastuzumab in high-grade serous endometrial cancer with Her2/neu overexpression.The study demonstrated a significant improvement in PFS Time will tell if OS will also improve
T4: No maintenance for Endometrial or Cervical—Except in those with mutations that they can use Keytruda—which is “kinda of” a maintenance
Yes. Maintenance with bevacizumab is standard for cervical and endometrial cancers as well as ovarian/fallopian tube/primary peritoneal cancers.

T5: What questions should a patient ask when offered a maintenance therapy?

Am I a good candidate for maintenance therapy? Which maintenance therapy is best for my cancer? How will we know when is the right time to stop treatment?
Some I would ask include: what are the side effects of long term use of the treatment? Will I be able to use this again if I recur? How much is the cost? And will my insurance cover it?
Cost can be a real burden with maintenance therapies. Important to ask so that risks and benefits can be weighed.
Women with gyn #leiomyosarcoma should ask to see the evidence for aromatase inhibitors, not just accept anecdotal information. For example, the fact that I did it is not proof it worked.
At #ASCO19 @Atul_Gawande spoke on asking patients about THEIR goals. This is the key with maintenance—what does your patient want? What is their goal?

Some information shared in this chat on Maintenance therapies appeared in @ASCO Educational Book article titled Wanna Get Away? Maintenance Treatments and Chemotherapy Holidays in Gynecologic Cancers https://ascopubs.org/doi/full/10.1200/EDBK_238755

We hope you will join and spread the word about the all-cancer chat #CancerSM on Thursday July 11, 2019 at 8pmET on the Basics of Biomarker Testing with @TimAllenMDJD .

Be sure to mark your calendar and join us for next month's chat Wednesday, Aug 14th on Finding Balance: “Cancer Life” vs. “Real Life”.

Dee
#gyncsm Co-founder

RESOURCES

Wanna Get Away? Maintenance Treatments and Chemotherapy Holidays in Gynecologic Cancers https://ascopubs.org/doi/full/10.1200/EDBK_238755

FORCE @FacingOurRisk site https://www.facingourrisk.org/understanding-brca-and-hboc/information/cancertreatment/ovarian-treatment/basics/maintenance-therapy-ovarian-cancer.php

NCCN updates from annual conference AJMC re: bev and parps https://www.ajmc.com/conferences/nccn-2019/nccn-ovarian-cancer-guidelines-add-options-for-parp-inhibitors-bevacizumab

Cost of maintenance therapies https://pharmaintelligence.informa.com/resources/product-content/how-ovarian-cancer-maintenance-therapies-stack-up-on-costs-and-value

Sunday, July 7, 2019

July 10, 2019 Maintenance Therapies for Gyn Cancers

Over the past few years the approval of maintenance therapies in gynecologic cancers have increased. The recent ASCO Annual meeting held a full session titled Wanna Get Away - Maintenance Treatments and Chemo Holidays in Gyn Cancers which included maintenance therapies for women diagnosed with gynecologic cancers. Women with High Grade Serous Ovarian Cancer (HGSOC) may choose to use Bevacizumab or PARP inhibitors as maintenance therapies. Women with Low Grade Serous Ovarian Cancer (LGSOC) may be offered hormonal treatment. Research into using maintenance therapies with endometrial and other gyn cancers continues.

On Wednesday, July 10, 2019 at 9pm ET (8pmCT, 6pmPT) join the #gyncsm community as we discuss the use of maintenance therapies for gyn cancers. Learn what treatments are available for your gyn cancer and what questions you should ask when considering maintenance therapy.

Chat topic Questions:
T1: What are maintenance therapies and why are they used?