Some thoughts....

 

Today is the last day of the year, and what a difficult year it has been. Although our retreat was held virtually, it proved yet again, to be of enormous benefit for all who attended. As one woman said, "I feel like the cowardly lion who had courage but did not know it.You all made me see that I can do this."

The bonds that are created are deep, powerful, and restorative. Being with other women who have gone through what you are experiencing, whose very presence can feel like a lifeline, is the gift that we give each other. 

When I was first diagnosed with Stage 3C ovarian cancer in 2015, I never imagined that a retreat existed.  I was just a few months out of treatment when I attended. I was excited to go but also nervous because I wouldn't know anyone there. And really, who isn't at least a little shy about spending time with a bunch of strangers? Yet, I have never been made to feel so welcome, and when the time came to leave I knew that I had been given an incredible gift. One new attendee this year best summed up the experience, "I am now part of a community of wise, compassionate women." And so for all of us out there, may 2021 bring us the courage, wisdom and compassion we need to meet whatever challenges the new year brings.

Ovarian cancer treatment options: Mayo Clinic Radio

People Who Are Immune-Suppressed and Get COVID-19 May Carry the Virus for More than Two Months

This headline appeared in today's SurvivorNet headline and was written by Sonya Collins. Given that many are in treatment, this article should be of interest.  

People who have COVID-19 after immune-compromising cancer treatments may carry the virus longer than others — and longer than previously believed. According to data on a small group of patients, published this week in the New England Journal of Medicine, this type of patient may shed detectable virus for up to two months after infection. This could mean that these patients continue to be contagious during that time. The new study underscores the fact that COVID-19 is still a relatively new virus and researchers continue to learn more about it every day.

“The data in this study, while small, suggests that isolation of immunocompromised cancer patients positive for COVID-19 may need to be longer than currently recommended given that we show that they can shed live virus for up to 60 days,” Esther Babady, PhD, tells SurvivorNet. Babady, a microbiologist and director of Clinical Microbiology at Memorial Sloan Kettering Cancer Center, co-authored the study.

Immunocompromised Patients with COVID-19 May Be Contagious Longer

For the study, researchers tracked 20 immunocompromised cancer patients who tested positive for COVID-19. They took repeated nasal swabs from the group. Out of the 20 patients, three continued to shed detectable virus for 25 days or more. One of those three was still shedding virus at 61 days.

But how could the virus stick around for so long in immunocompromised people?

“The immune system of these patients is not functioning at full force because of either their disease or their treatment, which results in an inability of the body to clear the virus,” Babady says.

What If You’re on Immune-Suppressing Cancer Treatments?

Current CDC guidelines say that immunocompromised people are not likely to be contagious for more than 20 days after their symptoms start. But this study suggests that it’s possible.

If you are receiving immune-suppressing treatments for cancer, these study results underscore the importance of avoiding COVID-19 in the first place. Follow all federal guidelines, which include wearing a mask in public, avoiding large gatherings or crowds, staying six feet away from others, and washing your hands frequently.

Gynecologic Cancer Education: Genetics & Ovarian Cancer

Free Support Sessions for Women w/OC and their Caregivers from The Clearity Foundation

Those who follow this website know that I have written several times about The Clearity Foundation a wonderful organization on the West Coast. Yesterday in our Zoom meeting, some women started talking about the free counseling sessions offered - and then I got this email from the organization.  Several of our members have used their support services and have spoken very highly of it. In fact, Donna mentioned yesterday that one of the counsellors will be a guest speaker at the Beth C. Wright Cancer Institute (Zoom) Conference next week. 

Because I wasn't able to upload this brochure in the normal way, none of the links below will probably function but you can reach the site by following this link; other contact options are: counselor@stepsthrough.org or 1.866.830.5134 (toll free).

Register Now: Virtual Ovarian Cancer Support Do you know a woman with ovarian cancer who could benefit from our Steps Through OC program? Our services are available, at no charge, to women with ovarian cancer and their caregivers: Ten sessions of professional support over the course of six months Meetings by telephone or videoconference to any location in the U.S. Educational content, resources and referrals. As we continue to manage life with COVID-19, the support from Steps Through OC Counselors is as critical as ever, including: providing support in making difficult decisions, dealing with unpredictable emotions, handling the isolation of social distancing and managing uncertainty and stress. Steps Through OC is effective. Nearly 90% of participants felt that Steps Through OC helped them make progress toward meeting their personal goals.  Steps Through OC is open to all women and active caregivers managing an ovarian cancer diagnosis, at no charge. To register for the Steps Through OC program, please complete our secure and privacy-protected online  Self-Registration Form. If you have questions, please contact us directly at: counselor@stepsthrough.org or call (866) 830-5134. The Clearity Foundation strives to improve the survival and quality of life of women with ovarian cancer. We are dedicated to providing hope to women and their families. Learn more about Clearity's services at www.clearityfoundation.org. The Clearity Foundation | Steps Through OC Program www.clearityfoundation.org Copyright © 2020 The Clearity Foundation  ‌  ‌  ‌

Low-Grade Serous Ovarian Cancer

EMA Recommends Approval of Olaparib/Bevacizumab for Frontline Maintenance in HRD+ Advanced Ovarian Cancer

 This article is reprinted from OncLive. 

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for olaparib as maintenance treatment in adult patients with advanced, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response after first-line platinum-based chemotherapy plus bevacizumab and whose disease has homologous recombination deficiency positivity defined by either a BRCA1/2 mutation and/or genomic instability.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for olaparib (Lynparza) as maintenance treatment in adult patients with advanced, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response after first-line platinum-based chemotherapy plus bevacizumab (Avastin) and whose disease has homologous recombination deficiency (HRD) positivity defined by either a BRCA1/2 mutation and/or genomic instability.¹

 The recommendation for approval was based on data from a biomarker subgroup analysis of the phase 3 PAOLA-1 trial (NCT02477644), which had been published in the New England Journal of Medicine.² Results from the trial showed that the addition of olaparib to bevacizumab maintenance treatment resulted in a 67% reduction in the risk of disease progression or death (HR, 0.33; 95% CI, 0.25-0.45) in patients with HRD-positive tumors, including those that harbored a BRCA mutation.³ 

In this subgroup, the median progression-free survival (PFS) with olaparib/bevacizumab was 37.2 months versus 17.7 months with bevacizumab alone. For those with HRD positivity who did not harbor a BRCAmutation, the median PFS with the olaparib combination was 28.1 months versus 16.6 months with bevacizumab alone (HR, 0.43; 95% CI, 0.28-0.66). 

 
“Half of all patients with advanced ovarian cancer have HRD-positive tumors. [Olaparib] together with bevacizumab has demonstrated a median PFS benefit of more than 3 years versus 17.7 months with bevacizumab alone, offering new hope for women in this setting,” José Baselga, MD, PhD, stated in a press release. “This recommendation is a vital step toward addressing a large and critical unmet need and could bring a new treatment option that significantly delays relapse in this difficult-to-treat disease.”
 

The double-blind, placebo-controlled, phase 3 PAOLA-1 trial enrolled patients with newly diagnosed, advanced, FIGO stage III to IV, high-grade, serous or endometrioid ovarian, fallopian tube, or peritoneal cancer who had achieved a complete response (CR) or partial response (PR) to frontline platinum-based chemotherapy and bevacizumab, irrespective of genetic biomarker status or outcome before surgery. 

 
Participants were randomized in a 2:1 fashion to received either olaparib/bevacizumab (n = 537) or bevacizumab/placebo (n = 269) for frontline maintenance treatment. Bevacizumab was given at a dose of 15 mg/kg every 3 weeks on day 1 of the treatment cycle. In the experimental arm, olaparib was administered at a dose of 300 mg twice daily.
 

The primary end point of the trial was investigator-assessed PFS, while key secondary end points included PFS2, overall survival, time until first subsequent therapy or death, and global health status–quality of life dimension of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire.
 

With regard to safety, the most common toxicities reported in 20% or more patients in the investigational and control arms, respectively, included fatigue (53% vs 32%), nausea (53% vs 22%), hypertension (46% vs 60%), anemia (41% vs 10%), lymphopenia (24% vs 9%), vomiting (22% vs 11%), and arthralgia (22% vs 24%).

Updated results from the trial were presented during the 2020 ESMO Virtual Congress on response rates for patients with evidence of disease per RECIST criteria and/or CA-125 criteria at study entry. Here, the ORRs per RECIST criteria were 30% with olaparib/bevacizumab versus 25% with bevacizumab alone in the overall population.⁴ 
 

When broken down by subgroup, those with BRCA mutations (n = 47) experienced ORRs of 64% with the combination versus 42% with bevacizumab alone; 53% versus 31%, respectively in those with HRD positivity including BRCA mutations (n = 81), 32% versus 21% for those with HRD positivity without BRCA mutations (n = 33), and 13% versus 15% in those with HRD negativity (n = 83). 

 Moreover, the CA-125 response rate in the overall population with olaparib/bevacizumab was 36% versus 29% with bevacizumab alone. When broken down by subgroup, the CA-125 response rates with the combination in BRCA-positive patients was 83% versus 60% with bevacizumab alone; 70% versus 63%, respectively in those with HRD positivity, 50% versus 67% in those with HRD positivity and BRCA negativity, and 20% versus 0% in those with HRD negativity. 

In May 2020, the FDA approved olaparib in combination with bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to frontline platinum-based chemotherapy based on findings from PAOLA-1. 

Previously, in December 2018, the FDA approved olaparib for use as a maintenance treatment in patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in CR or PR to frontline platinum-based chemotherapy based on data from the phase 3 SOLO-1 trial.  

References:

1. Lynparza (olaparib) recommended for approval in EU by CHMP as first-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer. News release. AstraZeneca and Merck. September 21, 2020. Accessed September 21, 2020. https://bit.ly/3mGlFNd.
2. Ray-Coquard I, Pautier P, Pignata S, et al. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med. 2019;381(25):2416-2428. doi:10.1056/NEJMoa1911361
3. LYNPARZA (olaparib) approved by FDA as first-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer. News release. FDA. https://bit.ly/3cft3tu. May 8, 2020. Accessed September 21, 2020.
4. Colombo N, Gantzer J, Ataseven B, et al. Maintenance olaparib + bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: RECIST and/or CA-125 objective response rate in the phase III PAOLA-1 trial. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020; Virtual. Abstract 812M0.