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Opting out of radiation or chemo
Breast Cancer | Last Active: Dec 31, 2023 | Replies (98)Comment receiving replies
@anjalima Well, here is one with exemestane (I omitted some of the technical details), but another with Letrozole from some time ago I am trying to 'refind' (lost in my files!). I wrote a Dr who did a similar study (not yet published) with the same AI and he thought results would be similar for Arimidex, although arimidex is different from exemestane, a steroidal. Again, not all might agree with this...
On other issue, I know a woman with early stage bc who is in a clinical trial here in Canada to test whether 2 yrs on an AI is as good as 5 yrs...food for thought!
JAMA Oncol
. 2023 Mar 23;e230089. doi: 10.1001/jamaoncol.2023.0089. Online ahead of print.
Efficacy of Alternative Dose Regimens of Exemestane in Postmenopausal Women With Stage 0 to II Estrogen Receptor-Positive Breast Cancer: A Randomized Clinical Trial
Davide Serrano et al
PMID: 36951827 PMCID: PMC10037202 (available on 2024-03-23) DOI: 10.1001/jamaoncol.2023.0089
Abstract
Importance: Successful therapeutic cancer prevention requires definition of the minimal effective dose. Aromatase inhibitors decrease breast cancer incidence in high-risk women, but use in prevention and compliance in adjuvant settings are hampered by adverse events.
Objective: To compare the noninferiority percentage change of estradiol in postmenopausal women with estrogen receptor-positive breast cancer given exemestane, 25 mg, 3 times weekly or once weekly vs a standard daily dose with a noninferiority margin of -6%.
Design, setting, and participants: This multicenter, presurgical, double-blind phase 2b randomized clinical trial evaluated 2 alternative dosing schedules of exemestane. Postmenopausal women with estrogen receptor-positive breast cancer who were candidates for breast surgery were screened from February 1, 2017, to August 31, 2019. Blood samples were collected at baseline and final visit; tissue biomarker changes were assessed from diagnostic biopsy and surgical specimen. Biomarkers were measured in different laboratories between April 2020 and December 2021.
Interventions: Exemestane, 25 mg, once daily, 3 times weekly, or once weekly for 4 to 6 weeks before surgery.
Results: A total of 180 women were randomized into 1 of the 3 arms; median (IQR) age was 66 (60-71) years, 63 (60-69) years, and 65 (61-70) years in the once-daily, 3-times-weekly, and once-weekly arms, respectively. ... Sex hormone-binding globulin and high-density lipoprotein cholesterol had a better profile among participants in the 3-times-weekly arm compared with once-daily arm. Adverse events were similar in all arms.
Conclusions and relevance: In this randomized clinical trial, exemestane, 25 mg, given 3 times weekly in compliant patients was noninferior to the once-daily dosage in decreasing serum estradiol. This new schedule should be further studied in prevention studies and in women who do not tolerate the daily dose in the adjuvant setting.
Replies to "@anjalima Well, here is one with exemestane (I omitted some of the technical details), but another..."
Thank you! Interesting!
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@anjalima OK, here's the Letrozole one:
Double-blind, Randomized Trial of Alternative Letrozole Dosing Regimens in Postmenopausal Women with Increased Breast Cancer Risk
Cancer Prev Res (Phila). 2016 February ; 9(2): 142–148. doi:10.1158/1940-6207.CAPR-15-0322.
Ana Maria López et al
Abstract
Aromatase inhibitors (AIs) profoundly suppress estrogen levels in postmenopausal women and are effective in breast cancer prevention among high-risk postmenopausal women. Unfortunately, AI treatment is associated with undesirable side effects that limit patient acceptance for primary prevention of breast cancer. A double-blind, randomized trial was conducted to determine whether low and intermittent doses of letrozole can achieve effective estrogen suppression with a more favorable side effect profile. Overall, 112 postmenopausal women at increased risk for breast cancer were randomized to receive letrozole at 2.5 mg once daily (QD, standard dose arm), 2.5 mg every Monday, Wednesday, and Friday (Q-MWF), 1.0 mg Q-MWF or 0.25 mg Q-MWF for 24 weeks. Primary endpoint was suppression in serum estradiol levels at the end of letrozole intervention. Secondary endpoints included changes in serum estrone, testosterone, C-telopeptide (marker of bone resorption), lipid profile and quality of life measures (QoL) following treatment. Significant estrogen suppression was observed in all dose arms with an average of 75 – 78% and 86 – 93% reduction in serum estradiol and estrone levels, respectively. There were no differences among dose arms with respect to changes in C-telopeptide levels, lipid profile, adverse events (AEs) or QoL measures. We conclude that low and intermittent doses of letrozole are not inferior to standard dose in estrogen suppression and resulted in a similar side effect profile compared to standard dose. Further studies are needed to determine the feasibility of selecting an effective AI dosing schedule with better tolerability.