Cost of Tamoxifen vs Aromatase Inhibitors
They work by inhibiting the action of aromatase, which converts androgens into oestrogens (testosterone into estradiol and androstenedione into oestrone) 9. Median TTNT in our study was 22.5months, an endpoint not explored in PALOMA-2 neither in previous real-world studies. The overlapping value with PFS is reassuring of the consistency of these findings and supports the label indication of the use of palbociclib until disease progression. A lower median TPF was observed, 19.8 months, roughly 6 months less than reported by Wilkie et al. 16, which may reflect treatment discontinuation due to toxicity.
- By the cut-off date, a total of 91 patients had discontinued palbociclib from any cause.
- There is not sufficient evidence to state that red wine is a safe, effective treatment for breast cancer in postmenopausal women or that it is a safe and effective chemopreventive dietary product in humans 38.
- Both of the trials did not show statistically significant differences in DFS between AI alone group and tamoxifen sequenced with an AI group as well as an AI sequenced with tamoxifen group in BIG 1–98.
- The lowest costs found using coupons or prescription-assistance programs are also listed.
However, we could address this potential limitation by conducting a deterministic sensitivity analysis for the variables of uncertainty. This is because the model was based on costs retrieved from a Qatari hospital and analyzed to a WTP from a Qatari perspective. It is noteworthy to mention that while generalizability is a general limitation for all health economics analyses, Qatar economic system differs from many countries in the world in terms of the GDP. While the current average worldwide GDP is about 12,703 USD per capita, the GDP in Qatar reaches to USD 87,661 per capita (40). As discussed earlier, this has affected the WTP to which the cost-effectiveness was evaluated. Therefore, only countries with relatively similar GDP per capita can generalize the current findings of the study to their content.
The main flavonols include 3,3’,4’,5,5’7-hexahydroxyflavone (myricetin) and 3,3’,4’,5,7-pentahydroxyflavone (quercetin). Myricetin is anticarcinogenic https://recruitme.io/stacking-vs-solo-use-of-steroids-which-strategy-is/ and antioxidant 16 and has been shown to reduce cancer development in mice 17. Resveratrol, a prominent constituent in red wine, has been implicated as an aromatase inhibitor. Structurally similar to estrogen, resveratrol has agonist and antagonist activity at resveratrol receptors 18. Prevention strategies for EIA have not been well studied and remain a therapeutic issue for patients with BC (Freites-Martinez et al., 2018; Karatas et al., 2016). Preventative treatment with topical 5-alpha reductase inhibitors and nutritional supplements (i.e., vitamin C, omega-3 fatty acids) for EIA have shown promise and do not appear to adversely affect BC prognosis (Karatas et al., 2016).
Extended data figures and tables
CDK4/6 inhibitors are the first-line treatment for HR+/HER2- advanced breast cancer. To date, there is no thorough comparison among the three approved CDK4/6 inhibitors in terms of their cost-effectiveness. According to a five-year study involving 3,862 postmenopausal women at high risk of breast cancer, the daily use of Arimidex reduced the cancer risk by 53% with little difference in the rate of side effects compared to a placebo. For men with breast cancer, the 2020 American Society of Clinical Oncology Guidelines recommend tamoxifen be used instead of an aromatase inhibitor to reduce the risk of breast cancer recurrence. An aromatase inhibitor (in combination with ovarian suppression therapy) may be considered, however, for men who are unable to take tamoxifen for some reason. Nevertheless, since aromatase was first characterized, research has been impeded by the lack of its three dimensional structure.
Dermatologic adverse events
Subsequent to IRB-approvals from two medical centers and the Cancer Registry of California, women were recruited with flyers and mailed invitations in urban and suburban areas of South California. After written consent, data were collected with one-time personal interviews, done in English at a private place of the woman’s choice. Interviews were conducted by the first author who has extensive experience in qualitative interviewing, using a semi-structured guide designed for the study. Verbatim transcriptions of the audio recordings were checked for accuracy and de-identified. Thematic analysis was used to systematically analyze data obtained with face-to-face, open-ended interviews conducted with 54 women who had filled at least one prescription for an aromatase inhibitor. A total of 8,863 patient-years, including 5,920 and 2,493 patient-years for the AI and tamoxifen groups, respectively, were analyzed with a mean follow-up of 3.56 ± 1.03 years.
Breast cancer is the common cancer affecting women in Italy (17.1%) in accordance with the estimate from the Associazione Italiana Registri Tumori (AIRTUM) (22). The introduction of AI during the last decade has opened new horizons in the successful treatment of hormone receptor positive breast cancer. Their effectiveness is widely established in the adjuvant therapy of postmenopausal women with hormone responsive breast cancer in upfront, switch and sequential treatment settings.
All of the authors participated in interpretation of the data and drafting of the manuscript. This study focused on the use of palbociclib under an early access program, previous to reimbursement decision, which may potentially lead to channeling bias. Despite the best efforts to obtain adverse event data, the use of a cancer registry as the main data source limits the ability to fully characterize all AEs. In addition, the retrospective nature of the study may lead to misclassification bias for various outcomes, including PFS and AEs. In a real-world context, assessment of disease progression is not done at the same intervals as in interventional studies, thus potentially leading to overestimation of PFS. The same applies to the reporting of AEs, which is less rigorous in a real-world context, resulting on a potential underreporting, reason why we focused on AEs leading to treatment discontinuation.
Real-world studies evaluating the effectiveness of palbociclib combined with AIs have been recently conducted. In some of these studies, lower effectiveness as assessed by PFS has been reported 15, whereas others found higher effectiveness 16, 17. Other studies, considering the limited time of follow-up, were unable to estimate median PFS 18, 19.
Hormone therapies slow or stop the growth of hormone receptor-positive tumors by preventing the cancer cells from getting the hormones they need to grow. Quality of life was added as a secondary outcome on the suggestion of a peer reviewer. In addition, hormonal change was deleted from secondary outcomes because it is of limited clinical usefulness. The withdrawal rate after randomisation was 14.3% (10/70, two from the letrozole group and eight from the triptorelin group), mainly because of irregular follow‐up visits. Outcomes reported included reduction in fibroid volume (as determined by transvaginal ultrasound) and ovarian and follicular changes (as determined by transvaginal ultrasound). If required in future updates, we plan to perform sensitivity analyses by repeating the analyses to explore the influence of the following factors on effect size.