The story notes that starting a second hormonal therapy, namely, letrozole (brand name Femara), years after stopping tamoxifen is a new finding which may affect current clinical recommendations for adjuvant treatment for post-menopausal women with ER-positive, early-stage breast cancer. Current clinical practice guidelines state that letrozole may be appropriate treatment when started 3 months after finishing a 5-year course of tamoxifen.
The story provides positive relative and absolute data for the reduction of breast cancer recurrence in women who took letrozole compared with women who took a placebo. The story claims the drug is a "lifesaver", which may not be accurate. While continuation therapy with letrozole does appear to reduce the risk of breast cancer recurrence in women who might be at higher risk, the study notes that only very short-term survival data is available, and information about long-term survival benefits should be interpreted cautiously. Since this study was not a randomized controlled trial, the women who chose to take letrozole may have had fewer health problems, and those who did not take the medication may have died from health problems other than breast cancer. The story could have explained this.
The story does not mention the potential harms of taking hormone therapy for many years, which is a great oversight. Letrozole can cause joint or bone problems, and in other studies it increased “bad” cholesterol (also called LDL, or low-density lipoproteins). The story does not mention that women who took letrozole in the study were more likely to experience osteoporosis and bone fractures than women who took a placebo.
The story also notes that the "side effects start to pile up" after taking tamoxifen for more than five years, but these side effects are not discussed, nor is there a comparison with the potential benefits of continued hormone therapy. Common side effects of tamoxifen are menopausal symptoms, which may become less bothersome with time. Rare, but more serious side effects may include an increase chance of developing endometrial cancer, deep vein thrombosis, stroke, pulmonary embolism (about 1/2 and 1 extra case for every 100 women who take tamoxifen for 5 years).
Lastly, the story does not cite any authors of the Journal of Clinical Oncology paper, nor do reporters talk with oncologists who could put the study results in context. We are not told how results could alter clinical practice guidelines for women with early-stage breast cancer who have taken tamoxifen for 5 years. The cost of the drug is also not mentioned. Cost is an important consideration for women considering an additional multi-year therapy.
The story does not mention the cost of taking letrolzole for many years after tamoxifen, nor does it mention if this drug is covered by health insurance.
The story provides the relative and absolute numbers for the reduction in recurrence; however, the study notes that there is currently only very short-term survivial data and the women who chose to take letrozole may have had fewer health problems, so information about long-term survival should be interpreted cautiously. To claim the drug is a "lifesaver" is not correct; it does appear to reduced the risk of breast cancer recurrence in women who might be at higher risk. Because the story didn’t include appropriate caveats, we rate it unsatisfactory.
The does not mention the potential harms of taking hormone therapy for many years, which is an oversight. The story mentions that the "side effects start to pile up" after taking tamoxifen for more than five years, but we are not told what side effects or how these compare to the potential benefits of continued hormone therapy. Common side effects of tamoxifen are menopausal symptoms which may become less bothersome with time. Rare, but more serious side effects may include an increase chance of developing endometrial cancer, deep vein thrombosis, stroke, pulmonary embolism, (about 1/2 and 1 extra case for every 100 women who take tamoxifen for 5 years) . These risks increase with age. We are also not told the risks of letrozole. Letrozole can cause joint or bone problems, and in other studies it increased “bad” cholesterol (also called LDL, or low-density lipoproteins). Women who took letrozole in the study cited were more likely to experience osteoporosis and bone fractures than women who took a placebo.
The story presents some positive recurrence data and discusses the study briefly. However, the story does not mention that this was not a randomized controlled trial. Women in this study, a continuation of a longer RCT, chose to take letrozole or palcebo following a standard course of tamoxifen. The story also does not report side effects of the continuation therapy.
The story notes that using letrozole as continued hormonal treatment only applies to post-menopausal women with early-stage breast cancer who have estrogen-sensitive tumors. This is important information in the context of this study; however, letrolzole is sometimes used for ER-sensitive women with more advanced cancers.
The story does not site any authors of the Journal of Clinical Oncology paper, nor do reporters talk with oncologists who could put the study results in context. We are not told if the results will alter clinical practice guidelines for women with early-stage breast cancer who have taken tamoxifen for 5 years.
The story lists typical treatment options offered to women with early-stage breast cancers: surgery, radiation, chemotherapy and hormone therapy. The story does not mention that women with early-stage breast cancers may not need all of these treatments; this is important as some treatments may pose more harms than benefits, depending on the type of breast cancer.
While the story discussed results from a large clinical trial, the story also noted current clinical practice guidelines for continued hormonal treatment with letrozole (brand name Femara) after 5 years of tamoxifen. Letrozole is available and FDA approved as a hormonal therapy for the extended adjuvant treatment of early breast cancer in postmenopausal women who had received five years of adjuvant tamoxifen therapy.
The story notes the benefit of starting a second hormonal therapy years after stopping tamoxifen is a new finding and may affect current clinical recommendations for adjuvant treatment of ER-positive early-stage breast cancer.
We can’t be sure if the story relied solely or largely on a news release because no one is interviewed in the story.
Systematic, Criteria-Driven
Puleeeeease... this 'game changer' weight loss drug causes more nausea and vomiting than a placebo. Some game, some change. My friend Gary would spank you for using the eighth word medical reporters should never, ever use. @garyschwitzer @thackerpd
https://www.healthnewsreview.org/toolkit/just-journalists-writing-tips-case-studies/7-words-and-more-you-shouldnt-use-in-medical-news/ https://twitter.com/OttawaCitizen/status/1361426796126830597
A scary @statnews Op-Ed warns that govt attempts to rein in Pharma may cut off access to "life-changing" drugs.
It takes @garyschwitzer to let us know: the author spent 10 years as Pfizer's public-policy chief. https://twitter.com/garyschwitzer/status/1360325022578053123
.@TranspariMED criticizes STAT op-ed for not disclosing pharma funding of author’s institute - similar to criticism we’ve made of STAT op-eds in the past. @transparify @ThinkTankWatch @icer_review https://www.healthnewsreview.org/2021/02/transparency-watchdog-criticizes-stats-non-disclosure-on-pro-pharma-op-ed/
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