Research links Taxotere to lifelong hair loss
- 3% – 15% participationbreast cancerPatients can never regrow their hair.
Hundreds of women claim that the risks of chemotherapy have been hidden from patients and doctors. Now they are fighting back and filing assault lawsuits against the maker of Taxotere. You also can.
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Hair loss is so common during chemotherapy that few researchers decide to study it. In the world of oncology, alopecia is just a cost of doing business, and many patients are willing to bear that cost. By the way, permanent hair loss is extremely rare. The vast majority of patients are told that any hair loss is temporary and will grow back soon after stopping treatment. At least that's what we thought until recently. As many patients have learned, alopecia or hair loss can last a lifetime.
Taxotere hair loss: a permanent risk
New research has revealed that one chemotherapy drug in particular, Taxotere ordocetaxel, can cause permanent hair loss in many more patients than any other treatment. European researchers have known about this problem for years. In fact, patients will find evidence of permanent hair loss on Taxotere's European label. These warnings have been welcomed by patients in Europe since at least 2005. However, breast cancer patients in the United States did not receive this information until 2015.
A wave of large studies has linked the breast cancer chemotherapy drug Taxotere to risks of permanent hair loss. Furthermore, many women believe there is strong evidence that the drug's maker, the French multinational Sanofi, was aware of the risk but did nothing to warn the medical community or individual cancer patients. This is particularly worrisome, the women say, since another drug, paclitaxel, appears to offer exactly the same benefits as Taxotere, but with far fewer risks. Paclitaxel has never been associated with permanent hair loss. Taxotere, on the other hand, was unanimously rejected by an FDA advisory panel, fearing the drug was too toxic.
Taxotere lawsuits against hair loss
Breast cancer patients are now filing lawsuits against Taxotere, accusing Sanofi of hiding the chemotherapy drug's link to permanent hair loss from the American medical community.
In more than 100 complaints, women across the country say they have been misled about the risks and benefits of Taxotere. The lawsuits have now been consolidated in the US District Court for the Eastern District of Louisiana, led by Chief Judge Kurt D. Engelhardt. As part of a multi-district litigation (MDL), claims are filed in the pre-trial stage as a class.
dr. Scot Sedlacek: More than 6% risk of permanent hair loss
In 2006, Dr. Scot Sedlacek, an oncologist at Rocky Mountain Cancer Centers in Denver, conducted a study on what she described as "perhaps the side effect most feared by [cancer] patients": alopecia. Hair loss, Sedlacek noted, can be "emotionally devastating," especially for women who are likely to be cured of breast cancer. But doctors, she wrote, "have always told [their] patients, 'Don't worry, it will always come back.'" Sedlacek's findings, drawn from an analysis of her own patients, suggested that these assurances "may not be true."
Sedlacek is a practicing oncologist and specialist in the treatment of breast cancer. In the 11 years between January 1994 and December 2004, she treated at least 496 women with operable forms of breast cancer with various types of adjuvant chemotherapy. Most of these women, 258, were on a regimen that included doxorubicin, an agent that commonly causes temporary hair loss, but no taxane. 126 were treated with doxorubicin and paclitaxel, a taxane related to the active ingredient in Taxotere, docetaxel, but less potent. 112 of Sedlacek's patients received docetaxel in combination with doxorubicin.
Taxotere Only drug associated with permanent hair loss
Reviewing these women, focusing on the extent and duration of chemotherapy-related hair loss, Sedlacek only included patients whom he had followed for at least a year. However, for most, doctors were able to follow up for at least two years after the last dose of chemotherapy, and some women had been in contact with Sedlacek for more than seven years.
For the purposes of his study, Sedlacek defined PSA, or persistent alopecia of the scalp, as "hair growth of less than 50% of the pre-chemotherapy amount of hair, as judged by both the patient and the author." ", Sedlacek himself. for themselves:
- no women treated without a taxane had experienced persistent alopecia
- not a single woman treated with paclitaxel had persistent alopecia
- seven women treated with docetaxel had persistent alopecia
Of these seven women, only five received the four doses of the drug Taxotere that their oncologist had scheduled. Two had stopped using the drug "due to unacceptable toxicity" after receiving just one dose. But they also suffered from what appeared to be permanent hair loss, which Sedlacek said had lasted for at least seven years. As for their appearance after chemotherapy, the doctor wrote, most of these women "would describe their hair as male pattern baldness."
Sedlacek's conclusion, though qualified in the sense of most medical research, was forceful:
“From this data set, when docetaxel is administered after 4 doses of CA, there is a small but significant chance that hair growth will continue for up to 7 years. The emotionally devastating long-term toxicity of this combination must be taken into account when deciding on adjuvant chemotherapy schedules in women likely to be cured of their breast cancer."
He calculated that the risk of permanent hair loss from docetaxel is 6.3%. Prior to Sedlacek's study, no investigator, even in individual patient case reports, had identified a risk of permanent alopecia after taxane treatment.
"An unusual case"
Since Sedlacek conducted his study in 2006, several case reports have entered the medical literature describing patients receiving Taxotere who suffered from permanent alopecia. In 2010, for example, doctors at Boston University and Tufts University reported the "unusual case" of a 72-year-old woman who received adjuvant chemotherapy after a lumpectomy.
In their report, the doctors note that alopecia is a known side effect of chemotherapy, but apart from patients receiving high-dose chemotherapy and bone marrow transplants, cases of permanent alopecia are rare. In contrast, in patients receiving adjuvant therapies, "hair regrows completely within 6 months." In fact, in their review of the existing literature, only one previous case report, published in a 2009 issue, could be found.british journal of dermatology, a patient with permanent hair loss without a bone marrow transplant.
Perhaps that is why the doctors found the situation of their current patient so "unknown." She presented "a reported complaint of persistent hair loss 13 months after completing adjuvant chemotherapy," a regimen that included docetaxel, the active ingredient in Taxotere, as well as carboplatin and trastuzumab. The researchers found that her hair loss, which began two weeks after starting chemotherapy, extended beyond "the hairs on her scalp." She lost her eyebrows, eyelashes, and body hair. At the end of her treatments, she "was completely bald."
Taxotere 'serious' hair loss and a striking resemblance
Regrowth, what doctors usually say iscompletewithin 6 months of chemotherapy, it was minimal and "her hair remained severely thin, requiring the use of a scalp prosthesis." During the patient's examination, the doctors noted "severe diffuse hair loss" that was "most noticeable on the crown" of their patient's head, and a single eyebrow that the patient said had recently grown back. The doctors noted a striking similarity between their own patient's hair loss and that of two patients reported in the British Journal of Dermatology a year earlier who had been treated with docetaxel and paclitaxel.
In their discussion, the doctors ruled out both trastuzumab and carboplatin as possible causes of their patient's permanent alopecia. Trastuzumab, they are quick to point out, "lacks the usual [chemotherapy] side effects of neutropenia, mucositis and alopecia, and does not appear to increase the rate of hair loss when combined with standard chemotherapy for metastatic breast cancer." . , carboplatin only seems to causeluzAlopecia in only 5% of patients. With those possible causes eliminated, doctors were left with docetaxel, a drug they say caused alopecia in more than 83% of patients enrolled in a phase II clinical trial. So, at least in the case of this particular patient, "docetaxel is the implicit agent."
Taxotere linked to permanent alopecia – again
In March 2011, dermatologists in London and Bologna, Italy, reviewed the medical records of 8,430 patients treated for "non-scarring alopecia" at a hair restoration clinic. In the seven years of clinical practice reviewed, there were only seven cases of chemotherapy-induced permanent alopecia, but five of these seven patients had been treated with docetaxel. The other two patients had been treated with busulfan, a drug used almost exclusively to treat patients awaiting bone marrow transplantation and long known to cause permanent hair loss.
All seven patients, the doctors noted, suffered from diffuse alopecia, in which hair is lost all over the scalp rather than in a single spot. Two of the patients also suffered partial loss of their eyebrows, although the researchers did not specify whether these patients were treated with docetaxel, the active ingredient in Taxotere, or busulfan.
Although there is currently no "effective treatment" for chemotherapy-induced permanent alopecia, the authors recommended "appropriate counseling before and after chemotherapy" for patients treated with docetaxel.
Permanent hair loss 'could be easily misdiagnosed'
At the University of Miami, another team of dermatologists took a closer look and performed histological analysis on 10 patients who had developed permanent alopecia after chemotherapy.
Although the researchers did not intend to study patients specifically given docetaxel, it worked anyway. Six of his patients had been treated with docetaxel for breast cancer, another three with busulfan and one with cisplatin and etoposide for lung cancer, growing no more than 10 centimeters and "showing an altered texture".
After biopsy, the authors found that this form of chemotherapy-induced hair loss closely resembled androgenetic alopecia, a form of alopecia caused by elevated hormone levels. In both conditions, patients retain their original number of hair follicles, show a decrease in adult hair, but have more "telogen" hair than normal. Hair follicles enter their "telogen phase" after they have stopped growing and are more likely to fall out.
No condition is characterized by increased fibrosis or scar tissue, and despite all these similarities, the authors wrote that "dermatopathologists should be aware of this condition because the absence of fibrosis and the presence of miniaturized hairs can be considered characteristic constants of a diagnosis." of androgenetic alopecia. Therefore, in the absence of a good clinicopathological correlation, these cases could easily be misdiagnosed”.
Docetaxel "responsible" for permanent hair loss
In Europe, the European prescribing information for Taxotere has included references to the possibility of "persistent alopecia" since at least 2005. published inAnnals of Oncologyfrom a group of French physicians, was the first to report on a "complete series of patients with permanent diffuse and irreversible loss of scalp hair and loss of body hair" after docetaxel chemotherapy.
The aim of the study was not just to document hair loss in 20 docetaxel patients diagnosed with breast cancer between 2007 and 2011, but to find out what was causing their alopecia. To achieve this goal, the researchers performed a complete medical exam on each patient, looking at the women's iron, zinc, and androgen levels, as well as other common causes of permanent hair loss. But each of the 20 patients who presented with "a strikingly similar clinical presentation" passed these tests with flying colors.
All that was left to link the 20 patients was docetaxel, and the study concludes that "taxanes appear to be responsible for this side effect." In their conclusion, the group went beyond the "seems" and stated unreservedly that "severe and permanent hair loss, particularly scalp alopecia, is a new and rare cutaneous adverse reaction of sequential ECF-therapy. docetaxel used in early-stage breast cancer that becomes an adjuvant treatment. ”.
"clearly incomplete" regrowth
The patients' hair loss began uniformly within the first two weeks of chemotherapy. The regrowth, which began between four and six months after treatment, "was clearly incomplete," with "hair loss and lack of fibrosis [scar tissue], leaving a characteristic alopecia appearance of the scalp predominantly over the crown [. ..] almost always". hair loss with eyebrows and eyelashes.”
Aside from a causal remedy, the French group was aware of the "distressing" effect that permanent hair loss can have on a patient's life. Use ofQuality of life index in dermatology(DLQI), a questionnaire that measures the psychological and social consequences of dermatological conditions, the researchers found that "distressing psychological consequences were common and severe in all 20 patients." One patient even said that she "would have preferred not to receive chemotherapy for her breast cancer" if avoiding such treatment would also have prevented permanent hair loss.
Survey finds permanent alopecia in 15.8% of patients
By 2014, it was widely accepted by the cancer community that Taxotere can cause permanent alopecia. It would not have been controversial to start a study like the one presented by British researchers that year.National Institute for Cancer ResearchCancer Conference, with the simple statement that "a small number of patients receiving docetaxel-containing early breast cancer (EBC) therapy develop permanent alopecia." However, as the use of "small" suggests, the research community has found it difficult to estimate how many patients will experience permanent hair loss.
To get an idea of the true incidence, four doctors at the Clatterbridge Cancer Center in North West England sent 189 questionnaires to patients who had received docetaxel chemotherapy in 2010. They received 134 responses, and of those surveyed, 21 reported "significant hair loss and persistent on the scalp" three and a half years after receiving the last dose of docetaxel. That was the 15% of patients who returned the questionnaire, and the researchers' conclusion that 10-15% of patients could be affected by "significant long-term scalp alopecia" after treatment with docetaxel remains the highest risk estimate ever reported.
But the poll was more nuanced. Of the 21 patients who reported persistent alopecia, five reported that their eyebrows never grew back, two reported no eyelash growth, six still had no nasal hair, and fourteen, a total of 66% of patients, reported that they did not grow hair on the other parts of the body. , including the legs. Because all of the patients had been treated at Clatterbridge, the researchers were able to review their medical records and seek an explanation. Other than docetaxel, "there were no significant associations."
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