Hundreds of women claim that the chemo drug’s risks were withheld from patients and physicians. Now they’re fighting back, filing personal injury lawsuits against Taxotere’s manufacturer. You can, too.
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Hair loss is so common during chemo that few researchers choose to study it. In the world of oncology, alopecia is just the cost of doing business, and it’s a cost many patients are willing to bear. Permanent hair loss, for that matter, is extremely rare. The vast majority of patients are told that any hair loss will be temporary, regrowing soon after treatment has ended. At least, that was what we thought until recently. As many patients have learned, alopecia, or hair loss, can last a lifetime.
New research has found that a particular chemotherapy agent, Taxotere or docetaxel, may cause permanent hair loss in far more patients than any other treatment. European researchers have actually known about this problem for years. In fact, patients will find references to permanent hair loss on Taxotere’s European labeling. Those warnings have greeted patients in Europe since at least 2005. Breast cancer patients in the United States, however, were not given this information until 2015.
A wave of major studies has linked the breast cancer chemotherapy drug Taxotere to risks for permanent hair loss. Moreover, many women believe there is strong evidence that the drug’s manufacturer, French multinational Sanofi, knew about this risk but did nothing to warn the medical community or individual cancer patients. This is particularly distressing, women say, since a different drug, paclitaxel, appears to offer the exact same benefits as Taxotere, but with far fewer risks. Paclitaxel has never been linked to permanent hair loss. Taxotere, on the other hand, was unanimously rejected by an FDA advisory panel over fears that the drug was far too toxic.
Breast cancer patients are now filing Taxotere lawsuits, accusing Sanofi of hiding the chemo drug’s link to permanent hair loss from the American medical community.
In more than 100 complaints, women from across the country say they were misled on both Taxotere’s risks and benefits. The lawsuits have now been consolidated in the US District Court for the Eastern District of Louisiana under the guidance of Chief Judge Kurt D. Engelhardt. As part of a Multi-District Litigation, or MDL, the claims will move through pre-trial proceedings as a group.
In 2006, Dr. Scot Sedlacek, an oncologist at Denver’s Rocky Mountain Cancer Centers, completed a study on what he called “the one side effect possibly most dreaded by the [cancer] patient”: alopecia. Hair loss, Sedlacek noted, can be “emotionally devastating,” especially for women likely to be cured of breast cancer. But doctors, he wrote “have always told [their] female patients, ‘don’t worry, it will always come back.’ ” Sedlacek’s results, drawn from an analysis of his own patients, suggested that those assurances “may not be true.”
Sedlacek is a practicing oncologist, and a specialist in the treatment of breast cancer. Over the 11 years between January 1994 and December 2004, he treated at least 496 women with operable forms of breast cancer, using different types of adjuvant chemotherapy. The majority of these women, 258, received a regimen containing doxorubicin, an agent that routinely causes temporary hair loss, but no taxane drug. 126 were treated with both doxorubicin and paclitaxel, a taxane related to, but less potent, than Taxotere’s active ingredient, docetaxel. 112 of Sedlacek’s patients received docetaxel itself, in combination with doxorubicin.
In reviewing these women, with a focus on the extent and duration of their chemotherapy-related hair loss, Sedlacek included only patients with whom he had followed up for at least one year. For most, though, the doctor was able to obtain follow-up at least two years after their last dose of chemotherapy, and some women had remained in contact with Sedlacek for more than seven years.
For the purposes of his study, Sedlacek defined PSA, or persistent scalp alopecia, as “hair regrowth less than 50% of the pre-chemotherapy amount of hair as judged by both the patient and the author,” Sedlacek himself. His results are telling:
Of those seven women, only 5 actually received all four of the Taxotere drug doses their oncologist had intended. Two, after receiving only one dose, had stopped using the drug “due to unacceptable toxicity.” But they too suffered apparently permanent hair loss, which Sedlacek said had lasted at least seven years. As for their appearance post-chemo, most of these women, the doctor wrote, “would describe their hair as male pattern baldness.”
Sedlacek’s conclusion, although qualified in the manner of most medical research, was blunt:
“it appears from this dataset, that when docetaxel is administered after 4 doses of AC, there is a small but significant possibility of poor hair regrowth lasting up to 7 years. Such an emotionally devastating long term toxicity from this combination must be taken into account when deciding on adjuvant chemotherapy programs in women who will likely be cured of their breast cancer.”
He estimated the risk of permanent hair loss carried by docetaxel as 6.3%. Before Sedlacek’s study, no researchers, not even in case reports on individual patients, had identified a risk of permanent alopecia after taxane treatment.
Since Sedlacek conducted his 2006 study, several case reports have entered the medical literature, describing patients who received Taxotere and suffered from permanent alopecia. In 2010, for example, doctors at Boston University and Tufts University reported on the “unusual case” of a 72-year-old woman who had received adjuvant chemotherapy after undergoing a lumpectomy.
In their report, the physicians note that alopecia is a well-recognized side effect of chemotherapy, but beyond patients who receive both high-dose chemo and bone marrow transplants, cases of permanent alopecia are rare. For patients who receive adjuvant therapies, on the other hand, “hair grows back fully within 6 months.” In fact, their review of the existing literature could find only one previous case report, published in a 2009 edition of the British Journal of Dermatology, of a patient experiencing permanent hair loss in the absence of bone marrow transplantation.
Perhaps that’s why the doctors found their current patient’s situation so “unusual.” She presented with “a complaint, the report continues, “of persistent hair loss 13 months after completion of adjuvant chemotherapy,” a regimen that had included docetaxel, Taxotere’s active ingredient, as well as carboplatin and trastuzumab. Her hair loss, the researchers found, which began two weeks after the start of chemo, extended beyond “the hair on her scalp.” She lost her eyebrows, eyelashes and body hair. By the end of her treatments, “she was completely bald.”
Regrowth, which the doctors say is usually complete within 6 months after chemotherapy, was minimal, and “her hair remained severely thin, requiring use of a scalp prosthesis.” During their examination of the patient, the doctors noted “severe diffuse hair loss,” which was “most prominent over the crown” of their patient’s head, and a single eyebrow that the patient said had only regrown recently. The doctors noted a striking similarity between their own patient’s hair loss and that suffered by the two patients reported one year earlier in the British Journal of Dermatology, who had been treated with docetaxel and paclitaxel.
In their discussion, the doctors ruled out both trastuzumab and carboplatin as likely causes of their patient’s permanent alopecia. Trastuzumab, they are quick to note, “lacks the common [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.” For its part, carboplatin appears to cause only mild alopecia in just 5% of patients. With those potential causes dismissed, the physicians were left only with docetaxel, a drug they say was shown to cause alopecia in more than 83% of patients included in a phase II clinical trial. Thus, at least in the case of this particular patient, “docetaxel is the implicated agent.”
In March 2011, dermatologists in London and Bologna, Italy looked back through the medical charts of 8,430 patients who had been treated for “nonscarring alopecia” at a hair regrowth clinic. There were, in all seven years of clinical practice reviewed, only seven cases of chemotherapy-induced permanent alopecia, but five out of those seven patients had been treated with docetaxel. The two other patients had been treated with busulfan, an agent used almost exclusively to treat patients prior to bone marrow transplantation and one long-known to cause permanent hair loss.
All seven patients, the doctors noted, experienced diffuse alopecia, in which hair is lost across the entire scalp, rather than in one location. Two of the patients also experienced partial loss of their eyebrows, although the researchers did not specify whether these patients were treated with docetaxel, Taxotere’s active ingredient, or busulfan.
While no “effective treatment” currently exists for chemotherapy-induced permanent alopecia, the authors recommended “appropriate counseling before and after chemotherapy” for patients treated with docetaxel.
At the University of Miami, another team of dermatologists took an even closer look, performing histological analyses on 10 patients who had experienced permanent alopecia after undergoing chemotherapy.
While the researchers didn’t mean to study patients who had received docetaxel specifically, it worked out that way regardless. Six of their patients had been treated with docetaxel for breast cancer, while another three had received busulfan and one had been administered cisplatin and etoposide for lung cancer. The patients all exhibited “moderate to very severe hair thinning,” the researchers wrote, with scalp hair growing no longer than 10 centimeters, and “show[ing] altered texture.”
After biopsy, the authors observed that this form of chemotherapy-induced hair loss closely resembled androgenetic alopecia, a form of alopecia caused by increased hormone levels. In both conditions, patients retain their original amount of hair follicles, exhibit a decrease in adult hairs, but have more “telogen hairs” than normal. Hair follicles enter their “telogen” phase after they’ve stopped growing, and become more likely to fall out.
Neither condition is characterized by an increase in fibrosis, or scar tissue, and for all these similarities, the authors wrote that “dermatopathologists should be aware of this condition as the absence of fibrosis and the presence of miniaturized hairs may be considered as features consistent with a diagnosis of androgenetic alopecia. Hence, these cases could easily be misdiagnosed in the absence of a good clinicopathological correlation.”
In Europe, Taxotere’s European prescribing information has carried references to the possibility of “persisting alopecia” since at least 2005. In the US, on the other hand, similar warnings only appeared in late 2015. Thus it’s not hard to understand why a 2011 paper, published in the Annals of Oncology by a group of French clinicians, became the first to report on a “comprehensive series of patients with permanent diffuse and irreversible scalp alopecia and body hair loss following” a chemotherapy regimen that included docetaxel.
The study’s purpose was not simply to document the hair loss of 20 docetaxel patients, all of whom had been diagnosed with breast cancer between 2007 and 2011, but to figure out what caused their alopecia. In pursuit of that goal, the researchers performed a full medical work-up on each patient, reviewing 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 exhibited a “strikingly similar clinical presentation,” passed those tests with flying colors.
All that remained to link the 20 patients together was docetaxel, and the study concludes that “taxanes seem to be responsible for this side-effect.” In their conclusion, the group went beyond “seems” to state, without qualification, that “severe and permanent hair loss, especially scalp alopecia, is a new and rare cutaneous side-effect of the sequential FEC-docetaxel regimen used for early breast cancer adjuvant treatment.”
The patients’ hair loss uniformly began within the first two weeks of chemotherapy. Regrowth, which began between four and six months after treatment, “was clearly incomplete,” with “thinning hairs and absence of fibrosis [scar tissue] leaving a characteristic aspect of scalp alopecia predominating over the crown […] almost always associated with eyebrow and eyelash hair loss.”
Beyond a causal agent, the French group was mindful of the “distressing” effect permanent hair loss can have on a patient’s life. Using the Dermatology Life Quality Index (DLQI), a questionnaire intended to measure the psychological and social consequences of dermatologic conditions, researchers found that “distressing psychological consequences were common and severe” among the 20 patients. One patient even said that “she would have preferred not to receive any chemotherapy for her breast cancer,” if avoiding such treatment could have also avoided permanent hair loss.
By 2014, it was largely accepted within the oncology community that Taxotere can cause permanent alopecia. It would not have been controversial to begin a study, like the one presented by UK researchers at that year’s National Cancer Research Institute Cancer Conference, with the simple declaration that “a small number of patients who receive docetaxel-containing regimens for early breast cancer (EBC) experience permanent alopecia.” As their use of “small” suggests, however, the research community has been met with difficulty in estimating how many patients will experience permanent hair loss.
To put some perspective on the true incidence, four clinicians at the Clatterbridge Cancer Centre in northwest England sent out 189 questionnaires to patients who had received docetaxel chemotherapy in 2010. They received 134 responses, and among those respondents, 21 reported “significant persistent scalp hair loss” three and a half years after receiving their last dose of docetaxel. That was 15% of the patients who returned the questionnaire, and the researchers conclusion, that anywhere from 10% to 15% of patients may be affected by “long term significant scalp alopecia” after treatment with docetaxel, remains the highest risk estimate ever reported.
But the survey was more nuanced than that. Of the 21 patients who reported persistent alopecia, five said their eyebrows had never regrown, two reported no eyelash growth, six still had no nostril hair and fourteen, a full 66% of the patients, reported no hair growth on their other body parts, including the legs. Since all of the patients had been treated at Clatterbridge, the researchers were able to scour their medical records, searching for an explanation. Beyond docetaxel, there were “no significant associations.”