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‘Exciting’: Post-SCT, antiviral T-cell therapy shows promise
Of 58 adult and pediatric patients with a total of 70 viral infections at the time of enrollment in the open-label trial, 55 (95%) had a treatment response within 6 weeks of infusion with posoleucel, and the amount of circulating virus was reduced by an average of 97%, Thomas Pfeiffer, MD, and colleagues reported.
In 12 patients who had more than one viral infection, 10 (83%) had a response against each of the viruses, researchers noted.
The responses were defined as a reduction of viral load to normal range with complete response, or as a viral load reduction of at least 50 percent or a partial response.
The findings were published online in Clinical Cancer Research.
Specifically, the treatment evoked responses to adenovirus in 83% of 12 affected patients, BK virus in all 27 affected patients, CMV in 96% of 24 affected patients, Epstein-Barr virus in both affected patients, and human herpes virus in 75% of 4 patients. Additionally, one patient with JC virus experienced initial stabilization of viral symptoms, although the symptoms ultimately progressed, and the patient died.
“The key finding is that 95% of patients whose infections had been refractory to conventional therapies responded to posoleucel with corresponding reductions in viral load and with limited rates of GvHD [graft-versus-host disease],” Dr. Pfeiffer, a pediatric cancer specialist at Washington University in St. Louis, explained in a prepared statement. “Overall, posoleucel was found to be very effective and had a favorable safety profile in a highly vulnerable patient population.”
“Another exciting observation from this study was that posoleucel could be administered within 24 hours in some cases, with symptom resolution in a matter of days in some patients,” added senior author Bilal Omer, MD, a pediatric hematologist-oncologist at Texas Children’s Hospital and Baylor College of Medicine, Houston. “It was quite impressive how quickly patients could be treated.”
Dr. Omer explained that currently available treatments for patients who develop viral infections after allo-SCT have numerous limitations, including toxicities such as myelosuppression or kidney injury and limited efficacy.
In this study, 13 patients (22% percent) reported acute GvHD, but only 4 of the cases were considered de novo cases; 9 patients had been diagnosed with GvHD prior to posoleucel treatment. The most common GvHD symptoms were skin flares, which were successfully treated in the majority of cases, Dr. Omer explained.
No patients experienced cytokine release syndrome.
“The ability to target six viruses with a single therapy would be beneficial for patients with multiple viral infections,” he said, adding that posoleucel is the first T-cell therapy in development for BK virus, which can cause severe bladder infections.
Posoleucel utilizes healthy donor T cells rather than the patient’s or transplant donor’s T cells, which circumvents the lengthy development process of more customized therapies and allows for earlier treatment of viral infections, he noted.
The investigators are currently evaluating posoleucel in randomized phase 3 clinical trials to confirm these findings.
This study was supported by the National Heart, Lung, and Blood Institute Production Assistance for Cellular Therapies; Conquer Cancer Foundation/American Society for Clinical Oncology; the Dan L. Duncan Comprehensive Cancer Center; and the National Institutes of Health.
Dr. Omer disclosed pending patent applications for engineered T-cell therapies unrelated to this study, and he has received research funding from AlloVir, which manufactures posoleucel. Dr. Pfeiffer declared no conflicts of interest.
Of 58 adult and pediatric patients with a total of 70 viral infections at the time of enrollment in the open-label trial, 55 (95%) had a treatment response within 6 weeks of infusion with posoleucel, and the amount of circulating virus was reduced by an average of 97%, Thomas Pfeiffer, MD, and colleagues reported.
In 12 patients who had more than one viral infection, 10 (83%) had a response against each of the viruses, researchers noted.
The responses were defined as a reduction of viral load to normal range with complete response, or as a viral load reduction of at least 50 percent or a partial response.
The findings were published online in Clinical Cancer Research.
Specifically, the treatment evoked responses to adenovirus in 83% of 12 affected patients, BK virus in all 27 affected patients, CMV in 96% of 24 affected patients, Epstein-Barr virus in both affected patients, and human herpes virus in 75% of 4 patients. Additionally, one patient with JC virus experienced initial stabilization of viral symptoms, although the symptoms ultimately progressed, and the patient died.
“The key finding is that 95% of patients whose infections had been refractory to conventional therapies responded to posoleucel with corresponding reductions in viral load and with limited rates of GvHD [graft-versus-host disease],” Dr. Pfeiffer, a pediatric cancer specialist at Washington University in St. Louis, explained in a prepared statement. “Overall, posoleucel was found to be very effective and had a favorable safety profile in a highly vulnerable patient population.”
“Another exciting observation from this study was that posoleucel could be administered within 24 hours in some cases, with symptom resolution in a matter of days in some patients,” added senior author Bilal Omer, MD, a pediatric hematologist-oncologist at Texas Children’s Hospital and Baylor College of Medicine, Houston. “It was quite impressive how quickly patients could be treated.”
Dr. Omer explained that currently available treatments for patients who develop viral infections after allo-SCT have numerous limitations, including toxicities such as myelosuppression or kidney injury and limited efficacy.
In this study, 13 patients (22% percent) reported acute GvHD, but only 4 of the cases were considered de novo cases; 9 patients had been diagnosed with GvHD prior to posoleucel treatment. The most common GvHD symptoms were skin flares, which were successfully treated in the majority of cases, Dr. Omer explained.
No patients experienced cytokine release syndrome.
“The ability to target six viruses with a single therapy would be beneficial for patients with multiple viral infections,” he said, adding that posoleucel is the first T-cell therapy in development for BK virus, which can cause severe bladder infections.
Posoleucel utilizes healthy donor T cells rather than the patient’s or transplant donor’s T cells, which circumvents the lengthy development process of more customized therapies and allows for earlier treatment of viral infections, he noted.
The investigators are currently evaluating posoleucel in randomized phase 3 clinical trials to confirm these findings.
This study was supported by the National Heart, Lung, and Blood Institute Production Assistance for Cellular Therapies; Conquer Cancer Foundation/American Society for Clinical Oncology; the Dan L. Duncan Comprehensive Cancer Center; and the National Institutes of Health.
Dr. Omer disclosed pending patent applications for engineered T-cell therapies unrelated to this study, and he has received research funding from AlloVir, which manufactures posoleucel. Dr. Pfeiffer declared no conflicts of interest.
Of 58 adult and pediatric patients with a total of 70 viral infections at the time of enrollment in the open-label trial, 55 (95%) had a treatment response within 6 weeks of infusion with posoleucel, and the amount of circulating virus was reduced by an average of 97%, Thomas Pfeiffer, MD, and colleagues reported.
In 12 patients who had more than one viral infection, 10 (83%) had a response against each of the viruses, researchers noted.
The responses were defined as a reduction of viral load to normal range with complete response, or as a viral load reduction of at least 50 percent or a partial response.
The findings were published online in Clinical Cancer Research.
Specifically, the treatment evoked responses to adenovirus in 83% of 12 affected patients, BK virus in all 27 affected patients, CMV in 96% of 24 affected patients, Epstein-Barr virus in both affected patients, and human herpes virus in 75% of 4 patients. Additionally, one patient with JC virus experienced initial stabilization of viral symptoms, although the symptoms ultimately progressed, and the patient died.
“The key finding is that 95% of patients whose infections had been refractory to conventional therapies responded to posoleucel with corresponding reductions in viral load and with limited rates of GvHD [graft-versus-host disease],” Dr. Pfeiffer, a pediatric cancer specialist at Washington University in St. Louis, explained in a prepared statement. “Overall, posoleucel was found to be very effective and had a favorable safety profile in a highly vulnerable patient population.”
“Another exciting observation from this study was that posoleucel could be administered within 24 hours in some cases, with symptom resolution in a matter of days in some patients,” added senior author Bilal Omer, MD, a pediatric hematologist-oncologist at Texas Children’s Hospital and Baylor College of Medicine, Houston. “It was quite impressive how quickly patients could be treated.”
Dr. Omer explained that currently available treatments for patients who develop viral infections after allo-SCT have numerous limitations, including toxicities such as myelosuppression or kidney injury and limited efficacy.
In this study, 13 patients (22% percent) reported acute GvHD, but only 4 of the cases were considered de novo cases; 9 patients had been diagnosed with GvHD prior to posoleucel treatment. The most common GvHD symptoms were skin flares, which were successfully treated in the majority of cases, Dr. Omer explained.
No patients experienced cytokine release syndrome.
“The ability to target six viruses with a single therapy would be beneficial for patients with multiple viral infections,” he said, adding that posoleucel is the first T-cell therapy in development for BK virus, which can cause severe bladder infections.
Posoleucel utilizes healthy donor T cells rather than the patient’s or transplant donor’s T cells, which circumvents the lengthy development process of more customized therapies and allows for earlier treatment of viral infections, he noted.
The investigators are currently evaluating posoleucel in randomized phase 3 clinical trials to confirm these findings.
This study was supported by the National Heart, Lung, and Blood Institute Production Assistance for Cellular Therapies; Conquer Cancer Foundation/American Society for Clinical Oncology; the Dan L. Duncan Comprehensive Cancer Center; and the National Institutes of Health.
Dr. Omer disclosed pending patent applications for engineered T-cell therapies unrelated to this study, and he has received research funding from AlloVir, which manufactures posoleucel. Dr. Pfeiffer declared no conflicts of interest.
FROM CLINICAL CANCER RESEARCH
FDA approves pirtobrutinib for r/r mantle cell lymphoma
Pirtobrutinib is the first and only noncovalent Bruton’s tyrosine kinase inhibitor approved for use in this MCL setting, manufacturer Eli Lilly noted in a press release.
“The approval of Jaypirca represents an important advance for patients with relapsed or refractory MCL, who currently have limited options and historically have had a poor prognosis following discontinuation of treatment with a covalent Bruton’s tyrosine kinase inhibitor,” senior author Michael Wang, MD, University of Texas MD Anderson Cancer Center, Houston, said in the release.
The approval was based on efficacy demonstrated in the open-label, single-arm, phase 1/2 BRUIN trial – a multicenter study assessing 200 mg once-daily oral pirtobrutinib monotherapy in 120 patients with MCL who had previously received a Bruton’s tyrosine kinase inhibitor, most often ibrutinib (Imbruvica, 67%) acalabrutinib (Calquence, 30%) and zanubrutinib (Brukinsa, 8%). Pirtobrutinib was continued until disease progression or unacceptable toxicity.
Study participants had a median of three prior lines of therapy, and 83% discontinued their last Bruton’s tyrosine kinase inhibitor because of refractory or progressive disease.
The overall response rate in pirtobrutinib-treated patients was 50% with a complete response rate of 13%. Estimated median duration of response was 8.3 months, and the estimated duration of response at 6 months occurred in nearly two-thirds of patients.
Adverse reactions that occurred in at least 15% of patients included fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising. Grade 3 or 4 laboratory abnormalities occurring in at least 10% of patients included decreased neutrophil counts, lymphocyte counts, and platelet counts.
Prescribing information for pirtobrutinib includes warnings and precautions for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, and second primary malignancies, noted the FDA, which granted priority review, fast track designation, and orphan drug designation for the application submitted by Eli Lilly.
“Jaypirca can reestablish Bruton’s tyrosine kinase inhibition in MCL patients previously treated with a covalent Bruton’s tyrosine kinase inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) and extend the benefit of targeting the Bruton’s tyrosine kinase pathway,” according to Eli Lilly’s release.
Dr. Wang added that the agent “has the potential to meaningfully impact the treatment paradigm for relapsed and refractory MCL patients.”
Meghan Gutierrez, CEO at the Lymphoma Research Foundation, also noted that “the approval of Jaypirca brings a new treatment option and, along with that, new hope for people with relapsed or refractory MCL.”
The drug is expected to be available in the United States in the coming weeks, and the confirmatory phase 3 BRUIN trial is currently enrolling patients, Eli Lilly announced. The company also indicated the list price would be $21,000 for a 30-day supply of the 200-mg dose.
Serious adverse events believed to be associated with the use of pirtobrutinib or any medicine or device should be reported to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article first appeared on Medscape.com.
Pirtobrutinib is the first and only noncovalent Bruton’s tyrosine kinase inhibitor approved for use in this MCL setting, manufacturer Eli Lilly noted in a press release.
“The approval of Jaypirca represents an important advance for patients with relapsed or refractory MCL, who currently have limited options and historically have had a poor prognosis following discontinuation of treatment with a covalent Bruton’s tyrosine kinase inhibitor,” senior author Michael Wang, MD, University of Texas MD Anderson Cancer Center, Houston, said in the release.
The approval was based on efficacy demonstrated in the open-label, single-arm, phase 1/2 BRUIN trial – a multicenter study assessing 200 mg once-daily oral pirtobrutinib monotherapy in 120 patients with MCL who had previously received a Bruton’s tyrosine kinase inhibitor, most often ibrutinib (Imbruvica, 67%) acalabrutinib (Calquence, 30%) and zanubrutinib (Brukinsa, 8%). Pirtobrutinib was continued until disease progression or unacceptable toxicity.
Study participants had a median of three prior lines of therapy, and 83% discontinued their last Bruton’s tyrosine kinase inhibitor because of refractory or progressive disease.
The overall response rate in pirtobrutinib-treated patients was 50% with a complete response rate of 13%. Estimated median duration of response was 8.3 months, and the estimated duration of response at 6 months occurred in nearly two-thirds of patients.
Adverse reactions that occurred in at least 15% of patients included fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising. Grade 3 or 4 laboratory abnormalities occurring in at least 10% of patients included decreased neutrophil counts, lymphocyte counts, and platelet counts.
Prescribing information for pirtobrutinib includes warnings and precautions for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, and second primary malignancies, noted the FDA, which granted priority review, fast track designation, and orphan drug designation for the application submitted by Eli Lilly.
“Jaypirca can reestablish Bruton’s tyrosine kinase inhibition in MCL patients previously treated with a covalent Bruton’s tyrosine kinase inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) and extend the benefit of targeting the Bruton’s tyrosine kinase pathway,” according to Eli Lilly’s release.
Dr. Wang added that the agent “has the potential to meaningfully impact the treatment paradigm for relapsed and refractory MCL patients.”
Meghan Gutierrez, CEO at the Lymphoma Research Foundation, also noted that “the approval of Jaypirca brings a new treatment option and, along with that, new hope for people with relapsed or refractory MCL.”
The drug is expected to be available in the United States in the coming weeks, and the confirmatory phase 3 BRUIN trial is currently enrolling patients, Eli Lilly announced. The company also indicated the list price would be $21,000 for a 30-day supply of the 200-mg dose.
Serious adverse events believed to be associated with the use of pirtobrutinib or any medicine or device should be reported to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article first appeared on Medscape.com.
Pirtobrutinib is the first and only noncovalent Bruton’s tyrosine kinase inhibitor approved for use in this MCL setting, manufacturer Eli Lilly noted in a press release.
“The approval of Jaypirca represents an important advance for patients with relapsed or refractory MCL, who currently have limited options and historically have had a poor prognosis following discontinuation of treatment with a covalent Bruton’s tyrosine kinase inhibitor,” senior author Michael Wang, MD, University of Texas MD Anderson Cancer Center, Houston, said in the release.
The approval was based on efficacy demonstrated in the open-label, single-arm, phase 1/2 BRUIN trial – a multicenter study assessing 200 mg once-daily oral pirtobrutinib monotherapy in 120 patients with MCL who had previously received a Bruton’s tyrosine kinase inhibitor, most often ibrutinib (Imbruvica, 67%) acalabrutinib (Calquence, 30%) and zanubrutinib (Brukinsa, 8%). Pirtobrutinib was continued until disease progression or unacceptable toxicity.
Study participants had a median of three prior lines of therapy, and 83% discontinued their last Bruton’s tyrosine kinase inhibitor because of refractory or progressive disease.
The overall response rate in pirtobrutinib-treated patients was 50% with a complete response rate of 13%. Estimated median duration of response was 8.3 months, and the estimated duration of response at 6 months occurred in nearly two-thirds of patients.
Adverse reactions that occurred in at least 15% of patients included fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising. Grade 3 or 4 laboratory abnormalities occurring in at least 10% of patients included decreased neutrophil counts, lymphocyte counts, and platelet counts.
Prescribing information for pirtobrutinib includes warnings and precautions for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, and second primary malignancies, noted the FDA, which granted priority review, fast track designation, and orphan drug designation for the application submitted by Eli Lilly.
“Jaypirca can reestablish Bruton’s tyrosine kinase inhibition in MCL patients previously treated with a covalent Bruton’s tyrosine kinase inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) and extend the benefit of targeting the Bruton’s tyrosine kinase pathway,” according to Eli Lilly’s release.
Dr. Wang added that the agent “has the potential to meaningfully impact the treatment paradigm for relapsed and refractory MCL patients.”
Meghan Gutierrez, CEO at the Lymphoma Research Foundation, also noted that “the approval of Jaypirca brings a new treatment option and, along with that, new hope for people with relapsed or refractory MCL.”
The drug is expected to be available in the United States in the coming weeks, and the confirmatory phase 3 BRUIN trial is currently enrolling patients, Eli Lilly announced. The company also indicated the list price would be $21,000 for a 30-day supply of the 200-mg dose.
Serious adverse events believed to be associated with the use of pirtobrutinib or any medicine or device should be reported to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article first appeared on Medscape.com.
FDA calls for withdrawal of multiple myeloma drug Pepaxto
(melphalan flufenamide), the company announced in a press release.
The drug was granted an accelerated approval by the FDA in February 2021, for use in combination with dexamethasone in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
However, the phase 3 OCEAN study raised concerns about safety, as it showed a higher mortality associated with melphalan flufenamide in the experimental arm, compared with pomalidomide (Pomalyst).
The FDA already flagged this issue in July 2021, issuing a safety alert flagging the increased risk for death observed in the OCEAN trial among patients receiving melphalan flufenamide versus pomalidomide (47.6% vs. 43.4%) and a 5.3-month shorter overall survival.
The issue was also discussed in September 2022 by FDA’s Oncologic Drugs Advisory Committee, which voted 14-to-2 against maintaining the accelerated approval, citing an unfavorable risk/benefit profile.
The company stopped marketing the drug in the United States in October 2021 at the FDA’s request but continued to make it available for patients already undergoing treatment.
However, in March 2022, Oncopeptides rescinded the letter that voluntarily withdrew the agent from market, after further review of overall survival data from the OCEAN trial led the company to reconsider its decision. Notably, marketing efforts were still discontinued while the company worked with the FDA to interpret the data, it stated in the press release.
That review of the data showed that progression-free survival was 42% higher with melphalan flufenamide versus pomalidomide and overall response rates were 32.1% versus 26.5%, respectively.
Now, the FDA has requested that the company withdraw its U.S. marketing authorization.
“We respect FDA’s accelerated approval regulations,” Jakob Lindberg, CEO of Oncopeptides commented in the press release.
However, he also added, “multiple myeloma remains an incurable disease, and the treatment options for patients with triple-class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for nontransplanted elderly patients where the unmet medical need remains very high.”
Commercialization of the drug in Europe, under the brand name Pepaxti, is ongoing.
“Pepaxti has a full approval from the European Medicines Agency, EMA, since Aug. 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the U.K. on Nov 11, 2022,” the company noted.
A version of this article first appeared on Medscape.com.
(melphalan flufenamide), the company announced in a press release.
The drug was granted an accelerated approval by the FDA in February 2021, for use in combination with dexamethasone in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
However, the phase 3 OCEAN study raised concerns about safety, as it showed a higher mortality associated with melphalan flufenamide in the experimental arm, compared with pomalidomide (Pomalyst).
The FDA already flagged this issue in July 2021, issuing a safety alert flagging the increased risk for death observed in the OCEAN trial among patients receiving melphalan flufenamide versus pomalidomide (47.6% vs. 43.4%) and a 5.3-month shorter overall survival.
The issue was also discussed in September 2022 by FDA’s Oncologic Drugs Advisory Committee, which voted 14-to-2 against maintaining the accelerated approval, citing an unfavorable risk/benefit profile.
The company stopped marketing the drug in the United States in October 2021 at the FDA’s request but continued to make it available for patients already undergoing treatment.
However, in March 2022, Oncopeptides rescinded the letter that voluntarily withdrew the agent from market, after further review of overall survival data from the OCEAN trial led the company to reconsider its decision. Notably, marketing efforts were still discontinued while the company worked with the FDA to interpret the data, it stated in the press release.
That review of the data showed that progression-free survival was 42% higher with melphalan flufenamide versus pomalidomide and overall response rates were 32.1% versus 26.5%, respectively.
Now, the FDA has requested that the company withdraw its U.S. marketing authorization.
“We respect FDA’s accelerated approval regulations,” Jakob Lindberg, CEO of Oncopeptides commented in the press release.
However, he also added, “multiple myeloma remains an incurable disease, and the treatment options for patients with triple-class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for nontransplanted elderly patients where the unmet medical need remains very high.”
Commercialization of the drug in Europe, under the brand name Pepaxti, is ongoing.
“Pepaxti has a full approval from the European Medicines Agency, EMA, since Aug. 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the U.K. on Nov 11, 2022,” the company noted.
A version of this article first appeared on Medscape.com.
(melphalan flufenamide), the company announced in a press release.
The drug was granted an accelerated approval by the FDA in February 2021, for use in combination with dexamethasone in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
However, the phase 3 OCEAN study raised concerns about safety, as it showed a higher mortality associated with melphalan flufenamide in the experimental arm, compared with pomalidomide (Pomalyst).
The FDA already flagged this issue in July 2021, issuing a safety alert flagging the increased risk for death observed in the OCEAN trial among patients receiving melphalan flufenamide versus pomalidomide (47.6% vs. 43.4%) and a 5.3-month shorter overall survival.
The issue was also discussed in September 2022 by FDA’s Oncologic Drugs Advisory Committee, which voted 14-to-2 against maintaining the accelerated approval, citing an unfavorable risk/benefit profile.
The company stopped marketing the drug in the United States in October 2021 at the FDA’s request but continued to make it available for patients already undergoing treatment.
However, in March 2022, Oncopeptides rescinded the letter that voluntarily withdrew the agent from market, after further review of overall survival data from the OCEAN trial led the company to reconsider its decision. Notably, marketing efforts were still discontinued while the company worked with the FDA to interpret the data, it stated in the press release.
That review of the data showed that progression-free survival was 42% higher with melphalan flufenamide versus pomalidomide and overall response rates were 32.1% versus 26.5%, respectively.
Now, the FDA has requested that the company withdraw its U.S. marketing authorization.
“We respect FDA’s accelerated approval regulations,” Jakob Lindberg, CEO of Oncopeptides commented in the press release.
However, he also added, “multiple myeloma remains an incurable disease, and the treatment options for patients with triple-class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for nontransplanted elderly patients where the unmet medical need remains very high.”
Commercialization of the drug in Europe, under the brand name Pepaxti, is ongoing.
“Pepaxti has a full approval from the European Medicines Agency, EMA, since Aug. 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the U.K. on Nov 11, 2022,” the company noted.
A version of this article first appeared on Medscape.com.
Fungi inside cancer cells: ‘A new and emerging hallmark’
The investigators characterized the cancer mycobiome within 17,401 tissue, blood, and plasma samples from four international cohorts, revealing new information about fungi distribution, association with immune cells, and potential prognostic value.
Fungi were detected in all cancer types studied and were often intracellular, reported Lian Narunsky-Haziza, PhD, of Weizmann Institute of Science, Rehovot, Israel, and colleagues.
Additionally, multiple fungal-bacterial-immune ecologies were detected across tumors, and intratumoral fungi stratified clinical outcomes, including immunotherapy response, they noted. Also, cell-free fungal DNA diagnosed healthy and cancer patients in early-stage disease.
The findings, published online in the journal Cell, have potential implications for cancer detection, diagnosis, and treatment, the researchers suggested.
The existence of fungi in most human cancers “is both a surprise and to be expected,” study coauthor Rob Knight, PhD, a professor at the University of California, San Diego, stated in a press release. “It is surprising because we don’t know how fungi could get into tumors throughout the body. But it is also expected, because it fits the pattern of healthy microbiomes throughout the body, including the gut, mouth, and skin, where bacteria and fungi interact as part of a complex community.”
Exploration of the associations between cancer and microbes are nothing new, but cancer-associated fungi have rarely been examined, the authors noted.
The findings from this pan-cancer analysis, which suggested “prognostic and diagnostic capacities of the tissue and plasma mycobiomes, even in stage I cancers,” complement current “understanding of the interaction between cancer cells and the bacteria that exist in tumors alongside fungi, bacteria that have been shown to affect cancer growth, metastasis, and response to therapy,” they explained.
Of note, the study revealed multiple correlations between the presence of specific fungi in tumors and conditions related to treatment. For example, patients with breast cancer whose tumors contained Malassezia globosa – a fungus found naturally on the skin – had a much lower survival rate than those whose tumors did not contain the fungus. Furthermore, specific fungi were more prevalent in breast tumors from older vs. younger patients, in lung tumors of smokers vs. nonsmokers, and in melanoma tumors that responded to immunotherapy vs. those that did not respond.
These findings suggest that fungal activity is “a new and emerging hallmark of cancer,” stated study coleader Ravid Straussman, PhD, of the Weizmann molecular cell biology department. “These findings should drive us to better explore the potential effects of tumor fungi and to re-examine almost everything we know about cancer through a ‘microbiome lens.’ ”
Unique relationships observed between fungi and bacteria – for example, tumors that contain Aspergillus fungi tended to have specific bacteria in them, whereas tumors that contain Malassezia fungi tended to have other bacteria in them – may have implications for treatment, as they correlated with both tumor immunity and patient survival, according to the authors.
“This study sheds new light on the complex biological environment within tumors, and future research will reveal how fungi affect cancerous growth,” said coauthor Yitzhak Pilpel, PhD, a principal investigator at the Weizmann molecular genetics department. “The fact that fungi can be found not only in cancer cells but also in immune cells implies that, in the future, we’ll probably find that fungi have some effect not only on the cancer cells but also on immune cells and their activity.”
A further finding related to the presence of fungal and bacterial DNA in human blood further suggests that measuring microbial DNA in the blood could lead to early detection of cancer, the authors noted.
Dr. Straussman’s research is supported by the Swiss Society Institute for Cancer Prevention Research, the Fabricant-Morse Families Research Fund for Humanity, the Dr. Chantal d’Adesky Scheinberg Research Fund, and the Dr. Dvora and Haim Teitelbaum Endowment Fund.
A version of this article first appeared on Medscape.com.
The investigators characterized the cancer mycobiome within 17,401 tissue, blood, and plasma samples from four international cohorts, revealing new information about fungi distribution, association with immune cells, and potential prognostic value.
Fungi were detected in all cancer types studied and were often intracellular, reported Lian Narunsky-Haziza, PhD, of Weizmann Institute of Science, Rehovot, Israel, and colleagues.
Additionally, multiple fungal-bacterial-immune ecologies were detected across tumors, and intratumoral fungi stratified clinical outcomes, including immunotherapy response, they noted. Also, cell-free fungal DNA diagnosed healthy and cancer patients in early-stage disease.
The findings, published online in the journal Cell, have potential implications for cancer detection, diagnosis, and treatment, the researchers suggested.
The existence of fungi in most human cancers “is both a surprise and to be expected,” study coauthor Rob Knight, PhD, a professor at the University of California, San Diego, stated in a press release. “It is surprising because we don’t know how fungi could get into tumors throughout the body. But it is also expected, because it fits the pattern of healthy microbiomes throughout the body, including the gut, mouth, and skin, where bacteria and fungi interact as part of a complex community.”
Exploration of the associations between cancer and microbes are nothing new, but cancer-associated fungi have rarely been examined, the authors noted.
The findings from this pan-cancer analysis, which suggested “prognostic and diagnostic capacities of the tissue and plasma mycobiomes, even in stage I cancers,” complement current “understanding of the interaction between cancer cells and the bacteria that exist in tumors alongside fungi, bacteria that have been shown to affect cancer growth, metastasis, and response to therapy,” they explained.
Of note, the study revealed multiple correlations between the presence of specific fungi in tumors and conditions related to treatment. For example, patients with breast cancer whose tumors contained Malassezia globosa – a fungus found naturally on the skin – had a much lower survival rate than those whose tumors did not contain the fungus. Furthermore, specific fungi were more prevalent in breast tumors from older vs. younger patients, in lung tumors of smokers vs. nonsmokers, and in melanoma tumors that responded to immunotherapy vs. those that did not respond.
These findings suggest that fungal activity is “a new and emerging hallmark of cancer,” stated study coleader Ravid Straussman, PhD, of the Weizmann molecular cell biology department. “These findings should drive us to better explore the potential effects of tumor fungi and to re-examine almost everything we know about cancer through a ‘microbiome lens.’ ”
Unique relationships observed between fungi and bacteria – for example, tumors that contain Aspergillus fungi tended to have specific bacteria in them, whereas tumors that contain Malassezia fungi tended to have other bacteria in them – may have implications for treatment, as they correlated with both tumor immunity and patient survival, according to the authors.
“This study sheds new light on the complex biological environment within tumors, and future research will reveal how fungi affect cancerous growth,” said coauthor Yitzhak Pilpel, PhD, a principal investigator at the Weizmann molecular genetics department. “The fact that fungi can be found not only in cancer cells but also in immune cells implies that, in the future, we’ll probably find that fungi have some effect not only on the cancer cells but also on immune cells and their activity.”
A further finding related to the presence of fungal and bacterial DNA in human blood further suggests that measuring microbial DNA in the blood could lead to early detection of cancer, the authors noted.
Dr. Straussman’s research is supported by the Swiss Society Institute for Cancer Prevention Research, the Fabricant-Morse Families Research Fund for Humanity, the Dr. Chantal d’Adesky Scheinberg Research Fund, and the Dr. Dvora and Haim Teitelbaum Endowment Fund.
A version of this article first appeared on Medscape.com.
The investigators characterized the cancer mycobiome within 17,401 tissue, blood, and plasma samples from four international cohorts, revealing new information about fungi distribution, association with immune cells, and potential prognostic value.
Fungi were detected in all cancer types studied and were often intracellular, reported Lian Narunsky-Haziza, PhD, of Weizmann Institute of Science, Rehovot, Israel, and colleagues.
Additionally, multiple fungal-bacterial-immune ecologies were detected across tumors, and intratumoral fungi stratified clinical outcomes, including immunotherapy response, they noted. Also, cell-free fungal DNA diagnosed healthy and cancer patients in early-stage disease.
The findings, published online in the journal Cell, have potential implications for cancer detection, diagnosis, and treatment, the researchers suggested.
The existence of fungi in most human cancers “is both a surprise and to be expected,” study coauthor Rob Knight, PhD, a professor at the University of California, San Diego, stated in a press release. “It is surprising because we don’t know how fungi could get into tumors throughout the body. But it is also expected, because it fits the pattern of healthy microbiomes throughout the body, including the gut, mouth, and skin, where bacteria and fungi interact as part of a complex community.”
Exploration of the associations between cancer and microbes are nothing new, but cancer-associated fungi have rarely been examined, the authors noted.
The findings from this pan-cancer analysis, which suggested “prognostic and diagnostic capacities of the tissue and plasma mycobiomes, even in stage I cancers,” complement current “understanding of the interaction between cancer cells and the bacteria that exist in tumors alongside fungi, bacteria that have been shown to affect cancer growth, metastasis, and response to therapy,” they explained.
Of note, the study revealed multiple correlations between the presence of specific fungi in tumors and conditions related to treatment. For example, patients with breast cancer whose tumors contained Malassezia globosa – a fungus found naturally on the skin – had a much lower survival rate than those whose tumors did not contain the fungus. Furthermore, specific fungi were more prevalent in breast tumors from older vs. younger patients, in lung tumors of smokers vs. nonsmokers, and in melanoma tumors that responded to immunotherapy vs. those that did not respond.
These findings suggest that fungal activity is “a new and emerging hallmark of cancer,” stated study coleader Ravid Straussman, PhD, of the Weizmann molecular cell biology department. “These findings should drive us to better explore the potential effects of tumor fungi and to re-examine almost everything we know about cancer through a ‘microbiome lens.’ ”
Unique relationships observed between fungi and bacteria – for example, tumors that contain Aspergillus fungi tended to have specific bacteria in them, whereas tumors that contain Malassezia fungi tended to have other bacteria in them – may have implications for treatment, as they correlated with both tumor immunity and patient survival, according to the authors.
“This study sheds new light on the complex biological environment within tumors, and future research will reveal how fungi affect cancerous growth,” said coauthor Yitzhak Pilpel, PhD, a principal investigator at the Weizmann molecular genetics department. “The fact that fungi can be found not only in cancer cells but also in immune cells implies that, in the future, we’ll probably find that fungi have some effect not only on the cancer cells but also on immune cells and their activity.”
A further finding related to the presence of fungal and bacterial DNA in human blood further suggests that measuring microbial DNA in the blood could lead to early detection of cancer, the authors noted.
Dr. Straussman’s research is supported by the Swiss Society Institute for Cancer Prevention Research, the Fabricant-Morse Families Research Fund for Humanity, the Dr. Chantal d’Adesky Scheinberg Research Fund, and the Dr. Dvora and Haim Teitelbaum Endowment Fund.
A version of this article first appeared on Medscape.com.
FROM CELL
One-third of pancreatic cancer diagnoses missed on scans
say United Kingdom researchers who report a novel analysis.
The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.
The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.
They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.
The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).
In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.
The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.
In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.
Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
Details of missed imaging signs
The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.
Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.
The PIPC cases were categorized by type:
- Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
- Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
- Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
- Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)
“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
say United Kingdom researchers who report a novel analysis.
The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.
The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.
They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.
The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).
In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.
The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.
In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.
Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
Details of missed imaging signs
The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.
Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.
The PIPC cases were categorized by type:
- Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
- Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
- Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
- Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)
“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
say United Kingdom researchers who report a novel analysis.
The study set out to identify the incidence and root causes of missed pancreatic cancer diagnoses on CT and MRI scans, the investigators explained at the United European Gastroenterology Week 2022.
The team studied 600 pancreatic cancer cases, including 46 cases (7.7%) categorized as postimaging pancreatic cancer (PIPC) – cases not detected on imaging performed 3-18 months prior to diagnosis.
They also reviewed 46 CT scans and 4 MRI scans performed in PIPC patients.
The detailed analysis showed that 36% of cases of PIPC were potentially avoidable, reported first author Nosheen Umar, MD, a gastroenterology research fellow at the University of Birmingham (England).
In 10% of PIPC patients, imaging signs associated with pancreatic cancer, such as dilated bile or pancreatic ducts, were not recognized as such and were not investigated further. In 26% of scans, the signs of a mass lesion were not picked up by the radiologist.
The findings are notable as the time window for curative PC surgery is often short, and missing the diagnosis on cross-sectional imaging can result in worse clinical outcomes for patients already dealing with a challenging cancer that has generally poor outcomes, Dr. Umar said in an interview.
In fact, pancreatic cancer has the lowest survival rate of all cancers in Europe, the UEG noted in a press release. Life expectancy at the time of diagnosis is just 4.6 months, and 5-year survival is less than 10%, Dr. Umar said.
Pancreatic cancer causes 95,000 deaths in the European Union each year, the UEG noted, adding that by 2035 the number of cases is predicted to rise by almost 40%.
Details of missed imaging signs
The aim of this study was to establish the most plausible explanations for missed imaging signs of PC, Dr. Umar explained, adding that early diagnosis is vitally important for offering patients the best chance of survival.
Cases analyzed for the study were identified from electronic medical records of adults diagnosed with PC between 2016 and 2021 at two National Health Service providers. An algorithm was developed to categorize PIPC and assess potential causes of the missed diagnoses.
The PIPC cases were categorized by type:
- Type 1 – A focal lesion on previous imaging reported in the same pancreatic segment as PIPC (0% of cases)
- Type 2 – Imaging changes that can be associated with PC reported on previous imaging (20% of cases)
- Type 3 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC, but lesion or imaging changes noted on review after PIPC diagnosis (26% of cases)
- Type 4 – No lesion or imaging changes that can be associated with PC reported on previous imaging in the same pancreatic segment as PIPC and no lesion or imaging changes on review after PIPC diagnosis (54% of cases)
“We hope this study will raise awareness of the issue of postimaging pancreatic cancer and common reasons why pancreatic cancer can be initially missed,” Dr. Umar stated in the UEG press release. “This will help to standardize future studies of this issue and guide quality improvement efforts so we can increase the likelihood of an early diagnosis of pancreatic cancer, increase the chances of patient survival and, ultimately, save lives.”
The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cost paramount when choosing metastatic breast cancer treatment
While efficacy and quality of life outcomes are similar across commonly used treatments for endocrine-refractory or triple-negative metastatic breast cancer, the costs of these agents vary widely, a recent analysis reveals.
Notably, the authors found that
Given “razor thin” differences in outcomes, cost should become a major consideration, the researchers concluded.
“As a society, we urgently need more strategies to reduce cancer drug costs without compromising outcomes, and our analysis provides quantifiable evidence to help providers choose lower priced, but equally effective sequences of drugs,” first author Stephanie B. Wheeler, PhD, from the University of North Carolina at Chapel Hill, explained in a press release.
Although the drugs Dr. Wheeler and colleagues studied are reimbursed in the metastatic breast cancer setting, “the optimal sequencing of them has been unclear, which has led to considerable variation in physician preference and practice,” Dr. Wheeler said.
In the study, published in the Journal of Clinical Oncology, Dr. Wheeler and colleagues estimated the cost-effectiveness of different therapeutic options from the first- to third-line setting for this patient population.
The researchers used three dynamic microsimulation computer models to predict how hypothetical sets of 10,000 patients with specific types of metastatic breast cancer would respond to various therapy types and sequences. The cohorts were grouped according to prior chemotherapy exposure: cohort 1 had no taxane or anthracycline exposure, cohort 2 had taxane and anthracycline exposure, and cohort 3 had taxane exposure but was anthracycline naive.
On the basis of feedback from oncologists, the investigators focused on different agents in the three cohorts: paclitaxel, capecitabine, or pegylated liposomal doxorubicin for cohort 1; eribulin, capecitabine, or carboplatin for cohort 2; and pegylated liposomal doxorubicin, capecitabine, or eribulin for cohort 3.
Overall, the models showed “nearly indistinguishable differences” in quality of life. In fact, the “razor-thin incremental differences in quality-adjusted survival” across the treatment sequences often amounted to differences of only a few days or weeks, the authors noted, adding that, even in the most extreme of cases, 3 weeks separated the best and worst options for quality-adjusted life-years.
But the models did show considerable differences in costs.
The authors found that, for cohort 1, treatment with paclitaxel followed by capecitabine and then pegylated liposomal doxorubicin corresponded to the highest expected quality-adjusted life-year gain and the lowest costs – $686 per month versus the highest cost option of $1,765.
For cohort 2, treatment with carboplatin followed by capecitabine and then eribulin corresponded to the highest expected quality-adjusted life-year gain and lowest costs.
For cohort 3, treatment sequences beginning with capecitabine or pegylated liposomal doxorubicin followed by eribulin was most cost effective.
Notably, the authors found that eribulin – the most expensive treatment with a high expected adverse event burden – performed particularly poorly in the two cohorts in which it was evaluated, “suggesting it should be used last in a sequence, on the basis of cost-effectiveness alone.”
In other words, “more spending on cancer care does not necessarily confer greater health benefits,” said Dr. Wheeler, also a professor of health policy.
“I hope our study will help expand the framework that we use to make these decisions from one where we just think about the biologic action of the drug to one where we also consider the bigger picture of what the treatment experience is like for the patient, including their financial burden, investment of time, and side effects,” study coauthor Katherine E. Reeder-Hayes, MD, section chief of breast oncology at UNC, said in the press release.
The results demonstrate that therapeutic decisions in the endocrine-refractory or triple-negative metastatic setting “may prioritize costs without affecting clinical outcomes” and highlight the direct impact that a “high-quality, transparent, and accessible economic analysis” can have on patient care, Scott D. Ramsey, MD, PhD, of Fred Hutchinson Cancer Research Center, Seattle, and colleagues wrote in an accompanying editorial.
Following the treatment sequences outlined in this study would “reduce patient financial burden and save our health system hundreds of millions of dollars annually,” the editorialists wrote.
As for next steps, Dr. Wheeler and colleagues have developed a financial navigation program to help patients manage their out-of-pocket cancer care costs and are currently scaling up the intervention in nine rural and nonrural oncology practices across North Carolina.
The study was supported by the Center for Disease Control and Prevention through the Prevention Research Centers Program. Dr. Wheeler has received research funding and payment for travel, accommodations, and expenses from Pfizer. Dr. Ramsey has had consulting or advisory roles and has received research funding and/or payment for travel, accommodations, and expenses from Bayer, Genentech, AstraZeneca, Merck, GRAIL, Seattle Genetics, Biovica, and/or Flatiron Health. Because of their editorial roles at the journal, the Journal of Clinical Oncology recused Dr. Wheeler and Dr. Ramsey from having any role in the peer review of their respective manuscripts.
A version of this article first appeared on Medscape.com.
While efficacy and quality of life outcomes are similar across commonly used treatments for endocrine-refractory or triple-negative metastatic breast cancer, the costs of these agents vary widely, a recent analysis reveals.
Notably, the authors found that
Given “razor thin” differences in outcomes, cost should become a major consideration, the researchers concluded.
“As a society, we urgently need more strategies to reduce cancer drug costs without compromising outcomes, and our analysis provides quantifiable evidence to help providers choose lower priced, but equally effective sequences of drugs,” first author Stephanie B. Wheeler, PhD, from the University of North Carolina at Chapel Hill, explained in a press release.
Although the drugs Dr. Wheeler and colleagues studied are reimbursed in the metastatic breast cancer setting, “the optimal sequencing of them has been unclear, which has led to considerable variation in physician preference and practice,” Dr. Wheeler said.
In the study, published in the Journal of Clinical Oncology, Dr. Wheeler and colleagues estimated the cost-effectiveness of different therapeutic options from the first- to third-line setting for this patient population.
The researchers used three dynamic microsimulation computer models to predict how hypothetical sets of 10,000 patients with specific types of metastatic breast cancer would respond to various therapy types and sequences. The cohorts were grouped according to prior chemotherapy exposure: cohort 1 had no taxane or anthracycline exposure, cohort 2 had taxane and anthracycline exposure, and cohort 3 had taxane exposure but was anthracycline naive.
On the basis of feedback from oncologists, the investigators focused on different agents in the three cohorts: paclitaxel, capecitabine, or pegylated liposomal doxorubicin for cohort 1; eribulin, capecitabine, or carboplatin for cohort 2; and pegylated liposomal doxorubicin, capecitabine, or eribulin for cohort 3.
Overall, the models showed “nearly indistinguishable differences” in quality of life. In fact, the “razor-thin incremental differences in quality-adjusted survival” across the treatment sequences often amounted to differences of only a few days or weeks, the authors noted, adding that, even in the most extreme of cases, 3 weeks separated the best and worst options for quality-adjusted life-years.
But the models did show considerable differences in costs.
The authors found that, for cohort 1, treatment with paclitaxel followed by capecitabine and then pegylated liposomal doxorubicin corresponded to the highest expected quality-adjusted life-year gain and the lowest costs – $686 per month versus the highest cost option of $1,765.
For cohort 2, treatment with carboplatin followed by capecitabine and then eribulin corresponded to the highest expected quality-adjusted life-year gain and lowest costs.
For cohort 3, treatment sequences beginning with capecitabine or pegylated liposomal doxorubicin followed by eribulin was most cost effective.
Notably, the authors found that eribulin – the most expensive treatment with a high expected adverse event burden – performed particularly poorly in the two cohorts in which it was evaluated, “suggesting it should be used last in a sequence, on the basis of cost-effectiveness alone.”
In other words, “more spending on cancer care does not necessarily confer greater health benefits,” said Dr. Wheeler, also a professor of health policy.
“I hope our study will help expand the framework that we use to make these decisions from one where we just think about the biologic action of the drug to one where we also consider the bigger picture of what the treatment experience is like for the patient, including their financial burden, investment of time, and side effects,” study coauthor Katherine E. Reeder-Hayes, MD, section chief of breast oncology at UNC, said in the press release.
The results demonstrate that therapeutic decisions in the endocrine-refractory or triple-negative metastatic setting “may prioritize costs without affecting clinical outcomes” and highlight the direct impact that a “high-quality, transparent, and accessible economic analysis” can have on patient care, Scott D. Ramsey, MD, PhD, of Fred Hutchinson Cancer Research Center, Seattle, and colleagues wrote in an accompanying editorial.
Following the treatment sequences outlined in this study would “reduce patient financial burden and save our health system hundreds of millions of dollars annually,” the editorialists wrote.
As for next steps, Dr. Wheeler and colleagues have developed a financial navigation program to help patients manage their out-of-pocket cancer care costs and are currently scaling up the intervention in nine rural and nonrural oncology practices across North Carolina.
The study was supported by the Center for Disease Control and Prevention through the Prevention Research Centers Program. Dr. Wheeler has received research funding and payment for travel, accommodations, and expenses from Pfizer. Dr. Ramsey has had consulting or advisory roles and has received research funding and/or payment for travel, accommodations, and expenses from Bayer, Genentech, AstraZeneca, Merck, GRAIL, Seattle Genetics, Biovica, and/or Flatiron Health. Because of their editorial roles at the journal, the Journal of Clinical Oncology recused Dr. Wheeler and Dr. Ramsey from having any role in the peer review of their respective manuscripts.
A version of this article first appeared on Medscape.com.
While efficacy and quality of life outcomes are similar across commonly used treatments for endocrine-refractory or triple-negative metastatic breast cancer, the costs of these agents vary widely, a recent analysis reveals.
Notably, the authors found that
Given “razor thin” differences in outcomes, cost should become a major consideration, the researchers concluded.
“As a society, we urgently need more strategies to reduce cancer drug costs without compromising outcomes, and our analysis provides quantifiable evidence to help providers choose lower priced, but equally effective sequences of drugs,” first author Stephanie B. Wheeler, PhD, from the University of North Carolina at Chapel Hill, explained in a press release.
Although the drugs Dr. Wheeler and colleagues studied are reimbursed in the metastatic breast cancer setting, “the optimal sequencing of them has been unclear, which has led to considerable variation in physician preference and practice,” Dr. Wheeler said.
In the study, published in the Journal of Clinical Oncology, Dr. Wheeler and colleagues estimated the cost-effectiveness of different therapeutic options from the first- to third-line setting for this patient population.
The researchers used three dynamic microsimulation computer models to predict how hypothetical sets of 10,000 patients with specific types of metastatic breast cancer would respond to various therapy types and sequences. The cohorts were grouped according to prior chemotherapy exposure: cohort 1 had no taxane or anthracycline exposure, cohort 2 had taxane and anthracycline exposure, and cohort 3 had taxane exposure but was anthracycline naive.
On the basis of feedback from oncologists, the investigators focused on different agents in the three cohorts: paclitaxel, capecitabine, or pegylated liposomal doxorubicin for cohort 1; eribulin, capecitabine, or carboplatin for cohort 2; and pegylated liposomal doxorubicin, capecitabine, or eribulin for cohort 3.
Overall, the models showed “nearly indistinguishable differences” in quality of life. In fact, the “razor-thin incremental differences in quality-adjusted survival” across the treatment sequences often amounted to differences of only a few days or weeks, the authors noted, adding that, even in the most extreme of cases, 3 weeks separated the best and worst options for quality-adjusted life-years.
But the models did show considerable differences in costs.
The authors found that, for cohort 1, treatment with paclitaxel followed by capecitabine and then pegylated liposomal doxorubicin corresponded to the highest expected quality-adjusted life-year gain and the lowest costs – $686 per month versus the highest cost option of $1,765.
For cohort 2, treatment with carboplatin followed by capecitabine and then eribulin corresponded to the highest expected quality-adjusted life-year gain and lowest costs.
For cohort 3, treatment sequences beginning with capecitabine or pegylated liposomal doxorubicin followed by eribulin was most cost effective.
Notably, the authors found that eribulin – the most expensive treatment with a high expected adverse event burden – performed particularly poorly in the two cohorts in which it was evaluated, “suggesting it should be used last in a sequence, on the basis of cost-effectiveness alone.”
In other words, “more spending on cancer care does not necessarily confer greater health benefits,” said Dr. Wheeler, also a professor of health policy.
“I hope our study will help expand the framework that we use to make these decisions from one where we just think about the biologic action of the drug to one where we also consider the bigger picture of what the treatment experience is like for the patient, including their financial burden, investment of time, and side effects,” study coauthor Katherine E. Reeder-Hayes, MD, section chief of breast oncology at UNC, said in the press release.
The results demonstrate that therapeutic decisions in the endocrine-refractory or triple-negative metastatic setting “may prioritize costs without affecting clinical outcomes” and highlight the direct impact that a “high-quality, transparent, and accessible economic analysis” can have on patient care, Scott D. Ramsey, MD, PhD, of Fred Hutchinson Cancer Research Center, Seattle, and colleagues wrote in an accompanying editorial.
Following the treatment sequences outlined in this study would “reduce patient financial burden and save our health system hundreds of millions of dollars annually,” the editorialists wrote.
As for next steps, Dr. Wheeler and colleagues have developed a financial navigation program to help patients manage their out-of-pocket cancer care costs and are currently scaling up the intervention in nine rural and nonrural oncology practices across North Carolina.
The study was supported by the Center for Disease Control and Prevention through the Prevention Research Centers Program. Dr. Wheeler has received research funding and payment for travel, accommodations, and expenses from Pfizer. Dr. Ramsey has had consulting or advisory roles and has received research funding and/or payment for travel, accommodations, and expenses from Bayer, Genentech, AstraZeneca, Merck, GRAIL, Seattle Genetics, Biovica, and/or Flatiron Health. Because of their editorial roles at the journal, the Journal of Clinical Oncology recused Dr. Wheeler and Dr. Ramsey from having any role in the peer review of their respective manuscripts.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Experts sound alarm on ruling threatening preventive cancer care
In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”
The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).
Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.
The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.
But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.
After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.
In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.
Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”
In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.
“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.
For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.
“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”
A version of this article first appeared on Medscape.com.
In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”
The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).
Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.
The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.
But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.
After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.
In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.
Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”
In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.
“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.
For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.
“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”
A version of this article first appeared on Medscape.com.
In a statement, the groups highlighted that the decision “would result in a return to financial and other barriers proven to discourage Americans from obtaining lifesaving, preventive care.”
The ruling, issued earlier in September by a federal district judge in Texas, essentially says that the U.S. Preventive Services Task Force has no authority to determine which preventive care services must be fully covered by insurance companies – an ability granted by the Affordable Care Act (ACA).
Judge Reed O’Connor ruled that the method of appointing officers to the USPSTF is unconstitutional, which means the task force’s recommendations for no-cost preventive health care may no longer be guaranteed under the ACA for millions of insured Americans.
The judgment, however, is not yet final, and individuals still have access to these preventive services. The judge must first make the scope of the ruling clear, and the decision will likely be appealed. In addition, the decision does not affect the authority of two other entities that make recommendations about vaccinations and preventive care for infants, children, and adolescents.
But experts are concerned that the ruling will force some individuals to pay out of pocket for preventive cancer screenings and other care that would otherwise have been fully covered by insurance.
After the ruling, a group of 26 patient groups, including the American Cancer Society Cancer Action Network and the Leukemia and Lymphoma Society, took a stand.
In a statement, the groups highlighted that “access to preventive health care can prevent both disease and early death.” Under the ACA, more than 150 million Americans have benefited from expanded access to these services, and research reveals that high-quality coverage – which includes preventive services – improves health, reduces health disparities, and lowers health care costs. “This ruling directly threatens these benefits,” they explained.
Lisa Lacasse, MBA, president of ACS CAN, agreed that the ruling “threatens to erode more than a decade of progress reducing cancer deaths and suffering.”
In a statement, the ACS CAN urged the government to “swiftly appeal” the decision.
“We cannot risk returning to a system wherein every individual has to interpret their complex insurance plans to determine if a recommended mammogram will be covered or to determine how much their colonoscopy may cost,” Ms. Lacasse told this news organization.
For now, Ms. Lacasse urged patients and providers to remember that no changes to coverage requirements will occur while litigation continues.
“All preventive services required under the Affordable Care Act remain in place with no cost sharing for enrollees,” she said. “ACS CAN will continue to support and advocate for coverage of preventive services at no cost sharing.”
A version of this article first appeared on Medscape.com.
FDA warns of cancer risk in scar tissue around breast implants
.
The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.
“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.
One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.
The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.
Reported signs and symptoms included swelling, pain, lumps, or skin changes.
Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.
Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.
The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”
A version of this article first appeared on Medscape.com.
.
The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.
“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.
One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.
The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.
Reported signs and symptoms included swelling, pain, lumps, or skin changes.
Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.
Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.
The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”
A version of this article first appeared on Medscape.com.
.
The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.
“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.
One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.
The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.
Reported signs and symptoms included swelling, pain, lumps, or skin changes.
Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.
Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.
The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”
A version of this article first appeared on Medscape.com.
Drinking black tea linked to lower risk of dying from cardiovascular disease
Drinking tea has several reported health benefits, but most studies have been conducted in regions where green tea predominates.
The findings come from a prospective study of nearly 500,000 participants in the UK Biobank cohort, among whom drinking black tea was common. They suggest that drinking black tea may be associated with a moderately lower all-cause mortality risk, and the risk was lowest among those drinking two or more cups of tea per day.
The study was published online in Annals of Internal Medicine.
During a median follow-up of 11.2 years, those who drank at least two cups of tea each day had a lower all-cause mortality risk, reported Maki Inoue-Choi, PhD, and colleagues from the National Cancer Institute in Bethesda, Md.
After multivariate adjustment, the hazard ratios for death among tea drinkers, compared with no tea intake, were similar across intake levels: 0.95 for daily intake of up to 1 cup, 0.87 for 2-3 cups, 0.88 for 4-5 cups, 0.88 for 6-7 cups, 0.91 for 8-9 cups, and 0.89 for 10 or more cups.
Drinking tea also showed an inverse association with mortality from cardiovascular disease (adjusted HRs ranging from 0.98 to 0.76), ischemic heart disease (aHRs ranging from 1.03 to 0.74), and stroke (aHRs ranging from 0.92 to 0.48 ), However, the researchers added that “no clear trend was seen for cancer or respiratory disease mortality, with associations among higher intake categories tending toward the null.”
There is “no clear answer” as to why no association was observed between tea consumption and cancer mortality in the current study, Dr. Inoue-Choi said at a press briefing. Notably, the effects were apparent regardless of whether milk or sugar was added to tea, tea temperature, or genetic variations in caffeine metabolism among participants.
She and her colleagues controlled for these factors, as well as numerous others that could confound the results, including coffee consumption and baseline health and demographic characteristics..
The study subjects were 498,043 adults with a mean baseline age of 56.5 years. About 85% reported drinking tea, 90% reported drinking black tea, and most drank two to three cups (29%), four to five cups (26%), or six to seven cups (12%) per day.
A limitation of the study is the lack of information on certain aspects of tea intake, such as portion size and tea strength, the authors noted.
Tea is among the most frequently consumed beverages worldwide, and studies from places where green tea is popular, like China and Japan, have demonstrated health benefits. Data from places where black tea is more commonly consumed have been lacking and have provided conflicting results, Dr. Inoue-Choi said.
A presumed mechanism of action related to tea consumption is reduced oxidative stress and inflammation thanks to "polyphenols and flavonoids, namely catechins and their oxidated products," the authors explained. Oxidative stress and inflammation may promote carcinogenesis; therefore, reducing oxidative stress and inflammation may improve endothelial function, they added.
“While these findings may offer reassurance to tea drinkers, they do not indicate that people should start drinking tea or change their tea consumption for health benefits,” Dr. Inoue-Choi said, explaining that “the results need to be replicated in future studies and extended in other diverse populations.”
This study was funded by the National Cancer Institute Intramural Research Program and the NCI division of cancer epidemiology & genetics. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 8/31/22.
Drinking tea has several reported health benefits, but most studies have been conducted in regions where green tea predominates.
The findings come from a prospective study of nearly 500,000 participants in the UK Biobank cohort, among whom drinking black tea was common. They suggest that drinking black tea may be associated with a moderately lower all-cause mortality risk, and the risk was lowest among those drinking two or more cups of tea per day.
The study was published online in Annals of Internal Medicine.
During a median follow-up of 11.2 years, those who drank at least two cups of tea each day had a lower all-cause mortality risk, reported Maki Inoue-Choi, PhD, and colleagues from the National Cancer Institute in Bethesda, Md.
After multivariate adjustment, the hazard ratios for death among tea drinkers, compared with no tea intake, were similar across intake levels: 0.95 for daily intake of up to 1 cup, 0.87 for 2-3 cups, 0.88 for 4-5 cups, 0.88 for 6-7 cups, 0.91 for 8-9 cups, and 0.89 for 10 or more cups.
Drinking tea also showed an inverse association with mortality from cardiovascular disease (adjusted HRs ranging from 0.98 to 0.76), ischemic heart disease (aHRs ranging from 1.03 to 0.74), and stroke (aHRs ranging from 0.92 to 0.48 ), However, the researchers added that “no clear trend was seen for cancer or respiratory disease mortality, with associations among higher intake categories tending toward the null.”
There is “no clear answer” as to why no association was observed between tea consumption and cancer mortality in the current study, Dr. Inoue-Choi said at a press briefing. Notably, the effects were apparent regardless of whether milk or sugar was added to tea, tea temperature, or genetic variations in caffeine metabolism among participants.
She and her colleagues controlled for these factors, as well as numerous others that could confound the results, including coffee consumption and baseline health and demographic characteristics..
The study subjects were 498,043 adults with a mean baseline age of 56.5 years. About 85% reported drinking tea, 90% reported drinking black tea, and most drank two to three cups (29%), four to five cups (26%), or six to seven cups (12%) per day.
A limitation of the study is the lack of information on certain aspects of tea intake, such as portion size and tea strength, the authors noted.
Tea is among the most frequently consumed beverages worldwide, and studies from places where green tea is popular, like China and Japan, have demonstrated health benefits. Data from places where black tea is more commonly consumed have been lacking and have provided conflicting results, Dr. Inoue-Choi said.
A presumed mechanism of action related to tea consumption is reduced oxidative stress and inflammation thanks to "polyphenols and flavonoids, namely catechins and their oxidated products," the authors explained. Oxidative stress and inflammation may promote carcinogenesis; therefore, reducing oxidative stress and inflammation may improve endothelial function, they added.
“While these findings may offer reassurance to tea drinkers, they do not indicate that people should start drinking tea or change their tea consumption for health benefits,” Dr. Inoue-Choi said, explaining that “the results need to be replicated in future studies and extended in other diverse populations.”
This study was funded by the National Cancer Institute Intramural Research Program and the NCI division of cancer epidemiology & genetics. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 8/31/22.
Drinking tea has several reported health benefits, but most studies have been conducted in regions where green tea predominates.
The findings come from a prospective study of nearly 500,000 participants in the UK Biobank cohort, among whom drinking black tea was common. They suggest that drinking black tea may be associated with a moderately lower all-cause mortality risk, and the risk was lowest among those drinking two or more cups of tea per day.
The study was published online in Annals of Internal Medicine.
During a median follow-up of 11.2 years, those who drank at least two cups of tea each day had a lower all-cause mortality risk, reported Maki Inoue-Choi, PhD, and colleagues from the National Cancer Institute in Bethesda, Md.
After multivariate adjustment, the hazard ratios for death among tea drinkers, compared with no tea intake, were similar across intake levels: 0.95 for daily intake of up to 1 cup, 0.87 for 2-3 cups, 0.88 for 4-5 cups, 0.88 for 6-7 cups, 0.91 for 8-9 cups, and 0.89 for 10 or more cups.
Drinking tea also showed an inverse association with mortality from cardiovascular disease (adjusted HRs ranging from 0.98 to 0.76), ischemic heart disease (aHRs ranging from 1.03 to 0.74), and stroke (aHRs ranging from 0.92 to 0.48 ), However, the researchers added that “no clear trend was seen for cancer or respiratory disease mortality, with associations among higher intake categories tending toward the null.”
There is “no clear answer” as to why no association was observed between tea consumption and cancer mortality in the current study, Dr. Inoue-Choi said at a press briefing. Notably, the effects were apparent regardless of whether milk or sugar was added to tea, tea temperature, or genetic variations in caffeine metabolism among participants.
She and her colleagues controlled for these factors, as well as numerous others that could confound the results, including coffee consumption and baseline health and demographic characteristics..
The study subjects were 498,043 adults with a mean baseline age of 56.5 years. About 85% reported drinking tea, 90% reported drinking black tea, and most drank two to three cups (29%), four to five cups (26%), or six to seven cups (12%) per day.
A limitation of the study is the lack of information on certain aspects of tea intake, such as portion size and tea strength, the authors noted.
Tea is among the most frequently consumed beverages worldwide, and studies from places where green tea is popular, like China and Japan, have demonstrated health benefits. Data from places where black tea is more commonly consumed have been lacking and have provided conflicting results, Dr. Inoue-Choi said.
A presumed mechanism of action related to tea consumption is reduced oxidative stress and inflammation thanks to "polyphenols and flavonoids, namely catechins and their oxidated products," the authors explained. Oxidative stress and inflammation may promote carcinogenesis; therefore, reducing oxidative stress and inflammation may improve endothelial function, they added.
“While these findings may offer reassurance to tea drinkers, they do not indicate that people should start drinking tea or change their tea consumption for health benefits,” Dr. Inoue-Choi said, explaining that “the results need to be replicated in future studies and extended in other diverse populations.”
This study was funded by the National Cancer Institute Intramural Research Program and the NCI division of cancer epidemiology & genetics. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
This article was updated 8/31/22.
FROM ANNALS OF INTERNAL MEDICINE
After cancer, abortion experience highlights post-Roe reality
The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.
Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.
No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.
This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.
At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.
But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.
“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”
Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
Imminent danger
On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.
The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.
On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.
This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.
However, legal definitions of what qualifies as “life-threatening” remain murky.
The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?
“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”
Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.
Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.
Some women living in states with abortion bans won’t have the resources to cross state lines for care.
“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
Navigating a crossroads
Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.
Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.
Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.
Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.
Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.
In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.
“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”
Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.
“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.
The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.
Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.
With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.
At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.
But she faced a ticking clock in the event her cancer returned.
If you want to have a baby, “try soon,” her doctor warned.
A dead end
After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.
The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.
But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.
“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.
The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.
She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.
But every road was a dead end.
Ultimately, testing revealed Finley had triploidy, and all lines led to one point.
“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”
However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.
Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.
She welcomed the wait … just in case she changed her mind.
“At that point I wanted to carry him as far as I could,” she says.
For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.
Through this process, her doctor’s support helped keep her grounded.
“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.
Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.
That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.
To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.
Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.
Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.
Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
‘Baby killers work here’
Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”
“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.
“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “
A nurse held her hand during the procedure.
“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.
There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.
His ashes arrived a few weeks later.
By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.
The weeks and months that followed were a blur of grief, anger, and medical testing.
But she received some good news. A second triploidy pregnancy was extremely unlikely.
Several weeks later, Ms. DeSpain got more good news.
“I had a follow-up cancer appointment, and everything was completely clear,” she says.
She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.
“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.
If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.
For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.
In a public post to Facebook, she laid bare her pregnancy journey.
“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”
Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.
Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.
No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.
This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.
At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.
But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.
“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”
Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
Imminent danger
On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.
The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.
On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.
This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.
However, legal definitions of what qualifies as “life-threatening” remain murky.
The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?
“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”
Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.
Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.
Some women living in states with abortion bans won’t have the resources to cross state lines for care.
“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
Navigating a crossroads
Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.
Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.
Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.
Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.
Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.
In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.
“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”
Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.
“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.
The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.
Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.
With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.
At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.
But she faced a ticking clock in the event her cancer returned.
If you want to have a baby, “try soon,” her doctor warned.
A dead end
After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.
The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.
But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.
“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.
The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.
She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.
But every road was a dead end.
Ultimately, testing revealed Finley had triploidy, and all lines led to one point.
“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”
However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.
Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.
She welcomed the wait … just in case she changed her mind.
“At that point I wanted to carry him as far as I could,” she says.
For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.
Through this process, her doctor’s support helped keep her grounded.
“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.
Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.
That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.
To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.
Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.
Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.
Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
‘Baby killers work here’
Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”
“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.
“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “
A nurse held her hand during the procedure.
“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.
There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.
His ashes arrived a few weeks later.
By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.
The weeks and months that followed were a blur of grief, anger, and medical testing.
But she received some good news. A second triploidy pregnancy was extremely unlikely.
Several weeks later, Ms. DeSpain got more good news.
“I had a follow-up cancer appointment, and everything was completely clear,” she says.
She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.
“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.
If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.
For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.
In a public post to Facebook, she laid bare her pregnancy journey.
“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”
Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.
Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.
No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.
This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.
At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.
But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.
“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”
Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
Imminent danger
On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.
The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.
On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.
This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.
However, legal definitions of what qualifies as “life-threatening” remain murky.
The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?
“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”
Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.
Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.
Some women living in states with abortion bans won’t have the resources to cross state lines for care.
“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
Navigating a crossroads
Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.
Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.
Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.
Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.
Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.
In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.
“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”
Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.
“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.
The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.
Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.
With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.
At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.
But she faced a ticking clock in the event her cancer returned.
If you want to have a baby, “try soon,” her doctor warned.
A dead end
After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.
The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.
But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.
“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.
The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.
She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.
But every road was a dead end.
Ultimately, testing revealed Finley had triploidy, and all lines led to one point.
“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”
However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.
Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.
She welcomed the wait … just in case she changed her mind.
“At that point I wanted to carry him as far as I could,” she says.
For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.
Through this process, her doctor’s support helped keep her grounded.
“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.
Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.
That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.
To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.
Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.
Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.
Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
‘Baby killers work here’
Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”
“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.
“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “
A nurse held her hand during the procedure.
“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.
There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.
His ashes arrived a few weeks later.
By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.
The weeks and months that followed were a blur of grief, anger, and medical testing.
But she received some good news. A second triploidy pregnancy was extremely unlikely.
Several weeks later, Ms. DeSpain got more good news.
“I had a follow-up cancer appointment, and everything was completely clear,” she says.
She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.
“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.
If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.
For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.
In a public post to Facebook, she laid bare her pregnancy journey.
“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”
Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.