Archive for month: August, 2024

In a retrospective analysis in The American Journal of Surgery examining 162 thyroid cancer patients undergoing surgery, researchers revealed a significant association between higher pre-operative Tg levels & increased odds of high-risk disease, corresponding with larger tumor sizes & high-risk histology.

The lower the pre-operative Tg, the more likely the patient will experience an excellent response to therapy following initial surgical management.

“Elevated Tg levels were associated with less favorable responses to initial surgical treatment, indicating its potential usefulness in guiding both initial treatment decisions and subsequent follow-up strategies,” the researchers wrote.

Thyroid cancer generally carries a positive prognosis, yet no pre-operative biochemical marker has demonstrated the ability to differentiate between low and high-risk diseases or reliably predict response to treatment.

Thyroglobulin, a protein produced by thyroid cells, is a valuable biomarker in monitoring thyroid cancer. Elevated levels of Tg before surgery can indicate the presence of residual thyroid tissue or metastasis, guiding clinicians in planning appropriate treatment strategies post-surgery. This measurement is particularly significant for patients undergoing thyroidectomy, where accurate assessment of Tg levels helps predict the likelihood of cancer recurrence.

Against the above background, Martin Jose Barrio, University of Colorado School of Medicine, Aurora, CO, United States, and colleagues retrospectively reviewed patients at our institution with a diagnosis of differentiated thyroid cancer (DTC) to determine the correlation between pre-operative Tg levels with ATA structural risk of recurrence based on surgical histopathology and response to therapy following initial therapy.

They retrospectively reviewed 162 patients who underwent thyroid surgery for thyroid cancer between 2006-2022, in whom a pre-operative thyroglobulin level was measured.

Patients were subdivided into low, intermediate, and high-risk thyroid cancer, and based on their response to therapy per American Thyroid Association (ATA) guidelines.

The following were the key findings of the study:

· As pre-operative Tg level increased, patients were more likely to have high-risk disease.

· There was a linear association between the primary tumor size and high-risk histology with pre-operative Tg.

· Pre-operative Tg level was significantly associated with response to therapy following initial surgical management.

· As pre-operative Tg increases, patients are less likely to achieve an excellent response.

In conclusion, the findings showed that pre-operative thyroglobulin levels had a significant correlation with the ATA’s structural risk of recurrence and response to therapy, suggesting potential utility in directing initial treatment and subsequent follow-up care.

Reference:

Barrio, M. J., Pozdeyev, N., Raeburn, C. D., McIntyre, R. C., Marshall, C. B., Haugen, B., & La Greca, A. (2024). Pre-operative Thyroglobulin Measurement for Thyroid Cancer Risk of Recurrence and Response to Therapy. The American Journal of Surgery, 115818. https://doi.org/10.1016/j.amjsurg.2024.115818

New Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the active postmarketing surveillance (PMS) study of fixed-dose combination (FDC) Levonorgestrel 0.15 mg plus Ethinyloestradiol 0.03 mg tablets.

However, the expert panel stated that the result of the study should be submitted to CDSCO for review by the committee.

This came after Pfizer presented an active postmarketing surveillance (PMS) study protocol before the committee, as per the condition mentioned in Form CT-23 dated 18.12.2023.

Levonorgestrel/ethinyl estradiol is a combination birth control medicine used to prevent pregnancy in women. Levonorgestrel/Ethinyl estradiol contains 2 types of hormones: levonorgestrel (a progestin) and ethinyl estradiol (an estrogen).

Levonorgestrel, also known as the morning-after pill, is a first-line oral emergency contraceptive pill with approval from the World Health Organization to prevent pregnancy. It is FDA-approved to be used within 72 hours of unprotected sexual intercourse or when a presumed contraceptive failure has occurred.

Ethinylestradiol (EE) is an estrogen medication that is widely used in birth control pills in combination with progestins. In the past, EE was widely used for various indications, such as the treatment of menopausal symptoms, gynecological disorders, and certain hormone-sensitive cancers. It is usually taken by mouth but is also used as a patch and vaginal ring.

At the recent SEC meeting for reproductive held on July 4, 2024, the expert panel reviewed the active PMS protocol of the FDC Levonorgestrel plus Ethinyloestradiol.

After detailed deliberation, the committee recommended conducting an active PMS study. Furthermore, the committee added that the result of the study should be submitted to CDSCO for review by the committee.

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New Delhi: The Bureau of Indian Standards (BIS), the National Standards Body of India, has advanced standardisation for the Ayush sector. 

With the establishment of a dedicated standardisation department, the Bureau has expedited standardisation activity in the domain.

The new department focuses on promoting safety, efficacy, and quality of Ayush products and practices, encompassing traditional Indian systems of medicine such as Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa–Rigpa, and Homoeopathy.

While explaining the process and structure of standardisation activity for Ayush, Sh. Pramod Kumar Tiwari, Director General, BIS, stated, “Under the leadership of renowned experts, the Ayush department at BIS has formed seven sectional committees, each addressing a specific Ayush system. These committees work collaboratively with various stakeholders, including experts, scientific and technical institutions, industry representatives, and regulatory bodies, to ensure comprehensive, evidence-based standards aligned with national and international guidelines.”

In a move towards environmental sustainability, BIS has formulated an indigenous Indian Standard for the “Cotton Yoga Mat,” supporting domestic manufacturers and farmers. The department has also identified future standardisation areas, including terminology, single herbs, yoga attire, Siddha diagnostics, and homoeopathic preparations.

While appreciating BIS initiatives, Secretary Ayush, Vaidya Rajesh Kotecha said, “As more people turn to Traditional Healthcare Systems, the need for consistent quality, safety, and efficacy in Ayush products and services is imperative. BIS has reflected its commitment in this area by establishing this dedicated department and developing critical standards, such as IS: 17873 ‘Cotton Yoga Mat’.

These are critical milestones in promoting and developing traditional Indian medicine. Through rigorous standards and innovation, BIS is committed to enhancing the acceptance and growth of Ayush systems nationally and internationally.”