The lancet oncology
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The lancet oncology · Sep 2023
ReviewRadiotherapy resources in Latin America and the Caribbean: a review of current and projected needs based on International Atomic Energy Agency data.
The inequitable access to radiotherapy globally is a complex undertaking that will require sustained work identifying gaps and mobilising efforts to resolve. The purpose of this review is to identify gaps and needs in radiotherapy in Latin America and the Caribbean. Data from 41 countries in Latin America and the Caribbean on teletherapy megavoltage units and brachytherapy resources were extracted from the International Atomic Energy Agency (IAEA) Directory of Radiotherapy Centers. ⋯ There is inequitable distribution of brachytherapy resources across the region primarily in the Caribbean. Adoption of hypofractionation can help overcome machine shortage; however, it will present technical challenges that need to be taken into account. Rays of Hope, is a novel IAEA initiative that is designed to mobilise global efforts to address radiotherapy gaps while ensuring the highest return on investment.
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The lancet oncology · Sep 2023
ReviewWithdrawn accelerated approvals for cancer indications in the USA: what is the marketing authorisation status in the EU?
As of April, 2023, 23 accelerated approvals for cancer indications granted by the US Food and Drug Administration (FDA) since 1992 have been withdrawn from the US market, with 17 (74%) of 23 withdrawn in the past 3 years. The marketing authorisation status of these indications in the EU has not been reported. A review of relevant documents from the FDA and the European Medicines Agency (EMA) was done to investigate whether the accelerated approvals for cancer indications withdrawn by the FDA have a marketing authorisation in the EU to date, and to compare the approval history of these indications by the EMA and FDA. ⋯ By comparison, only two conditional marketing authorisations for cancer indications have been withdrawn from the EU; both are no longer approved in the USA. These findings indicate a discrepancy in the approval policies between the FDA and EMA and imply either that some patient groups in the USA do not get access to relevant medical treatment, or that some patient groups in the EU are treated with medicine without a positive benefit-risk balance. These discrepancies could potentially be reduced by increased collaboration and information sharing between the two agencies.
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The lancet oncology · Sep 2023
Randomized Controlled TrialTumour stage, treatment, and survival of women with high-grade serous tubo-ovarian cancer in UKCTOCS: an exploratory analysis of a randomised controlled trial.
In UKCTOCS, there was a decrease in the diagnosis of advanced stage tubo-ovarian cancer but no reduction in deaths in the multimodal screening group compared with the no screening group. Therefore, we did exploratory analyses of patients with high-grade serous ovarian cancer to understand the reason for the discrepancy. ⋯ National Institute for Health Research, Medical Research Council, Cancer Research UK, The Eve Appeal.
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The lancet oncology · Sep 2023
Randomized Controlled TrialNeoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study.
The development of more potent selective oestrogen receptor antagonists and degraders (SERDs) that can be orally administered could help to address the limitations of current endocrine therapies. We report the primary and final analyses of the coopERA Breast Cancer study, designed to test whether giredestrant, a highly potent, non-steroidal, oral SERD, would show a stronger anti-proliferative effect than anastrozole after 2 weeks for oestrogen receptor-positive, HER2-negative, untreated early breast cancer. ⋯ F Hoffmann-La Roche.
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The lancet oncology · Sep 2023
Combined cytotoxic and immune-stimulatory gene therapy for primary adult high-grade glioma: a phase 1, first-in-human trial.
High-grade gliomas have a poor prognosis and do not respond well to treatment. Effective cancer immune responses depend on functional immune cells, which are typically absent from the brain. This study aimed to evaluate the safety and activity of two adenoviral vectors expressing HSV1-TK (Ad-hCMV-TK) and Flt3L (Ad-hCMV-Flt3L) in patients with high-grade glioma. ⋯ Funded in part by Phase One Foundation, Los Angeles, CA, The Board of Governors at Cedars-Sinai Medical Center, Los Angeles, CA, and The Rogel Cancer Center at The University of Michigan.