For patients with locally advanced head neck squamous cell carcinoma People who cannot tolerate platinum chemotherapy Docetaxel It’s a healthy alternative for increasing sensitivity to radiation therapy, researchers report. Phase 3 trial from india.
“This is the first randomized study to demonstrate the benefit of alternative radiosensitizers in cisplatin-ineligible patients,” they point out.
“The use of docetaxel as a radiosensitizer in patients ineligible for cisplatin has been shown to improve disease-free survival, locoregional control, and overall survival, without impacting quality of life, compared with the use of radiation alone. We found that it improved the rate of our patients,” the team reports.
investigators led by Vijay Marti Patil, MD, DMa medical oncologist at Mumbai’s Tata Memorial Hospital stopped the trial early after the benefits of adding docetaxel became apparent.
Cisplatin Although it is a common standard of care for sensitizing locally advanced head and neck tumors to radiotherapy, up to one-third of patients are affected by age, declining renal function, hearing lossand other issues, they point out.
Many alternatives to cisplatin have been used in this setting, but to date there has been no Level 1, Phase 3 evidence to guide selection.
cetuximab is the most frequently used alternative in the United States, but the supporting evidence was generated in trials in cisplatin-eligible patients, researchers note. There is also a high incidence of skin and other toxicities, with some studies pointing to less-than-ideal survival outcomes.
new research publish online on December 9th Journal of Clinical Oncology.
It “indicates what could be estimated but not known to be true in cisplatin-ineligible contexts: radiosensitizers improve outcomes over radiotherapy alone,” the paper said. author commented. Accompanying editorial.
“Docetaxel belongs to the go-to regimen armament,” they declare. Lauren Mel, M.D.University of California, San Diego, and Medical Oncologist Stuart Wong, M.D.Wisconsin Medical College, Milwaukee.
This research “closes an important gap in the world. head and neck cancer In literature, since [docetaxel] “Because it was not head-to-head compared with other radiosensitizer options, it should not be declared the only standard. It is time to discuss which (if any) is the most effective, and we need to define the standard of care,” they add.
Survey details
The trial randomized 356 adults who were ineligible for cisplatin equally to radiation alone or radiation plus docetaxel 15 mg/m.2 Once a week for up to 7 cycles. The investigator planned to enroll 600 of her patients, but stopped the trial early when it became clear that docetaxel improved survival.
Addition of docetaxel improved 2-year disease-free survival (42% vs. 30.3%; hazard ratio [HR]0.673; P. = .002); 2-year overall survival (50.8% vs 41.7%; HR, 0.747; P. = .035), and the 2-year locoregional failure rate (41.8% vs. 54.7%; HR, 0.661; P. = .002).
Median overall survival was 25.5 months in the docetaxel group and 15.3 months in the radiation-only group (P. = .035).
The benefit of docetaxel was most pronounced in patients with primary hypopharyngeal sites, in 61% of patients ultimately treated. There was “probably” benefit in the adjuvant therapy setting, but “further research will be needed to show definitive applicability,” the researchers said.
Grade ≥3 mucositis (49.7% vs. 22.2%), dysphagia (52.5% vs. 33.5%), and Dysphagia (33%), but “complications were manageable and did not affect compliance with either radiotherapy or docetaxel,” the team reported. Overall, his 86% of patients received his 5 or more cycles of docetaxel.
In an editorial, Mel and Wong noted that “the majority of patients did not receive intensity-modulated radiotherapy, which is standard in high-income countries,” but that “the use of conventional radiotherapy was associated with the efficacy of docetaxel.” I don’t think it degrades sex,” he added. .”
This trial was funded by Tata Memorial Hospital, where it was conducted. Several researchers had industry ties, including Patil, who reported research funding from Johnson & Johnson/Janssen, AstraZeneca, Intus, Natco Pharma, Eisai Germany and Novartis. Mell is an advisor to Cel-Sci, and Merck and he report research funding from AstraZeneca. Wong revealed research funding from Novartis and Merck.
J Clin On CallPublished online on December 9, 2022. overview, editorial
M. Alexander Otto is a Physician Assistant with a Master of Medicine and Journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news organizations before joining Medscape. Alex is also an MIT Knight Science Journalism Fellow. Email: aotto@mdedge.com.
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