A new agent reduces mucosal inflammation in head and neck cancer

A new agent reduces mucosal inflammation in head and neck cancer

CHICAGO – Researchers here report that acute oral mucositis among patients undergoing radiotherapy and platinum chemotherapy for locally advanced head and neck cancer can be significantly reduced by the novel agent avasopasem manganese.

About 64% of patients assigned to placebo had grade 3 or 4 oral mucositis in the ROMAN trial compared with 54% of patients treated with avasopasem manganese, a significant relative risk reduction of 16% (s= 0.045), said Karen Anderson, MD, a radiation oncologist at the University of Iowa in Iowa City.

In her oral presentation at the annual meeting of the American Society of Clinical Oncology, Anderson also reported other benefits with Avasobase manganese:

  • Relatively 56% fewer days of acute oral mucositis: 8 vs. 18 days (s= 0.002)
  • Trend of lower incidence of grade 4 oral mucositis: 24% versus 33% (s= 0.052)
  • Number of days less than grade 4, acute oral mucositis: 5.5 vs 7.2 days (s= 0.143)
  • Relatively 29% longer time to onset of severe oral mucositis: median 38 vs 49 days (s= 0.002)

“Intensity-modulated radiotherapy in addition to cisplatin is a well-established treatment for locally advanced head and neck cancer, but about 70% of patients develop acute oral mucositis, limiting their ability to take in solids or liquids, often requiring feeding via a feeding tube.” Anderson said. “There are no approved medications for acute oral mucositis.”

Anderson demonstrated that manganese Avasopasem is a small selective imitation molecule that converts the superoxide produced by radiotherapy into hydrogen peroxide. The superoxide starts tissue damage and leads to an inflammatory cascade that leads to inflammation of the oral mucosa. She said avasopasem manganese protects normal cells but does not protect cancer cells from radiation therapy.

In the ROMAN trial, patients with an oral cavity or oropharyngeal tumor and locally advanced squamous cell carcinoma were randomized at a ratio of 3:2 to manganese avasospam 90 mg for 7 weeks – infusion for 60 minutes 5 times a week ending approximately 1 hour before radiotherapy Or they were treated with a placebo.

Finally, 241 patients were assigned to the manganese avasopasem and 166 patients to the placebo arm. The mean age of patients was 61 years, and about 86% of men and about 82% were diagnosed with oropharyngeal cancer.

Commenting on the study, James Bonner, MD, chair of radiation oncology at the University of Alabama at Birmingham, said, “We need further follow-up, particularly with regard to cancer outcomes, in order to determine whether this agent can be included in our treatment algorithm.”

“There have been questions that have been raised about whether manganese of avasupasim as a ‘natural tissue protector’ may also protect cancer cells. A natural tissue protector is not useful if it protects cancer from treatment as well — a long-standing problem in our field,” he said.

“We need this information before providing this data,” Bonner said. MedPage today. “I suspect they have undisclosed information, as they say they are already submitting their findings to the Food and Drug Administration for approval. Therefore, there is unlikely to be any evidence that this treatment reduces the results of a standard therapeutic response against tumors.”

Bonner notes that treatment is not a simple procedure:

“This treatment requires an intravenous infusion for an hour before each radiotherapy, and it is nauseating. If the benefit isn’t really great, patients and doctors will be reluctant to expose patients to this onerous treatment.”

He added that clinicians often focus on outcomes related to cancer, but “acute oral mucositis is a problem that detracts from quality of life, and is very important for patients.”

  • Ed Sussman is a freelance medical writer based in Fort Pierce, Florida, USA.

Disclosures

The experiment was supported by Galera Therapeutics.

Anderson revealed his ties to Galera Therapeutics.

Bonner revealed his ties to Merck Serono.

2022-06-06 21:18:03

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