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Paired phase II trials evaluating cetuximab and radiotherapy

Paired phase II trials evaluating cetuximab and radiotherapy for low risk HPV associated oropharyngeal cancer and locoregionally advanced squamous cell carcinoma of the head and neck in patients not eligible for cisplatin.

Head Neck. 2020 Jan 27. doi: 10.1002/hed.26085. [Epub ahead of print]

Swiecicki PL1,2, Li P3, Bellile E3, Stucken C4, Malloy K4, Shuman A4,5, Spector ME4, Chinn S4, Casper K4, McLean S4, Moyer J4,5, Chepeha D4, Wolf GT4, Prince M4,5, Bradford C4, Nyati M6, Eisbruch A6, Worden FP6, Jolly S6, Mierzwa M6,7.

Author information

1. Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.

2. Department of Internal Medicine, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan.

3. Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan.

4. Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.

5. Department of Otolaryngology, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan.

6. Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.

7. Department of Radiation Oncology, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan.

Abstract

BACKGROUND:

Alternative therapeutic strategies are needed for localized oropharyngeal carcinoma. Cetuximab represents a potential option for those ineligible for cisplatin or, until recently, an agent for de-escalation in low risk HPV+ oropharyngeal carcinoma (OPSCC). Our objective was to define the toxicity and efficacy of cetuximab-radiotherapy.

METHODS:

We conducted paired phase II trials evaluating cetuximab-radiotherapy in two cohorts (a) low risk HPV+ OPSCC and (b) cisplatin ineligible. The mean follow-up was 48 months.

RESULTS:

Forty-two patients were enrolled in cohort A with a 2-year disease free survival (DFS) of 81%. Twenty-one patients were enrolled in cohort B prior to closure due to adverse outcomes with a 2-year DFS of 37%. Severe toxicities were seen in 60% of patients, 30% required enteral nutrition.

CONCLUSION:

Among cisplatin ineligible patients, cetuximab treatment engendered poor outcomes. Rates of severe toxicities were on par with platinum-based regimens suggesting that cetuximab is not a benign treatment.

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