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Safety and Efficacy of Avelumab in Small Bowel Adenocarcinoma.

Publication ,  Journal Article
Cardin, DB; Gilbert, J; Whisenant, JG; Ayers, GD; Jalikis, F; Dahlman, KB; O'Neal, JF; Revetta, F; Shi, C; Berlin, J
Published in: Clin Colorectal Cancer
September 2022

INTRODUCTION: Small bowel adenocarcinomas (SBAs) are rare and frequently treated like large intestinal adenocarcinomas. However, SBAs have a very different microenvironment and could respond differently to the same therapies. Our previous data suggested that SBAs might benefit from targeting the PD-1/PD-L1 axis based on PD-L1 staining in almost 50% of SBA tissue samples tested. Thus, we designed a phase 2 study to explore safety and efficacy of avelumab in SBA. PATIENTS AND METHODS: Patients with advanced or metastatic disease were enrolled; ampullary tumors were considered part of the duodenum and allowed. Prior PD-1/PD-L1 inhibition was not allowed. Avelumab (10 mg/kg) was given every 2 weeks, and imaging was performed every 8 weeks. Primary endpoint was response rate. RESULTS: Eight patients (n = 5, small intestine; n = 3, ampullary) were enrolled, with a majority (88%) being male and a median age of 61 years. Of 7 efficacy-evaluable patients, 2 (29%) experienced partial responses; stable disease occurred in 3 additional patients (71%). Median progression-free survival was 3.35 months. Most frequent, related toxicities were anemia, fatigue, and infusion-related reaction (25% each), mostly grade ≤2; grade 3 hypokalemia and hyponatremia occurred in one patient, and another reported grade 4 diabetic ketoacidosis. CONCLUSIONS: Despite the observed benefit, accrual was slower than expected and the study was closed early due to feasibility. A general clinic observation was that patients were receiving immunotherapy off-label as the availability of these agents increased. Off-label availability and disease rarity were likely drivers of insufficient accrual.

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Published In

Clin Colorectal Cancer

DOI

EISSN

1938-0674

Publication Date

September 2022

Volume

21

Issue

3

Start / End Page

236 / 243

Location

United States

Related Subject Headings

  • Tumor Microenvironment
  • Programmed Cell Death 1 Receptor
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Intestine, Small
  • Humans
  • Female
  • B7-H1 Antigen
  • Antibodies, Monoclonal, Humanized
 

Citation

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Cardin, D. B., Gilbert, J., Whisenant, J. G., Ayers, G. D., Jalikis, F., Dahlman, K. B., … Berlin, J. (2022). Safety and Efficacy of Avelumab in Small Bowel Adenocarcinoma. Clin Colorectal Cancer, 21(3), 236–243. https://doi.org/10.1016/j.clcc.2022.03.003
Cardin, Dana B., Jill Gilbert, Jennifer G. Whisenant, Gregory D. Ayers, Florencia Jalikis, Kimberly B. Dahlman, Jamye F. O’Neal, Frank Revetta, Chanjuan Shi, and Jordan Berlin. “Safety and Efficacy of Avelumab in Small Bowel Adenocarcinoma.Clin Colorectal Cancer 21, no. 3 (September 2022): 236–43. https://doi.org/10.1016/j.clcc.2022.03.003.
Cardin DB, Gilbert J, Whisenant JG, Ayers GD, Jalikis F, Dahlman KB, et al. Safety and Efficacy of Avelumab in Small Bowel Adenocarcinoma. Clin Colorectal Cancer. 2022 Sep;21(3):236–43.
Cardin, Dana B., et al. “Safety and Efficacy of Avelumab in Small Bowel Adenocarcinoma.Clin Colorectal Cancer, vol. 21, no. 3, Sept. 2022, pp. 236–43. Pubmed, doi:10.1016/j.clcc.2022.03.003.
Cardin DB, Gilbert J, Whisenant JG, Ayers GD, Jalikis F, Dahlman KB, O’Neal JF, Revetta F, Shi C, Berlin J. Safety and Efficacy of Avelumab in Small Bowel Adenocarcinoma. Clin Colorectal Cancer. 2022 Sep;21(3):236–243.
Journal cover image

Published In

Clin Colorectal Cancer

DOI

EISSN

1938-0674

Publication Date

September 2022

Volume

21

Issue

3

Start / End Page

236 / 243

Location

United States

Related Subject Headings

  • Tumor Microenvironment
  • Programmed Cell Death 1 Receptor
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Intestine, Small
  • Humans
  • Female
  • B7-H1 Antigen
  • Antibodies, Monoclonal, Humanized