Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 3

2576 - Interim analysis of a single arm phase 2 study of adjuvant nivolumab after salvage resection in head and neck squamous cell carcinoma patients previously treated with definitive therapy.

Date

30 Sep 2019

Session

Poster Display session 3

Topics

Tumour Site

Head and Neck Cancers

Presenters

Trisha Wise-draper

Citation

Annals of Oncology (2019) 30 (suppl_5): v449-v474. 10.1093/annonc/mdz252

Authors

T. Wise-draper1, S. Haque2, A. Steele1, S. Desai1, T. Harris1, M.K. Riaz1, J.C. Morris1, V. Takiar1, M. Nagasaka3, R. Jandarov1, A. Sukari4

Author affiliations

  • 1 Hematology Oncology, Cincinnati Hematology Oncology, 45267 - Cincinnati/US
  • 2 Oncology, Merck, 17868 - Riverside/US
  • 3 Oncology, Karmanos Cancer Institute, 48201-2013 - Detroit/US
  • 4 Oncology, Karmanos, 48201 - Detroit/US

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2576

Background

Surgical salvage is often the only potentially curative treatment in patients with recurrent head and neck squamous cell carcinoma (HNSCC). However, local control rates after salvage remain at 33-50% with a dismal long term overall survival of 20-40%. Many patients are ineligible for re-irradiation and chemotherapy alone has no survival benefit after salvage surgery necessitating new therapies. Although immune checkpoint inhibitors have demonstrated clinical activity in the metastatic setting, immunotherapy has not been explored after salvage surgery. Therefore, we initiated a multi-center Phase II investigation of adjuvant nivolumab after salvage resection in HNSCC patients (NCT03355560) supported by BMS.

Methods

HNSCC patients who failed definitive radiation, subsequently treated with curative intent salvage resection, were enrolled to receive 6 months of nivolumab beginning 4 to 11 weeks after surgery. Safety was evaluated with CTCAE v5.0 and disease free survival (DFS) was evaluated using time to event endpoints and Kaplan-Meier curves.

Results

Eighteen of 35 planned patients have been enrolled. Median age is 70 years (range, [45-85]), 4/18 (22%) were female, 17/18 (94%) were white, disease sites included oropharyngeal 3/18 (17%), oral cavity 8/18 (44%) and larynx 7/18 (39%), and 5/18 (28%) had high risk (positive margins or extranodal spread) pathological features. Four patients have recurred with DFS estimated at 55% at 10.2 months. Although estimated DFS is less than the predicted 62.3% DFS at 10.2 months (extrapolated from 2-year DFS of 33%), the chi-square p-value was 0.861 suggesting there is not enough evidence to reject the null hypothesis and the trial should proceed to the 2nd stage. Most common adverse events included fever (22%), fatigue (17%), arthralgias (22%), cough (28%) and infections (28%) most of which were unrelated. Grade 3 related events included arthralgia and cough.

Conclusions

Adjuvant nivolumab after salvage surgery in HNSCC patients is safe however, increased enrollment is required to establish efficacy.

Clinical trial identification

NCT03355560.

Editorial acknowledgement

Legal entity responsible for the study

Trisha Wise-Draper.

Funding

BMS.

Disclosure

T. Wise-Draper: Research grant / Funding (self): BMS; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): Merck; Research grant / Funding (institution): Tesaro. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.