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Poster Discussion – Head and neck cancer

2557 - Pembrolizumab and radiotherapy for locally advanced head and neck squamous cell carcinoma (LA-HNSCC) with contraindication to cisplatin therapy

Date

28 Sep 2019

Session

Poster Discussion – Head and neck cancer

Presenters

Siddharth Sheth

Citation

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

Authors

S. Sheth1, J.R. Bauman2, A. Deal1, B. Chera1, C. Shen1, T. Galloway2, T. Hackman1, J. Blumberg1, W. Yarbrough1, M. Weissler1, C. Hilliard1, R. Mehra3, J. Grilley-Olson1, J. Weiss1

Author affiliations

  • 1 Hematology/oncology, University of North Carolina-Lineberger Cancer Center, 27514 - Chapel Hill/US
  • 2 Head And Neck And Thoracic Oncology, Fox Chase Cancer Center, PA 19111 - Philadelphia/US
  • 3 Um Greenebaum Comprehensive Cancer Center, University of Maryland, 21231 - Baltimore/US

Resources

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Abstract 2557

Background

Concurrent bolus cisplatin with radiation therapy (XRT) is a standard of care for the treatment of LA-HNSCC. Contraindications such as hearing loss, tinnitus, renal dysfunction or neuropathy are common. Radiation elicits and promotes tumor-directed immune-stimulation, which may potentiate anti-PD-1 therapy.

Methods

This single arm, multi-institution, phase II study (NCT02609503) enrolled 29 patients (pts) with LA-HNSCC who are platinum ineligible. Patients received XRT concurrently with 3 cycles of pembrolizumab 200mg q3 weeks followed by 3 adjuvant cycles. The primary endpoint was progression free survival (PFS). Acute toxicity included events occurring within 6 months of completing XRT.

Results

The primary reasons for cisplatin ineligibility included abnormal hearing (48.3%), tinnitus (20.7%), nephropathy (17.2%), neuropathy (6.9%) and diabetes with poor control (6.9%). Oropharynx was the most common site of primary disease (20/29, 69.0%), of which 17/20 (85%) were p16 positive. All 29 pts completed 70 Gy XRT while 25 pts (86.2%) received 6 cycles of pembrolizumab. Radiation dermatitis, xerostomia, and mucositis were the most common acute toxicities (Table). Grade 3/4 toxicities were rare except for lymphopenia (17/29, 58.6%). Feeding tube placement (4/29, 13.8%) and treatment associated hospitalizations (3/29, 10.3%) were also uncommon. Currently, 24/29 (82.8%) pts are alive and free of disease progression, with median follow up of 15 months (range 8-29 months).Table: 1117PD

Toxicity code (n, %)Grade 1Grade 2Grade 3Grade 4
Dermatitis radiation8 (27.6)16 (55.2)..
Xerostomia13 (44.8)11 (37.9)..
Mucositis oral2 (6.9)15 (51.7)7 (24.1).
Dysgeusia17 (58.6)6 (20.7)..
Lymphopenia2 (6.9)4 (13.8)15 (51.7)2 (6.9)
Fatigue15 (51.7)3 (10.3)..
Nausea10 (34.4)1 (3.5))2 (6.9).
Dysphagia2 (6.9)8 (27.6)2 (6.9).
Anemia10 (35.5)1 (3.5)..
Weight loss6 (20.7)5 (17.2)..
Neutropenia7 (24.1)3 (10.3)..

Conclusions

This is the first study to report acute toxicities of combining pembrolizumab with radiation in LA-HNSCC. Pembrolizumab does not potentiate typical XRT associated toxicities and no unexpected immune related adverse events were observed. Further, lower rates of feeding tube placement and grade 3/4 dermatitis, xerostomia, and mucositis were noted when compared to RTOG1016 (concurrent XRT with cisplatin or cetuximab in LA-HNSCC).

Clinical trial identification

NCT02609503.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Merck Sharp & Dohme Corp.

Disclosure

All authors have declared no conflicts of interest.

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