385P - Pembrolizumab for cisplatin-failure recurrent/metastatic head and neck squamous cell carcinoma

Date 17 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Immunotherapy
Head and Neck Cancers
Presenter Wen-Chun Chen
Citation Annals of Oncology (2016) 27 (suppl_9): ix112-ix122. 10.1093/annonc/mdw587
Authors W. Chen1, P.M. Chang2, Y. Lee3, W. Lu4, M. Yang2
  • 1Medicine, Taipei Veterans General Hospital, 11217 - Taipei/TW
  • 2Department Of Oncology, Taipei Veterans General Hospital, 11217 - Taipei/TW
  • 3Department Of Medicine, Taipei Veterans General Hospital, 11217 - Taipei/TW
  • 4Department Of Medical Oncology, Changzhou Wujin People's Hospital, 213002 - Changzhou/CN



Head and neck squamous cell carcinoma (HNSCC) ranked the top cancer occurrence and death in Taiwan. For recurrent/metastatic (R/M) HNSCC, there is still no effective salvage therapy to prolong life expectancy. Anti-PD1 therapy has the potential of clinical benefit for this group of patients.


Seventeen R/M HNSCC patients who had accepted at least one-line cisplatin containing regimens and progressed and then received anti-PD1 monoclonal antibody pembrolizumab as salvage therapy were enrolled for analysis. Pembrolizumab was given with fixed dose 100 mg every three weeks. Three patients were combined with local palliative radiation. No other chemo or target drugs were combined with pembrolizumab.


There were seven patients (41.2%) receiving more than three cycles of pembrolizumab therapy. Based on RECIST criteria v1.1, two patients (11.8%) had partial response and one patient (5.9%) had stable disease, with disease control rate (14.7%). Five patients had confirmed progress disease while two of them had continuous progression over target lesion after shrinkage of other metastases. One patient developed immune-related pneumonitis and resolved quickly after steroid treatment. No other severe adverse effects were detected among all the patients.rn

Table: 385P Patient characteristics (n = 17)

N (%), median (range)
Age60.9 (36.8 − 87.0)
M12 (70.6)
F5 (29.4)
Primary site
Oral cavity5 (29.4)
Oro/hypopharynx/Larynx8 (47.1)
Unknown primary site4 (23.5)
Previous Definite therapy
Surgery + RT4 (23.5)
Surgery + CCRT4 (23.5)
CCRT6 (47.1)
Chemotherapy1 (5.9)
Lines of systemic therapies beyond recurrence or metastasis
0-111 (64.7)
≥ 26 (35.3)
Previous systemic therapies
Cisplatin + 5-FU9(52.9)
Completion of RT to Immunotherapy
> 6 months6 (35.3)
≤ 6 months8 (47.1)
incorporated with immunotherapy3 (17.6)
Pembrolizumab dose (mg/Kg)1.7 (1.2 − 4.6)
Fixed 100 mg16 (94.1)
Fixed 200 mg1(5.9)

Based on RECIST criteria (version 1.1)


Two patients had discordant response between different lesions



Pembrolizumab is beneficial and well-tolerated for some refractory R/M HNSCC patients. How to identify the biomarkers for responsive patients is important for the trial design in the future.

Clinical trial indentification

Legal entity responsible for the study

Taipei Veterans General Hospital


Taipei Veterans General Hospital


All authors have declared no conflicts of interest.