Maintenance Immunotherapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Abstract

The purpose of this study was to determine the efficacy and safety of a maintenance immunotherapy regimen administered to patients with recurrent/metastatic squamous cell carcinoma of the head and neck (RMHN) who showed clinical benefit from docetaxel, ifosfamide, and cisplatin chemotherapy (DIP). Every 4 weeks, patients with RMHN received 60 mg/m docetaxel on day 1, and 1200 mg/m ifosfamide and 20 mg/m cisplatin on days 1 to 4. Low-dose subcutaneous interleukin-2 and oral 13-cis-retinoic acid were administered as maintenance immunotherapy to patients who showed a clinical benefit (complete or partial response, disease stability). The primary end point was response; secondary end points were progression-free survival, overall survival, toxicity, and evaluations of lymphocytes, natural killer cells, and serum vascular endothelial growth factor (VEGF). After a median follow-up of 22 months, 263 courses of chemotherapy were administered to the 54 patients. The overall response rate was 59%. Forty-two patients (78%) had a clinical benefit and received 185 courses of maintenance immunotherapy. Median progression-free survival and overall survival were 11.1 and 21.8 months, respectively. Statistically significant, progressive increases in lymphocytes and natural killer cells and a decrease in VEGF were observed in patients treated with maintenance immunotherapy. The toxicity was relatively well tolerated and caused no death. Outpatient administration of DIP, followed by low-dose interleukin-2 and 13-cis-retinoic acid, was generally well tolerated and showed promising activity against RMHN. Longitudinal changes in lymphocytes, natural killer cells, and VEGF might be useful biomarkers for response and survival.

Tumour growth and immune evasion as targets for a new strategy in advanced cancer

“…In the 100 patients, the median PFS and OS were 37.1 and 57.5 months, respectively. PFS and OS were 44.7 and 64.5, respectively, in the 68 patients with ER+ tumours compared with 32.7 and 51.4, respectively, in the 23 patients with ER− tumours (Recchia et al 2008).…”

Better understanding tumor–host interaction in head and neck cancer to improve the design and development of immunotherapeutic strategies

“…IL‐2 administered as maintenance immunotherapy to patients' responder to chemotherapy showed some immunomodulation (an increase in lymphocytes and NK cells and a decrease of VEGF), but the clinical value of these changes was not assessed 122. In another trial, IL‐2 added to neoadjuvant chemotherapy in patients with advanced head and neck cancer did not show any clinical benefit 123.…”

The final resort treatment options of recurrent head and neck cancer

“…[40] Toma ve ark.nın [40] 26 hasta üzerinde yaptıkları bir çalışmada hastaların %34.6'sında tedaviye yanıt alındığı belirtilirken ortalama sağkalım süresi dokuz ay olarak bildirilmiştir. Recchia ve ark.nın [41] 54 hasta üzerinde yaptıkları bir çalışmada hastaların %59'unda tedaviye yanıt izlendiği bildirilmiştir. Ortalama sağkalım süresi 21.8 ay izlenirken bir yıl ve iki yıl sağkalım oranı sırasıyla %79 ile %39 olarak tespit edilmiştir.…”