Modified biweekly cisplatin, docetaxel plus cetuximab (TPEx) as first-line treatment for patients with recurrent/metastatic head and neck cancer

Abstract

Three weekly high-dose chemotherapy regimens in combination with weekly cetuximab are the treatment of choice for patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (SCCHN), although the majority of patients suffer from severe side effects. Thus, we investigated the efficacy and safety of an alternative, more convenient and less toxic biweekly modified cisplatin, docetaxel plus cetuximab (TPEx) regimen in this retrospective analysis. Thirty-eight patients receiving off-protocol cisplatin (50 mg/m2) in combination with docetaxel (50 mg/m2) plus cetuximab (500 mg/m2) every other week were included. Data collection included baseline demographic, response rate (ORR) and toxicity data as well as disease control rate, overall survival (OS) and progression-free survival (PFS). The median age was 60 years, and the majority of patients suffered from oral cavity carcinomas (44.7%) followed by oropharyngeal (28.9%) and laryngeal (17.9%) carcinomas. The ORR was 50%, and four (10.5%) patients achieved a complete response, while 15 (39.5%) patients had a partial response. The OS and PFS were 10.8 months (95% CI 6.7–14.2) and 6.3 months (95% CI 5.7–6.8), respectively. The one-year survival rate was 44.7%. The therapy was well tolerated, and the most common grade 3/4 adverse events were myelosuppression (13.2%), hypomagnesaemia (23.7%) and acne-like rash (13.1%). In conclusion, modified biweekly TPEx is of comparable efficacy with conventional TPEx and represents a well-tolerated regimen in R/M SCCHN patients. Further evaluation of this protocol in prospective clinical trials is warranted.

Maintenance Therapy with Biweekly Cetuximab: Optimizing Schedule Can Preserve Activity and Improves Compliance in Advanced Head and Neck Cancer

“…Acneiform rash was the most common toxicity of any grade (66%), and rash was also the most common grade 3 toxicity (11%). These findings are similar to the skin toxicity experiences reported in prior studies of standard weekly or 500 mg/m 2 q2w dosing of cetuximab [18,23,24].…”

“…This study promotes the idea that the biweekly schedule improves compliance and patients' quality of life [23]. Very recently, other data have enforced the idea that biweekly cetuximab also in association with other chemotherapeutics has comparable toxicity and efficacy [24]. However, until now, no randomized head-to-head studies comparing weekly and biweekly regimen in SCCHN patients were performed.…”

Cisplatin, Docetaxel and Cetuximab (TPEx) as First-line Treatment for Patients With Recurrent or Metastatic Head and Neck Cancer: A Multicenter Real-World Study

“…Given that not all patients can tolerate the EXTREME regimen, alternative treatment protocols were developed, mostly replacing 5-uorouracil by taxanes. The phase 2 GORTEC study evaluated fty-four patients with R/M SCCHN using cisplatin, docetaxel, and cetuximab in the rst-line setting 14 22 . In this study, the median OS, PFS, and ORR were 10.8 months, 6.3 months, and 50%, respectively.…”

Targeting mTOR-CCL20 Signaling May Improve Response to Docetaxel in Head and Neck Squamous Cell Carcinoma

“…Chemotherapy agents that include platinum-based agents and taxanes have been used widely on patients with advanced HNSCC. Cisplatin is the backbone of the chemotherapy agents used to treat HNSCC, but the taxanes have been clinically adopted only in the setting of induction chemotherapy [ 4 , 5 ] or for palliative purposes after the failure of CRT [ 6 , 7 ].…”