Researchers identify promising treatment regimen for head and neck squamous cell carcinoma
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Neoadjuvant chemotherapy and surgery followed by risk-adapted adjuvant therapy produced “excellent” outcomes among patients with head and neck squamous cell carcinoma, study data showed.
“The treatment of locally advanced head and neck cancer has evolved substantially, with chemoradiotherapy offering an alternative to large, morbid surgical resections,” Jared M. Weiss, MD, associate professor in the School of Medicine at University of North Carolina, Chapel Hill, and colleagues wrote. “More recently, transoral endoscopic head and neck surgery has offered select patients a less invasive surgical option with low morbidity, low blood loss, excellent functional and cosmetic outcomes, and rapid recovery.”
The researchers performed a phase 2 trial that included 40 patients with transorally resectable, stage III or stage IV HNSCC. Both HPV-positive and -negative cancers were included in the study.
Patients who had pathology with margins of less than 5 mm, extracapsular extension, N2a lymph node status, perineural invasion or lymphovascular space invasion received adjuvant radiotherapy and concurrent weekly cisplatin. Those who had pathology with N2c or N3 lymph node status or positive margins received radiation with bolus cisplatin.
The main outcome was clinical response rate to induction therapy; feasibility served as a secondary outcome.
Thirty-seven patients completed the study.
The rate of clinical response was 93%, and the pathologic complete response rate was 36%.
Researchers observed no association between clinical response and pathologic complete response.
In general, toxicity was modest. Diarrhea was the most common adverse event, occurring at grade 1 and grade 2 among 38% of patients and at grade 3 and grade 4 among 5%. Neutropenia occurred among 18% of patients at grade 1 and grade 2 and 38% of patients at grade 3 and grade 4.
No patients died or experienced recurrence during follow-up.
Of 39 patients who underwent surgery, 29 avoided radiation.
Patients’ swallowing and speech functions were well-preserved.
“We do not believe that these results are practice-changing and did not intend them to be so at the time of study design,” the researchers wrote. “However, we do believe that these results can meaningfully impact future investigations.”
Weiss and colleagues added that they have begun a study of weekly carboplatin, nanoparticle albumin-bound-paclitaxel and durvalumab (Imfinzi, AstraZeneca). – by Andy Polhamus
Disclosures: The authors report no relevant financial disclosures.