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Novel induction regimen associated with favorable outcomes in HNSCC
The novel induction regimen of nab-paclitaxel and cetuximab given with cisplatin and 5-fluorouracil chemotherapy resulted in a high complete response rate at the primary tumor site among patients with squamous cell carcinoma of the head neck, according to results of a phase 2 study.
The researchers enrolled 33 patients aged 18 years or older with untreated stage III or stage Iva/b squamous cell carcinoma of the head and neck (HNSCC). Twenty-two of the 33 patients enrolled had large T3/T4 primary tumors.
Patients were treated with ACPF, which consisted of 100 mg/m2 of nab-paclitaxel a week, 250 mg/m2 cetuximab a week, 75 mg/m2 of cisplatin on day 1, and 5-fluorouracil (5-FU) 750 mg/m2 continuous infusion daily on days 1 to 3. The researchers administered this regimen every 21 days for three cycles, followed by chemotherapy and concurrent radiotherapy.
After two cycles of ACPF treatment, the researchers assessed the patients’ tumor response at the primary site by clinical examination via laryngoscopy in office or the operating room. Complete response at the primary tumor site served as the primary endpoint.
The complete response rate was 53% after two cycles, and the overall response was 100%. At 2 years, OS was 84% and PFS was 65%.
“The novel induction regimen of ACPF was feasible and resulted in a high CR rate (53%) at the primary tumor site even in large (T3 or T4) primary tumors,” the authors wrote. “ACPF did not adversely affect delivery of definitive CRT. The 2-year survival outcomes with ACPF followed by definitive CRT were favorable and warrant further investigation.”
Perspective
Back to TopAdkins and colleagues report on a phase 2 study on an investigational induction chemotherapy regimen adding nab-paclitaxel and cetuximab to cisplatin and 5-fluorouracil [compared with the standard docetaxel, cisplatin and 5-flurouracil (TPF) regimen] in the treatment of locally advanced squamous cell cancers of the head and neck. Using this novel induction chemotherapy regimen, reported response rates are impressive. Complete responses — which include near-complete responses — were 43% by physical examination, although this drops to 14% by CT scan and 24% by FDG-PET/CT. This is not significantly different than the 17% reported for the TAX 324 study with TPF.
In addition, the investigators make two significant changes from TPF: (1) nab-paclitaxel substituted for docetaxel and (2) the addition of cetuximab to the regimen. It is impossible to determine which of these two changes will lead to any benefit in the investigational regimen, if one does exist.
The final issue concerns the placement of induction chemotherapy in the treatment of locally advanced head and neck cancers. Results of the DECIDE and PARADIGM studies, both of which evaluated the additional benefit of TPF to standard concurrent chemotherapy and radiation therapy, were presented at the 2012 ASCO Annual Meeting. Although both studies were stopped early due to poor accrual, neither suggested any benefit with the addition of induction chemotherapy with TPF. Unless new data is presented, induction chemotherapy at this time should not be considered a standard treatment option and only reserved for a few selective scenarios.