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Randomized phase 2 study of concomitant chemoradiotherapy using weekly carboplatin/paclitaxel with or without daily subcutaneous amifostine in patients with locally advanced head and neck cancer
Cancer, 07/31/09

Haddad R et al. - In a study to investigate the efficacy/toxicity of combining concomitant boost radiation and weekly carboplatin/paclitaxel with or without amifostine in pts with locally advanced squamous cell carcinoma of the head and neck (SCCHN), it was found that 4 wkly doses of carboplatin/paclitaxel with concomitant boost radiation is a highly effective regimen in this pt population with advanced SCCHN. Overall survival (OS) rate was 89%. Time to percutaneous endoscopic gastrostomy removal was prolonged. Amifostine did not improve rates of xerostomia and mucositis with this fairly intensive chemoradiotherapy regimen.

Methods

Pts with newly diagnosed, locally advanced stage III or IV SCCHN received 4 wkly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 wks.
Pts were randomized to subcutaneous daily amifostine at 500 mg (Arm A) or no amifostine (Arm B).
Toxicity data were collected wkly, and saliva collection was performed with and without citric acid stimulation.
To evaluate correlation between serum cytokine levels and severity of oral mucositis, a subset (13 pts in Arm A and 11 in Arm B) of subjects were evaluated at baseline and on alternate wks.

Results

58 pts were enrolled, 29 in each arm.
A majority of pts were men (90%), had stage IV disease (82%), and had the oropharynx as the primary tumor site (60%).
Major toxicities encountered were similar in both arms and included grade 3 mucositis (75% in Arm A and 70% in Arm B) and grade 2 xerostomia (41% in both arms).
Median number of amifostine doses delivered was 28, with skin toxicity (grade 3 in 11 pts) as the limiting factor.
Saliva production showed no difference between the arms.
Median follow-up was 34 mos, and only 5 failures had been encountered (2 local and 3 distant) at last follow-up, with an OS rate of 89%.
Neck dissection was performed in 25 pts; 5 pts demonstrated persistent disease and 4 pts were alive without disease recurrence at last follow-up.
Median time to percutaneous endoscopic gastrostomy removal was 9.6 mos in Arm A and 10.4 mos in Arm B.
Only 1 pt remained percutaneous endoscopic gastrostomy-dependent at last follow-up.
Correlation was noted between levels of selected cytokines and mucositis severity, in which higher levels of proinflammatory cytokines (tumor necrosis factor, interleukin [IL]-1, and IL-6) and lower levels of anti-inflammatory cytokines (IL-13) were noted.
No changes in C-reactive protein levels were noted.