Abstract
To retrospectively evaluate the efficacy and safety of modified TPEx (docetaxel 60 mg/m2 on day 1, cisplatin 60 mg/m2 on day 1, and weekly cetuximab 250 mg/m2 with loading dose of 400 mg/m2) followed by maintenance cetuximab as first-line treatment for inoperable recurrent and/or metastatic squamous cell carcinoma of the head and neck. We analyzed 22 Japanese patients receiving modified TPEx every 21 days for four cycles with or without prophylactic granulocyte colony-stimulating factor (G-CSF). The best overall response rate was 55% [95% confidence interval (CI)=35-73]. The median progression-free survival and overall survival were 8.9 months (95%CI=3.9-10.2) and 14.3 months (95%CI=10.1-28.2), respectively. Without prophylactic G-CSF, Grade 3/4 neutropenia and febrile neutropenia was common (94% versus 20%; p=0.003 and 41% versus 0%; p=0.11, respectively). The modified TPEx is effective, while prophylactic G-CSF is essential.
Highlights
A phase III trial established six cycles of cisplatin and 5fluorouracil (5-FU) in combination with cetuximab (EXTREME regimen: cisplatin 100 mg/m2 on day 1, 5-FU 1000 mg/m2/day on days [1-4], and weekly cetuximab 250 mg/m2 with loading dose of 400 mg/m2) followed by maintenance weekly cetuximab 250 mg/m2 as the standard of first-line treatment for
We evaluated the efficacy of modified TPEx regimen as first-line treatment for patients with recurrent/metastatic HNSCC, and found that median overall survival (OS) was 14.3 months
Given that median OS for original TPEx regimen was 14.0-14.5 months (2, 3), the modified TPEx regimen seems comparable with the original TPEx regimen in efficacy, it is difficult to draw a firm conclusion from comparison across studies
Summary
A phase III trial established six cycles of cisplatin and 5fluorouracil (5-FU) in combination with cetuximab (EXTREME regimen: cisplatin 100 mg/m2 on day 1, 5-FU 1000 mg/m2/day on days [1-4], and weekly cetuximab 250 mg/m2 with loading dose of 400 mg/m2) followed by maintenance weekly cetuximab 250 mg/m2 as the standard of first-line treatment for. Under prophylactic use of granulocyte colony-stimulating factor (GCSF), grade 3/4 neutropenia was observed in 20% of the patients, and 7% of the patients developed grade 3 febrile neutropenia (FN) Given these promising results, the phase III trial, termed as TPExtreme, was conducted to compare the efficacy between EXTREME and TPEx regimens (3). Maintenance cetuximab was modified from biweekly 500 mg/m2 to weekly 250 mg/m2 We started using this modified TPEx regimen as first-line treatment for Japanese patients with recurrent/metastatic HNSCC without prophylactic. We retrospectively evaluated the efficacy and safety of modified TPEx with respect to prophylactic G-CSF
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