Concomitant chemoradiotherapy using low-dose weekly gemcitabine versus low-dose weekly paclitaxel in locally advanced head and neck squamous cell carcinoma: A phase III study
Medical Oncology,  Clinical Article

Halim AAF et al. – The objective of this study was to compare concomitant chemoradiotherapy based on weekly low-dose gemcitabine versus weekly low-dose paclitaxel in locally advanced head and neck squamous cell carcinoma. The regimen based on paclitaxel was significantly more tolerable and effective; however, the difference was not enormous.

Methods

  • Previously untreated patients with locally advanced squamous cell carcinoma of head and neck randomly assigned to 1 of 2 concomitant chemoradiation regimens: (1) weekly gemcitabine at dose of 100 mg/m2 over 30 min 1–2 h before radiotherapy and (2) weekly paclitaxal at dose of 20 mg/m2 over 60 min 4–6 h before radiotherapy
  • Planned radiotherapy dose 65 Gy over 6.5 weeks in 32 settings
  • 216 patients were randomly divided into 2 groups: group A (110 patients) and group B (106 patients) who received concomitant weekly low-dose gemcitabine and low-dose paclitaxal, respectively, with radiotherapy protocol

Results
  • Hematological toxicity generally mild
  • Non-hematologic toxicities severe
  • Grade III mucositis occurred in 36% in group A and in 24% in group B (P = 0.04)
  • Moreover, grade III dermatitis were encountered in 24% in group A and 13% in group B (P = 0.049)
  • Thirty-two (29%) of group A and 18(17%) of group B patients required enteral or parenteral feeding (P = 0.01)
  • Sixteen (15%) of group A and 6 (6%) of group B required enteral or parenteral feeding that lasted for 6 months (P = 0.03)
  • Regarding late effect on swallowing, 8% of patients in group A and 2% of patients in group B required enteral or parenteral feeding for more than 6 months (P = 0.035)
  • Response rates 78 and 89% in groups A and B (P = 0.038)
  • 2-year PFAS figures 54 and 64% of groups A and B
  • 2-year OS figures 56 and 67%
  • 3-year PFS figures 39 and 48% for groups A and B
  • Both concomitant chemoradiotherapy regimens easily given in outpatient clinic

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