Phase III Study Comparing Cisplatin (C) & 5-Flurouracil (F) Versus Cisplatin & Paclitaxel (T) In Metastatic/Recurrent Head & Neck Cancer (MHNC)
Diana Stripp, MD
University of Pennsylvania Cancer
Last Modified: May 13, 2001
Presenter: B Murphy
Affiliation: Vanderbilt-Ingram Cancer Center
- CF is the standard combination regimen for MHNC. With expected response rate of 30%, medium survival (MS) 6 mos, 1 yr overal survival (OS) of 20%.
- An ECOG trial found paclitaxel is an active agent for the treatment of squamous cell carcinoma of the head and neck.
- Another ECOG trial showed no differences between high and low dose Paclitaxel and Cisplatin.
- This trial was performed to determine if paclitaxel is superior to 5-FU when combined with Cisplatin for the treatment of MHNC
Materials and Methods:
- Eligible patients had untreated metastatic or recurrent head and neck cancer.
- Treatment included: Arm 1: CF Arm 2: CT
- The FACT-HN (quality of life survey) was administered at baseline, 7, 16 and 24 wks.
- The primary outcome measure was 1-year survival.
- 218 pts were enrolled in the study
- There was no significant difference in survival for Arm 1 vs. Arm 2: 1-year survival 41% vs. 34%, p=0.3; median survival 8.8 mo vs. 9.1 mo p=0.85.
- Response rates were not significantly different between the two arms
- Grade 3-5 toxicities (% of pts) for Arms 1 & 2 included: leukopenia 66 vs. 38, granulocytopenia 68 vs 48, thrombocytopenia 19 vs 4, anemia 31 vs 13, infection 19 vs 12, vomiting 15 vs 9, diarrhea 5 vs 0, stomatitis 29 vs 0.
- Quality of life analysis did not showed any statistical differences.
- Better performance status leads to a better outcome.
- There was no significant difference in survival with MS of 9 mons and 1 yr- survival of 41% vs 34%.
- No statically significant difference in quality of life between CT and CF; however, CT is associated with decreased hematologic and GI toxicity.
- This study failed to show superiority of paclitaxel over 5-FU when added to Cisplatin for the treatment of MHNC. CF remains the standard regimen in the treatment of this disease.