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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

Background:

1. 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%.
2. An ECOG trial found paclitaxel is an active agent for the treatment of squamous cell carcinoma of the head and neck.
3. Another ECOG trial showed no differences between high and low dose Paclitaxel and Cisplatin.
4. 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:

1. Eligible patients had untreated metastatic or recurrent head and neck cancer.
2. Treatment included: Arm 1: CF Arm 2: CT
3. The FACT-HN (quality of life survey) was administered at baseline, 7, 16 and 24 wks.
4. The primary outcome measure was 1-year survival.

Results:

1. 218 pts were enrolled in the study
2. 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.
3. Response rates were not significantly different between the two arms
4. 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.
5. Quality of life analysis did not showed any statistical differences.
6. Better performance status leads to a better outcome.

Authors' Conclusions

1. There was no significant difference in survival with MS of 9 mons and 1 yr- survival of 41% vs 34%.
2. No statically significant difference in quality of life between CT and CF; however, CT is associated with decreased hematologic and GI toxicity.

Clinical/Scientific Implications:

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.