Journal of Clinical Oncology, Vol 10, 1245-1251, Copyright © 1992 by American Society of Clinical Oncology
Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: a Southwest Oncology Group study
AA Forastiere, B Metch, DE Schuller, JF Ensley, LF Hutchins, P Triozzi, JA Kish, S McClure, E VonFeldt and SK Williamson
University of Michigan Medical Center, Ann Arbor.
PURPOSE: The Southwest Oncology Group (SWOG) conducted a randomized
comparison of cisplatin plus fluorouracil (5-FU) and carboplatin plus 5- FU
versus single-agent methotrexate (MTX) in patients with recurrent and
metastatic squamous-cell carcinoma (SCC) of the head and neck. The primary
objective was to compare separately the response rates of each combination
regimen to standard weekly MTX. PATIENTS AND METHODS: Two hundred
seventy-seven patients diagnosed with SCC of the head and neck were
randomized to one of three treatments: (1) cisplatin 100 mg/m2
intravenously (IV) on day 1 and 5-FU 1,000 mg/m2 per day for a 96-hour
continuous infusion repeated every 21 days; (2) carboplatin 300 mg/m2 IV on
day 1 and 5-FU 1,000 mg/m2 per day for a 96-hour continuous infusion
repeated every 28 days; and (3) MTX 40 mg/m2 IV given weekly. RESULTS: All
three treatment regimens were well tolerated. However, both hematologic and
nonhematologic toxicities were significantly greater with cisplatin plus
5-FU compared with MTX (P = .001). Toxicity from carboplatin plus 5-FU was
intermediate compared with the other regimens. The complete and partial
response rates were 32% for cisplatin plus 5-FU, 21% for carboplatin plus
5-FU, and 10% for MTX. The comparison of cisplatin plus 5-FU to MTX was
statistically significant (P less than .001), and the comparison of
carboplatin plus 5-FU to MTX was of borderline statistical significance (P
= .05). Median response durations and median survival times were similar
for all three treatment groups. Logistic regression models showed that only
treatment assigned was associated significantly with response (P = .001).
Cox proportional hazards models indicated that only performance status was
associated significantly with survival (P less than .01). CONCLUSIONS: We
conclude that combination chemotherapy resulted in improved response rates
but was associated with an increased toxicity and no improvement in overall
survival. Therefore, new treatments that may alter the course of disease in
recurrent head and neck cancer patients still need to be identified.
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