R. Hitt et al., Phase II trial of cisplatin and Gemcitabine in advanced squamous-cell carcinoma of the head and neck, ANN ONCOL, 9(12), 1998, pp. 1347-1349
Background. To evaluate the toxicity profile and efficacy of cisplatin comb
ined with gemcitabine in patients with irresectable locally recurrent or me
tastatic squamous cell carcinoma of the head and neck.
Patients and methods: Gemcitabine was given at a dose of 800 mg/m(2) on day
s 1, 8 and 15, plus cisplatin at a dose of 50 mg/m(2) on days 1 and 8; ever
y four weeks.
Results. Twenty-four patients with a median age of 59 years (range 42-74) w
ere included. All patients were evaluable for toxicity and 22 patients were
assessable for response. Eleven cases had advanced recurrent locoregional
disease while 13 patients had metastatic disease. One CR (4.7%) and four PR
(18%) were observed, for an overall response rate of 22.7% (95% CI: 8%-42%
). The main toxicity was hematological: neutropenia grade 3-4 in 28% of the
cycles and thrombocytopenia grade 3-4 in 16%. The most significant non-hem
atological toxicity was asthenia grade 2-3 in 24% of the cycles.
Conclusions. This cisplatin plus gemcitabine combination schedule has a fav
ourable toxicity profile with a discrete activity in patients with locally
recurrent or metastatic squamous-cell carcinoma of the head and neck.