A combination of cisplatin and 5-fluorouracil (5-FU) is an effective and well-tolerated regimen for patients with squamous cell carcinoma of the penis (SCCP), show study findings.
The therapy, which is currently used for palliative purposes among SCCP patients, is associated with a moderate response rate and is well tolerated by patients, say Giuseppe de Lorenzo (University Frederico II, Naples, Italy) and team.
Cisplatin used either alone or in nonbleomycin-containing regimens is considered the mainstay of first-line treatment for patients with advanced penile cancer, with a more favorable toxicity profile than bleomycin-methotrexate-cisplatin.
And a combination of cisplatin plus continuous infusion of 5-FU appears especially promising for its safety and efficacy profile. However, whether this combination therapy is associated with a survival advantage or symptomatic improvement is uncertain, due to a lack of phase III trials.
"The present retrospective study, to the best of our knowledge, represents the largest report of patients with penile cancer receiving this regimen," says the team.
In their analysis of 25 patients with stage IV SCCP who underwent treatment cycles with cisplatin plus 5-FU every 3 weeks, Lorenzo and colleagues assessed radiologic reports to determine response rate and progression-free survival (PFS).
Patients had received a median dose of cisplatin 75 mg/m2 on day 1 of each 21-day cycle, followed by a median dose of 5-FU 900 mg/m2 for the following 4 days until disease progression or unacceptable toxicity was reached.
According to response evaluation criteria in solid tumors (RECIST) criteria, eight of the patients (32%) had a confirmed radiologic response, which is in line with the response rate of bleomycin-methotrexate-cisplatin, say the researchers.
Forty percent of the group had stable disease and the remainder (28%) had progressive disease, giving a disease control rate of 72%.
As reported in BJU International, the most common grade 3-4 toxic effects were neutropenia and anemia, occurring in five (20%) and three (12%) patients, respectively, and there was no death or interruption of treatment for toxicity.
The team also reports that the median PFS was 20 weeks and the median overall survival was 8 months.
"This combination regimen is a valid first-line therapeutic option in the metastatic setting," say Lorenzo et al.
"Prospective trials are required to confirm the efficacy and tolerance of this combination, and also to explore the additional therapeutic advantages of its combination with biological agents," concludes the team.
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