Evaluation of 96-hour infusion fluorouracil plus cisplatin in combination with alpha interferon for patients with advanced squamous cell carcinoma of the head and neck. A southwest oncology group study

Abstract

Background. Recurrent cancer of the head and neck after primary therapy is almost always fatal. The combination of 5‐fluorouracil (5‐FU) and cisplatin is considered the best available therapy but complete response rates remain too low to affect survival. This study was designed to evaluate the complete response rate and toxicity of 5‐FU, cisplatin, and alpha‐interferon (α‐IFN) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Methods. Fifty eligible patients with recurrent or metastatic SCCHN and no prior chemotherapy (40 men, 10 women; age range, 26–77 years; median, 59 years; 82% white; 88% had prior surgery and 92% had prior radiation therapy) were treated every 21 days with 96‐bour infusion of 5‐FU 1000 mg/m2/day; cisplatin 100 mg/m2, day 1; and α‐IFN 5 × 106 units/day, days 1–4. Results. One hundred fifty‐seven courses of chemotherapy were administered, with a median of three courses. Thirty‐seven patients experienced Grade 3 or 4 toxicity. Of the 17 patients with Grade 4 toxicity; 12 had hematologic toxicity, 3 stomatitis, and 2 vomiting. Two additional patients died of myelosuppression‐related sepsis. Of the 50 patients, 3 (6%) achieved a complete response, five (10%) had a partial response, 3 (6%) had unconfirmed response (1 complete and 2 partial), 10 (20%) had stable disease, 17 (34%) progressed, and 12 (24%) were considered nonresponders owing to early death (6) or inadequate assessment (6). The median survival was 5 months. Conclusion. The complete response rate of patients with recurrent or metastatic SCCHN treated with 5‐FU, cisplatin, and α‐IFN does not appear to be superior to that observed for 5‐FU and cisplatin. Alpha‐interferon appears to augment hematologic and gastrointestinal toxicities associated with this combination.

Paclitaxel, cisplatin, and 5-fluorouracil for patients with advanced or recurrent squamous cell carcinoma of the head and neck

“…Despite higher response rates reported with combination chemotherapy, the median survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) is still 6 months. 3,4 The combination of cisplatin and 5-fluorouracil (5-FU) is considered the standard, with reported response rates varying from 11% to 80% but without a demonstrable impact on survival. [5][6][7][8] Paclitaxel 250 mg/m 2 given as a 24-hour infusion has demonstrated clinical activity in patients with advanced SCCHN, with a single-agent response rate of 40% (4 complete and 8 partial responses in 30 patients).…”

Ifosfamide, cisplatin, and 13-Cis retinoic acid for patients with advanced or recurrent squamous cell carcinoma of the head and neck

“…The Southwest Oncology Group evaluated the combination of ␣-interferon (5 ϫ 10 6 IU) with 5-fluorouracil and CDDP for 4 consecutive days every 3 weeks. 32 A modest 16% response rate was achieved among 50 patients, with a median survival of 5 months. In a previous multicenter Phase II study, we combined CDDP and 5-fluorouracil with two biologic response modifiers (thymopentin and retinyl palmitate) with the intent to improve results in the treatment of patients with SCC of the head and neck.…”

Proliferation marker Ki-S11 - a prognostic indicator for squamous cell carcinoma of the hypopharynx

“…SCCs of the head and neck are fast growing tumors [8], and, despite modern therapeutic approaches combining surgery, radiotherapy, and chemotherapy, the prognosis of these patients is often poor [22]. This is especially true for carcinomas of the hypopharynx [9] because of the absence of symptoms in the early stages [24].…”