Paclitaxel, cisplatin and 5-fluorouracil in recurrent squamous cell carcinoma of the head and neck: A phase II trial from an Italian cooperative group

Abstract

The aim of this multicenter trial was to test the feasibility and the activity of a three-drug combination where paclitaxel is added to cisplatin and 5-fluorouracil. Patients with metastatic or relapsed SCC-HN unsuitable for further loco-regional radical treatment, not previously treated with chemotherapy, were eligible to receive paclitaxel 160 mg/m2 (3-hr infusion) day 1, CDDP 25 mg/m2/day and 5-FU 250 mg/m2/day bolus on days 1, 2, 3 every three weeks up to a maximum of five courses. Fourty-seven patients were enrolled by five Institutions in Italy. Main grade III-IV toxicities were: neutropenia (48%), thrombocytopenia (6%), anemia (4%), diarrhea (2%), mucositis (2%). Six patients had a complete response (13.3%) and eight a partial response (17.8%). Median progression free survival and overall survival are 4.1 and 7.9 months. One-year progression free survival and overall survival are 16% and 29%. This three-drug regimen has an excellent safety profile. The activity in the palliation of recurrent SCC-HN, however, does not appear to be improved in comparison with cisplatin and 5-fluorouracil or cisplatin and paclitaxel regimens. Recent studies indicate a more promising role of taxanes including triplets in the induction therapy of previously untreated patients.

Cetuximab Concomitant with Second-Line Radiation Therapy in Patients with Locally Advanced Recurrent Squamous Cell Head and Neck Cancer

“…In the phase 2 study by Janinis et al [15] comparing the combination of PF with docetaxel with PF combination, mean survival time in the docetaxel arm was 11 months, but febrile neutropenia was observed in 15% of the patients. In a phase 2 study by Benasso et al [16] including 47 patients, mean survival time with paclitaxel + PF combination was 7.9 months, but grade 3–4 neutropenia was seen in 48% of the patients.…”

Cetuximab: a standard approach to the first-line treatment of recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck

“…Although chemotherapy doublets are an accepted approach to treatment, their main benefit appears to be in improving tumor response rates, compared with single-agent chemotherapy, and there is little evidence that these improved response rates translate into improved survival [9]. Phase II studies indicate that triplet therapy with cisplatin, a taxane and 5-fluorouracil (5-FU) does not improve efficacy beyond that achieved with doublet regimens [12,13] and is more toxic [13]. For some time now, the median survival for patients with recurrent and/or metastatic disease treated according to standard practices has plateaued at around 6-7 months.…”

Metastatic Nasopharyngeal Carcinoma Outcomes in Patients on Cisplatin with Nolatrexed or 5-Fluorouracil

“…Both the MST of 10 months and the RR of 35.3% of our FP regimen were superior to those of the randomized phase III trial (MST: 10 months, RR: 27.0%) reported by Gibson et al [14]. In a phase II trial, patients with recurrent squamous cell head and neck carcinoma received 160 mg/m 2 paclitaxel (3-h infusion) on day 1 and 250 mg/m 2 /day 5-fluorouracil, 25 mg/m 2 /day cisplatin, and a bolus on days 1, 2, and 3 every 3 weeks [15]. The MST, RR, and 1-year survival rate were 7.9 months, 31.1%, and 29%, respectively.…”