TY - JOUR
T1 - Paclitaxel, cisplatin, and 5-fluorouracil in patients with advanced or recurrent squamous cell carcinoma of the head and neck
T2 - A preliminary report
AU - Hussain, M.
AU - Salwen, W.
AU - Kucuk, O.
AU - Ensley, J.
PY - 1997/12/1
Y1 - 1997/12/1
N2 - The combination of 5-fluorouracil (5-FU) and cisplatin is considered the most active chemotherapy for patients with recurrent squamous cell carcinoma of the head and neck (SCCHN), with an overall response rate of 30%. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has demonstrated activity in SCCHN and synergy with cisplatin. To augment the activity of the combination of 5-FU and cisplatin, a pilot study was designed to determine the feasibility of combining 3-hour infusional paclitaxel with 5-FU and cisplatin. To be eligible, patients had to have recurrent or advanced SCCHN with measurable or evaluable disease and no prior chemotherapy. A minimum of three courses had to be delivered to determine cumulative toxicity. The starting dose level consisted of paclitaxel 135 mg/m2 on day 1, cisplatin 75 mg/m2 on day 2, and S-FU 1 g/m2 on days 2 through 6. The first treated patient developed grade 4 mucositis, which resulted in reducing dose level I of 5-FU to 800 mg/m2/d on days 2 through 6 (seven patients); subsequently, the 5-FU dose was adjusted to 1 g/m2/d on days 2 through 5 (nine patients). To date, 17 patients have been enrolled, with a median age of 62 years (range, 48 to 75 years). Of the 17 patients, nine had recurrent disease following prior surgery and/or radiotherapy and eight had previously untreated advanced SCCHN. Major toxicities were neutropenia and mucositis. There were four early deaths (two treatment- related and two cancer-related). Forty-seven courses of therapy were delivered, with a median of two (range, one to five). The overall response rate in 14 response-evaluable patients was 71% (10 of 14 patients; eight partial and two complete responses). Five of seven response-evaluable patients with recurrent disease had major responses (one complete and four partial responses). At the current dose, the combination of paclitaxel/5- FU/cisplatin is feasible and shows very encouraging activity, particularly in patients with recurrent SCCHN.
AB - The combination of 5-fluorouracil (5-FU) and cisplatin is considered the most active chemotherapy for patients with recurrent squamous cell carcinoma of the head and neck (SCCHN), with an overall response rate of 30%. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has demonstrated activity in SCCHN and synergy with cisplatin. To augment the activity of the combination of 5-FU and cisplatin, a pilot study was designed to determine the feasibility of combining 3-hour infusional paclitaxel with 5-FU and cisplatin. To be eligible, patients had to have recurrent or advanced SCCHN with measurable or evaluable disease and no prior chemotherapy. A minimum of three courses had to be delivered to determine cumulative toxicity. The starting dose level consisted of paclitaxel 135 mg/m2 on day 1, cisplatin 75 mg/m2 on day 2, and S-FU 1 g/m2 on days 2 through 6. The first treated patient developed grade 4 mucositis, which resulted in reducing dose level I of 5-FU to 800 mg/m2/d on days 2 through 6 (seven patients); subsequently, the 5-FU dose was adjusted to 1 g/m2/d on days 2 through 5 (nine patients). To date, 17 patients have been enrolled, with a median age of 62 years (range, 48 to 75 years). Of the 17 patients, nine had recurrent disease following prior surgery and/or radiotherapy and eight had previously untreated advanced SCCHN. Major toxicities were neutropenia and mucositis. There were four early deaths (two treatment- related and two cancer-related). Forty-seven courses of therapy were delivered, with a median of two (range, one to five). The overall response rate in 14 response-evaluable patients was 71% (10 of 14 patients; eight partial and two complete responses). Five of seven response-evaluable patients with recurrent disease had major responses (one complete and four partial responses). At the current dose, the combination of paclitaxel/5- FU/cisplatin is feasible and shows very encouraging activity, particularly in patients with recurrent SCCHN.
UR - http://www.scopus.com/inward/record.url?scp=0031475069&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0031475069&partnerID=8YFLogxK
M3 - Article
C2 - 9427265
AN - SCOPUS:0031475069
SN - 0093-7754
VL - 24
SP - S19-43-S19-45
JO - Seminars in Oncology
JF - Seminars in Oncology
IS - 6 SUPPL. 19
ER -
