A phase II study of weekly paclitaxel and epirubicin in recurrent or refractory squamous cell carcinoma of the head and neck.
OBJECTIVE
The combination of taxanes and anthracyclines has been proved to be active for treatment of many cancers. We conducted a phase II study to determine the response and toxicity of paclitaxel and epirubicin (TE) in patients with incurable squamous cell carcinoma of the head and neck (SCCHN).


METHODS
Patients with metastatic or recurrent SCCHN and adequate hematologic, renal and hepatic function and a Karnofsky performance status >/=60% were enrolled. Prior chemotherapy and/or radiotherapy were permitted with 4-week interval. The regimen was paclitaxel 60 mg/m(2) and epirubicin 20 mg/m(2), on Days 1, 8 and 15, as an intravenous infusion, repeated every 28 days. Patients with disease progression or unacceptable toxicity were excluded from the study.


RESULTS
The current study was intended to treat 43 patients but closed at the planned interim analysis due to early evidence of insufficient efficacy than expectation. Fifteen patients with a median age of 52 years (range, 37-72 years) were accrued. Previously, most patients had received radiotherapy and chemotherapy, and a majority (87%) of patients had treatment-free interval of <6 months. Median Karnofsky performance status was 70% (range, 60-90%). There was one clinical response (7%) and another three (20%) had stable disease. Median overall survival time was 4.5 months. The most common major toxicity was infection (47%), which caused four treatment-related mortalities. Grade 3-4 neutropenia occurred in five patients, but other toxicities were mild and manageable.


CONCLUSIONS
In the population with majority of refractory disease of SCCHN, the response rate to TE was lower than expected. Such dose schedule is not recommended unless in chemotherapy naïve patients or in combination with newer agents.
Wang
Tso-Fu
TF
Division of Oncology and Hematology, Buddhist Tzu-Chi General Hospital, 707, Sec.3, Chung-Yang Rd. Hualien, Taiwan.
Chu
Sung-Chao
SC
Kao
Ruey-Ho
RH
Yao
Chao-Yuan
CY
Li
Chi-Cheng
CC
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary*; D064420:Drug-Related Side Effects and Adverse Reactions; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D017671:Platinum Compounds / Q000008:administration & dosage; D016019:Survival Analysis
D017671:Platinum Compounds; D015251:Epirubicin; D017239:Paclitaxel