Weekly docetaxel (D) and irinotecan (I) in patients (pts) with recurrent or metastatic head and neck cancer (HNC): A phase II trial of the Eastern Cooperative Oncology Group (ECOG)

Abstract

5528 Background: D and I have single-agent activity in recurrent or metastatic HNC. This combination is of interest because of partially non-overlapping toxicities and preclinical evidence of synergy. A previous phase I study demonstrated that both drugs can be safely given on a weekly schedule (Cancer Biology and Therapy 2002;1:646). Methods: Pts with recurrent or metastatic squamous cell HNC received D 35 mg/m2 and I 60 mg/m2, intravenously, on days 1 and 8, every 21 days, until disease progression or intolerable toxicities. Eligibility criteria included unidimensionally measurable disease, ECOG performance status 0–1, absolute neutrophil count > 1500/μL, platelets >100,000 μL, and normal bilirubin. Response assessment was performed after every 3 cycles using RECIST criteria. Results: 54 pts have been enrolled: 17 chemotherapy naive (cohort A) and 37 previously treated with 1 prior chemotherapy regimen (cohort B). 78% were males; median age 61 years (32–82); 78% of previously treated patients were paclitaxel-exposed. Response data are available in 47 pts: in cohort A, 4 objective responses (all partial), 3 confirmed and 1 unconfirmed by repeat imaging, were observed in 17 pts (24%); in B, 1 in 30 pts (3%) responded. Median progression-free survival and overall survival were 3.2 and 9.8 months in cohort A and 1.8 and 5.2 months in cohort B. Major toxicities in 51 evaluable pts were: grade (G) 3 /4 neutropenia 8%/10%, G 3 fatigue 16%, G 3 /4 anorexia 8%/4%, G 3 /4 diarrhea 24%/2%, G 3 stomatitis 2%, G 3 /4 vomiting 4%/2%, febrile neutropenia 4%, G 3/4 infection with G 3/4 neutropenia 2%/4%, G 3 /4 dyspnea 2%/2%, and G 3 /4 creatinine 2%/4%. Conclusions: Preliminary analysis shows that D plus I is active in HNC. Toxicities were acceptable and predominantly gastrointestinal. No significant financial relationships to disclose.