TPF plus cetuximab induction chemotherapy followed by biochemoradiation with weekly cetuximab plus weekly cisplatin or carboplatin: a randomized phase II EORTC trial |
| |
| Affiliation: | 1. Department of Oncology, Antwerp University Hospital, Edegem and Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium;2. Head & Neck Department, National Institute for Oncology, Budapest, Hungary;3. Department of Oncology, Head and Neck Unit, Free University Medical Center, Amsterdam, The Netherlands;4. Department of Hematology Oncology, Hospital Network Antwerp, Antwerp, Belgium;5. Head and Neck Cancer Medical Oncology Unit, IRCCS National Cancer Institute, Milan, Italy;6. Medical Oncology Clinic, Institute Jules Bordet, Brussels;7. Department of Oncology, Catholic University of Louvain, Louvain;8. European Organisation for Research and Treatment of Cancer, EORTC Headquarters, Brussels, Belgium |
| |
| Abstract: | BackgroundOur aim was to test the safety of cetuximab added to chemoradiation with either cisplatin or carboplatin after prior induction chemotherapy.MethodsPatients with stage III/IV unresectable, squamous cell carcinoma of the head and neck received up to four cycles of TPF-E (cisplatin and docetaxel 75 mg/m2 on day 1 followed by 5-FU 750 mg/m2/day as a continuous infusion on days 1–5 plus cetuximab at a loading dose of 400 mg/m2 followed by a weekly dose of 250 mg/m2), with prophylactic antibiotics but no growth factors. Patients not progressing after four cycles of TPF-E were randomly assigned to radiotherapy (70 Gy over 7 weeks in 2 Gy fractions) and weekly cetuximab with either weekly cisplatin 40 mg/m2 or carboplatin, AUC of 1.5 mg/ml/min. Primary endpoint was feasibility.ResultsForty-seven patients were recruited. One patient did not start TPF (hypersensitivity reaction during the cetuximab loading dose). Induction TPF-E was discontinued in 12 patients due to toxicity (6 patients), medical decision (2), death (1), patient refusal (1), protocol violation (1), co-morbidity (1). Three further patients were not randomized [progressive disease (1), protocol violation (1), toxicity and co-morbidity (1)]. Of particular interest are three patients who suffered from bowel perforation, one patient who died as results of pneumonia and septic shock, and a second patient who was found dead at home 12 days after starting TPF-E (cause of death unknown). Weekly cisplatin and carboplatin was stopped early in seven and four patients, respectively. Radiotherapy was stopped in two patients with cisplatin and interrupted in one patient with cisplatin and four patients with carboplatin.ConclusionsThe addition of cetuximab to full dose TPF induction chemotherapy led to unacceptable complications and premature closing of the study. Only 34 out of 46 patients completed four cycles of TPF-E and only 30 started biochemoradiation. |
| |
| Keywords: | |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
