Prospective pilot study of consolidation chemotherapy with docetaxel and cisplatin after concurrent chemoradiotherapy for advanced head and neck cancer.
OBJECTIVE
With the improvement concurrent chemoradiotherapy (CCRT) in the management of patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC), distant failures have become a more relevant problem in terms of survival. The primary objective of this Phase II study is to assess the feasibility of docetaxel and cisplatin consolidation after primary CCRT for patients with HNSCC.


METHODS
Patients with locoregionally advanced HNSCC received chemotherapy with three cycles of cisplatin, 100 mg/m(2), on Days 1, 22, and 43. Concurrent radiotherapy to the primary tumor and neck was given in a daily dose of 2 Gy to a total dose of 70-70.2 Gy over 7 weeks. After completion of CCRT, patients without evidence of disease progression received an additional four cycles of consolidation chemotherapy with docetaxel, 75 mg/m(2), and cisplatin, 75 mg/m(2), every 3 weeks.


RESULTS
Of 33 patients, 27 (81%) completed CCRT. After CCRT, three complete and 19 partial responses were recorded, giving an overall response rate of 67%. Of 19 patients who went to the consolidation phase, only 4 (21%) received all four cycles of docetaxel and cisplatin. Causes of failure of consolidation chemotherapy were toxicity in 11 patients, including three treatment-related deaths, and progression in 4 patients. Three patients died of sepsis during the consolidation phase. Median survival was 11 months for all patients and 8 months for those treated with consolidation chemotherapy.


CONCLUSIONS
The poor compliance and high incidence of severe toxicities prompted no further evaluation of this consolidation chemotherapy after CCRT.
Lee
Kyun Chan
KC
Department of Radiation Oncology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Lee
Seok Ho
SH
Lee
Yuna
Y
Park
Se Hoon
SH
Park
Jinny
J
Cho
Eun Kyung
EK
Shin
Dong Bok
DB
Lee
Jae Hoon
JH
Kim
Dong Young
DY
Kim
Seon Tae
ST
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D012074:Remission Induction; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin