Comparison of four cisplatin-based radiochemotherapy regimens for nonmetastatic stage III/IV squamous cell carcinoma of the head and neck.
OBJECTIVE
To compare the outcomes of four cisplatin-based radiochemotherapy regimens in 311 patients with Stage III/IV squamous cell carcinoma of the head and neck.


METHODS
Concurrent chemotherapy consisted of three courses of cisplatin 100 mg/m(2) on Day 1 (Group A, n = 74), two courses of cisplatin 20 mg/m(2) on Days 1-5 plus 5-fluorouracil 1,000 mg/m(2) on Days 1-5 (Group B, n = 49), two courses of cisplatin 20 mg/m(2) on Days 1-5 plus 5-fluorouracil 600 mg/m(2) on Days 1-5 (Group C, n = 102), or two courses of cisplatin 20 mg/m(2) on Days 1-5 (Group D, n = 86). The groups were retrospectively compared for toxicity and outcomes, and 11 additional factors were evaluated for outcomes.


RESULTS
No significant difference was observed among the groups regarding radiation-related acute oral mucositis and radiation-related late toxicities. Acute Grade 3 skin toxicity was significantly more frequent in Group B than in the patients of the other three groups (p = .013). The chemotherapy-related Grade 3 nausea/vomiting rate was 24% for Group A, 8% for Group B, 9% for Group C, and 6% for Group D (p = .003). The corresponding Grade 3 nephrotoxicity rates were 8%, 1%, 2%, and 1% (p = .019). The corresponding Grade 3-4 hematologic toxicity rates were 35%, 41%, 19%, and 21% (p = .027). Chemotherapy could be completed in 50%, 59%, 74%, and 83% of the Group A, B, C, and D patients, respectively (p = .002). Toxicity-related radiotherapy breaks occurred in 39%, 43%, 21%, and 15% of Groups A, B, C, and D, respectively (p = .005). The 3-year locoregional control rate was 67%, 72%, 60%, and 59% for Groups A, B, C, and D, respectively (p = .48). The corresponding 3-year metastasis-free survival rates were 67%, 74%, 63%, and 79% (p = .31), and the corresponding 3-year survival rates were 60%, 63%, 50%, and 71% (p = .056). On multivariate analysis, Karnofsky performance status, histologic grade, T/N category, preradiotherapy hemoglobin level, completion of chemotherapy, and radiotherapy breaks were associated with the outcome.


CONCLUSIONS
The four compared radiochemotherapy regimens were not significantly different regarding treatment outcomes. Two courses of cisplatin 20 mg/m(2) on Days 1-5 were better tolerated than the other three regimens.
Rades
Dirk
D
Department of Radiation Oncology, University of Lubeck, Lubeck, Germany. Rades.Dirk@gmx.net
Kronemann
Stefanie
S
Meyners
Thekla
T
Bohlen
Guenther
G
Tribius
Silke
S
Kazic
Nadja
N
Schroeder
Ursula
U
Hakim
Samer G
SG
Schild
Steven E
SE
Dunst
Juergen
J
D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D010610:Pharyngeal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D011832:Radiation Injuries / Q000150:complications; D011855:Radiodermatitis / Q000209:etiology; D013280:Stomatitis / Q000209:etiology; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D002945:Cisplatin; D005472:Fluorouracil