Long-term results of a phase III randomized trial of postoperative radiotherapy with or without carboplatin in patients with high-risk head and neck cancer.
BACKGROUND
The role of postoperative radiotherapy and carboplatin in squamous cell carcinoma of the head and neck (SCCHN) has not been established.


METHODS
Patients with macroscopically resected stage III/IV SCCHN with high-risk pathologic features (> or =3 lymph nodes, extracapsular extension, perineural or angiolymphatic invasion, or involved margins) were randomized to receive postoperative radiotherapy alone (arm A) or the same radiotherapy plus carboplatin 100 mg/m intravenously once weekly during radiation (arm B). The primary endpoint was 2-year disease-free survival.


RESULTS
Seventy-six patients were randomized, of whom 72 were eligible and analyzable (36 in each arm). The study was prematurely closed because of slow accrual. With a median follow-up of 5.3 years, the disease-free survival at 2 and 5 years was 71% and 53% in arm B versus 58% (P = .27) and 49% (P = .72) in arm A. The overall survival at 2 and 5 years was 74% and 47% in arm B versus 51% (P = .04) and 41% (P = .61) in arm A. Serious toxicities were infrequent in both arms.


CONCLUSIONS
We could not demonstrate a benefit with the addition of carboplatin to postoperative radiotherapy, possibly because of insufficient sample size.
Argiris
Athanassios
A
Division of Hematology-Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA 15232, USA. argirisae@upmc.edu
Karamouzis
Michalis V
MV
Johnson
Jonas T
JT
Heron
Dwight E
DE
Myers
Eugene
E
Eibling
David
D
Cano
Elmer
E
Urba
Susan
S
Gluckman
Jack
J
Grandis
Jennifer R
JR
Wang
Yun
Y
Agarwala
Sanjiv S
SS
D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care; D012307:Risk Factors; D013997:Time Factors
D000970:Antineoplastic Agents; D016190:Carboplatin