Simultaneous radiation therapy and cisplatin chemotherapy in advanced cancer of the head and neck. A pilot study at Tygerberg Hospital, Parowvallei, South Africa

Fifty patients with advance carcinoma of the head and neck were treated in a randomized pilot study utilizing simultaneous cisplatin and radiotherapy. Treatment was delivered in two segments. The initial partial course (PC) consisted of 75-100 mg/m2 of cisplatin and concomitant radiotherapy to 20.00 Gy in 1 week, with 4-week split. Patients who tolerated therapy and experienced at least a partial response (PR) went on to complete the full course of therapy (FC), with the second phase consisting of 120 mg/M2 of cisplatin and 38.40 Gy of radiation. Total cisplatin delivered ranged between 195 and 220 mg/m2, and the total radiation dose was 58.40 Gy. Of 38 evaluable patients, 31 (82%) had at least a partial response (PR). However, at time of analysis 20 months after study, 27 (71%) patients were alive with disease or dead. Mean disease-free survival (DFS) for patients receiving FC therapy (10.05 months) was greater that that for patients who received only PC therapy (2.65 months) but the difference in overall survival (OS) was not statistically significant (11.95 FC versus 10.29 PC). Response rates and the minimal toxicity are within the range of other reported studies. Randomized studies should seek optimal time-dose schedule and establish advantages in terms of crude survival and disease-free survival.