Glutathione in the prevention of cisplatin induced toxicities - A prospectively randomized pilot trial in patients with head and neck cancer and non small cell lung cancer

Purpose: Glutathione has been shown to be an effective chemoprotector again st cisplatin-induced side effects in patients with ovarian cancer. In view of this fact, we performed a randomized clinical pilot-trial in the managem ent of other solid tumors in order to compare application of Glutathione to intensive hydration in patients undergoing chemotherapy with a regimen inc luding cisplatin. Patients and methods: Twenty patients suffering from advanced non small cel l lung cancer (n = 6) or head-and neck cancer (n = 14) were enrolled in the study. All patients received 80 mg/m(2) cisplatin along with etoposide or 5-fluorouracil every 4 weeks. Patients randomized to application of Glutath ione (n = 11) received 5 g of Glutathione immediately before application of cisplatin followed by 2000 ml of normal saline. Patients in the control gr oup (n = 9) received 2000 mi electrolyte infusion before and 2000 mi of nor mal saline with forced diuresis after cisplatin. Results: The intensity of hematologic toxicity was significantly less prono unced in patients treated with Glutathione than in the control group (hemog lobin: 10.7 vs 9.5 mg% respectively, p = 0.039; white blood cell count 3.3 vs 2.2 x 103/mu l respectively, p = 0.004; platelets 167 vs 95 x 103/mu l r espectively, p = 0.02), whereas in terms of non-hematologic toxixity no dif ference was observed. Objective remission occurred in 6 out of 11 evaluable patients from the group receiving Glutathione (55%; complete remission: 9% ; partial remission: 46%), and in 4 out of 8 evaluable patients from the co ntrol group (partial remission: 50%). However, there was no statistical dif ference in terms of response and;overall survival (13.5 months vs. 10.5 mon ths) between the two groups. Conclusions: Application of Cisplatin and Glutathione seems to be safe and feasible and the antitumoral efficacy of cisplatin is apparently not impair ed by the concomitant use of Glutathione in patients with solid tumors.