New Liposomal Formulation of Cisplatin May Reduce Toxicities

Allison Gandey

July 20, 2007

July 20, 2007 (Chicago) — A new trial shows that liposomal platin for advanced squamous-cell carcinoma of the head and neck decreases the toxicities of conventional therapy. Cisplatin, reportedly 1 of the most active chemotherapeutic agents used for these patients, has been limited by renal and hematological toxicities. This latest randomized multicenter phase 3 study, presented at the American Society of Clinical Oncology 43rd Annual Meeting, demonstrates that the new liposomal formulation of cisplatin may reduce both.

"This reduction of side effects will influence the chance to preserve the dose density of chemotherapy and thereby the efficacy of treatment," reported lead author and presenter Christian Jehn, MD, from the Charité Campus Mitte, in Berlin, Germany.

The investigators randomized 62 patients with advanced squamous-cell carcinoma of the head and neck. From this, 43 patients were evaluable for outcome and toxicity. Those in the new liposomal formulation group received 100 mg/m 2/day of the drug plus 1000 mg/m 2/day 5-FU every 3 weeks for 6 cycles. Patients in the cisplatin group received 100 mg/m 2/day cisplatin plus 1000 mg/m 2/day 5-FU every 3 weeks for 6 cycles.

The researchers found the rate of anemia was similar between treatment groups. They report that in the cisplatin cohort, hematotoxicity was generally more frequent.

Hematotoxicity

Grade Cisplatin (n) Liposomal Platin (n)
1 and 2 28 15
3 and 4 2 3



Renal toxicity was measured by a reduction in creatinine clearance, with grade 1 calculated as 99 to 75 mL/min, grade 2 as 74 to 50 mL/min, and grade 3 as less than 50 mL/min.

Renal Toxicity

Grade Cisplatin (n) Liposomal Platin (n)
1 1 3
2 3 10
3 5 0
Total 9 13



Dr. Jehn and colleagues also presented outcome data. In the liposomal platin group, 3 patients experienced a partial response, 13 patients had stable disease, and 9 patients had progressive disease. In the cisplatin group, more patients had a partial response, with a total of 8. Fewer had stable disease compared with the new therapy, at 9, and just 1 patient experienced progressive disease. The researchers reported that the nonprogressive-disease patients along with those with stable disease were 16/25 (64%) in the liposomal platin group vs 17/18 (94%) cases in the cisplatin group.

They conclude that liposomal platin appears to reduce both the renal and hematological toxicity compared with conventional cisplatin to a clinically relevant extent.

American Society of Clinical Oncology 43rd Annual Meeting: Abstract 6040. Presented June 4, 2007.

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