AMRUBICIN FOR SCLC

NEW YORK (Reuters Health) Jul 05 - A chemotherapy sequence of irinotecan and cisplatin followed by amrubicin is effective and well tolerated in patients with extensive-stage small-cell lung cancer (SCLC), Japanese researchers report in the July Journal of Thoracic Oncology.

Among the 43 patients who were evaluable for response and survival, the phase II study established a 79% overall response rate, median progression-free survival of 6.5 months and median overall survival of 15.4 months.

Although these results were similar to those from the irinotecan-and-cisplatin arm of a Japanese study of patients with SCLC that was published in 2002, in the current study the overall survival was longer (15.4 versus 12.8 months), Dr. Masashi Kobayashi of the Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, told Reuters Health by e-mail.

Dr. Kobayashi also noted that a phase II study published earlier this year showed that amrubicin has promising activity as a second-line therapy in patients with platinum-refractory SCLC.

Amrubicin (Calsed, Sumitomo Pharmaceuticals), a novel 9-aminoanthracycline and a topoisomerase II inhibitor, is currently used only in Japan, Kobayashi said.

The study included 45 patients (average age 63) with extensive-stage SCLC and no prior chemotherapy, surgery or radiation. A large majority (89%) had distant metastases.

Study treatment consisted of irinotecan 60 mg/m2 on days 1 and 8 plus cisplatin 60 mg/m2 on day 1 every 3 weeks for 3 cycles and then amrubicin 40 mg/m2 alone on days 1 to 3 every 3 weeks for three cycles.

Twenty-eight patients (64%) completed the full planned chemotherapy of three cycles each of irinotecan/cisplatin and amrubicin.

Amrubicin's main toxicity was myelosuppression. No treatment-related deaths were seen.

Small cell cancer accounts for approximately 15% of all lung cancers, according to the authors. The observed longer overall survival is promising, they say, and further investigation of this sequential triplet chemotherapy is warranted.

http://journals.lww.com/jto/pages/currenttoc.aspx

J Thorac Oncol 2010.