Efficacy and safety analysis of temozolomide combined with sunitinib in treatment of metastat-ic mucosal melanoma
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Abstract:
Objective: To investigate the application value of temozolomide (TMZ) combined with sunitinib (SUN)in the treatment of metastatic mucosal melanoma. Methods: This research retrospectively analyzed the data of pa-tients with metastatic mucosal melanoma that treated with TMZ combined with SUN in Peking University Cancer Hospital from August, 2008 to December, 2016. Patients showed no BRAF/NRAS mutation. The combination regi-men of SUN (37.5 mg, d1-28) and TMZ (200 mg/m 2 , d1-5) was continued in a 28-days cycle until disease progres-sion or toxicity intolerance. The primary observation indices were objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and toxic side effect rate. Results: Among the included 27 patients, primary in-testinal lesion occurred in 4 patients, genitourinary lesion occurred in 9 patient, nasal lesions in 5 patient, oral le-sions in 7 patients and esophagal lesion in 2 patients; 19 patients had been previously treated with anti-tumor treat-ment. Median treatment cycle was 3.0 of TMZ combined with SUN treatment. ORR was 19.2%, disease control rate was 81.5%, median PFS and OS were (3.0±0.7) months and (7.1±0.9) months, respectively. KIT mutation was de-tected in 4 patients, and the use of KIT inhibitor might be beneficial to those patients. The combination therapy was well tolerated, and only 2 patients required a dose reduction of SUN to 25 mg due to thrombocytopenia (grade Ⅳ).Grade Ⅲ-Ⅳ toxicities mainly included thrombocytopenia (19.2%), leucopenia (19.2%), and hepatic injury (3.9%).No treatment related death occurred. Conclusion: For metastatic mucosal melanoma, TMZ+SUN might be an effec-tive and safe approach.
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Project supported by the National Program on Key Basic Research Project of China (973 Project) (No. 2013CB911004)