Objective： To investigate fotemustine plus dacarbazine （DTIC） with dendritic cell （DC） vaccines on patients with advanced acral lentiginous melanoma （ALM）. Fotemustine is a cytotoxic alkylating agent with a rem...Objective： To investigate fotemustine plus dacarbazine （DTIC） with dendritic cell （DC） vaccines on patients with advanced acral lentiginous melanoma （ALM）. Fotemustine is a cytotoxic alkylating agent with a remarkable antitumor activity as single agent but also in association with （DTIC）. DC is the strongest antigen presenting cell which could induce durable clinical responses. Methods： This was a single-center study. Between July 2003 and June 2006, twenty-eight chemotherapy-naive patients of advanced ALM received fotemustine 100 mg/m^2, dr, 12, DTIC 400 mg/d d2-6, DC vaccines subcutaneously dT, 9, 13 repeated every 28 days. Ten HLA-A02＋24＋ patients received vaccines pulsed with melanoma antigen derived peptides, melanoma antigen recognized by T-cells 1 （Mart-i） and S-100. Eighteen patients received DC loaded with allogeneic melanoma lysate. The primary end-point was progression free survival （PFS）. Secondary end-points were overall survival （OS）, overall response rate （ORR） and toxicity. Tumor assessment was performed every 8 weeks and evaluated according to response evaluation criteria in solid tumors （RECIST）. Results： The 15 men and 13 women had a median age of 51 years. 16 patients had stage Mlc disease and 11/16 had liver metastasis. Patients received an average of 3.82±1.25 cycles. Follow-up for the 18 surviving patients ranged from 7-41 months with a median of 12 months. Median PFS was 8.5 months （95% CI： 7.86-15.21） with 12 patients remaining progression free. Only 10 patients died. Median OS was 12 months （95% CI： 10.33-18.24）. ORR （CR＋PR） was 35.7% including 3 complete response （CR） and 7 partial response （PR）. Six patients had disease stable. A total of 19 Grade Ⅲ/Ⅳ toxicities were observed including thrombocytopenia （n=8）, neutropenia （n=5）, fatigue （n=6） and hypersensitivity reaction （n=1）. One patient died of Grade IV thrombocytopenia. Conclusion： Fotemustine and dacarbazine plus DC vaccines are safe and tolerable to Chinese ALM patients. The regimen brings clinical benefit with a higher ORR and may provide a survival advantage. Updated survival data will be presented.展开更多
文摘Objective： To investigate fotemustine plus dacarbazine （DTIC） with dendritic cell （DC） vaccines on patients with advanced acral lentiginous melanoma （ALM）. Fotemustine is a cytotoxic alkylating agent with a remarkable antitumor activity as single agent but also in association with （DTIC）. DC is the strongest antigen presenting cell which could induce durable clinical responses. Methods： This was a single-center study. Between July 2003 and June 2006, twenty-eight chemotherapy-naive patients of advanced ALM received fotemustine 100 mg/m^2, dr, 12, DTIC 400 mg/d d2-6, DC vaccines subcutaneously dT, 9, 13 repeated every 28 days. Ten HLA-A02＋24＋ patients received vaccines pulsed with melanoma antigen derived peptides, melanoma antigen recognized by T-cells 1 （Mart-i） and S-100. Eighteen patients received DC loaded with allogeneic melanoma lysate. The primary end-point was progression free survival （PFS）. Secondary end-points were overall survival （OS）, overall response rate （ORR） and toxicity. Tumor assessment was performed every 8 weeks and evaluated according to response evaluation criteria in solid tumors （RECIST）. Results： The 15 men and 13 women had a median age of 51 years. 16 patients had stage Mlc disease and 11/16 had liver metastasis. Patients received an average of 3.82±1.25 cycles. Follow-up for the 18 surviving patients ranged from 7-41 months with a median of 12 months. Median PFS was 8.5 months （95% CI： 7.86-15.21） with 12 patients remaining progression free. Only 10 patients died. Median OS was 12 months （95% CI： 10.33-18.24）. ORR （CR＋PR） was 35.7% including 3 complete response （CR） and 7 partial response （PR）. Six patients had disease stable. A total of 19 Grade Ⅲ/Ⅳ toxicities were observed including thrombocytopenia （n=8）, neutropenia （n=5）, fatigue （n=6） and hypersensitivity reaction （n=1）. One patient died of Grade IV thrombocytopenia. Conclusion： Fotemustine and dacarbazine plus DC vaccines are safe and tolerable to Chinese ALM patients. The regimen brings clinical benefit with a higher ORR and may provide a survival advantage. Updated survival data will be presented.
