Targeted combined anti-inflammatory and angiostatic therapy in advanced melanoma: a randomized phase II trial.
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Targeted combined anti-inflammatory and angiostatic therapy in advanced melanoma: a randomized phase II trial. / Reichle, Albrecht; Vogt, Thomas; Coras, Brigitte; Terheyden, Peter; Neuber, Karsten; Trefzer, Uwe; Schultz, Erwin; Berand, Anna; Bröcker, E B; Landthaler, Michael; Andreesen, Reinhard.
in: MELANOMA RES, Jahrgang 17, Nr. 6, 6, 2007, S. 360-364.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Targeted combined anti-inflammatory and angiostatic therapy in advanced melanoma: a randomized phase II trial.
AU - Reichle, Albrecht
AU - Vogt, Thomas
AU - Coras, Brigitte
AU - Terheyden, Peter
AU - Neuber, Karsten
AU - Trefzer, Uwe
AU - Schultz, Erwin
AU - Berand, Anna
AU - Bröcker, E B
AU - Landthaler, Michael
AU - Andreesen, Reinhard
PY - 2007
Y1 - 2007
N2 - An angiostatic approach was used to assess the impact of anti-inflammatory therapy in combination with metronomic low-dose chemotherapy. A randomized multi-institutional phase II trial was designed to select metronomic chemotherapy (arm A: trofosfamide 50 mg orally three times daily, day 1+) or combined anti-inflammatory/angiostatic treatment (arm B: trofosfamide as above mentioned plus rofecoxib 25 mg orally, day 1+, and pioglitazone 60 mg orally, day 1+) for further evaluation. A total of 76 patients, mostly (>60%) refractory to at least one previous chemotherapy with maximum tolerated doses, and progression of metastatic melanoma were included. The estimated progression-free survival (PFS) rates at one year were 0% for metronomic chemotherapy (A), but 9% for additional anti-inflammatory therapy (B). Vice versa the hazard ratio for the intent-to-treat analysis of A versus B was 1.9 (P=0.008). By Cox analysis, the impact of anti-inflammatory therapy on PFS achieved significance (P=0.016) as well as C-reactive protein response on overall survival (P=0.045). WHO grade 3 (no grade 4) toxicities were reported in arm A/B in 19 and 28%, respectively. In conclusion, control of tumour-associated inflammatory processes (C-reactive protein response) is associated with longer PFS than achieved with metronomic chemotherapy alone in metastatic melanoma.
AB - An angiostatic approach was used to assess the impact of anti-inflammatory therapy in combination with metronomic low-dose chemotherapy. A randomized multi-institutional phase II trial was designed to select metronomic chemotherapy (arm A: trofosfamide 50 mg orally three times daily, day 1+) or combined anti-inflammatory/angiostatic treatment (arm B: trofosfamide as above mentioned plus rofecoxib 25 mg orally, day 1+, and pioglitazone 60 mg orally, day 1+) for further evaluation. A total of 76 patients, mostly (>60%) refractory to at least one previous chemotherapy with maximum tolerated doses, and progression of metastatic melanoma were included. The estimated progression-free survival (PFS) rates at one year were 0% for metronomic chemotherapy (A), but 9% for additional anti-inflammatory therapy (B). Vice versa the hazard ratio for the intent-to-treat analysis of A versus B was 1.9 (P=0.008). By Cox analysis, the impact of anti-inflammatory therapy on PFS achieved significance (P=0.016) as well as C-reactive protein response on overall survival (P=0.045). WHO grade 3 (no grade 4) toxicities were reported in arm A/B in 19 and 28%, respectively. In conclusion, control of tumour-associated inflammatory processes (C-reactive protein response) is associated with longer PFS than achieved with metronomic chemotherapy alone in metastatic melanoma.
M3 - SCORING: Zeitschriftenaufsatz
VL - 17
SP - 360
EP - 364
JO - MELANOMA RES
JF - MELANOMA RES
SN - 0960-8931
IS - 6
M1 - 6
ER -
