High-dose folinic acid (FA) and fluorouracil (FU) plus or minus thymostimulin (TS) for treatment of metastatic colorectal cancer: results of a randomized multicenter clinical trial.
The purpose of this study was to ascertain the possible protective effect of thymostimulin (TS) on chemotherapy-induced leukopenia and related febrile episodes, beside the potential of improving therapeutic efficacy and tolerability of high-dose folinic acid (FA) plus fluorouracil (FU) in metastatic colorectal cancer. In 211 evaluable patients the objective responses were 19/105 (18%) in the FA-FU arm versus 32/106 (30%) obtained with the same regimen plus TS. The difference was statistically significant (p = 0.02). No difference was observed in terms of hematological toxicity, while the TS treated patients experienced a significantly lower incidence of mucositis and diarrhoea (p = 0.03). No significant differences were recorded in the incidence of febrile episodes and other treatment-related toxicities. The possibility of improving response to chemotherapy in advanced colorectal cancer without increasing systemic toxicity is particularly interesting and deserves further attention.
Centro Oncologico, Universita di Trieste, Italy.
G
G
Mustacchi
L
L
Pavesi
S
S
Milani
V
V
Iaffaioli
A
A
Caraco
G
G
Comella
A
A
Contu
A
A
Farris
G
G
Attado-Parinello
M
M
Narcisi
D015179:Colorectal Neoplasms / Q000628:therapy*; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D013949:Thymus Extracts / Q000009:adverse effects / Q000627:therapeutic use*
D013949:Thymus Extracts; C031407:thymostimulin; D002955:Leucovorin; D005472:Fluorouracil