BACKGROUND AND AIM: In vitro, methotrexate (MTX) is the best modulator for bolus 5-fluorouracil (5FU), whereas folinic acid (FA) is the best for continuous infusion. We evaluated the effect of 5FU modulated by both MTX (bolus administration) and FA (continuous infusion) as second-line treatment of patients with metastatic colorectal cancer. PATIENTS AND METHODS: Entry criteria were: at least one 5FU-based chemotherapy regimen as first-line treatment for metastatic disease, or progression within twelve months after 5FU-containing adjuvant therapy. Treatment schedule: MTX 200 mg/m2 i.v. days 1 and 15; 5FU 600 mg/m2 i.v. bolus, days 2 and 16; 5FU 200 mg/m2 i.v. continuous infusion for 21 days, starting on day 29; FA 20 mg/m2 i.v. bolus weekly during the three weeks of 5FU infusion. Cycles were repeated every 56 days. The primary end-point was tumour control rate, including partial responses and stabilizations. RESULTS: 34/35 patients enrolled were evaluable for response. Five (14.7\%) had a partial response, 13 (38.2\%) disease stabilization, and 16 (47.1\%) progressed; tumour control rate was 52.9\%. Median TTP was 5.8 months (95\% CI 4.03-7.83); 29 patients had died. Median OAS was 15.9 months (95\% CI 8.8-21.9). Toxicity was mild. CONCLUSIONS: The regimen constituted by 5FU modulated by MTX (bolus administration) and FA (continuous infusion) is active as second-line treatment of metastatic colorectal cancer.

Second-line chemotherapy with a hybrid-alternating regimen of bolus 5FU modulated by methotrexate and infusional 5FU modulated by folinic acid in patients with metastatic colorectal cancer pretreated with 5FU. A phase 2 study / Carlomagno, Chiara; Lauria, Rossella; DE LAURENTIIS, Michelino; Arpino, Grazia; Massarelli, Erminia; Ferrara, Claudia; Milano, Andrea; Vernaglia, LOMBARDI ALESSANDRA; Costanzo, Raffaele; G., Catalano; Bianco, ANGELO RAFFAELE; DE PLACIDO, Sabino. - In: ONCOLOGY. - ISSN 0030-2414. - STAMPA. - 63:3(2002), pp. 219-225. [10.1159/000065468]

Second-line chemotherapy with a hybrid-alternating regimen of bolus 5FU modulated by methotrexate and infusional 5FU modulated by folinic acid in patients with metastatic colorectal cancer pretreated with 5FU. A phase 2 study.

CARLOMAGNO, Chiara;LAURIA, ROSSELLA;DE LAURENTIIS, MICHELINO;ARPINO, GRAZIA;MASSARELLI, ERMINIA;FERRARA, CLAUDIA;MILANO, ANDREA;VERNAGLIA, LOMBARDI ALESSANDRA;COSTANZO, RAFFAELE;BIANCO, ANGELO RAFFAELE;DE PLACIDO, SABINO
2002

Abstract

BACKGROUND AND AIM: In vitro, methotrexate (MTX) is the best modulator for bolus 5-fluorouracil (5FU), whereas folinic acid (FA) is the best for continuous infusion. We evaluated the effect of 5FU modulated by both MTX (bolus administration) and FA (continuous infusion) as second-line treatment of patients with metastatic colorectal cancer. PATIENTS AND METHODS: Entry criteria were: at least one 5FU-based chemotherapy regimen as first-line treatment for metastatic disease, or progression within twelve months after 5FU-containing adjuvant therapy. Treatment schedule: MTX 200 mg/m2 i.v. days 1 and 15; 5FU 600 mg/m2 i.v. bolus, days 2 and 16; 5FU 200 mg/m2 i.v. continuous infusion for 21 days, starting on day 29; FA 20 mg/m2 i.v. bolus weekly during the three weeks of 5FU infusion. Cycles were repeated every 56 days. The primary end-point was tumour control rate, including partial responses and stabilizations. RESULTS: 34/35 patients enrolled were evaluable for response. Five (14.7\%) had a partial response, 13 (38.2\%) disease stabilization, and 16 (47.1\%) progressed; tumour control rate was 52.9\%. Median TTP was 5.8 months (95\% CI 4.03-7.83); 29 patients had died. Median OAS was 15.9 months (95\% CI 8.8-21.9). Toxicity was mild. CONCLUSIONS: The regimen constituted by 5FU modulated by MTX (bolus administration) and FA (continuous infusion) is active as second-line treatment of metastatic colorectal cancer.
2002
Second-line chemotherapy with a hybrid-alternating regimen of bolus 5FU modulated by methotrexate and infusional 5FU modulated by folinic acid in patients with metastatic colorectal cancer pretreated with 5FU. A phase 2 study / Carlomagno, Chiara; Lauria, Rossella; DE LAURENTIIS, Michelino; Arpino, Grazia; Massarelli, Erminia; Ferrara, Claudia; Milano, Andrea; Vernaglia, LOMBARDI ALESSANDRA; Costanzo, Raffaele; G., Catalano; Bianco, ANGELO RAFFAELE; DE PLACIDO, Sabino. - In: ONCOLOGY. - ISSN 0030-2414. - STAMPA. - 63:3(2002), pp. 219-225. [10.1159/000065468]
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/338154
Citazioni
  • ???jsp.display-item.citation.pmc??? 0
  • Scopus ND
  • ???jsp.display-item.citation.isi??? 2
social impact