Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with weekly high-dose 48-hour continuous-infusion fluorouracil for advanced colorectal cancer : a Spanish Cooperative Group for Gastrointestinal Tumor Therapy (TTD) study
PURPOSE: The objective of this multicenter study was to compare the efficacy and toxicity profiles of a combination of 5-fluorouracil (5-FU) given by bolus injection together with intravenous leucovorin (LV) versus high-dose 5-FU in continuous infusion (CI) in the treatment of advanced colorectal cancer.
PATIENTS AND METHODS: A total of 306 patients were randomized to receive either 5-FU 425 mg/m2 given by bolus injection on days 1-5 plus intravenous (i.v.) LV 20 mg/m2 every four to five weeks or 5-FU 3.5 g/m2/week in a 48-hour CI. Therapy was continued until disease progression. Second-line chemotherapy was allowed in both arms.
RESULTS: The response rates in 306 patients with measurable lesions were 19.2% (modulated arm) and 30.3% (CI arm, P < 0.05). The median progression-free survival times were 23.5 weeks (modulated arm) and 25 weeks (CI arm, P = NS). Median survival times were 42.5 weeks (modulated arm) and 48 weeks (CI arm, P = NS). There were no significant differences in grade 3-4 toxicity profiles but if we consider all grades we observed more mucositis in the modulated arm and more hand-foot syndrome in the CI arm.
CONCLUSIONS: In terms of response rate, the continuous infusion regimen was more effective than the modulated regimen. There was no significant difference in survival and time to progression, and none in grade 3-4 toxicity.
| Medienart: |
Artikel |
|---|
| Erscheinungsjahr: |
1998 |
|---|---|
| Erschienen: |
1998 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:9 |
|---|---|
| Enthalten in: |
Annals of oncology : official journal of the European Society for Medical Oncology - 9(1998), 7 vom: 14. Juli, Seite 727-31 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Aranda, E [VerfasserIn] |
|---|
| Themen: |
Antimetabolites, Antineoplastic |
|---|
| Anmerkungen: |
Date Completed 03.11.1998 Date Revised 03.02.2020 published: Print Citation Status MEDLINE |
|---|
| Förderinstitution / Projekttitel: |
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|---|
| PPN (Katalog-ID): |
NLM096781718 |
|---|
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| 007 | tu | ||
| 008 | 231222s1998 xx ||||| 00| ||eng c | ||
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| 035 | |a (DE-627)NLM096781718 | ||
| 035 | |a (NLM)9739438 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Aranda, E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with weekly high-dose 48-hour continuous-infusion fluorouracil for advanced colorectal cancer |b a Spanish Cooperative Group for Gastrointestinal Tumor Therapy (TTD) study |
| 264 | 1 | |c 1998 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
| 338 | |a Band |b nc |2 rdacarrier | ||
| 500 | |a Date Completed 03.11.1998 | ||
| 500 | |a Date Revised 03.02.2020 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: The objective of this multicenter study was to compare the efficacy and toxicity profiles of a combination of 5-fluorouracil (5-FU) given by bolus injection together with intravenous leucovorin (LV) versus high-dose 5-FU in continuous infusion (CI) in the treatment of advanced colorectal cancer | ||
| 520 | |a PATIENTS AND METHODS: A total of 306 patients were randomized to receive either 5-FU 425 mg/m2 given by bolus injection on days 1-5 plus intravenous (i.v.) LV 20 mg/m2 every four to five weeks or 5-FU 3.5 g/m2/week in a 48-hour CI. Therapy was continued until disease progression. Second-line chemotherapy was allowed in both arms | ||
| 520 | |a RESULTS: The response rates in 306 patients with measurable lesions were 19.2% (modulated arm) and 30.3% (CI arm, P < 0.05). The median progression-free survival times were 23.5 weeks (modulated arm) and 25 weeks (CI arm, P = NS). Median survival times were 42.5 weeks (modulated arm) and 48 weeks (CI arm, P = NS). There were no significant differences in grade 3-4 toxicity profiles but if we consider all grades we observed more mucositis in the modulated arm and more hand-foot syndrome in the CI arm | ||
| 520 | |a CONCLUSIONS: In terms of response rate, the continuous infusion regimen was more effective than the modulated regimen. There was no significant difference in survival and time to progression, and none in grade 3-4 toxicity | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Antimetabolites, Antineoplastic |2 NLM | |
| 650 | 7 | |a Leucovorin |2 NLM | |
| 650 | 7 | |a Q573I9DVLP |2 NLM | |
| 650 | 7 | |a Fluorouracil |2 NLM | |
| 650 | 7 | |a U3P01618RT |2 NLM | |
| 700 | 1 | |a Díaz-Rubio, E |e verfasserin |4 aut | |
| 700 | 1 | |a Cervantes, A |e verfasserin |4 aut | |
| 700 | 1 | |a Antón-Torres, A |e verfasserin |4 aut | |
| 700 | 1 | |a Carrato, A |e verfasserin |4 aut | |
| 700 | 1 | |a Massutí, T |e verfasserin |4 aut | |
| 700 | 1 | |a Tabernero, J M |e verfasserin |4 aut | |
| 700 | 1 | |a Sastre, J |e verfasserin |4 aut | |
| 700 | 1 | |a Trés, A |e verfasserin |4 aut | |
| 700 | 1 | |a Aparicio, J |e verfasserin |4 aut | |
| 700 | 1 | |a López-Vega, J M |e verfasserin |4 aut | |
| 700 | 1 | |a Barneto, I |e verfasserin |4 aut | |
| 700 | 1 | |a García-Conde, J |e verfasserin |4 aut | |
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| 773 | 1 | 8 | |g volume:9 |g year:1998 |g number:7 |g day:14 |g month:07 |g pages:727-31 |
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