Increased tolerability of bimonthly 12-hour timed flat infusion 5-fluorouracil/irinotecan regimen in advanced colorectal cancer: A dose-finding study

  • Authors:
    • C. Ficorella
    • E. Ricevuto
    • M. F. Morelli
    • R. Morese
    • K. Cannita
    • G. Cianci
    • G. Porzio
    • Z. C. Di Rocco
    • F. De Galitiis
    • M. De Tursi
    • N. Tinari
    • S. Iacobelli
    • P. Marchetti
  • View Affiliations

  • Published online on: May 1, 2006     https://doi.org/10.3892/or.15.5.1345
  • Pages: 1345-1350
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Abstract

A dose-finding study was designed to determine the maximum tolerated dose (MTD) of a bimonthly 12-h (10:00 p.m to 10:00 a.m), timed flat infusion (TFI) of 5-fluorouracil (5-FU) plus irinotecan (CPT-11), without leucovorin (LV), for metastatic colorectal carcinoma (CRC). A total of 33 patients were treated. Seven dose levels included a fixed CPT-11 dose of 180 mg/m2 on days 1 and 15 (d1,15) and escalating doses of 5-FU 600-1200 mg/m2 on days 1-4 and 15-18 (d1-4,15-18). Dose-limiting toxicities (DLTs) were: grade 3-4 non-hematologic, grade 4 hematologic and any toxicity causing a more than a 2-week delay in treatment. The MTD was reached at the seventh dose level. DLTs were observed in 5/8 patients (63%): G3 diarrhea, 2 patients, associated with G3 mucositis in one instance; G4 neutropenia, 2 patients, associated with severe asthenia in 1 patient; G3 hand-foot syndrome, 1 patient. The recommended doses (RDs) were established at the sixth dose level: 5-FU, 1100 mg/m2/d1-4,15-18; CPT-11 180 mg/m2/d1,15 [5-FU and CPT-11 dose intensity (DI), 2200 and 90 mg/m2 per week (w), respectively]. At the recommended dose, the DLTs in 38 cycles were: mucositis, 2 cycles (5%); afebrile G4 neutropenia and hand-foot syndrome, 1 cycle (3%). In 24 assessable patients, the overall response rate was 37.5%. The present CPT-11/5-FU schedule is highly tolerable in an outpatient setting using the highest recommended 5-FU dose effective in advanced CRC.

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May 2006
Volume 15 Issue 5

Print ISSN: 1021-335X
Online ISSN:1791-2431

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Spandidos Publications style
Ficorella C, Ricevuto E, Morelli MF, Morese R, Cannita K, Cianci G, Porzio G, Di Rocco ZC, De Galitiis F, De Tursi M, De Tursi M, et al: Increased tolerability of bimonthly 12-hour timed flat infusion 5-fluorouracil/irinotecan regimen in advanced colorectal cancer: A dose-finding study. Oncol Rep 15: 1345-1350, 2006
APA
Ficorella, C., Ricevuto, E., Morelli, M.F., Morese, R., Cannita, K., Cianci, G. ... Marchetti, P. (2006). Increased tolerability of bimonthly 12-hour timed flat infusion 5-fluorouracil/irinotecan regimen in advanced colorectal cancer: A dose-finding study. Oncology Reports, 15, 1345-1350. https://doi.org/10.3892/or.15.5.1345
MLA
Ficorella, C., Ricevuto, E., Morelli, M. F., Morese, R., Cannita, K., Cianci, G., Porzio, G., Di Rocco, Z. C., De Galitiis, F., De Tursi, M., Tinari, N., Iacobelli, S., Marchetti, P."Increased tolerability of bimonthly 12-hour timed flat infusion 5-fluorouracil/irinotecan regimen in advanced colorectal cancer: A dose-finding study". Oncology Reports 15.5 (2006): 1345-1350.
Chicago
Ficorella, C., Ricevuto, E., Morelli, M. F., Morese, R., Cannita, K., Cianci, G., Porzio, G., Di Rocco, Z. C., De Galitiis, F., De Tursi, M., Tinari, N., Iacobelli, S., Marchetti, P."Increased tolerability of bimonthly 12-hour timed flat infusion 5-fluorouracil/irinotecan regimen in advanced colorectal cancer: A dose-finding study". Oncology Reports 15, no. 5 (2006): 1345-1350. https://doi.org/10.3892/or.15.5.1345