Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study

J T Hartmann; K Oechsle; D Quietzsch; A Wein; R D Hofheinz; F Honecker; O Nehls; C-H Köhne; G Käfer; L Kanz; C Bokemeyer

doi:10.1038/sj.bjc.6601412

Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study

Standard

Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study. / Hartmann, J T; Oechsle, K; Quietzsch, D; Wein, A; Hofheinz, R D; Honecker, F; Nehls, O; Köhne, C-H; Käfer, G; Kanz, L; Bokemeyer, C.

In: BRIT J CANCER, Vol. 89, No. 11, 01.12.2003, p. 2051-6.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Hartmann, JT, Oechsle, K, Quietzsch, D, Wein, A, Hofheinz, RD, Honecker, F, Nehls, O, Köhne, C-H, Käfer, G, Kanz, L & Bokemeyer, C 2003, 'Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study', BRIT J CANCER, vol. 89, no. 11, pp. 2051-6. https://doi.org/10.1038/sj.bjc.6601412

APA

Hartmann, J. T., Oechsle, K., Quietzsch, D., Wein, A., Hofheinz, R. D., Honecker, F., Nehls, O., Köhne, C-H., Käfer, G., Kanz, L., & Bokemeyer, C. (2003). Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study. BRIT J CANCER, 89(11), 2051-6. https://doi.org/10.1038/sj.bjc.6601412

Vancouver

Hartmann JT, Oechsle K, Quietzsch D, Wein A, Hofheinz RD, Honecker F et al. Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study. BRIT J CANCER. 2003 Dec 1;89(11):2051-6. https://doi.org/10.1038/sj.bjc.6601412

Bibtex

@article{bb10654faa5f465db3130a2f643968d8,

title = "Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study",

abstract = "The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-flourouracil (FU) plus folinic acid, and to assess the toxicity and activity in patients with previously treated colorectal and gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks. At least three patients were treated at each dose level. A total of 16 patients have been included in the phase I study. At the highest dose level (MMC 10 mg m(-2)), grade III thrombocytopenia, dyspnoea, mucositis and diarrhoea were observed in one patient each (17 %). In the phase II study 45 patients, 33 with colorectal cancer and 12 with gastric cancer, 23 patients after failure of first- and 22 patients after at least second-line or subsequent chemotherapy have been treated. Seven partial responses (PR) were registered (16%), one (3%; CI(95%), 0-16) in colorectal and six (50%; CI(95%), 21-79%) in gastric cancer patients. In all, 17 (38%) achieved disease stabilisation, 15 colorectal (45%, CI(95%), 28-64%) and two gastric cancer patients (17%; CI(95%), 2-48%). The median progression-free survival was 3.1 months (range, 0.9-9.1) in colorectal and 4.6 months (range, 0.7-12.4) in gastric cancer. The median overall survival time was 6.6 months (range, 1.9-15.6) in colorectal and 7.1 months (range, 1.7-20.8) in patients with gastric cancer. This regimen was considered to be safe and well tolerated for pretreated patients with gastrointestinal adenocarcinoma. In gastric cancer,MMC plus infusional 5-FU/folinic acid may be a potential second-line regimen with promising antitumour activity.",

keywords = "Adenocarcinoma, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Drug Administration Schedule, Female, Fluorouracil, Gastrointestinal Neoplasms, Humans, Leucovorin, Male, Maximum Tolerated Dose, Middle Aged, Mitomycin, Treatment Outcome",

author = "Hartmann, {J T} and K Oechsle and D Quietzsch and A Wein and Hofheinz, {R D} and F Honecker and O Nehls and C-H K{\"o}hne and G K{\"a}fer and L Kanz and C Bokemeyer",

year = "2003",

month = dec,

day = "1",

doi = "10.1038/sj.bjc.6601412",

language = "English",

volume = "89",

pages = "2051--6",

journal = "BRIT J CANCER",

issn = "0007-0920",

publisher = "NATURE PUBLISHING GROUP",

number = "11",

}

RIS

TY - JOUR

T1 - Protracted infusional 5-fluorouracil plus high-dose folinic acid combined with bolus mitomycin C in patients with gastrointestinal cancer: a phase I/II dose escalation study

AU - Hartmann, J T

AU - Oechsle, K

AU - Quietzsch, D

AU - Wein, A

AU - Hofheinz, R D

AU - Honecker, F

AU - Nehls, O

AU - Köhne, C-H

AU - Käfer, G

AU - Kanz, L

AU - Bokemeyer, C

PY - 2003/12/1

Y1 - 2003/12/1

N2 - The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-flourouracil (FU) plus folinic acid, and to assess the toxicity and activity in patients with previously treated colorectal and gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks. At least three patients were treated at each dose level. A total of 16 patients have been included in the phase I study. At the highest dose level (MMC 10 mg m(-2)), grade III thrombocytopenia, dyspnoea, mucositis and diarrhoea were observed in one patient each (17 %). In the phase II study 45 patients, 33 with colorectal cancer and 12 with gastric cancer, 23 patients after failure of first- and 22 patients after at least second-line or subsequent chemotherapy have been treated. Seven partial responses (PR) were registered (16%), one (3%; CI(95%), 0-16) in colorectal and six (50%; CI(95%), 21-79%) in gastric cancer patients. In all, 17 (38%) achieved disease stabilisation, 15 colorectal (45%, CI(95%), 28-64%) and two gastric cancer patients (17%; CI(95%), 2-48%). The median progression-free survival was 3.1 months (range, 0.9-9.1) in colorectal and 4.6 months (range, 0.7-12.4) in gastric cancer. The median overall survival time was 6.6 months (range, 1.9-15.6) in colorectal and 7.1 months (range, 1.7-20.8) in patients with gastric cancer. This regimen was considered to be safe and well tolerated for pretreated patients with gastrointestinal adenocarcinoma. In gastric cancer,MMC plus infusional 5-FU/folinic acid may be a potential second-line regimen with promising antitumour activity.

AB - The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-flourouracil (FU) plus folinic acid, and to assess the toxicity and activity in patients with previously treated colorectal and gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks. At least three patients were treated at each dose level. A total of 16 patients have been included in the phase I study. At the highest dose level (MMC 10 mg m(-2)), grade III thrombocytopenia, dyspnoea, mucositis and diarrhoea were observed in one patient each (17 %). In the phase II study 45 patients, 33 with colorectal cancer and 12 with gastric cancer, 23 patients after failure of first- and 22 patients after at least second-line or subsequent chemotherapy have been treated. Seven partial responses (PR) were registered (16%), one (3%; CI(95%), 0-16) in colorectal and six (50%; CI(95%), 21-79%) in gastric cancer patients. In all, 17 (38%) achieved disease stabilisation, 15 colorectal (45%, CI(95%), 28-64%) and two gastric cancer patients (17%; CI(95%), 2-48%). The median progression-free survival was 3.1 months (range, 0.9-9.1) in colorectal and 4.6 months (range, 0.7-12.4) in gastric cancer. The median overall survival time was 6.6 months (range, 1.9-15.6) in colorectal and 7.1 months (range, 1.7-20.8) in patients with gastric cancer. This regimen was considered to be safe and well tolerated for pretreated patients with gastrointestinal adenocarcinoma. In gastric cancer,MMC plus infusional 5-FU/folinic acid may be a potential second-line regimen with promising antitumour activity.

KW - Adenocarcinoma

KW - Adult

KW - Aged

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Drug Administration Schedule

KW - Female

KW - Fluorouracil

KW - Gastrointestinal Neoplasms

KW - Humans

KW - Leucovorin

KW - Male

KW - Maximum Tolerated Dose

KW - Middle Aged

KW - Mitomycin

KW - Treatment Outcome

U2 - 10.1038/sj.bjc.6601412

DO - 10.1038/sj.bjc.6601412

M3 - SCORING: Journal article

C2 - 14647137

VL - 89

SP - 2051

EP - 2056

JO - BRIT J CANCER

JF - BRIT J CANCER

SN - 0007-0920

IS - 11

ER -