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A Phase I/II Evaluation of Metoclopramide as a Radiosensitiser in Patients with Inoperable Squamous Cell Carcinoma of the Lung

Kjellén, Elisabeth LU ; Pero, Ronald LU ; Brun, Eva LU ; Ewers, Sven-Börje LU ; Jarlman, Olof LU ; Knöös, Tommy LU ; Malmström, Per LU ; Tennvall, Jan LU ; Killander, Dick LU and Olsson, A., et al. (1995) In European Journal of Cancer 31(13-14). p.2196-2202
Abstract
The feasibility of administering metoclopramide (MCA) as a radiosensitizer has been evaluated in 23 patients with a pathological or cytological diagnosis of a squamous cell carcinoma of the lung, clinically evaluated as inoperable. All patients received 40-60 Gy radiotherapy fractionated into 1.8 Gy fractions 5 times per week (Monday-Friday). Two MCA treatment regimens were used: (i) MCA at 2 mg/kg administered by intravenous infusion 1-2 h prior to radiotherapy 3 times per week (Monday, Wednesday, Friday); and (ii) MCA at 1 mg/kg administered by intravenous infusion 1-2 h prior to radiotherapy 5 times per week (Monday-Friday). 11 of the 23 patients treated with radiotherapy and MCA had none to mild pneumonitis or fibrosis and another 8 of... (More)
The feasibility of administering metoclopramide (MCA) as a radiosensitizer has been evaluated in 23 patients with a pathological or cytological diagnosis of a squamous cell carcinoma of the lung, clinically evaluated as inoperable. All patients received 40-60 Gy radiotherapy fractionated into 1.8 Gy fractions 5 times per week (Monday-Friday). Two MCA treatment regimens were used: (i) MCA at 2 mg/kg administered by intravenous infusion 1-2 h prior to radiotherapy 3 times per week (Monday, Wednesday, Friday); and (ii) MCA at 1 mg/kg administered by intravenous infusion 1-2 h prior to radiotherapy 5 times per week (Monday-Friday). 11 of the 23 patients treated with radiotherapy and MCA had none to mild pneumonitis or fibrosis and another 8 of the 23 had moderate levels. No patient had their therapy interrupted due to radiation-related side-effects. The MCA-related side-effects were as expected, i.e. 78% of the patients experienced sedation/tiredness and 48% expressed restlessness/anxiety symptoms. Both the total dose and serum levels of MCA were significantly associated to the MCA side-effect profile. Tumour response, duration of tumour response and survival were significantly positively correlated to the total and weekly doses of MCA administered to the patients during their radiotherapy treatment. These favourable phase II data have justified the initiation of a phase II/III randomised multicentred trial being carried out in Europe to evaluate MCA as a radiosensitiser. (Less)
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publication status
published
subject
keywords
metoclopramide, radiosensitiser, lung cancer, phase I/II trial, squamous cell carcinoma
in
European Journal of Cancer
volume
31
issue
13-14
pages
2196 - 2202
publisher
Elsevier
external identifiers
  • scopus:0029587109
ISSN
1879-0852
DOI
10.1016/0959-8049(95)00424-6
language
English
LU publication?
yes
id
c99405b7-0585-42ef-a44b-86d31b7aa7d1 (old id 1109826)
date added to LUP
2008-07-29 16:17:23
date last changed
2017-01-01 05:02:03
@article{c99405b7-0585-42ef-a44b-86d31b7aa7d1,
  abstract     = {The feasibility of administering metoclopramide (MCA) as a radiosensitizer has been evaluated in 23 patients with a pathological or cytological diagnosis of a squamous cell carcinoma of the lung, clinically evaluated as inoperable. All patients received 40-60 Gy radiotherapy fractionated into 1.8 Gy fractions 5 times per week (Monday-Friday). Two MCA treatment regimens were used: (i) MCA at 2 mg/kg administered by intravenous infusion 1-2 h prior to radiotherapy 3 times per week (Monday, Wednesday, Friday); and (ii) MCA at 1 mg/kg administered by intravenous infusion 1-2 h prior to radiotherapy 5 times per week (Monday-Friday). 11 of the 23 patients treated with radiotherapy and MCA had none to mild pneumonitis or fibrosis and another 8 of the 23 had moderate levels. No patient had their therapy interrupted due to radiation-related side-effects. The MCA-related side-effects were as expected, i.e. 78% of the patients experienced sedation/tiredness and 48% expressed restlessness/anxiety symptoms. Both the total dose and serum levels of MCA were significantly associated to the MCA side-effect profile. Tumour response, duration of tumour response and survival were significantly positively correlated to the total and weekly doses of MCA administered to the patients during their radiotherapy treatment. These favourable phase II data have justified the initiation of a phase II/III randomised multicentred trial being carried out in Europe to evaluate MCA as a radiosensitiser.},
  author       = {Kjellén, Elisabeth and Pero, Ronald and Brun, Eva and Ewers, Sven-Börje and Jarlman, Olof and Knöös, Tommy and Malmström, Per and Tennvall, Jan and Killander, Dick and Olsson, A. and Sheng, Y. and Wennerberg, Johan},
  issn         = {1879-0852},
  keyword      = {metoclopramide,radiosensitiser,lung cancer,phase I/II trial,squamous cell carcinoma},
  language     = {eng},
  number       = {13-14},
  pages        = {2196--2202},
  publisher    = {Elsevier},
  series       = {European Journal of Cancer},
  title        = {A Phase I/II Evaluation of Metoclopramide as a Radiosensitiser in Patients with Inoperable Squamous Cell Carcinoma of the Lung},
  url          = {http://dx.doi.org/10.1016/0959-8049(95)00424-6},
  volume       = {31},
  year         = {1995},
}