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Effect of a prostaglandin--given rectally for prevention of radiation-induced acute proctitis--on late rectal toxicity. Results of a phase III randomized, placebo-controlled, double-blind study

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Effect of a prostaglandin--given rectally for prevention of radiation-induced acute proctitis--on late rectal toxicity. Results of a phase III randomized, placebo-controlled, double-blind study. / Kertesz, Tereza; Herrmann, Markus K A; Zapf, Antonia; Christiansen, Hans; Hermann, Robert M; Pradier, Olivier; Schmidberger, Heinz; Hess, Clemens F; Hille, Andrea.

In: STRAHLENTHER ONKOL, Vol. 185, No. 9, 09.2009, p. 596-602.

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

Harvard

Kertesz, T, Herrmann, MKA, Zapf, A, Christiansen, H, Hermann, RM, Pradier, O, Schmidberger, H, Hess, CF & Hille, A 2009, 'Effect of a prostaglandin--given rectally for prevention of radiation-induced acute proctitis--on late rectal toxicity. Results of a phase III randomized, placebo-controlled, double-blind study', STRAHLENTHER ONKOL, vol. 185, no. 9, pp. 596-602. https://doi.org/10.1007/s00066-009-1978-8

APA

Kertesz, T., Herrmann, M. K. A., Zapf, A., Christiansen, H., Hermann, R. M., Pradier, O., Schmidberger, H., Hess, C. F., & Hille, A. (2009). Effect of a prostaglandin--given rectally for prevention of radiation-induced acute proctitis--on late rectal toxicity. Results of a phase III randomized, placebo-controlled, double-blind study. STRAHLENTHER ONKOL, 185(9), 596-602. https://doi.org/10.1007/s00066-009-1978-8

Vancouver

Kertesz T, Herrmann MKA, Zapf A, Christiansen H, Hermann RM, Pradier O et al. Effect of a prostaglandin--given rectally for prevention of radiation-induced acute proctitis--on late rectal toxicity. Results of a phase III randomized, placebo-controlled, double-blind study. STRAHLENTHER ONKOL. 2009 Sep;185(9):596-602. https://doi.org/10.1007/s00066-009-1978-8

Bibtex

@article{73c60b1838c64a91be1b6dcd7345a816,
title = "Effect of a prostaglandin--given rectally for prevention of radiation-induced acute proctitis--on late rectal toxicity. Results of a phase III randomized, placebo-controlled, double-blind study",
abstract = "BACKGROUND AND PURPOSE: To assess the late effect of a prostaglandin, given rectally during irradiation, on late rectal toxicity. In the acute treatment setting no significant differences in reducing the incidence of acute proctitis symptoms in patients receiving misoprostol, however, significantly more rectal bleeding had been reported.PATIENTS AND METHODS: A total of 100 patients who had undergone radiotherapy for prostate cancer had been entered into this phase III randomized, placebo-controlled, double-blind study with misoprostol or placebo suppositories. The toxicity was evaluated yearly after cessation of irradiation by the RTOG/LENT-SOMA scale.RESULTS: The median follow-up was 50 months. 20 patients suffered from grade 1, four patients from grade 2 as well, and three patients only from grade 2 toxicity. Frequency, bleeding and urgency were the most commonly reported symptoms. In keeping with other studies and clinical experience, the symptoms peaked within the first 2 years with a median for grade 1 of 13 months and for grade 2 of 15 months. The presence of acute toxicity grade 2 showed a correlation with the development of any late toxicity (p = 0.03). Any acute rectal bleeding was significant correlated with any late rectal bleeding (p = 0.017).CONCLUSION: Misoprostol given as once-daily suppository for prevention of acute radiation-induced proctitis does neither influence the incidence and severity of radiation-induced acute nor late rectal toxicity. Misoprostol has no negative impact on the incidence and severity of late rectal bleeding, in contrast to acute rectal bleeding. The routine clinical use of misoprostol suppositories cannot be recommended.",
keywords = "Administration, Rectal, Aged, Anti-Ulcer Agents, Double-Blind Method, Follow-Up Studies, Humans, Male, Middle Aged, Misoprostol, Proctitis, Prostatic Neoplasms, Radiotherapy, Time Factors, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial",
author = "Tereza Kertesz and Herrmann, {Markus K A} and Antonia Zapf and Hans Christiansen and Hermann, {Robert M} and Olivier Pradier and Heinz Schmidberger and Hess, {Clemens F} and Andrea Hille",
year = "2009",
month = sep,
doi = "10.1007/s00066-009-1978-8",
language = "English",
volume = "185",
pages = "596--602",
journal = "STRAHLENTHER ONKOL",
issn = "0179-7158",
publisher = "Urban und Vogel",
number = "9",

}

RIS

TY - JOUR

T1 - Effect of a prostaglandin--given rectally for prevention of radiation-induced acute proctitis--on late rectal toxicity. Results of a phase III randomized, placebo-controlled, double-blind study

AU - Kertesz, Tereza

AU - Herrmann, Markus K A

AU - Zapf, Antonia

AU - Christiansen, Hans

AU - Hermann, Robert M

AU - Pradier, Olivier

AU - Schmidberger, Heinz

AU - Hess, Clemens F

AU - Hille, Andrea

PY - 2009/9

Y1 - 2009/9

N2 - BACKGROUND AND PURPOSE: To assess the late effect of a prostaglandin, given rectally during irradiation, on late rectal toxicity. In the acute treatment setting no significant differences in reducing the incidence of acute proctitis symptoms in patients receiving misoprostol, however, significantly more rectal bleeding had been reported.PATIENTS AND METHODS: A total of 100 patients who had undergone radiotherapy for prostate cancer had been entered into this phase III randomized, placebo-controlled, double-blind study with misoprostol or placebo suppositories. The toxicity was evaluated yearly after cessation of irradiation by the RTOG/LENT-SOMA scale.RESULTS: The median follow-up was 50 months. 20 patients suffered from grade 1, four patients from grade 2 as well, and three patients only from grade 2 toxicity. Frequency, bleeding and urgency were the most commonly reported symptoms. In keeping with other studies and clinical experience, the symptoms peaked within the first 2 years with a median for grade 1 of 13 months and for grade 2 of 15 months. The presence of acute toxicity grade 2 showed a correlation with the development of any late toxicity (p = 0.03). Any acute rectal bleeding was significant correlated with any late rectal bleeding (p = 0.017).CONCLUSION: Misoprostol given as once-daily suppository for prevention of acute radiation-induced proctitis does neither influence the incidence and severity of radiation-induced acute nor late rectal toxicity. Misoprostol has no negative impact on the incidence and severity of late rectal bleeding, in contrast to acute rectal bleeding. The routine clinical use of misoprostol suppositories cannot be recommended.

AB - BACKGROUND AND PURPOSE: To assess the late effect of a prostaglandin, given rectally during irradiation, on late rectal toxicity. In the acute treatment setting no significant differences in reducing the incidence of acute proctitis symptoms in patients receiving misoprostol, however, significantly more rectal bleeding had been reported.PATIENTS AND METHODS: A total of 100 patients who had undergone radiotherapy for prostate cancer had been entered into this phase III randomized, placebo-controlled, double-blind study with misoprostol or placebo suppositories. The toxicity was evaluated yearly after cessation of irradiation by the RTOG/LENT-SOMA scale.RESULTS: The median follow-up was 50 months. 20 patients suffered from grade 1, four patients from grade 2 as well, and three patients only from grade 2 toxicity. Frequency, bleeding and urgency were the most commonly reported symptoms. In keeping with other studies and clinical experience, the symptoms peaked within the first 2 years with a median for grade 1 of 13 months and for grade 2 of 15 months. The presence of acute toxicity grade 2 showed a correlation with the development of any late toxicity (p = 0.03). Any acute rectal bleeding was significant correlated with any late rectal bleeding (p = 0.017).CONCLUSION: Misoprostol given as once-daily suppository for prevention of acute radiation-induced proctitis does neither influence the incidence and severity of radiation-induced acute nor late rectal toxicity. Misoprostol has no negative impact on the incidence and severity of late rectal bleeding, in contrast to acute rectal bleeding. The routine clinical use of misoprostol suppositories cannot be recommended.

KW - Administration, Rectal

KW - Aged

KW - Anti-Ulcer Agents

KW - Double-Blind Method

KW - Follow-Up Studies

KW - Humans

KW - Male

KW - Middle Aged

KW - Misoprostol

KW - Proctitis

KW - Prostatic Neoplasms

KW - Radiotherapy

KW - Time Factors

KW - Clinical Trial, Phase III

KW - Journal Article

KW - Randomized Controlled Trial

U2 - 10.1007/s00066-009-1978-8

DO - 10.1007/s00066-009-1978-8

M3 - SCORING: Journal article

C2 - 19756426

VL - 185

SP - 596

EP - 602

JO - STRAHLENTHER ONKOL

JF - STRAHLENTHER ONKOL

SN - 0179-7158

IS - 9

ER -