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Randomized phase II exploratory study of prophylactic amifostine in cancer patients who receive radical radiotherapy to the pelvis.

Katsanos KH, Briasoulis E, Tsekeris P, Batistatou A, Bai M, Tolis C, Capizzello A, Panelos I, Karavasilis V, Christodoulou D, Tsianos EV - J. Exp. Clin. Cancer Res. (2010)

Bottom Line: Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%).Amifostine side effects were mild.Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.

View Article: PubMed Central - HTML - PubMed

Affiliation: 1st Department of Internal Medicine & Hepato-Gastroenterology Unit, Medical School of Ioannina, Leoforos Stavrou Niarxou, Ioannina, 451 10, Greece. etsianos@uoi.gr

ABSTRACT

Background: This study aimed to investigate the efficacy of prophylactic amifostine in reducing the risk of severe radiation colitis in cancer patients receiving radical radiotherapy to the pelvis.

Methods: Patients with pelvic tumours referred for radical radiotherapy who consented participation in this trial, were randomly assigned to receive daily amifostine (A) (subcutaneously, 500 mg flat dose) before radiotherapy or radiotherapy alone (R). Sigmoidoscopy and blinded biopsies were scheduled to conduct prior to initiation and following completion of radiotherapy and again 6 to 9 months later. Radiation colitis was assessed by clinical, endoscopic and histolopathological criteria.

Results: A total 44 patients were enrolled in this trial, the majority with rectal (20 patients) and cervical cancer (12 patients) and were assigned 23 in R arm and 21 in the A arm. In total 119 sigmoidoscopies were performed and 18 patients (18/44, 40.9%) were diagnosed with radiation colitis (15 grade 1 and 2, and 3 grade 3 and 4). Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%). Acute and grade IV radiation colitis was only developed in four patients (17.4%) in the R group. Amifostine side effects were mild. Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.

Conclusions: Amifostine given subcutaneously can lower the risk of acute severe radiation colitis in patients who receive radical radiotherapy to pelvic tumors.

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Histopathological findings of radiation-induced colitis. A. Acute injury, characterized by ulceration, absence of viable crypts, diffuse infiltration by polymorphonuclear leucocytes, and prominent capillaries lined by plump endothelial cells (H + E × 400). B. Early regenerative changes, characterized by absence of ulceration, considerably less acute inflammation, infiltration by plasma cells and lymphocytes, presence of viable crypts with disarray, absence of cryptitis or acute epithelial damage (H+E × 400). C. Late regenerative changes, characterized by absence of acute inflammation, mild diffuse infiltration by plama cells and lymphocytes, architectural crypt distortion, with reduced crypts, crypt branching and shortening as well as moderate/severe fibrosis of the lamina propria (H + E × 400).
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Figure 2: Histopathological findings of radiation-induced colitis. A. Acute injury, characterized by ulceration, absence of viable crypts, diffuse infiltration by polymorphonuclear leucocytes, and prominent capillaries lined by plump endothelial cells (H + E × 400). B. Early regenerative changes, characterized by absence of ulceration, considerably less acute inflammation, infiltration by plasma cells and lymphocytes, presence of viable crypts with disarray, absence of cryptitis or acute epithelial damage (H+E × 400). C. Late regenerative changes, characterized by absence of acute inflammation, mild diffuse infiltration by plama cells and lymphocytes, architectural crypt distortion, with reduced crypts, crypt branching and shortening as well as moderate/severe fibrosis of the lamina propria (H + E × 400).

Mentions: Based on the histologic features noted with the haematoxylin-eosin stain, cases were allocated to one of the following four groups: 1) no changes, when no changes were noted in bowel mucosa; 2) acute injury, characterized by the presence of ulceration and diffuse infiltration by polymorphonuclear leucocytes as well as eosinophil granulocytes, the near absence of viable crypts, the presence of cryptitis and other damage in the surviving epithelium, endothelial degeneration and platelet thrombi (Figure 2A); 3) early regenerative changes, characterized by absence of ulceration, considerably less acute inflammation but noteworthy infiltration by eosinophil granulocytes, as well as plasma cells, lymphocytes and muciphages, presence of viable crypts with disarray, absence of cryptitis or acute epithelial damage, some endothelial degeneration and telangiectasia as well as mild fibrosis of the lamina propria (Figure 2B) and 4) late regenerative changes, characterized by minimal (if any) acute inflammation, mild diffuse infiltration by plama cells and lymphocytes, consistent presence of muciphages, architectural crypt distortion, with reduced crypts, crypt branching and shortening as well as moderate/severe fibrosis of the lamina propria (Figure 2C). The presence of eosinophils in the lamina propria, particularly on the acute and early regenerative phase was noted in almost all specimens. However, in contrast with the radiation colitis induced by pre-operative irradiation no "eosinophil crypt abscesses" was observed, even in acute injury.


Randomized phase II exploratory study of prophylactic amifostine in cancer patients who receive radical radiotherapy to the pelvis.

Katsanos KH, Briasoulis E, Tsekeris P, Batistatou A, Bai M, Tolis C, Capizzello A, Panelos I, Karavasilis V, Christodoulou D, Tsianos EV - J. Exp. Clin. Cancer Res. (2010)

Histopathological findings of radiation-induced colitis. A. Acute injury, characterized by ulceration, absence of viable crypts, diffuse infiltration by polymorphonuclear leucocytes, and prominent capillaries lined by plump endothelial cells (H + E × 400). B. Early regenerative changes, characterized by absence of ulceration, considerably less acute inflammation, infiltration by plasma cells and lymphocytes, presence of viable crypts with disarray, absence of cryptitis or acute epithelial damage (H+E × 400). C. Late regenerative changes, characterized by absence of acute inflammation, mild diffuse infiltration by plama cells and lymphocytes, architectural crypt distortion, with reduced crypts, crypt branching and shortening as well as moderate/severe fibrosis of the lamina propria (H + E × 400).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2903531&req=5

Figure 2: Histopathological findings of radiation-induced colitis. A. Acute injury, characterized by ulceration, absence of viable crypts, diffuse infiltration by polymorphonuclear leucocytes, and prominent capillaries lined by plump endothelial cells (H + E × 400). B. Early regenerative changes, characterized by absence of ulceration, considerably less acute inflammation, infiltration by plasma cells and lymphocytes, presence of viable crypts with disarray, absence of cryptitis or acute epithelial damage (H+E × 400). C. Late regenerative changes, characterized by absence of acute inflammation, mild diffuse infiltration by plama cells and lymphocytes, architectural crypt distortion, with reduced crypts, crypt branching and shortening as well as moderate/severe fibrosis of the lamina propria (H + E × 400).
Mentions: Based on the histologic features noted with the haematoxylin-eosin stain, cases were allocated to one of the following four groups: 1) no changes, when no changes were noted in bowel mucosa; 2) acute injury, characterized by the presence of ulceration and diffuse infiltration by polymorphonuclear leucocytes as well as eosinophil granulocytes, the near absence of viable crypts, the presence of cryptitis and other damage in the surviving epithelium, endothelial degeneration and platelet thrombi (Figure 2A); 3) early regenerative changes, characterized by absence of ulceration, considerably less acute inflammation but noteworthy infiltration by eosinophil granulocytes, as well as plasma cells, lymphocytes and muciphages, presence of viable crypts with disarray, absence of cryptitis or acute epithelial damage, some endothelial degeneration and telangiectasia as well as mild fibrosis of the lamina propria (Figure 2B) and 4) late regenerative changes, characterized by minimal (if any) acute inflammation, mild diffuse infiltration by plama cells and lymphocytes, consistent presence of muciphages, architectural crypt distortion, with reduced crypts, crypt branching and shortening as well as moderate/severe fibrosis of the lamina propria (Figure 2C). The presence of eosinophils in the lamina propria, particularly on the acute and early regenerative phase was noted in almost all specimens. However, in contrast with the radiation colitis induced by pre-operative irradiation no "eosinophil crypt abscesses" was observed, even in acute injury.

Bottom Line: Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%).Amifostine side effects were mild.Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.

View Article: PubMed Central - HTML - PubMed

Affiliation: 1st Department of Internal Medicine & Hepato-Gastroenterology Unit, Medical School of Ioannina, Leoforos Stavrou Niarxou, Ioannina, 451 10, Greece. etsianos@uoi.gr

ABSTRACT

Background: This study aimed to investigate the efficacy of prophylactic amifostine in reducing the risk of severe radiation colitis in cancer patients receiving radical radiotherapy to the pelvis.

Methods: Patients with pelvic tumours referred for radical radiotherapy who consented participation in this trial, were randomly assigned to receive daily amifostine (A) (subcutaneously, 500 mg flat dose) before radiotherapy or radiotherapy alone (R). Sigmoidoscopy and blinded biopsies were scheduled to conduct prior to initiation and following completion of radiotherapy and again 6 to 9 months later. Radiation colitis was assessed by clinical, endoscopic and histolopathological criteria.

Results: A total 44 patients were enrolled in this trial, the majority with rectal (20 patients) and cervical cancer (12 patients) and were assigned 23 in R arm and 21 in the A arm. In total 119 sigmoidoscopies were performed and 18 patients (18/44, 40.9%) were diagnosed with radiation colitis (15 grade 1 and 2, and 3 grade 3 and 4). Of them, 6 patients belonged to the A group (6/21, 28.6%) and 12 to the R group (12/23, 52.2%). Acute and grade IV radiation colitis was only developed in four patients (17.4%) in the R group. Amifostine side effects were mild. Amifostine treated patients were less likely to develop histologically detectable mucosal lesions, which indicate protection from acute mucosal injury.

Conclusions: Amifostine given subcutaneously can lower the risk of acute severe radiation colitis in patients who receive radical radiotherapy to pelvic tumors.

Show MeSH
Related in: MedlinePlus