After a dose of 45Gy the small bowel was excluded and an additional dose of 5.4Gy was given to boost the volume using a shrinking field Perifosine 157716-52-4 technique (days 36�C38). Chemotherapy Starting at day 1 of RT, patients received capecitabine 500mgm?2 orally bid within 30min after a meal (generally after breakfast and dinner) for the whole time of irradiation (days 1�C38), and weekly irinotecan 50mgm?2 beginning on day 1 of RT for 5 consecutive weeks (days 1, 8, 15, 22, and 29) (Hofheinz et al, 2005). All patients received standard antiemetic prophylaxis using 5-HT3 antagonists and dexamethasone. If a patient reported one of the following adverse events according to National Cancer Institute common toxicity criteria (NCI-CTC version 3.
0), chemotherapy was interrupted until adverse events had resolved to grade 0 or 1: leucocytopenia grade 2, thrombocytopenia grade 2, diarrhoea grade 2, mucositis/stomatitis grade 2, skin adverse events grade 2, and other adverse events >grade 2. Treatment was resumed in these cases with a dose reduction of 25% for both drugs (in case of hand-foot skin reaction only capecitabine was reduced by 25%). On the second occurrence of an adverse event grade 2, the capecitabine and irinotecan dose was to be reduced to 50% of the starting dose (except in the case of, hand-foot skin reaction; only capecitabine was to be reduced by 50%). The application of postoperative adjuvant chemotherapy was left at the discretion of the treating physician. All effort was made to continue daily RT without interruption, unless the patient experienced persistent or severe adverse event.
The RT schedule was not modified or interrupted, unless an adverse event (such as a skin adverse event grade 2) was related to radiation. In these cases, RT was withheld until adverse events resolved to grade 0 or 1. Surgery and histopathologic examination of resected specimen Surgical resection (either low anterior or abdomino-perineal resection) with total mesorectal excision (TME) was scheduled 4�C6 weeks after completion of CapIri-RT. A time interval of 4�C6 weeks between the termination of chemoradiotherapy and surgery was chosen, because it is considered a standard of care by most German centers. Pathological examination of the surgical specimen involved opening the specimen, identification of the former tumour-bearing area and macroscopic description followed by fixation in 10% neutral-buffered formalin for 24h.
After fixation, specimens were processed according to standard protocols (Compton, 2000). For obvious residual tumour, at least four paraffin blocks were processed. If no obvious residual tumour was present, the whole former tumour-bearing area was sliced and embedded. The completion of TME, circumferential Entinostat resection margins, proximal and distal tumour-free margins, tumour mass, fibrotic changes, and irradiation vasculopathy were evaluated and semiquantitatively described whenever feasible.
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