Intensified irinotecan-based neoadjuvant chemoradiotherapy in rectal cancer: four consecutive designed studies to minimize acute toxicity and to optimize efficacy measured by pathologic complete response.
BACKGROUND
The objective of the present study was to analyse toxicity and efficacy of irinotecan-based neoadjuvant chemoradiotherapy by the help of four consecutively planed and prospectively performed phase II studies.


METHODS
Patients with locally advanced rectal cancer received radiotherapy and concurrently chemotherapy consisting 5-Fu/capecitabine in a continuous or intermittent application and irinotecan in two different total doses (240 vs. 200 mg/m(2)).


RESULTS
Diarrhea CTC grade III was seen in 35% in continuous application of 5-Fu/capecitabine versus 12.5% in intermittent application (p= 0,008). Complete response according to the irinotecan dose during chemoradiotherapy (240 mg/m(2) vs. 200 mg/m(2)) was 24% and 0%.


CONCLUSIONS
Chemoradiotherapy of the last phase II study with intermittent capecitabine (1500 mg/m(2)/day, delivered on days 1-14 and 22-35) and irinotecan (4 x 60 mg/m(2)) concurrently to radiotherapy is a safe treatment with low toxicity and high efficacy.
Klautke
Gunther
G
Department of Radiotherapy, University Hospital, Sudring 75, Rostock, Germany. gunther.klautke@med.uni-rostock.de
Küchenmeister
Ute
U
Foitzik
Thomas
T
Ludwig
Kaja
K
Semrau
Sabine
S
Prall
Friedrich
F
Klar
Ernst
E
Fietkau
Rainer
R
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000633:toxicity; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000633:toxicity; D000069287:Capecitabine; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000401:mortality / Q000628:therapy*
D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin