title: Gender-specific acute organ toxicity during intensified preoperative radiochemotherapy for rectal cancer.
abstract: Patients with locally advanced rectal cancer (cUICC stages II/III) are typically treated with preoperative 5-fluorouracil-based (5-FU-based) radiochemotherapy (RCT). However, trials are currently being conducted to improve the complete remission rates and the systemic control by combining 5-FU with oxaliplatin. The primary objective was to identify the subgroups of rectal cancer patients who were at risk for high-grade toxicity. All 196 patients who were included in the present study were treated with 50.4 Gy and chemotherapy that included either 5-FU (n = 115) or 5-FU+oxaliplatin (n = 81). The preoperative RCT was followed by a total mesorectal excision and adjuvant chemotherapy. Acute toxicity was monitored weekly and a toxicity grade ≥3 (Common Toxicity Criteria) for a skin reaction, cystitis, proctitis, or enteritis was defined as high-grade acute organ toxicity. After RCT with 5-FU+oxaliplatin, complete tumor remission was achieved in 13.6% of the patients and in 11.3% after RCT with 5-FU alone. Complete irradiation dosages of 50.4 Gy were given to 99% (5-FU) and 95% (5-FU+oxaliplatin) of the patients. Concomitant chemotherapy was fully administered in 95% of the patients treated with 5-FU compared with the 84% of patients treated with 5-FU+oxaliplatin. A significantly higher proportion of acute organ toxicity was found in the patients who were treated with 5-FU+oxaliplatin compared with those who were treated with 5-FU. Additionally, women with a low body mass index were at the highest risk for acute organ toxicity. These results suggest that there are basic clinical parameters, such as gender and body mass index, that may be potential markers for generating individual risk profiles of RCT-induced toxicity.
authors.affiliation: Department of Radiotherapy and Radiooncology, University Medical Center Göttingen, Robert-Koch-Strasse 40, 37075 Göttingen, Germany. hendrik.wolff@med.uni-goettingen.de
authors.forename: Hendrik A
authors.initials: HA
authors.lastname: Wolff
authors.forename: Lena-Christin
authors.initials: LC
authors.lastname: Conradi
authors.forename: Markus
authors.initials: M
authors.lastname: Schirmer
authors.forename: Tim
authors.initials: T
authors.lastname: Beissbarth
authors.forename: Thilo
authors.initials: T
authors.lastname: Sprenger
authors.forename: Margret
authors.initials: M
authors.lastname: Rave-Fränk
authors.forename: Steffen
authors.initials: S
authors.lastname: Hennies
authors.forename: Clemens F
authors.initials: CF
authors.lastname: Hess
authors.forename: Heinz
authors.initials: H
authors.lastname: Becker
authors.forename: Hans
authors.initials: H
authors.lastname: Christiansen
authors.forename: Torsten
authors.initials: T
authors.lastname: Liersch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D015992:Body Mass Index; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000009:adverse effects* / Q000627:therapeutic use; D000077150:Oxaliplatin; D011300:Preoperative Care; D012004:Rectal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D012737:Sex Factors
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil