title: Neoadjuvant chronomodulated capecitabine with radiotherapy in rectal cancer: a phase II brunch regimen study.
abstract: OBJECTIVE
  The aim of this study was to evaluate efficacy and safety of chronomodulated capecitabine administered according to a specific time schedule (Brunch Regimen: Breakfast and Lunch) as a part of neoadjuvant chemoradiation therapy in patients with locally advanced rectal cancer.
  
  
  METHODS
  Eighty-five patients with stage II and III rectal cancer were included. Patients received capecitabine (1,650 mg/m(2) per day; 60% dose at 8:00 AM and 40% dose at 12:00 noon) administered during pelvic radiation (total 50.4 Gy in 28 fractions, 1.8 Gy daily dose between 2:00 p.m. and 4:00 p.m.). After chemoradiotherapy, patients underwent surgery. The primary endpoints were pathological complete response (pCR) rate and toxicity.
  
  
  RESULTS
  In 17 patients (20%), total tumor regression was achieved according to Dworak pathological grading system. Grade III diarrhea occurred in nine patients (10.5%), while only one patient had grade 3 thrombocytopenia. Grade II or III proctitis were seen in nine (10.5%) subjects, and grade I or II cystitis in six (6.9%). Only three patients (3.3%) developed hand and foot syndrome (both grade I-II). There were no grade IV toxicities.
  
  
  CONCLUSIONS
  Brunch Regimen for locally advanced rectal cancer consisting of neoadjuvant chronomodulated capecitabine and concurrent radiation therapy is effective and well tolerated with good safety profile, particularly with regard to the occurrence of hand and foot syndrome, in patients with locally advanced rectal cancer.
authors.affiliation: Department of Radiation Oncology, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.
authors.forename: Zuleyha
authors.initials: Z
authors.lastname: Akgun
authors.forename: Sezer
authors.initials: S
authors.lastname: Saglam
authors.forename: Serap
authors.initials: S
authors.lastname: Yucel
authors.forename: Zeynep
authors.initials: Z
authors.lastname: Gural
authors.forename: Emre
authors.initials: E
authors.lastname: Balik
authors.forename: Gokhan
authors.initials: G
authors.lastname: Cipe
authors.forename: Seyma
authors.initials: S
authors.lastname: Yildiz
authors.forename: Sadettin
authors.initials: S
authors.lastname: Kilickap
authors.forename: Alper
authors.initials: A
authors.lastname: Okyar
authors.forename: Esra
authors.initials: E
authors.lastname: Kaytan-Saglam
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000069287:Capecitabine; D059186:Chemoradiotherapy, Adjuvant / Q000379:methods; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D055870:Drug Chronotherapy; D016903:Drug Monitoring; D004354:Drug Screening Assays, Antitumor; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology / Q000503:physiopathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009367:Neoplasm Staging; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil