Addition of oxaliplatin to neo-adjuvant radiochemotherapy for irresectable rectal cancer, a phase I study.
BACKGROUND
The aim was to determine the maximum tolerable dose of oxaliplatin added to (oral) 5FU in irresectable rectal cancer.


METHODS
Nineteen patients were treated; 13 patients received 5FU/LV and 6 patients capecitabine. Oxaliplatin was administered on days 1 and 29 at dose levels 85 and 130 mg/m2. Four to seven weeks thereafter, surgery was performed.


RESULTS
In 6 patients treated with 85 mg/m2, one grade 3 elevation of liver transaminases occurred. Of 7 patients who received 130 mg/m2, 1 patient experienced a grade III thrombocytopenia and 1 patient died of neutropenic fever, probably due to an urosepsis. Six patients were treated with capecitabine, of whom 3 developed a grade III gastrointestinal toxicity. An R0 resection could be performed in 93%, a pT0-2N0 in 39%, with 2 pCR's.


CONCLUSIONS
The addition of oxaliplatin at 85 mg/m2 on days 1 and 29 to radiotherapy and 5FU/LV or capecitabine in irresectable rectal cancer is feasible.
Reerink
Onne
O
Department of Radiation Oncology, University Hospital Groningen, 9700 RB Groningen, The Netherlands.
Mulder
Nanno H
NH
Verschueren
René C J
RC
Wiggers
Theo
T
Szabo
Ben G
BG
Hospers
Geke A P
GA
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy / Q000379:methods*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D000077150:Oxaliplatin; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D013997:Time Factors
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil