Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer
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Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer. / Rödel, Claus; Liersch, Torsten; Hermann, Robert Michael; Arnold, Dirk; Reese, Thomas; Hipp, Matthias; Fürst, Alois; Schwella, Nimrod; Bieker, Michael; Hellmich, Gunter; Ewald, Hermann; Haier, Jörg; Lordick, Florian; Flentje, Michael; Sülberg, Heiko; Hohenberger, Werner; Sauer, Rolf.
In: J CLIN ONCOL, Vol. 25, No. 1, 01.01.2007, p. 110-7.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer
AU - Rödel, Claus
AU - Liersch, Torsten
AU - Hermann, Robert Michael
AU - Arnold, Dirk
AU - Reese, Thomas
AU - Hipp, Matthias
AU - Fürst, Alois
AU - Schwella, Nimrod
AU - Bieker, Michael
AU - Hellmich, Gunter
AU - Ewald, Hermann
AU - Haier, Jörg
AU - Lordick, Florian
AU - Flentje, Michael
AU - Sülberg, Heiko
AU - Hohenberger, Werner
AU - Sauer, Rolf
PY - 2007/1/1
Y1 - 2007/1/1
N2 - PURPOSE: To evaluate the activity and safety of preoperative radiotherapy (RT) and concurrent capecitabine and oxaliplatin (XELOX-RT) plus four cycles of adjuvant XELOX in patients with rectal cancer.PATIENTS AND METHODS: One hundred ten patients with T3/T4 or N+ rectal cancer were entered onto the trial in 11 investigator sites and received preoperative RT (50.4 Gy in 28 fractions). Capecitabine was administered concurrently at 1,650 mg/m2 on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m2 on days 1, 8, 22, and 29. Surgery was scheduled 4 to 6 weeks after completion of XELOX-RT. Four cycles of adjuvant XELOX (capecitabine 1,000 mg/m2 bid on days 1 to 14; oxaliplatin 130 mg/m2 on day 1) were administered. The main end points were activity as assessed by the pathologic complete response (pCR) rate and the feasibility of postoperative XELOX chemotherapy.RESULTS: After XELOX-RT, 103 of 104 eligible patients underwent surgery; pCR was achieved in 17 patients (16%), one patient had ypT0N1 disease, and 53 patients showed tumor regression of more than 50% of the tumor mass. R0 resections were achieved in 95% of patients, and sphincter preservation was accomplished in 77%. Full-dose preoperative XELOX-RT was administered in 96%. Grade 3 or 4 diarrhea occurred in 12% of patients. Postoperative complication occurred in 43% of patients. Sixty percent of patients received all four cycles of adjuvant XELOX, with sensory neuropathy (18%) and diarrhea (12%) being the main grade 3 or 4 toxicities.CONCLUSION: Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment.
AB - PURPOSE: To evaluate the activity and safety of preoperative radiotherapy (RT) and concurrent capecitabine and oxaliplatin (XELOX-RT) plus four cycles of adjuvant XELOX in patients with rectal cancer.PATIENTS AND METHODS: One hundred ten patients with T3/T4 or N+ rectal cancer were entered onto the trial in 11 investigator sites and received preoperative RT (50.4 Gy in 28 fractions). Capecitabine was administered concurrently at 1,650 mg/m2 on days 1 to 14 and 22 to 35, and oxaliplatin was administered at 50 mg/m2 on days 1, 8, 22, and 29. Surgery was scheduled 4 to 6 weeks after completion of XELOX-RT. Four cycles of adjuvant XELOX (capecitabine 1,000 mg/m2 bid on days 1 to 14; oxaliplatin 130 mg/m2 on day 1) were administered. The main end points were activity as assessed by the pathologic complete response (pCR) rate and the feasibility of postoperative XELOX chemotherapy.RESULTS: After XELOX-RT, 103 of 104 eligible patients underwent surgery; pCR was achieved in 17 patients (16%), one patient had ypT0N1 disease, and 53 patients showed tumor regression of more than 50% of the tumor mass. R0 resections were achieved in 95% of patients, and sphincter preservation was accomplished in 77%. Full-dose preoperative XELOX-RT was administered in 96%. Grade 3 or 4 diarrhea occurred in 12% of patients. Postoperative complication occurred in 43% of patients. Sixty percent of patients received all four cycles of adjuvant XELOX, with sensory neuropathy (18%) and diarrhea (12%) being the main grade 3 or 4 toxicities.CONCLUSION: Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment.
KW - Adult
KW - Aged
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Capecitabine
KW - Chemotherapy, Adjuvant
KW - Combined Modality Therapy
KW - Deoxycytidine
KW - Female
KW - Fluorouracil
KW - Humans
KW - Male
KW - Middle Aged
KW - Organoplatinum Compounds
KW - Rectal Neoplasms
KW - Remission Induction
KW - Treatment Outcome
U2 - 10.1200/JCO.2006.08.3675
DO - 10.1200/JCO.2006.08.3675
M3 - SCORING: Journal article
C2 - 17194912
VL - 25
SP - 110
EP - 117
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 1
ER -