Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3. Export

@article{citeulike:5700913, abstract = {PURPOSE The primary objective of this randomized, multicenter, phase III trial was to investigate whether the addition of irinotecan to the de Gramont infusional fluorouracil (FU)/leucovorin (LV) adjuvant regimen (LV5FU2) would improve disease-free survival (DFS) in patients with stage III colon cancer. PATIENTS AND METHODS After curatively intentioned surgery, patients with stage II and III colon cancer were randomly allocated surgery to receive LV5FU2 (LV 200 mg/m(2) as a 2-hour infusion, followed by FU; as a 400 mg/m(2) bolus and then a 600 mg/m(2) continuous infusion over 22 hours, days 1 and 2, every 2 weeks for 12 cycles: de Gramont regimen) with or without irinotecan (180 mg/m(2) as a 30- to 90-minute infusion, day 1, every 2 weeks). In total, 260 (7.9\%) of 3,278 patients received an alternative high-dose infusional FU/LV regimen (Arbeitsgemeinschaft Internische Onkologie regimen) with or without irinotecan. Results The principal efficacy analysis was based on 2,094 treated patients with stage III disease, randomly allocated in the LV5FU2 strata. After a median follow-up of 66.3 months, the 5-year DFS rate was 56.7\% with irinotecan/LV5FU2 and 54.3\% with LV5FU2 alone (primary end point: log-rank P = .106). Combining irinotecan with LV5FU2 did not significantly improve overall survival in this patient group compared with LV5FU2 alone (5-year rate 73.6\% v 71.3\%, respectively; log-rank P = .094). The addition of irinotecan to LV5FU2 was associated with an increased incidence of grade 3 to 4 GI events and neutropenia. CONCLUSION Irinotecan added to LV5FU2 as adjuvant therapy did not confer a statistically significant improvement in DFS or overall survival in patients with stage III colon cancer compared with LV5FU2 alone.}, author = {Van Cutsem, Eric and Labianca, Roberto and Bodoky, Gy\"{o}rgy and Barone, Carlo and Aranda, Enrique and Nordlinger, Bernard and Topham, Claire and Tabernero, Josep and Andr\'{e}, Thierry and Sobrero, Alberto F. and Mini, Enrico and Greil, Richard and Di Costanzo, Francesco and Collette, Laurence and Cisar, Laura and Zhang, Xiaoxi and Khayat, David and Bokemeyer, Carsten and Roth, Arnaud D. and Cunningham, David}, citeulike-article-id = {5700913}, citeulike-linkout-0 = {http://dx.doi.org/10.1200/JCO.2008.21.6663}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/19451425}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=19451425}, day = {1}, doi = {10.1200/JCO.2008.21.6663}, issn = {1527-7755}, journal = {Journal of clinical oncology : official journal of the American Society of Clinical Oncology}, keywords = {cancer, chemo, crc, petacc3}, month = {July}, number = {19}, pages = {3117--3125}, posted-at = {2009-09-01 21:55:36}, priority = {2}, title = {Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3.}, url = {http://dx.doi.org/10.1200/JCO.2008.21.6663}, volume = {27}, year = {2009} }

TY - JOUR ID - citeulike:5700913 L3 - citeulike-article-id:5700913 N2 - PURPOSE The primary objective of this randomized, multicenter, phase III trial was to investigate whether the addition of irinotecan to the de Gramont infusional fluorouracil (FU)/leucovorin (LV) adjuvant regimen (LV5FU2) would improve disease-free survival (DFS) in patients with stage III colon cancer. PATIENTS AND METHODS After curatively intentioned surgery, patients with stage II and III colon cancer were randomly allocated surgery to receive LV5FU2 (LV 200 mg/m(2) as a 2-hour infusion, followed by FU; as a 400 mg/m(2) bolus and then a 600 mg/m(2) continuous infusion over 22 hours, days 1 and 2, every 2 weeks for 12 cycles: de Gramont regimen) with or without irinotecan (180 mg/m(2) as a 30- to 90-minute infusion, day 1, every 2 weeks). In total, 260 (7.9%) of 3,278 patients received an alternative high-dose infusional FU/LV regimen (Arbeitsgemeinschaft Internische Onkologie regimen) with or without irinotecan. Results The principal efficacy analysis was based on 2,094 treated patients with stage III disease, randomly allocated in the LV5FU2 strata. After a median follow-up of 66.3 months, the 5-year DFS rate was 56.7% with irinotecan/LV5FU2 and 54.3% with LV5FU2 alone (primary end point: log-rank P = .106). Combining irinotecan with LV5FU2 did not significantly improve overall survival in this patient group compared with LV5FU2 alone (5-year rate 73.6% v 71.3%, respectively; log-rank P = .094). The addition of irinotecan to LV5FU2 was associated with an increased incidence of grade 3 to 4 GI events and neutropenia. CONCLUSION Irinotecan added to LV5FU2 as adjuvant therapy did not confer a statistically significant improvement in DFS or overall survival in patients with stage III colon cancer compared with LV5FU2 alone. IS - 19 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology SN - 1527-7755 EP - 3125 TI - Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3. VL - 27 SP - 3117 KW - cancer KW - chemo KW - crc KW - petacc3 AU - Van Cutsem, Eric AU - Labianca, Roberto AU - Bodoky, György AU - Barone, Carlo AU - Aranda, Enrique AU - Nordlinger, Bernard AU - Topham, Claire AU - Tabernero, Josep AU - André, Thierry AU - Sobrero, Alberto AU - Mini, Enrico AU - Greil, Richard AU - Di Costanzo, Francesco AU - Collette, Laurence AU - Cisar, Laura AU - Zhang, Xiaoxi AU - Khayat, David AU - Bokemeyer, Carsten AU - Roth, Arnaud AU - Cunningham, David PY - 2009/07/01/ UR - http://dx.doi.org/10.1200/JCO.2008.21.6663 ER -