大腸直腸癌 抗癌藥物治療指引 討論日期 團隊討論 : 105 年 10 月 19 日 三院討論 : 105 年 12 月 7 日 團隊確認 : 106 年 1 月 25 日 核備日期 : 106 年 4 月 18 日

Transcription

1 大腸直腸癌 抗癌藥物治療指 討論日期 團隊討論 : 05 年 0 月 9 日 三院討論 : 05 年 2 月 7 日 團隊確認 : 06 年 月 25 日 核備日期 : 06 年 4 月 8 日

2 Adjuvant Therapy of Colon Cancer mfolfox6 參考文獻 -3 Oxaliplatin 85 Q2W 2 Leucovorin 400 Q2W 2 5-FU 400 Q2W 2 5-FU Q2W 2 FOLFOX4 參考文獻 9 週期 Oxaliplatin 85 Q2W 2 Leucovorin Q2W 2 5-FU Q2W 2 5-FU Q2W 2 FLOX 參考文獻 4 週期 Oxaliplatin 85,5,29 Q8W 3 Leucovorin 500,8,5,22,29,36 Q8W 3 5-FU 500,8,5,22,29,36 Q8W 3 33

3 Capecitabine 參考文獻 5 週期 Capecitabine 250 PO BID -4 Q3W 8 CapeOx 參考文獻 6 Oxaliplatin 30 Q3W 8 Capecitabine 000 PO BID -4 Q3W 8 5-FU+LV 參考文獻 7 Leucovorin 5-FU ,8,5,22,29,36,8,5,22,29,36 Q8W Q8W 4 4 slv5fu2 參考文獻 8 週期 Leucovorin 400 Q2W 2 5-FU 400 Q2W 2 5-FU Q2W 2 34

4 LV5FU Leucovorin 5-FU UFUR /day Q2W Q2W TS Q42D 參考文獻,. Andre T Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 2004;350: Cheeseman SL, Joel SP, Chester JD, et al. A modified de Gramont regimen of fluorouracil, alone and with oxaliplatin, for advanced colorectal cancer. Br J Cancer 2002;87: Maindrault-Goebel F, degramont A, Louvet C,et al. Evaluation of oxaliplatin dose intensity in bimonthly leucovorin and 48- hour 5-fluorouracil continuous infusion regimens (FOLFOX) in pretreated metastatic colorectal cancer. Annals of Oncology 2000;: Kuebler JP, Wieand HS, O Connell MJ, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol 2007;25: Twelves C, Wong A, Nowacki MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 2005;352: Schmoll HJ, Cartwright T, Taernero J, et al. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in,864 patients. J Clin Oncol 2007;25:

5 7. Haller DG, Catalano P, Macdonald JS Mayer RJ. Phase III study of fluorouracil, leucovorin and levamisole in high risk stage II and III colon cancer: final report of Intergroup J Clin Oncol 2005;23: Andre T, Louvet C, Maindrault-Goebel F, et al. CPT- (irinotecan) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. Eur J Cancer 999;35(9): degramont A, Figer A, Seymour M, et al. Leucovorin and Fluorouracil With or Without Oxaliplatin as First-Line Treatment in Advanced Colorectal Cancer. J Clon Oncol 2000;8:

6 Adjuvant Therapy of Rectal Cancer Chemotherapy mfolfox6 參考文獻 -3 Oxaliplatin 85 Q2W 2 Leucovorin 400 Q2W 2 5-FU 400 Q2W 2 5-FU Q2W 2 slv5fu2 參考文獻 4 週期 Leucovorin 400 Q2W 2 5-FU 400 Q2W 2 5-FU Q2W 2 Capecitabine 參考文獻 5 週期 Capecitabine 250 PO BID -4 Q3W 8 37 CapeOx 參考文獻 6,7 Oxaliplatin Capecitabine PO BID -4 Q3W Q3W 8

7 5-FU+LV 參考文獻 8 Leucovorin 5-FU ,8,5,22,29,36,8,5,22,29,36 Q8W Q8W 4 4 LV5FU Leucovorin 5-FU Chemotherapy + RT Q2W Q2W XRT + continuous infusion 5-FU 參考文獻 9 5-FU or 7 days Q4W During XRT XRT + 5-FU/LV 參考文獻 0 5-FU Leucovorin Q4W Q4W During week, 5 of XRT 38

8 XRT + Capecitabine 參考文獻,2 Capecitabine 825 PO BID -5 QW 5 XRT + mfolfox6 Oxaliplatin 85 Leucovorin FU FU XRT + 5-FU/LV 5-FU 325 Leucovorin 20 XRT + 5-FU/LV 5-FU 400 Leucovorin Q4W Q4W Q4W Q4W 39 UFUR /day TS Q42D

9 參考文獻,. Andre T Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med 2004;350: Cheeseman SL, Joel SP, Chester JD, et al. A modified de Gramont regimen of fluorouracil, alone and with oxaliplatin, for advanced colorectal cancer. Br J Cancer 2002;87: Maindrault-Goebel F, degramont A, Louvet C,et al. Evaluation of oxaliplatin dose intensity in bimonthly leucovorin and 48- hour 5-fluorouracil continuous infusion regimens (FOLFOX) in pretreated metastatic colorectal cancer. Annals of Oncology 2000;: Andre T, Louvet C, Maindrault-Goebel F, et al. CPT- (irinotecan) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. Eur J Cancer 999;35(9): Twelves C, Wong A, Nowacki MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 2005;352: Schmoll HJ, Cartwright T, Taernero J, et al. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in,864 patients. J Clin Oncol 2007;25: Haller DG, Tabernero J, Maroun J, et al. Capecitabine Plus Oxaliplatin Compared With Fluorouracil and Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer. J Clin Oncol 20;29: Petrelli N, Douglass Jr HO, Herrare L, et al. The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: a prospective randomized phase III trial. J Clin Oncol 989;7: O Connell MJ, Martenson JA, Wieand HS, et al. Improving adjuvant therapy for rectal cancer by combining protracted-infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med 994;33:

10 0. Tepper JE, O Connell M, Niedzwiecki D, et al. Adjuvant therapy in rectal cancer: analysis of stage, sex, and local control final report of Intergroup 04. J Clin Oncol 2002;20: O Connell MJ, Colangelo LH, Beart RW, et al. Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04. J Clin Oncol 204;32: Hofheinz R, Wenz FK, Post S, et al. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: A randomized, multicenter, non-inferiority, phase 3 trial. Lancet Oncol 202;3:

11 Chemotherapy for Advanced or Metastastic Disease Colon and Rectal Cancer mfolfox6 or mfolfox7 參考文獻,2,3,29 Oxaliplatin 85 Q2W 2 Leucovorin 400 Q2W 2 5-FU (optional) 400 Q2W 2 5-FU Q2W 2 FOLFOX4 參考文獻 3 Oxaliplatin 85 Q2W 2 Leucovorin Q2W 2 5-FU Q2W 2 5-FU Q2W 2 FOLFOX + Bevacizumab 參考文獻 4 Oxaliplatin 85 Q2W Leucovorin 400 Q2W 5-FU (optional) 400 Q2W 5-FU Q2W Bevacizumab 5 mg/kg Q2W 42

12 FOLFOX + Panitumumab (KRAS/NRAS WT gene only) 參考文獻 5 Oxaliplatin 85 Q2W Leucovorin 400 Q2W 5-FU (optional) 400 Q2W 5-FU Q2W Panitumumab 6 mg/kg Q2W FOLFOX + Cetuximab (KRAS/NRAS WT gene only) 參考文獻 6 Oxaliplatin 85 Q2W Leucovorin 400 Q2W 5-FU (optional) 400 Q2W 5-FU Q2W Cetuximab 500 ( ) Q2W (QW) CapeOx 參考文獻 7 Oxaliplatin Capecitabine PO BID -4 Q3W Q3W

13 CapeOx + Bevacizumab 參考文獻 7 週期 Oxaliplatin 30 Q3W 6 Capecitabine PO BID -4 Q3W 6 Bevacizumab 7.5 mg/kg Q3W 6 FOLFIRI 參考文獻 8,9 Irinotecan 80 Q2W Leucovorin 400 Q2W 5-FU 400 Q2W 5-FU Q2W FOLFIRI + Bevacizumab 參考文獻 0 Irinotecan 80 Q2W Leucovorin 400 Q2W 5-FU 400 Q2W 5-FU Q2W Bevacizumab 5 mg/kg Q2W 44

14 FOLFIRI + Cetuximab (KRAS/NRAS WT gene only) 參考文獻,2 Irinotecan 80 Q2W Leucovorin 400 Q2W 5-FU 400 Q2W 5-FU Q2W Cetuximab 500 ( ) Q2W (QW) FOLFIRI + Panitumumab (KRAS/NRAS WT gene only) 參考文獻 3 Irinotecan 80 Q2W Leucovorin 400 Q2W 5-FU 400 Q2W 5-FU Q2W Panitumumab 6 mg/kg Q2W FOLFIRI + Ziv-Aflibercept 參考文獻 4 Irinotecan 80 Q2W Leucovorin 400 Q2W 5-FU 400 Q2W 5-FU Q2W Ziv-Aflibercept 4 mg/kg Q2W 45

15 FOLFIRI + Ramucirumab 參考文獻 5 Irinotecan 80 Q2W Leucovorin 400 Q2W 5-FU 400 Q2W 5-FU Q2W Ramucirumab 8 mg/kg Q2W Capecitabine 參考文獻 7 週期 Capecitabine PO BID -4 Q3W 6 Capecitabine + Bevacizumab 參考文獻 6 Capecitabine Bevacizumab PO BID 7.5 mg/kg -4 Q3W Q3W Bolus or Infusional 5FU/Leucovorin Roswell Park 參考文獻 7 Leucovorin 5-FU ,8,5,22,29,36,8,5,22,29,36 Q8W Q8W 46

16 Simplified biweely infusional 5-FU/LV 參考文獻 8 Leucovorin 400 Q2W 5-FU 400 Q2W 5-FU Q2W Weekly 參考文獻 8 Leucovorin 5-FU QW QW Leucovorin 5-FU QW QW 參考文獻 9 IROX 參考文獻 20 Oxaliplatin Irinotecan Q3W Q3W 47

17 FOLFOXIRI ± Bevacizumab 參考文獻 2,22 Irinotecan 65 Q2W Oxaliplatin 85 Q2W Leucovorin 400 Q2W 5-FU Q2W ±Bevacizumab 5 mg/kg Q2W Irinotecan 參考文獻 23,24 Irinotecan 25 (80) ( ),8()() Q3W (Q2W) (Q3W) Cetuximab (KRAS/NRAS WT gene only) 參考文獻 2,25 Cetuximab 500 ( ) Q2W (QW) Cetuximab (KRAS/NRAS WT gene only) + Irinotecan 參考文獻 2,25 Cetuximab Irinotecan 500 ( ) 25 (80) ( ) Q2W (QW) Q3W (Q2W) (Q3W) 48

18 Panitumumab (KRAS/NRAS WT gene only) 參考文獻 26 Panitumumab 6 mg/kg Q2W Regorafenib 參考文獻 27 Regorafenib 60 mg PO -2 Q4W UFUR UFUR TS- 參考文獻 TS Q42D 參考文獻 /day 參考文獻. degramont A, Figer A, Seymour M, et al. Leucovorin and Fluorouracil With or Without Oxaliplatin as First-Line Treatment in Advanced Colorectal Cancer. J Clon Oncol 2000;8: Cheeseman SL, Joel SP, Chester JD, et al. A 'modified de Gramont' regimen of fluorouracil, alone and with oxaliplatin, for advanced colorectal cancer. Br J Cancer 2002;87: Maindrault-Goebel F, degramont A, Louvet C, et al. Evaluation of oxaliplatin dose intensity in bimonthly leucovorin and 48-hour 5-fluorouracil continuous infusion regimens (FOLFOX) in pretreated metastatic colorectal cancer. Ann Oncol 49

19 2000;: Emmanouiliders C, Sfakiotaki G, Androulakis N, et al. Front-line Bevacizumab in combination with Oxaliplatin, Leucovorin and 5-Fluorouracil (FOLFOX) in patients with metastatic colorectal cancer: a multicenter phase II study. BMC Cancer 2007;7:9. 5. Douillard JY, Siena S, Cassidy J, et al. Randomized, Phase III Trial of Panitumumab With Infusional Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX4) Versus FOLFOX4 Alone As First-Line Treatment in Patients With Previously Untreated Metastatic Colorectal Cancer: The PRIME Study. J Clin Oncol 200;28: Venook AP, Niedzwiecki D, Lenz H-J, et al. CALGB/SWOG 80405: Phase III trial of irinotecan/5-fu/leucovorin (FOLFIRI) or oxaliplatin/5-fu/leucovorin (mfolfox6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum [abstract]. ASCO Meeting Abstracts 204;32:LBA3. 7. Saltz LB, Clarke S, Diaz-Rubio E, et al. Bevacizumab in Combination With Oxaliplatin-Based Chemotherapy As First-Line Therapy in Metastatic Colorectal Cancer: A Randomized Phase III Study. J Clin Oncol 2008;26: Andre T, Louvet C, Maindrault-Goebel F, et al. CPT- (Irinotecan) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. Eur J Cancer 999;35(9): Fuchs CS, Marshall J, Mitchell E, et al. Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study. J Clin Oncol 2007;25: Heinemann V, von Weikersthal LF, Decker T, et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol Cunningham D, Humblet Y, Siena S, et al. Cetuximab Monotherapy and Cetuximab plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal Cancer. N Engl J Med 2004;35: Martin-Martorell P, Rosello' S, Rodriguez-Braun E, et al. Biweekly cetuximab and irinotecan in advanced colorectal cancer patients progressing after at least one previous line of chemotherapy: results of a phase II single institution trial. Br J Cancer 2008;99: Peeters M, Prince TJ, Cervantes A, et al. Randomized Phase III Study of Panitumumab With Fluorouracil, Leucovorin, and 50

20 Irinotecan (FOLFIRI) Compared With FOLFIRI Alone As Second-Line Treatment in Patients With Metastatic Colorectal Cancer. J Clin Oncol 200;28: Van Cutsem E, Tabemero J, Lakomy R, et al. Addition of Aflibercept to Fluorouracil, Leucovorin, and Irinotecan Improves Survival in a Phase III Randomized Trial in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin- Based Regimen. J Clin Oncol 202;30: Tabernero J, Yoshino T, Cohn AL, et al. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomized, double-blind, multicentre, phase 3 study. Lancet Oncol 205;6: Cunningham D, Lang I, Marcuello E, et al. Bevacizumab plus capecitabine versus capecitabine alone in elderly patients with previously untreated metastatic colorectal cancer (AVEX): an open-label, randomised phase 3 trial. Lancet Oncol 203;4: Wolmark N, Rockette H, Fisher B, et al. The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J Clin Oncol 993;: Jäger E, Heike M, Bemhard H, et al. Weekly high-dose leucovorin versus low-dose leucovorin combined with fluorouracil in advanced colorectal cancer: results of a randomized multicenter trial. J Clin Oncol 996;4: Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as firstline treatment for metastatic colorectal cancer: a multicentre randomised trial. The Lacncet 2000;355: Haller DG, Rothenberg ML, Wong AO, et al. Oxaliplatin Plus Irinotecan Compared With Irinotecan Alone as Second-Line Treatment After Single-Agent Fluoropyrimidine Therapy for Metastatic Colorectal Carcinoma. J Clin Oncol 2008;26: Falcone A, Ricci S, Brunetti I, et al. Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) As First-Line Treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest. J Clin Oncol 2007;25(3): Cremolini C, Loupakis F, Antoniotti C, et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open- 5

21 label, phase 3 TRIBE study. Lancet Oncol 205;6: Cunningham D, Pyrhonen S, James R, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. The Lancet 998;352: Fuchs CS, Moore MR, Harker G, et al. Phase III Comparison of Two Irinotecan Dosing Regimens in Second-Line Therapy of Metastatic Colorectal Cancer. J Clin Oncol 2003;2: Van Cutsem E, Tejpar S, Vanbeckevoort D, et al. Intrapatient Cetuximab Dose Escalation in Metastatic Colorectal Cancer According to the Grade of Early Skin Reactions: The Randomized EVEREST Study. J Clin Oncol 202;30: Van Custem E, Peeters M, Siena S, et al. Open-Label Phase III Trial of Panitumumab Plus Best Supportive Care Compared With Best Supportive Care Alone in Patients With Chemotherapy-Refractory Metastatic Colorectal Cancer. J Clin Oncol 2007;25: Grothey A, Van Custem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 203;38: Mayer RJ, Van Cutsem E, Falcone A, et al. Randomized Trial of TAS-02 for Refractory Metastatic Colorectal Cancer (RECOURSE). N Engl J Med 205;372: Hochster HS, Grothey A, Hart L, et al. Improved time to treatment failure with an intermittent oxaliplatin strategy: results of CONcePT. Ann Oncol 204;25: Andre T, Louvet C, Maindrault-Goebel F, et al. CPT- (irinotecan) addition to bimonthly, high-dose leucovorin and bolus and continuous-infusion 5-fluorouracil (FOLFIRI) for pretreated metastatic colorectal cancer. Eur J Cancer 999;35(9): degramont A, Figer A, Seymour M, et al. Leucovorin and Fluorouracil With or Without Oxaliplatin as First-Line Treatment in Advanced Colorectal Cancer. J Clon Oncol 2000;8:

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