Read GUIDELINE text version

NCCN Colon Cancer Guidelines V.1.2011 ­ Update Meeting ­ June 29, 2010

Guideline Page and Request COL-1, COL-2 Internal request: Add rare cancers that are treated similar to colon cancer.

Panel Discussion

References

Vote YES NO 0

COL-4 Internal request: Add the combination regimen of capecitabine/ oxaliplatin (CapeOx) as an option for adjuvant therapy in stage III disease. COL-4 Internal request: Change the category recommendation for bolus 5-FU/leucovorin/ oxaliplatin (FLOX) to a category 1 for adjuvant therapy in stage III disease. COL-C 1 of 5 Internal request: Add the combination regimen of irinotecan/oxaliplatin (IROX) as an option for second-line therapy for advanced or metastatic disease.

To address this issue, the panel added the following footnote to the Guidelines, "Small bowel and appendiceal adenocarcinoma may be treated with systemic chemotherapy according to the NCCN Colon Cancer Guidelines." Data from XELOXA study demonstrated a 3-year disease-free survival for stage III disease (71.0% vs 67.0% for CapeOX vs bolus 5-FU/LV, respectively; HR=0.80; P=0.0045). Based upon this data, the panel considers CapeOx to be equivalent to bolus 5-FU/leucovorin in the adjuvant setting. Based upon the published reference and panel consensus supporting the recommendation of the combination regimen of bolus 5-FU/leucovorin/oxaliplatin the category designation changed from a 2A to category 1.

21

Haller DH, Tabernero J, Maroun J, et al. First efficacy findings from a randomized phase III trial of capecitabine and oxaliplatin vs bolus 5-FU/LV for stage III colon cancer (NO16968/XELOXA study). European Journal of Cancer Supplements 2009;7(3):5 (abstr 5LBA).

21

0

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;25:2198-2204. ·

21

0

Panel consensus was to add the combination regimen of irinotecan/oxaliplatin as an option for second-line therapy for advanced or metastatic disease based upon the data presented in the noted references.

·

Sanoff HK, Sargent DJ, Campbell ME, et al. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008;26:5721-5727. 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;26:4544-4550.

21

0

NCCN Colon Cancer Guidelines V.1.2011 ­ Update Meeting ­ June 29, 2010

COL-C 1 of 5 Internal request: Move the combination of capecitabine ± bevacizumab from "patients not appropriate for intensive therapy" to "patients appropriate for intensive therapy" COL-C 1 of 5: External request: Add single-agent bevacizumab as an option in maintenance therapy for patients with advanced or metastatic cancer. Panel consensus was to move the combination of capecitabine ± bevacizumab as an option for firstline therapy from "patients not appropriate for intensive therapy" to "patients appropriate for intensive therapy for advanced or metastatic disease." 21 0

Currently, evidence is insufficient to add singleagent bevacizumab as an option in maintenance therapy for advanced or metastatic disease.

· Bekaii-Saab T, Bendell J, Cohn A, et al. Bevacizumab (BV) plus chemotherapy (CT) in second-line metastatic colorectal cancer (mCRC): initial results from ARIES, a second BV observational cohort study (OCS). J Clin Oncol 28(suppl 15):284s. ASCO Abstract #3595. · Cohn AL, Bekaii-Saab T, Bendell JC, et al. Clinical outcomes in bevacizumab (BV)treated patients (pts) with metastatic colorectal cancer (mCRC): results from ARIES observational cohort study (OCS) and confirmation of BRiTE data on BV beyond progression (BBP). J Clin Oncol 28(suppl 15):284s. ASCO Abstract #3596. · Tabernero J, Aranda E, Gomez A, et al. Phase III study of first-line XELOX plus bevacizumab (BEV) for 6 cycles followed by XELOX plus BEV or single-agent (s/a) BEV as maintenance therapy in patients (pts) with metastatic colorectal cancer (mCRC): the MACRO trial (Spanish Cooperative Group for the Treatment of Digestive Tumors [TTD]). J Clin Oncol 28(suppl 15):261s. ASCO Abstract #3501.

0

21

NCCN Rectal Cancer Guidelines V.1.2011 ­ Update Meeting ­ June 29, 2010

Guideline Page and Request REC-3, REC-4 Internal request: Modify category designation for capecitabine/RT in the adjuvant setting. REC-3, REC-4 Internal request: Add the combination regimen of capecitabine/ oxaliplatin (CapeOx) as an option for adjuvant therapy.

Panel Discussion

References

Vote YES NO 0

Panel consensus supporting the recommendation of capecitabine/RT in the adjuvant setting changed the category designation from a 2B to a 2A. Data from XELOXA study demonstrated a 3year disease-free survival for stage III disease (71.0% vs 67.0% for CapeOX vs bolus 5-FU/LV, respectively; HR=0.80; P=0.0045). Based upon this data, the panel considers CapeOx to be equivalent to bolus 5-FU/leucovorin in the adjuvant setting. Panel consensus supporting the recommendation of capecitabine/RT in the perioperative adjuvant setting changed the category designation from a 2B to a 2A. Panel consensus was to add the combination regimen of irinotecan/oxaliplatin as an option for second-line therapy for advanced or metastatic disease based upon the data presented in the noted references. · Sanoff HK, Sargent DJ, Campbell ME, et al. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008;26:5721-5727. 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;26:4544-4550. Haller DH, Tabernero J, Maroun J, et al. First efficacy findings from a randomized phase III trial of capecitabine and oxaliplatin vs bolus 5-FU/LV for stage III colon cancer (NO16968/XELOXA study). European Journal of Cancer Supplements 2009;7(3):5 (abstr 5LBA).

21

21

0

REC-5 Internal request: Modify category designation for capecitabine/RT in the perioperative adjuvant setting. REC-E 1 of 5 Internal request: Add the combination regimen of irinotecan/oxaliplatin (IROX) as an option for second-line therapy for advanced or metastatic disease.

21

0

21

0

·

NCCN Rectal Cancer Guidelines V.1.2011 ­ Update Meeting ­ June 29, 2010

REC-E 1 of 5 Internal request: Move the combination of capecitabine ± bevacizumab from "patients not appropriate for intensive therapy" to "patients appropriate for intensive therapy" REC-E 1 of 5: External request: Add single-agent bevacizumab as an option in maintenance therapy for patients with advanced or metastatic cancer.

Panel consensus was to move the combination of capecitabine ± bevacizumab as an option for first-line therapy from "patients not appropriate for intensive therapy" to "patients appropriate for intensive therapy for patients with advanced or metastatic disease. Currently, evidence is insufficient to add single-agent bevacizumab as an option in maintenance therapy for advanced or metastatic disease.

21

0

· Bekaii-Saab T, Bendell J, Cohn A, et al. Bevacizumab (BV) plus chemotherapy (CT) in second-line metastatic colorectal cancer (mCRC): initial results from ARIES, a second BV observational cohort study (OCS). J Clin Oncol 28(suppl 15):284s. ASCO Abstract #3595. · Cohn AL, Bekaii-Saab T, Bendell JC, et al. Clinical outcomes in bevacizumab (BV)-treated patients (pts) with metastatic colorectal cancer (mCRC): results from ARIES observational cohort study (OCS) and confirmation of BRiTE data on BV beyond progression (BBP). J Clin Oncol 28(suppl 15):284s. ASCO Abstract #3596. · Tabernero J, Aranda E, Gomez A, et al. Phase III study of first-line XELOX plus bevacizumab (BEV) for 6 cycles followed by XELOX plus BEV or single-agent (s/a) BEV as maintenance therapy in patients (pts) with metastatic colorectal cancer (mCRC): the MACRO trial (Spanish Cooperative Group for the Treatment of Digestive Tumors [TTD]). J Clin Oncol 28(suppl 15):261s. ASCO Abstract #3501.

0

21

Information

GUIDELINE

4 pages

Find more like this

Report File (DMCA)

Our content is added by our users. We aim to remove reported files within 1 working day. Please use this link to notify us:

Report this file as copyright or inappropriate

365736


You might also be interested in

BETA
GUIDELINE
Microsoft Word - CMS_Transparency_Colon_1.2012