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| − | ==Introduction== | + | ==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}== |
| − | This is a page to be used for HemOnc.org's users to experiment with MediaWiki formatting. Feel free to try anything you'd like. Instructions for the most common formatting used can be found on the [[Help:Contents | help page]].
| + | CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab |
| − | [[User:PeterYang|PeterYang]] ([[User talk:PeterYang|talk]]) 19:44, 8 March 2013 (EST)
| + | <div class="toccolours" style="background-color:#eeeeee"> |
| − | ----
| + | ===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}=== |
| − | | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
| − | <!-- This is a comment and is only viewable on the edit screen. Please insert test information below.--> | + | !style="width: 20%"|Study |
| − | | + | !style="width: 20%"|Dates of enrollment |
| − | {| class="wikitable" style="float:right; margin-right: 5px;" | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| | + | !style="width: 20%"|Comparator |
| | + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
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| − | |<div style="background-color: #66FF66; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} regimens on this page</b></font></div> | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)] |
| − | <div style="background-color: #66CCFF; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} variants on this page</b></font></div>
| + | {| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3" |
| − | <div style="background-color: ##FFFF99; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Citation |limit=10000|format=sum}} citations on this page</b></font></div>
| + | |[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]] |
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| − | |<div style="background-color: #66FF66; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[Regimen::+]] |?Regimen |limit=10000|format=sum}} regimens on HemOnc.org</b></font></div> | + | |Click to learn more! |
| − | <div style="background-color: #66CCFF; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[Variant::+]] |?Variant |limit=10000|format=sum}} variants on HemOnc.org</b></font></div>
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| − | ==Carboplatin, Paclitaxel, Bevacizumab (PacCBev)==
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| − | |[[#top|back to top]]
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| − | |}
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| − | PacCBev: '''<u>Pac</u>'''litaxel, '''<u>C</u>'''arboplatin, '''<u>Bev</u>'''acizumab
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| − | ==Carboplatin, Paclitaxel, Bevacizumab (PacCBev) {{#subobject:1c2c25|Regimen=1}}==
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| − | |[[#top|back to top]]
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| | |} | | |} |
| − | PacCBev: '''<u>Pac</u>'''litaxel, '''<u>C</u>'''arboplatin, '''<u>Bev</u>'''acizumab
| + | |2017-2019 |
| − | | + | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) |
| − | ===Endorsements===
| + | |1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]] |
| − | {| class="wikitable" ; margin-right: 5px;"
| + | | style="background-color:#1a9850" |Superior EFS (co-primary endpoint)<br>Median EFS: 31.6 vs 20.8 mo<br>(HR 0.63, 97.38% CI 0.43-0.91)<br><br>Superior pCR rate (co-primary endpoint)<br>pCR rate: 24% vs 2.2%<br>(OR 13.94, 99% CI 3.49-55.75) |
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| − | |<div style="background: blue; color: white; text-align:center; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4">ASCO 2015 update</font></div>
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| − | |<div style="background: #841B2D; color: white; text-align:center; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4">NCCN v.3.2016</font></div>
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| − | |}
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| − | | |
| − | ===Regimen #1 {{#subobject:7df5c3|Variant=1}}===
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| − | {| border="1" style="text-align:center;" !align="left"
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| − | |'''Study'''
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| − | |[[Levels_of_Evidence#Evidence|'''Evidence''']]
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| − | |[[Overall response rate|'''ORR''']] | |
| − | |'''Comparator'''
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| − | |[http://jco.ascopubs.org/content/22/11/2184.full Johnson et al. 2004]
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| − | |style="background-color:#00CD00"|Randomized Phase II
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| − | |Put overall response rate here
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| − | |[[Non-small_cell_lung_cancer#Carboplatin_.26_Paclitaxel_2|Carboplatin & Paclitaxel]]
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| − | |[http://www.nejm.org/doi/full/10.1056/NEJMoa061884 Sandler et al. 2006 (ECOG 4599)]
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| − | |style="background-color:#00CD00"|Phase III | |
| − | |Put overall response rate here
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| − | |[[Non-small_cell_lung_cancer#Carboplatin_.26_Paclitaxel_2|Carboplatin & Paclitaxel]]
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| − | |}
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| − | *[[Carboplatin (Paraplatin)]] AUC 6 IV over 15 to 30 minutes once on day 1, '''given second, starting 60 minutes after the completion of paclitaxel'''
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| − | *[[Paclitaxel (Taxol)]] 200 mg/m2 IV over 3 hours once on day 1, '''given first'''
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| − | *[[Bevacizumab (Avastin)]] 15 mg/kg IV on day 1, '''given third, starting 60 minutes after the completion of carboplatin'''
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| − | **Infusion time for bevacizumab per Johnson, et al. 2004 was over 90 minutes for cycle 1; if tolerated, bevacizumab was given over 30 to 60 minutes for cycles 2 and later
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| − | | |
| − | '''21-day cycle x up to 6 cycles, or until progression of disease, or unacceptable toxicity'''
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| − | | |
| − | ''After 6 cycles, patients in ECOG 4599 who had stable disease or response continued to [[Non-small_cell_lung_cancer#Bevacizumab_.28Avastin.29|bevacizumab maintenance therapy]].''
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| − | | |
| − | ===Regimen #2 {{#subobject:8e5de0|Variant=1}}===
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| − | {| border="1" style="text-align:center;" !align="left"
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| − | |'''Study'''
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| − | |[[Levels_of_Evidence#Evidence|'''Evidence''']]
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| − | |'''Comparator'''
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| − | |[http://jco.ascopubs.org/content/31/34/4349.long Patel et al. 2013 (PointBreak)]
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| − | |style="background-color:#00CD00"|Phase III | |
| − | |[[Non-small_cell_lung_cancer#Carboplatin.2C_Pemetrexed.2C_Bevacizumab_.28PemCBev.29|PemCBev]] -> [[Non-small_cell_lung_cancer#Bevacizumab_.26_Pemetrexed|Maintenance PemBev]]
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| − | |}
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| − | *[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1
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| − | *[[Paclitaxel (Taxol)]] 200 mg/m2 IV once on day 1
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| − | *[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1
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| − | Supportive medications:
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| − | *Premedications per paclitaxel label
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| − | *Erythropoietic agents or granulocyte colony-stimulating factors allowed per ASCO & NCCN guidelines
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| − | | |
| − | '''21-day cycle x 4 cycles'''
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| − | | |
| − | ''Patients with complete response, partial response, or stable disease proceeded to [[Non-small_cell_lung_cancer#Bevacizumab_.28Avastin.29|bevacizumab maintenance therapy]].''
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| − | | |
| − | ===References===
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| − | # Johnson DH, Fehrenbacher L, Novotny WF, Herbst RS, Nemunaitis JJ, Jablons DM, Langer CJ, DeVore RF 3rd, Gaudreault J, Damico LA, Holmgren E, Kabbinavar F. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2004 Jun 1;22(11):2184-91. [http://jco.ascopubs.org/content/22/11/2184.full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/15169807 PubMed]
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| − | # Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. [http://www.nejm.org/doi/full/10.1056/NEJMoa061884 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17167137 PubMed]
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| − | ## '''Subset analysis''': Ramalingam SS, Dahlberg SE, Langer CJ, Gray R, Belani CP, Brahmer JR, Sandler AB, Schiller JH, Johnson DH; Eastern Cooperative Oncology Group. Outcomes for elderly, advanced-stage non small-cell lung cancer patients treated with bevacizumab in combination with carboplatin and paclitaxel: analysis of Eastern Cooperative Oncology Group Trial 4599. J Clin Oncol. 2008 Jan 1;26(1):60-5. [http://jco.ascopubs.org/content/26/1/60.full link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18165641 PubMed]
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| − | # Patel JD, Socinski MA, Garon EB, Reynolds CH, Spigel DR, Olsen MR, Hermann RC, Jotte RM, Beck T, Richards DA, Guba SC, Liu J, Frimodt-Moller B, John WJ, Obasaju CK, Pennella EJ, Bonomi P, Govindan R. PointBreak: a randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Dec 1;31(34):4349-57. [http://jco.ascopubs.org/content/31/34/4349.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/24145346 PubMed]
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| − | ==CapeOx, XELOX {{#subobject:cf9acc|Regimen=1}}==
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| − | {| class="wikitable" style="float:right; margin-left: 5px;"
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| − | |-
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| − | |[[#top|back to top]]
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| − | CapeOX: '''<u>Cape</u>'''citabine, '''<u>OX</u>'''aliplatin <br>
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| − | XELOX: '''<u>XEL</u>'''oda (Capecitabine), '''<u>OX</u>'''aliplatin
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| − | | |
| − | ===Regimen #1 {{#subobject:1ef938|Variant=1}}===
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| − | {| border="1" style="text-align:center;" !align="left"
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| − | |'''Study'''
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| − | |[[Levels_of_Evidence#Evidence|'''Evidence''']]
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| − | |'''Comparator'''
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| − | |[http://jco.ascopubs.org/content/25/1/102.long Schmoll et al. 2007]
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| − | |style="background-color:#00CD00"|Phase III
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| − | |[[Colon_cancer#Fluorouracil_.26_Folinic_acid|5-FU & Leucovorin]]
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| − | |-
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| − | |}
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| − | | |
| − | ''Note: This is the same trial as described by Haller et al. 2011, but the schedule for [[Capecitabine (Xeloda)]] is slightly different.''
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| − | *[[Capecitabine (Xeloda)]] 1000 mg/m2 PO BID, starting the evening of day 1, to continue through the morning of day 15 (28 total doses)
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| − | *[[Oxaliplatin (Eloxatin)]] 130 mg/m2 IV over 2 hours once on day 1
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| − | | |
| − | '''21-day cycles x 8 cycles'''
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| − | | |
| − | ===Regimen #2 {{#subobject:205ad6|Variant=1}}===
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| − | {| border="1" style="text-align:center;" !align="left"
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| − | |'''Study'''
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| − | |[[Levels_of_Evidence#Evidence|'''Evidence''']]
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| − | |'''Comparator'''
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| − | |-
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| − | |[http://jco.ascopubs.org/content/29/11/1465.long Haller et al. 2011]
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| − | |style="background-color:#00CD00"|Phase III
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| − | |[[Colon_cancer#Fluorouracil_.26_Folinic_acid|5-FU & Leucovorin]]
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| | |} | | |} |
| − | | + | ''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.'' |
| − | ''Note: This is the same trial as described by Schmoll et al. 2007, but the schedule for [[Capecitabine (Xeloda)]] is slightly different.'' | + | <div class="toccolours" style="background-color:#fdcdac"> |
| − | *[[Capecitabine (Xeloda)]] 1000 mg/m2 PO BID on days 1 to 14
| + | ====Biomarker eligibility criteria==== |
| − | *[[Oxaliplatin (Eloxatin)]] 130 mg/m2 IV over 2 hours once on day 1
| + | *CheckMate 816: No sensitizing EGFR or ALK mutations |
| − | | + | </div></div> |
| − | '''21-day cycles x 8 cycles'''
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| − | | |
| − | ===Example orders=== | |
| − | *[[Example orders for CapeOx (XELOX) in colon cancer]]
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| − | | |
| − | ===References===
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| − | # Schmoll HJ, Cartwright T, Tabernero J, Nowacki MP, Figer A, Maroun J, Price T, Lim R, Van Cutsem E, Park YS, McKendrick J, Topham C, Soler-Gonzalez G, de Braud F, Hill M, Sirzén F, Haller DG. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol. 2007 Jan 1;25(1):102-9. [http://jco.ascopubs.org/content/25/1/102.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17194911 PubMed]
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| − | # Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011 Apr 10;29(11):1465-71. Epub 2011 Mar 7. [http://jco.ascopubs.org/content/29/11/1465.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21383294/ PubMed]
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