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==Introduction==
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{{TOC limit|limit=3}}
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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]].
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=Level 1=
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[[User:PeterYang|PeterYang]] ([[User talk:PeterYang|talk]]) 19:44, 8 March 2013 (EST)
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<div class="toccolours" style="background-color:#f2f3f5">
−
----
+
==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}==
−
 
+
CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab
−
<!-- This is a comment and is only viewable on the edit screen. Please insert test information below.-->
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<div class="toccolours" style="background-color:#356dff">
−
 
+
===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}===
−
{| class="wikitable" style="float:right; margin-right: 5px;"
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)]
 +
{| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3"
 +
|[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]]
 
|-
 
|-
−
|<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>
+
|Click to learn more!
−
<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>
 
−
<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>
 
−
|}
 
−
 
 
−
{| class="wikitable" style="float:right; margin-right: 5px;"
 
 
|-
 
|-
−
|<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>
 
−
<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>
 
 
|}
 
|}
−
 
+
|2017-2019
−
==Carboplatin, Paclitaxel, Bevacizumab (PacCBev)==
+
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
|1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]]
 +
| 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)
 
|-
 
|-
−
|[[#toc|back to top]]
 
 
|}
 
|}
−
PacCBev: '''<u>Pac</u>'''litaxel, '''<u>C</u>'''arboplatin, '''<u>Bev</u>'''acizumab
+
''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.''
−
 
+
<div class="toccolours" style="background-color:#ffd7b5">
 +
====Biomarker eligibility criteria====
 +
*CheckMate 816: No sensitizing EGFR or ALK mutations
 +
</div>
 +
<div class="toccolours" style="background-color:#f2f3f4">
 +
====Chemotherapy====
 +
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 3
 +
*[[Dacarbazine (DTIC)]] 220 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 to 3
 +
====Endocrine therapy====
 +
*[[Tamoxifen (Nolvadex)]] as follows:
 +
**Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
 +
**Cycle 2: 10 mg PO twice per day on days 1 to 8
 +
'''21-day cycle for 2 cycles'''
 +
</div></div>
 +
===References===
 +
# Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. [https://doi.org/10.1200/JCO.1999.17.3.968 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/10071291/ PubMed]
 +
</div><br>
  
−
==Carboplatin, Paclitaxel, Bevacizumab (PacCBev) {{#subobject:1c2c25|Regimen=1}}==
+
<div class="toccolours" style="background-color:#f2f3f5">
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}==
 +
CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab
 +
<div class="toccolours" style="background-color:#6892ff">
 +
===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[[#toc|back to top]]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)]
−
|}
+
{| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3"
−
PacCBev: '''<u>Pac</u>'''litaxel, '''<u>C</u>'''arboplatin, '''<u>Bev</u>'''acizumab
+
|[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]]
−
 
 
−
===Endorsements===
 
−
{| class="wikitable" ; margin-right: 5px;"
 
 
|-
 
|-
−
|<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>
+
|Click to learn more!
 
|-
 
|-
−
|<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>
+
|}
 +
|2017-2019
 +
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 +
|1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]]
 +
| 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)
 
|-
 
|-
 
|}
 
|}
 +
''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.''
 +
<div class="toccolours" style="background-color:#ffd7b5">
 +
====Biomarker eligibility criteria====
 +
*CheckMate 816: No sensitizing EGFR or ALK mutations
 +
</div>
 +
<div class="toccolours" style="background-color:#f2f3f4">
 +
====Chemotherapy====
 +
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 3
 +
*[[Dacarbazine (DTIC)]] 220 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 to 3
 +
====Endocrine therapy====
 +
*[[Tamoxifen (Nolvadex)]] as follows:
 +
**Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
 +
**Cycle 2: 10 mg PO twice per day on days 1 to 8
 +
'''21-day cycle for 2 cycles'''
 +
</div></div>
 +
===References===
 +
# Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. [https://doi.org/10.1200/JCO.1999.17.3.968 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/10071291/ PubMed]
 +
</div><br>
  
−
===Regimen #1 {{#subobject:7df5c3|Variant=1}}===
+
==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}==
−
{| border="1" style="text-align:center;" !align="left"  
+
CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab
−
|'''Study'''
+
<div class="toccolours" style="background-color:#eeeeee">
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+
===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}===
−
|[[Overall response rate|'''ORR''']]
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
|'''Comparator'''
+
!style="width: 20%"|Study
−
|-
+
!style="width: 20%"|Dates of enrollment
−
|[http://jco.ascopubs.org/content/22/11/2184.full Johnson et al. 2004]
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
|<span
+
!style="width: 20%"|Comparator
−
style="background:#00CD00;
+
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Randomized Phase II</span>
 
−
|Put overall response rate here
 
−
|[[Non-small_cell_lung_cancer#Carboplatin_.26_Paclitaxel_2|Carboplatin & Paclitaxel]]
 
 
|-
 
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)]
 +
{| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3"
 +
|[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]]
 
|-
 
|-
−
|[http://www.nejm.org/doi/full/10.1056/NEJMoa061884 Sandler et al. 2006 (ECOG 4599)]
+
|Click to learn more!
−
|<span
 
−
style="background:#00CD00;
 
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase III</span>
 
−
|Put overall response rate here
 
−
|[[Non-small_cell_lung_cancer#Carboplatin_.26_Paclitaxel_2|Carboplatin & Paclitaxel]]
 
 
|-
 
|-
 
|}
 
|}
−
 
+
|2017-2019
−
*[[Carboplatin (Paraplatin)]] AUC 6 IV over 15 to 30 minutes once on day 1, '''given second, starting 60 minutes after the completion of paclitaxel'''
+
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
−
*[[Paclitaxel (Taxol)]] 200 mg/m2 IV over 3 hours once on day 1, '''given first'''
+
|1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]]
−
*[[Bevacizumab (Avastin)]] 15 mg/kg IV on day 1, '''given third, starting 60 minutes after the completion of carboplatin'''
+
| 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)
−
**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
 
−
 
 
−
'''21-day cycle x up to 6 cycles, or until progression of disease, or unacceptable toxicity'''
 
−
 
 
−
''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]].''
 
−
 
 
−
===Regimen #2 {{#subobject:8e5de0|Variant=1}}===
 
−
{| border="1" style="text-align:center;" !align="left"
 
−
|'''Study'''
 
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
 
−
|'''Comparator'''
 
−
|-
 
−
|[http://jco.ascopubs.org/content/31/34/4349.long Patel et al. 2013 (PointBreak)]
 
−
|<span
 
−
style="background:#00CD00;
 
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase III</span>
 
−
|[[Non-small_cell_lung_cancer#Carboplatin.2C_Pemetrexed.2C_Bevacizumab_.28PemCBev.29|PemCBev]] -> [[Non-small_cell_lung_cancer#Bevacizumab_.26_Pemetrexed|Maintenance PemBev]]
 
 
|-
 
|-
 
|}
 
|}
−
 
+
''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.''
−
*[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1
+
<div class="toccolours" style="background-color:#fdcdac">
−
*[[Paclitaxel (Taxol)]] 200 mg/m2 IV once on day 1
+
====Biomarker eligibility criteria====
−
*[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1
+
*CheckMate 816: No sensitizing EGFR or ALK mutations
−
 
+
</div>
−
Supportive medications:
+
<div class="toccolours" style="background-color:#f2f3f4">
−
*Premedications per paclitaxel label
+
====Chemotherapy====
−
*Erythropoietic agents or granulocyte colony-stimulating factors allowed per ASCO & NCCN guidelines
+
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 3
−
 
+
*[[Dacarbazine (DTIC)]] 220 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 to 3
−
'''21-day cycle x 4 cycles'''
+
====Endocrine therapy====
−
 
+
*[[Tamoxifen (Nolvadex)]] as follows:
−
''Patients with complete response, partial response, or stable disease proceeded to [[Non-small_cell_lung_cancer#Bevacizumab_.28Avastin.29|bevacizumab maintenance therapy]].''
+
**Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
 +
**Cycle 2: 10 mg PO twice per day on days 1 to 8
 +
'''21-day cycle for 2 cycles'''
 +
</div></div>
  
 
===References===
 
===References===
−
# 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]
+
# Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. [https://doi.org/10.1200/JCO.1999.17.3.968 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/10071291/ PubMed]
−
# 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]
 
−
## '''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]
 
−
# 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]
 
−
 
 
−
==CapeOx, XELOX {{#subobject:cf9acc|Regimen=1}}==
 
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#toc|back to top]]
 
−
|}
 
−
CapeOX: '''<u>Cape</u>'''citabine, '''<u>OX</u>'''aliplatin <br>
 
−
XELOX: '''<u>XEL</u>'''oda (Capecitabine), '''<u>OX</u>'''aliplatin
 
−
 
 
−
===Regimen #1 {{#subobject:1ef938|Variant=1}}===
 
−
{| border="1" style="text-align:center;" !align="left"
 
−
|'''Study'''
 
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
 
−
|'''Comparator'''
 
−
|-
 
−
|[http://jco.ascopubs.org/content/25/1/102.long Schmoll et al. 2007]
 
−
|<span
 
−
style="background:#00CD00;
 
−
padding:3px 6px 3px 6px;
 
−
border-color:black;
 
−
border-width:2px;
 
−
border-style:solid;">Phase III</span>
 
−
|[[Colon_cancer#Fluorouracil_.26_Folinic_acid|5-FU & Leucovorin]]
 
−
|-
 
−
|}
 
  
−
''Note: This is the same trial as described by Haller et al. 2011, but the schedule for [[Capecitabine (Xeloda)]] is slightly different.''
 
−
*[[Capecitabine (Xeloda)]] 1000 mg/m2 PO BID, starting the evening of day 1, to continue through the morning of day 15 (28 total doses)
 
−
*[[Oxaliplatin (Eloxatin)]] 130 mg/m2 IV over 2 hours once on day 1
 
  
−
'''21-day cycles x 8 cycles'''
 
  
−
===Regimen #2 {{#subobject:205ad6|Variant=1}}===
+
<div class="toccolours" style="background-color:#f0ffff">
−
{| border="1" style="text-align:center;" !align="left"  
+
==Cisplatin, Dacarbazine, Tamoxifen {{#subobject:5c5a07|Regimen=1}}==
−
|'''Study'''
+
<div class="toccolours" style="background-color:#ee6b6e">
−
|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+
===Regimen {{#subobject:4bf143|Variant=1}}===
−
|'''Comparator'''
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/29/11/1465.long Haller et al. 2011]
+
|[https://doi.org/10.1200/JCO.1999.17.3.968 Rosenberg et al. 1999]
−
|<span
+
|1993-1997
−
style="background:#00CD00;
+
|style="background-color:#1a9851"|Phase 3 (C)
−
padding:3px 6px 3px 6px;
+
|[[#Cisplatin.2C_Dacarbazine.2C_Tamoxifen|Cisplatin, Dacarbazine, Tamoxifen]], then [[#Interferon_.26_Interleukin-2_999|IFN & IL-2]]
−
border-color:black;
+
|style="background-color:#ffffbf"|Did not meet primary endpoint of ORR
−
border-width:2px;
 
−
border-style:solid;">Phase III</span>
 
−
|[[Colon_cancer#Fluorouracil_.26_Folinic_acid|5-FU & Leucovorin]]
 
 
|-
 
|-
 
|}
 
|}
−
 
+
''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.''
−
''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:#f2f3f4">
−
*[[Capecitabine (Xeloda)]] 1000 mg/m2 PO BID on days 1 to 14
+
====Chemotherapy====
−
*[[Oxaliplatin (Eloxatin)]] 130 mg/m2 IV over 2 hours once on day 1
+
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 3
−
 
+
*[[Dacarbazine (DTIC)]] 220 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 to 3
−
'''21-day cycles x 8 cycles'''
+
====Endocrine therapy====
−
 
+
*[[Tamoxifen (Nolvadex)]] as follows:
−
===Example orders===
+
**Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
−
*[[Example orders for CapeOx (XELOX) in colon cancer]]
+
**Cycle 2: 10 mg PO twice per day on days 1 to 8
−
 
+
'''21-day cycle for 2 cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# 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]
+
# Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. [https://doi.org/10.1200/JCO.1999.17.3.968 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/10071291/ PubMed]
−
# 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]
+
</div>

Latest revision as of 01:55, 31 July 2024


Level 1

Carboplatin & Paclitaxel (CP) & Nivolumab

CP & Nivolumab: Carboplatin, Paclitaxel, Nivolumab

Regimen variant #1, 5/175/360

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Forde et al. 2022 (CheckMate 816)
Alt text
Click to learn more!
2017-2019 Phase 3 (E-RT-esc) 1a. CP
1b. CVb
1c. DC 		Superior EFS (co-primary endpoint)
Median EFS: 31.6 vs 20.8 mo
(HR 0.63, 97.38% CI 0.43-0.91)

Superior pCR rate (co-primary endpoint)
pCR rate: 24% vs 2.2%
(OR 13.94, 99% CI 3.49-55.75)

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.

Biomarker eligibility criteria

  • CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

Endocrine therapy

  • Tamoxifen (Nolvadex) as follows:
    • Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
    • Cycle 2: 10 mg PO twice per day on days 1 to 8

21-day cycle for 2 cycles

References

  1. Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. link to original article dosing details in manuscript have been reviewed by our editors PubMed


Carboplatin & Paclitaxel (CP) & Nivolumab

CP & Nivolumab: Carboplatin, Paclitaxel, Nivolumab

Regimen variant #1, 5/175/360

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Forde et al. 2022 (CheckMate 816)
Alt text
Click to learn more!
2017-2019 Phase 3 (E-RT-esc) 1a. CP
1b. CVb
1c. DC 		Superior EFS (co-primary endpoint)
Median EFS: 31.6 vs 20.8 mo
(HR 0.63, 97.38% CI 0.43-0.91)

Superior pCR rate (co-primary endpoint)
pCR rate: 24% vs 2.2%
(OR 13.94, 99% CI 3.49-55.75)

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.

Biomarker eligibility criteria

  • CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

Endocrine therapy

  • Tamoxifen (Nolvadex) as follows:
    • Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
    • Cycle 2: 10 mg PO twice per day on days 1 to 8

21-day cycle for 2 cycles

References

  1. Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. link to original article dosing details in manuscript have been reviewed by our editors PubMed


Carboplatin & Paclitaxel (CP) & Nivolumab

CP & Nivolumab: Carboplatin, Paclitaxel, Nivolumab

Regimen variant #1, 5/175/360

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Forde et al. 2022 (CheckMate 816)
Alt text
Click to learn more!
2017-2019 Phase 3 (E-RT-esc) 1a. CP
1b. CVb
1c. DC 		Superior EFS (co-primary endpoint)
Median EFS: 31.6 vs 20.8 mo
(HR 0.63, 97.38% CI 0.43-0.91)

Superior pCR rate (co-primary endpoint)
pCR rate: 24% vs 2.2%
(OR 13.94, 99% CI 3.49-55.75)

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.

Biomarker eligibility criteria

  • CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

Endocrine therapy

  • Tamoxifen (Nolvadex) as follows:
    • Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
    • Cycle 2: 10 mg PO twice per day on days 1 to 8

21-day cycle for 2 cycles

References

  1. Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. link to original article dosing details in manuscript have been reviewed by our editors PubMed


Cisplatin, Dacarbazine, Tamoxifen

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Rosenberg et al. 1999 1993-1997 Phase 3 (C) Cisplatin, Dacarbazine, Tamoxifen, then IFN & IL-2 Did not meet primary endpoint of ORR

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.

Chemotherapy

Endocrine therapy

  • Tamoxifen (Nolvadex) as follows:
    • Cycle 1: 40 mg PO once on day 0, then 10 mg PO twice per day on days 1 to 21
    • Cycle 2: 10 mg PO twice per day on days 1 to 8

21-day cycle for 2 cycles

References

  1. Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Seipp CA, Einhorn JH, White DE, Steinberg SM. Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b. J Clin Oncol. 1999 Mar;17(3):968-75. link to original article dosing details in manuscript have been reviewed by our editors PubMed
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