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− | == | + | {{TOC limit|limit=3}} |
− | + | =Level 1= | |
− | + | <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 | |
− | < | + | <div class="toccolours" style="background-color:#356dff"> |
− | + | ===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}=== | |
− | {| class="wikitable" style=" | + | {| 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]] | |
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− | | | + | |Click to learn more! |
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|} | |} | ||
− | + | |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) | |
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|} | |} | ||
− | + | ''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> | ||
− | === | + | <div class="toccolours" style="background-color:#f2f3f5"> |
− | {| class="wikitable" ; | + | ==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]] | ||
|- | |- | ||
− | | | + | |[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]] | ||
|- | |- | ||
− | | | + | |Click to learn more! |
|- | |- | ||
|} | |} | ||
+ | |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: | + | ==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:#eeeeee"> |
− | |[[Levels_of_Evidence#Evidence| | + | ===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=" | + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
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− | |[[ | ||
|- | |- | ||
+ | |[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]] | ||
|- | |- | ||
− | | | + | |Click to learn more! |
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|} | |} | ||
− | + | |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) | |
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− | + | ''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.'' | |
− | *[[ | + | <div class="toccolours" style="background-color:#fdcdac"> |
− | *[[ | + | ====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 | |
− | '''21-day cycle | + | ====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=== | ===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] |
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− | ===Regimen # | + | <div class="toccolours" style="background-color:#f0ffff"> |
− | {| | + | ==Cisplatin, Dacarbazine, Tamoxifen {{#subobject:5c5a07|Regimen=1}}== |
− | | | + | <div class="toccolours" style="background-color:#ee6b6e"> |
− | |[[Levels_of_Evidence#Evidence| | + | ===Regimen {{#subobject:4bf143|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]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1200/JCO.1999.17.3.968 Rosenberg et al. 1999] |
− | | | + | |1993-1997 |
− | style="background | + | |style="background-color:#1a9851"|Phase 3 (C) |
− | + | |[[#Cisplatin.2C_Dacarbazine.2C_Tamoxifen|Cisplatin, Dacarbazine, Tamoxifen]], then [[#Interferon_.26_Interleukin-2_999|IFN & IL-2]] | |
− | + | |style="background-color:#ffffbf"|Did not meet primary endpoint of ORR | |
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− | |||
− | |[[ | ||
|- | |- | ||
|} | |} | ||
− | + | ''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: | + | <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=== | ===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> | |
− | |||
− |
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)
|
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
- Cisplatin (Platinol) 25 mg/m2 IV over 30 minutes once per day on days 1 to 3
- Dacarbazine (DTIC) 220 mg/m2 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
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. 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)
|
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
- Cisplatin (Platinol) 25 mg/m2 IV over 30 minutes once per day on days 1 to 3
- Dacarbazine (DTIC) 220 mg/m2 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
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. 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)
|
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
- Cisplatin (Platinol) 25 mg/m2 IV over 30 minutes once per day on days 1 to 3
- Dacarbazine (DTIC) 220 mg/m2 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
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. 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
- Cisplatin (Platinol) 25 mg/m2 IV over 30 minutes once per day on days 1 to 3
- Dacarbazine (DTIC) 220 mg/m2 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
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. link to original article dosing details in manuscript have been reviewed by our editors PubMed