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==Radiation therapy==
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==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}==
==Radiation therapy==
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CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab
 
 
===Links===
 
[[#Radiation_therapy|Radiation therapy]]
 
 
 
[[#Radiation_therapy_2|Radiation therapy]]
 
 
 
 
 
==Blah below here==
 
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
===Regimen variant #3, weekly cisplatin x 6, no cap {{#subobject:63d249|Variant=1}}===
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===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
Line 18: Line 10:
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
|[https://doi.org/10.1200/JCO.2002.20.4.966 Pearcey et al. 2002]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)]
|1991-1996
+
{| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3"
|style="background-color:#1a9851"|Phase 3 (E-esc)
+
|[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]]
|[[Cervical_cancer_-_historical#Radiation_therapy|RT]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS36
 
 
|-
 
|-
|rowspan=2|[https://doi.org/10.1056/NEJM199904153401502 Rose et al. 1999 (GOG 120)]
+
|Click to learn more!
|rowspan=2|1992-1997
 
|rowspan=2 style="background-color:#1a9851"|Phase 3 (E-esc)
 
|1. [[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_Hydroxyurea.2C_RT|Cisplatin, Fluorouracil, Hydroxyurea, RT]]
 
|style="background-color:#ffffbf"|Did not meet co-primary endpoints of PFS/OS
 
|-
 
|2. [[#Hydroxyurea_.26_RT|Hydroxyurea & RT]]
 
|style="background-color:#1a9850"|Superior OS (co-primary endpoint)
 
|-
 
|[https://doi.org/10.1200/jco.2009.25.9663 Dueñas-González et al. 2011 (B9E-MC-JHQS)]
 
|2002-2004
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|[[#Cisplatin_.26_Gemcitabine_.28GC.29_.26_RT|Cisplatin, Gemcitabine, RT]]
 
|style="background-color:#fc8d59"|Seems to have inferior OS
 
|-
 
|[https://doi.org/10.1093/annonc/mdr628 Sehouli et al. 2012]
 
|2003-2008
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|[[#Carboplatin_.26_Paclitaxel_999|Carboplatin & Paclitaxel]], then [[Cervical_cancer_-_historical#Radiation_therapy|RT]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
|-
 
|[https://doi.org/10.1200/jco.2013.50.1205 Zuliani et al. 2014]
 
|2003-2010
 
|style="background-color:#1a9851"|Phase 3 (E-esc)
 
|[[Cervical_cancer_-_historical#Radiation_therapy|RT]]
 
| style="background-color:#1a9850" |Superior OS<sup>1</sup> (co-primary endpoint)<br>(HR 0.53, 95% CI 0.31-0.92)
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3912330/ DiSilvestro et al. 2014 (GOG 219)]
 
|2006-2009
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|[[#Cisplatin.2C_Tirapazamine.2C_RT_777|Cisplatin, Tirapazamine, RT]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
|-
 
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc9588898/ Yang et al. 2022]
 
|2018-2020
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|[[#Nedaplatin_.26_RT|Nedaplatin & RT]]
 
| style="background-color:#d73027" |Inferior PFS
 
 
|-
 
|-
 
|}
 
|}
''<sup>1</sup>Reported efficacy is based on the 2020 update.''<br>
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|2017-2019
''Note: In GOG 120, this regimen was intended for disease.''
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| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
<div class="toccolours" style="background-color:#b3e2cd">
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|1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]]
====Chemotherapy====
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| 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)
*[[Cisplatin (Platinol)]] 40 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15, 22, 29, 36, '''given 1 to 4 hours prior to radiation'''
 
====Radiotherapy====
 
*Concurrent [[External_beam_radiotherapy|radiation therapy]] by the following study-specific criteria:
 
**GOG 120, stage IIB: 1.7 Gy x 24 fractions, for an initial dose of 40.8 Gy
 
**GOG 219: 1.8 Gy x 23 to 25 fractions, for an initial dose of 41.4 to 45 Gy
 
**Pearcey et al. 2002 & Zuliani et al. 2014: 1.8 Gy x 25 fractions, for an initial dose of 45 Gy
 
**B9E-MC-JHQS & Sehouli et al. 2012: 1.8 Gy x 28 fractions, for an initial dose of 50.4 Gy
 
**GOG 120, stage III or IVA: 1.7 Gy x 30 fractions, for an initial dose of 51 Gy
 
**Yang et al. 2022: 1.8 Gy/fraction/day, 5 days/week, a total of 25-28 fractions
 
 
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
!style="width: 25%"|Study
 
!style="width: 25%"|Dose per fraction
 
!style="width: 25%"|Number of fractions
 
!style="width: 25%"|Total dose
 
|-
 
|GOG 120, stage IIB
 
|1.7 Gy
 
|24
 
|40.8 Gy
 
|-
 
|GOG 219
 
|1.8 Gy
 
|23 to 25
 
|41.4 to 45 Gy
 
|-
 
|Pearcey et al. 2002 & Zuliani et al. 2014
 
|1.8 Gy
 
|25 fractions
 
|45 Gy
 
|-
 
|B9E-MC-JHQS & Sehouli et al. 2012
 
|1.8 Gy
 
|28 fractions
 
|50.4 Gy
 
|-
 
|GOG 120, stage III or IVA
 
|1.7 Gy
 
|30
 
|51 Gy
 
|-
 
|Yang et al. 2022
 
|1.8 Gy
 
|25-28
 
|45 to 50.4 Gy
 
 
|-
 
|-
 
|}
 
|}
 
+
''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.''
'''6-week course, followed in 1 to 3 weeks by:'''
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<div class="toccolours" style="background-color:#fdcdac">
</div>
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====Biomarker eligibility criteria====
<div class="toccolours" style="background-color:#cbd5e8">
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*CheckMate 816: No sensitizing EGFR or ALK mutations
====Subsequent treatment====
+
</div></div>
*Sequential [[#Brachytherapy_protocol|brachytherapy]]
 
</div><br>
 
<div class="toccolours" style="background-color:#eeeeee">
 

Latest revision as of 12:58, 18 July 2024

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