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*Brachytherapy | *Brachytherapy | ||
</div></div> | </div></div> | ||
+ | |||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #3, weekly cisplatin x 6, no cap {{#subobject:63d249|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.2002.20.4.966 Pearcey et al. 2002] | ||
+ | |1991-1996 | ||
+ | |style="background-color:#1a9851"|Phase 3 (E-esc) | ||
+ | |[[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)] | ||
+ | |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> | ||
+ | ''Note: In GOG 120, this regimen was intended for disease.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[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 | ||
+ | |- | ||
+ | |} | ||
+ | |||
+ | '''6-week course, followed in 1 to 3 weeks by:''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Subsequent treatment==== | ||
+ | *Sequential [[#Brachytherapy_protocol|brachytherapy]] | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> |
Revision as of 15:15, 4 December 2023
Carboplatin & RT
Carboplatin & RT: Carboplatin & Radiation Therapy
Regimen variant #1, weekly carboplatin
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Monk et al. 2023 (CALLA) | 2019-02-15 to 2020-12-10 | Phase 3 (C) | 1a. Carboplatin, Durvalumab, RT 1b. Cisplatin, Durvalumab, RT |
Did not meet primary endpoint of PFS |
Chemotherapy
- Carboplatin (Paraplatin) AUC 2 IV once per day on days 1, 8, 15, 22, 29
Radiotherapy
- Concurrent radiation therapy, 1.8 Gy per fraction on days 1 to 5, 8 to 12, 15 to 19, 22 to 26, 29 to 33 (45 Gy total in 25 fractions)
5-week course
Subsequent treatment
- Brachytherapy
Regimen variant #3, weekly cisplatin x 6, no cap
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Pearcey et al. 2002 | 1991-1996 | Phase 3 (E-esc) | RT | Did not meet primary endpoint of OS36 |
Rose et al. 1999 (GOG 120) | 1992-1997 | Phase 3 (E-esc) | 1. Cisplatin, Fluorouracil, Hydroxyurea, RT | Did not meet co-primary endpoints of PFS/OS |
2. Hydroxyurea & RT | Superior OS (co-primary endpoint) | |||
Dueñas-González et al. 2011 (B9E-MC-JHQS) | 2002-2004 | Phase 3 (C) | Cisplatin, Gemcitabine, RT | Seems to have inferior OS |
Sehouli et al. 2012 | 2003-2008 | Phase 3 (C) | Carboplatin & Paclitaxel, then RT | Did not meet primary endpoint of PFS |
Zuliani et al. 2014 | 2003-2010 | Phase 3 (E-esc) | RT | Superior OS1 (co-primary endpoint) (HR 0.53, 95% CI 0.31-0.92) |
DiSilvestro et al. 2014 (GOG 219) | 2006-2009 | Phase 3 (C) | Cisplatin, Tirapazamine, RT | Did not meet primary endpoint of PFS |
Yang et al. 2022 | 2018-2020 | Phase 3 (C) | Nedaplatin & RT | Inferior PFS |
1Reported efficacy is based on the 2020 update.
Note: In GOG 120, this regimen was intended for disease.
Chemotherapy
- Cisplatin (Platinol) 40 mg/m2 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 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
Study | Dose per fraction | Number of fractions | 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 |
6-week course, followed in 1 to 3 weeks by:
Subsequent treatment
- Sequential brachytherapy