Difference between revisions of "Ovarian cancer, HRD-positive"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m
Line 21: Line 21:
 
===Regimen {{#subobject:8a3c0d|Variant=1}}===
 
===Regimen {{#subobject:8a3c0d|Variant=1}}===
 
{| class="wikitable" style="width: 100%; text-align:center;"  
 
{| class="wikitable" style="width: 100%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 20%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 20%"|Years of enrollment
−
!style="width: 25%"|Comparator
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
 
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1810858 Moore et al. 2018 (SOLO-1)]
 
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1810858 Moore et al. 2018 (SOLO-1)]
 +
|2013-2015
 
|style="background-color:#1a9851"|Phase III (E-RT-esc)
 
|style="background-color:#1a9851"|Phase III (E-RT-esc)
−
|[[#Placebo|Placebo]]
+
|[[Ovarian_cancer_-_null_regimens#Placebo|Placebo]]
 
|style="background-color:#1a9850"|Superior PFS
 
|style="background-color:#1a9850"|Superior PFS
 
|-
 
|-
Line 37: Line 39:
  
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
−
===References===
 
−
# '''SOLO-1:''' Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. Epub 2018 Oct 21. [https://www.nejm.org/doi/full/10.1056/NEJMoa1810858 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30345884 PubMed]
 
−
 
−
==Placebo==
 
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
−
===Regimen===
 
−
{| class="wikitable" style="width: 100%; text-align:center;"
 
−
!style="width: 25%"|Study
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 25%"|Comparator
 
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1810858 Moore et al. 2018 (SOLO-1)]
 
−
|style="background-color:#1a9851"|Phase III (C)
 
−
|[[#Olaparib_monotherapy|Olaparib]]
 
−
|style="background-color:#d73027"|Inferior PFS
 
−
|-
 
−
|}
 
−
''No active antineoplastic treatment after initial treatment.''
 
−
 
 
===References===
 
===References===
 
# '''SOLO-1:''' Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. Epub 2018 Oct 21. [https://www.nejm.org/doi/full/10.1056/NEJMoa1810858 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30345884 PubMed]
 
# '''SOLO-1:''' Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. Epub 2018 Oct 21. [https://www.nejm.org/doi/full/10.1056/NEJMoa1810858 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/30345884 PubMed]
Line 72: Line 51:
 
===Regimen {{#subobject:81de0d|Variant=1}}===
 
===Regimen {{#subobject:81de0d|Variant=1}}===
 
{| class="wikitable" style="width: 100%; text-align:center;"  
 
{| class="wikitable" style="width: 100%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 20%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 20%"|Years of enrollment
−
!style="width: 25%"|Comparator
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
 
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30469-2/fulltext Pujade-Lauraine et al. 2017 (SOLO2)]
 
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30469-2/fulltext Pujade-Lauraine et al. 2017 (SOLO2)]
 +
|2013-2014
 
|style="background-color:#1a9851"|Phase III (E-RT-esc)
 
|style="background-color:#1a9851"|Phase III (E-RT-esc)
−
|[[#Placebo_2|Placebo]]
+
|[[Ovarian_cancer_-_null_regimens#Placebo_2|Placebo]]
 
|style="background-color:#1a9850"|Superior PFS
 
|style="background-color:#1a9850"|Superior PFS
 
|-
 
|-
Line 91: Line 72:
 
===References===
 
===References===
 
<!-- # '''Abstract:''' Kathleen N. Moore, Paul DiSilvestro, Elizabeth S. Lowe, Sally Garnett, Eric Pujade-Lauraine. SOLO1 and SOLO2: Randomized phase III trials of olaparib in patients (pts) with ovarian cancer and a BRCA1/2 mutation (BRCAm). 2014 ASCO Annual Meeting abstract TPS5616. [http://meetinglibrary.asco.org/content/131636-144 link to abstract] -->
 
<!-- # '''Abstract:''' Kathleen N. Moore, Paul DiSilvestro, Elizabeth S. Lowe, Sally Garnett, Eric Pujade-Lauraine. SOLO1 and SOLO2: Randomized phase III trials of olaparib in patients (pts) with ovarian cancer and a BRCA1/2 mutation (BRCAm). 2014 ASCO Annual Meeting abstract TPS5616. [http://meetinglibrary.asco.org/content/131636-144 link to abstract] -->
−
# '''SOLO2:''' Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. Epub 2017 Jul 25. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30469-2/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28754483 PubMed]
 
−
 
−
==Placebo==
 
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
−
===Regimen===
 
−
{| class="wikitable" style="width: 100%; text-align:center;"
 
−
!style="width: 25%"|Study
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 25%"|Comparator
 
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30469-2/fulltext Pujade-Lauraine et al. 2017 (SOLO2)]
 
−
|style="background-color:#1a9851"|Phase III (C)
 
−
|[[#Olaparib_monotherapy_2|Olaparib]]
 
−
|style="background-color:#d73027"|Inferior PFS
 
−
|-
 
−
|}
 
−
''No further active antineoplastic treatment.''
 
−
====Preceding treatment====
 
−
*Platinum-based chemotherapy
 
−
 
−
===References===
 
 
# '''SOLO2:''' Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. Epub 2017 Jul 25. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30469-2/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28754483 PubMed]
 
# '''SOLO2:''' Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. Epub 2017 Jul 25. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30469-2/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28754483 PubMed]
  
Line 126: Line 82:
 
|}
 
|}
 
===Regimen {{#subobject:5cec53|Variant=1}}===
 
===Regimen {{#subobject:5cec53|Variant=1}}===
−
{| class="wikitable" style="width: 50%; text-align:center;"  
+
{| class="wikitable" style="width: 75%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Years of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
 
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2960893-8/fulltext Audeh et al. 2010 (ICEBERG 2)]
 
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2960893-8/fulltext Audeh et al. 2010 (ICEBERG 2)]
 +
|{{#subobject:xx|ToDo=1}}
 
|style="background-color:#91cf61"|Phase II
 
|style="background-color:#91cf61"|Phase II
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057749/ Kaufman et al. 2014 (Study 42)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057749/ Kaufman et al. 2014 (Study 42)]
 +
|2010-2012
 
|style="background-color:#91cf61"|Phase II (RT)
 
|style="background-color:#91cf61"|Phase II (RT)
 
|-
 
|-

Revision as of 14:10, 17 February 2020

Section editor
Dewdney.jpg
 Summer B. Dewdney, MD
Rush University
Chicago, IL
11 regimens on this page
14 variants on this page

Note: this page has regimens which are specific to ovarian cancer that is BRCA-mutated. Please see the main ovarian cancer page for other chemotherapy regimens.


Maintenance after first-line therapy

Olaparib monotherapy

back to top

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Moore et al. 2018 (SOLO-1) 2013-2015 Phase III (E-RT-esc) Placebo Superior PFS

Patients had BRCA1/2 mutations.

Chemotherapy

Continued indefinitely

References

  1. SOLO-1: Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. Epub 2018 Oct 21. link to original article contains protocol PubMed

Maintenance after second-line therapy for platinum-sensitive disease

Olaparib monotherapy

back to top

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Pujade-Lauraine et al. 2017 (SOLO2) 2013-2014 Phase III (E-RT-esc) Placebo Superior PFS

Patients had platinum-sensitive relapsed disease and BRCA1/2 mutations.

Chemotherapy

Continued indefinitely

References

  1. SOLO2: Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P; SOLO2/ENGOT-Ov21 investigators. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1274-1284. Epub 2017 Jul 25. link to original article contains protocol PubMed

Relapsed or recurrent disease, platinum-resistant

Olaparib monotherapy

back to top

Regimen

Study Years of enrollment Evidence
Audeh et al. 2010 (ICEBERG 2) Phase II
Kaufman et al. 2014 (Study 42) 2010-2012 Phase II (RT)

Patients in Study 42 were resistant to prior platinum-containing therapy.

Chemotherapy

Continued indefinitely

References

  1. ICEBERG 2: Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, Bell-McGuinn KM, Scott C, Weitzel JN, Oaknin A, Loman N, Lu K, Schmutzler RK, Matulonis U, Wickens M, Tutt A. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet. 2010 Jul 24;376(9737):245-51. Epub 2010 Jul 6. link to original article contains verified protocol PubMed
  2. Study 42: Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Steiner M, Loman N, Bowen K, Fielding A, Domchek SM. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015 Jan 20;33(3):244-50. Epub 2014 Nov 3. link to original article contains verified protocol link to PMC article PubMed
    1. Subgroup analysis: Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Loman N, Robertson JD, Mann H, Kaufman B. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol. 2016 Feb;140(2):199-203. Epub 2015 Dec 23. link to original article link to PMC article PubMed

Additional resources

back to top
Retrieved from "https://hemonc.org/w/index.php?title=Ovarian_cancer,_HRD-positive&oldid=42830"