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

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===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]
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=Relapsed or recurrent disease, platinum-sensitive=
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==Olaparib monotherapy {{#subobject:f47yha|Regimen=1}}==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[#top|back to top]]
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|}
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===Regimen {{#subobject:81dg0d|Variant=1}}===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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!style="width: 20%"|Study
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!style="width: 20%"|Years of enrollment
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
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|-
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|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7145583/ Penson et al. 2020 (SOLO3)]
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|2015-2018
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|style="background-color:#1a9851"|Phase III (E-switch-ooc)
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|Investigator's choice of:<br> 1. [[#Paclitaxel_monotherapy|Paclitaxel]]<br> 2. [[#Gemcitabine_monotherapy|Gemcitabine]]<br> 3. [[#Doxorubicin_pegylated_liposomal_monotherapy|PLD]]<br> 4. [[#Topotecan_monotherapy|Topotecan]]
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| style="background-color:#91cf60" |Seems to have superior PFS
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|-
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====Biomarker eligibility criteria====
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*Germline BRCA1/2 mutations
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====Targeted therapy====
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*[[Olaparib (Lynparza)]] 300 mg PO twice per day
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'''Continued indefinitely'''
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===References===
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#'''SOLO3:''' Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidziński M, Kim JW, Nam JH, Madry R, Hernández C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. Epub 2020 Feb 19. [https://doi.org/10.1200/jco.19.02745 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7145583/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/32073956 PubMed] NCT00628251
  
 
=Maintenance after second-line therapy for platinum-sensitive disease=
 
=Maintenance after second-line therapy for platinum-sensitive disease=

Revision as of 02:37, 27 September 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

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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.

Targeted therapy

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

Relapsed or recurrent disease, platinum-sensitive

Olaparib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Penson et al. 2020 (SOLO3) 2015-2018 Phase III (E-switch-ooc) Investigator's choice of:
1. Paclitaxel
2. Gemcitabine
3. PLD
4. Topotecan 		Seems to have superior PFS

Biomarker eligibility criteria

  • Germline BRCA1/2 mutations

Targeted therapy

Continued indefinitely

References

  1. SOLO3: Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidziński M, Kim JW, Nam JH, Madry R, Hernández C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. Epub 2020 Feb 19. link to original article link to PMC article contains verified protocol PubMed NCT00628251

Maintenance after second-line therapy for platinum-sensitive disease

Olaparib monotherapy

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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.

Targeted therapy

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

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Regimen

Study Years of enrollment Evidence
Audeh et al. 2010 (ICEBERG 2) 2007-NR Phase II
Kaufman et al. 2014 (Study 42) 2010-2012 Phase II (RT)

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

Targeted therapy

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 NCT00494442
  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

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