Difference between revisions of "Ovarian cancer, HRD-positive"
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==[http://www.asco.org/ ASCO]== | ==[http://www.asco.org/ ASCO]== | ||
*'''2020:''' Tew et al. [https://doi.org/10.1200/jco.20.01924 PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline] | *'''2020:''' Tew et al. [https://doi.org/10.1200/jco.20.01924 PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline] | ||
| − | |||
=Maintenance after first-line therapy= | =Maintenance after first-line therapy= | ||
==Olaparib monotherapy {{#subobject:fac248|Regimen=1}}== | ==Olaparib monotherapy {{#subobject:fac248|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:8a3c0d|Variant=1}}=== | ===Regimen {{#subobject:8a3c0d|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
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''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ||
| + | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*BRCA1 or BRCA2 mutations | *BRCA1 or BRCA2 mutations | ||
| + | </div> | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Olaparib (Lynparza)]] 300 mg PO twice per day | *[[Olaparib (Lynparza)]] 300 mg PO twice per day | ||
| − | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
| + | </div></div> | ||
===References=== | ===References=== | ||
# '''SOLO1:''' 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://doi.org/10.1056/NEJMoa1810858 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30345884 PubMed] NCT01844986 | # '''SOLO1:''' 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://doi.org/10.1056/NEJMoa1810858 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30345884 PubMed] NCT01844986 | ||
## '''HRQoL analysis:''' Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. Epub 2021 Apr 13. [https://doi.org/10.1016/s1470-2045(21)00098-x link to original article] [https://pubmed.ncbi.nlm.nih.gov/33862001/ PubMed] | ## '''HRQoL analysis:''' Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. Epub 2021 Apr 13. [https://doi.org/10.1016/s1470-2045(21)00098-x link to original article] [https://pubmed.ncbi.nlm.nih.gov/33862001/ PubMed] | ||
## '''Update:''' Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, González-Martín A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. Epub 2021 Oct 26. Erratum in: Lancet Oncol. 2021 Dec;22(12):e539. [https://doi.org/10.1016/s1470-2045(21)00531-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34715071/ PubMed] | ## '''Update:''' Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, González-Martín A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. Epub 2021 Oct 26. Erratum in: Lancet Oncol. 2021 Dec;22(12):e539. [https://doi.org/10.1016/s1470-2045(21)00531-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34715071/ PubMed] | ||
| − | |||
=Relapsed or recurrent disease, platinum-sensitive= | =Relapsed or recurrent disease, platinum-sensitive= | ||
==Olaparib monotherapy {{#subobject:f47yha|Regimen=1}}== | ==Olaparib monotherapy {{#subobject:f47yha|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:81dg0d|Variant=1}}=== | ===Regimen {{#subobject:81dg0d|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| Line 63: | Line 64: | ||
|- | |- | ||
|} | |} | ||
| + | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*Germline BRCA1/2 mutations | *Germline BRCA1/2 mutations | ||
| + | </div> | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Olaparib (Lynparza)]] 300 mg PO twice per day | *[[Olaparib (Lynparza)]] 300 mg PO twice per day | ||
| − | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
| − | + | </div></div> | |
===References=== | ===References=== | ||
#'''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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7145583/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32073956 PubMed] NCT00628251 | #'''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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7145583/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32073956 PubMed] NCT00628251 | ||
##'''Subgroup analysis:''' DiSilvestro P, 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 CA, Bradley WH, Mathews CA, Liu J, Lowe ES, Bloomfield R, Moore KN. Efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial. J Clin Oncol. 2020 Oct 20;38(30):3528-3537. Epub 2020 Aug 4. [https://doi.org/10.1200/jco.20.00799 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32749942/ PubMed] | ##'''Subgroup analysis:''' DiSilvestro P, 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 CA, Bradley WH, Mathews CA, Liu J, Lowe ES, Bloomfield R, Moore KN. Efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial. J Clin Oncol. 2020 Oct 20;38(30):3528-3537. Epub 2020 Aug 4. [https://doi.org/10.1200/jco.20.00799 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32749942/ PubMed] | ||
| − | |||
=Maintenance after second-line therapy for platinum-sensitive disease= | =Maintenance after second-line therapy for platinum-sensitive disease= | ||
| − | |||
==Olaparib monotherapy {{#subobject:f4c078|Regimen=1}}== | ==Olaparib monotherapy {{#subobject:f4c078|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:81de0d|Variant=1}}=== | ===Regimen {{#subobject:81de0d|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| Line 95: | Line 96: | ||
''<sup>1</sup>Reported efficacy is based on the 2021 update.''<br> | ''<sup>1</sup>Reported efficacy is based on the 2021 update.''<br> | ||
''Patients had platinum-sensitive relapsed disease.'' | ''Patients had platinum-sensitive relapsed disease.'' | ||
| + | <div class="toccolours" style="background-color:#fdcdac"> | ||
====Biomarker eligibility criteria==== | ====Biomarker eligibility criteria==== | ||
*BRCA1 or BRCA2 mutations | *BRCA1 or BRCA2 mutations | ||
| + | </div> | ||
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Olaparib (Lynparza)]] 300 mg PO twice per day | *[[Olaparib (Lynparza)]] 300 mg PO twice per day | ||
| − | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
| − | + | </div></div> | |
===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://doi.org/10.1016/S1470-2045(17)30469-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28754483 PubMed] NCT01874353 | # '''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://doi.org/10.1016/S1470-2045(17)30469-2 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28754483 PubMed] NCT01874353 | ||
## '''Update:''' Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; 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 final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. Epub 2021 Mar 18. [https://doi.org/10.1016/s1470-2045(21)00073-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33743851/ PubMed] | ## '''Update:''' Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; 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 final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. Epub 2021 Mar 18. [https://doi.org/10.1016/s1470-2045(21)00073-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33743851/ PubMed] | ||
| − | |||
=Relapsed or recurrent disease, platinum-resistant= | =Relapsed or recurrent disease, platinum-resistant= | ||
| − | |||
==Olaparib monotherapy {{#subobject:6ab358|Regimen=1}}== | ==Olaparib monotherapy {{#subobject:6ab358|Regimen=1}}== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:5cec53|Variant=1}}=== | ===Regimen {{#subobject:5cec53|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
| Line 126: | Line 127: | ||
|- | |- | ||
|} | |} | ||
| − | ''Patients in Study 42 were resistant to prior platinum-containing therapy.'' | + | ''Note: Patients in Study 42 were resistant to prior platinum-containing therapy.'' |
| + | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Olaparib (Lynparza)]] 400 mg PO twice per day | *[[Olaparib (Lynparza)]] 400 mg PO twice per day | ||
| − | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
| − | + | </div></div> | |
===References=== | ===References=== | ||
# '''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. [https://doi.org/10.1016/S0140-6736(10)60893-8 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20609468 PubMed] NCT00494442 | # '''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. [https://doi.org/10.1016/S0140-6736(10)60893-8 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20609468 PubMed] NCT00494442 | ||
| Line 137: | Line 138: | ||
# '''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. [https://doi.org/10.1200/jco.2014.56.2728 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6057749/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25366685 PubMed] NCT01078662 | # '''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. [https://doi.org/10.1200/jco.2014.56.2728 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6057749/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25366685 PubMed] NCT01078662 | ||
## '''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. [https://doi.org/10.1016/j.ygyno.2015.12.020 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4992984/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26723501 PubMed] | ## '''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. [https://doi.org/10.1016/j.ygyno.2015.12.020 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4992984/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26723501 PubMed] | ||
| − | |||
=Additional resources= | =Additional resources= | ||
| − | |||
*[https://oncomx.org/searchview/?gene=BRCA1 OncoMX -- BRCA1] | *[https://oncomx.org/searchview/?gene=BRCA1 OncoMX -- BRCA1] | ||
*[https://oncomx.org/searchview/?gene=BRCA2 OncoMX -- BRCA2] | *[https://oncomx.org/searchview/?gene=BRCA2 OncoMX -- BRCA2] | ||
| − | |||
[[Category:Ovarian cancer regimens]] | [[Category:Ovarian cancer regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Gynecologic cancers]] | [[Category:Gynecologic cancers]] | ||
Revision as of 12:03, 24 January 2023
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.
Guidelines
ASCO
- 2020: Tew et al. PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline
Maintenance after first-line therapy
Olaparib monotherapy
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Moore et al. 2018 (SOLO1) | 2013-2015 | Phase 3 (E-RT-esc) | Placebo | Superior PFS1 PFS: 56 vs 13.8 mo (HR 0.33, 95% CI 0.25-0.43) |
1Reported efficacy is based on the 2021 update.
Biomarker eligibility criteria
- BRCA1 or BRCA2 mutations
References
- SOLO1: 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 dosing details in abstract PubMed NCT01844986
- HRQoL analysis: Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, González-Martín A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. Epub 2021 Apr 13. link to original article PubMed
- Update: Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, González-Martín A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. Epub 2021 Oct 26. Erratum in: Lancet Oncol. 2021 Dec;22(12):e539. link to original article PubMed
Relapsed or recurrent disease, platinum-sensitive
Olaparib monotherapy
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Penson et al. 2020 (SOLO3) | 2015-2018 | Phase 3 (E-switch-ooc) | Investigator's choice of: 1a. Paclitaxel 1b. Gemcitabine 1c. PLD 1d. Topotecan |
Seems to have superior PFS Median PFS: 13.4 vs 9.2 mo (HR 0.62, 95% CI 0.43-0.91) |
Biomarker eligibility criteria
- Germline BRCA1/2 mutations
References
- 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 dosing details in manuscript PubMed NCT00628251
- Subgroup analysis: DiSilvestro P, 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 CA, Bradley WH, Mathews CA, Liu J, Lowe ES, Bloomfield R, Moore KN. Efficacy of Maintenance Olaparib for Patients With Newly Diagnosed Advanced Ovarian Cancer With a BRCA Mutation: Subgroup Analysis Findings From the SOLO1 Trial. J Clin Oncol. 2020 Oct 20;38(30):3528-3537. Epub 2020 Aug 4. link to original article PubMed
Maintenance after second-line therapy for platinum-sensitive disease
Olaparib monotherapy
Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Pujade-Lauraine et al. 2017 (SOLO2) | 2013-2014 | Phase 3 (E-RT-esc) | Placebo | Seems to have superior OS1 Median OS: 52 vs 39 mo (HR 0.74, 95% CI 0.54-1.00) |
1Reported efficacy is based on the 2021 update.
Patients had platinum-sensitive relapsed disease.
Biomarker eligibility criteria
- BRCA1 or BRCA2 mutations
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. link to original article contains dosing details in abstract PubMed NCT01874353
- Update: Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, Korach J, Huzarski T, Pignata S, Friedlander M, Baldoni A, Park-Simon TW, Tamura K, Sonke GS, Lisyanskaya A, Kim JH, Filho EA, Milenkova T, Lowe ES, Rowe P, Vergote I, Pujade-Lauraine E; 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 final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):620-631. Epub 2021 Mar 18. link to original article PubMed
Relapsed or recurrent disease, platinum-resistant
Olaparib monotherapy
Regimen
| Study | Years of enrollment | Evidence |
|---|---|---|
| Audeh et al. 2010 (ICEBERG 2) | 2007-NR | Phase 2 |
| Kaufman et al. 2014 (Study 42) | 2010-2012 | Phase 2 (RT) |
Note: Patients in Study 42 were resistant to prior platinum-containing therapy.
References
- 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 dosing details in manuscript PubMed NCT00494442
- 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 dosing details in manuscript link to PMC article PubMed NCT01078662
- 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