Difference between revisions of "Ovarian cancer, HRD-positive"
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===Regimen {{#subobject:68aa39|Variant=1}}=== | ===Regimen {{#subobject:68aa39|Variant=1}}=== | ||
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!style="width: 33%"|Study | !style="width: 33%"|Study | ||
!style="width: 33%"|Years of enrollment | !style="width: 33%"|Years of enrollment | ||
Revision as of 01:00, 1 July 2021
| Section editor | |
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Summer B. Dewdney, MD Rush University Chicago, IL |
11 regimens on this page
14 variants on this page
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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
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Moore et al. 2018 (SOLO1) | 2013-2015 | Phase III (E-RT-esc) | Placebo | Superior PFS PFS36: 60% vs 27% (HR 0.30, 95% CI 0.23-0.41) |
Biomarker eligibility criteria
- BRCA1 or BRCA2 mutations
Targeted therapy
- Olaparib (Lynparza) 300 mg PO twice per day
Continued indefinitely
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 protocol 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 Apr 13:S1470-2045(21)00098-X. Epub ahead of print. link to original article 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
- Olaparib (Lynparza) 300 mg PO twice per day
Continued indefinitely
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 verified protocol 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
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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 | Seems to have superior OS1 Median OS: 52 mo 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
Targeted therapy
- Olaparib (Lynparza) 300 mg PO twice per day
Continued indefinitely
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 protocol 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 Mar 18:S1470-2045(21)00073-5. Epub ahead of print. link to original article 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
- Olaparib (Lynparza) 400 mg PO twice per day
Continued indefinitely
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 verified protocol 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 verified protocol 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
Rucaparib monotherapy
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Regimen
| Study | Years of enrollment | Evidence |
|---|---|---|
| Kristeleit et al. 2017 (Study 10) | 2011-2013 | Phase II (RT) |
Targeted therapy
- Rucaparib (Rubraca) 600 mg PO twice per day
Continued indefinitely
References
- Study 10: Kristeleit R, Shapiro GI, Burris HA, Oza AM, LoRusso P, Patel MR, Domchek SM, Balmaña J, Drew Y, Chen LM, Safra T, Montes A, Giordano H, Maloney L, Goble S, Isaacson J, Xiao J, Borrow J, Rolfe L, Shapira-Frommer R. A Phase I-II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors. Clin Cancer Res. 2017 Aug 1;23(15):4095-4106. Epub 2017 Mar 6. link to orginal article PubMed NCT01482715
- Pooled subgroup analysis: Kristeleit RS, Oaknin A, Ray-Coquard I, Leary A, Balmaña J, Drew Y, Oza AM, Shapira-Frommer R, Domchek SM, Cameron T, Maloney L, Goble S, Lorusso D, Ledermann JA, McNeish IA. Antitumor activity of the poly(ADP-ribose) polymerase inhibitor rucaparib as monotherapy in patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade ovarian cancer, and an update on safety. Int J Gynecol Cancer. 2019 Nov;29(9):1396-1404. link to original article PubMed
Additional resources
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