Low-grade serous ovarian cancer
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| Section editor | |
|---|---|
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Alaina J. Brown, MD, MPH Vanderbilt University Nashville, TN, USA |
Note: this page has regimens which are specific to low-grade serous ovarian cancer (LGSOC). Please see the main ovarian cancer page for other chemotherapy regimens.
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Ovarian Cancer, Including Fallopian Tube Cancer and Primary Peritoneal Cancer.
Relapsed or recurrent disease
Letrozole monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (C) | Trametinib | Inferior PFS |
References
- LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02101788
Paclitaxel monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Monk et al. 2020 (MILO) | 2013-2016 | Phase 3 (C) | Binimetinib | Did not meet primary endpoint of PFS Median PFS: 10.6 vs 9.1 mo (HR 0.83, 95% CI 0.54-1.27) |
| Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (C) | Trametinib | Inferior PFS |
Chemotherapy
- Paclitaxel (Taxol) 80 mg/m2 IV over 60 minutes once per day on days 1, 8, 15
28-day cycles
References
- MILO: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01849874
- LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02101788
Pegylated liposomal doxorubicin monotherapy
Regimen variant #1, 40 mg/m2
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Monk et al. 2020 (MILO) | 2013-2016 | Phase 3 (C) | Binimetinib | Did not meet primary endpoint of PFS Median PFS: 10.6 vs 9.1 mo (HR 0.83, 95% CI 0.54-1.27) |
| Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (C) | Trametinib | Inferior PFS |
Note: this is the lower bound of dosing in LOGS.
Chemotherapy
- Pegylated liposomal doxorubicin (Doxil) 40 mg/m2 IV over 60 minutes once on day 1
28-day cycles
Regimen variant #2, 50 mg/m2
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (C) | Trametinib | Inferior PFS |
Note: this is the upper bound of dosing in LOGS.
Chemotherapy
- Pegylated liposomal doxorubicin (Doxil) 50 mg/m2 IV over 60 minutes once on day 1
28-day cycles
References
- MILO: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01849874
- LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02101788
Selumetinib monotherapy
Regimen
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Farley et al. 2013 (GOG-0239) | 2007-2009 | Phase 2 |
References
- GOG-0239: Farley J, Brady WE, Vathipadiekal V, Lankes HA, Coleman R, Morgan MA, Mannel R, Yamada SD, Mutch D, Rodgers WH, Birrer M, Gershenson DM. Selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum: an open-label, single-arm, phase 2 study. Lancet Oncol. 2013 Feb;14(2):134-40. Epub 2012 Dec 21. link to original article link to PMC article contains dosing details in manuscript PubMed NCT00551070
Tamoxifen monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (C) | Trametinib | Inferior PFS |
References
- LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02101788
Topotecan monotherapy
Regimen variant #1, 5 days per cycle
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Monk et al. 2020 (MILO) | 2013-2016 | Phase 3 (C) | Binimetinib | Did not meet primary endpoint of PFS Median PFS: 10.6 vs 9.1 mo (HR 0.83, 95% CI 0.54-1.27) |
Chemotherapy
- Topotecan (Hycamtin) 1.25 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycles
Regimen variant #2, 3 weeks out of 4
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (C) | Trametinib | Inferior PFS |
Chemotherapy
- Topotecan (Hycamtin) 4 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycles
References
- MILO: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01849874
- LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02101788
Trametinib monotherapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (E-switch-ooc) | Investigator's choice of: 1a. Paclitaxel 1b. Topotecan 1c. PLD 1d. Letrozole 1e. Tamoxifen |
Superior PFS (primary endpoint) Median PFS: 13 vs 7.2 mo (HR 0.48, 95% CI 0.36-0.64) |
References
- LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02101788