Low-grade serous ovarian cancer

Section editor transclusions 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.

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

Endocrine therapy

• Letrozole (Femara) 2.5 mg PO once per day

Continued indefinitely

References

1. 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 (F)	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

1. 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
2. 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 (F)	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

1. 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
2. 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

Targeted therapy

• Selumetinib (Koselugo) 50 mg PO twice per day

28-day cycles

References

1. 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

Endocrine therapy

• Tamoxifen (Nolvadex) 20 mg PO twice per day

Continued indefinitely

References

1. 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 (F)	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

1. 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
2. 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)

Targeted therapy

• Trametinib (Mekinist) 2 mg PO once per day

Continued indefinitely

References

1. 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