Low-grade serous ovarian cancer

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search

Section editor
Alaina J. Brown, MD, MPH
Vanderbilt University
Nashville, TN, USA

LinkedIn

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.

7 regimens on this page
9 variants on this page


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


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

28-day cycles

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 dosing details in manuscript have been reviewed by our editors 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

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 dosing details in manuscript have been reviewed by our editors 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 dosing details in manuscript have been reviewed by our editors 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

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

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 dosing details in manuscript have been reviewed by our editors 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 dosing details in manuscript have been reviewed by our editors PubMed NCT02101788


Selumetinib monotherapy

Regimen

Study Dates of enrollment Evidence
Farley et al. 2013 (GOG-0239) 2007-2009 Phase 2

Targeted therapy

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 dosing details in manuscript have been reviewed by our editors 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

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 dosing details in manuscript have been reviewed by our editors 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

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

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 dosing details in manuscript have been reviewed by our editors 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 dosing details in manuscript have been reviewed by our editors 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

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 dosing details in manuscript have been reviewed by our editors PubMed NCT02101788