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خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

MDS/AML in randomized ovarian cancer PARP inhibitor maintenance trials

MDS/AML in randomized ovarian cancer PARP inhibitor maintenance trials
Trial Agent PARPi duration MDS/AML events by arm/total # of patients % patients with MDS/AML in PARPi versus comparator arm
PARPi Comparator
SOLO1[1] Olaparib 2 years 4/260 1/130 1.5 versus <1
PRIMA 2024[2]     11/484 4/244 2.3 versus 1.6
PAOLA1[3] Olaparib 2 years 6/535 1/267 1 versus <1
Study19[4] Olaparib Until disease progression, 18% >3 years 2/136 1/129 1.5 versus <1
SOLO2[5] Olaparib Until disease progression, mean 29.1 months 16/195 4/99 8 versus 4
NOVA[6] Niraparib Until disease progression 13/367 3/179 3.5 versus 1.7
  • gBRCAm
     9/136 2/65 6.6 versus 3.1
  • non-gBRCAm
     4/231 1/114 1.7 versus 0.9
ARIEL3[7] Rucaparib Until disease progression, median 8.3 months 14/372 6/189 3.8 versus 3.2
  • PARPi >24 months[8]
     9/79 (11.4%)    
  • Non-BRCAm
     5/245 1/123 2 versus 0.8
  • BRCAm
     9/130 3/63 6.9 versus 4.8
  • PARPi >24 months
     7/46 (15.2%)    
Median time to onset of MDS/AML 17.8 months.[9]
AML: acute myeloid leukemia; gBRCAm: mutations in breast cancer susceptibility genes 1 and 2; MDS: myelodysplastic syndrome; PARP: poly(ADP-ribose) polymerase; PARPi: PARP inhibitor.
References:
  1. Bradley W, Moore K, Colombo N, et al. Maintenance olaparib for patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation: 5-year follow-up from SOLO1. Gynecol Oncol 2021; 162:S25.
  2. Monk BJ, Barretina-Ginesta MP, Pothuri B, et al. Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: Final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Ann Oncol 2024; 35:981.
  3. Ray-Coquard I, Pautier P, Pignata S, et al. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med 2019; 381:2416.
  4. Ledermann J, Harter P, Gourley C, et al. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: An updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet 2016; 17:1579.
  5. Poveda A, Floquet A, Ledermann JA, et al. Final overall survival (OS) results from SOLO2/ENGOT-ov21: A phase III trial assessing maintenance olaparib in patients (pts) with platinum-sensitive, relapsed ovarian cancer and a BRCA mutation. J Clin Oncol 2020; 38:S6002.
  6. Matulonis U, Herrstedt J, Oza A, et al. Long-term safety and secondary efficacy endpoints in the ENGOT-OV16/NOVA phase III trial of niraparib in recurrent ovarian cancer. Gynecol Oncol 2021; 162;S24.
  7. Coleman RL, Oza AM, Lorusso D, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2017; 390:1949.
  8. O'Malley DM, Oza AM, Lorusso D, et al. Clinical and molecular characteristics of ARIEL3 patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian carcinoma. Gynecol Oncol 2022; 167:404.
  9. Morice PM, Leary A, Dolladille, C, et al. Myelodysplastic syndrome and acute myeloid leukaemia in patients treated with PARP inhibitors: A safety meta-analysis of randomised controlled trials and a retrospective study of the WHO pharmacovigilance database. Lancet Haematol 2021; 8:e122.
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