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خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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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
After completion of first-line therapy
SOLO1[1] Olaparib 2 years 3/260 0/130 1.2 versus 0
PRIMA[2] Niraparib 3 years 1/484 0/244 <1 versus 0
PAOLA1[3] Olaparib 2 years 6/535 1/267 1 versus <1
After completion of second-line or greater platinum-sensitive chemotherapy
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 6/56 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 3/375 0/189 1 versus 0
Median time to onset of MDS/AML 17.8 months.[8]
MDS: myelodysplastic syndrome; AML: acute myeloid leukemia; PARP: poly(ADP-ribose) polymerase; PARPi: PARP inhibitor; gBRCAm: mutations in breast cancer susceptibility genes 1 and 2.
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; 162S; SGO #38.
  2. Gonzalez-Martin A, Pothouri B, Vergote I, et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med 2019; 381:2391.
  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; 38S: ASCO #6002.
  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; 162S; SGO #37.
  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. 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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