Clinical Outcomes of Poly(ADP–Ribose) Polymerase Inhibitors as Maintenance Therapy in Patients with Ovarian Cancer in the Southeastern Region of Korea
Abstract
:1. Introduction
2. Materials and Methods
3. Results
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Characteristics | n (Total = 96) (%) |
---|---|
Age (yr) (median, range) | 54 (32–82) |
Height (cm) (mean) | 157.0 |
Weight (kg) (mean) | 55.8 |
<77 kg | 95 (98.9) |
≥77 kg | 1 (1.1) |
BMI (median, range) | 23.0 (16.7–40.5) |
Type of surgery | |
Primary debulking surgery | 77 (80.2) |
Interval debulking surgery | 19 (19.8) |
Type of adjuanvt chemotherapy preceding PARPi | |
Paclitaxel + Carboplatin | 85 (88.5) |
Paclitaxel + Carboplatin + Bevacizumab | 10 (10.4) |
Docetaxel + Carboplatin | 1 (1.0) |
CA 125 level at the time of diagnosis (median) U/mL | |
Patients with primary debulking surgery | 604.5 (11.9–10,630) |
Patients with neoadjuvant chemotherapy | 1069 (22.5–12,920) |
CA 125 level after adjuvant chemotherapy, before PARP inhibitor use | |
<35 U/mL | 88 (91.6) |
≥35 U/mL | 4 (4.2) |
NA | 4 (4.2) |
Type of PARP inhibitor | |
Olaparib | 27 (28.1) |
Niraparib | 69 (71.8) |
Starting dose | |
Olaparib 300 mg bid (tablet) | 23 (23.9) |
Olaparib 400 mg bid (capsule) | 4 (4.2) |
Niraparib 100 mg Qd | 4 (4.2) |
Niraparib 200 mg Qd | 64 (66.7) |
Niraparib 300 mg Qd | 1 (1.0) |
BRCA1 and BRCA2 status | |
Wild-type | 58 (60.4) |
BRCA1 mutated | 19 (19.8) |
BRCA2 mutated | 19 (19.8) |
Characteristics | n (Total = 96) (%) |
---|---|
Tumor origin | |
Epithelial ovarian cancer | 91 (94.8) |
Fallopian tube | 3 (3.1) |
Primary peritoneal cancer | 2 (2.1) |
Tumor histology | |
High-grade serous carcinoma | 82 (85.4) |
Endometrioid carcinoma | 7 (7.3) |
Others | 5 (5.2) |
FIGO stage | |
I | 9 (9.4) |
II | 4 (4.2) |
III | 58 (60.4) |
IV | 25 (26.0) |
Residual tumor size | |
Microscopic | 65 (67.7) |
≤1 cm | 19 (19.8) |
>1 cm | 12 (12.5) |
Response of adjuvant chemotherapy | |
Complete response | 62 (64.6) |
Partial response | 33 (34.4) |
Stable Disease | 1 (1.0) |
Progression-Free Survival (Event = 20) | ||||
---|---|---|---|---|
Univariate | Multivariate | |||
HR (95% CI) | p-Value | HR (95% CI) | p-Value | |
BRCA1 or BRCA2 status | 0.025 | |||
Wild-type | 1 | 1 | ||
BRCA1 or BRCA2 PV | 0.2 (0.05–0.73) | 0.008 | 0.22 (0.06–0.83) | |
Residual disease | ||||
absent | 1 | |||
present | 1.96 (0.76–5.09) | 0.16 | ||
response to chemotherapy | ||||
complete response | 1 | |||
partial response | 2.27 (0.88–5.87) | 0.083 | ||
Type of surgery | 0.070 | |||
PDS | 1 | 1 | ||
NAC + IDS | 4.23 (1.17–15.3) | 0.017 | 3.23 (0.91–11.5) |
Total (n = 96) | Olaparib (n = 27) | Niraparib (n = 69) | p-Value | |
---|---|---|---|---|
duration of use (mo) | 16.8 | 14.6 | 17.6 | 0.17 |
dose interruption | 19 (19.8%) | 8 (29.6%) | 11 (15.9%) | 0.13 |
dose reduction | 35 (36.5%) | 9 (33.3%) | 26 (37.7%) | 0.691 |
discontinuation | 21 (21.9%) | 9 (33.3%) | 12 (17.4%) | 0.089 |
due to side effect | 3 (3.1%) | 1 (3.7%) | 2 (2.9%) | 0.838 |
due to progression | 15 (15.6%) | 6 (22.2%) | 9 (13.0%) | 0.265 |
due to non-medical reason | 3 (3.1%) | 2 (7.4%) | 1 (1.4%) | 0.09 |
Total (n = 96) | Olaparib (n = 27) | Niraparib (n = 69) | p-Value | |
---|---|---|---|---|
Any adverse events | ||||
any grade | 74 (77.1%) | 22 (81.5%) | 52 (75.4%) | 0.521 |
grade ≥ 3 | 16 (16.7%) | 4 (14.8%) | 12 (17.4%) | 0.761 |
Anemia | ||||
any grade | 57 (59.4%) | 16 (59.3%) | 41 (59.4%) | 0.988 |
grade ≥ 3 | 8 (8.3%) | 3 (11.1%) | 5 (7.2%) | 0.538 |
Thrombocytopenia | ||||
any grade | 19 (19.8%) | 4 (14.8%) | 15 (21.7%) | 0.444 |
grade ≥ 3 | 8 (8.3%) | 1 (3.7%) | 7 (10.1%) | 0.305 |
neutropenia | ||||
any grade | 62 (64.6%) | 21 (77.8%) | 41 (59.4%) | 0.091 |
grade ≥ 3 | 5 (5.2%) | 2 (7.4%) | 3 (4.3%) | 0.544 |
MDS/AML | ||||
any grade | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | NA |
grade ≥ 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | NA |
Nausea/Vomiting | ||||
any grade | 13 (13.5%) | 6 (22.2%) | 7 (10.1%) | 0.12 |
grade ≥ 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | NA |
Constipation | ||||
any grade | 2 (2.1%) | 0 (0.0%) | 2 (2.9%) | 0.371 |
grade ≥ 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | NA |
Abdominal pain | ||||
any grade | 1 (1.0%) | 0 (0.0%) | 1 (1.4%) | 0.529 |
grade ≥ 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | NA |
Fatigue | ||||
any grade | 4 (4.2%) | 2 (7.4%) | 2 (2.9%) | 0.320 |
grade ≥ 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | NA |
Dizziness | ||||
any grade | 2 (2.1%) | 1 (3.7%) | 1 (1.4%) | 0.487 |
grade ≥ 3 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | NA |
Others | ||||
any grade | 8 (8.3%) | 0 (0.0%) | 8 (11.6%) | |
grade ≥ 3 | 3 (3.1%) | 0 (0.0%) | 3 (4.3%) |
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Ha, H.I.; Yoon, H.J.; Song, C.; Kim, E.T.; Suh, D.-S.; Kim, K.H.; Na, Y.J.; Song, Y.J. Clinical Outcomes of Poly(ADP–Ribose) Polymerase Inhibitors as Maintenance Therapy in Patients with Ovarian Cancer in the Southeastern Region of Korea. Curr. Oncol. 2024, 31, 6711-6722. https://doi.org/10.3390/curroncol31110495
Ha HI, Yoon HJ, Song C, Kim ET, Suh D-S, Kim KH, Na YJ, Song YJ. Clinical Outcomes of Poly(ADP–Ribose) Polymerase Inhibitors as Maintenance Therapy in Patients with Ovarian Cancer in the Southeastern Region of Korea. Current Oncology. 2024; 31(11):6711-6722. https://doi.org/10.3390/curroncol31110495
Chicago/Turabian StyleHa, Hyeong In, Hyung Joon Yoon, Changho Song, Eun Taeg Kim, Dong-Soo Suh, Ki Hyung Kim, Yong Jin Na, and Yong Jung Song. 2024. "Clinical Outcomes of Poly(ADP–Ribose) Polymerase Inhibitors as Maintenance Therapy in Patients with Ovarian Cancer in the Southeastern Region of Korea" Current Oncology 31, no. 11: 6711-6722. https://doi.org/10.3390/curroncol31110495