TABLE 1.
Clinical trials of PARP inhibitors in combination with radiotherapy.
| Clinical trial | PARP inhibitor | Clinical status | Localization | Patient number | Radiotherapy plan | ORR | PFS | OS | AEs |
|---|---|---|---|---|---|---|---|---|---|
| Karam et al. (2018) | Olaparib | Phase I Trial | Head and neck | 16 | 69.3 Gy in 33 fractions | local control 72%, distant control 79% | 2-year PFS rate 63% | 2-year OS rate 72% | dermatitis 38%, mucositis 69% |
| Jagsi et al. (2018) | Veliparib | Phase I trial | Breast cancer | 30 | 50 Gy + 10 Gy (boost)/25 fr | NA | 3-year PFS rate 50% | 3-year OS rate 34% | Fibrosis |
| Loap et al. (2021) | Olaparib | Phase 1 Trial | TNBC | 24 | 50 Gy/25 fr | NA | NA | NA | No grade ≥3 toxicity; few grade 2 skin toxicity |
| Loap et al. (2022) | Olaparib | Phase 1 Trial | TNBC | 24 | 50.4 Gy/28 fr | NA | 3 years event free survival(EFS) rate 65% | 3 years OS rate 83% | grade 2 breast pain, fibrosis, and deformity |
| de Haan et al. (2021) | Olaparib | Phase 1 Trial | NSCLC | 28 | 66 Gy/24 fr | 2 years loco control rate 84% | NA | Median OS was 28 months | grade 5 pulmonary AEs was 18% |
| Argiris et al. (2021) | Veliparib | Phase 2 Trial | NSCLC | 21 | 60 Gy/30 fr | ORR veliparib vs. placebo:56% vs. 69% | 1 year PFS veliparib vs. placebo:47% vs. 46% | 1 year PFS veliparib vs. placebo:89% vs. 54% | pneumonitis, esophagitis, neutropenia |
| Tuli et al. (2019) | Veliparib | Phase 1 Trial | Pancreas | 30 | 36 Gy/15 fr | NA | NA | Median OS was 15 months | lymphopenia (96%) and anemia (36%) |
| Sim et al. (2021) | Veliparib | Phase 2 Trial | Glioblastoma | 125 | 60 Gy/30 fr | NA | 6 months PFS rate, experimental vs. standard arms:46% vs. 31% | Median OS, experimental vs. standard arms:12.7 months vs. 12.8 months | Thrombocytopenia, neutropenia |
| Czito et al. (2017) | Veliparib | Phase 1b Trial | Rectum | 32 | 50.4 Gy/28 fr | NA | NA | NA | nausea, diarrhea, and fatigue |
| Mehta et al. (2015) | Veliparib | Phase 1 Trial | Brain metastases | 81 | 30 Gy/10 fr | NA | NA | NSCLC was 10.0 months; breast was 7.7 months | Nausea, fatigue, alopecia, headache |
| Reiss et al. (2017) | Veliparib | Phase 1 Trial | Peritoneal carcinomatosis | 32 | 21.6 Gy/36 fr | NA | median PFS was 3.6 months | median OS was 9.1 months | lymphopenia, anemia, thrombocytopenia, neutropenia, leukopenia, nausea, diarrhea, anorexia, vomiting, fatigue |
PARP, poly ADP-ribose polymerase; OS, overall survival; PFS, progression-free survival; TBNC, triple-negative breast cancer; DLT, dose limiting toxicity; EFS, event free survival; NSCLS, non-small cell lung carcinoma; ORR, objective response rate; DDR, DNA, damage response.