In randomized phase II SOFT Preop, five-fraction SBRT better preserved patient-reported quality of life than 28-fraction chemoradiotherapy. Pathological nodal positivity did not differ significantly, but oncologic noninferiority was not established.
In a small phase II study, induction and concurrent paclitaxel with RT, usually followed by surgery, achieved 82.5% two-year PFS in cutaneous angiosarcoma. Grade 3+ acute and late toxicity occurred in 58% and 32%, respectively.
NRG-HN009 found no reduction in overall acute grade 3-4 toxicity with weekly versus three-weekly cisplatin during definitive head and neck RT. Toxicity profiles differed, and neither phase II cohort met the criteria to proceed to phase III.
In PACE-A, moderate-to-severe erectile dysfunction at 5 years affected 44% of SBRT respondents vs 89% after prostatectomy. The patient-reported difference was significant, but analyses were as treated and follow-up questionnaires were incomplete.
In MDT-BRIDGE, patients who became unresectable during neoadjuvant durvalumab plus chemotherapy could transition to definitive CRT and consolidation durvalumab, with 85% 12-month PFS in a small selected cohort.
TRIDENT found no OS benefit from starting TTFields during RT/TMZ rather than at maintenance in newly diagnosed glioblastoma. Median OS was 17.7 vs 17.5 months. A post hoc MGMT-methylated subgroup signal remains exploratory.
In phase II LipCap, liposomal irinotecan plus capecitabine with long-course chemoradiotherapy produced a 21.7% overall complete response rate in LARC, with grade 3-4 toxicity in 16.7%. Long-term efficacy remains unknown.
In randomized TORCH-iTNT, adding 25 Gy in 5 fractions before CAPOX plus toripalimab increased complete response from 37.1% to 61.5% in pMMR locally advanced rectal cancer. Long-term outcomes remain pending.
In a randomized phase III trial, short-course RT-based TNT produced a numerically higher pCR rate than long-course chemoradiotherapy, but no significant DFS, LRFS, or OS benefit emerged after 28 months of follow-up.
In randomized TORCH-PM01, adding FAPI-guided hypofractionated RT and cadonilimab to second-line systemic therapy increased objective response from 15% to 60% and conversion to cytoreductive surgery from 20% to 60%.
In randomized STELLAR II, adding sintilimab to short-course RT-based TNT increased complete response from 26.8% to 51.9% in pMMR locally advanced rectal cancer, with higher toxicity. Three-year DFS remains pending.
In randomized phase III PACE-A, 5-fraction SBRT and radical prostatectomy both achieved excellent long-term disease control in localized prostate cancer, with no significant efficacy difference after a median 8 years of follow-up.
In phase III NRG-CC009, SRS did not improve neurocognitive failure vs HA-WBRT plus memantine, but median OS was 17.4 vs 8.6 months. Adjusted intracranial control, neurologic mortality, and grade 3-5 toxicity were similar.
In phase III Alliance A071801, postoperative fractionated SRS improved 1-year surgical bed control to 87% vs 81% with single-fraction SRS, without significantly increasing radiation necrosis. Overall survival also favored fSRS.
In randomized phase III NRG-GI003, protons substantially reduced non-tumor liver dose but did not improve OS, PFS, or local progression over photons in advanced HCC. Grade 3+ toxicity was numerically lower.