Long-Term Results of a Phase 1 Dose-Escalation Trial and Subsequent Institutional Experience of Single-Fraction Stereotactic Ablative Radiation Therapy for Liver Metastases.
Adult
Aged
Aged, 80 and over
Female
Follow-Up Studies
Humans
Liver
/ diagnostic imaging
Liver Neoplasms
/ diagnostic imaging
Magnetic Resonance Imaging
Male
Maximum Tolerated Dose
Middle Aged
Organs at Risk
Progression-Free Survival
Radiosurgery
/ methods
Radiotherapy Dosage
Time Factors
Treatment Outcome
Tumor Burden
Journal
International journal of radiation oncology, biology, physics
ISSN: 1879-355X
Titre abrégé: Int J Radiat Oncol Biol Phys
Pays: United States
ID NLM: 7603616
Informations de publication
Date de publication:
01 04 2021
01 04 2021
Historique:
received:
27
05
2020
revised:
21
11
2020
accepted:
10
12
2020
pubmed:
20
12
2020
medline:
30
7
2021
entrez:
19
12
2020
Statut:
ppublish
Résumé
We report long-term outcomes from our phase 1 dose-escalation study to determine the maximum tolerated dose of single-fraction liver SABR pooled with our subsequent single institutional experience with patients treated postprotocol at the highest dose level (40 Gy) established from the phase 1 study. Patients with liver metastases from solid tumors located outside of the central liver zone were treated with single-fraction SABR on a phase 1 dose escalation trial. At least 700 cc of normal liver had to receive <9.1 Gy. Seven patients with 10 liver metastases received the initial prescription dose of 35 Gy, and dose was then escalated to 40 Gy for 7 more patients with 7 liver metastases. An additional 19 postprotocol patients with 22 liver metastases were treated to 40 Gy in a single fraction. Patients were followed for toxicity and underwent serial imaging to assess local control. Median imaging follow-up for the combined cohort (n = 33, 39 lesions) was 25.9 months; 38.9 months for protocol patients and 20.2 months for postprotocol patients. Median lesion size was 2.0 cm (range, 0.5-5.0 cm). There were no dose-limiting toxicities observed for protocol patients, and only 3 grade 2 toxicities were observed in the entire cohort, with no grade ≥3 toxicities attributable to treatment. Four-year actuarial local control of irradiated lesions in the entire cohort was 96.6%, 100% in the protocol group and 92.9% in the subsequent patients. Two-year overall survival for all treated patients was 82.0%. For selected patients with liver metastases, single-fraction SABR at doses of 35 and 40 Gy was safe and well-tolerated, and shows excellent local control with long-term follow-up; results in subsequent patients treated with single-fraction SABR doses of 40 Gy confirmed our earlier results.
Identifiants
pubmed: 33340601
pii: S0360-3016(20)34658-7
doi: 10.1016/j.ijrobp.2020.12.012
pii:
doi:
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1387-1395Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.