Definitive local consolidative therapy for oligometastatic solid tumors: Results from the lead-in phase of the randomized basket trial EXTEND Journal Article
| Authors: | Sherry, A. D.; Bathala, T. K.; Liu, S.; Fellman, B. M.; Chun, S. G.; Jasani, N.; Guadagnolo, B. A.; Jhingran, A.; Reddy, J. P.; Corn, P. G.; Shah, A. Y.; Kaiser, K. W.; Ghia, A. J.; Gomez, D. R.; Tang, C. |
| Article Title: | Definitive local consolidative therapy for oligometastatic solid tumors: Results from the lead-in phase of the randomized basket trial EXTEND |
| Abstract: | Purpose: The benefit of local consolidative therapy (LCT) for oligometastasis across histologies remains uncertain. EXTernal beam radiation to Eliminate Nominal metastatic Disease (EXTEND; NCT03599765) is a randomized phase 2 basket trial evaluating the effectiveness of LCT for oligometastatic solid tumors. We report here the prospective results of the single-arm “lead-in” phase intended to identify histologies most likely to accrue to histology-specific endpoints in the randomized phase. Methods and Materials: Eligible histologies included colorectal, sarcoma, lung, head and neck, ovarian, renal, melanoma, pancreatic, prostate, cervix/uterine, breast, and hepatobiliary. Patients received LCT to all sites of active metastatic disease and primary/regional disease (as applicable) plus standard-of-care systemic therapy or observation. The primary endpoint in EXTEND was progression-free survival (PFS), and the primary endpoint of the lead-phase was histology-specific accrual feasibility. Adverse events were graded by Common Terminology Criteria for Adverse Events version 4.0. Results: From August 2018 through January 2019, 50 patients were enrolled and 49 received definitive LCT. Prostate, breast, and kidney were the highest enrolling histologies and identified for independent accrual in the randomization phase. Most patients (73%) had 1 or 2 metastases, most often in lung or bone (79%), and received ablative radiation (62%). Median follow-up for censored patients was 38 months (range, 16-42 months). Median PFS was 13 months (95% confidence interval, 9-24), 3-year overall survival rate was 73% (95% confidence interval, 57%-83%), and local control rate was 98% (93 of 95 tumors). Two patients (4%) had Common Terminology Criteria for Adverse Events grade 3 toxic effects related to LCT; no patient had grade 4 or 5 toxic effects. Conclusions: The prospective lead-in phase of the EXTEND basket trial demonstrated feasible accrual, encouraging PFS, and low rates of severe toxic effects at mature follow-up. The randomized phase is ongoing with histology-based baskets that will provide histology-specific evidence for LCT in oligometastatic disease. © 2022 Elsevier Inc. |
| Keywords: | cancer survival; clinical article; controlled study; human tissue; treatment outcome; aged; overall survival; clinical trial; histopathology; case report; diarrhea; systemic therapy; bone metastasis; cancer patient; cancer radiotherapy; pancreas cancer; follow up; prospective study; prospective studies; colorectal cancer; melanoma; metastasis; progression free survival; ovary cancer; phase 2 clinical trial; breast cancer; esophagitis; nausea; randomized controlled trial; carcinoma, non-small-cell lung; lung neoplasms; cohort analysis; lung cancer; pathology; cancer therapy; histology; backache; coughing; fever; pneumonia; prostate cancer; sarcoma; confidence interval; health care quality; lung tumor; lung metastasis; feasibility study; head and neck cancer; tumors; uterine cervix cancer; urology; patient safety; limb pain; anxiety disorder; pleura effusion; kidney cancer; toxicity; disease control; lung infection; biological organs; solid tumors; metastatic disease; non small cell lung cancer; progression-free survival; randomized controlled trial (topic); vagina bleeding; tumor ablation; in-phase; adverse events; common terminology criteria; chylothorax; hepatobiliary system cancer; Common Terminology Criteria for Adverse Events; noncardiac chest pain; humans; human; male; female; article; solid malignant neoplasm; toxic effect; prospectives; industrial poisons |
| Journal Title: | International Journal of Radiation Oncology, Biology, Physics |
| Volume: | 114 |
| Issue: | 5 |
| ISSN: | 0360-3016 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2022-12-01 |
| Start Page: | 910 |
| End Page: | 918 |
| Language: | English |
| DOI: | 10.1016/j.ijrobp.2022.05.023 |
| PUBMED: | 35691448 |
| PROVIDER: | scopus |
| PMCID: | PMC11041161 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 3 January 2023 -- Source: Scopus |
