Randomized phase II trial of proton craniospinal irradiation versus photon involved-field radiotherapy for patients with solid tumor leptomeningeal metastasis Journal Article
| Authors: | Yang, J. T.; Wijetunga, N. A.; Pentsova, E.; Wolden, S.; Young, R. J.; Correa, D.; Zhang, Z.; Zheng, J.; Steckler, A.; Bucwinska, W.; Bernstein, A.; Betof Warner, A.; Yu, H.; Kris, M. G.; Seidman, A. D.; Wilcox, J. A.; Malani, R.; Lin, A.; DeAngelis, L. M.; Lee, N. Y.; Powell, S. N.; Boire, A. |
| Article Title: | Randomized phase II trial of proton craniospinal irradiation versus photon involved-field radiotherapy for patients with solid tumor leptomeningeal metastasis |
| Abstract: | PURPOSE: Photon involved-field radiotherapy (IFRT) is the standard-of-care radiotherapy for patients with leptomeningeal metastasis (LM) from solid tumors. We tested whether proton craniospinal irradiation (pCSI) encompassing the entire CNS would result in superior CNS progression-free survival (PFS) compared with IFRT. PATIENTS AND METHODS: We conducted a randomized, phase II trial of pCSI versus IFRT in patients with non-small-cell lung cancer and breast cancers with LM. We enrolled patients with other solid tumors to an exploratory pCSI group. For the randomized groups, patients were assigned (2:1), stratified by histology and systemic disease status, to pCSI or IFRT. The primary end point was CNS PFS. Secondary end points included overall survival (OS) and treatment-related adverse events (TAEs). RESULTS: Between April 16, 2020, and October 11, 2021, 42 and 21 patients were randomly assigned to pCSI and IFRT, respectively. At planned interim analysis, a significant benefit in CNS PFS was observed with pCSI (median 7.5 months; 95% CI, 6.6 months to not reached) compared with IFRT (2.3 months; 95% CI, 1.2 to 5.8 months; P < .001). We also observed OS benefit with pCSI (9.9 months; 95% CI, 7.5 months to not reached) versus IFRT (6.0 months; 95% CI, 3.9 months to not reached; P = .029). There was no difference in the rate of grade 3 and 4 TAEs (P = .19). In the exploratory pCSI group, 35 patients enrolled, the median CNS PFS was 5.8 months (95% CI, 4.4 to 9.1 months) and OS was 6.6 months (95% CI, 5.4 to 11 months). CONCLUSION: Compared with photon IFRT, we found pCSI improved CNS PFS and OS for patients with non-small-cell lung cancer and breast cancer with LM with no increase in serious TAEs. |
| Keywords: | controlled study; clinical trial; antineoplastic agent; phase 2 clinical trial; randomized controlled trial; antineoplastic combined chemotherapy protocols; carcinoma, non-small-cell lung; lung neoplasms; lung tumor; protons; carcinomatous meningitis; proton; non small cell lung cancer; adverse event; craniospinal irradiation; meningeal carcinomatosis; proton therapy; humans; human |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 40 |
| Issue: | 33 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2022-11-20 |
| Start Page: | 3858 |
| End Page: | 3867 |
| Language: | English |
| DOI: | 10.1200/jco.22.01148 |
| PUBMED: | 35802849 |
| PROVIDER: | scopus |
| PMCID: | PMC9671756 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 December 2022 -- Source: Scopus |
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