Randomized Phase II Trial of Proton Craniospinal Irradiation Versus Photon Involved-Field Radiotherapy for Patients With Solid Tumor Leptomeningeal Metastasis

Author:

Yang Jonathan T.1ORCID,Wijetunga N. Ari1ORCID,Pentsova Elena2,Wolden Suzanne1ORCID,Young Robert J.3ORCID,Correa Denise2ORCID,Zhang Zhigang4,Zheng Junting4,Steckler Alexa1,Bucwinska Weronika1ORCID,Bernstein Ashley1,Betof Warner Allison5ORCID,Yu Helena6ORCID,Kris Mark G.6,Seidman Andrew D.7,Wilcox Jessica A.2ORCID,Malani Rachna2ORCID,Lin Andrew2ORCID,DeAngelis Lisa M.2,Lee Nancy Y.1ORCID,Powell Simon N.1,Boire Adrienne28ORCID

Affiliation:

1. Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY

2. Department of Neurology, Memorial Sloan Kettering Cancer Center, New York, NY

3. Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY

4. Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY

5. Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Melanoma and Immunotherapeutics Service, New York, NY

6. Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Thoracic Oncology Service, New York, NY

7. Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Breast Medicine Service, New York, NY

8. Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, Brain Tumor Center, New York, NY

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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