دورية أكاديمية
Stereotactic Body Radiation Therapy for Stage IIA to IIIA Inoperable Non-Small Cell Lung Cancer: A Phase 1 Dose-Escalation Trial.
| العنوان: | Stereotactic Body Radiation Therapy for Stage IIA to IIIA Inoperable Non-Small Cell Lung Cancer: A Phase 1 Dose-Escalation Trial. |
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| المؤلفون: | Rimner A; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Radiation Oncology, University of Freiburg, Robert-Koch-Strasse 3, 79106 Freiburg, Germany. Electronic address: rimner@uniklinik-freiburg.de., Gelblum DY; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Wu AJ; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Shepherd AF; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Mueller B; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Zhang S; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York; Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China., Cuaron J; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Shaverdian N; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Flynn J; Department of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Fiasconaro M; Department of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York; Flatiron Health, New York, New York., Zhang Z; Department of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., von Reibnitz D; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Surgery, Stadtspital Waid, Zurich, Switzerland., Li H; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., McKnight D; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., McCune M; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Gelb E; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Gomez DR; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Simone CB 2nd; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York., Deasy JO; Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York., Yorke ED; Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York., Ng KK; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York., Chaft JE; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York. |
| المصدر: | International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2024 Jul 01; Vol. 119 (3), pp. 869-877. Date of Electronic Publication: 2023 Dec 26. |
| نوع المنشور: | Journal Article; Clinical Trial, Phase I |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-355X (Electronic) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: New York, NY : Elsevier, Inc Original Publication: Elmsford, N. Y., Pergamon Press. |
| مواضيع طبية MeSH: | Carcinoma, Non-Small-Cell Lung*/pathology , Carcinoma, Non-Small-Cell Lung*/radiotherapy , Carcinoma, Non-Small-Cell Lung*/mortality , Radiosurgery*/adverse effects , Radiosurgery*/methods , Lung Neoplasms*/pathology , Lung Neoplasms*/radiotherapy , Lung Neoplasms*/mortality , Maximum Tolerated Dose*, Humans ; Male ; Aged ; Female ; Aged, 80 and over ; Middle Aged ; Neoplasm Staging ; Disease Progression ; Dose Fractionation, Radiation |
| مستخلص: | Purpose: Larger tumors are underrepresented in most prospective trials on stereotactic body radiation therapy (SBRT) for inoperable non-small cell lung cancer (NSCLC). We performed this phase 1 trial to specifically study the maximum tolerated dose (MTD) of SBRT for NSCLC >3 cm. Methods and Materials: A 3 + 3 dose-escalation design (cohort A) with an expansion cohort at the MTD (cohort B) was used. Patients with inoperable NSCLC >3 cm (T2-4) were eligible. Select ipsilateral hilar and single-station mediastinal nodes were permitted. The initial SBRT dose was 40 Gy in 5 fractions, with planned escalation to 50 and 60 Gy in 5 fractions. Adjuvant chemotherapy was mandatory for cohort A and optional for cohort B, but no patients in cohort B received chemotherapy. The primary endpoint was SBRT-related acute grade (G) 4+ or persistent G3 toxicities (Common Terminology Criteria for Adverse Events version 4.03). Secondary endpoints included local failure (LF), distant metastases, disease progression, and overall survival. Results: The median age was 80 years; tumor size was >3 cm and ≤5 cm in 20 (59%) and >5 cm in 14 patients (41%). In cohort A (n = 9), 3 patients treated to 50 Gy experienced G3 radiation pneumonitis (RP), thus defining the MTD. In the larger dose-expansion cohort B (n = 25), no radiation therapy-related G4+ toxicities and no G3 RP occurred; only 2 patients experienced G2 RP. The 2-year cumulative incidence of LF was 20.2%, distant failure was 34.7%, and disease progression was 54.4%. Two-year overall survival was 53%. A biologically effective dose (BED) <100 Gy was associated with higher LF (P = .006); advanced stage and higher neutrophil/lymphocyte ratio were associated with greater disease progression (both P = .004). Conclusions: Fifty Gy in 5 fractions is the MTD for SBRT to tumors >3 cm. A higher BED is associated with fewer LFs even in larger tumors. Cohort B appears to have had less toxicity, possibly due to the omission of chemotherapy. (Copyright © 2023 Elsevier Inc. All rights reserved.) |
| تواريخ الأحداث: | Date Created: 20231228 Date Completed: 20240608 Latest Revision: 20240609 |
| رمز التحديث: | 20240610 |
| DOI: | 10.1016/j.ijrobp.2023.12.018 |
| PMID: | 38154510 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1879-355X |
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| DOI: | 10.1016/j.ijrobp.2023.12.018 |