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Stereotactic Body Radiation Therapy for Stage IIA to IIIA Inoperable Non-Small Cell Lung Cancer: A Phase 1 Dose-Escalation Trial.
Rimner, Andreas; Gelblum, Daphna Y; Wu, Abraham J; Shepherd, Annemarie F; Mueller, Boris; Zhang, Siyuan; Cuaron, John; Shaverdian, Narek; Flynn, Jessica; Fiasconaro, Megan; Zhang, Zhigang; von Reibnitz, Donata; Li, Henry; McKnight, Dominique; McCune, Megan; Gelb, Emily; Gomez, Daniel R; Simone, Charles B; Deasy, Joseph O; Yorke, Ellen D; Ng, Kenneth K; Chaft, Jamie E.
Afiliação
  • 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; 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.
Int J Radiat Oncol Biol Phys ; 119(3): 869-877, 2024 Jul 01.
Article em En | MEDLINE | ID: mdl-38154510
ABSTRACT

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.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Radiocirurgia / Carcinoma Pulmonar de Células não Pequenas / Dose Máxima Tolerável / Neoplasias Pulmonares Limite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Radiat Oncol Biol Phys Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Radiocirurgia / Carcinoma Pulmonar de Células não Pequenas / Dose Máxima Tolerável / Neoplasias Pulmonares Limite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Radiat Oncol Biol Phys Ano de publicação: 2024 Tipo de documento: Article