Evidence map›Paper›PMID 38154510›Full record

ArticleInternational journal of radiation oncology, biology, physics2024

Stereotactic Body Radiation Therapy for Stage IIA to IIIA Inoperable Non-Small Cell Lung Cancer: A Phase 1 Dose-Escalation Trial.

Andreas Rimner, Daphna Y Gelblum, Abraham J Wu, Annemarie F Shepherd, Boris Mueller, Siyuan Zhang, John Cuaron, Narek Shaverdian, Jessica Flynn, Megan Fiasconaro and 12 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in International journal of radiation oncology, biology, physics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Andreas RimnerDepartment 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.
Daphna Y GelblumDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Abraham J WuDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Annemarie F ShepherdDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Boris MuellerDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Siyuan ZhangDepartment 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.
John CuaronDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Narek ShaverdianDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Jessica FlynnDepartment of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Megan FiasconaroDepartment of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York; Flatiron Health, New York, New York.
Zhigang ZhangDepartment of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Donata von ReibnitzDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Surgery, Stadtspital Waid, Zurich, Switzerland.
Henry LiDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Dominique McKnightDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Megan McCuneDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Emily GelbDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Daniel R GomezDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Charles B SimoneDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Joseph O DeasyDepartment of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York.
Ellen D YorkeDepartment of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York.
Kenneth K NgDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Jamie E ChaftDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeLarger 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.

resultsThe 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).

conclusionsFifty 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.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsMaximum Tolerated DoseRadiosurgeryAgedAged, 80 and overDisease ProgressionDose Fractionation, RadiationFemaleHumansMaleMiddle AgedNeoplasm Staging

Identifiers

PMID38154510
PMCPMC12094679

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.