A phase 3 trial of whole brain radiation therapy and stereotactic radiosurgery alone versus WBRT and SRS with temozolomide or erlotinib for non-small cell lung cancer and 1 to 3 brain metastases: Radiation Therapy Oncology Group 0320

Sperduto, Paul W.; Wang, Meihua; Robins, H. Ian; Schell, Michael C.; Werner-Wasik, Maria; Komaki, Ritsuko; Souhami, Luis; Buyyounouski, Mark K.; Khuntia, Deepak; Demas, William; Shah, Sunjay A.; Nedzi, Lucien A.; Perry, Gad; Suh, John H.; Mehta, Minesh P.

doi:10.1016/j.ijrobp.2012.11.042

Cited by 274Brain Metastases and TreatmentGlioma Diagnosis and TreatmentLung Cancer Diagnosis and Treatment

A phase 3 trial of whole brain radiation therapy and stereotactic radiosurgery alone versus WBRT and SRS with temozolomide or erlotinib for non-small cell lung cancer and 1 to 3 brain metastases: Radiation Therapy Oncology Group 0320

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Sperduto, Paul W., Wang, Meihua, Robins, H. Ian, Schell, Michael C., Werner-Wasik, Maria, Komaki, Ritsuko, Souhami, Luis, Buyyounouski, Mark K. +7 more·2013·International Journal of Radiation Oncology*Biology*Physics

DOI 10.1016/j.ijrobp.2012.11.042PMC PMC3740376

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Abstract

Background A phase 3 Radiation Therapy Oncology Group (RTOG) study subset analysis demonstrated improved overall survival (OS) with the addition of stereotactic radiosurgery (SRS) to whole brain radiation therapy (WBRT) in non-small cell lung cancer (NSCLC) patients with 1 to 3 brain metastases. Because temozolomide (TMZ) and erlotinib (ETN) cross the blood-brain barrier and have documented activity in NSCLC, a phase 3 study was designed to test whether these drugs would improve the OS associated with WBRT + SRS.Methods and materials NSCLC patients with 1 to 3 brain metastases were randomized to receive WBRT (2.5 Gy × 15 to 37.5 Gy) and SRS alone, versus WBRT + SRS + TMZ (75 mg/m(2)/day × 21 days) or ETN (150 mg/day). ETN (150 mg/day) or TMZ (150-200 mg/m(2)/day × 5 days/month) could be continued for as long as 6 months after WBRT + SRS. The primary endpoint was OS.Results After 126 patients were enrolled, the study closed because of accrual limitations. The median survival times (MST) for WBRT + SRS, WBRT + SRS + TMZ, and WBRT + SRS + ETN were qualitatively different (13.4, 6.3, and 6.1 months, respectively), although the differences were not statistically significant. Time to central nervous system progression and performance status at 6 months were better in the WBRT + SRS arm. Grade 3 to 5 toxicity was 11%, 41%, and 49% in arms 1, 2, and 3, respectively (P<.001).Conclusion The addition of TMZ or ETN to WBRT + SRS in NSCLC patients with 1 to 3 brain metastases did not improve survival and possibly had a deleterious effect. Because the analysis is underpowered, these data suggest but do not prove that increased toxicity was the cause of inferior survival in the drug arms.

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The Radiation Therapy Oncology Group conducted a phase III trial of WBRT and SRS, given alone or with temozolamide or erlotinib, in patients with NSCLC with one to three brain metastases.
“The Radiation Therapy Oncology Group conducted a phase III trial of WBRT and SRS, given alone or with either temozolamide or erlotinib, for patients with NSCLC with one to three brain metastases.116”
From The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation–Positive Non–Small Cell Lung Cancer: Status in 2016 (2016) · cites this paper as [116]
Patients in that RTOG trial were not tested for EGFR mutation.
“Patients were not tested for EGFR mutation in this study”
From The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation–Positive Non–Small Cell Lung Cancer: Status in 2016 (2016) · cites this paper as [116]
In that RTOG trial, grade 3 to 5 toxicity rates were 41% to 49% in the two arms incorporating concurrent drug treatment.
“Grade 3 to 5 toxicity rates were 41% to 49% in the two arms incorporating concurrent drug treatment.”
From The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation–Positive Non–Small Cell Lung Cancer: Status in 2016 (2016) · cites this paper as [116]

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Abstract 736: RTOG 0320:A phase III trial comparing whole brain radiation therapy (WBRT) and stereotactic radiosurgery (SRS) alone versus WBRT with temozolomide (TMZ) or erlotinib for non-small cell lung cancer (NSCLC) and 1-3 brain metastases
Sperduto, P. W., Wang, M., Robins, H. I., Schell, M. C., Werner‐Wasik, M., Komaki, R. U., Souhami, L., Buyyounouski, M. K., Khuntia, D., Demas, W. F., et al. (2012) · Cancer Research · doi:10.1158/1538-7445.am2012-736 · Cited by 4 · see citing works
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[Whole brain radiation therapy plus temozolomide in the treatment of brain metastases from non small cell lung cancer: a meta-analysis].
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Whole-Brain Radiation Therapy Plus Concomitant Temozolomide for the Treatment of Brain Metastases From Non–Small-Cell Lung Cancer: A Randomized, Open-Label Phase II Study
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Response and safety of whole‐brain radiotherapy plus temozolomide for patients with brain metastases of non‐small‐cell lung cancer: A meta‐analysis
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Whole brain radiation therapy followed by intensity-modulated boosting treatment combined with concomitant temozolomide for brain metastases from non-small-cell lung cancer
Wang, Q.-J., Jiang, Z., Qi, X., Lu, S., WANG, S.-J., Leng, C., Lu, F., Liu, H., Liang, S., & Shi, J. (2014) · Clinical & Translational Oncology · doi:10.1007/s12094-014-1190-x · Cited by 10 · see citing works

Authors: Sperduto, P. W., Wang, M., Robins, H. I., Schell, M. C., Werner-Wasik, M., Komaki, R., Souhami, L., Buyyounouski, M. K., Khuntia, D., Demas, W., Shah, S. A., Nedzi, L. A., Perry, G., Suh, J. H., & Mehta, M. P.
Affiliations: University of Wisconsin–Madison (US)
University of Rochester Medicine (US)
The University of Texas MD Anderson Cancer Center (US)
Fox Chase Cancer Center (US)
Summa Akron City Hospital (US)
The University of Texas Southwestern Medical Center (US)
Ottawa Hospital (CA)
Cleveland Clinic (US)
Northwestern Memorial Hospital (US)
Corresponding author: Sperduto, Paul W.
ORCID: Sperduto, Paul W.
Wang, Meihua
Komaki, Ritsuko
Buyyounouski, Mark K.
Khuntia, Deepak
Nedzi, Lucien A.
Suh, John H.
Mehta, Minesh P.
Venue: International Journal of Radiation Oncology*Biology*Physics
Publisher: Elsevier BV
Published: 2013-04
Volume: 85
Issue: 5
Pages: 1312-1318
ISSN: 0360-3016 (ISSN-L)
DOI: 10.1016/j.ijrobp.2012.11.042
PMC: PMC3740376
OpenAlex: W2102149158
Cited by: 274
References: 15
Citations by year: 2026: 4 · 2025: 6 · 2024: 3 · 2023: 9 · 2022: 11 · 2021: 14 · 2020: 20 · 2019: 20 · 2018: 30 · 2017: 36 · 2016: 46 · 2015: 33 · 2014: 29 · 2013: 11 · 2012: 2
FWCI: 32.24
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: International Journal of Radiation Oncology*Biology*Physics (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (U10-CA-21661, U10CA037422, U10CA37422, U10CA021661)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Brain Metastases and Treatment
Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: non-small cell lung cancer, brain metastases, whole brain radiotherapy, stereotactic radiosurgery, temozolomide, erlotinib, adjuvant chemotherapy, overall survival, radiation toxicity, central nervous system progression, blood-brain barrier drug delivery, performance status, time to progression
MeSH terms: Erlotinib Hydrochloride, Temozolomide, Aged, Antineoplastic Agents, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Combined Modality Therapy, Dacarbazine, Humans, Lung Neoplasms, Middle Aged, Quinazolines, Radiotherapy Dosage, Cranial Irradiation, Radiosurgery, Antineoplastic Agents, Alkylating, Protein Kinase Inhibitors

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A phase 3 trial of whole brain radiation therapy and stereotactic radiosurgery alone versus WBRT and SRS with temozolomide or erlotinib for non-small cell lung cancer and 1 to 3 brain metastases: Radiation Therapy Oncology Group 0320

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