Multiinstitutional prospective observational study of stereotactic radiosurgery for patients with multiple brain metastases from non–small cell lung cancer (JLGK0901 study–NSCLC)

Takashi Shuto, Atsuya Akabane, Masaaki Yamamoto, Toru Serizawa, Yoshinori Higuchi, Yasunori Sato, Jun Kawagishi, Kazuhiro Yamanaka, Hidefumi Jokura, Shoji Yomo, Osamu Nagano, Hidefumi Aoyama

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE Previous Japanese Leksell Gamma Knife Society studies (JLGK0901) demonstrated the noninferiority of stereotactic radiosurgery (SRS) alone as the initial treatment for patients with 5–10 brain metastases (BMs) compared with those with 2–4 BMs in terms of overall survival and most secondary endpoints. The authors studied the aforementioned treatment outcomes in a subset of patients with BMs from non–small cell lung cancer (NSCLC). METHODS Patients with initially diagnosed BMs treated with SRS alone were enrolled in this prospective observational study. Major inclusion criteria were the existence of up to 10 tumors with a maximum diameter of less than 3 cm each, a cumulative tumor volume of less than 15 cm 3 , and no leptomeningeal dissemination in patients with a Karnofsky Performance Scale score of 70% or better. RESULTS Among 1194 eligible patients, 784 with NSCLC were categorized into 3 groups: group A (1 tumor, n = 299), group B (2–4 tumors, n = 342), and group C (5–10 tumors, n = 143). The median survival times were 13.9 months in group A, 12.3 months in group B, and 12.8 months in group C. The survival curves of groups B and C were very similar (hazard ratio [HR] 1.037; 95% CI 0.842–1.277; p < 0.0001, noninferiority test). The crude and cumulative incidence rates of neurological death, deterioration of neurological function, newly appearing lesions, and leptomeningeal dissemination did not differ significantly between groups B and C. SRS-induced complications occurred in 145 (12.1%) patients during the median post-SRS period of 9.3 months (IQR 4.1–17.4 months), including 46, 54, 29, 11, and 5 patients with a Common Terminology Criteria for Adverse Events v3.0 grade 1, 2, 3, 4, or 5 complication, respectively. The cumulative incidence rates of adverse effects in groups A, B, and C 60 months after SRS were 13.5%, 10.0%, and 12.6%, respectively (group B vs C: HR 1.344; 95% CI 0.768–2.352; p = 0.299). The 60-month post-SRS rates of neurocognitive function preservation were 85.7% or higher, and no significant differences among the 3 groups were found. CONCLUSIONS In this subset analysis of patients with NSCLC, the noninferiority of SRS alone for the treatment of 5–10 versus 2–4 BMs was confirmed again in terms of overall survival and secondary endpoints. In particular, the incidence of neither post-SRS complications nor neurocognitive function preservation differed significantly between groups B and C. These findings further strengthen the already-reported noninferiority hypothesis of SRS alone for the treatment of patients with 5–10 BMs.

Original languageEnglish
Pages (from-to)86-94
Number of pages9
JournalJournal of neurosurgery
Volume129
DOIs
Publication statusPublished - 2018 Dec 1

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Radiosurgery
Non-Small Cell Lung Carcinoma
Observational Studies
Prospective Studies
Neoplasm Metastasis
Brain
Survival
Neoplasms
Incidence
Karnofsky Performance Status
Tumor Burden
Terminology
Therapeutics
Mortality

Keywords

  • Complications
  • Gamma Knife
  • Neurocognitive function
  • Non–small cell lung cancer
  • Oncology
  • Stereotactic radiosurgery

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

Multiinstitutional prospective observational study of stereotactic radiosurgery for patients with multiple brain metastases from non–small cell lung cancer (JLGK0901 study–NSCLC). / Shuto, Takashi; Akabane, Atsuya; Yamamoto, Masaaki; Serizawa, Toru; Higuchi, Yoshinori; Sato, Yasunori; Kawagishi, Jun; Yamanaka, Kazuhiro; Jokura, Hidefumi; Yomo, Shoji; Nagano, Osamu; Aoyama, Hidefumi.

In: Journal of neurosurgery, Vol. 129, 01.12.2018, p. 86-94.

Research output: Contribution to journalArticle

Shuto, Takashi ; Akabane, Atsuya ; Yamamoto, Masaaki ; Serizawa, Toru ; Higuchi, Yoshinori ; Sato, Yasunori ; Kawagishi, Jun ; Yamanaka, Kazuhiro ; Jokura, Hidefumi ; Yomo, Shoji ; Nagano, Osamu ; Aoyama, Hidefumi. / Multiinstitutional prospective observational study of stereotactic radiosurgery for patients with multiple brain metastases from non–small cell lung cancer (JLGK0901 study–NSCLC). In: Journal of neurosurgery. 2018 ; Vol. 129. pp. 86-94.
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abstract = "OBJECTIVE Previous Japanese Leksell Gamma Knife Society studies (JLGK0901) demonstrated the noninferiority of stereotactic radiosurgery (SRS) alone as the initial treatment for patients with 5–10 brain metastases (BMs) compared with those with 2–4 BMs in terms of overall survival and most secondary endpoints. The authors studied the aforementioned treatment outcomes in a subset of patients with BMs from non–small cell lung cancer (NSCLC). METHODS Patients with initially diagnosed BMs treated with SRS alone were enrolled in this prospective observational study. Major inclusion criteria were the existence of up to 10 tumors with a maximum diameter of less than 3 cm each, a cumulative tumor volume of less than 15 cm 3 , and no leptomeningeal dissemination in patients with a Karnofsky Performance Scale score of 70{\%} or better. RESULTS Among 1194 eligible patients, 784 with NSCLC were categorized into 3 groups: group A (1 tumor, n = 299), group B (2–4 tumors, n = 342), and group C (5–10 tumors, n = 143). The median survival times were 13.9 months in group A, 12.3 months in group B, and 12.8 months in group C. The survival curves of groups B and C were very similar (hazard ratio [HR] 1.037; 95{\%} CI 0.842–1.277; p < 0.0001, noninferiority test). The crude and cumulative incidence rates of neurological death, deterioration of neurological function, newly appearing lesions, and leptomeningeal dissemination did not differ significantly between groups B and C. SRS-induced complications occurred in 145 (12.1{\%}) patients during the median post-SRS period of 9.3 months (IQR 4.1–17.4 months), including 46, 54, 29, 11, and 5 patients with a Common Terminology Criteria for Adverse Events v3.0 grade 1, 2, 3, 4, or 5 complication, respectively. The cumulative incidence rates of adverse effects in groups A, B, and C 60 months after SRS were 13.5{\%}, 10.0{\%}, and 12.6{\%}, respectively (group B vs C: HR 1.344; 95{\%} CI 0.768–2.352; p = 0.299). The 60-month post-SRS rates of neurocognitive function preservation were 85.7{\%} or higher, and no significant differences among the 3 groups were found. CONCLUSIONS In this subset analysis of patients with NSCLC, the noninferiority of SRS alone for the treatment of 5–10 versus 2–4 BMs was confirmed again in terms of overall survival and secondary endpoints. In particular, the incidence of neither post-SRS complications nor neurocognitive function preservation differed significantly between groups B and C. These findings further strengthen the already-reported noninferiority hypothesis of SRS alone for the treatment of patients with 5–10 BMs.",
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author = "Takashi Shuto and Atsuya Akabane and Masaaki Yamamoto and Toru Serizawa and Yoshinori Higuchi and Yasunori Sato and Jun Kawagishi and Kazuhiro Yamanaka and Hidefumi Jokura and Shoji Yomo and Osamu Nagano and Hidefumi Aoyama",
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TY - JOUR

T1 - Multiinstitutional prospective observational study of stereotactic radiosurgery for patients with multiple brain metastases from non–small cell lung cancer (JLGK0901 study–NSCLC)

AU - Shuto, Takashi

AU - Akabane, Atsuya

AU - Yamamoto, Masaaki

AU - Serizawa, Toru

AU - Higuchi, Yoshinori

AU - Sato, Yasunori

AU - Kawagishi, Jun

AU - Yamanaka, Kazuhiro

AU - Jokura, Hidefumi

AU - Yomo, Shoji

AU - Nagano, Osamu

AU - Aoyama, Hidefumi

PY - 2018/12/1

Y1 - 2018/12/1

N2 - OBJECTIVE Previous Japanese Leksell Gamma Knife Society studies (JLGK0901) demonstrated the noninferiority of stereotactic radiosurgery (SRS) alone as the initial treatment for patients with 5–10 brain metastases (BMs) compared with those with 2–4 BMs in terms of overall survival and most secondary endpoints. The authors studied the aforementioned treatment outcomes in a subset of patients with BMs from non–small cell lung cancer (NSCLC). METHODS Patients with initially diagnosed BMs treated with SRS alone were enrolled in this prospective observational study. Major inclusion criteria were the existence of up to 10 tumors with a maximum diameter of less than 3 cm each, a cumulative tumor volume of less than 15 cm 3 , and no leptomeningeal dissemination in patients with a Karnofsky Performance Scale score of 70% or better. RESULTS Among 1194 eligible patients, 784 with NSCLC were categorized into 3 groups: group A (1 tumor, n = 299), group B (2–4 tumors, n = 342), and group C (5–10 tumors, n = 143). The median survival times were 13.9 months in group A, 12.3 months in group B, and 12.8 months in group C. The survival curves of groups B and C were very similar (hazard ratio [HR] 1.037; 95% CI 0.842–1.277; p < 0.0001, noninferiority test). The crude and cumulative incidence rates of neurological death, deterioration of neurological function, newly appearing lesions, and leptomeningeal dissemination did not differ significantly between groups B and C. SRS-induced complications occurred in 145 (12.1%) patients during the median post-SRS period of 9.3 months (IQR 4.1–17.4 months), including 46, 54, 29, 11, and 5 patients with a Common Terminology Criteria for Adverse Events v3.0 grade 1, 2, 3, 4, or 5 complication, respectively. The cumulative incidence rates of adverse effects in groups A, B, and C 60 months after SRS were 13.5%, 10.0%, and 12.6%, respectively (group B vs C: HR 1.344; 95% CI 0.768–2.352; p = 0.299). The 60-month post-SRS rates of neurocognitive function preservation were 85.7% or higher, and no significant differences among the 3 groups were found. CONCLUSIONS In this subset analysis of patients with NSCLC, the noninferiority of SRS alone for the treatment of 5–10 versus 2–4 BMs was confirmed again in terms of overall survival and secondary endpoints. In particular, the incidence of neither post-SRS complications nor neurocognitive function preservation differed significantly between groups B and C. These findings further strengthen the already-reported noninferiority hypothesis of SRS alone for the treatment of patients with 5–10 BMs.

AB - OBJECTIVE Previous Japanese Leksell Gamma Knife Society studies (JLGK0901) demonstrated the noninferiority of stereotactic radiosurgery (SRS) alone as the initial treatment for patients with 5–10 brain metastases (BMs) compared with those with 2–4 BMs in terms of overall survival and most secondary endpoints. The authors studied the aforementioned treatment outcomes in a subset of patients with BMs from non–small cell lung cancer (NSCLC). METHODS Patients with initially diagnosed BMs treated with SRS alone were enrolled in this prospective observational study. Major inclusion criteria were the existence of up to 10 tumors with a maximum diameter of less than 3 cm each, a cumulative tumor volume of less than 15 cm 3 , and no leptomeningeal dissemination in patients with a Karnofsky Performance Scale score of 70% or better. RESULTS Among 1194 eligible patients, 784 with NSCLC were categorized into 3 groups: group A (1 tumor, n = 299), group B (2–4 tumors, n = 342), and group C (5–10 tumors, n = 143). The median survival times were 13.9 months in group A, 12.3 months in group B, and 12.8 months in group C. The survival curves of groups B and C were very similar (hazard ratio [HR] 1.037; 95% CI 0.842–1.277; p < 0.0001, noninferiority test). The crude and cumulative incidence rates of neurological death, deterioration of neurological function, newly appearing lesions, and leptomeningeal dissemination did not differ significantly between groups B and C. SRS-induced complications occurred in 145 (12.1%) patients during the median post-SRS period of 9.3 months (IQR 4.1–17.4 months), including 46, 54, 29, 11, and 5 patients with a Common Terminology Criteria for Adverse Events v3.0 grade 1, 2, 3, 4, or 5 complication, respectively. The cumulative incidence rates of adverse effects in groups A, B, and C 60 months after SRS were 13.5%, 10.0%, and 12.6%, respectively (group B vs C: HR 1.344; 95% CI 0.768–2.352; p = 0.299). The 60-month post-SRS rates of neurocognitive function preservation were 85.7% or higher, and no significant differences among the 3 groups were found. CONCLUSIONS In this subset analysis of patients with NSCLC, the noninferiority of SRS alone for the treatment of 5–10 versus 2–4 BMs was confirmed again in terms of overall survival and secondary endpoints. In particular, the incidence of neither post-SRS complications nor neurocognitive function preservation differed significantly between groups B and C. These findings further strengthen the already-reported noninferiority hypothesis of SRS alone for the treatment of patients with 5–10 BMs.

KW - Complications

KW - Gamma Knife

KW - Neurocognitive function

KW - Non–small cell lung cancer

KW - Oncology

KW - Stereotactic radiosurgery

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