Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450)

Dirk De Ruysscher; Rinus Wanders; Lizza E. Hendriks; Angela van Baardwijk; Bart Reymen; Ruud Houben; Gerben Bootsma; Cordula Pitz; Linda van Eijsden; Anne Marie C. Dingemans

doi:10.1016/j.jtho.2018.07.098

Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450)

Dirk De Ruysscher^*, Rinus Wanders, Lizza E. Hendriks, Angela van Baardwijk, Bart Reymen, Ruud Houben, Gerben Bootsma, Cordula Pitz, Linda van Eijsden, Anne Marie C. Dingemans

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

72 Citations (Scopus)

Abstract

Introduction:

Two randomized studies have shown an increased progression-free survival (PFS) by adding a radical local treatment to systemic therapy in responding patients with oligometastatic NSCLC, but long-term data are lacking. We updated the results of our previous phase II trial with a minimal follow-up exceeding 7 years.

Methods:

This is a prospective single-arm phase II trial. The main inclusion criteria were pathologically proven NSCLC stage IV with less than five metastases at primary diagnosis, amendable for radical local treatment (surgery or radiotherapy). No previous response to systemic treatment was needed.

Results:

Forty patients were enrolled, 39 of whom were evaluable (18 men, 21 women); mean age was 62.1 ± 9.2 years (range, 44 to 81 years). Twenty-nine (74%) had N2 or N3 disease; 17 (44%) brain, 7 (18%) bone, and 4 (10%) adrenal gland metastases. Thirty-five (87%) had a single metastatic lesion. Thirty-seven (95%) of the patients received chemotherapy as part of their primary treatment. Median overall survival (OS) was 13.5 months (95% confidence interval: 7.6–19.4 months); 1-, 2-, 3-, 5-, and 6- year OS was 56.4%, 23.3%,12.8%, 10.3%, 7.7%, and 5.1%, respectively. Median PFS was 12.1 months (95% confidence interval: 9.6–14.3 months); 1-, 2-, 3-, 5-, and 6- year OS was 51.3%, 13.6%, %,12.8%, 7.7%, 7.7%, and 2.5%, respectively. Only three patients (7.7%) had a local recurrence.

Conclusions:

In patients who were not selected according to response to systemic treatment, the PFS at 5 years was 8%. Entering patients in trials combining local therapy with novel systemic agents (e.g., immunotherapy) remains mandatory.

Original language	English
Pages (from-to)	1958-1961
Number of pages	4
Journal	Journal of Thoracic Oncology
Volume	13
Issue number	12
DOIs	https://doi.org/10.1016/j.jtho.2018.07.098
Publication status	Published - Dec 2018
Externally published	Yes

Bibliographical note

Funding Information:
Disclosure: Dr. De Ruysscher has been on the advisory boards of Astra Zeneca, Bristol-Myers Squibb, Roche/Genentech, Merck/Pfizer, Celgene, Noxxon, Mologen and has received investigator-initiated grants from Bristol-Myers-Squibb and Boehringer Ingelheim outside of this work. Dr. Hendriks has received research funding from Roche, has been on the advisory board for Boehringer, Bristol-Myers Squibb and has received travel reimbursement from Roche and Bristol-Myers Squibb outside of this work. Dr. Dingemans has been on the advisory boards for Boehringer, BMS, Roche, MSD, Lilly, Takeda, Pfizer outside of this work. The remaining authors declare no conflict of interest.

Funding Information:
This study was funded by the Maastro Clinic.

Publisher Copyright:
© 2018 International Association for the Study of Lung Cancer

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10.1016/j.jtho.2018.07.098

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De Ruysscher, D., Wanders, R., Hendriks, L. E., van Baardwijk, A., Reymen, B., Houben, R., Bootsma, G., Pitz, C., van Eijsden, L., & Dingemans, A. M. C. (2018). Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450). Journal of Thoracic Oncology, 13(12), 1958-1961. https://doi.org/10.1016/j.jtho.2018.07.098

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title = "Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450)",

abstract = "Introduction: Two randomized studies have shown an increased progression-free survival (PFS) by adding a radical local treatment to systemic therapy in responding patients with oligometastatic NSCLC, but long-term data are lacking. We updated the results of our previous phase II trial with a minimal follow-up exceeding 7 years.Methods: This is a prospective single-arm phase II trial. The main inclusion criteria were pathologically proven NSCLC stage IV with less than five metastases at primary diagnosis, amendable for radical local treatment (surgery or radiotherapy). No previous response to systemic treatment was needed.Results: Forty patients were enrolled, 39 of whom were evaluable (18 men, 21 women); mean age was 62.1 ± 9.2 years (range, 44 to 81 years). Twenty-nine (74%) had N2 or N3 disease; 17 (44%) brain, 7 (18%) bone, and 4 (10%) adrenal gland metastases. Thirty-five (87%) had a single metastatic lesion. Thirty-seven (95%) of the patients received chemotherapy as part of their primary treatment. Median overall survival (OS) was 13.5 months (95% confidence interval: 7.6–19.4 months); 1-, 2-, 3-, 5-, and 6- year OS was 56.4%, 23.3%,12.8%, 10.3%, 7.7%, and 5.1%, respectively. Median PFS was 12.1 months (95% confidence interval: 9.6–14.3 months); 1-, 2-, 3-, 5-, and 6- year OS was 51.3%, 13.6%, %,12.8%, 7.7%, 7.7%, and 2.5%, respectively. Only three patients (7.7%) had a local recurrence. Conclusions:In patients who were not selected according to response to systemic treatment, the PFS at 5 years was 8%. Entering patients in trials combining local therapy with novel systemic agents (e.g., immunotherapy) remains mandatory.",

author = "{De Ruysscher}, Dirk and Rinus Wanders and Hendriks, {Lizza E.} and {van Baardwijk}, Angela and Bart Reymen and Ruud Houben and Gerben Bootsma and Cordula Pitz and {van Eijsden}, Linda and Dingemans, {Anne Marie C.}",

note = "Funding Information: Disclosure: Dr. De Ruysscher has been on the advisory boards of Astra Zeneca, Bristol-Myers Squibb, Roche/Genentech, Merck/Pfizer, Celgene, Noxxon, Mologen and has received investigator-initiated grants from Bristol-Myers-Squibb and Boehringer Ingelheim outside of this work. Dr. Hendriks has received research funding from Roche, has been on the advisory board for Boehringer, Bristol-Myers Squibb and has received travel reimbursement from Roche and Bristol-Myers Squibb outside of this work. Dr. Dingemans has been on the advisory boards for Boehringer, BMS, Roche, MSD, Lilly, Takeda, Pfizer outside of this work. The remaining authors declare no conflict of interest. Funding Information: This study was funded by the Maastro Clinic. Publisher Copyright: {\textcopyright} 2018 International Association for the Study of Lung Cancer",

year = "2018",

month = dec,

doi = "10.1016/j.jtho.2018.07.098",

language = "English",

volume = "13",

pages = "1958--1961",

journal = "Journal of Thoracic Oncology",

issn = "1556-0864",

publisher = "Elsevier Inc.",

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De Ruysscher, D, Wanders, R, Hendriks, LE, van Baardwijk, A, Reymen, B, Houben, R, Bootsma, G, Pitz, C, van Eijsden, L & Dingemans, AMC 2018, 'Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450)', Journal of Thoracic Oncology, vol. 13, no. 12, pp. 1958-1961. https://doi.org/10.1016/j.jtho.2018.07.098

Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450). / De Ruysscher, Dirk; Wanders, Rinus; Hendriks, Lizza E. et al.
In: Journal of Thoracic Oncology, Vol. 13, No. 12, 12.2018, p. 1958-1961.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450)

AU - De Ruysscher, Dirk

AU - Wanders, Rinus

AU - Hendriks, Lizza E.

AU - van Baardwijk, Angela

AU - Reymen, Bart

AU - Houben, Ruud

AU - Bootsma, Gerben

AU - Pitz, Cordula

AU - van Eijsden, Linda

AU - Dingemans, Anne Marie C.

N1 - Funding Information: Disclosure: Dr. De Ruysscher has been on the advisory boards of Astra Zeneca, Bristol-Myers Squibb, Roche/Genentech, Merck/Pfizer, Celgene, Noxxon, Mologen and has received investigator-initiated grants from Bristol-Myers-Squibb and Boehringer Ingelheim outside of this work. Dr. Hendriks has received research funding from Roche, has been on the advisory board for Boehringer, Bristol-Myers Squibb and has received travel reimbursement from Roche and Bristol-Myers Squibb outside of this work. Dr. Dingemans has been on the advisory boards for Boehringer, BMS, Roche, MSD, Lilly, Takeda, Pfizer outside of this work. The remaining authors declare no conflict of interest. Funding Information: This study was funded by the Maastro Clinic. Publisher Copyright: © 2018 International Association for the Study of Lung Cancer

PY - 2018/12

Y1 - 2018/12

N2 - Introduction: Two randomized studies have shown an increased progression-free survival (PFS) by adding a radical local treatment to systemic therapy in responding patients with oligometastatic NSCLC, but long-term data are lacking. We updated the results of our previous phase II trial with a minimal follow-up exceeding 7 years.Methods: This is a prospective single-arm phase II trial. The main inclusion criteria were pathologically proven NSCLC stage IV with less than five metastases at primary diagnosis, amendable for radical local treatment (surgery or radiotherapy). No previous response to systemic treatment was needed.Results: Forty patients were enrolled, 39 of whom were evaluable (18 men, 21 women); mean age was 62.1 ± 9.2 years (range, 44 to 81 years). Twenty-nine (74%) had N2 or N3 disease; 17 (44%) brain, 7 (18%) bone, and 4 (10%) adrenal gland metastases. Thirty-five (87%) had a single metastatic lesion. Thirty-seven (95%) of the patients received chemotherapy as part of their primary treatment. Median overall survival (OS) was 13.5 months (95% confidence interval: 7.6–19.4 months); 1-, 2-, 3-, 5-, and 6- year OS was 56.4%, 23.3%,12.8%, 10.3%, 7.7%, and 5.1%, respectively. Median PFS was 12.1 months (95% confidence interval: 9.6–14.3 months); 1-, 2-, 3-, 5-, and 6- year OS was 51.3%, 13.6%, %,12.8%, 7.7%, 7.7%, and 2.5%, respectively. Only three patients (7.7%) had a local recurrence. Conclusions:In patients who were not selected according to response to systemic treatment, the PFS at 5 years was 8%. Entering patients in trials combining local therapy with novel systemic agents (e.g., immunotherapy) remains mandatory.

AB - Introduction: Two randomized studies have shown an increased progression-free survival (PFS) by adding a radical local treatment to systemic therapy in responding patients with oligometastatic NSCLC, but long-term data are lacking. We updated the results of our previous phase II trial with a minimal follow-up exceeding 7 years.Methods: This is a prospective single-arm phase II trial. The main inclusion criteria were pathologically proven NSCLC stage IV with less than five metastases at primary diagnosis, amendable for radical local treatment (surgery or radiotherapy). No previous response to systemic treatment was needed.Results: Forty patients were enrolled, 39 of whom were evaluable (18 men, 21 women); mean age was 62.1 ± 9.2 years (range, 44 to 81 years). Twenty-nine (74%) had N2 or N3 disease; 17 (44%) brain, 7 (18%) bone, and 4 (10%) adrenal gland metastases. Thirty-five (87%) had a single metastatic lesion. Thirty-seven (95%) of the patients received chemotherapy as part of their primary treatment. Median overall survival (OS) was 13.5 months (95% confidence interval: 7.6–19.4 months); 1-, 2-, 3-, 5-, and 6- year OS was 56.4%, 23.3%,12.8%, 10.3%, 7.7%, and 5.1%, respectively. Median PFS was 12.1 months (95% confidence interval: 9.6–14.3 months); 1-, 2-, 3-, 5-, and 6- year OS was 51.3%, 13.6%, %,12.8%, 7.7%, 7.7%, and 2.5%, respectively. Only three patients (7.7%) had a local recurrence. Conclusions:In patients who were not selected according to response to systemic treatment, the PFS at 5 years was 8%. Entering patients in trials combining local therapy with novel systemic agents (e.g., immunotherapy) remains mandatory.

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Progression-Free Survival and Overall Survival Beyond 5 Years of NSCLC Patients With Synchronous Oligometastases Treated in a Prospective Phase II Trial (NCT 01282450)

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