A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14)

R C Boshuizen, V Vd Noort, J A Burgers, G J M Herder, S M S Hashemi, T J N Hiltermann, P W Kunst, J A Stigt, M M van den Heuvel

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BACKGROUND: Symptomatic malignant pleural effusion (MPE) occurs frequently in patients with metastatic cancer. The associated prognosis is poor and the success rate of talc pleurodesis (TP) is low. Indwelling pleural catheters (IPCs) are commonly inserted when TP has been unsuccessful.

METHODS: We compared talc pleurodesis with the use of an indwelling pleural catheter in patients with recurrent MPE in a multicenter randomized controlled trial (superiority design). The primary endpoint was improvement from baseline in Modified Borg Score (MBS) 6weeks after randomized treatment. Secondary endpoints were hospitalization days, re-interventions, and adverse events.

RESULTS: Dyspnea improved significantly (p<0.01) after either treatment, but the magnitude of this improvement did not differ significantly between arms (median 3 and 1 for TP:IPC respectively in rest, p=0.16, (TP 13:IPC 16) and 3 and 1 during exercise, p=0.72 (TP 13:IPC 17)). There was no difference in dyspnea during exercise between TP and IPC at week 6 following treatment, while at rest TP patients (n=13) reported less dyspnea than IPC patients (n=18) (median 0 vs 1, p=0.002). Compared to TP, patients with an IPC had significantly less hospital days during randomized treatment (median: 0 vs 5, p<0.0001), and total hospitalizations for all causes (median: 1.6 vs 1.0, p=0.0035). Fewer IPC patients underwent more than one re-intervention (7/45 vs 15/43, p=0.09). The mean number of re-interventions was lower following IPC (0.21 vs 0.53, p=0.05). Equal number of adverse events occurred.

CONCLUSIONS: IPC was not superior in the primary endpoint, improvement of the modified Borg scale (MBS). However, IPC patients had lower hospital stay, fewer admissions and fewer re-interventions. The IPC is an effective treatment modality in patients with symptomatic malignant pleural effusion.

Original languageEnglish
Pages (from-to)9-14
Number of pages6
JournalLung Cancer
Volume108
DOIs
Publication statusPublished - Jun 2017

Cite this

Boshuizen, R. C., Vd Noort, V., Burgers, J. A., Herder, G. J. M., Hashemi, S. M. S., Hiltermann, T. J. N., ... van den Heuvel, M. M. (2017). A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14). Lung Cancer, 108, 9-14. https://doi.org/10.1016/j.lungcan.2017.01.019
Boshuizen, R C ; Vd Noort, V ; Burgers, J A ; Herder, G J M ; Hashemi, S M S ; Hiltermann, T J N ; Kunst, P W ; Stigt, J A ; van den Heuvel, M M. / A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14). In: Lung Cancer. 2017 ; Vol. 108. pp. 9-14.
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title = "A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14)",
abstract = "BACKGROUND: Symptomatic malignant pleural effusion (MPE) occurs frequently in patients with metastatic cancer. The associated prognosis is poor and the success rate of talc pleurodesis (TP) is low. Indwelling pleural catheters (IPCs) are commonly inserted when TP has been unsuccessful.METHODS: We compared talc pleurodesis with the use of an indwelling pleural catheter in patients with recurrent MPE in a multicenter randomized controlled trial (superiority design). The primary endpoint was improvement from baseline in Modified Borg Score (MBS) 6weeks after randomized treatment. Secondary endpoints were hospitalization days, re-interventions, and adverse events.RESULTS: Dyspnea improved significantly (p<0.01) after either treatment, but the magnitude of this improvement did not differ significantly between arms (median 3 and 1 for TP:IPC respectively in rest, p=0.16, (TP 13:IPC 16) and 3 and 1 during exercise, p=0.72 (TP 13:IPC 17)). There was no difference in dyspnea during exercise between TP and IPC at week 6 following treatment, while at rest TP patients (n=13) reported less dyspnea than IPC patients (n=18) (median 0 vs 1, p=0.002). Compared to TP, patients with an IPC had significantly less hospital days during randomized treatment (median: 0 vs 5, p<0.0001), and total hospitalizations for all causes (median: 1.6 vs 1.0, p=0.0035). Fewer IPC patients underwent more than one re-intervention (7/45 vs 15/43, p=0.09). The mean number of re-interventions was lower following IPC (0.21 vs 0.53, p=0.05). Equal number of adverse events occurred.CONCLUSIONS: IPC was not superior in the primary endpoint, improvement of the modified Borg scale (MBS). However, IPC patients had lower hospital stay, fewer admissions and fewer re-interventions. The IPC is an effective treatment modality in patients with symptomatic malignant pleural effusion.",
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Boshuizen, RC, Vd Noort, V, Burgers, JA, Herder, GJM, Hashemi, SMS, Hiltermann, TJN, Kunst, PW, Stigt, JA & van den Heuvel, MM 2017, 'A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14)' Lung Cancer, vol. 108, pp. 9-14. https://doi.org/10.1016/j.lungcan.2017.01.019

A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14). / Boshuizen, R C; Vd Noort, V; Burgers, J A; Herder, G J M; Hashemi, S M S; Hiltermann, T J N; Kunst, P W; Stigt, J A; van den Heuvel, M M.

In: Lung Cancer, Vol. 108, 06.2017, p. 9-14.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - A randomized controlled trial comparing indwelling pleural catheters with talc pleurodesis (NVALT-14)

AU - Boshuizen, R C

AU - Vd Noort, V

AU - Burgers, J A

AU - Herder, G J M

AU - Hashemi, S M S

AU - Hiltermann, T J N

AU - Kunst, P W

AU - Stigt, J A

AU - van den Heuvel, M M

N1 - Copyright © 2017 Elsevier B.V. All rights reserved.

PY - 2017/6

Y1 - 2017/6

N2 - BACKGROUND: Symptomatic malignant pleural effusion (MPE) occurs frequently in patients with metastatic cancer. The associated prognosis is poor and the success rate of talc pleurodesis (TP) is low. Indwelling pleural catheters (IPCs) are commonly inserted when TP has been unsuccessful.METHODS: We compared talc pleurodesis with the use of an indwelling pleural catheter in patients with recurrent MPE in a multicenter randomized controlled trial (superiority design). The primary endpoint was improvement from baseline in Modified Borg Score (MBS) 6weeks after randomized treatment. Secondary endpoints were hospitalization days, re-interventions, and adverse events.RESULTS: Dyspnea improved significantly (p<0.01) after either treatment, but the magnitude of this improvement did not differ significantly between arms (median 3 and 1 for TP:IPC respectively in rest, p=0.16, (TP 13:IPC 16) and 3 and 1 during exercise, p=0.72 (TP 13:IPC 17)). There was no difference in dyspnea during exercise between TP and IPC at week 6 following treatment, while at rest TP patients (n=13) reported less dyspnea than IPC patients (n=18) (median 0 vs 1, p=0.002). Compared to TP, patients with an IPC had significantly less hospital days during randomized treatment (median: 0 vs 5, p<0.0001), and total hospitalizations for all causes (median: 1.6 vs 1.0, p=0.0035). Fewer IPC patients underwent more than one re-intervention (7/45 vs 15/43, p=0.09). The mean number of re-interventions was lower following IPC (0.21 vs 0.53, p=0.05). Equal number of adverse events occurred.CONCLUSIONS: IPC was not superior in the primary endpoint, improvement of the modified Borg scale (MBS). However, IPC patients had lower hospital stay, fewer admissions and fewer re-interventions. The IPC is an effective treatment modality in patients with symptomatic malignant pleural effusion.

AB - BACKGROUND: Symptomatic malignant pleural effusion (MPE) occurs frequently in patients with metastatic cancer. The associated prognosis is poor and the success rate of talc pleurodesis (TP) is low. Indwelling pleural catheters (IPCs) are commonly inserted when TP has been unsuccessful.METHODS: We compared talc pleurodesis with the use of an indwelling pleural catheter in patients with recurrent MPE in a multicenter randomized controlled trial (superiority design). The primary endpoint was improvement from baseline in Modified Borg Score (MBS) 6weeks after randomized treatment. Secondary endpoints were hospitalization days, re-interventions, and adverse events.RESULTS: Dyspnea improved significantly (p<0.01) after either treatment, but the magnitude of this improvement did not differ significantly between arms (median 3 and 1 for TP:IPC respectively in rest, p=0.16, (TP 13:IPC 16) and 3 and 1 during exercise, p=0.72 (TP 13:IPC 17)). There was no difference in dyspnea during exercise between TP and IPC at week 6 following treatment, while at rest TP patients (n=13) reported less dyspnea than IPC patients (n=18) (median 0 vs 1, p=0.002). Compared to TP, patients with an IPC had significantly less hospital days during randomized treatment (median: 0 vs 5, p<0.0001), and total hospitalizations for all causes (median: 1.6 vs 1.0, p=0.0035). Fewer IPC patients underwent more than one re-intervention (7/45 vs 15/43, p=0.09). The mean number of re-interventions was lower following IPC (0.21 vs 0.53, p=0.05). Equal number of adverse events occurred.CONCLUSIONS: IPC was not superior in the primary endpoint, improvement of the modified Borg scale (MBS). However, IPC patients had lower hospital stay, fewer admissions and fewer re-interventions. The IPC is an effective treatment modality in patients with symptomatic malignant pleural effusion.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Catheters, Indwelling

KW - Female

KW - Humans

KW - Kaplan-Meier Estimate

KW - Lung Neoplasms/diagnosis

KW - Male

KW - Middle Aged

KW - Pleural Effusion, Malignant/diagnosis

KW - Pleurodesis/adverse effects

KW - Talc/therapeutic use

KW - Treatment Outcome

U2 - 10.1016/j.lungcan.2017.01.019

DO - 10.1016/j.lungcan.2017.01.019

M3 - Article

VL - 108

SP - 9

EP - 14

JO - Lung Cancer

JF - Lung Cancer

SN - 0169-5002

ER -