R C Boshuizen1, V Vd Noort2, J A Burgers3, G J M Herder4, S M S Hashemi5, T J N Hiltermann6, P W Kunst7, J A Stigt8, M M van den Heuvel9. 1. Dep. of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands; Dep. of Respiratory Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. Electronic address: r.c.boshuizen@olvg.nl. 2. Biometrics Dep., The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: v.vd.noort@nki.nl. 3. Dep. of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: s.burgers@nki.nl. 4. Dep. of Pulmonary Diseases, St. Antonius Hospital Nieuwegein, The Netherlands. Electronic address: j.herder@antoniusziekenhuis.nl. 5. Dep. of Pulmonary Diseases, VU University Medical Center, Amsterdam, The Netherlands. Electronic address: s.hashemi@vumc.nl. 6. Dep. of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: t.j.n.hiltermann@umcg.nl. 7. Dep. of Respiratory Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands; Dep. of Respiratory Medicine, Academic Medical Center, Amsterdam, The Netherlands. Electronic address: p.w.a.kunst@olvg.nl. 8. Dep. of Pulmonolgy, Isala Klinieken, Zwolle, The Netherlands. Electronic address: j.a.stigt@isala.nl. 9. Dep. of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address: m.vd.heuvel@nki.nl.
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.
RCT Entities:
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 IPCpatients (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.
Authors: Ricardo Mingarini Terra; Priscila Berenice da Costa; Alberto Jorge Monteiro Dela Vega; Paulo Manuel Pêgo-Fernandes Journal: J Thorac Dis Date: 2020-07 Impact factor: 2.895
Authors: Lucía Ferreiro; Juan Suárez-Antelo; José Manuel Álvarez-Dobaño; María E Toubes; Vanessa Riveiro; Luis Valdés Journal: Can Respir J Date: 2020-09-23 Impact factor: 2.409