Subcutaneous octreotide therapy for malignant pleural effusion after pleurodesis with talc powder: a placebo-controlled, triple-blind, randomized trial.

PURPOSE

In many cases, pleurodesis is the only treatment available for the treatment of malignant pleural effusion (MPE), and in the case of excessive daily pleural effusion, its therapeutic effect may be reduced. In this study, we intended to investigate the therapeutic effects and safety of octreotide in patients with MPE undergoing pleurodesis with talc powder.

METHODS

This study was a single-center, placebo-controlled, and triple-blind, randomized trial designed to investigate the therapeutic effects and safety of octreotide in patients with MPE in Tehran, Iran, from March 2020 to March 2021. Patients with MPE were randomly divided into two parallel groups, one receiving subcutaneous octreotide (3 doses of 50 µg/day) and the other receiving placebo before and after pleurodesis with talc powder. The patients were followed up with a chest X-ray 1 week, 1 month, and 3 months later. The primary outcome measures of this study were the amount of discharge from the chest tube before and after pleurodesis and the length of hospital stay. Treatment failure, relapse, pleural effusion analysis, and side effects were considered the secondary outcome measures of the study.

RESULTS

A total of 46 patients (23 in the octreotide group and 23 in the placebo group) with MPE was included in this study. Our findings demonstrated that adjunctive treatment with subcutaneous octreotide increases the efficacy of pleurodesis with talc powder. We showed that compared to the placebo group, patients in the octreotide group have significantly decreased production of pleural effusion both before (p = 0.009) and after (p = 0.002) pleurodesis. Octreotide treatment led to a decreased hospital stay (p = 0.004 before pleurodesis and p = 0.001 after pleurodesis) and reduced treatment failure (p = 0.022). However, octreotide did not decrease the relapse at 1-week, 1-month, and 3-month follow-ups. Moreover, octreotide did not affect pleural effusion parameters compared to placebo. Ultimately, our results also showed that treatment with octreotide was safe and did not have significant side effects.

CONCLUSION

Our findings demonstrated that adjunctive treatment with subcutaneous octreotide increases the efficacy of pleurodesis with talc powder without any significant side effects. Future studies with a larger sample size and longer follow-up time can confirm the results of this study and also determine the appropriate dose of octreotide for the treatment of MPE.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials, IRCT20210915052492N1. Registered 11 October 2021 - Retrospectively registered, https://www.irct.ir/trial/58776 .