Atsuko Ishida

Intrapleural cisplatin and OK432 therapy for malignant pleural effusion caused by non-small cell lung cancer

Objective:u2003 To evaluate the efficacy of combined intrapleural therapy with cisplatin, an antineoplastic agent, and OK432, a sclerosing agent, in controlling malignant pleural effusions, when compared with monotherapy with either agent.

Novel approach for talc pleurodesis by dedicated catheter through flexi-rigid thoracoscope under local anesthesia

For pleurodesis, talc administered by poudrage is usually insufflated blindly from a single port of entry using the standard method with a small-diameter rigid thoracoscope. In order to visually perform talc poudrage from a single port, we introduced a catheter technique through a flexi-rigid thoracoscope. Patients with uncontrolled and symptomatic pleural effusion requiring pleurodesis underwent flexi-rigid thoracoscopy under local anesthesia for talc poudrage. A dedicated catheter with 2.1-mm inner diameter was connected to a talc atomizer and inserted through the working channel of the flexi-rigid thoracoscope to insufflate talc into the pleural cavity under visualization. Nine patients were included in this study. Three patients were >75 years old, and two were Karnofsky performance status 50. Three patients received propofol for sedation and six were not sedated. Mean operative time was 30.8 min for all patients, and 21.3 min for cases without sedation. All procedures were performed easily under clear visualization with no major complications or catheter obstructions. This novel approach for talc pleurodesis using a catheter was well-tolerated and seems feasible for patients with uncontrolled pleural effusion. We consider this technique useful even for difficult cases, such as elderly patients or those with relatively low performance status.

Intractable pneumothorax managed by talc pleurodesis and bronchial occlusion with spigots.

Three cases of inoperable secondary spontaneous pneumothorax were diagnosed in patients with chronic obstructive pulmonary disease. Two cases initially underwent bronchial occlusion with endobronchial Watanabe spigot (EWS), while one underwent talc poudrage with pleuroscopy. As air leaks were not stopped completely in all cases with the initial procedures, we performed additional interventional treatments: pleuroscopic talc poudrage in cases when bronchial occlusion was performed first; and bronchial occlusion with EWS for a case that initially underwent talc pleurodesis. The air leaks ceased in all cases without complication. We successfully removed chest tubes 2–10 days after secondary procedure, which was 10–23 days after the first procedure. The combination of talc pleurodesis and bronchial occlusion with EWS, when a single, initial interventional treatment fails, can be considered in cases of intractable, inoperable secondary pneumothorax.

The Efficacy and Safety of Sterile Graded Talc in Pleurodesis for MalignantPleural Effusion: Phase II Study

Objective: Introduction of NPC-05 (sterile graded talc) into Japanese clinical practice is expected to lead to persistent prevention of re-accumulation of MPE and alleviation of concomitant symptoms in patients, including dyspnea and chest pain. We conduct an investigator-initiated trial in Japan to clarify the efficacy and safety of NPC-05 for use as a pleurodesis agent. Methods: This study is a multicenter uncontrolled open-label phase II study. An uncontrolled open-label joint clinical study is conducted in 6 institutes, involving 30 patients with MPE. Conclusion: Sterile graded talc has been described as the most useful pleurodesis drug for treating malignant pleural effusion in many guidelines and meta-analyses; thus, it is used as a standard pleurodesis agent in Western countries. However, its efficacy and safety have not been examined in Japan. This study assessed the efficacy and safety of NC-05, sterile graded talc, in 30 Japanese patients with malignant pleural effusion.

Sterilized talc pleurodesis for malignant pleural effusions: a Phase II study for investigational new drug application in Japan

BackgroundnMalignant pleural effusion is a commonly seen complication of malignancies such as lung and breast cancers. In Western countries, talc is frequently used as a standard therapeutic agent (pleurodesis agent) with the aim of alleviating symptoms including dyspnea and chest pain. Talc is not recognized as a pleurodesis agent in Japan. The aim of this study was to verify the efficacy and safety of sterilized talc (NPC-05) for the introduction of talc in Japan.nnnMethodsnThe study was a single-arm, open-label, investigator-initiated trial conducted jointly at six institutions. The subjects were 30 patients with malignant pleural effusions. A solution of 4 g NPC-05 suspended in 50 ml physiological saline was instilled into the pleural space to perform pleurodesis.nnnResultsnThe efficacy of NPC-05 for pleural adhesion 30 days after pleurodesis was 83.3% (25/30 cases). Amelioration of dyspnea and pain (chest pain) was seen. Commonly seen adverse effects were increased C-reactive protein (CRP) and fever. Nearly all adverse events were phenomena previously reported as adverse effects of talc. No acute respiratory distress syndrome (ARDS) or other serious side effects occurred.nnnConclusionnThe efficacy and safety of NPC-05 for malignant pleural effusion in Japanese patients was verified, and the clinical outcomes with talc were confirmed to be the same as previously reported in other countries. There is thought to be a high level of need for this agent in the treatment of malignant pleural effusion in Japan.

Flexi-Rigid Thoracoscopy

In routine clinical practice, pulmonologists are frequently required to evaluate patients with pleural effusions. For diagnosis, conventional methods such as thoracentesis and closed pleural biopsy are often performed first. However, approximately 20–25 % of pleural effusions remain undiagnosed (Boutin et al. 1993; Loddenkemper 1998) and medical thoracoscopy should then be performed.