Clinical usefulness of cell-free and concentrated ascites reinfusion therapy (CART) in combination with chemotherapy for malignant ascites: a post-marketing surveillance study

Ishitani, Ken; Isoai, Ayako; Ito, Tetsuya; Sugiyama, Hiroshi; Arakawa, Atsushi; Yamada, Yosuke; Onodera, Hirokazu; Kobayashi, Ryosuke; Torii, Naoko; Soneda, Noriko; Matsuno, Yoshihiro; Utsugisawa, Taiju; Kato, Masaaki; Hanafusa, Norio

doi:10.1007/s10147-021-01883-2

Cited by 5 publications

(2 citation statements)

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“…As a larger volume of drainage may be associated with a longer paracentesis interval, we may need to standardize or specify the drainage volume in both arms to compare the efficacy of treatments in a future study. Third, further studies are needed to evaluate the efficacy and safety of CART in combination with chemotherapy, while this study included patients who received no further anticancer treatments to eliminate their effect on the outcomes [ 29 , 30 ]. Fourth, as we measured ESAS:AM every other day, findings of ESAS:AM might lack reliability.…”

Section: Discussionmentioning

confidence: 99%

Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites

et al. 2022

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Background Malignant ascites often causes discomfort in advanced cancer patients. Paracentesis is the most common treatment modality, but it requires frequently repeated treatment. Cell-free and concentrated ascites reinfusion therapy (CART) may prolong the paracentesis interval, but controlled trials are lacking. We assessed the feasibility of a randomized controlled trial of CART vs. paracentesis alone for patients with refractory malignant ascites. Methods This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients admitted to four designated cancer hospitals who received no further anticancer treatments were eligible. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Secondary endpoints included paracentesis-free survival, patient’s request on the questionnaire for paracentesis (PRO-paracentesis)-free survival (the period until the patients first reported that they would want paracentesis if indicated), and adverse events. Results We screened 953 patients for eligibility. Of 61 patients with refractory malignant ascites, 21 patients were determined as eligible. Finally, 20 patients consented and were allocated; 18 patients (90%, 95% CI: 68.3–98.8) completed the study intervention. All patients had an ECOG performance status of 3 or 4. The median drained ascites volume was 3,200 mL in the CART arm and 2,500 mL in the control arm. In the CART arm, the median reinfused albumin volume was 12.6 g. Median paracentesis-free survivals were 5 days (95% CI: 2–6) in the CART arm, and 6 days (3–9) in the control arm. Median PRO-paracentesis-free survivals were 4 days (2–5) and 5 days (1–9), respectively. A total of 73% of patients received paracentesis within 2 days from their first request for the next paracentesis. One patient in the CART arm developed Grade 1 fever. Conclusions A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible. The efficacy and safety of CART should be assessed in future trials. PRO-paracentesis-free survival may be a complementary outcome measure with paracentesis-free survival in future trials. Trial registration Registered at University Hospital Medical Information Network Clinical Trial Registry as UMIN000031029. Registered on 28/01/2018.

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Section: Discussionmentioning

confidence: 99%

Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites

et al. 2022

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“…In total, 17% of patients showed increased ECOG PS after CART, and continued chemotherapies were frequently conducted in these patients. The combination of CART and antineoplastic agents was proven to be as safe as CART alone in cases of MRA [ 36 ]. CART may contribute to improved survival in patients with advanced gynecological and gastrointestinal cancers [ 26 , 29 ].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of Cell-Free and Concentrated Ascites Reinfusion Therapy in the Treatment of Malignancy-Related Ascites: A Systematic Review and Meta-Analysis

Hao

Ishihara

Horita

et al. 2021

Cancers

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Background: Malignancy-related ascites (MRA) is one of the symptoms causing discomfort in advanced cancer patients. Cell-free and concentrated ascites reinfusion therapy (CART) is one of the palliative treatments widely conducted in Japan only. Methods: A systematic review following a meta-analysis of CART was performed. The efficiency and adverse events were evaluated. Results: A total of 2567 patients and 6013 procedures of CART were identified in this study. The mean volume of MRA collected was 4.29 (95% confidence interval (CI) 3.47–5.11) L, and the volume reinfused after concentrating was 0.49 (95% CI 0.39–0.60) L. A total of 86.1 (95% CI 77.1–95.2) g protein and 42.9 (95% CI 36.0–50.0) g albumin was reinfused. The mean time to the next paracentesis was 20.7 (95% CI 15.6–25.8) days. The body weight was reduced by 3.38 (95% CI 1.90–4.86; p < 0.01) kg, and abdominal circumference was reduced by 7.86 (95% CI 6.58–9.14; p < 0.001) cm. Serum albumin increased an average of 0.14 (95% CI −0.01–0.28; p = 0.07) mg/dL the day after CART. Abdominal distension, dyspnea, and fatigue were alleviated by 6.0 (95% CI 5.59–6.51), 2.66 (95% CI 2.05–3.28), and 2.64 (95% CI 1.86–3.42) points using a numerical rating scale system ranging from 0 to 10. Overall, 17% (95% CI 0.03–0.31%) of patients had improved performance status after CART. Significant body temperature elevation was observed, at an average of 0.4 °C (95% CI 0.18–0.62 °C). Conclusions: CART might be a safe and effective palliative therapy in MRA and further clinical trials are necessary.

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Advances in the treatment of malignant ascites in China

Zhang,

Qi,

et al. 2024

Support Care Cancer

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Clinical usefulness of cell-free and concentrated ascites reinfusion therapy (CART) in combination with chemotherapy for malignant ascites: a post-marketing surveillance study

Cited by 5 publications

References 20 publications

Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites

Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites

Effectiveness of Cell-Free and Concentrated Ascites Reinfusion Therapy in the Treatment of Malignancy-Related Ascites: A Systematic Review and Meta-Analysis

Advances in the treatment of malignant ascites in China

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