JCO global oncology · 2026
Carica Papaya Leaf Extract to Improve Chemotherapy-Induced Thrombocytopenia: A Phase III Triple-Blinded, Randomized, Placebo-Controlled, Multicentric Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод пока не подготовлен
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Ostwal Vikas, Parulekar Manali, Naughane Deepali, Ramaswamy Anant, Garkal Tejashree, John George, Mandavkar Sarika, Bhargava Prabhat, Gupta Anuj, Kapoor Akhil, Joshi Pradnya, Shetty Omshree, Srinivas Sujay, Kannan Sadhana, Chaugule Deepali, Jadhav Poonam, Joshi Amit, Ghosh Jaya, Noronha Vanita, Menon Nandini, Prabhash Kumar, Khandare Mahesh, More Sucheta, Gaud Supriya, Banavali Shripad, Gupta Sudeep
Аннотация
PURPOSE: Carica papaya leaf extract (CPLE) is known to increase platelet counts (PCs) in certain infections.
METHODS: Patients were randomly assigned in a 2:1 ratio to the CPLE or placebo arm and continued treatment until the PC improved to 75,000 × 109/L or above, a platelet transfusion was required, or upto D+10. The primary outcome was to evaluate whether CPLE improves PC faster compared with placebo in a significant proportion of patients with a modified intention-to-treat protocol.
RESULTS: Between March 2020 and October 2024, 219 patients were randomly assigned, of whom 198 patients (CPLE arm: 129; placebo arm: 69) were analyzed for outcomes. The primary end point with modified intention-to-treat analysis showed a statistically significant increase in PC to ≥75,000 × 109/L in a greater proportion of patients by D+4 compared with placebo (59% v 44%; P = .042). The primary outcome of increasing PC >75,000 × 109/L at D+4 was significantly improved by CPLE (83/129, 64% v 33/69, 48%; P = .034) compared with placebo as per protocol analysis. There was no grade 3 or grade 4 treatment-related adverse events associated with CPLE. About 43% of patients in the placebo arm versus 25% of patients in the CPLE arm needed dose reductions or delays in their subsequent chemotherapy treatment for patients with grade 2 chemotherapy-induced thrombocytopenia (CIT) at the baseline (P 0.033) and not significant in grade 3 CIT.
CONCLUSION: CPLE is a potential therapeutic intervention to improve CIT faster and to a greater extent than placebo in this phase III randomized trial without any safety concerns. It could be potentially used as a secondary prophylaxis to maintain the chemotherapy intensity.
METHODS: Patients were randomly assigned in a 2:1 ratio to the CPLE or placebo arm and continued treatment until the PC improved to 75,000 × 109/L or above, a platelet transfusion was required, or upto D+10. The primary outcome was to evaluate whether CPLE improves PC faster compared with placebo in a significant proportion of patients with a modified intention-to-treat protocol.
RESULTS: Between March 2020 and October 2024, 219 patients were randomly assigned, of whom 198 patients (CPLE arm: 129; placebo arm: 69) were analyzed for outcomes. The primary end point with modified intention-to-treat analysis showed a statistically significant increase in PC to ≥75,000 × 109/L in a greater proportion of patients by D+4 compared with placebo (59% v 44%; P = .042). The primary outcome of increasing PC >75,000 × 109/L at D+4 was significantly improved by CPLE (83/129, 64% v 33/69, 48%; P = .034) compared with placebo as per protocol analysis. There was no grade 3 or grade 4 treatment-related adverse events associated with CPLE. About 43% of patients in the placebo arm versus 25% of patients in the CPLE arm needed dose reductions or delays in their subsequent chemotherapy treatment for patients with grade 2 chemotherapy-induced thrombocytopenia (CIT) at the baseline (P 0.033) and not significant in grade 3 CIT.
CONCLUSION: CPLE is a potential therapeutic intervention to improve CIT faster and to a greater extent than placebo in this phase III randomized trial without any safety concerns. It could be potentially used as a secondary prophylaxis to maintain the chemotherapy intensity.