Study: The use of curcumin with gemcitabine in patients with advanced pancreatic cancer

In dieser Studie geht es um die Untersuchung der Sicherheit und Verträglichkeit von hohen Dosen von Curcumin bei Patienten mit Gemcitabin-resistentem Bauchspeicheldrüsenkrebs. Es handelt sich um eine Phase-I/II-Studie, bei der 21 Patienten mit fortgeschrittenem Bauchspeicheldrüsenkrebs eingeschlossen wurden. Der primäre Endpunkt der Phase-I-Studie war die Sicherheit von oralem Curcumin, während der primäre Endpunkt der Phase-II-Studie die Abschlussrate der Behandlung mit oralem Curcumin war. Sekundäre Endpunkte waren die Ansprechrate, das Gesamtüberleben und die Compliance. Die Studie zeigte, dass Curcumin-Dosen von 8 Gramm pro Tag gut vertragen wurden und keine dosislimitierenden Toxizitäten auftraten. Es wurden positive Ergebnisse hinsichtlich der Verträglichkeit und des Überlebens …
This study deals with the examination of the security and tolerance of high doses of curcumin in patients with gemcitabine-resistant abdominal gland cancer. It is a phase I/II study in which 21 patients with advanced pancreatic cancer were enclosed. The primary endpoint of the phase I study was the security of oral curcumin, while the primary end point of the phase II study was the final rate of treatment with oral curcumin. Secondary endpoints were the response rate, the overall survival and the compliance. The study showed that curcumin doses of 8 grams per day were well tolerated and no dose-limiting toxicities occurred. Positive results regarding the tolerance and survival ... (Symbolbild/natur.wiki)

Study: The use of curcumin with gemcitabine in patients with advanced pancreatic cancer

This study deals with the examination of the security and tolerance of high doses of curcumin in patients with gemcitabine-resistant abdominal gland cancer. It is a phase I/II study in which 21 patients with advanced pancreatic cancer were enclosed. The primary endpoint of the phase I study was the security of oral curcumin, while the primary end point of the phase II study was the final rate of treatment with oral curcumin. Secondary endpoints were the response rate, the overall survival and the compliance. The study showed that curcumin doses of 8 grams per day were well tolerated and no dose-limiting toxicities occurred. Positive results regarding the tolerance and survival were determined, which could indicate a synergistic effect of curcumin and gemcitabine. However, further research on the use of curcumin in integrative oncology is required.

Reference

Kanai M, Yoshimura K, Asada M, et al. A phase I/II study on Gemcitabina-based chemotherapy plus curcumin in patients with gemcitabine-resistant abdominal gland cancer. cancer chemother pharmacol . September 22, 2010. [Epub Ahead of Print]

Design

phase I/II security and feasibility study by oral curcumin

endpoints

The primary end point of the phase I study was the safety of 8 grams of oral curcumin. The primary end point of the phase II study was the final rate of treatment with oral curcumin. Secondary endpoints for phase II were response rate, overall survival (OS) and compliance.

participant

21 patients with advanced pancreatic cancer, whose disease progress.

most important knowledge

In the phase I study with 8.0 grams of curcumin every day In 3 patients, no dose-limiting toxicities were observed. None of the 21 study participants broke the study due to an intolerance to curcumin. Plasma curcumin was tested in 5 patients and was between 29 and 91 ng/ml, with the exception of a patient with a value of 412 ng/ml. The compliance was very good: 19 (90 %) participants were able to consume more than 90 % of the prescribed daily dose. Seventeen (81 %) participants died during the study period and three were still alive at the time of publication. The middle overall survival (OS) was 161 days (95 %-KI: 109–223 days). The one-year survival rate was 19 %.

effects on practice

The cancer -inhibiting effect of curcumin in high doses is well occupied. Most of its cancer effect is based on its ability to reduce the activation of NF-KB, which leads to its anti-proliferative, anti-angiogenic, anti-invasive and proapopototic effects on cancer cells. In addition, there are in-vitro demonstrations of its effect as a synergist active ingredient with several chemotherapy, including 5-fluorouracil, vinorelbin and gemcitabine. to find integrative oncology.

This small study showed that high curcumin doses of patients with advanced pancreatic cancer are well tolerated despite the possible impairments of digestion.

This small study showed that high curcumin doses of patients with advanced pancreatic cancer are well tolerated despite the possible impairments of digestion. Although it is assumed that the consumption of curcumin would optimize absorption together with fat, this is not disclosed anywhere in the publication. The patient was given the opportunity to split the dose through the day to increase the tolerance, which, in the view of the authors, could have led to better tolerance than in previous studies.

While this study has been proven with this study, what about the patient results? There are good reasons to speculate that the combination of curcumin and gemcitabine had a synergistic cytotoxic effect. Kunnamakkara et al. showed in vitro and in a mouse model of pancreatic cancer that the combination of curcumin with gemcitabine after treatment led to a lower tumor volume as a gemcitabine alone. 3 A recent study confirmed this and showed that curcumin and gemcitabine are synergistically in the tumor editing of bladder cancer worked. 4

The average survival time for patients whose disease has progressed under gemcitabine and who only receive supporting treatment is about 10 weeks. 5 In this study, the middle survival time was 23 weeks. However, it should be noted that the secondary endpoints may have been influenced by the S-1 comedy. Of the 21 participants participating in the study, 19 S-1, an oral fluorine pyrimidine, received a possible benefit in patients with advanced pancreatic cancer. 6.7 This certainly contradicts the conclusions that we can draw from the application of curcumin and gemcitabine.

The use of curcumin with gemcitabine in patients with advanced pancreatic cancer requires further research, since both in-vitro and in vivo data indicate synergistic cytotoxic effects. Until the final research results are published, we should definitely consider the use of curcumin in patients who take gemcitabine, as there is no evidence that this affects the treatment. However, keep in mind that the dose should be high to reproduce research.

For further research on integrative oncology, click here here.