Phase III trial comparing UFT + PSK to UFT + LV in stage IIB, III colorectal cancer (MCSGO-CCTG)

Miyake, Yoshihiro; Nishimura, Junichi; Kato, Takeshi; Ikeda, Masataka; Tomita, Masaki; Hata, Taishi; Takemasa, Ichiro; Mizushima, Tsunekazu; Yamamoto, Hirofumi; Sekimoto, Mitsugu; Nezu, Riichiro; Doki, Yuichiro; Mori, Masaki

doi:10.1007/s00595-017-1555-1

“…Table 1 presents the characteristics of the 23 included trials (Niimoto et al, 1988; Go and Chung, 1989; Torisu et al, 1990; Toi et al, 1992; Nakazato et al, 1994; Ogoshi et al, 1995; Morimoto et al, 1996; Shi et al, 1996; Mo et al, 1999; Liang et al, 2002; Tsang et al, 2003; Xu et al, 2003; Jing et al, 2007; Liu et al, 2008; Xu et al, 2008; Zhang et al, 2010; Liu, 2011; Zhao et al, 2012; Hu and GAN, 2013; Zhao et al, 2015; Chay et al, 2017; Miyake et al, 2018; Okuno et al, 2018). All the trials used C. versicolor related natural products (n = 14) (Niimoto et al, 1988; Go and Chung, 1989; Torisu et al, 1990; Toi et al, 1992; Nakazato et al, 1994; Ogoshi et al, 1995; Morimoto et al, 1996; Shi et al, 1996; Tsang et al, 2003; Xu et al, 2003; Xu et al, 2008; Chay et al, 2017; Miyake et al, 2018; Okuno et al, 2018) or G. lucidum related natural products (n = 9) (Mo et al, 1999; Liang et al, 2002; Jing et al, 2007; Liu et al, 2008; Zhang et al, 2010; Liu, 2011; Zhao et al, 2012; Hu and GAN, 2013; Zhao et al, 2015).…”

Section: Resultsmentioning

confidence: 99%

“…Table 1 presents the characteristics of the 23 included trials (Niimoto et al, 1988; Go and Chung, 1989; Torisu et al, 1990; Toi et al, 1992; Nakazato et al, 1994; Ogoshi et al, 1995; Morimoto et al, 1996; Shi et al, 1996; Mo et al, 1999; Liang et al, 2002; Tsang et al, 2003; Xu et al, 2003; Jing et al, 2007; Liu et al, 2008; Xu et al, 2008; Zhang et al, 2010; Liu, 2011; Zhao et al, 2012; Hu and GAN, 2013; Zhao et al, 2015; Chay et al, 2017; Miyake et al, 2018; Okuno et al, 2018). All the trials used C. versicolor related natural products (n = 14) (Niimoto et al, 1988; Go and Chung, 1989; Torisu et al, 1990; Toi et al, 1992; Nakazato et al, 1994; Ogoshi et al, 1995; Morimoto et al, 1996; Shi et al, 1996; Tsang et al, 2003; Xu et al, 2003; Xu et al, 2008; Chay et al, 2017; Miyake et al, 2018; Okuno et al, 2018) or G. lucidum related natural products (n = 9) (Mo et al, 1999; Liang et al, 2002; Jing et al, 2007; Liu et al, 2008; Zhang et al, 2010; Liu, 2011; Zhao et al, 2012; Hu and GAN, 2013; Zhao et al, 2015). The majority of trials were from China (Shi et al, 1996; Mo et al, 1999; Liang et al, 2002; Tsang et al, 2003; Xu et al, 2003; Jing et al, 2007; Liu et al, 2008; Xu et al, 2008; Zhang et al, 2010; Liu, 2011; Zhao et al, 2012; Hu and GAN, 2013; Zhao et al, 2015), whereas eight papers were from Japan (Niimoto et al, 1988; Torisu et al, 1990; Toi et al, 1992; Nakazato et al, 1994; Ogoshi et al, 1995; Morimoto et al, 1996; Miyake et al, 2018; Okuno et al, 2018), one paper was from in Taiwan (Go and Chung, 1989), and...…”

Section: Resultsmentioning

confidence: 99%

“…All the trials used C. versicolor related natural products (n = 14) (Niimoto et al, 1988; Go and Chung, 1989; Torisu et al, 1990; Toi et al, 1992; Nakazato et al, 1994; Ogoshi et al, 1995; Morimoto et al, 1996; Shi et al, 1996; Tsang et al, 2003; Xu et al, 2003; Xu et al, 2008; Chay et al, 2017; Miyake et al, 2018; Okuno et al, 2018) or G. lucidum related natural products (n = 9) (Mo et al, 1999; Liang et al, 2002; Jing et al, 2007; Liu et al, 2008; Zhang et al, 2010; Liu, 2011; Zhao et al, 2012; Hu and GAN, 2013; Zhao et al, 2015). The majority of trials were from China (Shi et al, 1996; Mo et al, 1999; Liang et al, 2002; Tsang et al, 2003; Xu et al, 2003; Jing et al, 2007; Liu et al, 2008; Xu et al, 2008; Zhang et al, 2010; Liu, 2011; Zhao et al, 2012; Hu and GAN, 2013; Zhao et al, 2015), whereas eight papers were from Japan (Niimoto et al, 1988; Torisu et al, 1990; Toi et al, 1992; Nakazato et al, 1994; Ogoshi et al, 1995; Morimoto et al, 1996; Miyake et al, 2018; Okuno et al, 2018), one paper was from in Taiwan (Go and Chung, 1989), and one from Singapore (Chay et al, 2017). Almost half of the 23 trials were published in Chinese (Shi et al, 1996; Mo et al, 1999; Liang et al, 2002; Xu et al, 2003; Jing et al, 2007; Liu et al, 2008; Xu et al, 2008; Zhang et al, 2010; Liu, 2011; Hu and GAN, 2013; Zhao et al, 2015), the others were published in English (Niimoto et al, 1988; Go and Chung, 1989; Torisu et al, 1990; Toi et al, 1992; Nakazato et al, 1994; Ogoshi et al, 1995; Morimoto et al, 1996; Tsang et al, 2003; Zhao et al, 2012; Chay et al, 2017; Miyake et al, 2018...…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Coriolus Versicolor and Ganoderma Lucidum Related Natural Products as an Adjunct Therapy for Cancers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Zhong

¹

,

Yan

²

,

Lam

³

et al. 2019

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Background: Cancer incidence and mortality rates keep rising globally. Coriolus versicolor and Ganoderma lucidum related natural products are commonly applied as a complementary therapeutic option for different stages and types of cancers. The aim of this study is to evaluate the efficacy and safety of the products for cancer therapy. Methods: Randomized controlled trials were identified by systematic search over seven databases from inceptions to May 10, 2019. Two independent reviewers extracted data and assessed the study quality. Meta-analyses were performed to pool hazard ratio ( HR ), risk ratio ( RR ), mean differences ( MD ), and 95% CI using random-effects models. The sources of heterogeneity were explored by subgroup analyses and sensitivity analyses. Publication bias was detected by Funnel plots, Begg’s test, and Egger’s test. Results: Twenty-three trials involving 4,246 cancer patients were included in this work. C. versicolor and G. lucidum related natural products were significantly associated with lower risks of mortality ( HR : 0.82; 95% CI : 0.72, 0.94) and higher total efficacy ( RR : 1.30; 95% CI : 1.09, 1.55), but not associated with control rate ( RR : 1.05; 95% CI : 0.96, 1.14) compared with control treatment. There was no significant difference between C. versicolor related natural products and control treatment in the effect on relapse-free survival ( HR : 1.19; 95% CI : 0.91, 1.55). Compared with control treatment, C. versicolor and G. lucidum related natural products had a favorable effect on elevated levels of CD3 ( MD : 9.03%; 95% CI : 2.10, 16.50) and CD4 ( MD : 9.2%; 95% CI : 1.01, 17.39), but had no effect on the levels of CD8 ( MD : −5.52%; 95% CI : −23.17, 12.13), CD4/CD8 ( MD : 0.73; 95% CI :-0.45, 1.91), or NK( MD : 5.87%; 95% CI : −1.06, 12.8). Conclusion: In this meta-analysis, we found that C. versicolor and G. lucidum related natural products might have potential benefits on the overall survival and quality of life in cancer patients.

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“…The improvement in the quality of life was mostly observed in lung cancer patients (8 of the 12 studies) [21,[52][53][54][55][56][57][58][59]. Among the included studies, only 5 of the 56 clinical studies on Yunzhi measured the quality of life of cancer patients after the co-administration of Yunzhi with various cytotoxic drugs (5-FU, cisplatin, carboplatin, capecitabine, cyclophosphamide, doxorubicin, etoposide, mitomycin, oxaliplatin, paclitaxel and UFT) and all of them showed improvement [48,49,[60][61][62].…”

Section: Effect On Survival and Quality Of Life A Clinical Evidencementioning

confidence: 99%

“…In clinical studies on Yunzhi, the use of PSK and PSP with cytotoxic drugs (5-FU, capecitabine, mitomycin, oxaliplatin, and UFT) ameliorated the general adverse effects, such as gastrointestinal discomfort (nausea and vomiting, diarrhea, and constipation) [48,61,136], mucositis [48], and fatigue [136]. Specific adverse effects of cytotoxic drugs, including peripheral neuropathy [143], mutations [172], and hand-foot syndrome [48], were also reduced.…”

Section: Alleviation Of the Other Adverse Effects Of Cytotoxic Drugs mentioning

confidence: 99%

Herb–drug interactions between the medicinal mushrooms Lingzhi and Yunzhi and cytotoxic anticancer drugs: a systematic review

Lam

¹

,

Cheng

²

,

Zhou

³

et al. 2020

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Background: Lingzhi and Yunzhi are medicinal mushrooms commonly used with cytotoxic chemotherapy in cancer patients in Asian countries. The current systematic review aims to identify potential pharmacokinetic or pharmacodynamic interactions from the existing literature to ensure their effective and safe combination usage in cancer patients. Methods: A systematic search was conducted on nine major Chinese and English databases, including China Journal Net, Allied and Complementary Medicine Database, and Ovid MEDLINE ® , etc., to identify clinical, animal, and in-vitro studies that evaluate the effect of combined use of Lingzhi or Yunzhi with cytotoxic drugs. The Jadad scale was used to assess the quality of clinical studies. Results: This search identified 213 studies, including 77 clinical studies that reported on the combined use of cytotoxic drugs with Yunzhi (n = 56) or Lingzhi (n = 21). Majority of these clinical studies demonstrated modest methodological quality. In clinical practice, the most commonly used cytotoxic drugs with Lingzhi were cisplatin, 5-fluorouracil (5-FU) and paclitaxel, whereas Tegafur/uracil (UFT)/Tegafur, 5-FU, and mitomycin were the ones used more often with Yunzhi. Only two clinical pharmacokinetic studies were available showing no significant interactions between Polysaccharide K (PSK) and Tegafur. From the pharmacodynamic interactions perspective, combination uses of Yunzhi/Lingzhi with cytotoxic drugs in clinical practice could lead to improvement in survival (n = 31) and quality of life (n = 17), reduction in tumor lesions (n = 22), immune modulation (n = 38), and alleviation of chemotherapy-related side effects (n = 14) with no reported adverse effects. Conclusion: Our findings suggest that the clinical combination use of Lingzhi or Yunzhi with cytotoxic drugs could enhance the efficacy and ameliorate the adverse effects of cytotoxic drugs, leading to improved quality of life in cancer patients. More high quality clinical studies including pharmacokinetic herb-drug interactions studies are warranted to verify these observations and mechanisms involved. Based on the high quality clinical data, pharmacoepidemiology methods and bioinformatics or data mining could be adopt for further identification of clinical meaningful herb-drug interactions in cancer therapies.

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Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results

Ito

¹

,

Hashimoto

²

,

Uemura

³

et al. 2021

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Key Points Question Is the interpretation and reporting of noninferiority trials with primary end point results that are not statistically significant correct, and what are the associated factors of misleading reporting? Findings This systematic review of 52 noninferiority randomized clinical trials of cancer treatments with results for primary end points that are not statistically significant, 75% included misleading reporting. Multivariable analysis found that the prevalence of misleading reporting was significantly lower in reports with funding from for-profit sources and higher in reports of novel experimental treatments. Meaning These findings suggest that authors should carefully consider noninferiority cancer clinical trial result interpretation and reporting, especially for primary outcome results that are not statistically significant.

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Phase III trial comparing UFT + PSK to UFT + LV in stage IIB, III colorectal cancer (MCSGO-CCTG)

Abstract: As adjuvant chemotherapy for stage IIB and III colorectal cancer patients, UFT/PSK adjuvant therapy was not non-inferior to UFT/LV therapy with respect to the DFS.

Cited by 16 publications

References 30 publications

Coriolus Versicolor and Ganoderma Lucidum Related Natural Products as an Adjunct Therapy for Cancers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Coriolus Versicolor and Ganoderma Lucidum Related Natural Products as an Adjunct Therapy for Cancers: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Herb–drug interactions between the medicinal mushrooms Lingzhi and Yunzhi and cytotoxic anticancer drugs: a systematic review

Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results

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