Phase I/II study of capecitabine and PHY906 in hepatocellular carcinoma

Yen, Yi‐Hao; So, Samuel; Rose, Michal G.; Saif, M. W.; Chu, Edward; Chen, L.; Liu, S.; Foo, Angeline; Tilton, Robert D.; Cheng, Yung Chi

doi:10.1200/jco.2008.26.15_suppl.4610

Cited by 44 publications

(58 citation statements)

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“…We unequivocally confirm the excellent safety profile of the DEB TACE-sorafenib combination. We already know that, when used independently, both DEB TACE and sorafenib therapy have an acceptable toxicity profile (11,12,25,26). DEB TACE may even be safer than conventional TACE (5,15,27,28); similarly, sorafenib therapy was shown to be generally well tolerated in two prospective randomized trials, although dose reductions were fairly common (11,12).…”

Section: Discussionmentioning

confidence: 99%

“…Sorafenib is a multitargeted tyrosine kinase inhibitor that predominantly inhibits tumor angiogenesis by way of vascular endothelial growth factor receptor 2 and platelet-derived growth factor receptor. Sorafenib provides a proved overall survival (OS) benefit in patients with advanced HCC and is a standard firstline systemic treatment option (11,12). The noninterventional global investigation of therapeutic decisions in hepatocellular carcinoma and its treatment with sorafenib, or GIDEON, reported that over one-half of patients who underwent sorafenib therapy previously underwent intraarterial therapy (13).…”

Section: Methodsmentioning

confidence: 99%

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Open-Label Single-Arm Phase II Trial of Sorafenib Therapy with Drug-eluting Bead Transarterial Chemoembolization in Patients with Unresectable Hepatocellular Carcinoma: Clinical Results

Cosgrove¹,

Reyes²,

Pawlik³

et al. 2015

Radiology

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).q RSNA, 2015 Purpose:To determine the efficacy of combined continuous sorafenib therapy and drug-eluting bead (DEB) transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC). Materials andMethods:This study was conducted in accordance with the principles of the Declaration of Helsinki, and all patients provided written informed consent prior to enrollment. Inclusion criteria included unresectable HCC, a treatment naïve status, an Eastern Cooperative Oncology Group score of 0-1, and a Child-Pugh score of A-B7. Continuous sorafenib therapy (400 mg twice daily) was started 1 week before the first round of DEB TACE, which was performed in 6-week cycles. Up to four rounds of DEB TACE therapy were allowed on demand within 6 months. The primary end point was safety. Secondary end points were time to progression (TTP), response rate, and overall survival (OS) and were stratified by the Barcelona Clinic Liver Cancer (BCLC) stage and the duration of sorafenib therapy. OS was assessed with Kaplan-Meier estimates, and the Mantel-Cox log-rank test was used to determine differences in survival. A two-sided P value of less than .05 was considered to indicate a significant difference. Results:Fifty patients-of whom 76% were male, 92% had a ChildPugh score of A, and 62% had BCLC stage C disease-underwent a median of three cycles of therapy. The 6-month disease control rate (defined as complete response plus partial response plus stable disease) was 94% according to the response evaluation criteria in solid tumors. Median TTP and OS were 13.9 and 20.4 months, respectively, and 81% of toxicities were grades 1-2. There was one death that was possibly treatment related. Conclusion:Combined continuous sorafenib therapy and on-demand DEB TACE provided excellent local disease control and did not lead to multiplicative toxicities. Long-term administration of sorafenib therapy in combination with DEB TACE may have a survival benefit in patients with advanced HCC.q RSNA, 2015

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Open-Label Single-Arm Phase II Trial of Sorafenib Therapy with Drug-eluting Bead Transarterial Chemoembolization in Patients with Unresectable Hepatocellular Carcinoma: Clinical Results

Cosgrove¹,

Reyes²,

Pawlik³

et al. 2015

Radiology

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“…The protective potential of PHY906 against CPT-11-induced toxicity led to a series of multi-center international clinical trials. 48 This formulation could be useful in humans decrease non-hematological side effects and enhance the anti-tumor activity of chemotherapeutic agents. PHY906 has the potential to be the first oral herbal medicine approved by the FDA.…”

Section: Phy906 For Anti-cancer Treatment In Patients With Colon LIVmentioning

confidence: 99%

“…A survey revealed that in 156 cancer patients (90% response rate), 52% were using at least one and 28% use 3 or more CAM treatments. 1 In focus groups with 48 Chinese cancer patients and their relatives conducted by an Australian research group, a majority supported the use of Chinese medicine and believed it would assist in cure. 2 In a survey of pediatric patients with cancers in Hong Kong, 42% of more than 200 children with cancer adopted herbal supplements while they were receiving chemotherapy.…”

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confidence: 99%

Supplements for immune enhancement in hematologic malignancies

Sze¹,

Chan²

2009

Hematology

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This brief review aims to discuss the various cellular immunological aspects and related mechanisms of the use of specific components from traditional herbal medicines. We begin with lessons learned from thalidomide as an effective single drug with multiple mechanisms of action to treat multiple myeloma. Examples of "supplements" or integrative therapy will be drawn from arsenic trioxide, medicinal mushrooms including Coriolus vesicular and Ganoderma lucidum, followed by the discussion of beta-glucans affecting various immunological important cellular subsets. Different classes of compounds may enhance distinct immune cell populations that might contribute to a multi-targeted holistic effects on anti-cancer treatment. Finally, we conclude by highlighting an herbal formulation PHY906 as a potential adjunct to chemotherapy that might become one of the first US Food and Drug Administration (FDA) approved oral herbal medicines for anti-cancer adjunct treatment.

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“…Several mechanisms of action are discussed [7]. Phase I/II studies have shown an increased therapeutic effect when PHY 906 is used in combination with chemotherapy for colorectal, pancreatic, and hepatocellular carcinomas [8][9][10]. Interestingly, one possible combination includes irinotecan, a drug which was also developed from a Chinese decoction.…”

Section: Pillars Of Chinese Medicinementioning

confidence: 99%

Western and Chinese Medicine in Oncology and Hematology

Lampe

Halle²,

Freund

2011

Forsch Komplementmed

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Based on a conclusive theoretical background, both Western and Chinese Medicine have developed diagnostic and therapeutic procedures which lead to reproducible treatment results. Whilst Western Medicine focuses on a most precise diagnosis of tumor histology and the extend of dissemination, Chinese Medicine has developed tools for a functional diagnoses of disturbed body functions. And as Western Medicine aims at producing most specific targeted drugs, Chinese Medicine intends to stabilize disturbed body functions mostly with decoctions. A combined treatment which synergizes specific tumor attack and patient stabilization seems promising. However, the different cultural backgrounds have led to different standards of evaluation. Although the scientific evaluation of Chinese Medicine has led to the development of new drugs, the majority of treatments with decoctions are not evaluated according to the accepted standards. As of today, modern research could only occasionally find explanations for the longstanding experience, but new research ideas have resulted from this confrontation. The approach of combining standard treatments with Chinese treatment concepts only started a few decades ago. The experiences and promising results from smaller studies stand against possible risks of unknown interactions with proven treatment concepts. Pharmacokinetic and clinical studies will be necessary to evaluate these combined treatment concepts. In everyday life, Western and Chinese Medicine should be used in sequence, whereas in studies and special situations the combined approach should be applied to offer possible benefits without causing unnecessary risks to the patients.

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Phase I/II study of capecitabine and PHY906 in hepatocellular carcinoma

Cited by 44 publications

References 0 publications

Open-Label Single-Arm Phase II Trial of Sorafenib Therapy with Drug-eluting Bead Transarterial Chemoembolization in Patients with Unresectable Hepatocellular Carcinoma: Clinical Results

Open-Label Single-Arm Phase II Trial of Sorafenib Therapy with Drug-eluting Bead Transarterial Chemoembolization in Patients with Unresectable Hepatocellular Carcinoma: Clinical Results

Supplements for immune enhancement in hematologic malignancies

Western and Chinese Medicine in Oncology and Hematology

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