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Phase I / II study of brentuximab vedotin in Japanese patients with relapsed or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large-cell lymphoma.

Ogura M, Tobinai K, Hatake K, Ishizawa K, Uike N, Uchida T, Suzuki T, Aoki T, Watanabe T, Maruyama D, Yokoyama M, Takubo T, Kagehara H, Matsushima T - Cancer Sci. (2014)

Bottom Line: Grade 3/4 adverse events in more than two patients were lymphopenia (50%) and neutropenia (15%).The pharmacokinetic profile was similar to that observed in the previous studies in the USA.These results show that brentuximab vedotin has an acceptable safety profile and promising antitumor activity in the Japanese population.

View Article: PubMed Central - PubMed

Affiliation: Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.

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Related in: MedlinePlus

Maximum percent reduction from baseline by patient per the Independent Review Facility in a phase II study of brentuximab vedotin in Japanese patients with refractory or relapsed CD30-positive Hodgkin's lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL). One patient had no measurable lesions per the Independent Review Facility.
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fig01: Maximum percent reduction from baseline by patient per the Independent Review Facility in a phase II study of brentuximab vedotin in Japanese patients with refractory or relapsed CD30-positive Hodgkin's lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL). One patient had no measurable lesions per the Independent Review Facility.

Mentions: Figure 1 shows the maximum tumor reduction in individual patients in phase II. Five patients (56%) with HL and four (80%) with sALCL had a best response of CR. In this part, five patients with HL had not previously undergone ASCT. Of these, four patients (80%) achieved an OR, including two CRs. Furthermore, three patients had primary cutaneous ALCL that had transformed to sALCL, and they all had a CR.


Phase I / II study of brentuximab vedotin in Japanese patients with relapsed or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large-cell lymphoma.

Ogura M, Tobinai K, Hatake K, Ishizawa K, Uike N, Uchida T, Suzuki T, Aoki T, Watanabe T, Maruyama D, Yokoyama M, Takubo T, Kagehara H, Matsushima T - Cancer Sci. (2014)

Maximum percent reduction from baseline by patient per the Independent Review Facility in a phase II study of brentuximab vedotin in Japanese patients with refractory or relapsed CD30-positive Hodgkin's lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL). One patient had no measurable lesions per the Independent Review Facility.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4317919&req=5

fig01: Maximum percent reduction from baseline by patient per the Independent Review Facility in a phase II study of brentuximab vedotin in Japanese patients with refractory or relapsed CD30-positive Hodgkin's lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL). One patient had no measurable lesions per the Independent Review Facility.
Mentions: Figure 1 shows the maximum tumor reduction in individual patients in phase II. Five patients (56%) with HL and four (80%) with sALCL had a best response of CR. In this part, five patients with HL had not previously undergone ASCT. Of these, four patients (80%) achieved an OR, including two CRs. Furthermore, three patients had primary cutaneous ALCL that had transformed to sALCL, and they all had a CR.

Bottom Line: Grade 3/4 adverse events in more than two patients were lymphopenia (50%) and neutropenia (15%).The pharmacokinetic profile was similar to that observed in the previous studies in the USA.These results show that brentuximab vedotin has an acceptable safety profile and promising antitumor activity in the Japanese population.

View Article: PubMed Central - PubMed

Affiliation: Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.

Show MeSH
Related in: MedlinePlus