MedicalResearch.com Interview with:
Joseph Germino, M.D., PhD
Vice President US Medical Affairs Oncology
Bayer Healthcare Pharmaceuticals
Whippany, N.J. 07981
MedicalResearch.com: What is the background for this study?
Response: Sorafenib (Nexavar®) is an oral anticancer therapy approved in more than 100 countries worldwide. It is approved for the treatment of patients with advanced hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; progressive, locally advanced or metastatic differentiated thyroid carcinoma (papillary/follicular/Hürthle cell), that is refractory to radioactive iodine (RAI).
The AAML 1031 is a recently completed Phase III clinical trial evaluating the use of bortezomib and sorafenib in patients 30 years or younger with newly diagnosed acute myeloid leukemia (AML).
At the 2019 ASCO Annual meeting, results of a report from the AAML1031 trial, which assessed whether intensification of Induction II chemotherapy (ADE or AraC/ Mitoxantrone) and liberalized stem cell transplant (SCT) donor source criteria improved clinical outcomes in patients with residual AML.
MedicalResearch.com: What are the main findings?
Response: According to the study, there was no difference in baseline characteristics between patients from AAML0531 (ADE; a study evaluating the combination of chemotherapy with or without gemtuzumab in patients with AML) (n=47) and patients from AAML1031 (AraC/Mitoxantrone) (n=95), with a five-year disease-free survival (DFS) of 17.5 months ± 11.4 months and 23.9 months ± 8.8 months, respectively. The study also found that five-year overall survival (OS) was 38.1 months ± 14.2 months for ADE and 33.3 months ± 10.7 months for AraC/Mitoxantone. Additionally, end of Induction II disease response and minimal residual disease (MRD) did not differ between patients treated with ADE and AraC/Mitoxantone. Patients receiving ADE had a higher probability of neutrophil recovery and recovered neutrophils a median of 7 days more quickly and had fewer inpatient hospital days (28 days versus 32 days, respectively). Lastly, the study found the percentage of patients receiving SCT, as well as post-SCT outcomes, did not differ.
MedicalResearch.com: What should readers take away from your report?
Response: Results of the study provide important insights on induction II chemotherapy and potential improvement of clinical outcomes in patients with residual AML. The study found that the intensification of Induction II was associated with increased hematologic toxicity and length of stay, and do not support the intensification of induction II chemotherapy with AraC/Mitoxantrone in this patient population.
Joseph Germino, M.D. is the vice president of medical affairs, oncology at Bayer.
Citation: ASCO 2019 Abstract #10002: Intensification of Induction II Chemotherapy and Liberalization of Stem Cell Donor Source does not Improve Outcomes for Children with High Risk Acute Myeloid Leukemia: A Report from the Children’s Oncology Group.
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