The long-term safety and efficacy of (PROMACTA® (Eltrombopag) was evaluated in an open label phase III extension study (EXTEND STUDY) and this study demonstrated that Eltrombopag (PROMACTA®) given for up to two years appears to have consistent benefit in raising the platelet counts without any significant adverse events. A new paradigm has emerged with the availability of a new class of agents such as PROMACTA®, targeting platelet production. Additional trials are underway evaluating the role of this agent in chemotherapy induced thrombocytopenia as well as Myelodysplastic Syndromes and the results are eagerly awaited with renewed interest.
Author: RR
Oncoprescribe Blog Just added Synopsis/Clinical Relevance for ARZERRA for CLL
We’ve just completed a write up for ARZERRA for CLL, including a recap of the research presented at ASCO 2009 by Kipps, T. et al.
In a nutshell, here are the findings:
*The authors concluded that single agent therapy with Ofatumumab (ARZERRA®) acheives a high overall response rate and improves disease symptoms as well as hematologic parameters in heavily pretreated CLL patients presenting with double refractory and bulky Fludarabine orefractory disease, irrespective of prior therapy with Rituximab.*u
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Oncoprescribe Blog N9831 trial
Timing of Trastuzumab administration when given along with chemotherapy in an adjuvant setting, is gaining more clarity. Updated information presented at the 2009 San Antonio Breast Cancer Symposium suggests that, as was administered in group C of the N9831 trial, Trastuzumab started concurrently with taxane resulted in a better outcome, with improvement in Disease Free Survival compared to sequentially administering Trastuzumab following completion of taxane chemotherapy. This should clearly be more appealing to patients, as the duration of adjuvant parenteral therapy would be shortened by approximately 3 months in addition to the decrease in the risk of disease recurrence.
Oncoprescribe Blog Dual HER-2 blockade in metastatic Breast Cancer
An updated analysis of the phase III EGF 104900 trial demonstrated some interesting findings. Combining Trastuzumab with Lapatinib – dual HER blockade, in patients with metastatic breast cancer who had progressed on anthracyclines, taxanes and trastuzumab, improved overall survival without significant adverse events. This is in spite of a 50% cross over from the control group to the dual HER blockade group. This may be a telling tale of how individuals with advanced metastatic breast cancer can benefit with targeted therapy.
Oncoprescribe Blog Anthracyclines in Breast Cancer
Should we be in a hurry to abandon anthracyclines due to cardiotoxicity concerns? Think again. Weigh the risk benefits. More to come.
Oncoprescribe Blog Targeted Agents in Oncology and Personalized Medicine
How do mutations and overexpression of certain oncogenes impact treatment decisions? So, Here is an answer the Oncoprescribe way.
If a patient with colon cancer has a tumor with KRAS mutation Erbitux or Vectibix ( EGFR targeted monoclonal antibodies ) will not work.
However if a patient with Non Small Cell Lung Cancer has a tumor with mutations involving exon 19 or exon 21, small molecule Tyrosine Kinase Inhibitors such as Tarceva (Erlotinib) may be more effective than chemotherapy.
Tumors in patients with Non Small Cell Lung Cancer with high ERCC 1 gene expression are resistant to platinum compounds and non-platinum combination regimens should be a serious consideration.
Oncoprescribe Blog ? Survival Benefit with Bevacizumab plus Interferon
Cross over in clinical trials skews up data. This however is a part and parcel of medical ethics. In the AVOREN trial following an interim analysis in December 2006, the superiority of Interferon plus Bevacizumab was significant enough that the study was unblinded and the Data Safety Monitoring Board recommended cross over of patients from placebo group to Bevacizumab group. Further approximately 63% of the patients in the Interferon and placebo group and 55% of the patients in the Interferon and Bevacizumab group went on to receive post protocol second and third line therapies with multitargeted Tyrosine Kinase Inhibitors (MKIs), mTOR inhibitors, cytokines and chemotherapy. This could have had an impact on overall survival results at the time of this analysis.
Oncoprescribe Blog AVOREN Study – Avastin(Bevacizumab) plus Interferon alfa
The RECIST( Response Evaluation Criteria In Solid Tumors ) which measures tumor responses by imaging techniques including X-rays, CT scans and MRIs has been of less value whereas clinical benefit including Progression Free Survival remains more relevant when assessing efficacy of MKIs in metastatic Renal Cancer. The addition of Bevacizumab to Interferon alfa 2a was however not only associated with a significant improvement in progression free survival (10.4 months vs 5.5 months, HR =0.63, P<0.0001) but also overall response rate (31% vs 12%, P<0.0001) compared to Interferon plus placebo. This may be relevant if preoperative treatment for renal cancer is a consideration and this response rate efficacy parameter may also benefit patients who have symptomatic unresectable locally advanced Renal Cancer.
Oncoprescribe Blog Survival benefit with Sunitinib
The survival benefit seen with Sunitinib is a major step in the right direction when it comes to treatment of renal cell carcinoma. The median overall survival was 26.4 months for sunitinib-treated patients compared with 21.8 months for IFN-α recipients (P=0.051) and objective response rate was 47% for sunitinib compared with 12% for IFN-alpha (P < .001). This should encourage more patients and convince more treating Oncologists to consider Sutent (Sunitinib) as first line treatment of metastatic Renal Cell Cancer.
Oncoprescribe Blog Pemetrexed (Alimta) Maintenance
The survival benefit with the use of Pemetrexed (Alimta) Maintenance is intriguing and maybe more relevant for patients with non-squamous cell histology.
Pemetrexed (Alimta®) was given as maintenance treatment following four cycles of induction with platinum based combination chemotherapy (without Pemetrexed). Pemetrexed maintenance resulted in improvement in progression free survival as well as overall survival, but these benefits were observed only in patients with non squamous histology.