Trials & Tribulations

Deciphering genomic testing options for diverse patient populations in early-stage breast cancer
FreeTrials & Tribulations

Deciphering genomic testing options for diverse patient populations in early-stage breast cancer

In my twenty-two years of practicing medicine, I have observed the evolution of genomic testing and its increasing utility in oncology. With the growing interest in precision medicine for breast cancer patients, I have found it important to decipher the differences between the two most clinically validated genomic tests, MammaPrint and Oncotype DX, and their phase III trials, MINDACT and TAILORx, respectively. To that end, now that some time has passed since the presentation of the TAILORx findings at the American Society for Clinical Oncology Annual Meeting, I'd like to take a step back and discuss what these findings mean for patients and clinicians.
The imaginary interview
FreeTrials & Tribulations

The imaginary interview

(with apologies to Molière, aka Jean-Baptiste Poquelin)As I read the latest offering from the US Preventive Services Task Force, this time another encyclical on prostate screening, I felt a recurrence of the extreme irritation left over from the last time they wasted my (and their) time. Borrowing from Molière's “The Imaginary Invalid”, I conceived an Imaginary Interview with an un-named representative of this band of bozo's that seem to have few boundaries, a high level of comfort in wasting taxpayer dollars and editorial space, and who seem set on providing useless homilies that, at best, provide no value. This is couched as a Paul Goldberg-style low-key interview… and so the play begins:
Sales Revenues at the Potential Expense of Patient Safety: The Example of You&i
FreeTrials & Tribulations

Sales Revenues at the Potential Expense of Patient Safety: The Example of You&i

Ibrutinib is a selective and irreversible inhibitor of Bruton's tyrosine kinase (BTK) that entered phase 1 clinical trials in 2009 based on preclinical efficacy in models of B-cell malignancy and autoimmune disease.[1, 2] The initial phase 1 trial showed clear efficacy in a number of lymphoid malignancies at doses as low as 1.25 mg/kg/d. Furthermore, full receptor occupancy was demonstrated at 2.5 mg/kg/d. Despite these pharmacological and early clinical findings, development of ibrutinib continued at doses of 420 mg qd and 560 mg qd, levels 3-4 fold higher than suggested by the pharmacological data. In addition, the absorption of ibrutinib is enhanced by administration of food, which may explain why even the lowest dose showed efficacy in some patients.