Ongoing under-reporting of clinically relevant safety data in phase II studies of tyrosine kinase inhibitors

Reply: Ongoing under-reporting of clinically relevant safety data in phase II studies of tyrosine kinase inhibitors

“…We acknowledge the discussion points raised by Schöffski et al (2010), both in their letter and in their prospective evaluation of sunitinib-induced hypothyroidism published in this journal in 2008 (Wolter et al, 2008).…”

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Sir,We acknowledge the discussion points raised by Schöffski et al (2010), both in their letter and in their prospective evaluation of sunitinib-induced hypothyroidism published in this journal in (Wolter et al, 2008.We reported on a small, open-label, phase II clinical trial of sunitinib on a continuous daily dosing schedule in patients with advanced NSCLC and, as noted in the discussion section of the paper, the primary end point of this trial (the reporting of at least five objective responses) was not reached. However, despite the low overall response rate, we were encouraged by the time-to-event results obtained, which we feel are concordant with a signal of activity and with time-to-event data observed on Schedule 4/2 (4 weeks on treatment followed by 2 weeks off; Socinski et al, 2008).

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