Study treatment and clinical response
pneumonitis, toxicity, stroke, pain, PD
DISEASE PROGRESSION, PNEUMONITIS, ADVERSE EVENTS, STROKE, DISEASE, BEST
Best responses achieved by patients enrolled in the study and the corresponding % change in target lesions from baseline are illustrated as a waterfall plot in Figure (A) Patients best response from baseline as a waterfall plot (Duration on study treatment and clinical response (Abbreviations: NE, not evaluable; PD, progression of disease; PFS, progression‐free survival; PR, partial response; SD, stable disease.Twelve of the 19 enrolled patients (63.2%) ultimately came off study due to disease progression and one patient died while on study. Of the 12 patients with disease progression, 4 were due to a >20% increase in sum of the long diameters of target lesions and 8 were due to the appearance of new or unequivocal progression of non‐target lesions. Six patients discontinued treatment due to AEs. The serious adverse events (SAEs) or AEs that caused patients to come off study included sunitinib grade 3/4 toxicity (2), grade 3 pneumonitis due to temsirolimus (1), grade 4 stroke possibly related to sunitinib (1), being off sunitinib for an extended period due to dental pain needing multiple teeth extractions (1), and one grade 5 toxicity‐death (1). One patient voluntarily withdrew from the study after completing 8 cycles of study treatment and achieving a partial response.The median treatment duration was 7.7 months (range 0.8–59.4). Patients received a median of 2 cycles (range 0–20) of study treatment. Treatment duration, changes in clinical response and reasons for treatment discontinuation are presented in Figure (A) Time on study treatment, reason for off study, and partial response start as a Swimmer plot (Only 19 patients out of the planned 37 patients were accrued to this clinical trial. The study was stopped before reaching the enrollment goal due primarily to the emergence of newer therapies for mRCC which slowed the rate and ability to accrue additional patients into the study. Furthermore, we undertook an unplanned interim analysis and imputed the PFS for the proposed remaining study cohort population 