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Patient reported side effects from molecularly targeted therapies in renal cell carcinoma (RCC)

Background: Multiple new therapies are now approved for patients (pts) with advanced RCC. As these agents enter widespread use, their perceived toxicities may differ from those reported in the literature and limit treatment duration and clinical outcomes. Patient reporting of toxicities may more accurately identify side effects most relevant to pts.

Methods: In an effort to collect patient-reported side effects from RCC pts treated with novel therapies, an on-line survey was developed. RCC pts were recruited through the Kidney Cancer Association.

Results: 177 pts completed the survey and 146 (64%M/36%F) received medication for RCC. Most common geographical regions were Midwest (20.8%); Northeast (17.4%); South/Southeast (16.7%); West (11.8%); and outside the U.S. (9.7%). 68 pts (47.2%) were treated at teaching hospitals; 55 pts (38.2%) in private oncology offices; and 21 pts (14.6%) at community hospitals. First-line treatments included sunitinib (Su) (52.1%, n=73); sorafenib (So) (15.7%, n=22); high dose IL-2 (14.3%, n=20); clinical trial (12.9%, n=18); bevacizumab (Bev) (5%, n=7); interferon (4.3%, n=6) and temsirolimus (Tem) (3.6%, n=5). The most common side effects reported for Su were fatigue (92.9%, n=65), altered taste (90%, n=63) and diarrhea (83.8%, n=57); So: hand foot syndrome (95.2%, n=20) and fatigue (95%, n=19); Bev: fatigue (83.3%, n=5) and altered taste (83.3%, n=5); Tem: fatigue, altered taste and rash (100%, n=4). Pts reported that the most difficult side effects from Su were diarrhea and fatigue (25%, n=18); So: hand foot syndrome (72.7%, n=16); Bev: fatigue (42.9%, n=3); Tem: rash (60%, n=3). Side effects necessitated changing the schedule, dose, or stopping Rx in 82% (n=18) of So pts and in 40% (n=28) of Su pts. QOL was affected very much/extremely for 56.6% of pts (n=73).

Conclusions: These results suggest that the patient-reported impact of molecularly targeted agent side effects may be more significant than suggested by phase III clinical trials. These results also identify specific side effects towards which improved symptom management strategies and enhanced patient education can be directed. Better side effect management may increase treatment duration and improve clinical outcomes.