"Sunitinib versus inteferon alfa in metastatic renal-cell
carcinoma," by Robert J. Motzer and 14 others, New England
Journal of Medicine, 356(2): 115-24, 11 January 2007.
Abstract: "BACKGROUND Since sunitinib
malate has shown activity in two uncontrolled studies in patients with
metastatic renal-cell carcinoma, a comparison of the drug with interferon
alfa in a phase 3 trial is warranted. METHODS We enrolled
750 patients with previously untreated, metastatic renal-cell carcinoma in
a multicenter, randomized, phase 3 trial to receive either repeated 6-week
cycles of sunitinib (at a dose of 50 mg given orally once daily for 4
weeks, followed by 2 weeks without treatment) or interferon alfa (at a dose
of 9 MU given subcutaneously three times weekly). The primary end point was
progression-free survival. Secondary end points included the objective
response rate, overall survival, patient-reported outcomes, and safety.
RESULTS The median
progression-free survival was significantly longer in the sunitinib group
(11 months) than in the interferon alfa group (5 months), corresponding to
a hazard ratio of 0.42 (95% confidence interval, 0.32 to 0.54; P<0.001).
Sunitinib was also associated with a higher objective response rate than
was interferon alfa (31% vs .6%, P<0.001). The proportion of patients
with grade 3 or 4 treatment-related fatigue was significantly higher in the
group treated with interferon alfa, whereas diarrhea was more frequent in
the sunitinib group (P<0.05). Patients in the sunitinib group reported a
significantly better quality of life than did patients in the interferon
alfa group (P<0.001). CONCLUSIONS Progression-free
survival was longer and response rates were higher in patients with
metastatic renal-cell cancer who received sunitinib than in those receiving
interferon alfa."
This 2007 report from the New England Journal of Medicine was
cited 65 times in current journal articles
indexed by Clarivate during September-October 2008. No other medicine
paper published in the last two years, aside from reviews, collected a
higher citation total during that two-month period. Thus, after appearing
among medicine's Top Ten most-cited papers for more than a year, this
report finally ascends to the #1 spot. Prior to the most recent bimonthly
count, citations to the paper have accrued as follows:
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