BACKGROUND The incidence of renal cell carcinoma (RCC) is increasing, largely due to the widespread use of cross‐sectional imaging. Most renal tumors are detected incidentally as small, asymptomatic masses. To study their natural history, the authors prospectively followed a series of patients with this type of lesion who were unsuited for or refused surgery. METHODS Twenty‐nine patients with 32 masses that measured < 4 cm in greatest dimension (25 solid masses and 7 complex cystic masses) were studied. The primary outcome was tumor size, which was calculated as volume over time. All patients were followed with serial abdominal imaging, and each mass had at least three follow‐up measurements. The median follow‐up was 27.9 months (range, 5.3–143.0 months). RESULTS Overall, the average growth rate did not differ statistically from zero growth (P = 0.09; 95% confidence interval, − 0.005–0.2 cm per year) and was not associated with either initial size (P = 0.28) or mass type (P = 0.41). Seven masses (22%) reached 4 cm in greatest dimension after 12–85 months of follow‐up. Eight masses (25%) doubled their volumes within 12 months. Overall, 11 masses (34%) fulfilled 1 of these 2 criteria of rapid growth. Nine tumors were removed surgically after an average of 3.1 years of follow‐up because it was believed that they were growing fast. No patient had disease progression. CONCLUSIONS Approximately one‐third of small renal masses that are presumed RCCs grow if they are managed conservatively and are followed with serial imaging. The growth rate is slow or undetectable in the majority of patients. These observations raise the possibility of a period of initial observation in selected patients, particularly the elderly or infirm. Cancer 2004;100:738–45. © 2004 American Cancer Society.

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were analyzed using the Kaplan-Meier method and Cox regression analysis. RESULTSThe median age of patients was 68 years with a mean (median) follow-up time of 35 (29) months. The 30, 60 and 90-day postoperative mortality rates were 1.3%, 2.6% and 3.2%, respectively. The 5-year overall, recurrencefree and cancer-specific survival was 57%, 48% and 67%, respectively, with a local recurrence rate of 6%. Pathological stage distribution was < pT2N0, n = 498 (23%); pT2N0, n = 365 (17%); pT3N0, n = 463 (21%); pT4N0, n = 170 (8%); and pTxN + , n = 507 (23%). Only 3.1% of patients received neoadjuvant chemotherapy and 19.4% received adjuvant chemotherapy. On multivariate analysis, lower pathological stage, negative surgical margins, receipt of adjuvant chemotherapy, performance of pelvic lymphadenectomy and an absence of smoking were associated with prolonged disease-specific and overall survival.

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