Randomized trials

Kidney cancer. Principles and practice. Second edition. Primo N. Lara, Jr. Eric Jonasch (Editors). Springer International Publishing (2015)


In 2001, the pooled results of two randomized trials were published demonstrating a significant OS advantage in patients with mRCC who received CN prior to interferon alpha [2, 3]. The Southwest Oncology Group (SWOG) trial 8949 and the European Organization for the Research and Treatment of Cancer (EORTC) trial 30947 randomized patients with mRCC to either nephrectomy followed by interferon alpha or interferon alpha monotherapy. The eligibility criteria for both trials were the same: diagnosis of mRCC (spread beyond regional lymph nodes) with a resectable primary tumor in place, an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, a serum creatinine <3.0 mg/dl, and a serum total bilirubin of less than three time the upper limit of normal. In a combined analysis of the two trials (n = 331), the median survival for patients receiving interferon monotherapy was significantly lower than combined nephrectomy with subsequent interferon therapy, 7.8 months versus 13.6 months, respectively [3]. This 5.8 month difference in OS represents a 31% decrease in the risk of death (Fig. 10.1). With the report of these two randomized trials, cytoreductive nephrectomy became the standard of care for many patients with synchronous mRCC prior to planned treatment with cytokine therapy.

__Kidney Cancer_ Principles and Practice-Springer International Publishing (2015) 10.1

Fig. 10.1. Combined 50 analysis of overall survival 40 in the EORTC 30947 and SWOG 8949 trials. Median overall survival is 7.8 months in the observation group (O=interferon monotherapy) versus 13.6 months in the nephrectomy group (N = nephrectomy + interferon)

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