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Randomized Evidence for Testis NSGCT
- MRC Trial TE08 (1998-2003) -- 2 CT scans vs 5 CT scans
- Randomized. 414 patients, clinical Stage I NSGCT. Treated with orchiectomy. 10% high risk (LVI). Normal serum markers. Arm 1) 2 CT scans (3 and 12 months) vs. Arm 2) 5 CT scans (3, 6, 9, 12, and 24 months). CT was chest/abdomen; all other investigations (CXR, serum markers) were same between arms
- 2007 PMID 17416851 — "Randomized Trial of Two or Five Computed Tomography Scans in the Surveillance of Patients With Stage I Nonseminomatous Germ Cell Tumors of the Testis: Medical Research Council Trial TE08, ISRCTN56475197—The National Cancer Research Institute Testis Cancer Clinical Studies Group." (Rustin GJ et al. J Clin Oncol. 2007 Apr 10; 25(11):1310-1315.) Median F/U 3.3 years
- Outcome: 2-year RFS 2-scan 79% vs. 5-scan 84% (NS). For pts with vascular invasion, relapse 63% to 67%. No pts relapsed with poor prognosis disease; intermediate prognosis relapse in 2 pts (5.6% of relapses) in 2 scan group and 1 pt (3%) in 5 scan group.
- First indication of relapse: markers 39%, abd CT 39%. 9 relapses were picked up by the 12 month CT scan.
- Conclusion: CT scans at 3 months and 12 months after orchiectomy reasonable options in low-risk patients. 12 month CT scan is necessary.
- AUO AH 01/94 (Germany)(1996-2005) -- RPLND vs. BEP 1 cycle
- Randomized. 382 patients, clinical Stage I NSGCT. Arm 1) retroperitoneal lymph node dissection vs. Arm 2) bleomycin, etoposide, cisplatin (BEP) x1 cycle
- 5-years; 2008 PMID 18458040 -- "Randomized phase III trial comparing retroperitoneal lymph node dissection with one course of bleomycin and etoposide plus cisplatin chemotherapy in the adjuvant treatment of clinical stage I Nonseminomatous testicular germ cell tumors: AUO trial AH 01/94 by the German Testicular Cancer Study Group." (Albers P, J Clin Oncol. 2008 Jun 20;26(18):2966-72. Epub 2008 May 5.). Median F/U 4.7 years
- Outcome: 2-year RFS surgery 92% vs. BEP 99% (HR 7.9, SS)
- Conclusion: One course of BEP is superior over RPLND in clinical Stage I disease