ORCHIECTOMY ONLY FOR CLINICAL STAGE I NONSEMINOMATOUS GERM CELL TESTIS TUMORS: COMPARISON WITH PATHOLOGIC STAGE I DISEASE FUAD FREIHA, M.D. FRANK TORTI, M.D. From the Divisions of Urology and Medical Oncolog3, and the GU Oncology Clinic, Stanford, California
ABSTRACT--Twenty-three men with nonseminomatous germ cell tumors confined within the tunica albuginea of the testis and negative metastatic evaluation were placed on surw;illance after radical orchiectomy. Metastatic disease developed in 3 for a relapse rate of 13 percent. During the same period, 17 men with pathologic Stage I disease were followed up in the same manner, and metastatic disease developed in 3 for a relapse rate of 18 percent. All six men were treated with either combination chemotherapy or retroperitoneal lymphadenectomy, and all are alive without disease for at least two years from end of therapy. If strict criteria are followed, surveillance has a place in the management of carefully selected young men with clinical Stage I disease.
Until 1980, we recommended retroperitoneal lymph node dissection (RPLND) after orchiectomy for all patients with low-stage nonseminomatous germ cell tumors of the testis (NSGCT), even in the absence of demonstrable retroperitoneal nodal disease. This is no longer common practice. Effective chemotherapy in advanced disease and more accurate staging procedures have,' encouraged us to carefully select a group of young men with clinical Stage I disease and follow them without RPLND to preserve their ejaculatory function and fertility. We present the .details of 23 such men and compare their progress to that of 17 men with pathologic Stage I disease treated and followed during the same period. Material and Methods q~eenty-three men with NSGCT who had tumors confined to the body of the testis (T1), normal postorchiectomy tumor markers, normal findings on abdominal, pelvic, and chest CT scans, and normal bipedal lymphangiograms were placed on surveillance after radical orchiectomy. They were followed up in the GU Oncology Clinic at Stanford with physical examination, tumor markers, and chest radio-
graphs every month for the first year, every two months for the second year, ~wery four months for the third year, and every six months thereafter. In addition, CT scans of the abdomen and pelvis were done at three, six, nine, and fifteen months after the initial staging. The median follow-up for these 23 men was forty-four months with a range of twenty-four to sixty-six months. D u r i n g the same period, 17 men w i t h NSGCT who were treated with orehieetomy followed by RPLND because of abnormalities seen on either CT scan or lymphangiogram, or because of microvaseular invasion in the primary tumor, and who were found to have negative nodes (pathologic Stage I disease), were followed in the same m a n n e r except for the routine abdominal and pelvic CT scans. The median follow-up for these 17 men was fortytwo months with a range of twenty-four to sixty-six months. Table I lists the characteristics of the patients and their tumors. Violation of the scrotum during orehieetomy or prior inguinal operation occurred in 4 patients, 3 in the RPLND group and 1 in the surveillance group.
V O L U M E XXXIV, N U M B E R 6
Patient and tumor characteristics
Surveillance RPLND No. of patients Pure embryonal carcinoma Mixed germ cell tumor with choriocarcinoma elements Elevated preorchiectomy markers Alpha-fetoprotein fl-HCG Microvascular invasion
23 3 20 1 15 13 12 0
17 1 16 1 10 10 8 2
Results No patient was lost to follow-up. Three patients (13 %) in the surveillance group had recurrence of disease, in the lung in one at three months and in the retroperitoneum in two at six and eight months, respectively. Two of the 3 patients were treated with combination chemotherapy and the third with RPLND. All 3 patients are alive and without evidence of disease for at least two years from end of therapy for the recurrent disease. None of those 3 patients had had prior inguinal surgery or violation of the scrotum. All 3 patients (18%) in the RPLND group had recurrent disease in the lungs at three, three, and six months, respectively. All 3 patients were treated with eombination chemotherapy, and all 3 are alive without evidence of disease for at least two years from end of therapy for the recurrent disease. One of the 3 patients had microvascular invasion in the original tumor, and 1 had had violation of the scrotum during the orchiectomy.
ture is due to patient selection. The series reporting high rates of relapse include patients with more advanced tumors than T1 and tumors with microvascular invasion, two parameters which have been found to correlate with a significant incidence of metastatic disease. 5 We believe that surveillance after orchiectomy has a place in the management of young men with clinical Stage I NSGCT but only if strict selection criteria are observed. The selection criteria for surveillance we recommend are: 1. Young men whose fertility is important in their family planning. 2. Tumors confined to within the tunica albuginea without rete testes or epididymal involvement (T1) and without microvascular or microlymphatic invasion. 3. Normal postorehiectomy tumor markers. 4. Absolutely normal findings on CT scans of the abdomen, pelvis, and chest and bipedal lymphangiograms. 5. Close follow-up with chest radiographs, tumor markers, and physical examination on a monthly basis for the first year, every two months for the second year, every three months for the third year, and every six months thereafter. Since the rate of relapse in our patients with pathologic Stage I disease is the same as in those on surveillance, we also follow them up in the same manner. In addition, patients on surveillance should be followed up w i t h abdominal and pelvic CT scans at three, six, nine, and fifteen months after the initial staging. Two of the three relapses in our patients occurred in the retroperitoneum and were identified by the routine CT scans.
Comment The effectiveness of combination chemotherapy in curing the majority of patients with metastatic nonseminomatous testieular cancer has encouraged urologists to identify a group of men with clinical Stage I disease and treat them with orchiectomy and surveillance to avoid the complications of retroperitoneal lymph node dissection and preserve ejaculation and fertility. This has been criticized recently because of the high relapse rate in patients on surveillance. The reported relapse rate in patients on surveillance is between 16 pereent and 28 percent. 1-4 The relapse rate in the present series is only 13 percent and is equivalent to the relapse rate in patients with pathologic Stage I disease treated with orchiectomy and RPLND. This difference in the rate of relapse between the present series and what is reported in the litera-
Division of Urology, $287 Stanford, California 94305-5118 (DR. FREIHA) References 1. Johnson DE, Lo RK, yon Eschenbach AC, and Swanson DA: Surveillance alone for patients with clinical stage I n o n -
germ cell tumors of the testis: preliminary results, J Urol 131:491 (1984). 2. Sogani PC, Whitmore WF, Herr HW, and Bosl GJ: Orchiectomy alone in the treatment of clinical stage I non-seminomatous germ cell tumor of the testis, J Clin Oncol 2:267 (1984). 3. Hoskins P, et ah Prognostic factors in stage I nonseminomatous germ-cell testicular tumors managed by orchiectomy and surveillance: implications for adjuvant chemotherapy, J Clin Oncol 4:1031 (1986). 4. Pizzocaro G, et ah Difficulties of a surveillance study omitting retroperitoneal lymphadenectomy in clinical stage I nonseminomatons germ cell tumors of the testis, J Urol 138:1393 (1987). 5. Raghavan D: Tumor classification and size in germ-cell testicular cancer. Influence on the occurrence of metastasis, Cancer 50:1591 (1982). seminomatous
VOLUME XXXIV, NUMBER 6