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5053 Background: Previous studies showed that men with HIV-associated germ cell cancer (HIV-GCC) have a similar cancer-free outcome compared with their HIV-negative counterparts. However, the overall survival (OS) was inferior and little data is available on treatment and outcome of HIV-GCC in the era of combined antiretroviral therapy (cART). Methods: Men living with HIV aged ≥ 18 years (yrs) with a diagnosis of histologically proven GCC made from 01/1996 to 07/2018 were included. Primary outcomes were OS and progression-free survival (PFS). Secondary outcomes included characteristics of GCC and HIV-infection, treatment and causes of death. Results: Data of 89 men from 23 institutions and 6 countries with a total of 92 HIV-GCC (2 synchronous and 1 metachronous bilateral GCC) were analysed, among them 64 (70%) seminomas and 28 (30%) nonseminomas. 10/89 (11%) cases were primary extragonadal GCC. Median age was 36 yrs (range, 22-52) and median time from HIV to GCC diagnosis was 5 yrs (range, 0-29). Median CD4 count at GCC diagnosis was 420 cells/µl (range, 3-1503) and 83% of pts were on cART. Stage I disease was found in 44/80 (55%) gonadal GCC (metachronous bilateral case included). Of 46 cases with stage II/III/extragonadal GCC 78%, 17% and 4% were assigned to the IGCCCG good, intermediate and poor prognosis group, respectively. Of the 44 stage I cases, 22 (50%) were followed by active surveillance, and 11 (25%) received adjuvant chemotherapy (CT) or radiotherapy. Relapses occurred in 14 pts (6 from stage I, 8 in pts primary disseminated GCC) and CT was applied to 13/14 pts, of which 3 received high-dose CT. Overall, 12/89 (13%) pts have died. Causes of death were refractory GCC (n = 5), an AIDS-defining illness (n = 3) and other (n = 4). After a median follow-up of 6.5 yrs (range, 0.3-20.9), the 5- and 10-year PFS rate was 81% and 73%, and the 5- and 10-year OS rate was 91% and 85%, respectively. There were no significant differences between the good and intermediate prognosis group or between pts with CD4 counts < 200/µl or ≥ 200/µl. Conclusions: The 5- and 10-year PFS and OS rates of men with HIV-GCC are similar to those reported for HIV-negative GCC. Pts with HIV-GCC should remain on cART and be managed in an identical fashion to HIV-negative pts.

5052 Background: Testicular germ cell tumors (TGCT) in clinical stage I (CSI) are tumors confined to the testis without evidence of metastasis. Around 50% of all TGCT patients present with elevated serum tumor markers (TM) such as alpha-feto protein (AFP), beta-humanochoriongonadotropin (ß-HCG) and lactate-dehydrogenase (LDH). After ablatio testis, TMs usually return to normal according to half-life kinetics, however, in clinical stage IS (CSIS) TMs remain elevated or increase after surgery. Follow-up data on CSIS is scarce and our study aims to assess clinical characteristics and oncologic outcomes in a large TGCT cohort. Methods: In this multicenter study we collected data from 5 tertiary referring hospitals in Germany, included patients with CSIS and evaluated TM levels, treatment and the primary outcome relapse-free survival. False CSIS was defined as documented CSIS but TMs that returned to normal after respective half-life kinetics. Differences between predefined groups (chemotherapy, TM, true/false CSIS) was analyzed with fisher’s exact and chi-square test. Results: Overall, 2616 patient data files were analyzed. Forty-three patients (1.6%) were documented as CSIS of which 27 (63%) were true and 16 (37%) false CSIS. Six (14%) had seminomas and 37 (86%) non-seminomas. In the true CSIS group AFP, ß-HCG, AFP plus ß-HCG and LDH were elevated in 13, 6, 3 and 2 cases. Four true CSIS patients received surveillance, 21 had 3x or 2x courses of BEP (bleomycin, etoposide and cisplatin) and 2 carboplatin. Within the false CSIS group, 2 patients were treated with surveillance, 10 received 3x BEP, one 3x PEI (cisplatin, etoposide and ifosfamid) and 3 had carboplatin. Chi-Square test revealed no difference between true or false CSIS classification in respect to application of chemotherapy (any chemotherapy, p = 0.83). Relapse-free survival after 5 and 10 years was 88.9% and 77.8%, respectively. Three patients in the true CSIS group relapsed (2 seminomas had carboplatin, 1 non-seminoma had surveillance). All relapses were treated with 3 courses of BEP with no documented death in the CSIS population. Conclusions: Overall, less than 2% of all TGCT were documented CSIS of which 37% were falsely classified. We report a high proportion of relapse-free survival in CSIS treated with surveillance or BEP with a high heterogeneity in treatment patterns. Correct classification of CSIS remains of critical importance to avoid toxicity for patients that could be safely treated with surveillance.

5512 Background: One cycle of adjuvant BEP has shown superiority in recurrence free survival over RPLND in patients (pts) with clinical stage (CS) I nonseminomatous germ cell tumor of the testis (NSGCT) (JCO 2008). We report recurrences and late toxicities of this randomized trial after 13 yrs of follow-up (FU). Methods: Questionnaires of 382 unselected pts with CS I NSGCT treated within a phase III trial comparing recurrence rate after 1 cycle of adjuvant BEP (arm A) vs. RPLND (arm B) were evaluated regarding recurrences and late toxicity. Overall (OS) and progression free survival (PFS) was calculated by Kaplan-Meier and arms were compared using logrank test. Categorial data were analyzed by chi-square test (PRISM v8). Results: In each arm 191 pts were analyzed as intention-to-treat with a median FU of 13.75 yrs (0-22.9 yrs); 3/191 pts (1.6 %) in arm A and 16/191 pts (8.4 %) in arm B had a recurrence. 20-yrs PFS in arm A / B was 97 % (CI 96-99 %) / 92 % (CI 90-95 %), ( p = .0049). 20-yrs OS in arm A / B was 90 % (CI 86-94 %) / 88 % (CI 86-94 %), ( p = .83). 23/382 (6 %) pts have died, 22/23 not related to testis cancer, 1/23 died of a recurrence in arm B. 8/191 pts (4.2 %) in arm A and 4/191 pts (2.1 %) in arm B showed metachronous secondary testis cancer ( p = .26). 5/191 pts (2.6 %) in arm A and 4/191 pts (2.1 %) in arm B developed other malignancies. 170/382 questionnaires were evaluable (arm A: 95; arm B: 75). 45 pts were lost to FU. There were no significant differences comparing both treatment arms regarding potentially treatment-related late toxicities. However, excluding pre-existing complaints, ototoxicity (9/95 (9 %) vs. 4/75 (5 %) pts, p = .31) was reported more frequently in arm A. Excluding pre-existing neurological conditions, peripheral neuropathy of all grades was more frequently reported in arm A (15/95 pts; 16 % vs. 9/75 pts; 12 % pts; p = .48). Retrograde ejaculation occurred more frequently after RPLND (9/95 pts; 9% vs. 18/75 pts; 24 %, p = .01). Conclusions: After more than 13 yrs of FU, recurrences in non-risk factor selected pts with CS I NSGCT remain to be significantly more frequent with RPLND. No excess mortality due to secondary malignancies was observed. Late toxicities did not differ between 1 cycle of BEP and RPLND. Only retrograde ejaculation was observed significantly more frequent after RPLND. With long-term observation, 1 cycle of BEP has not only a high efficacy to prevent recurrence but also seems to be tolerated without clinically relevant long-term toxicity.

566 Background: Growing teratoma syndrome (GTS) is an infrequent clinical phenomenon constituting only about 2 to 8% of all testis cancer patients. Data in the literature on the therapy of GTS are sparse, reflecting the rarity of the disease. The objective of was to determine the diagnostic, surgical and oncological outcome of patients with GTS treated in the 21st century. Methods: Between 01/2000 and 01/2010 post-chemotherapeutic retroperitoneal lymph node dissections (PCRLND) were performed in 296 patients with advanced NSGCT. We analysed the peri- and postoperative outcome of 16 patients (5.4%) that fulfilled the criteria of a GTS: enlarging metastatic mass in the retroperitoneum or visceral organs during systemic chemotherapy with normalized or decreasing tumour markers. Results: Mean patient age was 31 years (17-57). Initially, all patients had NSGCT with a good or intermediate prognosis according to IGCCCG; one patient had a poor prognosis. In all cases the primary tumour predominantly contained mature teratoma; two patients had a clinical stage IIb, nine and three presented with clinical stage IIc and III respectively. Median tumour diameter at time of surgery was 8.1 cm (1.5-32). Tumour markers were plateauing or normalized in all patients. Tumour masses were localized in the retroperitoneum in 15 patients; one patient demonstrated a pulmonary mass. After a median follow-up of 4.2 years, 2 patients developed outfield recurrences; all but one patients are alive. Conclusions: GTS is a rare disease among patients with advanced NSGCT and necessitates complete surgical resection of the masses with curative intention. Surgery should be considered at time of progression to facilitate complete removal of the growing teratoma and be performed in tertiary referral centers only.

Purpose Retroperitoneal lymph node dissection (RPLND) and adjuvant chemotherapy are two adjuvant treatment options for patients with clinical stage I nonseminomatous germ cell tumors of the testis (NSGCT). Aim of this trial was to prove the advantage of one cycle of bleomycin, etoposide, and cisplatin (BEP) chemotherapy compared with RPLND in terms of recurrence. Patients and Methods Between 1996 and 2005, 382 patients were randomly assigned to receive either RPLND (n = 191) or one course of BEP (n = 191) after orchidectomy. The primary study end point was the rate of recurrence. The trial was powered to detect a 7% reduction (from 10% to 3%) of recurrence with chemotherapy compared with surgery. Results After a median follow-up of 4.7 years, two and 15 recurrences were observed in the intention-to-treat population with chemotherapy and surgery, respectively (P = .0011). The difference in the 2-year recurrence-free survival rate between chemotherapy (99.46%; 95% CI, 96.20% to 99.92%) and surgery (91.87%; 95% CI, 86.87% to 95.02%) was 7.59% (95% CI, 3.13% to 12.05%). The hazard ratio to experience a tumor recurrence with surgery as opposed to chemotherapy was 7.937 (95% CI, 1.808 to 34.48). Conclusion To our knowledge, this is the largest randomized trial investigating adjuvant treatment strategies in clinical stage I NSGCT, which showed the superiority of one course BEP over RPLND performed according to community standards to prevent recurrence. Although not standard treatment, one course of BEP is active in an unselected group of patients with clinical stage I disease and merits further investigation.

376 Background: There is need for more serum biomarkers of testicular germ cell tumors (GCTs) because the management of GCT is largely based on marker monitoring but only 60% of patients express the classical markers AFP and beta HCG. We measured serum levels of microRNA miR-371a-3p (miR-371) in GCT patients with the aim of establishing a new biomarker. Methods: Serum samples of 130 consecutive patients with GCT (75 seminoma, 55 nonseminoma; 90 clinical stage 1, 40 higher stages) were examined for miR-371a-3p before and after treatment. 105 young males with nonmalignant testicular diseases and 10 patients with non-GCT testis tumors served as controls. Serum levels of miR-371a-3p were measured by quantitative polymerase chain reaction with quantification in relation to miR-20a as internal standard. Measurements were correlated with clinical data, analysis involved descriptive statistical methods. Results: Over 90% of all patients had higher serum levels of miR-371a-3p than controls. After treatment, all elevated levels decreased to the normal range. All metastasized patients had significantly higher mean levels than stage 1 patients, serum levels appear to correlate with tumor bulk. Upon chemotherapy levels decreased with each cycle of therapy. After orchiectomy in stage 1 cases, serum levels dropped by 95% within 24 hours. Nonseminomas had higher mean levels than seminoma. Teratoma does not express miR-371a-3p. The levels remained low during follow-up. Conclusions: Serum levels of microRNA miR-371a-3p appear to comprise of all attributes of a valuable serum biomarker of germ cell tumors. This marker is also expressed in seminoma and it apparently outperforms the classical markers. Evaluation in a large scale multicentric study is warranted.

e15050 Background: The aim of this analysis was to identify parameters to predict additional vascular procedures during RTR in a multicenter setting in patients (pts) with GCT after chemotherapy. M...

229 Background: PC-RPLND remains an integral part of the multimodality treatment for advanced NSGCT. The need to resect and to replace the major retroperitoneal vessels must be known preoperatively to enable complete resection of the residual masses. Methods: PC-RPLND was performed in 411 patients with NSGCT and normalized (81%) or plateauing (19%) tumor markers following 3-4 cycles PEB/PEI. PC-RPLND was performed in 5 institutions with a variable surgical frequency of 14 to 158 PC-RPLNDs. Good, intermediate, and poor prognosis according to the IGCCCG criteria was identified in in 59.8%, 21.2%, and 19% respectively. Results: Resection of the inferior vena cava was performed in 28 (6.81%), resection of the abdominal aorta was necessary in 13 (3.16%) patients. In 29/41 (70.7%) adjunctive surgical procedures such as nephrectomy, small bowel resection, ureteral resection had to be performed to ensure complete resection of the residual masses. Histologically vital cancer or mature teratoma was identified in 78.1% of the resected vascular specimens. Mean time of surgery was 295 (243-615) Min., mean blood loss was 690 (350 – 3400) ml. Good prognosis was identified in 15.4%, intermediate and poor prognosis was present in 41%and 43.6%, resp. Of all 411 patients involvement of the major retroperitoneal vessels was found in 3.2%, 18.4% and 21.8% with good, intermediate, and poor prognosis, resp. The mean tumor diameter was 5.9 (1.0 – 32) cm for the entire cohort and 9.8 (4-32) cm for the cohort of patients with vascular surgery. Significant prognosticators to predict vascular involvement were identified by multivariate analysis: intermediate/poor prognosis, number of cycles of chemotherapy, tumor diameter > 14cm, circumferential encasement of > 50% of the vessel diameter. Conclusions: Complete resection of the inferior vena cava or the abdominal aorta during PC-RPLND is necessary in about 10% of patients. The identified predictors enable already preoperatively a risk adapted interdisciplinary approach for complete resection of the residual masses in an experienced centre. No significant financial relationships to disclose.

230 Background: PC-RPLND is a potentially complicated intervention. By the time the rate of complications and adjunctive surgery increased. Only few data are available concerning PC-RPLND in patients with advanced seminomas and residual retroperitoneal tumour lesions. We examined the intra and postoperative complications as well as the frequency of adjunctive surgeries in patients with seminoma and compared the data to a cohort of patients with NSGCT who underwent PC-RPLND. Methods: In our multicenter retrospective analyses 408 patients underwent PC-RPLND between 1989 and 2010. 47 patients with advanced seminomas and 327 patients with NSGCT. The surgical approach was preferred via a midline incision or a thoracoabdominal approach due to the location of the residual tumour. In one center a laparoscopic approach was preferred. Results: Of the 47 patients with seminoma a total number of 18 adjunctive surgeries were performed in 11 patients (8 nephrectomies, 3 inferior v.cava resections, 3 resections of the abdominal aorta, 2 resections of the colon, one nerv and 2 hepatic resections/biopsies). There was only one major intraoperative complication, injury of the v. cava and two postoperative complications, (prolonged intestinal paralyses). There were no significant differences adjunctive surgeries and postoperative complications (p=0.48 and p=0.133). There were significantly less intraoperative complications in favour of seminomas (p=0.006). Conclusions: PCRLND in seminomas and NSGCT is a demanding surgical intervention. In contrast to other series we did not find significant differences in the two patient groups concerning adjunctive surgeries and postoperative complications. The indication for PCLND in patients with seminoma is limited, but if necessary it can be performed safely in experienced centers. No significant financial relationships to disclose.

224 Background: The current guidelines recommend the resection of all visible residual tumors in NSGCT after a cisplatin based chemotherapy. There are controversial data concerning the necessity of PC-RPLND in patients with residual tumours less than one centimetre in diameter. The aim of our study was to evaluate the pathological findings in a modern series with regard of the residual tumour size. Methods: A retrospective analysis of the patient's charts was performed including patients who underwent PC-RPLND between 1989 and 2010. Of 408 patients 330 had a NSGCT, 78 patients had a pure seminoma or a primary extragonadal germ cell cancer and were excluded from analysis. The tumour size at the time of surgery was available in 261 patients in the remaining 69 pateints no preopretive data with regard to the tumour size were recorded in the radiology reports. Due to the location of the residual tumour a median laparotomy, a thoracoabdominal approach was used. In one center a laparoscopic approach was preferred. Results: Mean tumour diameter was 4.7 (0 to 32) cm. The patients were stratified in three groups: group 1 n=28 (RT11.5cm). The histological specimens contained teratoma in 21.4%, 39.1%, 44.5% respectively, viable cancer in 10.7%, 17.4% and 22% respectively, and fibrosis/necrosis in 64.3%, 52.2% and 37.8% respectively in the three grpups respectively. Conclusions: The finding of both teratoma and viable cancer decreases with decreasing sizes of the residual tumour. Nevertheless lesions No significant financial relationships to disclose.

5050 Background: RT and CT are efficient adjuvant therapies in seminoma stage I and were compared in this trial. Clinical results will be reported elsewhere. Secondary endpoint was to assess QoL. Materials and Methods: Pts were randomized to receive RT (5x2 Gy/wk, 26–30 Gy total dose) or carboplatinum (300–460 mg/m2, 1 h iv d 1, 29). The QLQ C30 vs. 2.0 (15 QoL dimensions) and the Testicular Tumour Questionnaire (TTQ, 16 domains) were completed at randomization (0) and 1, 4, and 12 months (m) after trial entry. QoL was compared over time within the two arms (Wilcoxon) and between treatments (Mann-Whitney) by intent-to-treat. Results: 807 pts were randomized. Questionnaire compliance was 72% at 0, 75% at 1, 69% at 4 and 70% at 12m. Sign. variation (p No significant financial relationships to disclose.

4512 Background: The incidence of relapse was analyzed in patients with clinical stage I (CS I) NSGCT after either retroperitoneal lymph node dissection (RPLND) or one course of adjuvant cisplatin, etoposide, and bleomycin (PEB) chemotherapy. Methods: Between September 1996 and February 2005, 382 patients with stage I NSGCT were included in the German Prospective Multicenter Trial. After orchiectomy, patients were randomized to either RPLND (191 patients) or one cycle of cisplatin 20 mg/sqm d1–5, etoposide 100 mg/sqm d1–5, and bleomycin 30 mg d1, 8, 15 (PEB, 191 patients). Pathological stage II after RPLND (18% of CS I) was followed by adjuvant chemotherapy (2 × PEB). The primary endpoint was relapse rate. The trial was powered to show an advantage for chemotherapy (planned sample size 360 patients, alpha 5%, power 80%) after a median follow-up of 3 years. Results: Thirty-six patients were excluded due to violation of the inclusion criteria. Of the remaining 346 eligible cases, 172 patients were treated by RPLND and 174 patients received one course of PEB. Median time of follow-up was 47 months, with 323 patients (93%) followed-up for at least 1 year. Of the evaluable patients 331 (96%) have remained disease-free. Thirteen (8%) patients experienced relapse after RPLND and 2 (1%) after one course of adjuvant PEB (p = 0.0028). All patients with relapse have been successfully treated. Five patients developed pulmonary metastases, 3 patients relapsed with retroperitoneal metastases, 3 patients showed marker elevations, and 2 patients had an inguino-scrotal relapse after RPLND. The patients with one cycle of PEB relapsed with a tumor marker elevation and a mature teratoma retroperitoneal metastases, respectively. Conclusions: This randomized trial revealed only two relapses among 174 patients treated with one course of PEB. The low risk of recurrence supports one course of PEB over RPLND for the treatment of patients with clinical stage I NSGCT. No significant financial relationships to disclose.

4572 Introduction: In the last 10 years there has been reports of increased risk of late occurrence of non-germ cell cancers 20 years or more after radiation as adjuvant for stage 1 seminoma. Prompted by a randomised study suggesting that 1 course carboplatin was equally effective but also in the short term(5years) was associated with significantly less tumours in the contrateral testis, this abstract reports 10 and 20 year follow up experience from the phase 2 studies of 1 and 2 course carboplatin that preceeded the randomised trial. Methods: Research of published papers identified 5 publications and 2 abstract with 837 cases followed for a median of 75 months. The data for relapse, germ cell cancer mortality, 2nd GCT and non-GCT causes of death have been pooled and the authors contacted for follow up. Results: 521 patients received 2 courses with 15(2.9%) relapse, 0 GCT deaths 0 second GCT and 7(1.3%) non GCT deaths (p ns). 316 received 1 course with 14(4.4%) relapses, 10/16(8.6%) in those receiving 400...