BEP in intermediate- and poor-risk advanced non-seminomatous germ cell tumor (NSGCT): Standing the test of time.

Abstract

5026 Background: Bleomycin, etoposide, and cisplatin (BEP) has been the cornerstone of treatment for advanced NSGCT for decades. With the advent of newer regimens such as VIP (Etoposide, ifosfamide and cisplatin) and improved outcomes over the years, it is imperative to assess whether BEP has truly stood the test of time, especially for those in the intermediate and poor risk. Methods: This was a retrospective analysis of a prospectively collected dataset of NSGCT patients treated at a comprehensive cancer care centre in India. Adolescent and adult males with intermediate or poor-risk as per IGCCCG were included. The progression-free survival (PFS) and overall survival (OS) were calculated from date of diagnosis to date of progression and death respectively. Log-rank method was used to compare outcomes between BEP and VIP. Results: A total of 351 patients were analysed. The median age was 28 years (IQR: 23-34 years) (Table 1). Primary high-inguinal orchidectomy (HIO) was done in 208 (59.3%) and after completion of chemotherapy in 63 (17.9%) patients. There were 209 (59.5%) patients with poor-risk. Forty-seven (13.4%) received less than 4 cycles of chemotherapy. Retroperitoneal lymph node dissection (RPLND) was done in 195 (55.6%) patients. Overall, 45 (12.8%) patients had toxicities requiring hospitalization. Viable residual disease was seen in 33 (9.4%) patients. The median follow-up of the cohort was 58.9 + 3.6 months (95% CI: 51.9 – 65.9 months). Patients who received BEP had better 7-year PFS (68.4% vs 47.5%, p< 0.001) and 7-year OS (77.9% vs 55.2%, p<0.001) as compared to VIP albeit higher lung toxicities and deaths due to chemotherapy. The cohort which received VIP had higher percentage of smokers, mediastinal primary, visceral metastases and S3 tumor markers. Conclusions: BEP has stood the test of time and remains the standard of care. However, for patients who are smokers, or have aggressive disease, VIP is a good alternative. Patient, disease and treatment characteristics. Characteristics BEP(n = 226) VIP(n = 125) p-value Age group (years) 0.217 < 35 181 (80.1%) 93 (74.4%) > 35 45 (19.9%) 32 (25.6%) ECOG PS 0.004 0-1 216 (95.6%) 110 (88%) 2-3 10 (4.4%) 15 (12%) Smokers 19 (8.4%) 20 (16%) 0.034 Primary site < 0.001 Testis 206 (91.2%) 95 (76%) Retro-peritoneum 12 (5.3%) 3 (2.4%) Mediastinum 8 (3.5%) 27 (21.6%) Tumor markers (S) 0.061 Sx 6 (2.7%) 1 (0.8%) S0 3 (1.3%) 0 S1 11 (4.9%) 8 (6.5%) S2 124 (54.9%) 53 (43.1%) S3 82 (36.3%) 61 (49.6%) Sites of metastases None 53 (23.4%) 5 (4%) < 0.001 Non-regional lymph nodes 92 (40.7%) 62 (49.6%) 0.108 Pulmonary 115 (50.9%) 86 (68.8%) 0.001 Non-pulmonary visceral 43 (19.0%) 28 (22.4%) 0.074 Less than 4 cycles chemotherapy 31 (13.7%) 16 (12.8%) 0.809 Toxicities Grade 3-4 febrile neutropenia 54 (23.9%) 42 (33.6%) 0.214 Grade 3-4 hematological toxicities 93 (41.1%) 77 (61.6%) 0.003 Lung toxicities 29 (12.8%) 2 (1.6%) < 0.001 Toxicities requiring hospitalization 29 (12.8%) 16 (12.8%) 0.806 Deaths 5 (2.2%) 1 (0.8%) 0.328 Viable residual disease after chemotherapy 17 (7.52%) 16 (12.8%) 0.041