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We retrospectively analysed overall survival (OS) and potential predictive biomarkers of OS in patients with metastatic melanoma treated with ipilimumab plus nivolumab in a single institution. Electronic medical records of patients with advanced melanoma receiving ≥ 1 dose of a combined ipilimumab plus nivolumab regimen between March 3, 2016 and March 7, 2020 in a single institution, were reviewed. OS was analysed using the Kaplan–Meier method. Sub-group analyses were conducted to examine several endpoints according to relevant clinical, molecular and pathological variables using logistic and Cox models. Forty-four cases were reviewed, 38 (86.4%), of whom had cutaneous melanoma, 21 (47.7%) were BRAF mutant, 21 (47.7%) presented high lactate dehydrogenase (LDH) values, 23 (52.3%) had ≥ 3 disease sites, and 10 (22.7%) patients had brain metastases. The median follow-up was 37.7 months, and the median OS was 21.1 months (95% CI 8.2–NR). In the multivariate analysis, the OS was significantly longer in patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, LDH ≤ upper limit of normal, absence of liver metastases and neutrophil-to-lymphocyte ratio (NLR)

Background Immune checkpoint combination therapy with nivolumab and Ipilimumab for untreated metastatic melanoma has shown higher rates of response rates, progression free survival and overall survival compared to monotherapy (Long et al. ESMO 2019), including patients with brain metastasis, at a cost of higher toxicity. Several clinical factors had been identified as prognostic of response to immunotherapy, such as LDH, dLNR and toxicity. Methods We analysed all patients with melanoma treated with ipilimumab and nivolumab between March 2017 and September 2019 institution. Statistical analysis was preformed with IBM SPSS Statistics 24.0. Results 42 patients (p) treated with ipilimumab and nivolumab were included. 22 (52.4%) men, 38 (90%) ECOG 0-1 (%). Stages at treatment: IVA (n = 4), IVB (n = 11), IVC (n = 17), IVD (n = 9). 20p (48%) presented a positive BRAF mutation. 10p (24%) had a previous adjuvant treatment. LDH: N (n = 25, 60%), 1.2xULN (n = 10, 24%). Cycles completed: 1 (n = 4), 2 (n = 16), 3 (n = 7), 4 (n = 12). Best Overall Response (BOR): Progressive disease (n = 22, 52%), stable disease (n = 4, 10%), partial response (n = 10, 24%), complete response (n = 6, 14%). Immunorelated adverse events (irAEs): Yes (n = 27, 64,3%), no (n = 15, 35,7%). Hepatitis 15, colitis 5, hypophysitis 5, thyroiditis 1, Nephritis 1. Grades: 1 (n = 2), 2 (n = 14), 3 (n = 8), 4 (n = 3), Number of CNS lesions: 1 (n = 0), 2 (n = 2), 3 (n = 0) and >3 (n = 8). 9 patients presented CNS disease, 4 of them had symptoms requiring steroid treatment. OS from the whole population was 34.7 months (m) (22.6-46.8, IC 95%). Independent predictors of OS where ECOG (p = 0.1, IC 95%), no previous treatment (p = 0.07, IC 95%), LDH (p = 0.02, IC 95%), irAES (p = 0.05), No 25.6m (8,9-42,4), Yes 39.1m (26.1-52.2), IC 95%). BRAF status, cycles, number of extracranial lesions, number of intracranial lesions and dNLR were not found to be predictors of OS. A significant association was found between BOR and irAEs (p = 0.009), LDH (p = 0.018), ECOG (p = 0.027). Conclusion In our cohort, LDH, ECOG and irAEs and no previous treatment were found predictors of response and overall survival. Our median OS and ORR were slighly slower than reported in trials. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure A.M. Arance Fernandez: Honoraria (self): Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

Background Despite improvements in diagnosis and aggressive chemotherapy treatment, a proportion of young patients are still dying from germ cell cancer (GCC). We aim to identify additional prognostic factors that help to select patients that might benefit from new treatment strategies. Anaemia is prognostic in several tumours. Thus, our objective was to address the prognostic significance of anaemia in disseminated testicular GCC. Methods A multicentre, observational, retrospective study of patients with disseminated testicular GCC receiving first-line platinum-containing chemotherapy between 2000-2014, pooled from the Spanish Germ-Cell Cancer Group registry and another 3 tertiary hospitals. All patients with haemoglobin level available at diagnosis were selected for the analysis. We used the Cox-proportional hazard model to identify prognostic factors. Results 665 consecutive patients from 18 centres were included for analysis. The patient distribution according to the International Germ Cell Cancer Collaboration Group (IGCCCG) classification was: 427, 125 and 113 patients for good, intermediate and poor risk categories, respectively. Hb Conclusions In our series, Hb Legal entity responsible for the study The Spanish Germ Cell Cancer Group (SGCCG). Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Background After decades of irradiation as standard therapy for clinical stage I testicular seminoma, alternative treatment approaches have emerged including postorchiectomy surveillance and adjuvant chemotherapy. This study was performed to assess a dual policy of surveillance and selective single-agent carboplatin (for high-risk cases) in a multicenter setting. Patients and methods From 1994 to 1999, 203 patients with stage I seminoma were included. Sixty (29.6%) were considered poor-risk cases (i.e. with vascular invasion and/or pathological tumor stage pT2 or greater) and received two courses of adjuvant carboplatin, whereas 143 (70.4%) without risk criteria underwent close surveillance. Results Median follow-up was 52 months (range 14–92). Relapses were observed in two (3.3%) patients treated with carboplatin and in 23 patients (16.1%) on surveillance, with a median time to recurrence of 11 months (range 3.9–39.6). All relapsing patients were rendered disease-free, mainly with cisplatin-based chemotherapy. Four patients died from tumor-unrelated causes. Actuarial 5-year overall survival was 96.7% and cause-specific survival was 100%. Five-year disease-free survival was 83.5% for patients on surveillance, and 96.6% for those receiving carboplatin. Conclusions This dual treatment policy is feasible in a multicenter setting and preserves 70% of patients from adjuvant chemotherapy. Single-agent carboplatin is effective in reducing the relapse rate in patients with high-risk stage I seminoma. A better definition of local risk features would probably improve patient selection, thus minimizing the incidence of recurrences on surveillance.

Objective: To describe the clinical characteristics and treatment results obtained with the application of a homogeneous treatment protocol in 1490 patients with germ-cell tumours (GCT) registered in the 55 hospitals belonging to the Spanish Germ-Cell Cancer Group (GG) during the period between January 1994 and April 2001. Methods: In general, surveillance was the common policy for stage I patients without local poor prognosis factors, whereas they received adjuvant chemotherapy in case those factor were present. Chemotherapy schedules used in advanced cases were cisplatin and etoposide (EP) for seminoma and BEP or BOMP-EPI in non-seminoma, according to whether the patient was in the good or poor prognosis IGCCCG (International Germ-Cell Cancer Collaborative Group) group. Excision of residual masses was mandatory in non-seminomatous germ-cell tumour (NSGCT). Results: Initial local symptomatology was increased testis size in 90% of cases. Sonography was an excellent diagnostic tool to suggest tumour. Non-seminoma (64.2%) was more frequent than seminoma (35.8%). Approximately 10% had the antecedent of cryptorchidism. Non-seminoma patients were 7 years younger than seminoma. Right testis was involved predominantly. Pre-orchidectomy tumour markers were elevated in 21% of seminoma (βHGC) and 79% in non-seminoma (αFP and/or βHGC). Scrotum violation occurred in only 1.8%. There were significant differences among stage I and the IGCCCG prognosis groups related to a longer interval between the first symptom and orchiectomy. Eighteen percent of non-seminomatous germ-cell tumour belonged to the poor prognosis IGCCCG group. With a median follow-up to 33 months, this series has achieved a 3 year overall survival of 98% for seminoma and 94% for non-seminoma. Only 10% of excised residual masses present after chemotherapy contained malignant cells. Conclusion: Spanish GCT have a similar clinical pattern to that described in the other occidental countries except for a slight increased proportion of non-seminoma upon seminoma. Co-operative groups as GG are unique structures to obtain quick and wide experience on the treatment of testis tumours, contributing to achieve a high cure rate.