Phase 2 analysis on Covid-19- adopted etoposide (E) and cisplatin (P) regimens for patients (pts) with an advanced germ cell tumor (GCT): The CovGCT study

Naban, N.; Tiemeier, G.; Kocache, A.; Taylor, R.; Keogh, G.; Hennah, L.; Sarwar, N.; Seckl, M.; Gonzalez, M.

Background: The Covid19 pandemic has imposed risks to healthcare delivery for all cancer pts including young adults diagnosed with a GCT. Here, we examine Emergency EP (EmEP, Cohort A) and a novel 1-day Escalateddose EP (EscEP, Cohort B) administered every 2 weeks as upfront or first-relapse therapy to minimise hospital days. Methods: Single-centre analysis in GCT pts receiving emergency and routine chemotherapy following our first National lockdown on 23 March 2020. In Cohort A, eligible pts receive EmEP E100mg/m2 , P20mg/m2 prior to EscEP within the acute setting as previously defined. In Cohort B, EscEP E500mg/m2 , P60mg/m2 is compared to standard care chemotherapy BEP or POMB-ACE. Data collection includes demographics, treatment details, clinical outcome and Covid19 complications. Results: To date, we have accrued 19 pts with a median age 32 (range 18 to 65). In Cohort A, 7 pts with symptomatic high-volume disease received a median 1 cycle EmEP, 6/7 for a new GCT diagnosis and 1/7 for a first relapse, including 2 males with IGCCCG intermediate-prognosis disease, 5 females with FIGO Stage III (n = 2) and IV (n = 3) disease. One pt required higher-level support for organ dysfunction at presentation. In Cohort B, 19 pts including 7 pts from Cohort A received a median 4 cycles EscEP: 8 males (2 seminomas, 6 nonseminomas;IGCCCG good-prognosis in 4, intermediate-prognosis in 2, poor-prognosis in 2), 11 females (1 dysgerminoma, 10 nondysgerminomas;FIGO Stage Ic in 6, III in 2, IV in 3). A majority (14/19, 74%) received EscEP for a new cancer diagnosis, 5/19 (26%) for a first relapse. Total median hospital stay: EscEP 5 days, BEP 21 days, POMB-ACE 28 days. Grade 3/4 neutropenic events: EscEP 28%, BEP 50%, POMB-ACE 43%. From April 2020, 16/16 pts were SARS-CoV-2 screened prior to each cycle: 3/19 (16%) testing positive, one prior to intubation and ventilation, 2 with asymptomatic infection. For Cohort B, at median follow-up 121 days (range 9-323 days), we have observed a complete response in 10 pts (53%), partial response in 3 pts (16%) and disease progression in 1 pt (5%). Five pts are still on treatment (26%). All pts remain alive. Conclusions: EmEP and EscEP represent safe options during the pandemic that minimise myelosuppression and total length in hospital days whilst bypassing the potential pulmonary toxicity from Bleomycin. Further follow-up will inform on long-term efficacy including a multicentre evaluation.