GAMMA: Results from a phase II study for relapsed germ cell tumors using an oxaliplatin-based treatment regimen.

Authors

null

Kenrick Ng

Barts Health NHS Trust, London, United Kingdom

Kenrick Ng , Aaron Prendergast , Abigail Carter , Yathushan Yogeswaran , Susanna B. Alexander , Sarah Rudman , Han Hsi Wong , Constantine Alifrangis , Ewa Nowosinska , Daniel Berney , Jonathan Shamash

Organizations

Barts Health NHS Trust, London, United Kingdom, Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom, Norfolk and Norwich University Hospitals, Norwich, United Kingdom, Guy's Hospital, London, United Kingdom, Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom, University College London Hospitals NHS Foundation Trust, London, United Kingdom, Department of Nuclear Medicine, Barts Health NHS Trust, London, United Kingdom, Barts Cancer Institute, London, United Kingdom, St Bartholomew's Hospital, London, United Kingdom

Research Funding

Other

Background: Following relapse from first line chemotherapy, 30-60% of patients with germ cell tumors (GCTs) can be salvaged with further chemotherapy. Oxaliplatin-based therapies may offer reduced toxicity. Methods: Eligible patients with GCTs who progressed following cisplatin-based chemotherapy were recruited into this single-arm, phase II clinical trial (NCT01782339). Participants were recruited from six centers and received four 21-day cycles of: Actinomycin D 1mg/m2, high dose Methotrexate 5-8g/m2 day 1, Paclitaxel 80mg/m2 days 1, 8 and 15, Oxaliplatin 85mg/m2 days 4 and 8 with Pegfilgrastim support. Participants underwent an FDG-PET scan at baseline, prior to cycle 2 and on completion of treatment. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS) and toxicity. Results: 44 patients received at least one dose of the study medication between November 2012 and February 2020. In this full analysis set (FAS) population, the median age was 38 (range 20-57), with 9 (20%) with seminoma, 23 (52%) non-seminoma and 12 (27%) of other histology. 31 (70%) patients had at least intermediate risk disease by IPFSG risk group criteria (n = 16, 36% intermediate risk, n = 6, 14% high risk, n = 9, 20% very high risk). 39 patients received 2 or more cycles of the treatment regimen and were deemed part of the subgroup of patients in the evaluable population. The ORR of the FAS population was 52.3% and 59.0% in the evaluable population. The metabolic response rate (MRR) was 52.3% in the FAS population and 59.0% in the evaluable population. The median radiological PFS in the FAS population was 17.0 months (95% CI, 5.7 months- not reached, NR) with a radiological PFS rate at two years of 38.7% (95% CI, 22.3%-54.9%). The median combined radiological or tumour marker PFS in the FAS population was 8.3 months (95% CI, 2.6 months-17.4 months) with a combined radiological or tumour marker PFS rate at two years of 28.9% (95% CI, 16.0%-43.1%). At a median follow-up of 26.8 months, the median OS in the FAS population was not reached (95% confidence interval [CI], 17.0 months-NR) with an OS rate at two years of 62.5% (95% CI, 46.1%-75.2%). Toxicity data and correlation between early metabolic response and outcomes will be presented at the meeting. Conclusions: The GAMMA chemotherapy regimen has demonstrated encouraging anti-tumor activity in relapsed GCT, despite recruiting a cohort of patients with relatively unfavorable outcomes. Clinical trial information: NCT01782339.

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Abstract Details

Meeting

2022 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer,Urethral Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT01782339

Citation

J Clin Oncol 40, 2022 (suppl 6; abstr 417)

DOI

10.1200/JCO.2022.40.6_suppl.417

Abstract #

417

Poster Bd #

Online Only

Abstract Disclosures

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