Treatment compliance and early toxicity in SAKK 01/10: Single-dose carboplatin and involved-node radiotherapy for treatment of stage IIA/B seminoma.

Authors

Alexandros Papachristofilou

Alexandros Papachristofilou

Department of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland

Alexandros Papachristofilou , Jens Bedke , Stefanie Hayoz , Natalie Fischer , Xaver Schiel , Ulrich Schratzenstaller , Susanne Krege , Anja Lorch , Daniel M. Aebersold , Paul-Martin Putora , Dominik R. Berthold , Deborah Zihler , Ngwa C. Azinwi , Friedemann Zengerling , Annette Dieing , Arndt-Christian Mueller , Richard Cathomas

Organizations

Department of Radiotherapy and Radiation Oncology, University Hospital Basel, Basel, Switzerland, Department of Urology, Universitätsklinikum Tübingen, Tübingen, Germany, Swiss Group for Clinical Cancer Research, Bern, Switzerland, Kantonsspital Winterthur, Winterthur, Switzerland, Department of Oncology, Hematology, Palliative Medicine and Internal Medicine, München Klinik Harlaching, Munich, Germany, Department of Urology, Kliniken Essen-Mitte, Essen, Germany, Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf, Duesseldorf, Germany, Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland, Kantonsspital St. Gallen, St. Gallen, Switzerland, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, Department of Oncology and Hematology, Kantonsspital Aarau, Aarau, Switzerland, Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland, Department of Urology and Pediatric Urology, University Hospital Ulm, University of Ulm, Ulm, Germany, Department of Hematology and Oncology, Vivantes Klinik am Urban, Berlin, Germany, Department of Radiation Oncology, University Hospital Tübingen, Tübingen, Germany, Department of Oncology, Cantonal Hospital Graubünden, Chur, Switzerland

Research Funding

Other Foundation
Rising Tide Foundation for Clinical Cancer Research.

Background: Standard treatment options for stage IIA/B seminoma include either extensive paraaortal/pelvic radiotherapy or intensive chemotherapy with 3x BEP or 4x EP. Both treatment modalities are associated with excellent efficacy but also a high rate of acute and late toxicities. Therefore, de-escalation strategies appear warranted for this patient group aiming to minimize acute and long-term toxicities while maintaining efficacy. SAKK 01/10 is a joint project of the Swiss Group for Clinical Cancer Research and the German Testicular Cancer Study Group. Methods: Patients with stage IIA/B seminoma (de novo or relapse on active surveillance) were eligible for participation in this single arm phase II trial. A repeat scan was advised in patients with equivocal lymph node enlargement. Treatment consisted of one cycle carboplatin AUC7 followed by involved-node radiotherapy with 30 Gy in stage IIA and 36 Gy in stage IIB disease. The primary endpoint of the trial is 3-year progression free survival. We report on treatment compliance and early toxicity during treatment and within 30 days. Results: 120 patients with stage IIA/B seminoma were recruited from 10/12 until 06/18 in 20 study centers in Switzerland and Germany. 116 patients were eligible and initiated treatment per protocol (40% stage IIA, 60% stage IIB). All patients received chemotherapy (CT) with a median applied dose of 984 mg (range: 560-1920 mg). The median planning target volume (PTV) for radiotherapy (RT) was 297 cm3 (range: 24-1047 cm3). RT was delayed/interrupted in two patients due to adverse events. During CT, grade 2 and grade 3 adverse events were seen in 21% and 2% of all patients respectively (most common grade 2 events: neutropenia 6%, nausea 5%). During RT, grade 2 and grade 3 adverse events were seen in 26% and 6% of all patients respectively (most common grade 2 events: neutropenia 15%, nausea 6%). One case of transient creatinine increase was reported as a severe adverse event, resolving without sequelae. Conclusions: Treatment with one cycle carboplatin AUC7 and 30-36 Gy involved-node radiotherapy for stage IIA/B seminoma is feasible and demonstrates a very favorable early toxicity profile. Clinical trial information: NCT01593241

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers

Track

Urothelial Carcinoma,Adrenal Cancer,Penile Cancer,Prostate Cancer - Advanced,Prostate Cancer - Localized,Testicular Cancer,Urethral Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT01593241

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 405)

Abstract #

405

Poster Bd #

E4

Abstract Disclosures