LBA30 Single-dose carboplatin followed by involved-node radiotherapy as curative treatment for seminoma stage IIA/B: Efficacy results from the international multicenter phase II trial SAKK 01/10

Papachristofilou, Alexandros; Bedke, Jens; Hayoz, Stefanie; Schratzenstaller, U; Pless, Miklos; Hentrich, M.; Krege, Susanne; Lorch, Anja; Aebersold, Daniel M.; Putora, PM; Berthold, Dominik R.; Zihler, Deborah; Azinwi, N.C.; Zengerling, Friedemann; Dieing, Annette; Mueller, A-C.; Schaer, Corinne; Biaggi, Christine; Gillessen, Sarah; Cathomas, Richard

doi:10.1016/j.annonc.2021.08.2106

Cited by 6 publications

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“…After a median follow-up of 4.6 years they reported no relapses. The prospective single-arm phase II SAKK 01/10 trial evaluated 3-year PFS in CS IIA/B seminoma patients treated with one cycle of Carboplatin AUC7 followed by reduced-field involved-node RT with 30 Gy in CS IIA and 36 Gy in CS IIB patients [ 43 – 45 ]. After a median follow-up of 4.5 years, 3-year PFS was 93.7% (CI 85.5–98.5%) in CS IIA and 95.2% (CI 85.2–96.4%) in CS IIB patients, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…After a median follow-up of 4.5 years, 3-year PFS was 93.7% (CI 85.5–98.5%) in CS IIA and 95.2% (CI 85.2–96.4%) in CS IIB patients, respectively. There were no cancer-specific deaths [ 45 ]. Additionally, the single-arm phase II SAKK 01/18 (NCT03937843) trial evaluates 3-year PFS in seminoma patients who receive one cycle of Carboplatin AUC7 (CS IIA) or EP (CS IIB) followed by reduced-field involved-node RT with 24 Gy (CS IIA) or 30 Gy (CS IIB).…”

Section: Discussionmentioning

confidence: 99%

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Therapy of clinical stage IIA and IIB seminoma: a systematic review

et al. 2021

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Purpose The optimal treatment for clinical stage (CS) IIA/IIB seminomas is still controversial. We evaluated current treatment options. Methods A systematic review was performed. Only randomized clinical trials and comparative studies published from January 2010 until February 2021 were included. Search items included: seminoma, CS IIA, CS IIB and therapy. Outcome parameters were relapse rate (RR), relapse-free (RFS), overall and cancer-specific survival (OS, CSS). Additionally, acute and long-term side effects including secondary malignancies (SMs) were analyzed. Results Seven comparative studies (one prospective and six retrospective) were identified with a total of 5049 patients (CS IIA: 2840, CS IIB: 2209). The applied treatment modalities were radiotherapy (RT) (n = 3049; CS IIA: 1888, CSIIB: 1006, unknown: 155) and chemotherapy (CT) or no RT (n = 2000; CS IIA: 797, CS IIB: 1074, unknown: 129). In CS IIA, RRs ranged from 0% to 4.8% for RT and 0% for CT. Concerning CS IIB RRs of 9.5%–21.1% for RT and of 0%–14.2% for CT have been reported. 5-year OS ranged from 90 to 100%. Only two studies reported on treatment-related toxicities. Conclusions RT and CT are the most commonly applied treatments in CS IIA/B seminoma. In CS IIA seminomas, RRs after RT and CT are similar. However, in CS IIB, CT seems to be more effective. Survival rates of CS IIA/B seminomas are excellent. Consequently, long-term toxicities and SMs are important survivorship issues. Alternative treatment approaches, e.g., retroperitoneal lymph node dissection (RPLND) or dose-reduced sequential CT/RT are currently under prospective investigation.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Therapy of clinical stage IIA and IIB seminoma: a systematic review

et al. 2021

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“…Seven patients (5.8%) relapsed and there were four (3.3%) second primary cancers including two seminomas, renal cancer, and cholangiocarcinoma. 114 Stage II non-seminoma Stage II non-seminoma is mostly managed with chemotherapy with BEP × 3 or EP × 4. Patients with serum markers in the normal range and lower volume retroperitoneal lymph nodes (<3 cm) may undergo nerve sparing RPLND.…”

Section: Stage I Seminomamentioning

confidence: 99%

“…Another multicenter single arm phase II study used sequential single dose carboplatin followed by involved node radiotherapy in 120 stage IIA-B seminomas and showed a 92.6% and 95.2% three year PFS, respectively. Seven patients (5.8%) relapsed and there were four (3.3%) second primary cancers including two seminomas, renal cancer, and cholangiocarcinoma 114…”

Section: Management Of Gctsmentioning

confidence: 99%

Advances in diagnosis and treatment of testicular cancer

Chovanec

Cheng

2022

BMJ

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Testicular cancer is a curable cancer. The success of physicians in curing the disease is underpinned by multidisciplinary advances. Cisplatin-based combination chemotherapy and the refinement of post-chemotherapy surgical procedures and diagnostic strategies have greatly improved long term survival in most patients. Despite such excellent outcomes, several controversial dilemmas exist in the approaches to clinical stage I disease, salvage chemotherapy, post-chemotherapy surgical procedures, and implementing innovative imaging studies. Relapse after salvage chemotherapy has a poor prognosis and the optimal treatment is not apparent. Recent research has provided insight into the molecular mechanisms underlying cisplatin resistance. Phase 2 studies with targeted agents have failed to show adequate efficacy; however, our understanding of cisplatin resistant disease is rapidly expanding. This review summarizes recent advances and discusses relevant issues in the biology and management of testicular cancer.

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“…Another recent phase 2 trial (SAKK 01/10) tested a single dose of carboplatin followed by involved-node radiotherapy as curative treatment for stage IIA/B seminoma [11] . Overall, 120 patients from 20 centers were recruited.…”

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confidence: 99%