A phase II study of carboplatin AUC-10 guided by positron emission tomography–defined metabolic response in metastatic seminoma

Shamash, Jonathan; Syed, Rabbani; Sarker, Shah-Jalal; Sarwar, Naveed; Sharma, Anand; Mutsvangwa, Katherine; Coetzee, Carike; Wilson, Peter; Rustin, G. J. S.

doi:10.1016/j.ejca.2019.04.013

Cited by 11 publications

(4 citation statements)

References 15 publications

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“…Considering the alternative advanced relapse definition ($ 3 cm), the increase associated with the three-scan schedule was small (six events, 2.0% increase, ITT) and noninferiority was demonstrated. Thus, the impact of a less frequent imaging schedule on the selection for the use of local treatment at relapse (either radiotherapy or, as recently reported, minimally invasive retroperitoneal surgery 31,32 ) is likely to be small, especially as our data suggest some centers use the same approach (either highdose carboplatin 23 or BEP) regardless of relapse stage/size. Hence, numbers of advanced relapses would not affect care.…”

Section: Discussionmentioning

confidence: 68%

“…Relapses were treated with low-dose carboplatin and paraaortic radiotherapy (33), combination chemotherapy (normally 43 BEP, 28), or high-dose carboplatin (17; Appendix Fig A2, online only). 23 Combination chemotherapy was slightly more common in the three-scan group, given the greater number of advanced relapses. Sixtyseven/80 (84%) of patients had a complete response (in Abbreviations: CT, computed tomography; ITT, intention-to-treat; MRI, magnetic resonance imaging; PP, per-protocol.…”

Section: Relapse Treatment and Long-term Outcomesmentioning

confidence: 98%

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Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST)

Joffe

Cafferty

Murphy

et al. 2022

JCO

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PURPOSE Survival in stage I seminoma is almost 100%. Computed tomography (CT) surveillance is an international standard of care, avoiding adjuvant therapy. In this young population, minimizing irradiation is vital. The Trial of Imaging and Surveillance in Seminoma Testis (TRISST) assessed whether magnetic resonance images (MRIs) or a reduced scan schedule could be used without an unacceptable increase in advanced relapses. METHODS A phase III, noninferiority, factorial trial. Eligible participants had undergone orchiectomy for stage I seminoma with no adjuvant therapy planned. Random assignment was to seven CTs (6, 12, 18, 24, 36, 48, and 60 months); seven MRIs (same schedule); three CTs (6, 18, and 36 months); or three MRIs. The primary outcome was 6-year incidence of Royal Marsden Hospital stage ≥ IIC relapse (> 5 cm), aiming to exclude increases ≥ 5.7% (from 5.7% to 11.4%) with MRI ( v CT) or three scans ( v 7); target N = 660, all contributing to both comparisons. Secondary outcomes include relapse ≥ 3 cm, disease-free survival, and overall survival. Intention-to-treat and per-protocol analyses were performed. RESULTS Six hundred sixty-nine patients enrolled (35 UK centers, 2008-2014); mean tumor size was 2.9 cm, and 358 (54%) were low risk (< 4 cm, no rete testis invasion). With a median follow-up of 72 months, 82 (12%) relapsed. Stage ≥ IIC relapse was rare (10 events). Although statistically noninferior, more events occurred with three scans (nine, 2.8%) versus seven scans (one, 0.3%): 2.5% absolute increase, 90% CI (1.0 to 4.1). Only 4/9 could have potentially been detected earlier with seven scans. Noninferiority of MRI versus CT was also shown; fewer events occurred with MRI (two [0.6%] v eight [2.6%]), 1.9% decrease (–3.5 to –0.3). Per-protocol analyses confirmed noninferiority. Five-year survival was 99%, with no tumor-related deaths. CONCLUSION Surveillance is a safe management approach—advanced relapse is rare, salvage treatment successful, and outcomes excellent, regardless of imaging frequency or modality. MRI can be recommended to reduce irradiation; and no adverse impact on long-term outcomes was seen with a reduced schedule.

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Section: Discussionmentioning

confidence: 68%

Section: Relapse Treatment and Long-term Outcomesmentioning

confidence: 98%

Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST)

Joffe

Cafferty

Murphy

et al. 2022

JCO

Self Cite

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“…Local control duration ranged from 5 to 12 months, and the median PFS time was 8 months. Studies have also shown that carboplatin can be used as an alternative to cisplatin-based combination chemotherapy to reduce the incidence of pulmonary toxicity, neurological damage and renal toxicity ( 35 , 36 ).…”

Section: Discussionmentioning

confidence: 99%

Iodine‑125 seeds combined with carboplatin in the treatment of retroperitoneal metastatic seminoma: A case report and literature review

Ran,

Liu,

Jiang

2024

Oncol Lett

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Testicular seminoma is a relatively rare malignant tumor, with the most common site of recurrence and metastasis being the retroperitoneal lymph nodes. Since seminoma is highly sensitive to radiotherapy and chemotherapy, even if it metastasizes, its cure rate is still >95%. However, the long-term toxicity and side effects of radiotherapy and chemotherapy cannot be ignored. Iodine-125 seeds represent a low-energy radioactive source that kills tumor cells while protecting the surrounding normal tissues, and brachytherapy using iodine-125 seeds has been widely used for the treatment of various malignancies. In addition, carboplatin can be used as an alternative to cisplatin-based combination chemotherapy to reduce the incidence of pulmonary toxicity, neurological damage and renal toxicity. In the present study, a case in which iodine-125 seeds were implanted for the treatment of retroperitoneal metastatic seminoma is reported. The patient was diagnosed with postoperative recurrence of seminoma that metastasized to the retroperitoneal lymph nodes. Since the tumor was large and surrounded blood vessels, surgical intervention and external radiotherapy were not considered. Moreover, considering the potential long-term toxic side effects of standard chemotherapy, a treatment plan for the patient using iodine-125 seed implantation combined with carboplatin (AUC7) therapy was finally formulated. No disease recurrence or toxic reactions occurred during the 3-year follow-up after treatment. The present case therefore demonstrated the antitumor efficacy and reduced toxicity of iodine-125 seeds combined with carboplatin for treating seminoma.

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“…Bei fehlender metabolischer Aktivität wurden 2 weitere Zyklen Carboplatin AUC10 verabreicht, bei PET-Positivität waren es 3 weitere Zyklen. Die Autoren berichteten über ein PFS von etwa 95 % [26]. Limitierend ist die Größe der Studie mit lediglich knapp 50 Patienten und die mediane Follow-up-Dauer von etwa 2,5 Jahren.…”

Section: Chemotherapieunclassified

Therapiemöglichkeiten des Seminoms im klinischen Stadium I und II unter Berücksichtigung der Langzeittoxizität

et al. 2020

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Zusammenfassung Hintergrund Bei mehr als 80 % aller Patienten mit einem Seminom wird die Diagnose im Stadium I–IIB gestellt. In den letzten Jahrzehnten wurden Therapiealgorithmen anhand von klinischen Studien definiert und mögliche Toxizitäten anhand von Langzeitbeobachtungen untersucht. Fragestellung Therapieoptionen werden unter Berücksichtigung der Langzeittoxizitäten dargelegt. Material und Methoden Es erfolgte eine Literaturrecherche sowie die kritische Auseinandersetzung mit Leitlinienempfehlungen und laufenden Studien. Ergebnisse Die präferierte Option im Stadium I ist die aktive Überwachung. Eine adjuvante Carboplatintherapie oder Strahlentherapie können das Rezidivrisiko senken. Im Stadium IIA/B wird eine primäre Strahlentherapie oder eine Polychemotherapie empfohlen. Experimentelle Ansätze testen die Lymphadenektomie und die deeskalierte Radio‑/Chemotherapie. Das Toxizitätsprofil von Radio- und Chemotherapie unterscheidet sich markant. Individuelle Nachsorgepläne nach Risikoprofil werden empfohlen. Schlussfolgerung Patienten mit Risikofaktoren im Stadium I haben ein relevantes Rezidivrisiko, sodass eine adjuvante Therapie gegenüber der aktiven Überwachung abgewogen werden kann. Die Wahl der Therapie im Stadium IIA/B sollte sich an der Tumorlast und den möglichen Spättoxizitäten orientieren. Strategien zur Therapiedeeskalation sind in Erarbeitung – mit ermutigenden ersten Resultaten.

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A phase II study of carboplatin AUC-10 guided by positron emission tomography–defined metabolic response in metastatic seminoma

Abstract: Conclusion Carboplatin AUC 10 monotherapy is effective with low toxicity. Early changes during PET scanning may allow de-escalation of therapy in high volume diseasecomparison against combination therapy is warranted. Clinicaltrials.gov identifier: NCT02272816

Cited by 11 publications

References 15 publications

Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST)

Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST)

Iodine‑125 seeds combined with carboplatin in the treatment of retroperitoneal metastatic seminoma: A case report and literature review

Therapiemöglichkeiten des Seminoms im klinischen Stadium I und II unter Berücksichtigung der Langzeittoxizität

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