Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Joffe JK

PROVIDER: S-EPMC7614664 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Joffe Johnathan K JK Cafferty Fay H FH Murphy Laura L Rustin Gordon J S GJS Sohaib Syed A SA Gabe Rhian R Stenning Sally P SP James Elizabeth E Noor Dipa D Wade Simona S Schiavone Francesca F Swift Sarah S Dunwoodie Elaine E Hall Marcia M Sharma Anand A Braybrooke Jeremy J Shamash Jonathan J Logue John J Taylor Henry H HH Hennig Ivo I White Jeff J Rudman Sarah S Worlding Jane J Bloomfield David D Faust Guy G Glen Hilary H Jones Rachel R Seckl Michael M MacDonald Graham G Sreenivasan Thiagarajan T Kumar Satish S Protheroe Andrew A Venkitaraman Ramachandran R Mazhar Danish D Coyle Victoria V Highley Martin M Geldart Tom T Laing Robert R Kaplan Richard S RS Huddart Robert A RA

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20220317 22

<h4>Purpose</h4>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.<h4>Methods</h4>A phase III, noninferiority, factorial trial. Elig ...[more]

PMID: 35298280

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Project description:PurposeThis study's objective was to report cancer control and toxicity outcomes after proton radiation therapy (RT) in testicular seminoma and to compare secondary malignancy (SMN) risks with photon-based treatment alternatives.Methods and materialsConsecutive patients with stage I-IIB testicular seminoma treated with proton RT at a single institution were retrospectively analyzed. Kaplan-Meier estimates for disease-free and overall survival were computed. Toxicities were scored using Common Terminology Criteria for Adverse Events version 5.0. Photon comparison plans, including 3-dimensional conformal RT (3D-CRT) and intensity modulated RT (IMRT)/volumetric arc therapy (VMAT), were created for each patient. Dosimetric parameters and SMN risk predictions for different in-field organs-at-risk were compared between the techniques. Excess absolute SMN risks were estimated with organ equivalent dose modeling.ResultsTwenty-four patients were included (median age, 38.5 years). The majority of patients had stage II disease (IIA, 12 [50.0%]; IIB, 11 [45.8%]; IA, 1 [4.2%]). Seven (29.2%) and 17 (70.8%) patients had de novo and recurrent disease, respectively (de novo/recurrent: IA, 1/0; IIA, 4/8; IIB, 2/9). Most acute toxicities were mild (grade 1 [G1], 79.2%; G2, 12.5%) with G1 nausea being most common (70.8%). No serious events (G3-5) occurred. With a median follow-up time of 3 years (interquartile range, 2.1-3.6 years), 3-year disease-free and overall survival rates were 90.9% (95% confidence interval, 68.1%-97.6%) and 100% (95% confidence interval, 100%-100%), respectively. There were no documented late toxicities in the follow-up period, including worsening serial creatinine levels suggestive of early nephrotoxicity. Proton RT had significant reductions in mean organ-at-risk doses to the kidneys, stomach, colon, liver, bladder, and body compared with both 3D-CRT and IMRT/VMAT. Proton RT had significantly lower SMN risk predictions compared with 3D-CRT and IMRT/VMAT.ConclusionsCancer control and toxicity outcomes using proton RT in stage I-IIB testicular seminoma are consistent with existing photon-based RT literature. However, proton RT may be associated with significantly lower SMN risks.

Project description:ObjectivesPrimary tumor size (PTS) is the main prognostic factor for relapse in clinical stage (CS) IA testicular seminoma (T1N0M0S0) and the 8th edition of the Tumor-Node-Metastasis staging system now subcategorizes pT1 tumors into pT1a and pT1b based on PTS (<3 cm and ≥3 cm, respectively). We attempted to assess PTS as a prognosticator for overall survival (OS) in CS IA seminoma and to evaluate the comparative effectiveness of active surveillance (AS) versus adjuvant therapy (AT) in patients with large primary tumors (LPT).Methods and materialsIn the National Cancer Database (2004-2014), 2455 (47.7%) and 2685 (52.3%) patients with CS IA seminoma were treated with AS and AT, respectively. AT was defined as the receipt of chemotherapy or radiation within 3 months after orchiectomy. A cut-point analysis was performed to determine the optimal PTS threshold predicting OS at 5 years after orchiectomy. Inverse-probability of treatment weighting (IPTW)-adjusted Kaplan-Meier curves and Cox regression analyses were used to compare OS of patients with LPT (using the optimal PTS cut-point) treated with AS versus AT.ResultsIn adjusted analysis, pathologic T-stage (pT1a vs. pT1b) did not predict OS and no OS benefit was noted in pT1b patients treated with AT. The optimal PTS cut-point was 4.5 cm. In multivariable analysis, patients with LPT (≥4.5 cm) had an increased risk of overall mortality (HR = 1.87, P = 0.003). Kaplan-Meier curves revealed that OS was superior in patients with LPT treated with AT (IPTW-adjusted log-rank P = 0.029). In IPTW-adjusted Cox regression analysis, AT was associated with an OS benefit in patients with LPT (HR = 0.59, 95%CI: 0.39-0.91, P = 0.017).ConclusionsIn this National Cancer Database analysis, PTS was a predictor of OS in CS IA seminoma. An OS benefit was noted for individuals with LPT (defined as PTS ≥4.5 cm) managed with AT. These findings may warrant refinement of Tumor-Node-Metastasis staging system.

Dataset Information

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

Purpose

Methods

Results

Conclusion

Publications

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

Similar Datasets

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