dc.contributor.author | Cafferty, FH | |
dc.contributor.author | White, JD | |
dc.contributor.author | Shamash, J | |
dc.contributor.author | Hennig, I | |
dc.contributor.author | Stenning, SP | |
dc.contributor.author | Huddart, RA | |
dc.contributor.author | TE23 Trial Management Group and Collaborators, | |
dc.date.accessioned | 2020-03-04T10:16:28Z | |
dc.date.issued | 2020-03-01 | |
dc.identifier.citation | European journal of cancer (Oxford, England : 1990), 2020, 127 pp. 139 - 149 | |
dc.identifier.issn | 0959-8049 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3525 | |
dc.identifier.eissn | 1879-0852 | |
dc.identifier.doi | 10.1016/j.ejca.2019.12.028 | |
dc.description.abstract | BACKGROUND: Up to 50% of men with poor prognosis, non-seminoma germ cell tumours (GCTs) die with standard BEP (bleomycin, etoposide and cisplatin) chemotherapy. An intensive regimen, CBOP/BEP (carboplatin, bleomycin, vincristine and cisplatin/BEP), met response targets in a randomised, phase II trial (74% complete response or partial response marker negative, 90% confidence interval (CI) 61%-85%). AIM: To assess long-term outcomes and late toxicity associated with CBOP/BEP. METHODS: Patients with poor prognosis extracranial GCT were randomised to 4xBEP or CBOP/BEP (2xCBOP, 2xBO, 3xBEP with 15,000iu of bleomycin). Low-dose, stabilising chemotherapy before entry was permitted. Response rates (primary outcome) were reported previously. Here, we report secondary outcomes: progression-free survival (PFS), overall survival (OS) and late toxicity. Prognostic factors and the impact of marker decline are assessed in exploratory analysis. RESULTS: Eighty-nine patients (43 CBOP/BEP) were randomised. After median 63 months follow-up, 3-year PFS is 55.7% (95% CI: 39.7%, 69.0%) for CBOP/BEP and 38.7% (95% CI: 24.7%, 52.4%) for BEP (hazard ratio [HR]: 0.59 (0.33, 1.06), p = 0.079). Three-year OS is 65.0% (48.8%, 77.2%) and 58.5% (43.0%, 71.2%), respectively (HR: 0.79 (0.41, 1.52), p = 0.49). Twelve-month toxicity was affected by subsequent treatments, with no clear differences between arms. Stabilising chemotherapy was associated with poorer PFS (HR: 2.09 (1.14, 3.81), p = 0.017), whereas unfavourable marker decline, in 60 (70%) patients, was not. CONCLUSION: Although not powered for PFS, results for CBOP/BEP are promising. Impact on OS was less clear (and will be affected by subsequent therapy). Further study in an international phase III trial is warranted. TRIAL REGISTRATION: ISRCTN 53643604. | |
dc.format | Print-Electronic | |
dc.format.extent | 139 - 149 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCI LTD | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | TE23 Trial Management Group and Collaborators | |
dc.subject | Humans | |
dc.subject | Neoplasms, Germ Cell and Embryonal | |
dc.subject | Neoplasm Recurrence, Local | |
dc.subject | Cisplatin | |
dc.subject | Carboplatin | |
dc.subject | Vincristine | |
dc.subject | Etoposide | |
dc.subject | Bleomycin | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Prognosis | |
dc.subject | Survival Rate | |
dc.subject | Follow-Up Studies | |
dc.subject | Adolescent | |
dc.subject | Adult | |
dc.subject | Middle Aged | |
dc.subject | Male | |
dc.subject | Young Adult | |
dc.title | Long-term outcomes with intensive induction chemotherapy (carboplatin, bleomycin, vincristine and cisplatin/bleomycin, etoposide and cisplatin) and standard bleomycin, etoposide and cisplatin in poor prognosis germ cell tumours: A randomised phase II trial (ISRCTN53643604). | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2019-12-21 | |
rioxxterms.versionofrecord | 10.1016/j.ejca.2019.12.028 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2020-03 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European journal of cancer (Oxford, England : 1990) | |
pubs.notes | No embargo | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart) | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart) | |
pubs.publication-status | Published | |
pubs.volume | 127 | |
pubs.embargo.terms | No embargo | |
icr.researchteam | Clinical Academic Radiotherapy (Huddart) | |
dc.contributor.icrauthor | Cafferty, Fay Helen | |
dc.contributor.icrauthor | Huddart, Robert | |