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  • American Society of Clinical Oncology (ASCO)  (4)
  • Gafita, Andrei  (4)
  • 1
    Online Resource
    Online Resource
    Novel framework for treatment response evaluation using PSMA-PET/CT in patients with metastatic castration-resistant prostate cancer (RECIP): An international multicenter study.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. 42-42
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 42-42
    Abstract: 42 Background: We aimed to develop a novel framework for Response Evaluation Criteria In PSMA-PET/CT (RECIP) 1.0 and a composite response classification which combines responses by PSA measurements and by RECIP 1.0 (PSA+RECIP). Methods: This was an international, multicenter, retrospective study. 124 men with mCRPC who underwent 177 Lu-PSMA therapy and received PSMA-PET/CT at baseline (bPET) and at interim at 12 weeks (iPET) were included. Pairs of bPET and iPET were interpreted by consensus among three blinded readers for appearance of new lesions. Tumor lesions were segmented and total PSMA-positive tumor volume (PSMA-VOL) was obtained. Appearance of new lesions and changes in PSMA-VOL were combined to develop RECIP 1.0, which was defined as: complete response (RECIP-CR: absence of any PSMA-ligand uptake on iPET), partial response (PSMA-PR: decline ≥30% in PSMA-VOL and no appearance of new lesions), progressive disease (RECIP-PD: increase ≥20% in PSMA-VOL and appearance of new lesions), stable disease (RECIP-SD: any condition but RECIP-PR or RECIP-PD). Changes in PSA levels at 12 weeks by PCWG3 were recorded. Responses by PSA+RECIP were defined as: response (PSA decline ≥50% or RECIP-PR/CR) and progression (PSA increase ≥25% or RECIP-PD). Study's primary outcome measure was the prognostic value of RECIP 1.0 for overall survival (OS). Secondary outcome measure was the prognostic accuracy (C-index) of PSA+RECIP vs PSA responses. Results: Patients with progressive disease (RECIP-PD; n=39; 8.3 mo) had shorter OS compared to patients with stable disease (RECIP-SD; n=47; 13.1 mo; p 〈 0.001) and to those with partial response (RECIP-PR; n=38; 21.7 mo; p 〈 0.001). PSA+RECIP had superior C-indices in identifying responders and progressors compared to PSA only: 0.65 vs 0.62 (p=0.028) and 0.66 vs 0.63 (p=0.044), respectively. Conclusions: PSMA-PET/CT by RECIP 1.0 is prognostic for OS and can be used as a response biomarker to monitor efficacy of 177 Lu-PSMA in men with mCRPC. PSA+RECIP may be used as a novel composite endpoint in mCRPC clinical trial design.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.042
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Efficacy and safety of 177 Lu-PSMA radionuclide treatment in patients with diffuse bone marrow involvement: A multicenter retrospective study.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e17543-e17543
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e17543-e17543
    Abstract: e17543 Background: 177 Lu-labelled prostate-specific membrane antigen (LuPSMA) radionuclide therapy of metastatic castration-resistant prostate cancer (mCRPC) is currently under investigation in phase III trial (VISION). However, patients with diffuse bone involvement, diagnosed with a superscan by bone scintigraphy at baseline, were excluded due to lack of efficacy and safety data. We therefore aimed to investigate the feasibility of LuPSMA in patients with diffuse bone marrow involvement on baseline PSMA-targeted PET/CT. Methods: Patients with progressive mCRPC treated with LuPSMA at six centers in Germany, USA and Australia were considered for inclusion.Eligible patients had 50% or greater bone involvement of the axial skeleton on the baseline PSMA PET. The primary endpoints were PSA response (PCWG3), toxicity (CTCAE v4.02), and overall survival (OS). Secondary endpoints included quality of life (assessed with Brief Pain Inventory-Short Form questionnaires) and radiological response (as measured by CT using RECIST 1.1). Results: 43 of 352 (12%) screened patients met inclusion criteria and were retrospectively analyzed. Median baseline PSA was 1000 (IQR 431-2151) ng/ml. PSA decline ≥50% was achieved in 26/43 (65%) patients, while median PSA progression-free survival was 4.8 (95%CI 2.4–7.1) mo. 15/42 (36%) evaluable patients exhibited pain progression with a median time-to-pain progression of 8.3 (95%CI 5.4–11.3) mo. After a median follow-up of 18.9 mo, median OS was 11.6 (95%CI 8.8-14.3) mo. Objective response in nodal or visceral disease was reported in 7/18 (39%) patients with evaluable target lesions on CT. Grade 3/4 anemia, thrombocytopenia and neutropenia occurred in 9/43 (21%), 10/43 (23%) and 3/43 (8%) patients, respectively. Of note, all patients had grade 1 anemia at baseline, with a median hemoglobin of 9.6 g/dl. 2/43 (5%) patients experienced an adverse event that required a reduction to the LuPSMA activity beginning with the third cycle. Conclusions: Patients with diffuse bone marrow involvement demonstrate similar LuPSMA efficacy and safety when compared to phase II evidence. Acceptable safety outcomes do not support exclusion of patients with a superscan from future LuPSMA treatment protocols.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e17543
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 3
    Online Resource
    Online Resource
    Interim PSMA PET/CT for response evaluation during LuPSMA treatment in mCRPC (INTERIM PET): An explorative, multicenter study.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 5066-5066
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 5066-5066
    Abstract: 5066 Background: The aim of this analysis was to evaluate the prognostic value of interim PSMA PET/CT in men with metastatic castration-resistant prostate cancer (mCRPC) treated with 177 Lu-PSMA and to develop a novel framework for Response Evaluation Criteria In PSMA-imaging (RECIP). Methods: This was an explorative, multicenter, retrospective study; 124 men with mCRPC who underwent 177 Lu-PSMA treatment and received PSMA-PET/CT at baseline (bPET) and at interim after two cycles of treatment (iPET) met the eligibility criteria and were included in this analysis. The primary endpoint was overall survival (OS). Pairs of bPET and iPET were interpreted by three independent readers for appearance of new lesions. Whole-body tumor lesions were segmented using qPSMA software and total PSMA-positive tumor volume (PSMA-VOL) was obtained. Changes in PSMA-VOL on iPET relative to bPET were calculated. After being tested separately for associations with OS, appearance of new lesions and changes in PSMA-VOL were combined to develop RECIP. Results: The median OS was 13.5 months (95%CI, 11.6-15.4). Appearance of at least one new lesion on iPET was observed in 73 (59%) patients and was associated with poor OS (hazard ratio [HR] 2.23; 95%CI, 1.51-3.28; P 〈 .001). Based on the current data, RECIP were defined as: partial response (PSMA-PR) as a decline ≥20% in PSMA-VOL and no appearance of new lesions; progressive disease (PSMA-PD) as an increase ≥20% in PSMA-VOL and appearance of new lesions; stable disease (PSMA-SD) was defined as any condition but not PSMA-PR or PSMA-PD. The OS of men with PSMA-PD (n = 41) was significantly worse compared to men with PSMA-SD (n = 47; HR 2.52; 95%CI, 1.61–3.93; P 〈 .001) and PSMA-PR (n = 36; HR 4.16; 95%CI, 2.54–6.78; P 〈 .001). PSMA-SD was associated with significantly worse OS compared to PSMA-PR (HR 1.65; 95%CI, 1.02–2.65; P =.039). The time dependent C-index of associations with OS for response according to RECIP was 0.68 (95%CI, 0.63-0.72). Conclusions: Interim staging using PSMA-PET/CT and response classification by RECIP is prognostic for survival of men with mCRPC treated with 177 Lu-PSMA. Validation of these findings in clinical trials is warranted.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.5066
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 4
    Online Resource
    Online Resource
    Prognostic markers for overall survival and outcome to LuPSMA radionuclide treatment in patients with metastatic castration-resistant prostate cancer.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 5548-5548
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 5548-5548
    Abstract: 5548 Background: The aim of this international multicenter retrospective analysis was to identify prognostic markers for the clinical outcome in late-stage mCRPC patients treated with 177 Lutetium-prostate-specific membrane antigen (LuPSMA) radionuclide treatment. Methods: Patients with progressive mCRPC treated with LuPSMA at six centers in Germany, USA, and Australia were considered for inclusion. Eligible patients had 24 predefined, pretherapeutic covariates (demographics, prior mCRPC treatments, and PSMA PET/CT derived parameters) and survival data available. Endpoints included overall survival (OS) and PSA progression-free survival (PSA-PFS). Covariates were tested using univariate and mulitvariate proportional hazards regression Cox models. Results: 267/414 (64%) patients met inclusion criteria and were analyzed. 113 patients participated in clinical trials (ACTRN12615000912583, NCT03042312), while 154 were enrolled in compassionate-access programs. After a median follow-up of 22.5 months, median OS was 13.0 months (95%CI 11.6-14.4); 83% of the patients died. Median PSA-PFS was 4.0 months (95%CI 3.2-4.7). In the multivariate analysis, factors associated with shorter OS were: shorter time since diagnosis of prostate cancer (HR=2.04; p=0.002), lower number of prior systemic therapies (≤3; HR=1.56; p=0.006), prior exposure to chemotherapy (HR=1.42; p=0.05), lower hemoglobin levels (HR=1.13; p=0.002), higher number of lesions (≥20: HR=1.53; p=0.009), multiple sites of metastases (bone/LN only vs. bone + LN; HR=1.39; p=0.03) and visceral involvement (M1c) (HR=1.45; p=0.01). Factors associated with longer PSA-PFS were: longer time since diagnosis of prostate cancer (HR=0.44; p 〈 0.001), higher hemoglobin levels (HR=0.32; p=0.03), presence of pelvic lymph nodes (LN) metastasis (N1) (HR=0.68; p=0.01), no distant lymph node metastases (M1a) (HR=0.66; p=0.01), no skeleton involvement (HR=0.44; p=0.01), no visceral metastases (M1c) (HR=0.51; p 〈 0.001), higher PSMA-positive tumor volume (HR=0.87; p=0.04), and higher SUVmean (HR=0.94; p=0.002). Conclusions: This retrospective analysis identified prognostic factors for survival and treatment response to LuPSMA. Along with the conventional risk factors in mCRPC, PSMA PET/CT can be a useful tool for stratifying patients and guide patient’s selection for LuPSMA radionuclide treatment.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.5548
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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