Circulating tumor cell (CTC) rise and outcome in patients with metastatic castration-resistant prostate cancer (mCRPC) with low baseline CTC counts.

David Lorente; David Olmos; Joaquin Mateo; Zafeiris Zafeiriou; Pasquale Rescigno; Diletta Bianchini; Niven Mehra; Arturo Molina; Thian Kheoh; Kurt Baeten; Robert Thomas Mccormack; Leon W.M.M. Terstappen; Howard I. Scher; Johann S. de Bono

Abstract

Background: CTCs are prognostic in CRPC. Baseline (BL) CTC < 5 CTCs/7.5mL are associated with improved prognosis. We have previously shown that a post-treatment 30% decline in CTC is associated with improved survival (OS) in patients with high (≥5) BL CTCs. We investigated the value of a rise in CTCs during the first 12-weeks (wks) of treatment in the COU-AA-301 (abiraterone) and IMMC-38 (chemotherapy) trial datasets in patients with low (<5) baseline CTC counts.

Methods: CTC of patients (pts) were determined using the CELLSEARCH (Janssen Diagnostics, LLC) platform. Pts with BL CTCs <5, and CTCs at 4, 8 or 12 weeks were evaluated. CTC progression (CTCrise) was defined as any increase in CTCs relative to BL at any of the 3 timepoints (4,8,12 wks). Landmark survival analyses at 12 wks were performed. Association of CTCrise with OS was evaluated with Cox regression in multivariable (MV) analysis (ECOG, LDH, ALP, Alb, Hb, BL CTC and PSA as covariates). Logistic regression was used to evaluate association with PSA response.

Results: 509 pts (419 in COU-301 and 90 in IMMC38) were identified as having a BL CTC<5; BL CTC was 0 in 257 pts (50.7%). Overall, median OS was 21.9m (95%CI:20.6-23.3). 212 pts (41.7%) experienced a CTCrise within 12-weeks of starting treatment; of these, 117 (55%) had a CTCrise as early as 4 weeks post-treatment. OS was significantly reduced (27.1 vs 15.2 months; HR: 3.5; 95%CI 2.6-4.7) in patients with a CTCrise in these first 12-weeks. Both BL CTC (log-transformed) and CTCrise were independently associated with OS in the MV survival model. Furthermore, a PSA rise of ≥25% from baseline at 12 wks was more frequent in pts with a CTC rise vs. no rise (46.9% vs 14%, p<0.001)

Conclusions: BL CTC and CTC rises are independently associated with OS in CRPC pts with low (<5) BLCTC treated with abiraterone and chemotherapy. These findings will require prospective validation

Original language	English
Pages (from-to)	5042-5042
Journal	Journal of clinical oncology
Volume	34
Issue number	15
Publication status	Published - 20 May 2016
Event	52nd ASCO Annual Meeting 2016: Collective Wisdom: The Future of Patient-Centered Care and Research - McCormick Place, Chicago, United States Duration: 3 Jun 2016 → 7 Jun 2016 Conference number: 52

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http://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.5042

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Lorente, D., Olmos, D., Mateo, J., Zafeiriou, Z., Rescigno, P., Bianchini, D., Mehra, N., Molina, A., Kheoh, T., Baeten, K., Mccormack, R. T., Terstappen, L. W. M. M., Scher, H. I., & de Bono, J. S. (2016). Circulating tumor cell (CTC) rise and outcome in patients with metastatic castration-resistant prostate cancer (mCRPC) with low baseline CTC counts. Journal of clinical oncology, 34(15), 5042-5042. http://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.5042

@article{87190dffeed348288e4732e46213f297,

title = "Circulating tumor cell (CTC) rise and outcome in patients with metastatic castration-resistant prostate cancer (mCRPC) with low baseline CTC counts.",

abstract = "Background: CTCs are prognostic in CRPC. Baseline (BL) CTC < 5 CTCs/7.5mL are associated with improved prognosis. We have previously shown that a post-treatment 30% decline in CTC is associated with improved survival (OS) in patients with high (≥5) BL CTCs. We investigated the value of a rise in CTCs during the first 12-weeks (wks) of treatment in the COU-AA-301 (abiraterone) and IMMC-38 (chemotherapy) trial datasets in patients with low (<5) baseline CTC counts.Methods: CTC of patients (pts) were determined using the CELLSEARCH (Janssen Diagnostics, LLC) platform. Pts with BL CTCs <5, and CTCs at 4, 8 or 12 weeks were evaluated. CTC progression (CTCrise) was defined as any increase in CTCs relative to BL at any of the 3 timepoints (4,8,12 wks). Landmark survival analyses at 12 wks were performed. Association of CTCrise with OS was evaluated with Cox regression in multivariable (MV) analysis (ECOG, LDH, ALP, Alb, Hb, BL CTC and PSA as covariates). Logistic regression was used to evaluate association with PSA response. Results: 509 pts (419 in COU-301 and 90 in IMMC38) were identified as having a BL CTC<5; BL CTC was 0 in 257 pts (50.7%). Overall, median OS was 21.9m (95%CI:20.6-23.3). 212 pts (41.7%) experienced a CTCrise within 12-weeks of starting treatment; of these, 117 (55%) had a CTCrise as early as 4 weeks post-treatment. OS was significantly reduced (27.1 vs 15.2 months; HR: 3.5; 95%CI 2.6-4.7) in patients with a CTCrise in these first 12-weeks. Both BL CTC (log-transformed) and CTCrise were independently associated with OS in the MV survival model. Furthermore, a PSA rise of ≥25% from baseline at 12 wks was more frequent in pts with a CTC rise vs. no rise (46.9% vs 14%, p<0.001)Conclusions: BL CTC and CTC rises are independently associated with OS in CRPC pts with low (<5) BLCTC treated with abiraterone and chemotherapy. These findings will require prospective validation",

author = "David Lorente and David Olmos and Joaquin Mateo and Zafeiris Zafeiriou and Pasquale Rescigno and Diletta Bianchini and Niven Mehra and Arturo Molina and Thian Kheoh and Kurt Baeten and Mccormack, {Robert Thomas} and Terstappen, {Leon W.M.M.} and Scher, {Howard I.} and {de Bono}, {Johann S.}",

year = "2016",

month = may,

day = "20",

language = "English",

volume = "34",

pages = "5042--5042",

journal = "Journal of clinical oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

number = "15",

note = "52nd ASCO Annual Meeting 2016 : Collective Wisdom: The Future of Patient-Centered Care and Research, ASCO 2016 ; Conference date: 03-06-2016 Through 07-06-2016",

}

Lorente, D, Olmos, D, Mateo, J, Zafeiriou, Z, Rescigno, P, Bianchini, D, Mehra, N, Molina, A, Kheoh, T, Baeten, K, Mccormack, RT, Terstappen, LWMM, Scher, HI & de Bono, JS 2016, 'Circulating tumor cell (CTC) rise and outcome in patients with metastatic castration-resistant prostate cancer (mCRPC) with low baseline CTC counts.', Journal of clinical oncology, vol. 34, no. 15, pp. 5042-5042. <http://ascopubs.org/doi/abs/10.1200/JCO.2016.34.15_suppl.5042>

TY - JOUR

T1 - Circulating tumor cell (CTC) rise and outcome in patients with metastatic castration-resistant prostate cancer (mCRPC) with low baseline CTC counts.

AU - Lorente, David

AU - Olmos, David

AU - Mateo, Joaquin

AU - Zafeiriou, Zafeiris

AU - Rescigno, Pasquale

AU - Bianchini, Diletta

AU - Mehra, Niven

AU - Molina, Arturo

AU - Kheoh, Thian

AU - Baeten, Kurt

AU - Mccormack, Robert Thomas

AU - Terstappen, Leon W.M.M.

AU - Scher, Howard I.

AU - de Bono, Johann S.

N1 - Conference code: 52

PY - 2016/5/20

Y1 - 2016/5/20

N2 - Background: CTCs are prognostic in CRPC. Baseline (BL) CTC < 5 CTCs/7.5mL are associated with improved prognosis. We have previously shown that a post-treatment 30% decline in CTC is associated with improved survival (OS) in patients with high (≥5) BL CTCs. We investigated the value of a rise in CTCs during the first 12-weeks (wks) of treatment in the COU-AA-301 (abiraterone) and IMMC-38 (chemotherapy) trial datasets in patients with low (<5) baseline CTC counts.Methods: CTC of patients (pts) were determined using the CELLSEARCH (Janssen Diagnostics, LLC) platform. Pts with BL CTCs <5, and CTCs at 4, 8 or 12 weeks were evaluated. CTC progression (CTCrise) was defined as any increase in CTCs relative to BL at any of the 3 timepoints (4,8,12 wks). Landmark survival analyses at 12 wks were performed. Association of CTCrise with OS was evaluated with Cox regression in multivariable (MV) analysis (ECOG, LDH, ALP, Alb, Hb, BL CTC and PSA as covariates). Logistic regression was used to evaluate association with PSA response. Results: 509 pts (419 in COU-301 and 90 in IMMC38) were identified as having a BL CTC<5; BL CTC was 0 in 257 pts (50.7%). Overall, median OS was 21.9m (95%CI:20.6-23.3). 212 pts (41.7%) experienced a CTCrise within 12-weeks of starting treatment; of these, 117 (55%) had a CTCrise as early as 4 weeks post-treatment. OS was significantly reduced (27.1 vs 15.2 months; HR: 3.5; 95%CI 2.6-4.7) in patients with a CTCrise in these first 12-weeks. Both BL CTC (log-transformed) and CTCrise were independently associated with OS in the MV survival model. Furthermore, a PSA rise of ≥25% from baseline at 12 wks was more frequent in pts with a CTC rise vs. no rise (46.9% vs 14%, p<0.001)Conclusions: BL CTC and CTC rises are independently associated with OS in CRPC pts with low (<5) BLCTC treated with abiraterone and chemotherapy. These findings will require prospective validation

AB - Background: CTCs are prognostic in CRPC. Baseline (BL) CTC < 5 CTCs/7.5mL are associated with improved prognosis. We have previously shown that a post-treatment 30% decline in CTC is associated with improved survival (OS) in patients with high (≥5) BL CTCs. We investigated the value of a rise in CTCs during the first 12-weeks (wks) of treatment in the COU-AA-301 (abiraterone) and IMMC-38 (chemotherapy) trial datasets in patients with low (<5) baseline CTC counts.Methods: CTC of patients (pts) were determined using the CELLSEARCH (Janssen Diagnostics, LLC) platform. Pts with BL CTCs <5, and CTCs at 4, 8 or 12 weeks were evaluated. CTC progression (CTCrise) was defined as any increase in CTCs relative to BL at any of the 3 timepoints (4,8,12 wks). Landmark survival analyses at 12 wks were performed. Association of CTCrise with OS was evaluated with Cox regression in multivariable (MV) analysis (ECOG, LDH, ALP, Alb, Hb, BL CTC and PSA as covariates). Logistic regression was used to evaluate association with PSA response. Results: 509 pts (419 in COU-301 and 90 in IMMC38) were identified as having a BL CTC<5; BL CTC was 0 in 257 pts (50.7%). Overall, median OS was 21.9m (95%CI:20.6-23.3). 212 pts (41.7%) experienced a CTCrise within 12-weeks of starting treatment; of these, 117 (55%) had a CTCrise as early as 4 weeks post-treatment. OS was significantly reduced (27.1 vs 15.2 months; HR: 3.5; 95%CI 2.6-4.7) in patients with a CTCrise in these first 12-weeks. Both BL CTC (log-transformed) and CTCrise were independently associated with OS in the MV survival model. Furthermore, a PSA rise of ≥25% from baseline at 12 wks was more frequent in pts with a CTC rise vs. no rise (46.9% vs 14%, p<0.001)Conclusions: BL CTC and CTC rises are independently associated with OS in CRPC pts with low (<5) BLCTC treated with abiraterone and chemotherapy. These findings will require prospective validation

M3 - Meeting Abstract

SN - 0732-183X

VL - 34

SP - 5042

EP - 5042

JO - Journal of clinical oncology

JF - Journal of clinical oncology

IS - 15

T2 - 52nd ASCO Annual Meeting 2016

Y2 - 3 June 2016 through 7 June 2016

ER -

Circulating tumor cell (CTC) rise and outcome in patients with metastatic castration-resistant prostate cancer (mCRPC) with low baseline CTC counts.

Abstract

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