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Efficacy of immune check-point inhibitors (ICPi) in large cell neuroendocrine tumours of lung (LCNET)
abstracts 1401P
Annals of Oncology
An Australian multi-centre experience of the use of peptide receptor radionuclide therapy for bronchial carcinoid tumours
L.E. Lim1, D.L. Chan2, D. Thomas3, D.K. Wyld4, G. Cehic5, W. Macdonald6, Y.T. Du5, G. Tincknell3, A. Kuchel4, N. Pavlakis2, D. Bailey2, A. Davis2, E. Segelov1 1 Medical Oncology, Monash Health, Melbourne, Australia, 2Medical Oncology, Royal North Shore Hospital, St Leonards, Australia, 3Medical Oncology, St George Hospital, Kogarah, Australia, 4Medical Oncology, Royal Brisbane and Women’s Hospital, Herston, Australia, 5Nuclear Medicine, The Queen Elizabeth Hospital, Woodville South, Australia, 6 Nuclear Medicine, Fiona Stanley Hospital, Murdoch, Australia
1403P
Efficacy of immune check-point inhibitors (ICPi) in large cell neuroendocrine tumours of lung (LCNET)
S. Sherman1, O. Rotem1, A. Zer1, T. Shochat2, E. Dudnik1 Oncology, Rabin Medical Center Davidoff Cancer Centre, Beilinson Campus, Petah Tikva, Israel, 2Statistical Consulting Unit, Rabin Medical Center, Peth Tikva, Israel
1
Table: 1401P Clinical characteristics (Four centres in South Australia, Victoria, New South Wales)
Background: Little is known regarding the efficacy of ICPi in LCNET.
Gender
Number (n ¼ 33)
Male Female Age (years) <70 70 Histopathology TC AC Current status Alive Dead
22 (67%) 11 (33%) 21 (64%) 12 (36%) 12 (36%) 21 (64%) 22 (67%) 11 (33%)
Conclusions: This is the largest series of patients with bronchial carcinoid treated with PRRT to be reported to date. Evaluation of lutetium-based PRRT in a prospective clinical trial is of interest to validate its efficacy as a therapeutic option. Legal entity responsible for the study: Monash Health. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
1402P
Extra-pulmonary (EP) high grade (HG) neuroendocrine carcinoma (NEC): Real-life outcomes of fifty-eight patients from a Portuguese cancer center
R.S. Conde1, S.C. Ferreira1, S. Esteves2, I. Claro3, A. Moreira1, M.T. Marques1, M.B. Goncalves1 1 Servic¸o de Oncologia Me´dica, Instituto Portugu^es de Oncologia de Lisboa Francisco ao Clınica, Instituto Gentil E.P.E. (IPO Lisboa), Lisbon, Portugal, 2Unidade de Investigac¸~ Portugu^es de Oncologia de Lisboa Francisco Gentil E.P.E. (IPO Lisboa), Lisbon, Portugal, 3 Servic¸o de Gastroenterologia, Instituto Portugu^es de Oncologia de Lisboa Francisco Gentil E.P.E. (IPO Lisboa), Lisbon, Portugal Background: EP-HG-NEC are rare malignancies with poor prognosis, mainly from the gastrointestinal (GI) tract, although they may originate anywhere in the body due to the wide distribution of the neuroendocrine system. Platinum plus etoposide regimen (PE) is standard of care. Our goal was to characterise EP-HG-NEC at our institute, evaluate primary tumor location as prognostic factor and the effectiveness of PE as firstline (1L) therapy. Methods: Records of patients (pts) diagnosed with EP-HG-NEC at a Portuguese terciary cancer center were reviewed retrospectively (January 2000-March 2019).
v572 | Neuroendocrine Tumours
Methods: Thirty seven consecutive patients (pts) with advanced LCNET were selected from the Davidoff Cancer Center database. These were divided into Groups A1 (pts treated with ICPi, n-23) and A2 (pts not treated with ICPi, n-14). Another cohort of advanced non-small cell lung cancer (NSCLC) pts treated with nivolumab at five Israeli cancer centers in 2015-2016 was chosen as a comparator (Group B, n-270). ORR, PFS with ICPi in Group A1 were assessed (RECIST 1.1), OS with ICPi was compared between Groups A1 and B. OS since advanced disease diagnosis (OSDx) was compared between Groups A1 and A2. Results: Baseline pts characteristics are presented in the table. In Group A1* (n-21, 2 pts receiving combined ICPi þ chemotherapy were excluded), ORR and median PFS with ICPi were 33%, and 4.2 months (95% CI, 2.4-8.1), respectively. With median follow-up since start of ICPi of 6.2 months [IQR 2.2-12.1] and 4.9 months [IQR 2.3-8.9] in Groups A1* and B, respectively, 52% of pts in Group A1* and 64% of pts in Group B had died. Median OS with ICPi comprised 11.8 months (95% CI, 3.7-NR) and 6.9 months (95% CI, 5.5-8.1) in Groups A1* and B, respectively (p-0.23). Median OSDx was 14.5 months (95% CI, 10.1-38.9) and 10.3 months (95% CI, 2.6-NR), in Groups A1 and A2, respectively (p-0.54). Abbreviations: Tx- treatment, N – nivolumab, P-pembrolizumab, A- atezolizumab.
Table: 1403P Baseline patients characteristics
Age (median, range), y Gender, % F M Smoking, % Smokers Never smokers NA ECOG PS at ICPi, % 0/1 2-4 NA Previous Tx lines, % 0 1 2-4 NA ICPi type: N/P/A/other, %
Group A1* (n-21)
Group B (n-270)
p value
62 (45-77)
67 (40-99)
0.004 0.09
52 48
33 67
86 14
77 14 9
67 24 9
46 47 7
10 80 10
6 66 25 10 (3) 100/0/0/0
1
0.06
0.2
62/9/20/9
NA
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz256.023/5576668 by guest on 24 October 2019
Background: Peptide receptor radionuclide therapy (PRRT) is an established treatment modality for advanced midgut neuroendocrine tumours (NET) (1), based on the presence of somatostatin receptors (SSTR). This therapy should be effective for SSTR expressing NETs from all sites of origin. SSTR expression correlates with grade, with higher expression seen in lower grade disease (2). No trials of PRRT have been undertaken in patients with typical carcinoid (TC) or atypical carcinoid (AC) of bronchial origin. Most guidelines for bronchopulmonary NET either do not comment on PRRT or acknowledge lack of data. However, small retrospective case series, reporting 11 to 34 patients, suggest potential benefit from lutetium (177Lu)-based PRRT (3-10). Methods: We undertook a retrospective chart review of patients with TC and AC who had received at least one dose of lutetium-based PRRT in six major NET centres across Australia. Demographics, histopathology and information on clinical course were collected. Results: Data was collected from 53 patients treated across six centres between January 2002 and 2019. Patient details from four centres are presented in the table. Each of these four centres had 1, 8, 9 and 15 eligible patients respectively. Of these 33 patients, 22 are still alive, with the duration of follow up post the first cycle of PRRT ranging from 3 to 67 months. Analysis of the whole cohort for treatment, dose, response, patient and disease outcomes will be presented.
Results: Fifty-eight pts (52% males) identified: median (m) follow-up was 21 months (M) (range: 4-43); at diagnosis, m age was 61 years (range 30-85), 81% had ECOG performance status of 0-1, 83% were symptomatic, 64% had metastatic disease (70% with liver metastasis), 48% had Ki67 above 55%. Primary tumor location was GI in 27 pts (33% Esophagus, 19% colorectal, 15% pancreas), unknown (CUP) in 24 pts and genitourinary (GU) in 7 pts. For all EP-HG-NEC, m overall survival (OS) was 15,7M. Pts with CUP seemed to have a worse prognosis (mOS¼8,5M), whereas GU and GI had a similar prognosis (mOS¼19,2 and 18,7M, respectively) (p ¼ 0.357).Thirty-nine pts (67%) got PE, 7 pts received a different chemotherapy (ChT) regimen and 9 pts got best supportive care (BSC) only. mPFS was 4,6M for PE group and 7,3M for other ChT regimen group (platinum alone, CAPTEM, 5FU-STZ) with no statistical significance (p ¼ 0.547). mOS was 15,7M for PE group and 6,9M for BSC group (p ¼ 0.54). With PE, 41% had grade 3 adverse events and no toxic deaths were reported. After 1L PE, 24 pts received a second L ChT, 50% with CAPTEM. Conclusions: Considering the limited data available, this retrospective case series contributes to a better understanding of this entity. Primary tumor location tends to predict outcome. We hypothesised that delaying treatment initiation for CUP while searching for primary tumor might be related to worse outcomes. The outcomes of 1L PE suggest that other options might be needed as standard of care. EP-HG-NEC has prognostic heterogeneity, multi-center studies are needed. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
Annals of Oncology Conclusions: In advanced LCNET, ICPi outcomes are comparable to the outcomes observed in advanced NSCLC. Future prospective research is needed to clarify the impact of ICPi on OS in LCNET. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: A. Zer: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca, Roche, BMS, MSD, BI, TAKADA. E. Dudnik: Research grant / Funding (self): Roche, Boehringer Ingelheim; Advisory / Consultancy: Boehringer Ingelheim, Roche, AstraZeneca, Pfizer, MSD, BMS, Novartis, Takeda. All other authors have declared no conflicts of interest.
HORMONET: Study of tamoxifen in well differentiated neuroendocrine tumours and hormone receptor positive expression
M. Barros1, T.C. Felismino1, V.H.F. de Jesus1, C.A. Mello1, V.S. Silva1, M. Camandaroba1, N. Rodrigues1, M.D. Donadio1, E. Nobrega1, L. Chinen1, L. De Brot1, R.F. Weschenfelder2, J.F. Rego3, J.B. Carvalheira4, R.P. Riechelmann1 1 Medical Oncology, A. C. Camargo Cancer Center, Sao Paulo, Brazil, 2Medical Oncology, Hospital Moinhos de Vento, Porto Alegre, Brazil, 3Clinica Medica, Hospital Universitario Onofre Lopes, Natal, Brazil, 4Clinica Medica, Hospital de Clinica da Universidade Estadual de Campinas, Campinas, Brazil Background: Patients (pts) with advanced neuroendocrine tumors (NET) represent an unmet medical need, what motivates the development of new treatments. Prior retrospective study conducted by our group showed that among 96 NET, immunohistochemistry (IHC) expression for estrogen (ER) and progesterone receptors (PR) were
Volume 30 | Supplement 5 | October 2019
observed in 20.8% and 18.8% of cases, respectively. Additionally, an old clinical trial (Mortel C, 1984) suggested antitumor effects of estrogen/progesterone-directed therapies in NET pts. Yet the effects of an antiestrogen agent in NET pts whose tumor express ER and/or PR are unknown. Hence we will conduct a clinical trial to test the efficacy of tamoxifen in ER/PR positive NET pts. Trial design: Single-arm phase II multicenter trial of tamoxifen 20mg PO continuously until intolerance and/or tumor progression. Eligible pts must be 18 years old, have histologically confirmed advanced, irresectable well-differentiated lung or gastroeteropancreatic NET, IHC expression of ER and/or PR 1%, documented progression in the prior 12 months, measurable disease, prior treatments with standard therapies and/ or no indication to start new treatment due to lack of access, risk of toxicities or without clinical indication (patients who meet criteria for watchful waiting may be included), ECOG 0-2, adequate organ function. Main exclusion criteria are: aggressive disease requiring cytotoxic therapy, use of oral anticoagulants, previous history of deep vein thrombosis or pulmonary embolism in the last 12 months, postmenopausal vaginal bleeding with no defined etiology. The primary endpoint is disease control rate (DCR) at week 24 as per RECIST 1.1. Secondary endpoints are progression-free survival, biochemical response, response rate. Exploratory evaluations: circulating tumor cells kinetics (qualitative and quantitative) and PET-CT gallium-68 intake intensity variation (at baseline and at week 24). Sample size assumptions: the H0 is DCR at week 24 of 50% and H1, 70%; with a type I error of 10%, power of 80% and attrition rate of 30%, the final sample size will be 22 pts. Clinical trial identification: NCT03870399. Legal entity responsible for the study: Rachel Riechelmann. Funding: AC Camargo Cancer Center. Disclosure: M. Barros: Honoraria (self): Novartis. J.F. Rego: Honoraria (self): Novartis. R.P. Riechelmann: Honoraria (self): Novartis. All other authors have declared no conflicts of interest.
doi:10.1093/annonc/mdz256 | v573
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz256.023/5576668 by guest on 24 October 2019
1404TiP
abstracts
Annals of Oncology
An Australian multi-centre experience of the use of peptide receptor radionuclide therapy for bronchial carcinoid tumours
L.E. Lim1, D.L. Chan2, D. Thomas3, D.K. Wyld4, G. Cehic5, W. Macdonald6, Y.T. Du5, G. Tincknell3, A. Kuchel4, N. Pavlakis2, D. Bailey2, A. Davis2, E. Segelov1 1 Medical Oncology, Monash Health, Melbourne, Australia, 2Medical Oncology, Royal North Shore Hospital, St Leonards, Australia, 3Medical Oncology, St George Hospital, Kogarah, Australia, 4Medical Oncology, Royal Brisbane and Women’s Hospital, Herston, Australia, 5Nuclear Medicine, The Queen Elizabeth Hospital, Woodville South, Australia, 6 Nuclear Medicine, Fiona Stanley Hospital, Murdoch, Australia
1403P
Efficacy of immune check-point inhibitors (ICPi) in large cell neuroendocrine tumours of lung (LCNET)
S. Sherman1, O. Rotem1, A. Zer1, T. Shochat2, E. Dudnik1 Oncology, Rabin Medical Center Davidoff Cancer Centre, Beilinson Campus, Petah Tikva, Israel, 2Statistical Consulting Unit, Rabin Medical Center, Peth Tikva, Israel
1
Table: 1401P Clinical characteristics (Four centres in South Australia, Victoria, New South Wales)
Background: Little is known regarding the efficacy of ICPi in LCNET.
Gender
Number (n ¼ 33)
Male Female Age (years) <70 70 Histopathology TC AC Current status Alive Dead
22 (67%) 11 (33%) 21 (64%) 12 (36%) 12 (36%) 21 (64%) 22 (67%) 11 (33%)
Conclusions: This is the largest series of patients with bronchial carcinoid treated with PRRT to be reported to date. Evaluation of lutetium-based PRRT in a prospective clinical trial is of interest to validate its efficacy as a therapeutic option. Legal entity responsible for the study: Monash Health. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
1402P
Extra-pulmonary (EP) high grade (HG) neuroendocrine carcinoma (NEC): Real-life outcomes of fifty-eight patients from a Portuguese cancer center
R.S. Conde1, S.C. Ferreira1, S. Esteves2, I. Claro3, A. Moreira1, M.T. Marques1, M.B. Goncalves1 1 Servic¸o de Oncologia Me´dica, Instituto Portugu^es de Oncologia de Lisboa Francisco ao Clınica, Instituto Gentil E.P.E. (IPO Lisboa), Lisbon, Portugal, 2Unidade de Investigac¸~ Portugu^es de Oncologia de Lisboa Francisco Gentil E.P.E. (IPO Lisboa), Lisbon, Portugal, 3 Servic¸o de Gastroenterologia, Instituto Portugu^es de Oncologia de Lisboa Francisco Gentil E.P.E. (IPO Lisboa), Lisbon, Portugal Background: EP-HG-NEC are rare malignancies with poor prognosis, mainly from the gastrointestinal (GI) tract, although they may originate anywhere in the body due to the wide distribution of the neuroendocrine system. Platinum plus etoposide regimen (PE) is standard of care. Our goal was to characterise EP-HG-NEC at our institute, evaluate primary tumor location as prognostic factor and the effectiveness of PE as firstline (1L) therapy. Methods: Records of patients (pts) diagnosed with EP-HG-NEC at a Portuguese terciary cancer center were reviewed retrospectively (January 2000-March 2019).
v572 | Neuroendocrine Tumours
Methods: Thirty seven consecutive patients (pts) with advanced LCNET were selected from the Davidoff Cancer Center database. These were divided into Groups A1 (pts treated with ICPi, n-23) and A2 (pts not treated with ICPi, n-14). Another cohort of advanced non-small cell lung cancer (NSCLC) pts treated with nivolumab at five Israeli cancer centers in 2015-2016 was chosen as a comparator (Group B, n-270). ORR, PFS with ICPi in Group A1 were assessed (RECIST 1.1), OS with ICPi was compared between Groups A1 and B. OS since advanced disease diagnosis (OSDx) was compared between Groups A1 and A2. Results: Baseline pts characteristics are presented in the table. In Group A1* (n-21, 2 pts receiving combined ICPi þ chemotherapy were excluded), ORR and median PFS with ICPi were 33%, and 4.2 months (95% CI, 2.4-8.1), respectively. With median follow-up since start of ICPi of 6.2 months [IQR 2.2-12.1] and 4.9 months [IQR 2.3-8.9] in Groups A1* and B, respectively, 52% of pts in Group A1* and 64% of pts in Group B had died. Median OS with ICPi comprised 11.8 months (95% CI, 3.7-NR) and 6.9 months (95% CI, 5.5-8.1) in Groups A1* and B, respectively (p-0.23). Median OSDx was 14.5 months (95% CI, 10.1-38.9) and 10.3 months (95% CI, 2.6-NR), in Groups A1 and A2, respectively (p-0.54). Abbreviations: Tx- treatment, N – nivolumab, P-pembrolizumab, A- atezolizumab.
Table: 1403P Baseline patients characteristics
Age (median, range), y Gender, % F M Smoking, % Smokers Never smokers NA ECOG PS at ICPi, % 0/1 2-4 NA Previous Tx lines, % 0 1 2-4 NA ICPi type: N/P/A/other, %
Group A1* (n-21)
Group B (n-270)
p value
62 (45-77)
67 (40-99)
0.004 0.09
52 48
33 67
86 14
77 14 9
67 24 9
46 47 7
10 80 10
6 66 25 10 (3) 100/0/0/0
1
0.06
0.2
62/9/20/9
NA
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz256.023/5576668 by guest on 24 October 2019
Background: Peptide receptor radionuclide therapy (PRRT) is an established treatment modality for advanced midgut neuroendocrine tumours (NET) (1), based on the presence of somatostatin receptors (SSTR). This therapy should be effective for SSTR expressing NETs from all sites of origin. SSTR expression correlates with grade, with higher expression seen in lower grade disease (2). No trials of PRRT have been undertaken in patients with typical carcinoid (TC) or atypical carcinoid (AC) of bronchial origin. Most guidelines for bronchopulmonary NET either do not comment on PRRT or acknowledge lack of data. However, small retrospective case series, reporting 11 to 34 patients, suggest potential benefit from lutetium (177Lu)-based PRRT (3-10). Methods: We undertook a retrospective chart review of patients with TC and AC who had received at least one dose of lutetium-based PRRT in six major NET centres across Australia. Demographics, histopathology and information on clinical course were collected. Results: Data was collected from 53 patients treated across six centres between January 2002 and 2019. Patient details from four centres are presented in the table. Each of these four centres had 1, 8, 9 and 15 eligible patients respectively. Of these 33 patients, 22 are still alive, with the duration of follow up post the first cycle of PRRT ranging from 3 to 67 months. Analysis of the whole cohort for treatment, dose, response, patient and disease outcomes will be presented.
Results: Fifty-eight pts (52% males) identified: median (m) follow-up was 21 months (M) (range: 4-43); at diagnosis, m age was 61 years (range 30-85), 81% had ECOG performance status of 0-1, 83% were symptomatic, 64% had metastatic disease (70% with liver metastasis), 48% had Ki67 above 55%. Primary tumor location was GI in 27 pts (33% Esophagus, 19% colorectal, 15% pancreas), unknown (CUP) in 24 pts and genitourinary (GU) in 7 pts. For all EP-HG-NEC, m overall survival (OS) was 15,7M. Pts with CUP seemed to have a worse prognosis (mOS¼8,5M), whereas GU and GI had a similar prognosis (mOS¼19,2 and 18,7M, respectively) (p ¼ 0.357).Thirty-nine pts (67%) got PE, 7 pts received a different chemotherapy (ChT) regimen and 9 pts got best supportive care (BSC) only. mPFS was 4,6M for PE group and 7,3M for other ChT regimen group (platinum alone, CAPTEM, 5FU-STZ) with no statistical significance (p ¼ 0.547). mOS was 15,7M for PE group and 6,9M for BSC group (p ¼ 0.54). With PE, 41% had grade 3 adverse events and no toxic deaths were reported. After 1L PE, 24 pts received a second L ChT, 50% with CAPTEM. Conclusions: Considering the limited data available, this retrospective case series contributes to a better understanding of this entity. Primary tumor location tends to predict outcome. We hypothesised that delaying treatment initiation for CUP while searching for primary tumor might be related to worse outcomes. The outcomes of 1L PE suggest that other options might be needed as standard of care. EP-HG-NEC has prognostic heterogeneity, multi-center studies are needed. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
Annals of Oncology Conclusions: In advanced LCNET, ICPi outcomes are comparable to the outcomes observed in advanced NSCLC. Future prospective research is needed to clarify the impact of ICPi on OS in LCNET. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: A. Zer: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca, Roche, BMS, MSD, BI, TAKADA. E. Dudnik: Research grant / Funding (self): Roche, Boehringer Ingelheim; Advisory / Consultancy: Boehringer Ingelheim, Roche, AstraZeneca, Pfizer, MSD, BMS, Novartis, Takeda. All other authors have declared no conflicts of interest.
HORMONET: Study of tamoxifen in well differentiated neuroendocrine tumours and hormone receptor positive expression
M. Barros1, T.C. Felismino1, V.H.F. de Jesus1, C.A. Mello1, V.S. Silva1, M. Camandaroba1, N. Rodrigues1, M.D. Donadio1, E. Nobrega1, L. Chinen1, L. De Brot1, R.F. Weschenfelder2, J.F. Rego3, J.B. Carvalheira4, R.P. Riechelmann1 1 Medical Oncology, A. C. Camargo Cancer Center, Sao Paulo, Brazil, 2Medical Oncology, Hospital Moinhos de Vento, Porto Alegre, Brazil, 3Clinica Medica, Hospital Universitario Onofre Lopes, Natal, Brazil, 4Clinica Medica, Hospital de Clinica da Universidade Estadual de Campinas, Campinas, Brazil Background: Patients (pts) with advanced neuroendocrine tumors (NET) represent an unmet medical need, what motivates the development of new treatments. Prior retrospective study conducted by our group showed that among 96 NET, immunohistochemistry (IHC) expression for estrogen (ER) and progesterone receptors (PR) were
Volume 30 | Supplement 5 | October 2019
observed in 20.8% and 18.8% of cases, respectively. Additionally, an old clinical trial (Mortel C, 1984) suggested antitumor effects of estrogen/progesterone-directed therapies in NET pts. Yet the effects of an antiestrogen agent in NET pts whose tumor express ER and/or PR are unknown. Hence we will conduct a clinical trial to test the efficacy of tamoxifen in ER/PR positive NET pts. Trial design: Single-arm phase II multicenter trial of tamoxifen 20mg PO continuously until intolerance and/or tumor progression. Eligible pts must be 18 years old, have histologically confirmed advanced, irresectable well-differentiated lung or gastroeteropancreatic NET, IHC expression of ER and/or PR 1%, documented progression in the prior 12 months, measurable disease, prior treatments with standard therapies and/ or no indication to start new treatment due to lack of access, risk of toxicities or without clinical indication (patients who meet criteria for watchful waiting may be included), ECOG 0-2, adequate organ function. Main exclusion criteria are: aggressive disease requiring cytotoxic therapy, use of oral anticoagulants, previous history of deep vein thrombosis or pulmonary embolism in the last 12 months, postmenopausal vaginal bleeding with no defined etiology. The primary endpoint is disease control rate (DCR) at week 24 as per RECIST 1.1. Secondary endpoints are progression-free survival, biochemical response, response rate. Exploratory evaluations: circulating tumor cells kinetics (qualitative and quantitative) and PET-CT gallium-68 intake intensity variation (at baseline and at week 24). Sample size assumptions: the H0 is DCR at week 24 of 50% and H1, 70%; with a type I error of 10%, power of 80% and attrition rate of 30%, the final sample size will be 22 pts. Clinical trial identification: NCT03870399. Legal entity responsible for the study: Rachel Riechelmann. Funding: AC Camargo Cancer Center. Disclosure: M. Barros: Honoraria (self): Novartis. J.F. Rego: Honoraria (self): Novartis. R.P. Riechelmann: Honoraria (self): Novartis. All other authors have declared no conflicts of interest.
doi:10.1093/annonc/mdz256 | v573
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz256.023/5576668 by guest on 24 October 2019
1404TiP
abstracts