- Email: [email protected]
The accuracy of the clinical PCI score in patients with peritoneal carcinomatosis of colorectal cancer
abstracts
Annals of Oncology
grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Aventis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Servier; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly. F. Overkamp: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Chugai; Honoraria (self), Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Cellex; Honoraria (self), Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Gilead; Honoraria (self), Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Consultancy: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Merck; Honoraria Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: Novonordisc; Honoraria (self), Advisory / Consultancy: Riemser; (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Servier. C. / Part-time employment: Merck Healthcare KGaA. F. Lamy: Full / Part-time employment: Healthcare KGaA. R. Esser: Full / Part-time employment: Merck Healthcare KGaA. D. / Part-time employment, Prometris provides statistical services for Merck Healthcare KGaA: Merck Healthcare KGaA. V. Rothe: Full / Part-time employment, Prometris provides statistical services for Merck Healthcare KGaA: Merck Healthcare KGaA. W. Chen: Full / Part-time employment: Merck Serono. T. Brodowicz: Honoraria (self): Roche; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: PharmaMar; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Lilly. C.C. Zielinski: Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Imugene; Honoraria (self), Advisory / Consultancy: ARIAD; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Merrimack; Honoraria (self), Advisory / Consultancy: Merck Healthcare KGaA; Honoraria (self), Advisory / Consultancy: FibroGen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Tesaro; Honoraria (self), Advisory / Consultancy: Gilead; Honoraria (self), Advisory / Consultancy: Servier; Honoraria (self), Advisory / Consultancy: Shire; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Athenex. All other authors have declared no conflicts of interest.
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POLAF study: Efficacy and safety of FOLFIRI/aflibercept in a phase II trial in patients with metastatic colorectal cancer: Results of plasmatic prognostic and predictive markers
omez-Espa~ na2, C. Gravalos3, P. Garcıa-Alfonso4, M.E. Elez Fernandez1, M.A. G na Suarez7, M. Toledano2, M. ValladaresB. Rodrıguez2, F. Losa5, I.C. Ales-Diaz6, B. Gra~ Ayerbes8, E. Polo Marques9, M. Salgado Fernandez10, E. Martınez de Castro11, M. Gil Raga12, M.A. Salud Salvia13, A. Ruiz-Casado14, A. Rodrıguez-Ariza2, E. Aranda Aguilar15 1 Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, 2Oncology, IMIBIC, Reina Sofıa Hospital, C ordoba, Spain, 3Oncology, University Hospital 12 de Octubre, Madrid, Spain, 4Servicio de Oncologıa Me´dica, General Universitario Gregorio Mara~ non, Madrid, Spain, 5Medical Oncology Department, Hospital de Sant Joan Despı Moise`s Broggi, Barcelona, Spain, 6Oncology, Servicio de Oncologıa Me´dica, Hospital Regional Universitario, Malaga, Spain, 7Medical Oncology, CHUAC - Complexo Hospitalario Universitario A Coru~ na, A Coru~ na, Spain, 8Medical Oncology Departament, University Hospital Virgen del Rocıo, Seville, Spain, 9Medical Oncology Department, Hospital Miguel Servet, Zaragoza, Spain, 10Medical Oncology, Complejo Hospitalario de Ourense, Ourense, Spain, 11Medical Oncology, Hospital Universitario Marque´s de Valdecilla, Santander, Spain, 12Medical Oncology, Hospital de Requena, Valencia, Spain, 13 Oncology, Hospital Universitario Arnau de Vilanova, Lleida, Spain, 14Medical Oncology, Hospital Universitario Puerta de Hierro, Madrid, Spain, 15Department of Medical Oncology, University Hospital Reina Sofia, Cordoba, Spain Background: Biomarkers associated to antiangiogiogenic agents in metastatic colorectal cancer (mCRC) have not yet been validated Here we present the efficacy and safety results of FOLFIRI and aflibercept in second line therapy for mCRC and the analysis of biomarkers as predictive factors of efficacy.
Volume 30 | Supplement 5 | October 2019
Methods: POLAF is a multicenter, non comparative, phase II study conducted in patients with mCRC previously treated with oxaliplatin (NCT02970916) Plasma biomarkers were assayed using ELISA Vascular endothelial growth factor (VEGF A) and angiotensin-converting enzyme (ACE) biomarkers were statistically analyzed (Roc Curve) with respect to the primary endpoint (PE): progression free survival (PFS) (Kaplan Meier). Results: Between November 2016 and December 2017, 101 patients for the PE were enrolled: male 59.4%, median age of 63.8 years and ECOG 0 in 46.5% of them The median of treatment duration was 5.7 months. Later antitumor therapies were received by 54.5% pts With a median follow up of 11.7 months, response rates were: PR 15.8%, SD 53.5% and PD 25.7%. The median OS, PFS, TTP and to TTF were 12.6, 7.4, 8.3 and 6.1 months, respectively Of note, both OS and PFS were significantly longer in pts with lower plasma VEGF A levels (<1.941 ng/ml) in comparison to those with higher levels (p < 0.001) No significant differences were detected in plasma ACE levels (Table) A total of 74.3% pts presented at least 1 grade 3 toxicity, being the most common asthenia (24.8%) hypertension (22.8%) and neutropenia (23.9%) and three pts presented grade 5 toxicity: one hepatic encephalopathy, one gastrointestinal toxicity and one unknown reason that treatment relationship could not be ruled out.
Table: 585P
VEFG-A
Cut offa
PFS
OS
<1.941 1.941
9.2 (8.4-10) 4.2 (2.7-5.6) p < 0.001
18.9 (14.8-23) 7.6 (4.5-10.7)
Conclusions: This study confirms the efficacy outcomes of FOLFIRI/aflibercept regimen in second line mCRC Our data shows that VEGF-A could be related to the survival of this population and its role as a potential predictive biomarker for efficacy should be considered. Legal entity responsible for the study: The authors. Funding: Sanofi. Disclosure: M.E. Elez Fernandez: Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Merck; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Sanofi; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Honoraria (institution), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Honoraria (self): Servier; Honoraria (self), Honoraria (institution): Array; Honoraria (institution): Novartis; Honoraria (institution): Boehringer Ingelheim; Honoraria (institution): MSD; Honoraria (institution): Servier; Honoraria (institution): Bayer; Honoraria (institution): GSK; Honoraria (institution): Pharmamar. B. Gra~ na Suarez: Research grant / Funding (self): Sanofi; Research grant / Funding (self): Gilead; Research grant / Funding (self): Amgen. M. Valladares-Ayerbes: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AMGEN; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Servier; Honoraria (self), Speaker Bureau / Expert testimony: Bayer; Honoraria (self): BRISTOL; Advisory / Consultancy: Sanofi. M. Salgado Fernandez: Travel / Accommodation / Expenses: Sanofi. E. Martınez de Castro: Speaker Bureau / Expert testimony: Sanofi. A. Ruiz-Casado: Honoraria (self), Research grant / Funding (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Merck; Honoraria (self): Lilly; Honoraria (self): Servier; Honoraria (self): Roche; Honoraria (self): Medtronic; Honoraria (self): BTG; Honoraria (self): Bayer. E. Aranda Aguilar: Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merck Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi. All other authors have declared no conflicts of interest.
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The accuracy of the clinical PCI score in patients with peritoneal carcinomatosis of colorectal cancer
N.L. De Boer, A. Brandt-Kerkhof, E. Madsen, K. Verhoef, J. Burger Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands Background: The Peritoneal Cancer Index (PCI) and completeness of cytoreduction are important prognostic factors in patients with peritoneal carcinomatosis from colorectal cancer, undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). The PCI is determined during laparotomy by an experienced surgeon before the decision is made to ‘do’ or ‘do not’ proceed with CRSHIPEC. The aim of this study is to determine the accuracy of the clinical PCI score (cPCI), by comparing the cPCI with the pathological PCI (pPCI) score.
doi:10.1093/annonc/mdz246 | v221
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q2w vs q1w schedule was tested with a hazard ratio (HR) margin of 1.25 using a Cox proportional hazards regression model. Differences in baseline characteristics were accounted for with inverse probability of treatment weighting (IPTW) based on a propensity score. Results: 763 (91% from NIS) and 554 (51% from NIS) patients were included in the q1w and q2w groups, respectively. Median (Q1-Q3) age in years was 66 (57-73) for q1w and 60 (53-69) for q2w. Liver-limited disease concerned 42.6% of patients for q1w and 37.9% for q2w. A baseline ECOG Performance Status of 0-1 was reported in 81.8% of q1w and 90.6% of q2w patients. FOLFIRI was most frequently used in combination with q1w (49.4%) and FOLFOX with q2w (59.2%). IPTW-adjusted HRs for OS were in favor of q2w: 0.83 (95% CI, 0.71-0.96) and 0.73 (95% CI, 0.61-0.88) when restricted to NIS. Other efficacy and safety results will be presented in the future. Conclusions: This pooled analysis confirmed the noninferiority of CET q2w vs q1w. This result suggests an improved OS with the q2w schedule. Editorial acknowledgement: ClinicalThinking, Inc, Hamilton, NJ, USA, funded by Merck Healthcare KGaA, Darmstadt, Germany. Legal entity responsible for the study: Merck Healthcare KGaA. Funding: Merck Healthcare KGaA. Disclosure: S. Kasper: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research
abstracts
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The impact of late-line treatment on overall survival (OS) from the initiation of first-line chemotherapy (CT) for patients (pts) with metastatic colorectal cancer (mCRC)
T. Kawakami1, T. Masuishi2, Y. Kawamoto3, H. Go4, H. Shirasu1, K. Kato5, R. Kumanishi6, K. Sawada7, K. Yamamoto4, S. Yuki8, Y. Komatsu9, H. Yasui10, K. Muro11, T. Yamanaka4, K. Yamazaki12 1 Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan, 2Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, 3Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan, 4 Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan, 5Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, 6 Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, 7Cancer Center, Hokkaido University Hospital, Sapporo, Japan, 8Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan, 9Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan, 10Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan, 11Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan, 12Gastroenterology, Sizuoka Cancer Center, Sundogun, Japan Background: For the past 20 years, the improvement in OS has been achieved in mCRC. Active agents including anti-VEGF and anti-EGFR antibodies have contributed to this progress. Late-line treatment with regorafenib (REGO) or trifluridine/tipiracil (FTD/TPI) has also been demonstrated to be effective and these drugs are widely used as standard CT. However, no study has reported to what extent the availability of these two drugs changes the total OS of patients that is measured from the initiation of first-line CT. Methods: We retrospectively enrolled consecutive mCRC pts at 3 institutions who received first-line CT between Jan 2005 and Sep 2016. We divided the pts into 3 groups according to the availability of drugs at the initiation of first-line CT; pts who started CT between Jan 2005 and Dec 2006 (cohort A: only cytotoxic drugs were available), between Jan 2007 and Dec 2011 (cohort B: anti-VEGF and anti-EGFR antibody were available), or between Jan 2012 and Sep 2016 (cohort C: REGO and FTD/TPI were available). Treatment outcomes were compared among the cohort A, B, and C. Results: A total of 1,426 pts were analyzed. Pts characteristics of the cohort A (165 pts), B (626 pts), and C (635 pts) were as follows: median age, 62/64/65 years; ECOG PS 2, 8.5%/8.8%/8.2%; right-sided primary, 26.1%/29.4%/29.9%; tumor grade Grade 3, 10.1%/13.1%/11.9%; KRAS mutation, 28.6%/38.4%/41.1%; and number of metastatic sites 2, 63.6%/61.3%/58.1%. In the cohort A, B, and C, 1.2%, 10.7%, and 31.2% of the pts received at least one of late-line treatment with REGO or FTD/TPI. Median OS of the cohort A, B, and C was 18.6 month (M), 25.3 M, and 27.2 M. Hazard ratio (HR) of death was 0.82 (95% confidential interval [CI], 0.68-0.98; p ¼ 0.0309) for the cohort B vs A, and 0.71 (95% CI, 0.59-0.86; p ¼ 0.0004) for the cohort C vs A, and 0.87 (95% CI 0.77-0.99; p ¼ 0.0356) for the cohort C vs B. Conclusions: This real-world data analysis indicates that late-line treatment with REGO or FTD/TPI could contribute to the prolongation of OS from the initiation of first-line CT for mCRC pts. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: T. Masuishi: Honoraria (self): Taiho Pharmaceutical, Merck Serono, Chugai Pharma, Yakult Honsha, Takeda, Eli Lilly, Bayer Yakuhin, Sanofi; Research grant / Funding (self): Yakult Honsha. Y. Kawamoto: Honoraria (self): Taiho Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Chugai Pharmaceutical, Merck Biopharma, Eli Lilly. S. Yuki: Honoraria (self): Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Bristol-Myers Squibb Co., Ltd., Eli Lilly Japan K.K., Bayer Yakuhin Co., Ltd., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Pharma International Inc., Yakult H. Y. Komatsu: Honoraria (self): Taiho, Chugai, Yakult, Daiichi Sankyo, Bayer, Merck, Takeda; Research grant / Funding (institution): Taiho, Chugai, Yakult, Daiichi Sankyo, Bayer, Merck, Takeda. K. Muro: Honoraria (self): Takeda, Chugai Pharma, Yakult Honsha, Merck Serono, Taiho Pharmaceutical, Lilly, Ono Pharmaceutical, Bayer; Research grant / Funding (self): Ono Pharmaceutical, MSD, Daiichi Sankyo, Shionogi, Kyowa Hakko Kirin, Gilead Sciences, Merck Serono, Pfizer, Sanofi. T. Yamanaka: Honoraria (self): Chugai, Takeda, Taiho, Boehringer-Ingelheim, Bayer, Pfizer; Advisory / Consultancy: Gilead Sciences, Daiichi-Sankyo, Sysmex, Huya Biosciences; Honoraria (institution): Chugai, Takeda, Taiho, Boehringer-Ingelheim, Bayer, Daiichi-Sankyo, Ono, Merck Serono, Astellas, Eli Lilly. K. Yamazaki:
v222 | Gastrointestinal Tumours, Colorectal
Honoraria (self): Chugai Pharma, Daiichi Sankyo, Yakult Honsha, Takeda, Bayer, Merck Serono, BristolMyers Squibb Japan, Taiho Pharmceutical, Lilly, Sanofi, Ono Pharmaceutical, MSD; Research grant / Funding (institution): Taiho Pharmaceutical. All other authors have declared no conflicts of interest.
588P
Efficacy and safety of FOLFIRI/Aflibercept (FA) in elderly population with mCRC after failure of oxaliplatin-based chemotherapy
N. Martinez Lago1, M. Carmona Campos2, P. Gonzalez Villarroel3, M. Salgado Fernandez4, J. De laCamara Gomez5, C. Romero Reinoso6, A. Cousillas Casti~ neiras7, Y. Vidal Insua8, J.C. Mendez Mendez9, C. Reboredo Rendo1, na Suarez1, A. Carral Maseda2, M. Covela Rua2, G. Quintero Aldana2, B. Gra~ M. Jorge Fernandez3, M.L. Pellon Augusto5, C. Grande Ventura3, M.E. Gallardo Martin7, A. Fernandez Montes10, M. Reboredo Lopez1 1 Medical Oncology, CHUAC - Complexo Hospitalario Universitario A Coru~ na, A Coru~ na, Spain, 2Medical Oncology, Hospital Universitario Lucus Augusti, Lugo, Spain, 3Medical Oncology, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain, 4Medical Oncology, Complejo Hospitalario de Ourense, Ourense, Spain, 5Medical Oncology, Complexo Hospitalario Universitario de Ferrol, Ferrol, Spain, 6Medical Oncology, POVISA, Vigo, Spain, 7Medical Oncology, Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain, 8Medical Oncology, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain, 9Medical Oncology, Centro Oncologico de Galicia, A Coru~ na, Spain, 10Medical Oncology, Complexo Hospitalario Universitario de Ourense, Orense, Spain Background: Aflibercept (Af) significantly improves progression-free (PFS) and overall survival (OS) when added to FOLFIRI, in the overall population of patients (pts) pretreated with oxaliplatin-based therapy. A subset analysis of pts (>65years) included in the VELOUR trial, suggests a consistent benefit in OS in PFS, but increased grade 3-4 toxicity. Our hypothesis was that selected pts >70y with good PS could benefit from FA, provided they underwent a careful monitoring of toxicity. Methods: Retrospective, multicenter, observational study of mCRC pts >70 years (y) treated with FA as part of routine clinical practice at 8 hospitals from the Galician Research Group on Digestive Tumours (GITuD). Results: From 338 patients treated with FA between June 2013 to November 2018, 75 pts were recorded. Median age was 72.7 y (range 70-84 y), and 33.4% were >75y. 65.3% were male, 87.5% ECOG PS0-1, 42.5 % left-sided location, 76.0 % low grade, 59.5% RASmt and 77.3 % primary tumor resection. Prior therapy included bevacizumab (56%) and anti-EGFR agents (24%), only adjuvant treatment (5.3%). Median of FA cycles was 10 (range 1-35 cycles). Overall Response Rate (ORR) and disease control rate (DCR) were 30.7% and 65.4%, respectively. With a median follow-up of 27.1 months (m), median PFS was 6.6 m (95% CI, 5.3-7.9 m) and median OS was 15.1 m (95% CI, 12.5-17.8 m). The most common grade 3-4 toxicities overall were asthenia (21.3%), neutropenia (14.7%) and diarrhoea (14.7%). Af-related toxicities were hypertension (5.3%), dysphonia (5.3%) and proteinuria (2.7%). Two patients experienced grade 5 toxicity.This toxicity was managed with dose reduction of Af in 34.7% of cases, dose reduction of FOLFIRI on 56.0% and discontinuation of Af in 18.6%. Conclusions: Older patients with mCRC are underrepresented in clinical trials. The VELOUR study included only 6.4% pts >75y of age and only 14% included in the substudy of patients >65y were >75y. Patients >65y treated with FA in the VELOUR trial experienced a high rate of G3-4 adverse events (89.3%). Our series confirms that with careful pt selection and dose adjustment based on toxicity, patients >70y can be treated with FA with a 52.0% of grade 3-4 toxicity, results that are comparable to those of younger patients. Legal entity responsible for the study: Galician Research Group on Digestive Tumours (GITuD). Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
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Fluoropyrimidine-induced cardiotoxicity in colorectal cancer patients: Preliminary data from the prospective observational CHECKPOINT trial (NCT02665312)
P. Lombardi1, G. Aimar1, I. Depetris2, A. Bonzano3, R. Filippi1, E. Fenocchio4, V. Quara1, o1, G. Cavalloni1, M. Milanesio1, R. Ferraris5, C. Cagnazzo6, C. Peraldo Neia7, M. Basiric M. Aglietta4, F. Leone8 1 Department of Medical Oncology, Candiolo Cancer Insititute, FPO - IRCCS, Candiolo, Italy, 2Department of Clinical and Experimental Oncology, Medical Oncology Unit 1, Veneto Institute of Oncology, Scientific Institute for Research and Healthcare, Padua, Italy, 3Cardiology Unit, Candiolo Cancer Institute, FPO - IRCCS, Candiolo, Italy, 4 Department of Medical Oncology, Candiolo Cancer Insititute, FPO - IRCCS, Candiolo, Italy, 5Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO a della Salute e della Scienza - Presidio IRCCS, Candiolo, Italy, 6Trial Office, AOU Citt Ospedaliero Infantile Regina Margherita, Turin, Italy, 7Cancer Genomics Lab, Fondazione Edo ed Elvo Tempia Valenta, Biella, Italy, 8Departement of Medical Oncology, ASL BI, Ospedale degli Infermi, Biella, Italy Background: Fluoropyrimidines (FP) are the backbone chemotherapy (CT) for colorectal cancer (CRC). Although the most common toxicities have been extensively studied, FP-induced cardiotoxicity (FIC), an infrequent but potentially life-threatening toxicity, still lacks of a comprehensive characterization. The correlation between FIC and known cardiovascular (CV) risk factors remains controversial and based on retrospective observations.
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz246.063/5577499 by guest on 26 October 2019
Methods: All consecutive patients who underwent CRS-HIPEC for peritoneal carcinomatosis from colorectal origin between February 2015 and June 2018 where identified. Relevant patient- and tumor related characteristics were collected. Results: In total 119 patients were included in this study; 60 males (50.4%). Median age was 64 years [IQR 55-71]. The pPCI was lower than the cPCI score in 80 patients (67.2%), the score was equal in 38 patients (31.9%), and in 1 patient (0.8%) the pPCI was higher than the cPCI. The median total cPCI 11 (IQR 6-16) was significantly higher than the median pPCI, (pPCI¼8, IQR 3-13, p < 0.001). In 21 patients (17.6%) the cPCI was overestimated 5 points. When patients were divided in different PCI categories, 0-5, 6-10, 11-15, 16 respectively, 39 patients (32.8%) moved to a lower pPCI category with corresponding better median survival rates. Conclusions: Clinical determination of the PCI often results in overestimation of the score. Far-reaching consequences are tied to the macroscopic evaluation of the cPCI by the surgeon, but this evaluation is not very reliable. Further research is warranted to determine whether the pPCI is a better scoring method/more precise prognostic factor for oncological outcomes after CRS-HIPEC. 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
Annals of Oncology
grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Aventis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Servier; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly. F. Overkamp: Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy: Chugai; Honoraria (self), Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Cellex; Honoraria (self), Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Gilead; Honoraria (self), Consultancy: Hexal; Honoraria (self), Advisory / Consultancy: Ipsen; Honoraria (self), Consultancy: Janssen-Cilag; Honoraria (self), Advisory / Consultancy: Merck; Honoraria Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: Novonordisc; Honoraria (self), Advisory / Consultancy: Riemser; (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Servier. C. / Part-time employment: Merck Healthcare KGaA. F. Lamy: Full / Part-time employment: Healthcare KGaA. R. Esser: Full / Part-time employment: Merck Healthcare KGaA. D. / Part-time employment, Prometris provides statistical services for Merck Healthcare KGaA: Merck Healthcare KGaA. V. Rothe: Full / Part-time employment, Prometris provides statistical services for Merck Healthcare KGaA: Merck Healthcare KGaA. W. Chen: Full / Part-time employment: Merck Serono. T. Brodowicz: Honoraria (self): Roche; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Bayer; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: PharmaMar; Honoraria (self), Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Lilly. C.C. Zielinski: Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Imugene; Honoraria (self), Advisory / Consultancy: ARIAD; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Merrimack; Honoraria (self), Advisory / Consultancy: Merck Healthcare KGaA; Honoraria (self), Advisory / Consultancy: FibroGen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Tesaro; Honoraria (self), Advisory / Consultancy: Gilead; Honoraria (self), Advisory / Consultancy: Servier; Honoraria (self), Advisory / Consultancy: Shire; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Athenex. All other authors have declared no conflicts of interest.
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POLAF study: Efficacy and safety of FOLFIRI/aflibercept in a phase II trial in patients with metastatic colorectal cancer: Results of plasmatic prognostic and predictive markers
omez-Espa~ na2, C. Gravalos3, P. Garcıa-Alfonso4, M.E. Elez Fernandez1, M.A. G na Suarez7, M. Toledano2, M. ValladaresB. Rodrıguez2, F. Losa5, I.C. Ales-Diaz6, B. Gra~ Ayerbes8, E. Polo Marques9, M. Salgado Fernandez10, E. Martınez de Castro11, M. Gil Raga12, M.A. Salud Salvia13, A. Ruiz-Casado14, A. Rodrıguez-Ariza2, E. Aranda Aguilar15 1 Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, 2Oncology, IMIBIC, Reina Sofıa Hospital, C ordoba, Spain, 3Oncology, University Hospital 12 de Octubre, Madrid, Spain, 4Servicio de Oncologıa Me´dica, General Universitario Gregorio Mara~ non, Madrid, Spain, 5Medical Oncology Department, Hospital de Sant Joan Despı Moise`s Broggi, Barcelona, Spain, 6Oncology, Servicio de Oncologıa Me´dica, Hospital Regional Universitario, Malaga, Spain, 7Medical Oncology, CHUAC - Complexo Hospitalario Universitario A Coru~ na, A Coru~ na, Spain, 8Medical Oncology Departament, University Hospital Virgen del Rocıo, Seville, Spain, 9Medical Oncology Department, Hospital Miguel Servet, Zaragoza, Spain, 10Medical Oncology, Complejo Hospitalario de Ourense, Ourense, Spain, 11Medical Oncology, Hospital Universitario Marque´s de Valdecilla, Santander, Spain, 12Medical Oncology, Hospital de Requena, Valencia, Spain, 13 Oncology, Hospital Universitario Arnau de Vilanova, Lleida, Spain, 14Medical Oncology, Hospital Universitario Puerta de Hierro, Madrid, Spain, 15Department of Medical Oncology, University Hospital Reina Sofia, Cordoba, Spain Background: Biomarkers associated to antiangiogiogenic agents in metastatic colorectal cancer (mCRC) have not yet been validated Here we present the efficacy and safety results of FOLFIRI and aflibercept in second line therapy for mCRC and the analysis of biomarkers as predictive factors of efficacy.
Volume 30 | Supplement 5 | October 2019
Methods: POLAF is a multicenter, non comparative, phase II study conducted in patients with mCRC previously treated with oxaliplatin (NCT02970916) Plasma biomarkers were assayed using ELISA Vascular endothelial growth factor (VEGF A) and angiotensin-converting enzyme (ACE) biomarkers were statistically analyzed (Roc Curve) with respect to the primary endpoint (PE): progression free survival (PFS) (Kaplan Meier). Results: Between November 2016 and December 2017, 101 patients for the PE were enrolled: male 59.4%, median age of 63.8 years and ECOG 0 in 46.5% of them The median of treatment duration was 5.7 months. Later antitumor therapies were received by 54.5% pts With a median follow up of 11.7 months, response rates were: PR 15.8%, SD 53.5% and PD 25.7%. The median OS, PFS, TTP and to TTF were 12.6, 7.4, 8.3 and 6.1 months, respectively Of note, both OS and PFS were significantly longer in pts with lower plasma VEGF A levels (<1.941 ng/ml) in comparison to those with higher levels (p < 0.001) No significant differences were detected in plasma ACE levels (Table) A total of 74.3% pts presented at least 1 grade 3 toxicity, being the most common asthenia (24.8%) hypertension (22.8%) and neutropenia (23.9%) and three pts presented grade 5 toxicity: one hepatic encephalopathy, one gastrointestinal toxicity and one unknown reason that treatment relationship could not be ruled out.
Table: 585P
VEFG-A
Cut offa
PFS
OS
<1.941 1.941
9.2 (8.4-10) 4.2 (2.7-5.6) p < 0.001
18.9 (14.8-23) 7.6 (4.5-10.7)
Conclusions: This study confirms the efficacy outcomes of FOLFIRI/aflibercept regimen in second line mCRC Our data shows that VEGF-A could be related to the survival of this population and its role as a potential predictive biomarker for efficacy should be considered. Legal entity responsible for the study: The authors. Funding: Sanofi. Disclosure: M.E. Elez Fernandez: Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Merck; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Sanofi; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Honoraria (institution), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Honoraria (self): Servier; Honoraria (self), Honoraria (institution): Array; Honoraria (institution): Novartis; Honoraria (institution): Boehringer Ingelheim; Honoraria (institution): MSD; Honoraria (institution): Servier; Honoraria (institution): Bayer; Honoraria (institution): GSK; Honoraria (institution): Pharmamar. B. Gra~ na Suarez: Research grant / Funding (self): Sanofi; Research grant / Funding (self): Gilead; Research grant / Funding (self): Amgen. M. Valladares-Ayerbes: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AMGEN; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Roche; Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Servier; Honoraria (self), Speaker Bureau / Expert testimony: Bayer; Honoraria (self): BRISTOL; Advisory / Consultancy: Sanofi. M. Salgado Fernandez: Travel / Accommodation / Expenses: Sanofi. E. Martınez de Castro: Speaker Bureau / Expert testimony: Sanofi. A. Ruiz-Casado: Honoraria (self), Research grant / Funding (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Merck; Honoraria (self): Lilly; Honoraria (self): Servier; Honoraria (self): Roche; Honoraria (self): Medtronic; Honoraria (self): BTG; Honoraria (self): Bayer. E. Aranda Aguilar: Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merck Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi. All other authors have declared no conflicts of interest.
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The accuracy of the clinical PCI score in patients with peritoneal carcinomatosis of colorectal cancer
N.L. De Boer, A. Brandt-Kerkhof, E. Madsen, K. Verhoef, J. Burger Department of Surgical Oncology, Erasmus MC Cancer Institute, Rotterdam, Netherlands Background: The Peritoneal Cancer Index (PCI) and completeness of cytoreduction are important prognostic factors in patients with peritoneal carcinomatosis from colorectal cancer, undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). The PCI is determined during laparotomy by an experienced surgeon before the decision is made to ‘do’ or ‘do not’ proceed with CRSHIPEC. The aim of this study is to determine the accuracy of the clinical PCI score (cPCI), by comparing the cPCI with the pathological PCI (pPCI) score.
doi:10.1093/annonc/mdz246 | v221
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q2w vs q1w schedule was tested with a hazard ratio (HR) margin of 1.25 using a Cox proportional hazards regression model. Differences in baseline characteristics were accounted for with inverse probability of treatment weighting (IPTW) based on a propensity score. Results: 763 (91% from NIS) and 554 (51% from NIS) patients were included in the q1w and q2w groups, respectively. Median (Q1-Q3) age in years was 66 (57-73) for q1w and 60 (53-69) for q2w. Liver-limited disease concerned 42.6% of patients for q1w and 37.9% for q2w. A baseline ECOG Performance Status of 0-1 was reported in 81.8% of q1w and 90.6% of q2w patients. FOLFIRI was most frequently used in combination with q1w (49.4%) and FOLFOX with q2w (59.2%). IPTW-adjusted HRs for OS were in favor of q2w: 0.83 (95% CI, 0.71-0.96) and 0.73 (95% CI, 0.61-0.88) when restricted to NIS. Other efficacy and safety results will be presented in the future. Conclusions: This pooled analysis confirmed the noninferiority of CET q2w vs q1w. This result suggests an improved OS with the q2w schedule. Editorial acknowledgement: ClinicalThinking, Inc, Hamilton, NJ, USA, funded by Merck Healthcare KGaA, Darmstadt, Germany. Legal entity responsible for the study: Merck Healthcare KGaA. Funding: Merck Healthcare KGaA. Disclosure: S. Kasper: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research
abstracts
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The impact of late-line treatment on overall survival (OS) from the initiation of first-line chemotherapy (CT) for patients (pts) with metastatic colorectal cancer (mCRC)
T. Kawakami1, T. Masuishi2, Y. Kawamoto3, H. Go4, H. Shirasu1, K. Kato5, R. Kumanishi6, K. Sawada7, K. Yamamoto4, S. Yuki8, Y. Komatsu9, H. Yasui10, K. Muro11, T. Yamanaka4, K. Yamazaki12 1 Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan, 2Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, 3Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan, 4 Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan, 5Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, 6 Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, 7Cancer Center, Hokkaido University Hospital, Sapporo, Japan, 8Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan, 9Department of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan, 10Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan, 11Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan, 12Gastroenterology, Sizuoka Cancer Center, Sundogun, Japan Background: For the past 20 years, the improvement in OS has been achieved in mCRC. Active agents including anti-VEGF and anti-EGFR antibodies have contributed to this progress. Late-line treatment with regorafenib (REGO) or trifluridine/tipiracil (FTD/TPI) has also been demonstrated to be effective and these drugs are widely used as standard CT. However, no study has reported to what extent the availability of these two drugs changes the total OS of patients that is measured from the initiation of first-line CT. Methods: We retrospectively enrolled consecutive mCRC pts at 3 institutions who received first-line CT between Jan 2005 and Sep 2016. We divided the pts into 3 groups according to the availability of drugs at the initiation of first-line CT; pts who started CT between Jan 2005 and Dec 2006 (cohort A: only cytotoxic drugs were available), between Jan 2007 and Dec 2011 (cohort B: anti-VEGF and anti-EGFR antibody were available), or between Jan 2012 and Sep 2016 (cohort C: REGO and FTD/TPI were available). Treatment outcomes were compared among the cohort A, B, and C. Results: A total of 1,426 pts were analyzed. Pts characteristics of the cohort A (165 pts), B (626 pts), and C (635 pts) were as follows: median age, 62/64/65 years; ECOG PS 2, 8.5%/8.8%/8.2%; right-sided primary, 26.1%/29.4%/29.9%; tumor grade Grade 3, 10.1%/13.1%/11.9%; KRAS mutation, 28.6%/38.4%/41.1%; and number of metastatic sites 2, 63.6%/61.3%/58.1%. In the cohort A, B, and C, 1.2%, 10.7%, and 31.2% of the pts received at least one of late-line treatment with REGO or FTD/TPI. Median OS of the cohort A, B, and C was 18.6 month (M), 25.3 M, and 27.2 M. Hazard ratio (HR) of death was 0.82 (95% confidential interval [CI], 0.68-0.98; p ¼ 0.0309) for the cohort B vs A, and 0.71 (95% CI, 0.59-0.86; p ¼ 0.0004) for the cohort C vs A, and 0.87 (95% CI 0.77-0.99; p ¼ 0.0356) for the cohort C vs B. Conclusions: This real-world data analysis indicates that late-line treatment with REGO or FTD/TPI could contribute to the prolongation of OS from the initiation of first-line CT for mCRC pts. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: T. Masuishi: Honoraria (self): Taiho Pharmaceutical, Merck Serono, Chugai Pharma, Yakult Honsha, Takeda, Eli Lilly, Bayer Yakuhin, Sanofi; Research grant / Funding (self): Yakult Honsha. Y. Kawamoto: Honoraria (self): Taiho Pharmaceutical, Daiichi Sankyo, Takeda Pharmaceutical, Chugai Pharmaceutical, Merck Biopharma, Eli Lilly. S. Yuki: Honoraria (self): Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Bristol-Myers Squibb Co., Ltd., Eli Lilly Japan K.K., Bayer Yakuhin Co., Ltd., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Pharma International Inc., Yakult H. Y. Komatsu: Honoraria (self): Taiho, Chugai, Yakult, Daiichi Sankyo, Bayer, Merck, Takeda; Research grant / Funding (institution): Taiho, Chugai, Yakult, Daiichi Sankyo, Bayer, Merck, Takeda. K. Muro: Honoraria (self): Takeda, Chugai Pharma, Yakult Honsha, Merck Serono, Taiho Pharmaceutical, Lilly, Ono Pharmaceutical, Bayer; Research grant / Funding (self): Ono Pharmaceutical, MSD, Daiichi Sankyo, Shionogi, Kyowa Hakko Kirin, Gilead Sciences, Merck Serono, Pfizer, Sanofi. T. Yamanaka: Honoraria (self): Chugai, Takeda, Taiho, Boehringer-Ingelheim, Bayer, Pfizer; Advisory / Consultancy: Gilead Sciences, Daiichi-Sankyo, Sysmex, Huya Biosciences; Honoraria (institution): Chugai, Takeda, Taiho, Boehringer-Ingelheim, Bayer, Daiichi-Sankyo, Ono, Merck Serono, Astellas, Eli Lilly. K. Yamazaki:
v222 | Gastrointestinal Tumours, Colorectal
Honoraria (self): Chugai Pharma, Daiichi Sankyo, Yakult Honsha, Takeda, Bayer, Merck Serono, BristolMyers Squibb Japan, Taiho Pharmceutical, Lilly, Sanofi, Ono Pharmaceutical, MSD; Research grant / Funding (institution): Taiho Pharmaceutical. All other authors have declared no conflicts of interest.
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Efficacy and safety of FOLFIRI/Aflibercept (FA) in elderly population with mCRC after failure of oxaliplatin-based chemotherapy
N. Martinez Lago1, M. Carmona Campos2, P. Gonzalez Villarroel3, M. Salgado Fernandez4, J. De laCamara Gomez5, C. Romero Reinoso6, A. Cousillas Casti~ neiras7, Y. Vidal Insua8, J.C. Mendez Mendez9, C. Reboredo Rendo1, na Suarez1, A. Carral Maseda2, M. Covela Rua2, G. Quintero Aldana2, B. Gra~ M. Jorge Fernandez3, M.L. Pellon Augusto5, C. Grande Ventura3, M.E. Gallardo Martin7, A. Fernandez Montes10, M. Reboredo Lopez1 1 Medical Oncology, CHUAC - Complexo Hospitalario Universitario A Coru~ na, A Coru~ na, Spain, 2Medical Oncology, Hospital Universitario Lucus Augusti, Lugo, Spain, 3Medical Oncology, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain, 4Medical Oncology, Complejo Hospitalario de Ourense, Ourense, Spain, 5Medical Oncology, Complexo Hospitalario Universitario de Ferrol, Ferrol, Spain, 6Medical Oncology, POVISA, Vigo, Spain, 7Medical Oncology, Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain, 8Medical Oncology, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain, 9Medical Oncology, Centro Oncologico de Galicia, A Coru~ na, Spain, 10Medical Oncology, Complexo Hospitalario Universitario de Ourense, Orense, Spain Background: Aflibercept (Af) significantly improves progression-free (PFS) and overall survival (OS) when added to FOLFIRI, in the overall population of patients (pts) pretreated with oxaliplatin-based therapy. A subset analysis of pts (>65years) included in the VELOUR trial, suggests a consistent benefit in OS in PFS, but increased grade 3-4 toxicity. Our hypothesis was that selected pts >70y with good PS could benefit from FA, provided they underwent a careful monitoring of toxicity. Methods: Retrospective, multicenter, observational study of mCRC pts >70 years (y) treated with FA as part of routine clinical practice at 8 hospitals from the Galician Research Group on Digestive Tumours (GITuD). Results: From 338 patients treated with FA between June 2013 to November 2018, 75 pts were recorded. Median age was 72.7 y (range 70-84 y), and 33.4% were >75y. 65.3% were male, 87.5% ECOG PS0-1, 42.5 % left-sided location, 76.0 % low grade, 59.5% RASmt and 77.3 % primary tumor resection. Prior therapy included bevacizumab (56%) and anti-EGFR agents (24%), only adjuvant treatment (5.3%). Median of FA cycles was 10 (range 1-35 cycles). Overall Response Rate (ORR) and disease control rate (DCR) were 30.7% and 65.4%, respectively. With a median follow-up of 27.1 months (m), median PFS was 6.6 m (95% CI, 5.3-7.9 m) and median OS was 15.1 m (95% CI, 12.5-17.8 m). The most common grade 3-4 toxicities overall were asthenia (21.3%), neutropenia (14.7%) and diarrhoea (14.7%). Af-related toxicities were hypertension (5.3%), dysphonia (5.3%) and proteinuria (2.7%). Two patients experienced grade 5 toxicity.This toxicity was managed with dose reduction of Af in 34.7% of cases, dose reduction of FOLFIRI on 56.0% and discontinuation of Af in 18.6%. Conclusions: Older patients with mCRC are underrepresented in clinical trials. The VELOUR study included only 6.4% pts >75y of age and only 14% included in the substudy of patients >65y were >75y. Patients >65y treated with FA in the VELOUR trial experienced a high rate of G3-4 adverse events (89.3%). Our series confirms that with careful pt selection and dose adjustment based on toxicity, patients >70y can be treated with FA with a 52.0% of grade 3-4 toxicity, results that are comparable to those of younger patients. Legal entity responsible for the study: Galician Research Group on Digestive Tumours (GITuD). Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
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Fluoropyrimidine-induced cardiotoxicity in colorectal cancer patients: Preliminary data from the prospective observational CHECKPOINT trial (NCT02665312)
P. Lombardi1, G. Aimar1, I. Depetris2, A. Bonzano3, R. Filippi1, E. Fenocchio4, V. Quara1, o1, G. Cavalloni1, M. Milanesio1, R. Ferraris5, C. Cagnazzo6, C. Peraldo Neia7, M. Basiric M. Aglietta4, F. Leone8 1 Department of Medical Oncology, Candiolo Cancer Insititute, FPO - IRCCS, Candiolo, Italy, 2Department of Clinical and Experimental Oncology, Medical Oncology Unit 1, Veneto Institute of Oncology, Scientific Institute for Research and Healthcare, Padua, Italy, 3Cardiology Unit, Candiolo Cancer Institute, FPO - IRCCS, Candiolo, Italy, 4 Department of Medical Oncology, Candiolo Cancer Insititute, FPO - IRCCS, Candiolo, Italy, 5Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO a della Salute e della Scienza - Presidio IRCCS, Candiolo, Italy, 6Trial Office, AOU Citt Ospedaliero Infantile Regina Margherita, Turin, Italy, 7Cancer Genomics Lab, Fondazione Edo ed Elvo Tempia Valenta, Biella, Italy, 8Departement of Medical Oncology, ASL BI, Ospedale degli Infermi, Biella, Italy Background: Fluoropyrimidines (FP) are the backbone chemotherapy (CT) for colorectal cancer (CRC). Although the most common toxicities have been extensively studied, FP-induced cardiotoxicity (FIC), an infrequent but potentially life-threatening toxicity, still lacks of a comprehensive characterization. The correlation between FIC and known cardiovascular (CV) risk factors remains controversial and based on retrospective observations.
Volume 30 | Supplement 5 | October 2019
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Methods: All consecutive patients who underwent CRS-HIPEC for peritoneal carcinomatosis from colorectal origin between February 2015 and June 2018 where identified. Relevant patient- and tumor related characteristics were collected. Results: In total 119 patients were included in this study; 60 males (50.4%). Median age was 64 years [IQR 55-71]. The pPCI was lower than the cPCI score in 80 patients (67.2%), the score was equal in 38 patients (31.9%), and in 1 patient (0.8%) the pPCI was higher than the cPCI. The median total cPCI 11 (IQR 6-16) was significantly higher than the median pPCI, (pPCI¼8, IQR 3-13, p < 0.001). In 21 patients (17.6%) the cPCI was overestimated 5 points. When patients were divided in different PCI categories, 0-5, 6-10, 11-15, 16 respectively, 39 patients (32.8%) moved to a lower pPCI category with corresponding better median survival rates. Conclusions: Clinical determination of the PCI often results in overestimation of the score. Far-reaching consequences are tied to the macroscopic evaluation of the cPCI by the surgeon, but this evaluation is not very reliable. Further research is warranted to determine whether the pPCI is a better scoring method/more precise prognostic factor for oncological outcomes after CRS-HIPEC. 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