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Simultaneous intravenous fluid infusion to prevent oxaliplatin infusion-related venous pain
abstracts
Annals of Oncology 1817P
Randomized phase II trial evaluating the safety of peripherally inserted central catheters vs implanted port catheters during adjuvant chemotherapy in early breast cancer patients
Background: Both peripherally inserted central catheters (PICC) and implanted port catheters (PORT) are used for adjuvant chemotherapy (ACT) administration in early breast cancer (EBC) patients. We evaluated the safety of the two devices in ACT setting. Methods: This monocentric phase II randomized trial (NCT02095743) included patients with an EBC and eligible to an ACT. Patients with curative anticoagulation were excluded. The primary endpoint was to identify the device with the less probability of occurrence of a significant adverse event related to the central venous device (SAERCVD) during the 37 weeks following device implantation. A SAERCVD was defined as: CTCAE grade 3, inducing a delay in CT administration >7 days, or requiring a replacement of the implanted device. PICC were removed the day of last CT administration; PORT were removed within 4 weeks after the last CT administration. Based on our previous study (Support Care Cancer. 2016; 24(3):1397-403), 256 patients were needed to meet the primary endpoint. Results: From February 2014 to April 2018, 256 patients were included; 248 (97%) were analyzed (PICC, n ¼ 125; PORT, n ¼ 123). Overall, 25 patients (10%) had a SAERCVD: thrombosis (n ¼ 13), local infection (n ¼ 6), systemic infection (n ¼ 3) and mechanical complication (n ¼ 3). Probability of occurrence of a SAERCVD within 37 weeks was 4.9% (6 SAERCVD) in PORT vs 15.2% (19 SAERCVD) in PICC (HR ¼ 3.2 [1.3-8.1], p ¼ 0.007). Regarding baseline characteristics, patients experiencing a SAERCVD had a trend toward a higher body mass index (p ¼ 0.08) and a history of thrombo-embolic disease (p ¼ 0.08) compared to patients without SAERCVD. Among the 223 patients without SAERCVD, probability of occurrence of a non-significant adverse event related to the device was 20.8% (22/106) in PICC vs 17.1% (20/117) in PORT (HR ¼ 1.2 [0.7-2.2], p ¼ 0.5), mainly grade 1 local pruritus. Grade3 adverse events not related to the implanted device were observed for 48 patients in each group (HR ¼ 1 [0.7-1.5], p ¼ 0.9), mainly CT induced neutropenia. Conclusions: Although side effects related to central venous devices are rare during ACT in EBC patients, SAERCVD are more frequently observed with PICC rather than PORT. Clinical trial identification: 2012-A01440-43 NCT02095743. Legal entity responsible for the study: Florian Clatot. Funding: La Ligue contre le cancer. Disclosure: F. Clatot: Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Lilly; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Research grant / Funding (institution): AstraZeneca; Travel / Accommodation / Expenses: Roche. All other authors have declared no conflicts of interest.
1818P
Simultaneous intravenous fluid infusion to prevent oxaliplatin infusion-related venous pain
S. Van Ravensteijn, B. van Merrienboer, S. van Asten, J. Pruijt, M. Hilbink, J. Tol Oncology, Jeroen Bosch Hospital, ’s-Hertogenbosch, Netherlands Background: Oxaliplatin is frequently used in the treatment of gastrointestinal cancer patients. A known side effect of oxaliplatin administration via a peripheral vein is infusion-related pain. In this retrospective cohort study we compared the incidence of infusion-related pain in patients treated with oxaliplatin with or without simultaneous fluid infusion (FI) (800 ml glucose 5% in 2 hours). Methods: As of December 2017, all patients treated with oxaliplatin at the Jeroen Bosch Hospital in the Netherlands received simultaneous FI. We retrospectively defined two cohorts: Patients treated with oxaliplatin and simultaneous intravenous FI starting treatment between January and November 2018, and the same number of patients treated without FI between January and November 2017. The incidence of infusionrelated venous pain was the primary outcome measure. Secondary outcomes included: Incidence of hypersensitivity reactions, infusion time, dose density, the number of patients switched to a central venous catheter and the incidence of peripheral neuropathy. Chi-square tests for categorical variables and T- tests for continuous variables were used. To identify possible confounders, we conducted a multivariate logistic regression analysis. Results: 100 patients were included: 50 patients in the FI group, 50 patients in the group treated without FI. Baseline characteristics were comparable, except for age (median 66.8 versus 62.4 years in groups with and without FI; p ¼ 0.017), and BMI (28.0 versus 25.7 kg/m2 respectively; p ¼ 0.012). Patients treated with simultaneous FI experienced significantly less vascular pain compared to those without FI (10% versus 78% respectively (p < 0.0001; OR 0.031 (95% CI: 0.01-0.098)). No difference was
Volume 30 | Supplement 5 | October 2019
1819P
Clinical practice evaluation of opioids induced constipation management in cancer patients: The EIO-Praxis project
on3, C.J. Camps Herrero4, A. Carrato E. Aranda Aguilar1, J. Garcia Foncillas2, A. Ant Mena5, M. Constenla Figueiras6, J.J. Cruz Hernandez7, E. Diaz Rubio8, P.N. Gascon9, opez11, M. Feyj oo12, J. Puente13 V. Guillem Porta10, R. L 1 Medical Oncology, Fundaci on ECO, Hospital Reina Sofıa de C ordoba, Cordoba, Spain, 2 Medical Oncology, Fundaci on ECO, Fundaci on Jime´nez Dıaz, Madrid, Spain, 3Medical Oncology, Fundaci on ECO, Hospital Universitario Miguel Servet, Zaragoza, Spain, 4 Medical Oncology, Fundaci on ECO, Hospital General de Valencia, Universidad de on ECO, Hospital Valencia, CIBERONC, Valencia, Spain, 5Medical Oncology, Fundaci Ram on y Cajal, IRYCIS, CIBERONC, Universidad de Alcala, Madrid, Spain, 6Medical Oncology, Fundaci on ECO, Complejo Hospitalario Universitario Pontevedra, on ECO, Hospital Clınico Universitario Pontevedra, Spain, 7Medical Oncology, Fundaci on ECO, Real Academia Nacional de de Salamanca, Salamanca, Spain, 8Fundaci on ECO, Medicina, IdISCC, CIBERONC, Madrid, Spain, 9Medical Oncology, Fundaci on ECO, Hospital Universitario Clinic, Barcelona, Spain, 10Medical Oncology, Fundaci 11 on Instituto Valenciano de Oncologıa, Valencia, Spain, Medical Oncology, Fundaci ECO, Hospital Clınico Universitario de Santiago de Compostela, Santiago De 12 on ECO, Hospital Universitario La Compostela, Spain, Medical Oncology, Fundaci on ECO, Hospital Clınico Moraleja Sanitas, Madrid, Spain, 13Medical Oncology, Fundaci San Carlos, Madrid, Spain Background: In 2017, the ECO Foundation (Excellence and Quality in Oncology) completed the EIO-50 project to learn about the diagnostic and treatment criteria of opioid-induced constipation (OIC) in cancer patients. The EIO-Praxis project was designed as a continuation of EIO-50, to learn about the current clinical practice of oncology professionals for the management of patients with OIC (process, follow-up and results). Methods: 77 health care professionals (HCP) from oncology units participated in the study. Each investigator collected information from 10 medical records of cancer patients who received OIC treatment, with a total of 770 records. In each center, 6 indicators of its structure were collected and the completion of a questionnaire with 15 questions regarding patient’s follow-up and treatment process was conducted. Results: According to healthcare professionals (HCP), an average proportion of 47.5% of cancer patients received treatment with opioids. From these, an average of 44.9% developed OIC. 51.9% of the investigators didn’t follow any guidelines for the management of patients with OIC. The mean age of the patients of the study was 61.6 years old. The mean duration of opioid treatment was 4.9 months, with an average time of 16.5 days from the start of opioid treatment to the appearance of the first symptoms of OIC. Only in 55.1% of the patients, the presence of functional constipation before starting opioid treatment was assessed. Patients of the study presented the following Rome IV criteria symptoms: 82.6% reduced bowel frequency, 52.9% fewer than three spontaneous bowel movements per week, 54.4% development or worsening of straining and stool consistency (54.2%). The majority of the patients were treated with laxatives (76.0%). Oral Peripherally Active m-Opioid Receptor Antagonist (PAMORA) was also used in 54.8% of the patients. Conclusions: Despite new guidelines for the management of constipation in cancer patients were published in 2018, the management of OIC is still insufficient. After laxative failures, the use of PAMORA drugs should be taken into consideration for the management of OIC. Legal entity responsible for the study: ECO Foundation. Funding: Kyowa Kirin. Disclosure: E. Aranda Aguilar: Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merck; Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi. J. Garcia Foncillas: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Research grant / Funding (institution): Merck. E. Diaz Rubio: Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Genomica; Advisory / Consultancy, Speaker Bureau / Expert testimony: Servier; Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Speaker Bureau / Expert testimony: MSD; Research grant / Funding (institution): Roche; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Sysmex. R. L opez: Shareholder / Stockholder / Stock options, Licensing / Royalties: Nasasbiotech; Shareholder / Stockholder / Stock options: Mtrap Inc; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: MSD; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Novartis; Advisory / Consultancy: Janssen; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: PharmaMar; Travel / Accommodation / Expenses: Pierre Fabre. All other authors have declared no conflicts of interest.
doi:10.1093/annonc/mdz265 | v739
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz265.063/5577777 by guest on 26 October 2019
F. Clatot1, M. Fontanilles1, L. Lefebvre2, J. Lequesne3, C. Veyret1, C. Alexandru1, M. Leheurteur4, C. Guillemet1, S. Goue´rant1, C. Petrau1, J-C. Thery1, O. Rigal1, C. Moldovan1, I. Tennevet Bouilly1, O. Rastelli4, M. Bubenheim5, D. Georgescu6, J. Goue´rant6, M. Gilles-Baray6, F. Di Fiore1 1 Medical Oncology, Centre Henri Becquerel, Rouen, France, 2Radiation Therapy, Centre Henri Becquerel, Rouen, France, 3Biostatistics, Centre Henri Becquerel, Rouen, France, 4 Clinical Research, Centre Henri Becquerel, Rouen, France, 5Biostatistics, Rouen University Hospital, Rouen, France, 6Surgical Oncology, Centre Henri Becquerel, Rouen, France
observed in dose density, treatment delay, or the need of central venous catheter. Multi-variate regression analysis showed no confounders affecting the primary outcome. No adverse events of FI were observed. Conclusions: Concurrent infusion of 800ml glucose 5% with peripheral venous administration of oxaliplatin significantly reduces the incidence of infusion-related pain in gastrointestinal cancer patients and is highly feasible and affordable in everyday clinical practice. 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 1817P
Randomized phase II trial evaluating the safety of peripherally inserted central catheters vs implanted port catheters during adjuvant chemotherapy in early breast cancer patients
Background: Both peripherally inserted central catheters (PICC) and implanted port catheters (PORT) are used for adjuvant chemotherapy (ACT) administration in early breast cancer (EBC) patients. We evaluated the safety of the two devices in ACT setting. Methods: This monocentric phase II randomized trial (NCT02095743) included patients with an EBC and eligible to an ACT. Patients with curative anticoagulation were excluded. The primary endpoint was to identify the device with the less probability of occurrence of a significant adverse event related to the central venous device (SAERCVD) during the 37 weeks following device implantation. A SAERCVD was defined as: CTCAE grade 3, inducing a delay in CT administration >7 days, or requiring a replacement of the implanted device. PICC were removed the day of last CT administration; PORT were removed within 4 weeks after the last CT administration. Based on our previous study (Support Care Cancer. 2016; 24(3):1397-403), 256 patients were needed to meet the primary endpoint. Results: From February 2014 to April 2018, 256 patients were included; 248 (97%) were analyzed (PICC, n ¼ 125; PORT, n ¼ 123). Overall, 25 patients (10%) had a SAERCVD: thrombosis (n ¼ 13), local infection (n ¼ 6), systemic infection (n ¼ 3) and mechanical complication (n ¼ 3). Probability of occurrence of a SAERCVD within 37 weeks was 4.9% (6 SAERCVD) in PORT vs 15.2% (19 SAERCVD) in PICC (HR ¼ 3.2 [1.3-8.1], p ¼ 0.007). Regarding baseline characteristics, patients experiencing a SAERCVD had a trend toward a higher body mass index (p ¼ 0.08) and a history of thrombo-embolic disease (p ¼ 0.08) compared to patients without SAERCVD. Among the 223 patients without SAERCVD, probability of occurrence of a non-significant adverse event related to the device was 20.8% (22/106) in PICC vs 17.1% (20/117) in PORT (HR ¼ 1.2 [0.7-2.2], p ¼ 0.5), mainly grade 1 local pruritus. Grade3 adverse events not related to the implanted device were observed for 48 patients in each group (HR ¼ 1 [0.7-1.5], p ¼ 0.9), mainly CT induced neutropenia. Conclusions: Although side effects related to central venous devices are rare during ACT in EBC patients, SAERCVD are more frequently observed with PICC rather than PORT. Clinical trial identification: 2012-A01440-43 NCT02095743. Legal entity responsible for the study: Florian Clatot. Funding: La Ligue contre le cancer. Disclosure: F. Clatot: Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Lilly; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Research grant / Funding (institution): AstraZeneca; Travel / Accommodation / Expenses: Roche. All other authors have declared no conflicts of interest.
1818P
Simultaneous intravenous fluid infusion to prevent oxaliplatin infusion-related venous pain
S. Van Ravensteijn, B. van Merrienboer, S. van Asten, J. Pruijt, M. Hilbink, J. Tol Oncology, Jeroen Bosch Hospital, ’s-Hertogenbosch, Netherlands Background: Oxaliplatin is frequently used in the treatment of gastrointestinal cancer patients. A known side effect of oxaliplatin administration via a peripheral vein is infusion-related pain. In this retrospective cohort study we compared the incidence of infusion-related pain in patients treated with oxaliplatin with or without simultaneous fluid infusion (FI) (800 ml glucose 5% in 2 hours). Methods: As of December 2017, all patients treated with oxaliplatin at the Jeroen Bosch Hospital in the Netherlands received simultaneous FI. We retrospectively defined two cohorts: Patients treated with oxaliplatin and simultaneous intravenous FI starting treatment between January and November 2018, and the same number of patients treated without FI between January and November 2017. The incidence of infusionrelated venous pain was the primary outcome measure. Secondary outcomes included: Incidence of hypersensitivity reactions, infusion time, dose density, the number of patients switched to a central venous catheter and the incidence of peripheral neuropathy. Chi-square tests for categorical variables and T- tests for continuous variables were used. To identify possible confounders, we conducted a multivariate logistic regression analysis. Results: 100 patients were included: 50 patients in the FI group, 50 patients in the group treated without FI. Baseline characteristics were comparable, except for age (median 66.8 versus 62.4 years in groups with and without FI; p ¼ 0.017), and BMI (28.0 versus 25.7 kg/m2 respectively; p ¼ 0.012). Patients treated with simultaneous FI experienced significantly less vascular pain compared to those without FI (10% versus 78% respectively (p < 0.0001; OR 0.031 (95% CI: 0.01-0.098)). No difference was
Volume 30 | Supplement 5 | October 2019
1819P
Clinical practice evaluation of opioids induced constipation management in cancer patients: The EIO-Praxis project
on3, C.J. Camps Herrero4, A. Carrato E. Aranda Aguilar1, J. Garcia Foncillas2, A. Ant Mena5, M. Constenla Figueiras6, J.J. Cruz Hernandez7, E. Diaz Rubio8, P.N. Gascon9, opez11, M. Feyj oo12, J. Puente13 V. Guillem Porta10, R. L 1 Medical Oncology, Fundaci on ECO, Hospital Reina Sofıa de C ordoba, Cordoba, Spain, 2 Medical Oncology, Fundaci on ECO, Fundaci on Jime´nez Dıaz, Madrid, Spain, 3Medical Oncology, Fundaci on ECO, Hospital Universitario Miguel Servet, Zaragoza, Spain, 4 Medical Oncology, Fundaci on ECO, Hospital General de Valencia, Universidad de on ECO, Hospital Valencia, CIBERONC, Valencia, Spain, 5Medical Oncology, Fundaci Ram on y Cajal, IRYCIS, CIBERONC, Universidad de Alcala, Madrid, Spain, 6Medical Oncology, Fundaci on ECO, Complejo Hospitalario Universitario Pontevedra, on ECO, Hospital Clınico Universitario Pontevedra, Spain, 7Medical Oncology, Fundaci on ECO, Real Academia Nacional de de Salamanca, Salamanca, Spain, 8Fundaci on ECO, Medicina, IdISCC, CIBERONC, Madrid, Spain, 9Medical Oncology, Fundaci on ECO, Hospital Universitario Clinic, Barcelona, Spain, 10Medical Oncology, Fundaci 11 on Instituto Valenciano de Oncologıa, Valencia, Spain, Medical Oncology, Fundaci ECO, Hospital Clınico Universitario de Santiago de Compostela, Santiago De 12 on ECO, Hospital Universitario La Compostela, Spain, Medical Oncology, Fundaci on ECO, Hospital Clınico Moraleja Sanitas, Madrid, Spain, 13Medical Oncology, Fundaci San Carlos, Madrid, Spain Background: In 2017, the ECO Foundation (Excellence and Quality in Oncology) completed the EIO-50 project to learn about the diagnostic and treatment criteria of opioid-induced constipation (OIC) in cancer patients. The EIO-Praxis project was designed as a continuation of EIO-50, to learn about the current clinical practice of oncology professionals for the management of patients with OIC (process, follow-up and results). Methods: 77 health care professionals (HCP) from oncology units participated in the study. Each investigator collected information from 10 medical records of cancer patients who received OIC treatment, with a total of 770 records. In each center, 6 indicators of its structure were collected and the completion of a questionnaire with 15 questions regarding patient’s follow-up and treatment process was conducted. Results: According to healthcare professionals (HCP), an average proportion of 47.5% of cancer patients received treatment with opioids. From these, an average of 44.9% developed OIC. 51.9% of the investigators didn’t follow any guidelines for the management of patients with OIC. The mean age of the patients of the study was 61.6 years old. The mean duration of opioid treatment was 4.9 months, with an average time of 16.5 days from the start of opioid treatment to the appearance of the first symptoms of OIC. Only in 55.1% of the patients, the presence of functional constipation before starting opioid treatment was assessed. Patients of the study presented the following Rome IV criteria symptoms: 82.6% reduced bowel frequency, 52.9% fewer than three spontaneous bowel movements per week, 54.4% development or worsening of straining and stool consistency (54.2%). The majority of the patients were treated with laxatives (76.0%). Oral Peripherally Active m-Opioid Receptor Antagonist (PAMORA) was also used in 54.8% of the patients. Conclusions: Despite new guidelines for the management of constipation in cancer patients were published in 2018, the management of OIC is still insufficient. After laxative failures, the use of PAMORA drugs should be taken into consideration for the management of OIC. Legal entity responsible for the study: ECO Foundation. Funding: Kyowa Kirin. Disclosure: E. Aranda Aguilar: Advisory / Consultancy: Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Merck; Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi. J. Garcia Foncillas: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Research grant / Funding (institution): Merck. E. Diaz Rubio: Advisory / Consultancy, Research grant / Funding (institution): Amgen; Advisory / Consultancy: Bayer; Advisory / Consultancy: Genomica; Advisory / Consultancy, Speaker Bureau / Expert testimony: Servier; Advisory / Consultancy, Research grant / Funding (institution): Merck Serono; Speaker Bureau / Expert testimony: MSD; Research grant / Funding (institution): Roche; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Sysmex. R. L opez: Shareholder / Stockholder / Stock options, Licensing / Royalties: Nasasbiotech; Shareholder / Stockholder / Stock options: Mtrap Inc; Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: MSD; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Advisory / Consultancy: Novartis; Advisory / Consultancy: Janssen; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer; Travel / Accommodation / Expenses: PharmaMar; Travel / Accommodation / Expenses: Pierre Fabre. All other authors have declared no conflicts of interest.
doi:10.1093/annonc/mdz265 | v739
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz265.063/5577777 by guest on 26 October 2019
F. Clatot1, M. Fontanilles1, L. Lefebvre2, J. Lequesne3, C. Veyret1, C. Alexandru1, M. Leheurteur4, C. Guillemet1, S. Goue´rant1, C. Petrau1, J-C. Thery1, O. Rigal1, C. Moldovan1, I. Tennevet Bouilly1, O. Rastelli4, M. Bubenheim5, D. Georgescu6, J. Goue´rant6, M. Gilles-Baray6, F. Di Fiore1 1 Medical Oncology, Centre Henri Becquerel, Rouen, France, 2Radiation Therapy, Centre Henri Becquerel, Rouen, France, 3Biostatistics, Centre Henri Becquerel, Rouen, France, 4 Clinical Research, Centre Henri Becquerel, Rouen, France, 5Biostatistics, Rouen University Hospital, Rouen, France, 6Surgical Oncology, Centre Henri Becquerel, Rouen, France
observed in dose density, treatment delay, or the need of central venous catheter. Multi-variate regression analysis showed no confounders affecting the primary outcome. No adverse events of FI were observed. Conclusions: Concurrent infusion of 800ml glucose 5% with peripheral venous administration of oxaliplatin significantly reduces the incidence of infusion-related pain in gastrointestinal cancer patients and is highly feasible and affordable in everyday clinical practice. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.