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Biosimilar filgrastim in the treatment and prevention of chemotherapy-induced neutropenia in elderly patients: A subanalysis of the next study
Abstracts
Keywords: Lung, Palliative care doi:10.1016/j.jgo.2014.09.128
Supportive care in elderly cancer patients P100 BIOSIMILAR FILGRASTIM IN THE TREATMENT AND THE PREVENTION OF CHEMOTHERAPY-INDUCED NEUTROPENIA: THE NEXT STUDY M. Frederic1,⁎, L. Stephane2, K. Didier3, B. Christian4, C. Laurent5, A. Helene6 1 Clinique Sainte Anne, Strasbourg, France 2 Hématologie, Centre Henri Becquerel, Rouen, France 3 Hôpital Privé de l’Ouest Parisien, TRAPPES, France 4 Hôpital Morvan, BREST, France 5 Hôpital Jean Minjoz, BESANCON, France 6 HOSPIRA FRANCE, Meudon La Foret, France
Introduction: Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy (CT). It is defined as an oral temperature N 38.5 °C, or two consecutive readings of N38.0 °C for 2 h, with an absolute neutrophil count b 0.5 × 109/L, or expected to fall below 0.5 × 109/L. Biosimilar filgrastim (Nivestim®, Hospira Ltd.) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive CT. Phase II and III clinical trials have demonstrated that its efficacy and safety are similar to the reference product (Neupogen®). Here we present the results of the NEXT (Nivestim® safety profile in patiEnts treated with cytotoXic in real-life clinical pracTice) observational study. Objectives: The primary objective of the NEXT study was to evaluate the safety of biosimilar filgrastim by gathering adverse event (AE) data. Secondary objectives included the description of patients (pts) treated with, and patterns of use of, biosimilar filgrastim. Methods: The NEXT study was a prospective, post-marketing, noninterventional, longitudinal, national and multicentre study. Adult pts (n = 2114) undergoing cytotoxic CT for malignancies (excluding chronic myeloproliferative and myelodysplastic syndrome) and receiving biosimilar filgrastim as primary or secondary prophylaxis, or as curative treatment, were included. Data were recorded on case report forms and included patient characteristics (demographics, medical history, CT-related data), biosimilar filgrastim treatment-related data (indication, dose, route of administration, treatment initiation) and treatment emergent AEs, especially FN. Pts were followed-up for a maximum of six CT cycles, at three visits: inclusion, a follow-up visit during treatment and the final visit following CT. Results: A total of 2102 pts from 183 centres were included in the study analysis (50.2% male). Mean age ± standard deviation (SD) was 63.5 ± 12.7 years. Overall, 75.0% of pts had solid tumours and 25.0% had haematological malignancies (lymphoma: 19.3%; myeloma: 2.2%; acute leukaemia: 0.2%; chronic lymphocytic leukaemia: 3.1% other haematological malignancies: 0.1%). The majority (98.2%) of pts received prophylactic biosimilar filgrastim (primary prophylaxis: 8.2%; secondary prophylaxis: 90.0%). Of the patients receiving prophylactic biosimilar filgrastim, 79.9% received a dose of 30 MIU and therapy was administered subcutaneously in 99.4% of these pts. Median time to initiation was 2 days after the last CT dose; mean treatment duration ± SD was 6.0 ± 3.8 days. Anti-infective prophylaxis was reported in 14.5% of pts. During the study, 20.4% of pts experienced ≥1 AE. 13.3% of pts reported bone, muscular and chest pain. The other most common AEs included gastrointestinal disorders (5.4%), nausea (3.0%), diarrhoea (2.3%) and headache (1.8%).
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Of the patients enrolled in this study, 4.9% (95% confidence interval, CI [4.06, 5.98]) experienced FN and 3.1% (95% CI [2.39, 3.93]) of pts had an infection. Mean duration of hospitalisation ± SD for FN and/or infection was 8.7 ± 10.9 days. Overall, 4.7% of pts had ≥1 CT dose reduction and 7.4% of pts had a delay in ≥1 cycle of CT. Conclusion: Biosimilar filgrastim (Nivestim®) was effective and well-tolerated in both the prophylactic and curative setting in pts undergoing cytotoxic CT for malignancies. Muscular and chest pain were the main expected adverse events. Disclosure of interest: None declared. Keywords: Breast cancer, Haematological, Lung, Lymphoma, Myeloma doi:10.1016/j.jgo.2014.09.129
Supportive care in elderly cancer patients P101 BIOSIMILAR FILGRASTIM IN THE TREATMENT AND PREVENTION OF CHEMOTHERAPY-INDUCED NEUTROPENIA IN ELDERLY PATIENTS: A SUBANALYSIS OF THE NEXT STUDY M. Frederic1,⁎, L. Stephane2, K. Didier3, B. Christian4, C. Laurent5, A. Helene6 1 Clinique Sainte-Anne, Strasbourg, France 2 Hématologie, Centre Henri becquerel, Rouen, France 3 Hôpital Privé de l’Ouest Parisien, TRAPPES, France 4 Hôpital Morvan, BREST, France 5 Hôpital Jean Minjoz, BESANCON, France 6 HOSPIRA FRANCE, Meudon La Foret, France Introduction: Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy (CT), especially in elderly patients. It is defined as an oral temperature N38.5 °C or two consecutive readings of N38.0 °C for 2 h, with an absolute neutrophil count b 0.5 × 109/L, or expected to fall below 0.5 × 109/L. Established guidelines allow the use of granulocyte-colony stimulating factor (GCSF) to treat or prevent CT-induced neutropenia and FN. Biosimilar filgrastim (Nivestim®, Hospira Ltd.) is a G-CSF that has demonstrated similarity to its reference product (Neupogen®) in phase II and III clinical trials. This subanalysis of the NEXT (Nivestim® safety profile in patiEnts treated with cytotoXic in real-life clinical pracTice) study explored tolerability and efficacy of biosimilar G-CSF in elderly patients (pts). Objectives: The primary objective of the NEXT study was to evaluate the safety of biosimilar filgrastim by gathering adverse event (AE) data. Secondary objectives included the description of pts treated with biosimilar filgrastim and patterns of use. Methods: The NEXT study was a prospective, post-marketing, noninterventional, longitudinal, national, multicentre study of adult pts (n = 2114) undergoing cytotoxic CT for malignancies (excluding chronic myeloproliferative and myelodysplastic syndrome), receiving biosimilar filgrastim as primary or secondary prophylaxis, or as curative treatment. Pts were followed-up for a maximum of six CT cycles, at three visits: inclusion, a follow-up visit during treatment and the final visit following CT. Data were recorded on case report forms and included pt characteristics (demographics, medical history, CT-related data), biosimilar filgrastim treatment-related data (indication, dose, route of administration, treatment initiation) and treatment emergent AEs, especially FN. Here we present a subanalysis of pts aged ≥70 years. Results: Overall, the NEXT study analysed 2102 pts; this subanalysis includes 708 pts aged ≥ 70 years (55.9% male; mean age ± standard deviation (SD): 76.3 ± 4.7 years). Of the pts aged
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Abstracts
≥70 years, 68.2% had solid tumours and 31.8% had hematological malignancies (lymphoma: 22.5%; myeloma: 3.7%; acute leukaemia: 0.7%; chronic lymphocytic leukaemia: 4.9%). The majority (98.3%) of pts received prophylactic biosimilar filgrastim (primary prophylaxis: 7.3%; secondary prophylaxis: 91.0%), with 81.9% of pts receiving a dose of 30 MIU and 99.3% of pts receiving therapy subcutaneously. Median time to treatment initiation was 2 days after the last CT dose; mean treatment duration ± SD was 6.1 ± 4.3 days. Anti-infective prophylaxis was reported in 17.7% of pts. In this subanalysis, 18.9% of pts had ≥1 AE with 11.8% of pts reporting bone, muscular and chest pain (vs 20.4% and 13.3%, respectively, in the overall population). During the study, 4.5% (95% confidence interval, CI [3.17, 6.41]) and 3.0% (95% CI [1.93, 4.64]) of pts had FN and infection, respectively (vs 4.9% and 3.1% in the overall population). Mean duration ± SD of hospitalization for FN/infection was 11.6 ± 15.6 days. A reduction in CT dose was required by 3.6% of pts and 7.0% had a delay in ≥1 cycle of CT (vs 4.7% and 7.4%, respectively, in the overall population). Conclusion: Biosimilar filgrastim (Nivestim®) was effective and well-tolerated in the treatment and prevention of FN in the elderly; efficacy and safety were comparable with that observed in the overall study population. Disclosure of interest: None declared. Keywords: Breast cancer, Hematological, Lung, Lymphoma, Myeloma doi:10.1016/j.jgo.2014.09.130
Supportive care in elderly cancer patients P102 SAFETY AND EFFICACY OF NEPA, A FIXED ORAL DOSE COMBINATION OF NETUPITANT AND PALONOSETRON, IN OLDER PATIENTS M. Aapro1,⁎, P.J. Hesketh2, R.J. Gralla3, K. Jordan4, G. Rizzi5 1 Clinique de Genolier, Genolier, Switzerland 2 Lahey Hospital & Medical Center, Burlington, United States 3 Albert Einstein College of Medicine, Bronx, United States 4 University of Halle, Halle, Germany 5 Helsinn Healthcare, Lugano, Switzerland Introduction: Prevention of chemotherapy-induced nausea and vomiting (CINV) in older cancer patients is critical, as these patients tend to be more sensitive to the adverse effects of cytotoxic therapy and thus more likely to experience dehydration and anorexia related to CINV. Antiemetic treatment regimens should be conveniently administered, well tolerated and highly effective, particularly considering the increased likelihood of cognitive impairments and cardiac comorbidities in this population. NEPA is a convenient, oral fixed-dose combination of a new NK1 receptor antagonist (RA), netupitant (NETU 300 mg), and palonosetron (PALO 0.50 mg), a pharmacologically distinct 5-HT3 RA. NEPA, which targets two critical pathways involved in emesis, has been shown to be superior to oral PALO (0.50 mg) in 2 registration trials and highly effective over multiple cycles in a third trial. Objectives: The intent of this retrospective analysis was to evaluate the efficacy/safety of NEPA during the first cycle of chemotherapy in an older subset of patients in these trials. Methods: NEPA data from 3 pivotal trials was combined for the ≥65 year old subset of chemotherapy-naïve patients with solid tumors undergoing either cisplatin-based highly emetogenic (HEC), anthracycline-based (AC) or non-AC moderately emetogenic chemotherapy (MEC). All patients also received oral dexamethasone on day
1 (MEC) or days 1–4 (HEC). Efficacy was assessed by complete response (CR: no emesis, no rescue medication); safety was assessed by adverse events and ECGs. No formal comparisons were performed for older patients vs the overall study population(s). Results: 214 patients were ≥65 years; of these, 80 were ≥70 and 20 were ≥75 years. Not surprisingly, CR rates for NEPA in the older patients were generally higher than those seen in the overall study population. Study 1 (HEC) Time period
Study 2 (AC MEC)
Study 3 (non-AC MEC/HEC)
≥65 yrs Overall ≥65 yrs Overall ≥65 yrs Overall (N = 20) population (N = 116) population (N = 78) population (N = 135) (N = 724) (N = 309)
Acute 100% (0-24 h) Delayed 100% (25-120 h) Overall 100% (0-120 h)
98.5%
94.0%
88.4%
97.4%
92.9%
90.4%
81.0%
76.9%
80.8%
83.2%
89.6%
79.3%
74.3%
78.2%
80.6%
The percentage of patients reporting adverse event(s) (AEs) during the cycle 1 was similar in patients ≥ 65 yrs (72.9%) and the overall population (70.0%). This was also the case for treatmentrelated AEs (8.4% vs 8.2%), while the proportion with serious AEs was slightly higher for the older subgroup (3.7% vs 2.7%). However, this was not unexpected when considering the greater number of existing comorbidities in an older cancer population (e.g., cardiac disorders: 25% older vs 18% for the overall population, diabetes: 19% older vs 9% overall). The mean changes from baseline in QTcB at 5 h post-dose were small and similar (11.3 and 13.5 ms) in the older subset and overall population, respectively. Values in both groups returned to baseline or lower at 120 h after treatment. Conclusion: In this retrospective analysis, NEPA was highly effective in preventing CINV in older patients undergoing a variety of emetogenic chemotherapy. Based on this efficacy and the expected safety profile, NEPA may be an excellent antiemetic option for older patients, particularly when considering the high rate of polypharmacy and cognitive impairment in this population and NEPA’s convenient single fixed- dose administration. The potential interactions with drugs metabolized through the cyp3a4 pathway should be verified. Disclosure of interest: M. Aapro consultant for: Helsinn Healthcare, Speakers Bureau: Helsinn Healthcare, P. Hesketh Consultant for: Helsinn Healthcare (not compensated), R. Gralla Consultant for: Helsinn Healthcare, K. Jordan consultant for: Helsinn Healthcare, G. Rizzi Employee of: Helsinn Healthcare. Keywords: Clinical trials, Drug development doi:10.1016/j.jgo.2014.09.131
Supportive care in elderly cancer patients P103 IMPACT OF TIME, PERSONAL CONTROL AND SELF-RATED HEALTH ON OLDER CANCER PATIENTS UNDERGOING A CHEMOTHERAPY REGIMEN C. Robb1⁎, D. Linder2, B. Djire2, E. Carter1, P. Jacobsen3, M. Extermann4 1 Epidemiology, United States 2 Biostatistics, Georgia Southern University, Statesboro, United States
Keywords: Lung, Palliative care doi:10.1016/j.jgo.2014.09.128
Supportive care in elderly cancer patients P100 BIOSIMILAR FILGRASTIM IN THE TREATMENT AND THE PREVENTION OF CHEMOTHERAPY-INDUCED NEUTROPENIA: THE NEXT STUDY M. Frederic1,⁎, L. Stephane2, K. Didier3, B. Christian4, C. Laurent5, A. Helene6 1 Clinique Sainte Anne, Strasbourg, France 2 Hématologie, Centre Henri Becquerel, Rouen, France 3 Hôpital Privé de l’Ouest Parisien, TRAPPES, France 4 Hôpital Morvan, BREST, France 5 Hôpital Jean Minjoz, BESANCON, France 6 HOSPIRA FRANCE, Meudon La Foret, France
Introduction: Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy (CT). It is defined as an oral temperature N 38.5 °C, or two consecutive readings of N38.0 °C for 2 h, with an absolute neutrophil count b 0.5 × 109/L, or expected to fall below 0.5 × 109/L. Biosimilar filgrastim (Nivestim®, Hospira Ltd.) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive CT. Phase II and III clinical trials have demonstrated that its efficacy and safety are similar to the reference product (Neupogen®). Here we present the results of the NEXT (Nivestim® safety profile in patiEnts treated with cytotoXic in real-life clinical pracTice) observational study. Objectives: The primary objective of the NEXT study was to evaluate the safety of biosimilar filgrastim by gathering adverse event (AE) data. Secondary objectives included the description of patients (pts) treated with, and patterns of use of, biosimilar filgrastim. Methods: The NEXT study was a prospective, post-marketing, noninterventional, longitudinal, national and multicentre study. Adult pts (n = 2114) undergoing cytotoxic CT for malignancies (excluding chronic myeloproliferative and myelodysplastic syndrome) and receiving biosimilar filgrastim as primary or secondary prophylaxis, or as curative treatment, were included. Data were recorded on case report forms and included patient characteristics (demographics, medical history, CT-related data), biosimilar filgrastim treatment-related data (indication, dose, route of administration, treatment initiation) and treatment emergent AEs, especially FN. Pts were followed-up for a maximum of six CT cycles, at three visits: inclusion, a follow-up visit during treatment and the final visit following CT. Results: A total of 2102 pts from 183 centres were included in the study analysis (50.2% male). Mean age ± standard deviation (SD) was 63.5 ± 12.7 years. Overall, 75.0% of pts had solid tumours and 25.0% had haematological malignancies (lymphoma: 19.3%; myeloma: 2.2%; acute leukaemia: 0.2%; chronic lymphocytic leukaemia: 3.1% other haematological malignancies: 0.1%). The majority (98.2%) of pts received prophylactic biosimilar filgrastim (primary prophylaxis: 8.2%; secondary prophylaxis: 90.0%). Of the patients receiving prophylactic biosimilar filgrastim, 79.9% received a dose of 30 MIU and therapy was administered subcutaneously in 99.4% of these pts. Median time to initiation was 2 days after the last CT dose; mean treatment duration ± SD was 6.0 ± 3.8 days. Anti-infective prophylaxis was reported in 14.5% of pts. During the study, 20.4% of pts experienced ≥1 AE. 13.3% of pts reported bone, muscular and chest pain. The other most common AEs included gastrointestinal disorders (5.4%), nausea (3.0%), diarrhoea (2.3%) and headache (1.8%).
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Of the patients enrolled in this study, 4.9% (95% confidence interval, CI [4.06, 5.98]) experienced FN and 3.1% (95% CI [2.39, 3.93]) of pts had an infection. Mean duration of hospitalisation ± SD for FN and/or infection was 8.7 ± 10.9 days. Overall, 4.7% of pts had ≥1 CT dose reduction and 7.4% of pts had a delay in ≥1 cycle of CT. Conclusion: Biosimilar filgrastim (Nivestim®) was effective and well-tolerated in both the prophylactic and curative setting in pts undergoing cytotoxic CT for malignancies. Muscular and chest pain were the main expected adverse events. Disclosure of interest: None declared. Keywords: Breast cancer, Haematological, Lung, Lymphoma, Myeloma doi:10.1016/j.jgo.2014.09.129
Supportive care in elderly cancer patients P101 BIOSIMILAR FILGRASTIM IN THE TREATMENT AND PREVENTION OF CHEMOTHERAPY-INDUCED NEUTROPENIA IN ELDERLY PATIENTS: A SUBANALYSIS OF THE NEXT STUDY M. Frederic1,⁎, L. Stephane2, K. Didier3, B. Christian4, C. Laurent5, A. Helene6 1 Clinique Sainte-Anne, Strasbourg, France 2 Hématologie, Centre Henri becquerel, Rouen, France 3 Hôpital Privé de l’Ouest Parisien, TRAPPES, France 4 Hôpital Morvan, BREST, France 5 Hôpital Jean Minjoz, BESANCON, France 6 HOSPIRA FRANCE, Meudon La Foret, France Introduction: Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy (CT), especially in elderly patients. It is defined as an oral temperature N38.5 °C or two consecutive readings of N38.0 °C for 2 h, with an absolute neutrophil count b 0.5 × 109/L, or expected to fall below 0.5 × 109/L. Established guidelines allow the use of granulocyte-colony stimulating factor (GCSF) to treat or prevent CT-induced neutropenia and FN. Biosimilar filgrastim (Nivestim®, Hospira Ltd.) is a G-CSF that has demonstrated similarity to its reference product (Neupogen®) in phase II and III clinical trials. This subanalysis of the NEXT (Nivestim® safety profile in patiEnts treated with cytotoXic in real-life clinical pracTice) study explored tolerability and efficacy of biosimilar G-CSF in elderly patients (pts). Objectives: The primary objective of the NEXT study was to evaluate the safety of biosimilar filgrastim by gathering adverse event (AE) data. Secondary objectives included the description of pts treated with biosimilar filgrastim and patterns of use. Methods: The NEXT study was a prospective, post-marketing, noninterventional, longitudinal, national, multicentre study of adult pts (n = 2114) undergoing cytotoxic CT for malignancies (excluding chronic myeloproliferative and myelodysplastic syndrome), receiving biosimilar filgrastim as primary or secondary prophylaxis, or as curative treatment. Pts were followed-up for a maximum of six CT cycles, at three visits: inclusion, a follow-up visit during treatment and the final visit following CT. Data were recorded on case report forms and included pt characteristics (demographics, medical history, CT-related data), biosimilar filgrastim treatment-related data (indication, dose, route of administration, treatment initiation) and treatment emergent AEs, especially FN. Here we present a subanalysis of pts aged ≥70 years. Results: Overall, the NEXT study analysed 2102 pts; this subanalysis includes 708 pts aged ≥ 70 years (55.9% male; mean age ± standard deviation (SD): 76.3 ± 4.7 years). Of the pts aged
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Abstracts
≥70 years, 68.2% had solid tumours and 31.8% had hematological malignancies (lymphoma: 22.5%; myeloma: 3.7%; acute leukaemia: 0.7%; chronic lymphocytic leukaemia: 4.9%). The majority (98.3%) of pts received prophylactic biosimilar filgrastim (primary prophylaxis: 7.3%; secondary prophylaxis: 91.0%), with 81.9% of pts receiving a dose of 30 MIU and 99.3% of pts receiving therapy subcutaneously. Median time to treatment initiation was 2 days after the last CT dose; mean treatment duration ± SD was 6.1 ± 4.3 days. Anti-infective prophylaxis was reported in 17.7% of pts. In this subanalysis, 18.9% of pts had ≥1 AE with 11.8% of pts reporting bone, muscular and chest pain (vs 20.4% and 13.3%, respectively, in the overall population). During the study, 4.5% (95% confidence interval, CI [3.17, 6.41]) and 3.0% (95% CI [1.93, 4.64]) of pts had FN and infection, respectively (vs 4.9% and 3.1% in the overall population). Mean duration ± SD of hospitalization for FN/infection was 11.6 ± 15.6 days. A reduction in CT dose was required by 3.6% of pts and 7.0% had a delay in ≥1 cycle of CT (vs 4.7% and 7.4%, respectively, in the overall population). Conclusion: Biosimilar filgrastim (Nivestim®) was effective and well-tolerated in the treatment and prevention of FN in the elderly; efficacy and safety were comparable with that observed in the overall study population. Disclosure of interest: None declared. Keywords: Breast cancer, Hematological, Lung, Lymphoma, Myeloma doi:10.1016/j.jgo.2014.09.130
Supportive care in elderly cancer patients P102 SAFETY AND EFFICACY OF NEPA, A FIXED ORAL DOSE COMBINATION OF NETUPITANT AND PALONOSETRON, IN OLDER PATIENTS M. Aapro1,⁎, P.J. Hesketh2, R.J. Gralla3, K. Jordan4, G. Rizzi5 1 Clinique de Genolier, Genolier, Switzerland 2 Lahey Hospital & Medical Center, Burlington, United States 3 Albert Einstein College of Medicine, Bronx, United States 4 University of Halle, Halle, Germany 5 Helsinn Healthcare, Lugano, Switzerland Introduction: Prevention of chemotherapy-induced nausea and vomiting (CINV) in older cancer patients is critical, as these patients tend to be more sensitive to the adverse effects of cytotoxic therapy and thus more likely to experience dehydration and anorexia related to CINV. Antiemetic treatment regimens should be conveniently administered, well tolerated and highly effective, particularly considering the increased likelihood of cognitive impairments and cardiac comorbidities in this population. NEPA is a convenient, oral fixed-dose combination of a new NK1 receptor antagonist (RA), netupitant (NETU 300 mg), and palonosetron (PALO 0.50 mg), a pharmacologically distinct 5-HT3 RA. NEPA, which targets two critical pathways involved in emesis, has been shown to be superior to oral PALO (0.50 mg) in 2 registration trials and highly effective over multiple cycles in a third trial. Objectives: The intent of this retrospective analysis was to evaluate the efficacy/safety of NEPA during the first cycle of chemotherapy in an older subset of patients in these trials. Methods: NEPA data from 3 pivotal trials was combined for the ≥65 year old subset of chemotherapy-naïve patients with solid tumors undergoing either cisplatin-based highly emetogenic (HEC), anthracycline-based (AC) or non-AC moderately emetogenic chemotherapy (MEC). All patients also received oral dexamethasone on day
1 (MEC) or days 1–4 (HEC). Efficacy was assessed by complete response (CR: no emesis, no rescue medication); safety was assessed by adverse events and ECGs. No formal comparisons were performed for older patients vs the overall study population(s). Results: 214 patients were ≥65 years; of these, 80 were ≥70 and 20 were ≥75 years. Not surprisingly, CR rates for NEPA in the older patients were generally higher than those seen in the overall study population. Study 1 (HEC) Time period
Study 2 (AC MEC)
Study 3 (non-AC MEC/HEC)
≥65 yrs Overall ≥65 yrs Overall ≥65 yrs Overall (N = 20) population (N = 116) population (N = 78) population (N = 135) (N = 724) (N = 309)
Acute 100% (0-24 h) Delayed 100% (25-120 h) Overall 100% (0-120 h)
98.5%
94.0%
88.4%
97.4%
92.9%
90.4%
81.0%
76.9%
80.8%
83.2%
89.6%
79.3%
74.3%
78.2%
80.6%
The percentage of patients reporting adverse event(s) (AEs) during the cycle 1 was similar in patients ≥ 65 yrs (72.9%) and the overall population (70.0%). This was also the case for treatmentrelated AEs (8.4% vs 8.2%), while the proportion with serious AEs was slightly higher for the older subgroup (3.7% vs 2.7%). However, this was not unexpected when considering the greater number of existing comorbidities in an older cancer population (e.g., cardiac disorders: 25% older vs 18% for the overall population, diabetes: 19% older vs 9% overall). The mean changes from baseline in QTcB at 5 h post-dose were small and similar (11.3 and 13.5 ms) in the older subset and overall population, respectively. Values in both groups returned to baseline or lower at 120 h after treatment. Conclusion: In this retrospective analysis, NEPA was highly effective in preventing CINV in older patients undergoing a variety of emetogenic chemotherapy. Based on this efficacy and the expected safety profile, NEPA may be an excellent antiemetic option for older patients, particularly when considering the high rate of polypharmacy and cognitive impairment in this population and NEPA’s convenient single fixed- dose administration. The potential interactions with drugs metabolized through the cyp3a4 pathway should be verified. Disclosure of interest: M. Aapro consultant for: Helsinn Healthcare, Speakers Bureau: Helsinn Healthcare, P. Hesketh Consultant for: Helsinn Healthcare (not compensated), R. Gralla Consultant for: Helsinn Healthcare, K. Jordan consultant for: Helsinn Healthcare, G. Rizzi Employee of: Helsinn Healthcare. Keywords: Clinical trials, Drug development doi:10.1016/j.jgo.2014.09.131
Supportive care in elderly cancer patients P103 IMPACT OF TIME, PERSONAL CONTROL AND SELF-RATED HEALTH ON OLDER CANCER PATIENTS UNDERGOING A CHEMOTHERAPY REGIMEN C. Robb1⁎, D. Linder2, B. Djire2, E. Carter1, P. Jacobsen3, M. Extermann4 1 Epidemiology, United States 2 Biostatistics, Georgia Southern University, Statesboro, United States