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Malignancy after renal transplantation: A case series study
indian journal of transplantation 9 (2015) 47–60
Abstract #: ISOT2015-92 Malignancy after renal transplantation: A case series study Shajan Mathew, Zachariah Paul, Anil Mathew, Rajesh Nair, George Kurian Amrita Institute of Medical Sciences, Kochi, India Background: Long-term use of immunosuppressive therapy in transplant recipients in order to prevent acute and chronic rejection increases the long-term risk of cancer. This study evaluates the incidence of cancer after renal transplantation and immunosuppressive therapy. Aims: This study is aimed to evaluate cancer incidence after renal transplantation and compare it with the malignancy series of other transplant registries. Methodology: This is a retrospective analysis of malignant tumors in renal graft recipients with more than one year graft survival. Patients were assessed according to their age, sex, diagnosis of cancer, immunosuppressive drugs, donors and period of dialysis before transplantation. Results: 300 patients were reviewed. They were followed up over a mean period of 60months. A total of six cases of cancer were diagnosed in six recipients: Most patients with cancer were male with a mean age of 55 years (range: 26–68 years). Tumor presented at a mean time of 48 months after transplantation. There were one patient with leukemia, one patients with SCC and three patients with lymphoma. One patient died of progressive malignant disease. Age, period of dialysis before transplantation, and using immunosuppressive and anti-rejection drugs had no significant impact on development of post transplant malignancy. Conclusions: The frequency of tumors in these patients is lower than what reported by other centers, probably due to short period of follow up and low incidence of cancer in our general population. The risk of malignancy was 30 fold higher among transplant recipients than in general population. http://dx.doi.org/10.1016/j.ijt.2015.09.022 Abstract #: ISOT2015-70 Once-daily tacrolimus as a potential immunosuppressive agent for the treatment of patients undergoing kidney or liver transplantation in India
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practice to assess the safety and efficacy of MR TAC in patients in India. Aims: To investigate/demonstrate the safety and efficacy of MR TAC in adult patients undergoing kidney or liver transplantation in India. Methodology: This was a Phase IV multicentre, prospective study of MR TAC in adults with end-stage kidney or liver disease eligible for de novo kidney or liver transplant at centres in India. The study (start: 21/03/2012; end: 14/05/2013) was conducted over 12 weeks with 9 regular patient visits. Patients received an initial MR TAC dose of 0.2 mg/kg/day (kidney transplant) or 0.1–0.2 mg/kg/day (liver transplant). There was no control group. Primary efficacy endpoint was the event rate of biopsy-confirmed acute rejections ≥Grade 1 (Banff 2007) for kidney transplant patients and Rejection Activity Index ≥ 4 (Banff 1997) for liver transplant patients within 12 weeks posttransplantation; secondary endpoints included corticosteroidresistant rejection incidence, time to first biopsy-confirmed acute rejection, graft loss and death. Safety endpoints included renal function (assessed by serum creatinine), lipid profile, incidence of new onset diabetes mellitus after transplantation (NODAT) and infection. Results: This study enrolled 92 patients (73 males, 19 females) with a mean (SD) age of 40.2 (11.5) years, undergoing kidney (81 [88%]) or liver transplant (11 [12%]). 76 patients (83%) completed the 12-week study and there were 8 deaths (9%; 6 kidney and 2 liver transplant patients). Discontinuations were due to adverse events (3, 3%), patient decision (3, 3%) or physician decision (2, 2%). 10 patients (11%) reached the primary efficacy endpoint (kidney transplant: Banff IA [7] and Banff 1B [3]); 1 liver transplant rejection did not reach the level required in the endpoint definition. There were 7 corticosteroid-sensitive rejections, 3 corticosteroid-resistant rejections; 1 patient received anti-lymphocyte antibodies. Median (range) time to kidney transplant rejection was 6.5 (1.0–76.0) days. Serum creatinine reduced over time. Overall increases in all lipids were seen at Visits 7–9. 11 instances of NODAT and 7 infections occurred. Conclusions: In de novo kidney and liver transplant recipients in India, MR TAC was well-tolerated and efficacious with a low incidence of acute rejection. Safety profile, including incidence of NODAT and clinically significant dyslipidaemias, was comparable with twice-daily tacrolimus from published data. http://dx.doi.org/10.1016/j.ijt.2015.09.023
D. Khullar 1,2,3,4,5,6,7, V. Reddy 1,2,3,4,5,6,7, B. Subbarao 1,2,3,4,5,6,7, M.M. Bahadur 1,2,3,4,5,6,7, V. Tamilarasi 1,2,3,4,5,6,7, A. Almeida 1,2,3,4,5,6,7, P. Shah 1,2,3,4,5,6,7 1 Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi, India 2 Care Hospitals, Banjara Hills, Hyderabad, India 3 Apollo Hospitals, 21 Greams Lane, Off. Greams Road, Chennai, India 4 Jaslok Hospital and Research Centre, 15, Dr Deshmukh Marg, Mumbai, India 5 Department of Nephrology, Christian Medical College, India 6 P.D. Hinduja National Hospital and Medical Research, Veer Savarkar Marg, Mahim, Mumbai, India 7 Astellas Pharma India Pvt, Ltd, 127 Andheri Kurla Road, Chakala, Andheri East, Mumbai, India Background: Tacrolimus has proven efficacy as an immunosuppressive therapy to prevent transplant rejection and is widely used in a twice-daily regimen. Once-daily modifiedrelease tacrolimus (MR TAC) aims to improve outcomes by reducing exposure variability and improving adherence. Nonadherence may contribute to graft loss. However, there is limited published data available on routine clinical
Abstract #: ISOT2015-55 Spectrum of acute rejections and short-term outcome after kidney transplant Anuja Porwal, Jai Inder Singh, Varun Verma, Alok Gupta, Manoj Singhal Fortis Hospital Noida, India Background: Acute rejection after transplant is associated with significant reduction in graft survival. With advent of newer immunosuppressants and induction agents the incidence of acute rejection has decreased worldwide, however antibody mediated rejections pose a continued challenge for short and long term graft survival. Aims: We have analyzed spectrum of acute rejections and short term outcome after kidney transplantation at our center. Methodology: This was single center, prospective observational study. We analyzed140 patients transplanted from May 2012 to May 2014, followed up till May 2015. Of 140 enrolled patients 30 patients were excluded (22 basiliximab induction, 5 deceased donor, 2 liver-kidney transplant and 1 <18 yrs age). 110 patients were analyzed. All patients were
Abstract #: ISOT2015-92 Malignancy after renal transplantation: A case series study Shajan Mathew, Zachariah Paul, Anil Mathew, Rajesh Nair, George Kurian Amrita Institute of Medical Sciences, Kochi, India Background: Long-term use of immunosuppressive therapy in transplant recipients in order to prevent acute and chronic rejection increases the long-term risk of cancer. This study evaluates the incidence of cancer after renal transplantation and immunosuppressive therapy. Aims: This study is aimed to evaluate cancer incidence after renal transplantation and compare it with the malignancy series of other transplant registries. Methodology: This is a retrospective analysis of malignant tumors in renal graft recipients with more than one year graft survival. Patients were assessed according to their age, sex, diagnosis of cancer, immunosuppressive drugs, donors and period of dialysis before transplantation. Results: 300 patients were reviewed. They were followed up over a mean period of 60months. A total of six cases of cancer were diagnosed in six recipients: Most patients with cancer were male with a mean age of 55 years (range: 26–68 years). Tumor presented at a mean time of 48 months after transplantation. There were one patient with leukemia, one patients with SCC and three patients with lymphoma. One patient died of progressive malignant disease. Age, period of dialysis before transplantation, and using immunosuppressive and anti-rejection drugs had no significant impact on development of post transplant malignancy. Conclusions: The frequency of tumors in these patients is lower than what reported by other centers, probably due to short period of follow up and low incidence of cancer in our general population. The risk of malignancy was 30 fold higher among transplant recipients than in general population. http://dx.doi.org/10.1016/j.ijt.2015.09.022 Abstract #: ISOT2015-70 Once-daily tacrolimus as a potential immunosuppressive agent for the treatment of patients undergoing kidney or liver transplantation in India
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practice to assess the safety and efficacy of MR TAC in patients in India. Aims: To investigate/demonstrate the safety and efficacy of MR TAC in adult patients undergoing kidney or liver transplantation in India. Methodology: This was a Phase IV multicentre, prospective study of MR TAC in adults with end-stage kidney or liver disease eligible for de novo kidney or liver transplant at centres in India. The study (start: 21/03/2012; end: 14/05/2013) was conducted over 12 weeks with 9 regular patient visits. Patients received an initial MR TAC dose of 0.2 mg/kg/day (kidney transplant) or 0.1–0.2 mg/kg/day (liver transplant). There was no control group. Primary efficacy endpoint was the event rate of biopsy-confirmed acute rejections ≥Grade 1 (Banff 2007) for kidney transplant patients and Rejection Activity Index ≥ 4 (Banff 1997) for liver transplant patients within 12 weeks posttransplantation; secondary endpoints included corticosteroidresistant rejection incidence, time to first biopsy-confirmed acute rejection, graft loss and death. Safety endpoints included renal function (assessed by serum creatinine), lipid profile, incidence of new onset diabetes mellitus after transplantation (NODAT) and infection. Results: This study enrolled 92 patients (73 males, 19 females) with a mean (SD) age of 40.2 (11.5) years, undergoing kidney (81 [88%]) or liver transplant (11 [12%]). 76 patients (83%) completed the 12-week study and there were 8 deaths (9%; 6 kidney and 2 liver transplant patients). Discontinuations were due to adverse events (3, 3%), patient decision (3, 3%) or physician decision (2, 2%). 10 patients (11%) reached the primary efficacy endpoint (kidney transplant: Banff IA [7] and Banff 1B [3]); 1 liver transplant rejection did not reach the level required in the endpoint definition. There were 7 corticosteroid-sensitive rejections, 3 corticosteroid-resistant rejections; 1 patient received anti-lymphocyte antibodies. Median (range) time to kidney transplant rejection was 6.5 (1.0–76.0) days. Serum creatinine reduced over time. Overall increases in all lipids were seen at Visits 7–9. 11 instances of NODAT and 7 infections occurred. Conclusions: In de novo kidney and liver transplant recipients in India, MR TAC was well-tolerated and efficacious with a low incidence of acute rejection. Safety profile, including incidence of NODAT and clinically significant dyslipidaemias, was comparable with twice-daily tacrolimus from published data. http://dx.doi.org/10.1016/j.ijt.2015.09.023
D. Khullar 1,2,3,4,5,6,7, V. Reddy 1,2,3,4,5,6,7, B. Subbarao 1,2,3,4,5,6,7, M.M. Bahadur 1,2,3,4,5,6,7, V. Tamilarasi 1,2,3,4,5,6,7, A. Almeida 1,2,3,4,5,6,7, P. Shah 1,2,3,4,5,6,7 1 Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi, India 2 Care Hospitals, Banjara Hills, Hyderabad, India 3 Apollo Hospitals, 21 Greams Lane, Off. Greams Road, Chennai, India 4 Jaslok Hospital and Research Centre, 15, Dr Deshmukh Marg, Mumbai, India 5 Department of Nephrology, Christian Medical College, India 6 P.D. Hinduja National Hospital and Medical Research, Veer Savarkar Marg, Mahim, Mumbai, India 7 Astellas Pharma India Pvt, Ltd, 127 Andheri Kurla Road, Chakala, Andheri East, Mumbai, India Background: Tacrolimus has proven efficacy as an immunosuppressive therapy to prevent transplant rejection and is widely used in a twice-daily regimen. Once-daily modifiedrelease tacrolimus (MR TAC) aims to improve outcomes by reducing exposure variability and improving adherence. Nonadherence may contribute to graft loss. However, there is limited published data available on routine clinical
Abstract #: ISOT2015-55 Spectrum of acute rejections and short-term outcome after kidney transplant Anuja Porwal, Jai Inder Singh, Varun Verma, Alok Gupta, Manoj Singhal Fortis Hospital Noida, India Background: Acute rejection after transplant is associated with significant reduction in graft survival. With advent of newer immunosuppressants and induction agents the incidence of acute rejection has decreased worldwide, however antibody mediated rejections pose a continued challenge for short and long term graft survival. Aims: We have analyzed spectrum of acute rejections and short term outcome after kidney transplantation at our center. Methodology: This was single center, prospective observational study. We analyzed140 patients transplanted from May 2012 to May 2014, followed up till May 2015. Of 140 enrolled patients 30 patients were excluded (22 basiliximab induction, 5 deceased donor, 2 liver-kidney transplant and 1 <18 yrs age). 110 patients were analyzed. All patients were