Contributions
Abstract: PB2365
Type: Publication Only
Background
Many malignancies occur in elderly and unfit patients who are not suitable for agressive chemotherapy due to side effects, poor response and poor survival with standard therapies. These patients often receive some benefit from orally administered palliative treatment regimens. A phase 1/2 clinical trial (MOM trial ANZCTR) was undertaken using Montelukast and Gemfibrozil to enhance the response to existing chemotherapy in Multiple Myeloma (reported elsewhere). One of the observations was that the patients felt significantly better on montelukast treatment and appeared to have less chemotherapy toxicity. Montelukast and Gemfibrozil was added to a number of oral treatment regimens administered with palliative intent to see whether side effects of treatment as well as the disease symptoms would improve.
Aims
To test whether the addition of Montelukast and Gemfibrozil to palliative treatment regimens improved the disease response, symptoms, treatment side effects and functional performance status.
Methods
All patients gave informed consent. Age range 67 -92. Median 84 yo. 14 patients on palliative oral treatment regimens for a variety of haematological malignancies(AML, CLL, NHL, Richters) were given Montelukast 30mg twice daily as well as 600mg Gemfibrozil twice daily. The effect on transfusions, admissions to hospital, clinical response as well as general well being was measured. Treatment regimens included low dose oral chlorambucil in CLL. Single agent 6-TG or busulphan in non responsive AML. Oral prednisolone, cyclophosphamide and etoposide in agressive nhl. Two patients with solid tumours received no additional chemotherapy.
Results
2/4 patients on palliative AML treatment have responded. Patient 1 became transfusion independent after 1 month. Patient 2 has had a response in peripheral blood after failing 6 months treatment with Azacytidine. 5/5 patients with CLL on 2 mg of oral chlorambucil per day have had a marked improvement in lymphocyte counts. 1/1 patient with waldenstroms macroglobulinaemia has become transfusion independent and shown response after previously having no resopnse to single agent chlorambucil. 1/1 patients with Richters transformation of CLL has had complete resoloution of B symptoms and complete resoloution on PET scan measured at 2 months. 1/1 patient with myeloma with bone marrow failure has become transfusion independent, improved white cell counts and improved performance status from 4 to 2. 1/1 with progressive disease following chemotherapy for lung cancer has had an improvement in performance status from 3 to1 as well as a reduction in tumour size. 2/2 patients with agressive lymphoma have had a complete response in less than 4 weeks with transformed lymphoma and angioimmunoblastic nhl. 1/1 patient with end stage airways disease and advanced non responsive GIST tumour went from ECOG 4 to ECOG 2 after 3 weeks of treatment. Fourteen of sixteen patients have shown demonstrable benefit.
Conclusion
Montelukast and Gemfibrozil both given alone and when added to palliative chemotherapy appears to improve the response to treatment and symptoms in the majority of patients. It appears to reduce transfusion dependency. There has been a marked improvement in performance status. There have also been some highly significant responses in otherwise incurable poor prognosis malignancies. As these improvements are ongoing, it is planned to update the results at the congress.
Session topic: 36. Quality of life, palliative care, ethics and health economics
Keyword(s): Acute Myeloid Leukemia, Drug sensitivity, Lymphoid malignancy, transfusion
Abstract: PB2365
Type: Publication Only
Background
Many malignancies occur in elderly and unfit patients who are not suitable for agressive chemotherapy due to side effects, poor response and poor survival with standard therapies. These patients often receive some benefit from orally administered palliative treatment regimens. A phase 1/2 clinical trial (MOM trial ANZCTR) was undertaken using Montelukast and Gemfibrozil to enhance the response to existing chemotherapy in Multiple Myeloma (reported elsewhere). One of the observations was that the patients felt significantly better on montelukast treatment and appeared to have less chemotherapy toxicity. Montelukast and Gemfibrozil was added to a number of oral treatment regimens administered with palliative intent to see whether side effects of treatment as well as the disease symptoms would improve.
Aims
To test whether the addition of Montelukast and Gemfibrozil to palliative treatment regimens improved the disease response, symptoms, treatment side effects and functional performance status.
Methods
All patients gave informed consent. Age range 67 -92. Median 84 yo. 14 patients on palliative oral treatment regimens for a variety of haematological malignancies(AML, CLL, NHL, Richters) were given Montelukast 30mg twice daily as well as 600mg Gemfibrozil twice daily. The effect on transfusions, admissions to hospital, clinical response as well as general well being was measured. Treatment regimens included low dose oral chlorambucil in CLL. Single agent 6-TG or busulphan in non responsive AML. Oral prednisolone, cyclophosphamide and etoposide in agressive nhl. Two patients with solid tumours received no additional chemotherapy.
Results
2/4 patients on palliative AML treatment have responded. Patient 1 became transfusion independent after 1 month. Patient 2 has had a response in peripheral blood after failing 6 months treatment with Azacytidine. 5/5 patients with CLL on 2 mg of oral chlorambucil per day have had a marked improvement in lymphocyte counts. 1/1 patient with waldenstroms macroglobulinaemia has become transfusion independent and shown response after previously having no resopnse to single agent chlorambucil. 1/1 patients with Richters transformation of CLL has had complete resoloution of B symptoms and complete resoloution on PET scan measured at 2 months. 1/1 patient with myeloma with bone marrow failure has become transfusion independent, improved white cell counts and improved performance status from 4 to 2. 1/1 with progressive disease following chemotherapy for lung cancer has had an improvement in performance status from 3 to1 as well as a reduction in tumour size. 2/2 patients with agressive lymphoma have had a complete response in less than 4 weeks with transformed lymphoma and angioimmunoblastic nhl. 1/1 patient with end stage airways disease and advanced non responsive GIST tumour went from ECOG 4 to ECOG 2 after 3 weeks of treatment. Fourteen of sixteen patients have shown demonstrable benefit.
Conclusion
Montelukast and Gemfibrozil both given alone and when added to palliative chemotherapy appears to improve the response to treatment and symptoms in the majority of patients. It appears to reduce transfusion dependency. There has been a marked improvement in performance status. There have also been some highly significant responses in otherwise incurable poor prognosis malignancies. As these improvements are ongoing, it is planned to update the results at the congress.
Session topic: 36. Quality of life, palliative care, ethics and health economics
Keyword(s): Acute Myeloid Leukemia, Drug sensitivity, Lymphoid malignancy, transfusion