Poonamalle Parthasarathy Bapsy1, Bandana Sharan2, Chaitanya Kumar3, Rajeev Patrick Das3, Bharath Rangarajan4, Minish Jain5, Venkata Sathya Suresh Attili6, Sundaram Subramanian7, Shyam Aggarwal8, Mala Srivastava9, Ashok Vaid10. 1. Department of Oncology, Apollo Hospital, Bangalore, India. 2. APAC Biotech Pvt Ltd, Gurgaon, India. Electronic address: drbandana@apacbiotech.com. 3. APAC Biotech Pvt Ltd, Gurgaon, India. 4. Narayan Hrudayalaya Hospital, Bangalore, India. 5. Ruby Hall Clinic, Pune, India. 6. Apollo Hospital, Hyderabad, India. 7. V.S. Hospital, Chennai, India. 8. Department of Medical Oncology, Sir Ganga Ram Hospital, New Delhi, India. 9. Nextvel Consulting LLP, Bangalore, India. 10. Department of Medical Oncology and Hematology, Medanta-the Medicity, Gurgaon, India.
Abstract
BACKGROUND AIMS: A phase II clinical trial of an autologous dendritic cell (DC) formulation for the management of refractory solid malignant tumors was conducted across six sites in India with an objective to study safety and efficacy. METHODS: A total of 51 patients with refractory cancer (either sex) with life expectancy ≥3 months, Eastern Cooperative Oncology Group score ≤2, available tumor tissue and adequate organ and bone marrow function were recruited. Monocytes obtained by leukapheresis, differentiated into DCs by cytokines and primed with autologous tumor lysate (fresh tissue biopsy or paraffin block). On the 8th day, mature DCs were analyzed for expression of CD40, CD80, CD83, CD86, DC205 and DC209. The treatment regime consisted of six doses (intravenous) over 14 weeks with 2 post-treatment follow-up visits, 6 weeks apart. Safety was assessed at all visits and responses were evaluated on days 58, 100 and 184 or at end of the study. RESULTS: A total of 38 patients were evaluated for safety and efficacy. One adverse event classified as possibly related was an episode of rigors or chills with mild pyrexia during one infusion. Objective response rate by Response Evaluation Criteria In Solid Tumors was 28.9% (11/38) and immune-related response criteria was 42.1% (16/38); 90% confidence interval for objective response rate was (17.2, 43.3) and (28.5, 56.7) by Response Evaluation Criteria In Solid Tumors and immune-related response criteria, respectively. The median time to treatment progression was >9 weeks. Median overall survival was 397 days. An increase in the expression of interferon-γ was not significant. CONCLUSIONS: Therapy was safe. The responses, time to treatment progression and survival are encouraging for patients with aggressive refractory disease.
BACKGROUND AIMS: A phase II clinical trial of an autologous dendritic cell (DC) formulation for the management of refractory solid malignant tumors was conducted across six sites in India with an objective to study safety and efficacy. METHODS: A total of 51 patients with refractory cancer (either sex) with life expectancy ≥3 months, Eastern Cooperative Oncology Group score ≤2, available tumor tissue and adequate organ and bone marrow function were recruited. Monocytes obtained by leukapheresis, differentiated into DCs by cytokines and primed with autologous tumor lysate (fresh tissue biopsy or paraffin block). On the 8th day, mature DCs were analyzed for expression of CD40, CD80, CD83, CD86, DC205 and DC209. The treatment regime consisted of six doses (intravenous) over 14 weeks with 2 post-treatment follow-up visits, 6 weeks apart. Safety was assessed at all visits and responses were evaluated on days 58, 100 and 184 or at end of the study. RESULTS: A total of 38 patients were evaluated for safety and efficacy. One adverse event classified as possibly related was an episode of rigors or chills with mild pyrexia during one infusion. Objective response rate by Response Evaluation Criteria In Solid Tumors was 28.9% (11/38) and immune-related response criteria was 42.1% (16/38); 90% confidence interval for objective response rate was (17.2, 43.3) and (28.5, 56.7) by Response Evaluation Criteria In Solid Tumors and immune-related response criteria, respectively. The median time to treatment progression was >9 weeks. Median overall survival was 397 days. An increase in the expression of interferon-γ was not significant. CONCLUSIONS: Therapy was safe. The responses, time to treatment progression and survival are encouraging for patients with aggressive refractory disease.
Authors: Alexandre Harari; Michele Graciotti; Michal Bassani-Sternberg; Lana E Kandalaft Journal: Nat Rev Drug Discov Date: 2020-08-06 Impact factor: 84.694
Authors: Sterre T Paijens; Ninke Leffers; Toos Daemen; Wijnand Helfrich; H Marike Boezen; Ben J Cohlen; Cornelis Jm Melief; Marco de Bruyn; Hans W Nijman Journal: Cochrane Database Syst Rev Date: 2018-09-10