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Reinduction therapy with everolimus in combination with dexamethasone, high‐dose cytarabin and cisplatinum in patients with relapsed or refractory classical Hodgkin lymphoma: an experimental phase I/II multicentre trial of the German Hodgkin Study Group (GHSG HD‐R3i)
- Source :
- British Journal of Haematology. 196:606-616
- Publication Year :
- 2021
- Publisher :
- Wiley, 2021.
-
Abstract
- Reinduction chemotherapy followed by high-dose chemotherapy and autologous stem cell transplant (HDCT + ASCT) is second-line standard of care for transplant-eligible patients with relapsed/refractory classical Hodgkin lymphoma (r/r cHL) but has a high failure rate. Because response to reinduction is predictive of the outcome after HDCT + ASCT, we aimed to improve the standard dexamethasone, high-dose cytarabine and cisplatinum (DHAP) reinduction regimen by addition of the oral mammalian target of rapamycin inhibitor everolimus (everDHAP). Transplant-eligible patients aged 18–60 years with histologically confirmed r/r cHL were included in this experimental phase I/II trial. Everolimus (10 mg/day, determined in phase-I-part) was administered on day 0–13 of each DHAP cycle. From July 2014 to March 2018, 50 patients were recruited to the phase II everDHAP group; two were not evaluable, three discontinued due to toxicity. Randomization to a placebo group stopped in October 2015 due to poor recruitment after nine patients. The primary end-point of computed tomography (CT)-based complete remission (CR) after two cycles of everDHAP was expected to be ≥40%. With a CT-based CR rate of 27% (n = 12/45) after two cycles of everDHAP the trial did not meet the primary end-point. Adding everolimus to DHAP is thus feasible; however, the everDHAP regimen failed to show an improved efficacy.
- Subjects :
- Adult
Male
Oncology
medicine.medical_specialty
Randomization
medicine.medical_treatment
Medizin
Kaplan-Meier Estimate
Dexamethasone
Young Adult
Refractory
Recurrence
Germany
DHAP
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Everolimus
Neoplasm Staging
Chemotherapy
business.industry
Remission Induction
Cytarabine
Induction Chemotherapy
Hematology
Middle Aged
Prognosis
Hodgkin Disease
Regimen
Drug Resistance, Neoplasm
Positron-Emission Tomography
Retreatment
Female
Cisplatin
Neoplasm Grading
business
medicine.drug
Subjects
Details
- ISSN :
- 13652141 and 00071048
- Volume :
- 196
- Database :
- OpenAIRE
- Journal :
- British Journal of Haematology
- Accession number :
- edsair.doi.dedup.....ff0e354fe4bdc404cc0b06b20f948d15