ABSTRACT
BACKGROUND: The IFM2009-02 trial studied pomalidomide (4 mg daily, 21/28 versus 28/28) and dexamethasone in very advanced relapsed or refractory multiple myeloma (RRMM). We observed that 40% of patients had a prolonged progression-free survival (PFS) and subsequently overall survival (OS). We sought to analyze the characteristics of these patients and study the effect of long exposure to pomalidomide. DESIGN: We separated the studied population into two groups: 3 months to 1 year (<1 year) and more than 1 year (≥1 year) of treatment with pomalidomide and dexamethasone based on clinical judgment and historical control studies. We then analyzed the characteristics of patients according to duration of treatment. RESULTS: The overall response rate (ORR) for the <1-year group was 43%, the median PFS 4.6 months [95% confidence interval (95% CI) 3.8-6.4] with only 6% at 12 months, and the median OS was 15 months (11.7-20.3) and 40% at 18 months. For the ≥1-year group, the response rate and survival were strikingly different, ORR at 83%, median PFS 20.7 months (14.7-35.4), median OS not reached, and 91% at 18 months. CONCLUSION: Pomalidomide and dexamethasone favored prolonged and safe exposure to treatment in 40% of heavily treated and end-stage RRMM, a paradigm shift in the natural history of RRMM characterized with a succession of shorter disease-free intervals and ultimately shorter survival. Although an optimization of pomalidomide-dexamethasone regimen is warranted in advanced RRMM, we claim that pomalidomide has proven once more to change the natural history of myeloma in this series, which should be confirmed in a larger study.
Subject(s)
Drug Resistance, Neoplasm/drug effects , Multiple Myeloma/drug therapy , Neoplasm Recurrence, Local/drug therapy , Thalidomide/analogs & derivatives , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Bortezomib/administration & dosage , Bortezomib/adverse effects , Dexamethasone/administration & dosage , Dexamethasone/adverse effects , Disease-Free Survival , Drug-Related Side Effects and Adverse Reactions/pathology , Female , Humans , Male , Middle Aged , Multiple Myeloma/pathology , Neoplasm Recurrence, Local/pathology , Thalidomide/administration & dosage , Thalidomide/adverse effectsABSTRACT
We report the case of a 37-year-old-man having a chronic myelogenous leukemia, who presented, one month after a splenic acutization, massive gastrointestinal bleeding from ulcerated nodules of the gastric fundus. The histologic examination of one of these nodules showed granulocytic sarcoma. In spite of an endoscopic treatment by sclerotherapy with adrenalined serum, the death occurred during a hemorrhagic recurrence. This observation, which is the third case reported of gastric granulocytic sarcoma during the acutization of a myelogenous chronic leukemia, and the first revealed by fatal gastrointestinal bleeding, shows the particular gravity of gastrointestinal bleeding complicating granulocytic sarcoma.
