ABSTRACT
Acalabrutinib is a Bruton tyrosine kinase inhibitor approved for patients with chronic lymphocytic leukemia (CLL). ASCEND is the pivotal phase 3 study of acalabrutinib versus investigator's choice of idelalisib plus rituximab (IdR) or bendamustine plus rituximab (BR) in patients with relapsed/refractory (R/R) CLL. In the primary ASCEND analysis (median 16.1-month follow-up), acalabrutinib showed superior efficacy with an acceptable tolerability profile versus IdR/BR; here, we report final ~4 year follow-up results. Patients with R/R CLL received oral acalabrutinib 100 mg twice daily until progression or unacceptable toxicity, or investigator's choice of IdR or BR. A total of 310 patients (acalabrutinib, n = 155; IdR, n = 119; BR, n = 36) were enrolled. At median follow-up of 46.5 months (acalabrutinib) and 45.3 months (IdR/BR), acalabrutinib significantly prolonged investigator-assessed progression-free survival (PFS) versus IdR/BR (median, not reached [NR] vs 16.8 months; P < 0.001); 42-month PFS rates were 62% (acalabrutinib) versus 19% (IdR/BR). Median overall survival (OS) was NR (both arms); 42-month OS rates were 78% (acalabrutinib) versus 65% (IdR/BR). Adverse events led to drug discontinuation in 23%, 67%, and 17% of patients in the acalabrutinib, IdR, and BR arms, respectively. Events of clinical interest (acalabrutinib vs IdR/BR) included all-grade atrial fibrillation/flutter (8% vs 3%), all-grade hypertension (8% vs 5%), all-grade major hemorrhage (3% vs 3%), grade ≥3 infections (29% vs 29%), and second primary malignancies excluding nonmelanoma skin cancer (7% vs 2%). At ~4 years follow-up, acalabrutinib maintained favorable efficacy versus standard-of-care regimens and a consistent tolerability profile in patients with R/R CLL.
ABSTRACT
A 48-year-old Caucasian woman with history of multiple sclerosis (MS) presented with erythematous papulonodular lesions in her extremities and trunk. She was being treated with glatiramer acetate (GA) for the past 10 years and the glatiramoid, Glatopa, for 2 years prior to this presentation. A skin biopsy showed CD30+ lymphoproliferative disorder consistent with lymphomatoid papulosis (LyP). Three weeks after stopping Glatopa, her skin lesions were improved. It remains unclear whether GA's or Glatopa's capability to alter T-cell differentiation, may have a link with LyP. This case report is a reminder to be vigilant for skin lesions in patients with MS.
ABSTRACT
BACKGROUND/AIM: Clinical response evaluation after neoadjuvant chemotherapy (NACT) for breast cancer could include various imaging methods, as well as clinical breast exam (CBE). We assessed the accuracy of CBE and imaging to predict pathologic response after NACT administration according to breast cancer subtype. PATIENTS AND METHODS: This retrospective cohort study included 84 patients with records of NACT and subsequent primary breast surgery from 2003-2013. Patients were divided into 4 breast cancer subtypes according to hormone receptor (HR) status and human epidermal growth factor receptor-2 (HER2) status. Negative predictive value (NPV), false-negative rate (FNR), false-positive rate (FPR) and positive predictive value (PPV) were calculated for CBE and imaging post-NACT and prior to breast cancer surgery. RESULTS: NPV, FNR, FPR and PPV varied by breast cancer subtype and clinical response evaluation method. Imaging resulted in a higher NPV and a lower FNR than CBE among the entire cohort. There was a lower FPR with CBE. Clinical response evaluation by CBE was highly accurate for predicting pathologic residual disease in HR+ tumors (CBE PPV: 95.5% in HR+HER2-, 100.0% in HR+HER2+). In triple-negative breast cancer (TNBC), the imaging NPV was 100% and the imaging FNR was 0%. CONCLUSION: The use of imaging in HR+ tumors post-NACT may provide little to no additional value that is not already garnered by performance of a CBE. For TNBC, imaging may play a critical role in the prediction of pathologic complete response (pCR) post-NACT.
Subject(s)
Antineoplastic Agents/therapeutic use , Breast Neoplasms/pathology , Physical Examination , Adult , Aged , Breast Neoplasms/diagnostic imaging , Breast Neoplasms/drug therapy , Chemotherapy, Adjuvant , Female , Humans , Middle Aged , Retrospective Studies , Young AdultABSTRACT
Elderly patients with advanced non-small cell lung cancer (NSCLC) are at higher risk for adverse events related to treatment of their disease. Chemotherapeutic agents used alone or together may increase survival, while leading to increased treatment related morbidity. New targeted agents used to treat NSCLC have yet to show sufficient improvement in disease outcomes. This review will discuss the current management of elderly patients with advanced non-small cell lung cancer.