Results from an international phase 2 study of the anti-CD22 immunotoxin moxetumomab pasudotox in relapsed or refractory childhood B-lineage acute lymphoblastic leukemia.

Background: In a multicenter phase 1 study of children with relapsed/refractory acute lymphoblastic leukemia (ALL), moxetumomab pasudotox, an anti-CD22 immunotoxin, demonstrated a manageable safety profile and preliminary evidence of clinical activity. A phase 2 study further evaluated efficacy.

Procedure: This international, multicenter, phase 2 study enrolled children with relapsed/refractory B-cell precursor ALL who received moxetumomab pasudotox 40 µg/kg intravenously every other day, for six doses per 21-day cycle.

Antibody-Drug Conjugates: Future Directions in Clinical and Translational Strategies to Improve the Therapeutic Index.

Since the first approval of gemtuzumab ozogamicin (Mylotarg; Pfizer; CD33 targeted), two additional antibody-drug conjugates (ADC), brentuximab vedotin (Adcetris; Seattle Genetics, Inc.; CD30 targeted) and inotuzumab ozogamicin (Besponsa; Pfizer; CD22 targeted), have been approved for hematologic cancers and 1 ADC, trastuzumab emtansine (Kadcyla; Genentech; HER2 targeted), has been approved to treat breast cancer. Despite a clear clinical benefit being demonstrated for all 4 approved ADCs, the toxicity profiles are comparable with those of standard-of-care chemotherapeutics, with dose-limiting toxicities associated with the mechanism of activity of the cytotoxic warhead.

Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia.

This is a pivotal, multicenter, open-label study of moxetumomab pasudotox, a recombinant CD22-targeting immunotoxin, in hairy cell leukemia (HCL), a rare B cell malignancy with high CD22 expression. The study enrolled patients with relapsed/refractory HCL who had ≥2 prior systemic therapies, including ≥1 purine nucleoside analog. Patients received moxetumomab pasudotox 40 µg/kg intravenously on days 1, 3, and 5 every 28 days for ≤6 cycles.

Management of adverse events associated with idelalisib treatment: expert panel opinion.

Idelalisib is a first-in-class selective, oral, phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor approved for the treatment of several types of blood cancer. Idelalisib has demonstrated significant efficacy and a tolerable safety profile in clinical trials. However, the US prescribing information contains a black box warning for fatal and/or severe diarrhea or colitis, hepatotoxicity, pneumonitis and intestinal perforation.

Administration of gemcitabine and cisplatin in cancer patients with renal failure under hemodialysis.

Purpose: There is no optimal dosing schedule of gemcitabine (GEM) and cisplatin (CDDP) combination for cancer patients with renal failure (RF) on hemodialysis (HD). The purpose of this study was to share our experience of using GEM and CDDP in such patients.

Methods: The starting dose of GEM was defined based on single-agent treatment of two cancer patients with RF.

Serum tartrate-resistant acid phosphatase 5b (TRACP5b) activity as a biomarker for bone metastasis in non-small cell lung cancer patients.

Background: Diagnosis and follow-up of bone metastasis (BMet) in non-small cell lung cancer (NSCLC) patients usually rely on symptoms and image studies. A serum marker of bone resorption may improve the quality of treatment in such patients. Tartrate-resistant acid phosphatase 5b (TRACP5b) is a specific marker for osteoclasts and we proposed it can be used as a marker of BMet in NSCLC patients.

Preliminary experience of cetuximab in the treatment of advanced-stage biliary tract cancer.

Background: Cetuximab has been proved to be effective alone or in combination with other chemotherapeutic agents in the treatment of various malignancies. The aim of this report was to describe our experience of using cetuximab with chemotherapeutics agents to treat advanced-stage biliary tract cancer.

Case Reports: We retrospectively analyzed the outcomes of 5 biliary tract cancer patients receiving cetuximab-containing therapy.

Lung cancer metastatic to the masticator space.

Background: Distant metastasis from lung cancer occurs most frequently to the brain, bone, adrenal gland, liver, lymph nodes, and spinal cord. However, masticator space metastasis is rarely found among lung cancer patients.

Case Report: We report a case of large cell neuroendocrine carcinoma of the lung with metastasis to the masticator space diagnosed by imaging and histopathological examinations.

Gemcitabine plus vinorelbine as an effective salvage chemotherapeutic regimen in cisplatin-refractory germ cell tumor.

Germ cell tumors (GCT) are the most common malignancies among male adolescents. Approximately 5% of GCTs are of extragonadal origin. Cisplatin-based chemotherapy is the standard first-line treatment for GCT.

Ectopic ACTH syndrome associated with large-cell neuroendocrine carcinoma of the lung.

Although ectopic adrenocorticotropic hormone (ACTH) syndrome (EAS) is a well-known paraneoplastic phenomenon, an association with large-cell neuroendocrine carcinoma of the lung (LCNEC) has not been reported. We describe a 63-year-old man with metastatic LCNEC to the left temporomandibular joint (TMJ) who presented with progressive muscle weakness and bilateral lower leg edema for 2 weeks. He did not have a typical Cushingoid appearance nor used diuretics.

Ectopic hepatocellular carcinoma of the diaphragm.

Ectopic hepatocellular carcinoma (HCC) is very rarely reported. It may occur at various sites. To the best of our knowledge, only one case of ectopic HCC of the diaphragm has been reported.

Detection of reactivation and genetic mutations of the hepatitis B virus in patients with chronic hepatitis B infections receiving hematopoietic stem cell transplantation.

Background: This study elucidates the profiles for hepatitis B virus (HBV) reactivation and genetic mutation of the core promoter and precore regions for HBV-carriers receiving hematopoietic stem cell transplantation (HSCT).

Methods: Sera from 20 HSCT patients diagnosed with hematological diseases, 13 donors and 36 healthy HBV-carriers, were collected regularly for analysis. The hepatic biochemistry profiles, serological HBV markers, and HBV-DNA titers were checked regularly, and primer-amplification of the HBV core promoter or precore region and sequencing were performed once the mutations were identified.