LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma.

Despite treatment advances, patients with multiple myeloma (MM) often progress through standard drug classes including proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies (mAbs). LocoMMotion (ClinicalTrials.gov identifier: NCT04035226) is the first prospective study of real-life standard of care (SOC) in triple-class exposed (received at least a PI, IMiD, and anti-CD38 mAb) patients with relapsed/refractory MM (RRMM).

Results of an Early Access Treatment Protocol of Daratumumab Monotherapy in Spanish Patients With Relapsed or Refractory Multiple Myeloma.

Daratumumab is a human CD38-targeted monoclonal antibody approved as monotherapy for heavily pretreated relapsed and refractory multiple myeloma. We report findings for the Spanish cohort of an open-label treatment protocol that provided early access to daratumumab monotherapy and collected safety and patient-reported outcomes data for patients with relapsed or refractory multiple myeloma. At 15 centers across Spain, intravenous daratumumab (16 mg/kg) was administered to 73 patients who had ≥3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or who were double refractory to both.

Bortezomib retreatment for relapsed and refractory multiple myeloma in real-world clinical practice.

Aims: Studies have shown that bortezomib retreatment is effective in relapsed/refractory multiple myeloma (MM). The observational, prospective electronic VELCADE OBservational Study (eVOBS) study assessed bortezomib-based therapies for patients with MM in everyday practice. Here, we report on those patients receiving retreatment with bortezomib.

Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice.

Objective: The efficacy and safety of bortezomib-based therapy for relapsed/refractory multiple myeloma (RRMM) in clinical trials may differ from the oncology practice experience. The electronic VELCADE OBservational Study was designed to prospectively evaluate bortezomib for multiple myeloma (MM) in real-world medical practice.

Method: Patients scheduled to receive intravenous bortezomib for MM were eligible.

A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS.

Erythropoiesis-stimulating agents are first choice for treating anemia in low-risk MDS. This double-blind, placebo-controlled study assessed the efficacy and safety of epoetin-α in IPSS low- or intermediate-1 risk (i.e.

Retreatment and prolonged therapy with subcutaneous bortezomib in patients with relapsed multiple myeloma: A randomized, controlled, phase III study.

Objectives: This randomized, international, multicenter, open-label phase III study investigated the effects of experimental retreatment with subcutaneous bortezomib plus dexamethasone (VD) followed by prolonged bortezomib therapy vs standard VD retreatment in patients with relapsed/refractory multiple myeloma.

Methods: Patients were randomized (2:1) to receive either experimental (n = 53) or standard (n = 27) retreatment, stratified by the number of prior therapy lines.

Results: The study was terminated prematurely with insufficient enrollment to adequately compare the retreatment therapies; results should be considered descriptive.

Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial.

The Dutch-Belgian Cooperative Trial Group for Hematology Oncology Group-65/German-speaking Myeloma Multicenter Group-HD4 (HOVON-65/GMMG-HD4) phase III trial compared bortezomib (BTZ) before and after high-dose melphalan and autologous stem cell transplantation (HDM, PAD arm) compared with classical cytotoxic agents prior and thalidomide after HDM (VAD arm) in multiple myeloma (MM) patients aged 18-65 years. Here, the long-term follow-up and data on second primary malignancies (SPM) are presented. After a median follow-up of 96 months, progression-free survival (censored at allogeneic transplantation, PFS) remained significantly prolonged in the PAD versus VAD arm (hazard ratio (HR)=0.

Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study.

This phase II study explored the effects of bortezomib consolidation versus observation on myeloma-related bone disease in patients who had a partial response or better after frontline high-dose therapy and autologous stem cell transplantation. Patients were randomized to receive four 35-day cycles of bortezomib 1·6 mg/m intravenously on days 1, 8, 15 and 22, or an equivalent observation period, and followed up for disease status/survival. The modified intent-to-treat population included 104 patients (51 bortezomib, 53 observation).

Revisiting the destiny compulsion.

This paper is an attempt to deal with some questions raised by the so-called 'compulsion of destiny' constellation. In presenting the standpoints of Freud and of psychoanalysts who after him were concerned with this problematic, the author takes the view that several aspects of the configuration merit further discussion. Accordingly, the dynamics of repetition compulsion, the complexity of the projective strategy, the coexistence of passive and omnipotent trends are considered.

Amnemonic traces: Traumatic after-effects.

Τhis article addresses the problem of amnemonic traces. The author considers various effects that traumatic experiences can have on the psychic apparatus and, more specifically, those that give rise to situations in which nothing is remembered and nothing is repeated by the patient. She presents data from the analyses of two patients and explores whether it might be possible to give a more accurate description of factors and processes that accelerate the fading of traumatic experiences from the memory network.

Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma.

Bortezomib-dexamethasone is widely used for relapsed myeloma in routine clinical practice, but comparative data versus single-agent bortezomib are lacking. This retrospective analysis compared second-line treatment with bortezomib-dexamethasone and bortezomib using 109 propensity score-matched pairs of patients treated in three clinical trials: MMY-2045, APEX, and DOXIL-MMY-3001. Propensity scores were estimated using logistic regression analyses incorporating 13 clinical variables related to drug exposure or clinical outcome.

Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS).

Background: Subcutaneous administration of Eprex(®) (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective Immunogenicity Surveillance Registry (PRIMS) was conducted to estimate the incidence of antibody-mediated PRCA with subcutaneous administration of a new coated-stopper syringe presentation of Eprex(®) and to compare this with the PRCA incidence with subcutaneous NeoRecormon(®) (epoetin beta) and Aranesp(®) (darbepoetin alfa).

Methods: PRIMS was a multicentre, multinational, non-interventional, parallel-group, immunogenicity surveillance registry.

Impact of hyperlipidaemia on the orbital bone cefotaxime levels in rats.

Facial injuries are critical conditions, leading to serious complications, such as occult facial infections. Infectious endophthalmitis occurs despite of antibiotics use during implantation of intraocular lenses and is generally resistant to antibiotic therapy. It is a crucial situation in ophthalmology, since it often induces a substantial reduction of visual acuity and in some cases the loss of the eye despite treatment.

Biocompatibility of resin composites subcutaneously implanted in rats with experimentally induced arthritis.

Objective: To evaluate the biocompatibility of resin composite specimens with different curing efficiency, subcutaneously implanted in rats with experimentally induced arthritis.

Methods: The amount of remaining CC bonds (%RDB) of hybrid resin composite specimens photopolymerized for 10s and 40s exposure time (n=3) was measured by micro-attenuated total reflectance Fourier transform infrared spectroscopy. Male Wistar rats (n=36) were classified in two groups (n=18) of healthy animals and of animals with experimentally induced arthritis.

Anticoagulant-induced changes on antibiotic concentrations in the serum and bones.

The aim of this study was to determine whether the co-administration of acenocoumarin as anticoagulant and certain quinolones, i.e., cefapirin, pefloxacin and ciprofloxacin increased the levels of the given antibiotics and whether this resulted in a prolongation of prothrombin time.

Methotrexate, etoposide, ifosfamide and cisplatin (MVIP): An effective salvage therapy for patients with refractory or relapsed germ-cell tumors.

Purpose: To study the efficacy and toxicity of a combination of methotrexate, etoposide, ifosfamide and cisplatin (MVIP) in patients with germ-cell tumors (GCTs) refractory to or relapsed after first-line platinum-based chemotherapy.

Patients And Methods: Between 1989 and 2001 22 male patients with GCTs refractory (n=7) or relapsed (n=15) after first-line platinum-based chemotherapy entered prospectively the study. Their median age was 29 years.

Erythropoietic growth factors for children with cancer: a systematic review of the literature.

Objective: To review evidence on the use of erythropoietic stimulating agents (erythropoietin or darbepoetin) in children with cancer.

Methods: A systematic review of the published literature was performed using MEDLINE (1966-July 2007) and references from a Cochrane systematic review (focusing mainly on adults) published in 2006.

Results: The review identified 12 studies, comprising five randomized trials, six case control studies and one open-label, dose-escalation study.

A multicenter phase II study of docetaxel in combination with gefitinib in gemcitabine-pretreated patients with advanced/metastatic pancreatic cancer.

Purpose: To evaluate the efficacy and tolerance of the docetaxel/gefitinib combination as second-line treatment in patients with advanced pancreatic cancer.

Patients And Methods: Twenty-six patients pretreated with gemcitabine-based chemotherapy were enrolled in the study. Docetaxel (75 mg/m(2), i.

Methotrexate, etoposide, ifosfamide and cisplatin (MVIP): an effective first-line therapy for IGCCC intermediate / poor prognosis patients with germ-cell tumors. Single institution experience.

Purpose: To evaluate the antitumor activity and toxicity of methotrexate (M), etoposide (V), ifosfamide (I) and cisplatin (P) combination chemotherapy (MVIP) administered to chemotherapy-naive patients with intermediate / poor prognosis germ-cell tumors (GCT) according to the International Germ Cell Cancer Collaborative Group (IGCCCG) consensus classification system (IGCCC).

Patients And Methods: From 1992 to 2001 24 consecutive intermediate (n=14)/poor prognosis (n=10) GCT male patients entered prospectively this phase II trial. Patients received methotrexate 250 mg/m(2), day 1, with folinic acid rescue; cisplatin 100 mg/m(2) with appropriate hydration, day 3; ifosfamide 5 g/m(2) with mesna uroprotection, day 3; and etoposide 100 mg/m(2)/day, days 3-5.

Intraoperative electron beam radiotherapy followed by moderate doses of external beam radiotherapy in the treatment of resected soft tissue sarcomas of the extremities.

Purpose: Soft tissue sarcomas (STS) have a high incidence of local recurrence. In an effort to improve the local control rate and the survival in patients with STS, treatment strategies employing intraoperative electron beam radiotherapy (IOERT) in combination with external beam radiotherapy (EBRT) and extensive surgical resection have been explored. This study assesses the rate of overall survival (OS), local control and toxicity of this multimodal approach for primary and recurrent STS of the extremities.

The RACOX phase I study: radiation (RA), capecitabine (C) and oxaliplatin (OX) as adjuvant treatment of stage II and III rectal cancer.

Purpose: The aim of this phase I trial was to deter- mine the maximum tolerated dose (MTD) of adjuvant che- motherapy (CT) with oxaliplatin in combination with capecitabine during concomitant pelvic radiotherapy (RT) in patients with rectal cancer.

Patients And Methods: Eligible patients had pathological stage II (T3-4N0M0) or III (any T N1-2M0) rectal adenocarcinoma, and no prior treatment other than curative resection. Fixed capecitabine dose (825 mg/m(2) bid on days 1-14 and 22-35) was given and external beam RT was delivered to the pelvis (50.

Phase I study of postoperative radiotherapy with concomitant weekly irinotecan, 5- fluorouracil and folinic acid in locally advanced rectal cancer.

Purpose: 5- fluorouracil (5-FU)-based chemotherapy with concomitant pelvic radiotherapy represents the gold standard of the adjuvant treatment of high-risk rectal cancer. This study aimed to determine the maximum tolerated dose (MTD) of weekly irinotecan (CPT-11) when combined with fixed 5FU/FA doses and pelvic irradiation.

Patients And Methods: Twenty- four patients with stage II or III rectal cancer were accrued.

Salvage chemotherapy with gemcitabine and oxaliplatin in heavily pretreated patients with metastatic breast cancer: a multicenter phase II study.

Purpose: It was the aim of this study to evaluate the activity and tolerance of gemcitabine and oxaliplatin in pretreated metastatic breast cancer patients.

Methods: Thirty-one patients who had disease relapse or progression after completion of an anthracycline- and/or taxane-based front-line regimen were treated with gemcitabine 1,500 mg/m(2) on days 1 and 8 as a 30-min intravenous infusion and oxaliplatin 130 mg/m(2) on day 8 as a 4-hour intravenous infusion, in cycles of 21 days.

Results: Complete response occurred in 1 patient (3%) and partial response in 4 patients (13%) (overall response rate 16%; 95% confidence interval 3.

A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer.

Our purpose was to determine the response rate and median and overall survival of gemcitabine as monotherapy versus gemcitabine plus irinotecan in advanced or metastatic pancreatic cancer. Patients with histologically or cytologically confirmed adenocarcinoma who were chemotherapy and radiotherapy naive were enrolled. Patients were centrally randomised at a one-to-one ratio to receive either gemcitabine monotherapy (900 mg m(-2) on days 1, 8 and 15 every 4 weeks (arm G), or gemcitabine (days 1 and 8) plus irinotecan (300 mg m(-2) on day 8) (arm IG), repeated every 3 weeks.