Prolonged Use of Zoledronic Acid (4 Years) Did Not Improve Outcome in Multiple Myeloma Patients.

Background: Bisphosphonates, especially zoledronic acid (ZA), show antitumor effects in multiple myeloma (MM) and other neoplasms. The standard time for ZA administration has been 2 years. However, with improvement in overall survival (OS) in MM with new agents, it unclear whether ZA could be administered for a prolonged time to improve OS.

Speckle-Tracking Echocardiography to Detect Cardiac Toxicity in Children Who Received Anthracyclines During Pregnancy.

Cardiac toxicities remain a possible risk to fetuses that received anthracyclines during pregnancy. The introduction of new echocardiographic techniques will improve the detection of early cardiac damage. Thus, we began a observational study using speckle-tracking echocardiography (STE) in children who had received anthracyclines during pregnancy, including the first trimester.

Rituximab as consolidation therapy did not improve outcome in patients with diffuse large B-cell lymphoma at complete response after dose-dense chemotherapy (CHOP-14).

The authors started a clinical trial to assess the efficacy and toxicity of rituximab (R) as consolidation in patients with diffuse large B-cell lymphoma, with poor prognostic factors, who were in complete response (CR) after dose-dense chemotherapy (CHOP-14). Four hundred sixty-five untreated patients, with advanced stages (III and IV), older (median age >60 years old), and high clinical risk, were treated with dose-dense CHOP-14 (cyclophosphamide 1500 mg/m(2), i.v.

Combined therapy in untreated patients improves outcome in nasal NK/T lymphoma: results of a clinical trial.

Nasal NK/T-cell lymphoma is a rare presentation of T-cell lymphoma in USA and in Europe, but is the most common presentation in Latin America. The lymphoma is associated with a worse prognosis even in the early stage. Until now, a better treatment has not been determined.

Rituximab in the treatment of diffuse large B-cell lymphoma primary of the lung.

Diffuse large B-cell lymphoma primary of lung (DLBCL-PL) is a rare presentation of extranodal lymphoma, in most cases chemotherapy-based anthracyclines: CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) has been the treatment, with excellent outcome. The addition of rituximab to CHOP (R-CHOP) has been considered the gold standard in the treatment of nodal DLBCL. Thus, we assess in a large number of cases of DLBCL-PL whether the use of R-CHOP could improve survival in this setting of patients.

Randomized clinical trial to assess the efficacy of radiotherapy in primary mediastinal large B-lymphoma.

Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14).

Methods And Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group).

ESHAP versus rituximab-ESHAP in frail patients with refractory diffuse large B-cell lymphoma.

Background: Treatment for refractory lymphoma in frail patients (older, poor performance status, or concomitant diseases) has not been defined.

Patients And Methods: A total of 100 frail patients naive to rituximab therapy were allocated to be treated with ESHAP (etoposide, methylprednisolone, cytosine arabinoside, and platinum; 53 patients) or RESHAP (rituximab plus ESHAP; 47 patients). Granulocyte colony-stimulating factor was used to ameliorate the presence of severe granulocytopenia.

Rituximab and dose-dense chemotherapy in primary testicular lymphoma.

Background: Treatment of primary testicular lymphoma (PTL) remains unsatisfactory even in patients with good prognosis, as < 30% of patients are alive at 3 years.

Patients And Methods: We began a phase II study to assess efficacy and toxicity of a dose-dense cyclophosphamide/epirubicin/vincristine/prednisone (CEOP14) regimen with rituximab (CEOP14R) in 38 previously untreated patients with PTL with early-stage (I or II) and low-risk disease, followed by adjuvant radiation therapy and central nervous system prophylaxis.

Results: Complete response was 86% (similar to historical controls), but improvement in outcome was observed; with actuarial curves at 5 years, event-free survival was 70%, and overall survival was 66%.

Rituximab and chemotherapy in primary gastric lymphoma.

Purpose: We performed a phase II clinical trial to assess the efficacy and toxicity of the addition of rituximab and conventional chemotherapy in primary gastric lymphoma (PGL).

Methods: Forty-two (42) patients with PGL, stage IE and IIE, and with low- or low-intermediate clinical risk were treated in a prospective longitudinal study with standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy and rituximab (375 mg/m2, intravenously) on day 1 of each cycle administered every 21 days, for 6 cycles. The endpoint was to assess improvement in outcome measured by prolongation in event-free survival (EFS) and overall survival (OS).

Results of a phase III clinical trial: CHOP versus CMED in peripheral T-cell lymphoma unspecified.

We performed a controlled clinical trial to define the use of a brief therapy: CMED (cyclophosphamide, etoposide, methotrexate, and dexamethasone) compared with standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) in the treatment of peripheral T-cell lymphoma unspecific (PTCLu). The end point to the study was to assess efficacy, measured from complete response rate (CRR), progression-free survival (PFS), and overall survival in 217 previously untreated patients with PTCLu. In an intent-to treat analysis all patients were evaluable.

Interferon and low dose methotrexate improve outcome in refractory mycosis fungoides/Sézary syndrome.

Treatment of refractory mycosis fungoides and Sézary syndrome remain unsatisfactory. In this study, we assessed the efficacy and toxicity of low-dose methotrexate (10 mg/m(2), biweekly) and interferon (9.0 MU, three times a week) as induction therapy by 6 or 12 months, followed, if patients achieved a complete remission, by interferon maintenance until toxicity or relapse.

Antitumor effect of zoledronic acid in previously untreated patients with multiple myeloma.

Bisphophonates are the treatment of choice to prevent skeletal events in patients with multiple myeloma. Some preclinical studies suggested that bisphophonates can be useful as antitumor drugs in some malignancies. We conducted a controlled clinical trial to assess if zoledronic acid can have this clinical activity.

Dose dense (CEOP-14) vs dose dense and rituximab (CEOP-14 +R) in high-risk diffuse large cell lymphoma.

To assess efficacy and toxicity of rituximab and dose chemotherapy in high-risk diffuse large cell lymphoma, we conducted a controlled clinical trial to assess efficacy and toxicity of a dose-dense regimen CEOP- 14 (cyclophosphamide, epirubicin, vincristine, and prednisone every 14 d) compared to CEOP-14 plus rituximab. One hundred and ninety-six patients were randomized to received CEOP-rituximab (cyclophosphamide 1500 mg/m2, epirubicin 120 mg/m2, vincristine, and prednisone at standard dose and rituximab at 375 mg/m2) compared with the same chemotherapy administered every 14 d (CEOP-14). In an intent-to-treat analysis all patients were available for efficacy and toxicity.

Rituximab and escalated chemotherapy in elderly patients with aggressive diffuse large-cell lymphoma: a controlled clinical trial.

The treatment of elderly patients with aggressive malignant lymphoma has not been defined. The addition of rituximab to conventional chemotherapy has been reported to improve the outcome, but most patients have good prognostic factors (performance status < 2, no severe associated diseases, low or low-intermediate clinical risk). Thus, we developed a combined regimen, including escalated doses of anthracycline and rituximab.

Addition of a short course of chemotherapy did not improve outcome in patients with localized marginal B-cell lymphoma of the orbit.

Objectives: Primary orbital malignant lymphoma (POML) is a rare malignancy, thus treatment remains to be defined. The present study was designed to define if the use of radiotherapy is sufficient in these patients or if the use of adjuvant chemotherapy would improve the outcome.

Methods: Between 1983 and 1995, 98 previously untreated patients diagnosed with POML, stage IE, were randomly allocated to receive either radiotherapy (34-40 Gy) or the same radiotherapy combined with chemotherapy including anthracycline.

Surgery and chemotherapy versus chemotherapy as treatment of high-grade MALT gastric lymphoma.

Background And Objectives: Treatment of high-grade MALT (mucosa-associated lymphoid tissue) gastric lymphoma remains uncertain. To assess efficacy and toxicity of the most common therapies--surgery followed by chemotherapy or chemotherapy alone--we began a controlled clinical trial in patients in early stage (I and II 1).

Methods: One hundred and two patients were randomized to be treated with surgery followed by six cycles of CEOP-Bleo (cyclophosphamide, epirubicin, vincristine, prednisone, and bleomycin at standard doses) (52 cases) or with chemotherapy alone (49 cases).

Residual disease after chemotherapy in aggressive malignant lymphoma: the role of radiotherapy.

Residual disease in patients with diffuse large B-cell lymphoma after intensive chemotherapy remains a problem. Radiotherapy has been used in some retrospective studies without definitive conclusions. We report the first controlled clinical trial to define the role of radiotherapy in this setting of patients.

Novel therapy in multiple myeloma.

Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a cut-off level < 65 years old) will be treated with chemotherapy and transplant procedures. However, most patients > 65 years old are not candidates for this therapeutic approach and the use of intensive chemotherapy could be associated to severe toxicity.

Late cardiac toxicity secondary to treatment in Hodgkin's disease. A study comparing doxorubicin, epirubicin and mitoxantrone in combined therapy.

Anthracyclines are a group of drugs that are useful in the treatment of Hodgkin's disease, but have been associated with severe, and in some cases lethal, cardiac toxicity. Apparently, cardiac toxicity is more frequent after 10 years of anthracycline therapy, but no longer studies of cardiac toxicity have been reported. Four hundred and seventy-six patients with Hodgkin's disease, stages III and IV, were randomly assigned to receive ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) compared with EBVD (epirubicin instead of doxorubicin) and MBVD (mitoxantrone instead of doxorubicin) at standard doses.

Testicular lymphoma: organ-specific treatment did not improve outcome.

Objectives: To assess whether the use of an organ-specific treatment could improve event-free survival (EFS) and overall survival as endpoints in testicular lymphoma in the early stage: IE and IIE.

Methods: Thirty-four patients were selected to be treated with orchiectomy following six cycles of anthracycline-based combined chemotherapy and radiotherapy (scrotum and contralateral testis in stage IE, contralateral testis and lymph nodes in stage IIE). Prophylaxis to the central nervous system was administered with four monthly cycles of a high dose of methotrexate: 6 g/m2.

Interferon alpha 2b as maintenance therapy improves outcome in follicular lymphoma.

The role of interferon alpha as maintenance therapy in follicular lymphoma (FL) remains unsolved. We started a controlled clinical trial to assess if interferon alpha 2b could improve outcome, measured with event free survival (EFS) and overall survival (OS) in patients with FL in complete remission after chemotherapy based anthracyclines and adjuvant radiotherapy to sites of initial bulky disease. Three hundred and eighty four patients in complete response after 6 cycles of CEOP-Bleo (cyclophosphamide, epirubicin, vincristine, prednisone and bleomycin, at standard doses), and adjuvant radiotherapy when necessary, were randomized to received Interferon alpha 2b, three times a week for 1 year or no treatment (control group).

Intensive chemotherapy in the treatment of aggressive diffuse large B-cell lymphoma: malignant lymphoma.

The aim of the present study was to evaluate an intensive chemotherapy regimen in patients with diffuse large B-cell lymphoma and poor prognosis, as presence of high- or high-intermediate clinical risk, bulky disease, high levels of beta 2 microgloblin, and more than two extranodal sites of involvement at diagnosis. One hundred previously untreated patients were treated with an intensive CEOP-Bleo regimen with increased doses of cyclophosphamide (1000 mg/m(2)) and epirubicin (120 mg/m(2)) in each cycle. Granulocyte colony-stimulating factors was employed to ameliorate severe granulocytopenia.

Gemcitabine and cisplatin in refractory malignant lymphoma.

Objective: We performed a pilot study to evaluate the effect of the high-dose gemcitabine-cisplatin combination in a brief weekly regimen in the treatment of primary refractory diffuse large cell lymphoma with high or high-intermediate clinical risk.

Methods: Thirty patients refractory to first-line anthracycline-based chemotherapy were treated with a combination of gemcitabine (1.5 g/m(2) i.

The role of surgery in primary gastric lymphoma: results of a controlled clinical trial.

Objective: We began a controlled clinical trial to assess efficacy and toxicity of surgery (S), surgery + radiotherapy (SRT), surgery + chemotherapy (SCT), and chemotherapy (CT) in the treatment of primary gastric diffuse large cell lymphoma in early stages: IE and II1.

Summary Background Data: Management of primary gastric lymphoma remains controversial. No controlled clinical trials have evaluated the different therapeutic schedules, and prognostic factors have not been identified in a uniform population.

Maintenance therapy with interferon-alpha 2b, cyclophosphamide, and prednisone in aggressive diffuse large cell lymphoma.

Maintenance therapy in patients with aggressive malignant lymphoma using biological modifiers remains uncertain. We conducted a controlled clinical trial to evaluate the efficacy and toxicity of interferon-alpha 2b, cyclophosphamide, and prednisone as maintenance therapy in patients with aggressive diffuse large B cell lymphomas in complete remission after aggressive chemotherapy. In an intent-to-treat analysis, 169 patients were eligible for this study; the end points were event-free survival (EFS) and overall survival (OS).