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PURPOSE Major progress has occurred in multiple myeloma (MM) treatment in recent years, but this is not seen in low- and middle-income countries. MATERIALS AND METHODS We retrospectively assessed the efficacy and safety of cyclophosphamide, thalidomide, and dexamethasone (cyclophosphamide 400 mg/m2 for 5 days, thalidomide 100 mg once daily, if tolerated, and dexamethasone 40 mg once weekly; in 28-day cycles) in patients with newly diagnosed MM treated at our institution between April 2008 and December 2012. Survival outcomes were estimated by the Kaplan-Meier method. RESULTS Fifty-nine patients were found to meet the selection criteria. Median age was 56 years (27-78). Fifty-nine percent (n = 35) were male. International Staging System three was found in 24%. The median number of treatment cycles was 11 (range 4-12). After a median of 81-month follow-up (range 5-138 months), the overall response rate was 69.5%. The complete response and very good partial response were 5% and 32%, respectively. Median progression-free survival (PFS) was 35 months (95% CI, 18 to 41). The 3-year PFS was 47.4% (95% CI, 34.5 to 59.6) and 5-year PFS was 24.9% (95% CI, 14.4 to 36.9). The median of overall survival (OS) was 81 months (95% CI, 33 to not reached). The 3-year OS was 63.4% (95% CI, 49.2 to 74.6), and 5-year OS was 57.5% (95% CI, 43.2 to 69.4). The most common adverse event was neutropenia (grade 3 and 4, 30.5%). Out of 23 patients eligible for stem-cell transplantation, 10 (43.5%) proceeded with autologous transplantation. Treatment-related deaths occurred in four patients (6.7%). CONCLUSION Cyclophosphamide, thalidomide, and dexamethasone achieves good response rates with tolerable toxicity, especially in patients age 65 years or younger representing a feasible approach for patients with MM in low-income health care settings.

Background Cefiderocol (CFDC), the first siderophore cephalosporin, is approved in the United States (complicated urinary tract infections [cUTI]) and Europe for the treatment of patients with Gram-negative (GN) infections with limited treatment options. Methods This analysis investigated the safety profile of CFDC across three prospective, multicenter, randomized clinical studies: APEKS-cUTI (double-blind, non-inferiority Phase 2 study in patients with cUTI) vs imipenem-cilastatin (1 g/1 g, three-times daily); APEKS-NP (double-blind, non-inferiority Phase 3 study in patients with nosocomial pneumonia [NP]) vs meropenem (2 g, q8h); CREDIBLE-CR (open-label, descriptive Phase 3 study in patients with cUTI, NP, bloodstream infections/sepsis [BSI/sepsis]) caused by carbapenem-resistant GN bacteria; patients in the control arm received best available therapy (BAT; up to 3 agents, dosing based on local label). CFDC was given at 2 g, q8h, infused over 1 (APEKS-cUTI) or 3 (APEKS-NP, CREDIBLE-CR) hours. One adjunctive agent with CFDC was only allowed in CREDIBLE-CR. Results 549 patients were treated with CFDC, 347 control treated (Table 1). More than 50% of patients were aged ≥65 years, except BAT arm in CREDIBLE-CR. The majority of patients were admitted to the ICU in APEKS-NP and CREDIBLE-CR. The median treatment duration with CFDC was similar (9–11 days) across studies. The rates of TEAEs and serious AEs (SAEs) between CDFC and comparators were similar in each study (Table 2). The rates of adverse drug reactions were lower with CFDC than with comparators in each study, with a greater difference in CREDIBLE-CR than in APEKS-cUTI and APEKS-NP. TEAEs leading to death rates are shown in Table 2. Eight CFDC-related Clostridioides difficile infections occurred across studies (APEKS-cUTI: n=1; APEKS-NP: n=4; CREDIBLE-CR: n=3 [ie, C. difficile colitis; pseudomembranous colitis]). In total, eight experienced seizures (APEKS-cUTI: CFDC n=1; APEKS-NP: CFDC n=3, meropenem n=2; CREDIBLE-CR: CFDC n=1, BAT n=1), none of which were related to study drugs. Parameters of iron homeostasis showed no differences between CFDC and comparators. Table 1. Baseline characteristics and treatment duration (safety populations) Table 2. Overall safety parameters (safety populations) Conclusion CFDC demonstrated a comparable safety profile to carbapenems or other cephalosporins and was generally well tolerated in critically ill patients. Disclosures Yuko Matsunaga, MD, Shionogi Inc. (Employee) Takuhiro Sonoyama, MD, Shionogi & Co., Ltd. (Employee) Luis Casanova, PharmD, Shionogi B.V. (Employee) Tsutae Den Nagata, MD, Shionogi & Co., Ltd. (Employee) Roger Echols, MD, Shionogi Inc. (Consultant) Fabio De Gregorio, MD, Shionogi B.V. (Employee) Eriko Ogura, MD, Shionogi & Co., Ltd. (Employee) Simon Portsmouth, MD, Shionogi Inc. (Employee)

Describe the characteristics of patients seen at the Cancer Prevention and Control Service at a Peruvian private cancer clinic in 2014.This retrospective clinical study analyzed the prevalence of 10 cancers and characteristics of patients seen at a private cancer center located in Lima, Peru. The study sample included 7680 adults, and data were collected from de-identified medical records.The average age of the patients was 44.71 years and 98,82% of them had private insurance. The majority of patients were women (67.69%). Our gross incidence rate of cancer was 35.16 per 100,000 in the Cancer Prevention and Control Service in 2014. Only 0.35% had cancer, and most of those diagnosed with cancer (77.78%) were diagnosed in the early stages, stages I and II. The two most common cancers observed were breast and thyroid cancer.The high rates of early, rather than late-stage diagnoses at this clinic are dramatically different than national rates. This difference may be because we are analyzing data from a prevention service seeing mainly patients with private insurance as opposed to national data, which consists primarily of patients seen in oncologic services with national insurance.

Purpose Describe the characteristics of patients seen at the Cancer Prevention and Control Service at a Peruvian private cancer clinic in 2014. Patients and methods This retrospective clinical study analyzed the prevalence of 10 cancers and characteristics of patients seen at a private cancer center located in Lima, Peru. The study sample included 7680 adults, and data were collected from de-identified medical records. Results The average age of the patients was 44.71 years and 98,82% of them had private insurance. The majority of patients were women (67.69%). Our gross incidence rate of cancer was 35.16 per 100,000 in the Cancer Prevention and Control Service in 2014. Only 0.35% had cancer, and most of those diagnosed with cancer (77.78%) were diagnosed in the early stages, stages I and II. The two most common cancers observed were breast and thyroid cancer. Conclusions The high rates of early, rather than late-stage diagnoses at this clinic are dramatically different than national rates. This difference may be because we are analyzing data from a prevention service seeing mainly patients with private insurance as opposed to national data, which consists primarily of patients seen in oncologic services with national insurance.

El shock séptico es una de las principales causas que puede llevar a la muerte. La reanimación hídrica constituye un destacado tratamiento para poder disminuir la mortalidad. Objetivo: determinar la relación entre el porcentaje de sobrecarga hídrica (%SH) y la mortalidad en niños con shock séptico. Métodos. Estudio de cohorte en pacientes con shock séptico de entre 1 y 17 años, posterior a la reanimación hídrica con presión venosa central ≥ 5 mmHg con monitoreo invasivo y registro completo de %SH hasta las 96 h. El seguimiento y la variable de desenlace se completaron hasta el día 28. Se registraron las siguientes variables del shock séptico, shock refractario, causa de la insuficiencia renal aguda, anemia, desnutrición, el tiempo de inicio de antimicrobiano, presión oncótica y puntaje de gravedad. Análisis estadístico: Se calculó el hazard ratio (HR) y se construyeron tres modelos pronósticos por riesgos proporcionales de Cox. Resultados. La población fue de 263 pacientes; con un promedio de edad de 8 ± 3 años y con mortalidad del 33 %. El %SH ≥ 10,1 acumulado a las 96 h fue el único asociado; el HR (IC 95 %) ajustado fue perfil hemodinámico HR = 2,6 (1,95,6); por shock refractario, HR = 2,5 (1,6-5,6) y por desnutrición, HR = 8,3 (3,5-14). Conclusiones. El %SH > 10,1 % se relacionó con una mayor mortalidad a 28 días de ajustado al perfil hemodinámico, la refractariedad del shock y el estado nutricional. Septic shock is one of the main causes of mortality. Fluid replacement stands out as the treatment of choice to reduce mortality. Objective. To determine the relation between the percentage of fluid overload (%FO) and mortality in children with septic shock. Methods. Cohort study in patients aged 1-17 years with septic shock, after fluid replacement with central venous pressure ≥ 5 mmHg, invasive monitoring, and complete recording of %FO up to 96 h. Follow-up and outcome measures were recorded up to day 28. The following outcome measures of septic shock were recorded: refractory shock, cause of acute kidney injury, anemia, malnutrition, time to antibiotic initiation, oncotic pressure, and severity score. Statistical analysis. The hazard ratio (HR) was estimated and three Cox proportional hazard models were developed. Results. The population included 263 patients; their average age was 8 ± 3 years. Mortality was 33 %. A %FO ≥ 10.1 % accumulated at 96 h was the only associated outcome measure; the HR (95 % confidence interval) was adjusted for hemodynamic profile, HR = 2.6 (1.95.6); refractory shock, HR = 2.5 (1.6-5.6); and malnutrition, HR = 8.3 (3.5-14). Conclusions. A %FO > 10.1 % was related to a higher mortality at 28 days of adjustment for hemodynamic profile, refractory shock, and nutritional status.

This article analyzes employment formalization in Argentina from 2003 to 2014 as well as the public policies associated with that process. It identifies the critical segments of informality along with the challenges they pose to a strategy aimed at reducing informality in a labor market that has proven relatively resistant to such reductions in recent years. The results show a decrease in informality for salaried employment, though there has not been a similar decrease among the self-employed. After a significant drop in non-registered salaried employment between 2003 and 2008, slower formal employment growth has offset advances in formalization. Informality affects nearly 44% of all employed individuals. The need to develop specific actions as part of a comprehensive strategy is due to the characteristics of the critical segments of the labor market and the persistence of a heterogeneous productive structure. It can also be attributed to a lower and more volatile rate of economic growth in recent years. In this context, the measures included in the "Law for the Promotion of Registered Employment and Labor Fraud Prevention” passed in 2014 are likely not only to improve working and employment conditions but also to increase productivity. However, in order for these tools to have a true impact on employment formalization, they must be accompanied by other productive, fiscal, social and labor policies, along with a macroeconomic framework that ensures stable economic growth.

Background: Primary cutaneous T-cell lymphomas constitute a heterogeneous and rare group of diseases with regional particularities in Latin America. Objective: To determine the clinicopathological features, relative frequency and survival among patients from a Peruvian institution. Methods: Primary cutaneous T-cell lymphomas were defined based on the absence of extracutaneous disease at diagnosis. Classification was performed following the 2008 World Health Organization Classification of Neoplasms of the Hematopoietic and Lymphoid tissues. Risk groups were established according to the 2005 World Health Organization-EORTC classification for cutaneous lymphomas. Data of patients admitted between January 2008 and December 2012 were analyzed. Results: 74 patients were included. Mean age was 49.5 years. In order of frequency, diagnoses were: mycosis fungoides (40.5%), peripheral T-cell lymphoma not otherwise specified (22.95%), adult T-cell lymphoma/leukemia (18.9%), CD30+ lymphoproliferative disorders (6.8%), hydroa vacciniforme-like lymphoma (5.4%), extranodal NK/T-cell lymphoma (4.1%) and Sézary syndrome (1.4%). Predominant clinical patterns were observed across different entities. Mycosis fungoides appeared mainly as plaques (93%). Peripheral T-cell lymphoma not otherwise specified and adult T-cell lymphoma/leukemia presentation was polymorphic. All patients with hydroa vacciniforme-like lymphoma presented with facial edema. All cases of extranodal NK/T-cell lymphoma appeared as ulcerated nodules/tumors. Disseminated cutaneous involvement was found in 71.6% cases. Forty-six percent of patients were alive at 5 years. Five-year overall survival was 76.4% and 19.2%, for indolent and high-risk lymphomas, respectively (p

Introduction: Adult T-cell Leukemia-Lymphoma (ATL) is a rare malignancy of T-cells infected with HTLV-1 and has the worst prognosis of the T-cell lymphomas. CC chemokine receptor 4 (CCR4) is overexpressed on ATL cells (>90% of ATL patients [pts]). Mogamulizumab (Moga) is a monoclonal antibody directed against CCR4 that has been approved in Japan for the treatment of CCR4+ ATL. There is no standard or effective treatment for relapsed/refractory (R/R) ATL pts outside of Japan. Methods: Pts from the USA, EU, and Latin America with R/R ATL (acute, lymphoma, and chronic subtypes) were randomized 2:1 to treatment with Moga, 1.0 mg/kg, given weekly for the first 4-week cycle and then biweekly, or to 1 of 3 investigator choice (IC) regimens (gemcitabine/oxaliplatin, DHAP, or pralatrexate). Pts randomized to the IC arm were permitted to cross over to Moga upon progression. The primary endpoint was confirmed objective response rate (ORR), defined as a response that is maintained for approximately 8 weeks, in those randomized to the Moga arm (based on modified Tsukasaki criteria). ORR was assessed by the treating investigator (IA) and in blinded fashion by independent review (IR). Key secondary endpoints were ORR for IC and after cross over to Moga, duration of response (DoR), progression-free survival (PFS), and overall survival (OS). Results: 71 pts were randomized (47 to Moga, 24 to IC). Tissue /blood from 65/71 pts (91.5%) expressed CCR4. Although randomized, there were baseline imbalances in known ATL prognostic factors. Pts with adverse prognostic features were more often randomized to Moga: these features included older age, poor ECOG performance status of 2, bone marrow involvement, and refractory to (vs having relapsed from) their most recent ATL therapy. Based on data through 31 March 2016, ORR (all responses, confirmed and unconfirmed) by IA was 34.0% (16/47) in the Moga group and 0% (0/24) in the IC group; these rates were largely concordant with ORR findings by IR of 27.7% (13/47) for the Moga group and 8.3% (2/24) for the IC group. Confirmed ORR for Moga was 14.9%; there were no confirmed responses in the IC group. 18 IC pts crossed over to Moga and 3 responded, including one confirmed response. The median (m) DoR for Moga was 5.65 months [mo] (95% CI 3.63, not reached). Two pts had responses lasting >9 mo. The 16 responders in the Moga arm (as assessed by IA) were evenly distributed over ATL subtypes: chronic 5/16 (31%), acute 5/16 (31%), and lymphoma 6/16 (38%). Of the 65 pts with any exposure to Moga (randomized plus crossover), response according to subtype was: chronic 5/10 (50%), acute 7/31 (23%), and lymphoma 7/24 (29%). While the study was not powered to demonstrate a difference between the treatment arms, the Kaplan-Meier plots of PFS and OS for the ITT population are presented below. The PFS curves deviate modestly in favor of the Moga group. The mPFS for Moga was 0.93 mo (min-max: 0.03-26.20 mo) with 21.5% of subjects progression free at 3 mo, while the mPFS for IC was 0.88 mo (0-4.23 mo) with 12.5 % of subjects progression free at 3 mo. The OS curves overlap. The mOS for the Moga arm was 4.90 mo (0.27-37.33 mo) with 38.9% alive at 12 mo, and the mOS for the IC arm was 6.87 mo ( 0.57-33.87 mo) with 37.5% alive at 12 mo. The OS curves may have been affected by the imbalance in prognostic factors and are confounded by the crossover of 75% of IC pts to Moga. Treatment emergent adverse events (TEAEs) occurring more often in the Moga group than the IC group were infections (51.1% vs 20.8%); respiratory disorders (48.9% vs 29.2%); infusion related reactions (46.8% vs 0%); and skin disorders (42.6% vs 8.3%). TEAEs ≥Grade 3 were 29/47 (61.7%) for Moga and 13/24 (54.2%) for IC. With the exception of known Moga-related events (infusion related reactions and drug eruptions), TEAE rates are similar when adjusted for exposure time to Moga or IC; for example, the AE rate per pt-mo of exposure for infections is 0.296 for the Moga group vs. 0.234 for the IC group. Conclusions: In the largest randomized clinical trial of pts with R/R ATL thus far conducted, commonly used cytotoxic regimens provided limited to no therapeutic benefit whereas treatment with Moga resulted in objective responses, a trend for favorable PFS, no clear survival advantage or disadvantage, and adverse events that are predictable, thereby supporting Moga's therapeutic potential in this setting. Figure Figure. Disclosures Phillips: Takeda: Speakers Bureau; Kyowa Kirin: Research Funding; Celgene: Speakers Bureau. Hermine:AB science: Consultancy, Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties, Research Funding, Speakers Bureau; Celgene: Research Funding; Novartis: Research Funding; Alexion: Research Funding. Lill:Kite: Research Funding; California Cord Blood Services: Consultancy; Sanofi: Speakers Bureau. Feldman:Seattle Genetics: Consultancy, Research Funding, Speakers Bureau; Abbvie/Pharmacyclics/Janssen: Speakers Bureau; Celgene: Consultancy, Speakers Bureau. Sawas:Gilead Sciences: Speakers Bureau; Seattle Genetics: Honoraria. Cook:Kyowa Kirin Pharmaceutical Development, Inc.: Consultancy. Kurman:Kyowa Kirin Pharmaceutical Development, Inc: Consultancy. George:Kyowa Kirin Pharmaceutical Development: Employment. Dwyer:Kyowa Kirin Pharmaceutical Development, Inc.: Employment. Leoni:Kyowa Kirin Pharmaceutical Development, Inc.: Employment. Gonsky:Bioclinica: Other: Compensation for independent review of trial data. Horwitz:Infinity Pharmaceuticals: Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Spectrum Pharmaceuticals: Consultancy, Honoraria, Research Funding; Kyowa Kirin Pharmaceutical: Research Funding; Millennium Pharmaceuticals: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Huya Bioscience International: Consultancy, Honoraria; Forty Seven, Inc.: Consultancy, Honoraria; ADC Therapeutics: Other: Travel.

Purpose We report the 5-year analysis from the phase III Dasatinib Versus Imatinib Study in Treatment-Naïve Chronic Myeloid Leukemia Patients (DASISION) trial, evaluating long-term efficacy and safety outcomes of patients with chronic myeloid leukemia (CML) in chronic phase (CP) treated with dasatinib or imatinib. Patients and Methods Patients with newly diagnosed CML-CP were randomly assigned to receive dasatinib 100 mg once daily (n = 259) or imatinib 400 mg once daily (n = 260). Results At the time of study closure, 61% and 63% of dasatinib- and imatinib-treated patients remained on initial therapy, respectively. Cumulative rates of major molecular response and molecular responses with a 4.0- or 4.5-log reduction in BCR-ABL1 transcripts from baseline by 5 years remained statistically significantly higher for dasatinib compared with imatinib. Rates for progression-free and overall survival at 5 years remained high and similar across treatment arms. In patients who achieved BCR-ABL1 ≤ 10% at 3 months (dasatinib, 84%; imatinib, 64%), improvements in progression-free and overall survival and lower rates of transformation to accelerated/blast phase were reported compared with patients with BCR-ABL1 greater than 10% at 3 months. Transformation to accelerated/blast phase occurred in 5% and 7% of patients in the dasatinib and imatinib arms, respectively. Fifteen dasatinib-treated and 19 imatinib-treated patients had BCR-ABL1 mutations identified at discontinuation. There were no new or unexpected adverse events identified in either treatment arm, and pleural effusion was the only drug-related, nonhematologic adverse event reported more frequently with dasatinib (28% v 0.8% with imatinib). First occurrences of pleural effusion were reported with dasatinib, with the highest incidence in year 1. Arterial ischemic events were uncommon in both treatment arms. Conclusion These final results from the DASISION trial continue to support dasatinib 100 mg once daily as a safe and effective first-line therapy for the long-term treatment of CML-CP.

The receptor for macrophage derived chemokine (MDC) and thymus- and activation-regulated chemokine (TARC) CC chemokine receptor 4 (CCR4) is over expressed in several T-cell malignancies including HTLV-1 related ATL where approximately 90% of malignant cells have been shown to over express this chemokine receptor. The HTLV-1 transactivator gene (Tax) does not directly induce CCR4 expression. Rather, expression of CCR4 is controlled by the constitutive activation of several transcription factors in HTLV-1 infected cells. Inhibiting the expression of these transcription factors with small-interfering RNAs has been shown to block CCR4 expression and also reduce proliferation of the affected cells. Patients with CCR4 positive ATL are more likely to have skin involvement and shorter overall survival (OS; median 9.5 months) compared with CCR4-negative (20.6 months) patients. Mogamulizumab is a defucosylated, humanized, monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (Potelligent®) against primary ATL cells that bind to CCR4.

A very quick neural network algorithm for cloud detection, based on a neural network, is developed. Cloud detection is speeded up through the use of the Class Assigning Space (CAS). The CAS is a classified Radiance Space (RS), which has been built using the trained neural network. The CAS is used to assign a class for each pixel in the image instead of using the ANN to treat every single pixel. The detection time is approximately one second. Channel 1 and channel 5 of NOAA-AVHRR images have been used. The Supervised ART-II artificial neural network has been employed. The system performance has been tested with different training sets and different input data.

Background This study was carried out to assess the isolation rate of bacterial and fungal causative agents in Mexican neutropenic adults with hematological neoplasia. Methods A prospective observational survey involving 120 consecutive episodes of febrile neutropenia during 1 year was carried out. These episodes were observed in 630 patients discharged with diagnoses of leukemia or lymphoma, or after bone-marrow transplantation. Results At least one pathogen was isolated in 42 of 120 episodes (35%), and was present in 39 patients with acute myeloid leukemia (AML) (43%), acute lymphoblastic leukemia (ALL) (23%), and in patients who underwent bone-marrow transplantation (20%). Primary bacteremia was the most frequent cause of fever (24 episodes, 57%), followed by intravascular device–related infections (5 episodes, 17%), and soft-tissue infections (5 episodes, 15%). Escherichia coli (33%) was the most frequently isolated agent of primary bacteremia, followed by coagulase-negative Staphylococcus (29%), and Klebsiella oxytoca (16%). Fungal infection was responsible for five events (4%): two episodes of pneumonia ( Penicillium marneffei and Aspergillus fumigatus , one event each); two cases of fungemia, one due to Candida tropicalis and one to Rhodotorula gluttinis , and one cryptococcal meningitis event. Conclusions The isolation rate, approximately 30%, was in accordance with previous reports; similar percentages of Gram-positive and Gram-negative isolates were found. A remarkably low rate of viridans group streptococci and fungal agents was observed, despite the fact that neutropenia is the main risk factor for infection due to these agents. Studies reporting local microbiological findings are necessary because they support an antibiotic choice for prophylaxis or therapy more accurately than reports from other areas.

We have performed a phase II study to evaluate the activity and toxicity of ifosfamide and cisplatin as first-line treatment for advanced ovarian cancer. Patients were treated with cisplatin 100 mg/m 2 on day 1 and ifosfamide 5 g/m 2 in 18-hr continuous infusion on day 1 or 1.5 g/m 2 bolus on days 1–5. Between August 1988 and March 1990, 30 women were entered in the trial, 26 of them with measurable disease. The overall clinical response rate was 69% (95% CI: 48–85%), including 34.6% complete responses (95% CI:17–55%). Reassessment laparotomy was performed in 12 cases, and 4 (33%) exhibited a pathologic complete response. For all patients, the median duration of progression-free survival was 14 months, and the median overall survival was 25 months. There were no major differences in the response rate or survival between the two ifosfamide administration modalities. Relevant toxicities were grade IV hematologic toxicity in 11/30 patients and grade IV renal toxicity in 2/30 patients. A patient with grade IV encephalopathy developed a trauma-related cerebral hemorrhage and died 2 months later. The combination of ifosfamide and cisplatin is active in first-line therapy in advanced ovarian cancer, although it does not seem to improve the efficacy or toxicity profile of conventional combinations.

Introduction: The introduction of imatinib mesylate as first-line treatment has led to great improvements in the prognosis of patients with chronic myeloid leukemia (CML). The most used prognostic scores are Sokal, EUTOS and Hasford. Also, the time from diagnosis to imatinib and cytogenetic response influence the prognosis of patients with CML. However, there is no information about CML patients in chronic phase treated with imatinib in developing countries. Objectives: The aim of this study was to determine the prognostic factors in Peruvian patients with CML in chronic phase treated with imatinib (Glivec). Methods: Retrospective cohort of peruvian patients with chronic phase CML that received Imatinib (Glivec-Novartis) through the Glivec International Patient Assistance Program (GIPAP) in a national cancer center. The patients were classified according to prognostic scores of Sokal, EUTOS and Hasford at the beginning of imatinib therapy. The overall survival (OS) was calculated from the date of initiation of imatinib until the date of death or last contact. Event-free survival (EFS) was calculated from the date of start of treatment to date of occurrence of death from any cause during treatment, progression to accelerated phase or blast crisis CML or loss of major cytogenetic response. Transformation-free survival (TFS) was calculated from the date of start of treatment to date of occurrence of accelerated progression to blastic phase. Survival curves were estimated by Kaplan-Meier and comparison was done by log-rank test. Multivariate analysis for OS was performed with the Cox proportional hazard regression model. Results: 99 patients met the eligibility criteria and had a median observation time of 71.3 months. The average time from diagnosis to start imatinib was 11.4 months (CI 7.58-15.31). 14% of the patients had an age>55 years. The complete cytogenetic response at 12+3 months was 36%; the partial response was 16.67% and the lower response was 13.89%. According to the criteria of Sokal, EUTOS and Hasford, 59.58%, 49.49% and 27.27% were classified as higher risk, respectively. The 5-yrs-OS was 66.67% (CI 0.04-0.18%); 5-yrs-EFS, 68.63% (CI 0.13-0.38%) and 5-yrs-TFS, 60.82% (CI 0.21-0.41%). The patients with an age>55 years had significantly lower OS compared with the younger patients (p=0.039). The patients with a time higher than 12 months from diagnosis to imatinib had significantly lower OS than the patients that started it earlier (p=0.0076). The OS was significantly different according to the risk groups of Sokal score (p=0.0221). Also, significant difference was found in the EFS according to cytogenetic response (p=0.042). In the multivariate analysis, the factors that influence OS were high risk according toSokal score (HR=9.42 CI1.09-81.29) and a time greater than 12 months from diagnosis Imatinib (HC=3.53 CI1.12-11.18). Conclusion: In this Peruvian population, the majority of patients are at high risk groups of Sokal, EUTOS and Hasford scores. High risk according to Sokal score and a time higher than 12 months from diagnosis to imatinib were the main prognostic factors. Disclosures No relevant conflicts of interest to declare.

8051Background: Major progress has occurred in multiple myeloma (MM) treatment in recent years. . However, due to limited healthcare resources, newer agents are not readily available. In this setti...

BACKGROUND AND OBJECTIVES We report the 8-year follow-up of 34 patients aged ≥ 69 years old with NHL included in a phase IIb open-label randomized parallel groups study to evaluate the effectiveness of amifostine in preventing the toxicity of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP regime) . PATIENTS AND METHODS Patients were randomized to receive classical CHOP (cyclophosphamide 750 mg/ m 2 , doxorubicin 50 mg/m 2 , vincristine 1.4 mg/m 2 [maximum 2 mg] on day 1 and prednisone 100 mg/day for 5 days) or CHOP plus amifostine (6 cycles of amifostine 910 mg/m 2 on day 1). Efficacy (time to progression, TTP; disease-free survival, DFS; overall survival, OS) and toxicity endpoints were evaluated. RESULTS Thirty-four patients were randomized to A-CHOP (n = 18) or CHOP (n = 16). Patients with A-CHOP vs CHOP had significantly lower toxicity; neutropenia grade 4 ocurred in 13/92 (13%) vs 23/85 (27%, P = 0.007) cycles, febrile neutropenia in 3/92 A-CHOP (3%) vs 8/85 (10%, P = .056) CHOP cycles, hospitalization for toxicity in 4/92 (4%) A-CHOP vs 11/85 (13%, P = .05) CHOP cycles. Median hospitalization stay for toxicity was 5 days with A-CHOP vs 8 days with CHOP ( P = .05). There were no significant differences at 8 years in TTP (A-CHOP, 48.9% vs CHOP, 36.3%; P = .65), DFS (A-CHOP, 72.9% vs CHOP 55.6%; P = .50) and OS (A-CHOP, 44.3% vs CHOP, 54.4%). There was no long-term toxicity of clinical interest. The only prognostic factor identified to 8 years was the International Prognostic Index (IPI low/low intermediate risk vs high intermediate/high risk; HR = 2.98; CI 95%:1.01-8.77; P = .048). CONCLUSION These results show that amifostine can be added to the standard CHOP treatment schedule with less acute toxicity and without influencing the outcome.

Purpose To determine whether addition of gemcitabine to concurrent cisplatin chemoradiotherapy and as adjuvant chemotherapy with cisplatin improves progression-free survival (PFS) at 3 years compared with current standard of care in locally advanced cervical cancer. Patients and Methods Eligible chemotherapy- and radiotherapy-naive patients with stage IIB to IVA disease and Karnofsky performance score ≥ 70 were randomly assigned to arm A (cisplatin 40 mg/m2 and gemcitabine 125 mg/m2 weekly for 6 weeks with concurrent external-beam radiotherapy [XRT] 50.4 Gy in 28 fractions, followed by brachytherapy [BCT] 30 to 35 Gy in 96 hours, and then two adjuvant 21-day cycles of cisplatin, 50 mg/m2 on day 1, plus gemcitabine, 1,000 mg/m2 on days 1 and 8) or to arm B (cisplatin and concurrent XRT followed by BCT only; dosing same as for arm A). Results Between May 2002 and March 2004, 515 patients were enrolled (arm A, n = 259; arm B, n = 256). PFS at 3 years was significantly improved in arm A versus arm B (74.4% v 65.0%, respectively; P = .029), as were overall PFS (log-rank P = .0227; hazard ratio [HR], 0.68; 95% CI, 0.49 to 0.95), overall survival (log-rank P = .0224; HR, 0.68; 95% CI, 0.49 to 0.95), and time to progressive disease (log-rank P = .0012; HR, 0.54; 95% CI, 0.37 to 0.79). Grade 3 and 4 toxicities were more frequent in arm A than in arm B (86.5% v 46.3%, respectively; P < .001), including two deaths possibly related to treatment toxicity in arm A. Conclusion Gemcitabine plus cisplatin chemoradiotherapy followed by BCT and adjuvant gemcitabine/cisplatin chemotherapy improved survival outcomes with increased but clinically manageable toxicity when compared with standard treatment.

A 68-year-old woman presented following a road accident with an undisplaced intertrochanteric fracture affecting an ankylosed hip and an ipsilateral calcaneal fracture. The interthrocanteric fracture was fixed with four 7.0 mm cannulated screws. The calcaneal fracture was fixed with K wires and immobilized in a plaster. Because of this combination of injuries, although she was allowed to mobilize non weight bearing from the first week, sitting and progressive weight bearing were not permitted for six weeks. Radiographs taken at the one year showed consolidation of the hip fracture without complications. Final functional indices showed an EQ-5D VAS score of 40, EQ-5D health state index adapted to Spanish value sets of 0.493 and an Oxford Hip Score of 31. Screw fixation of an undisplaced intertrochanteric fracture in an ankylosed hip may be sufficient in some instances provided the patient remains non weight bearing for long enough.

S66 we divided in three groups, the first group had 25 patients who received CHOP (10)/CHOEP (15) follow by external beam radiation, the second group had 12 patients who received external beam radiation followed by CHOP (8) or CHOEP (4)-based chemotherapy and the third group only had two patients who received concurrent radiotherapy plus CHOP-based chemotherapy. Variables were analyzed using univariate and multivariate analyses with CR as the dependent variable; it used Chi-square for comparing the risks among patient’s characteristics. Results: The mean of age was 37.72 years (14-68), males were 14 (35.9%), females were 25 (64.1%), stage I was 22 (56.4%), stage II were 17 (43.6%), B symptoms were 14 (35.9%), LDH above normal were 16 (41%), 6 patients received 1-3 CT cycles (15.4%), and 33 patients received 4-6 cycles(84.6%). Twenty-nine (74.4%) of 39 patients achieved CR. The group 1 had 76.0% (19/25) of CR, the group 2 had 75.0% (9/12), and the group 3 had 50% (1/2). Univariate analysis identified LDH and number of CT cycles, as significant predictors of CR (both P

Background: The randomized, phase 3 DASISION trial demonstrated improved efficacy with dasatinib compared with imatinib in treatment-naïve CML-CP patients (pts). Dasatinib was also well tolerated, and demonstrated a faster response at 3 months. Here, we report the results of the final, 5-year analysis of DASISION. Methods: Pts with newly diagnosed CML-CP were randomized to receive dasatinib 100 mg once daily (n=259) or imatinib 400 mg once daily (n=260) as previously reported. The primary endpoint was confirmed complete cytogenetic response (cCCyR) by 12 months. Long-term efficacy and safety data from pts with the predefined minimum 5 years of study treatment are presented. Results: Sixty-one percent of dasatinib-treated pts and 63% of imatinib-treated pts were still on their initial study therapy at study end. Cytogenetic and molecular response rates continued to be higher for dasatinib compared with imatinib (intent-to-treat population). Specifically, the rate of cCCyR by 5 years was higher with dasatinib versus imatinib (83% vs 78%, P=.187), as were the rates of major molecular response (MMR; BCR-ABL ≤0.1%; 76% vs 64%, P=.002) and MR4.5 (BCR-ABL ≤0.0032% IS; 42% vs 33%, P=.025) by 5 years. Time to cCCyR (hazard ratio [95% confidence interval]=1.46 [1.20–1.77], P=.0001) and MMR (hazard ratio [95% confidence interval]=1.54 [1.25–1.89], P10% at 3 months, improved PFS, OS, and lower rates of transformation to AP/BP have been previously reported and were maintained at 5 years for dasatinib (PFS: 89% vs 72%, P=.0014; OS: 94% vs 81%, P=.0028; transformation n=6/198 [3%] vs n=5/37 [14%]) and imatinib (PFS: 93% vs 72%, P Conclusion: At 5 years, dasatinib 100 mg once daily has demonstrated superior outcome compared to imatinib 400 mg once daily as initial therapy for CML. This is manifested by a faster time to cytogenetic and molecular responses, with more pts achieving BCR-ABL ≤10% at 3 months, sustained higher cumulative rates of response, and a lower rate of transformation. The 5-year rates of PFS and OS were equal in both arms. After 5 years, no new safety signals have been reported. These consistent results suggest that dasatinib offers meaningful advantages for pts with newly diagnosed CML-CP and remains a standard of care in this setting. Figure 1 Figure 1. Disclosures Cortes: ARIAD, BMS, Novartis, Pfizer, Teva: Consultancy, Research Funding. Saglio:Novartis: Consultancy, Fees for occasional speeches, Fees for occasional speeches Other; Pfizer: Consultancy, Fees for occasional speeches, Fees for occasional speeches Other; ARIAD: Consultancy, Fees for occasional speeches, Fees for occasional speeches Other; BMS: Consultancy, Fees for occasional speeches Other. Baccarani:Bristol-Myers Squibb: Consultancy, Honoraria, Speakers Bureau. Kantarjian:ARIAD: Research Funding; Pfizer: Research Funding; Amgen: Research Funding. Mayer:Bristol-Myers Squibb: Consultancy, Research Funding; Novartis: Consultancy, Research Funding. Shah:Bristol-Myers Squibb: Research Funding; ARIAD: Research Funding. Chuah:Bristol-Myers Squibb: Honoraria; Novartis: Honoraria. Bradley-Garelik:Bristol-Myers Squibb: Employment. Manos:Bristol-Myers Squibb: Employment. Hochhaus:Novartis: Research Funding; BMS: Research Funding; MSD: Research Funding; Ariad: Research Funding; Pfizer: Research Funding.

PURPOSE Standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy repeated at 3-week intervals is difficult to deliver in elderly patients with non-Hodgkin's lymphoma (NHL). The use of hemopoietic growth factors may decrease the hematologic toxicity of chemotherapy and allow the delivery of full-dose CHOP. PATIENTS AND METHODS We conducted a phase II trial with the addition of granulocyte-macrophage colony-stimulating factor (GM-CSF) to CHOP chemotherapy in NHL patients older than 60 years of age. Twenty-six previously untreated patients were assessable; median age was 67 years (range, 61 to 84 years). CHOP included cyclophosphamide 750 mg/m2 intravenously day 1; doxorubicin 50 mg/m2 intravenously day 1; vincristine 1.4 mg/m2 (2 mg total dose) intravenously day 1; and prednisone 100 mg orally days 1 through 5. GM-CSF 5 microg/kg was administered subcutaneously on days 4 through 13. Cycles were repeated every 21 days for six cycles. Results were analyzed for the total group and for two age subgroups: 61 to 69 years (n = 15) and 70 years or older (n = 11). RESULTS Sixteen patients (62%) achieved a complete response (CR), four patients (15%) achieved a partial response (PR), and six patients (23%) did not respond to therapy. After a median follow-up of 41 months, the median progression-free and overall survival were 19 and 30 months, respectively. Twenty patients completed six cycles. One hundred thirty-eight of the 156 planned cycles were delivered (88%). The relative dose-intensity was 95%. The chemotherapy-induced toxicity was important. Absolute neutrophil count was less than 500/mL in 43% of the cycles, platelet nadir was less than 20,000/mL in 19%, and febrile neutropenia occurred in 21%. There were no grades 3 to 4 mucositis. Treatment-related death occurred in two patients, and was associated with neutropenic septic shock. The toxicity related to GM-CSF was mild hypotension after the cytokine was administered in 7% of cycles. When the results of the study were analyzed by age subgroups, we observed that whereas response and median survival were similar in patients aged 61 to 69 years or 70 years or older, there were significant differences in dose delivery and toxicity. Chemotherapy was delivered in 86 of 90 planned cycles in patients aged 61 to 69 years, but in only 52 of 72 planned cycles in patients aged 70 to 84 years (P = .00008). Absolute neutrophil count was less than 500/mL in 24% of cycles in patients aged 61 to 69 years and 73% of cycles in patients aged 70 years or older (P = .00001). The platelet nadir of less than 20,000/mL occurred in 5% of patients aged 61 to 69 years and in 42% of patients aged 70 years or older (P < .0001). Fever and neutropenia occurred in 8% of patients aged 61 to 69 years and in 42% of patients aged 70 years or older (P < .0001). Mucositis (grades 1 to 2) occurred in 21% of patients aged 61 to 69 years and in 42% of patients aged 70 years or older (P = .006). CONCLUSION CHOP chemotherapy plus GM-CSF is an active regimen in elderly patients with NHL. Despite cytokine support, the toxicity of the regimen is elevated. We have identified two age subgroups (61 to 69 and > or = 70 years) that do not differ in treatment efficacy but show large differences in treatment-related toxicity.

e19538 Background: To evaluate prognostic factors in patients with primary non-Hodgkin lymphomas (NHL). Methods: We retrospectively analyzed prognostic factors (PFs) for overall survival (OS) in 2160 patients (pts) with NHL treated at INEN between 1990-2002. PFs were determinate according to Cox model with P-splines. Results: The median age was 54 years (range 14 - 96) and 51% were male. The majority of the pts had good performance status (73%, WHO 0-1). The Ann Arbor stage was I-II in 51%, III-IV in 49% and B symptoms were present in 38% of the pts. The hemoglobin (Hb) was low in 48%. Leukocytes (WBC), lymphocytes and LDH were elevated in 17.7%, 7.7% and 60% of pts, respectively. Of all patients, 709 (32.8 %) pts had died. The median follow-up was 12.6 months, with a median survival of 61.8 months and the survival rate at 5 and 10 years of 51.2 % and 41.7 % respectively. PFs identified were: age, sex, zubrod, clinical stage, Hb, leukocytes, lymphocytes and LDH. The following table shows the p-value and hazard ratio (HR). The effect of continuous covariates in the log(HR) is non-linear. The cutoff points of highest (HR >1) match the clinically defined ones, which are: age >60yrs, Hb240UI/L. Both leukocytes and lymphocytes have two higher risk breakpoints: leukocytes >3x103 and >10x103, lymphocytes 60%. Conclusions: PFs for OS in our group of pts were similar to other reports in NHL. Age, Hb, leukocytes, and lymphocytes are relevant to OS, which showed a nonlinear effect in the log (HR). [Table: see text]

7072 Background: Novel intensive chemotherapy regimens impacted in the prognosis of adolescent and young adult pts with ALL. The application of pediatric inspired therapies demonstrated complete response reported to be > 80%, and long-term survival rates range from 30% to 45%. In the past, ALL treatments had been designed on the presence of risk factors as elevated WBC, time to complete remission or immunophenotype. Recently, MRD monitoring had risen as a risk predictor. Hypothesis: Complete response(CR) associated with a CMR has impact in disease-free survival. Methods: Between March> 2010 and November 2012, 101 adolescent and young adult pts were diagnosed and treated for (Ph)–negative ALL with the C10403 intergroup protocol (N=47) and the 2008 Spanish PETHEMA regimen (N=54). The residual disease status was assessed after induction by multiparametric flow cytometry (MRD 9/L, 63 pts (62%) B immunophenotype, cytogenetics was unknown in 69 pts. After the induction, the CR was achieved in 81% vs 79.6% pts ( Int C10403 vs Pethema, respectively ). The induction mortality rate was 0% vs 7%. Slow responders to induction chemotherapy were 23.81% and 28.8% respectively (p=0.591). A CMR (CR+MRD ≤0.1%) was seen on 70.21% vs 63.27%. The kaplan-meier 2-year disease free-survival rate calculated for CMR patients on C10403 was 35% vs 17% for the Pethema, which was statistically significant (p< 0.04). A multivariate analysis of pts characteristics in CMR could not identified risk factors for disease prognosis. Conclusions: Two different regimens C10403 vs Pethema, could not demonstrate a statistic difference in morphological CR. Lately,the addition of minimal residual disease ≤0.1% (MRD) in the analysis, demonstrated a plausible monitoring variable of response. We suggest that a CMR (CR +MRD at induction) could be a new standard variable to assess responses regardless of previous risk categories. Further validation may be mandatory.

150 Background: Adjuvant chemoradiotherapy is the standard treatment in Western countries in gastric cancer patients submitted to curative resection. INT 0116 pivotal trial established adyuvant chemoradiation as the standar care for resected high risk adenocarcionoma of the stomach in US however was hampered by suboptimal surgery. There is controversial data about efficacy of this adjuvant therapy in patients who have undergone D2 lymphadenectomy predominantly. In our hospital D2 lymphadenectomy is standar surgery for gastric cancer. Methods: Retrospective study with gastric adenocarcinoma patients stage II to IV M0 who underwent curative resection at Instituto Nacional de enfermedades Neoplasicas Lima- Peru between 2001 and 2006 Standard treatment at institution is D2 lymphadenectomy. Chemoradiotherapy according to INT 0116 was given like adjuvant therapy. Survival curves were calculated according to Kaplan-Meier method and compared with log-rank test. Multivariate analysis of prognostic factors related to survival was performed by Cox proportional hazards model adjusted for age, stage and adjuvant chemoradiotherapy. Results: 84 patients were included 60.3% male and 39.3% female. Median age was 40.5 years old. The patologic stage were T1-T2 (12.3%), T3-T4 ( 50% ), N0-N1 (10.7%), N2-N3 (89.3%). D2 lymphadenectomy was performed in all patients. The 3-year DFS was 17% and 3-year overall survivall was 23.9% years.However when we analized by subgroups the overal survival was significantly longer in group N1 ( 61%) and N2 (58.9%) that N3 (18.3%) and DFS were N1 (60%), N2 (55%) and N3 (16.3%). Conclusions: Adjuvant chemoradiotherapy decreased risk of death and relapse in patients with node positive N1-N2 , who underwent curative resection with D2 lymphadenectomy, but recurrence was most frecuent in N3 node positive, maybe is necesary improve the chemotherapy in this group of patientes for dicrease the rate of relapse.

e18543 Background: Recent studies have shown that diffuse large B- cell lymphoma (DLBCL) cases with gene expression profiles of germinal centre B-like (GCB) had a better prognosis than DLBCL cases ...

CRA5507 Background: Cervical cancer is the second-most common cancer among women worldwide, in both incidence and mortality. Current standard therapy for locally advanced disease consists of concurrent Cis and external-beam radiation (XRT). This multicenter, open-label, randomized, phase III trial aimed to improve outcomes, capitalizing on the synergistic activity of Gem, Cis, XRT, and the potential value of adjuvant therapy. Methods: Eligible patients (pts) with bulky stage IIB to IVA, 18–70 years of age, chemotherapy- and radiotherapy-naive, with a Karnofsky Performance Status score ≥70, were randomized to Arm A: Cis 40 mg/m2 followed by Gem 125 mg/m2 weekly × 6 doses with concurrent XRT (50.4 Gy: in 28 fractions: 1.8 Gy/day, 5 days/week), followed by brachytherapy (brachy) (30–35 Gy) and then 2 adjuvant 21-day cycles of Gem (1,000 mg/m2 on Days 1 and 8) plus Cis (50 mg/m2 on Day 1); or Arm B: Cis 40 mg/m2 weekly × 6 doses with concurrent XRT followed by brachy, given as in Arm A. Primary endpoint was progression-free survival (PFS) at 3 years, compared between arms using Kaplan-Meier methods and a Z-statistic. Results: 515 pts were enrolled between 5/02 and 3/04 (259 pts Arm A, 256 pts Arm B). Median age was 46 years; stage IIB/IIIB/IVA in 61/37/2% of pts. Compliance in the concurrent and brachy phase was >90% for both arms; adjuvant cycles were completed by >75% of pts in Arm A. PFS at 3 years was 74% in Arm A compared to 65% in Arm B, resulting in a statistically significant improvement (p = 0.029). Overall survival (log-rank p = 0.0224) and time to progressive disease (log-rank p = 0.0008) were also significantly improved. Significantly more pts in Arm A experienced grade 3/4 toxicities (86.5%), compared to pts in Arm B (46.3%; Fisher's p < 0.001). In Arm A, 2 pts died due to causes probably related to treatment compared to 0 pts in Arm B. Conclusions: This novel regimen of concurrent Gem plus Cis and XRT followed by brachy and adjuvant Gem plus Cis significantly improved outcomes in pts with locally advanced carcinoma of the cervix, at the expense of increased but acceptable toxicity, compared to the current standard of care. [Table: see text]

19527 Background: Non-Hodgkin Lymphoma (NHL) is a malignant neoplasm of lymphoid system with marked differences in presentation and prognosis. The objective was to determine the clinical behavior a...

17520 Background: Extramedullary relapse (EMR) is a rare event in APL and reports have suggested a possible rol of ATRA in its pathogenesis. Our study intent to determine the pattern of EMR in Latin patients treated whit trans-retinoic acid (ATRA) and chemotherapy (CT). Methods: We evaluated 87 patients diagnosed of APL from January 2001 to December 2005. They were treated with ATRA and chemotherapy. Results: 74/87 received ATRA plus chemotherapy. Median age was 28 (5–68). 39/74 (53%) patients were female. Subtype M3v constituted 21/74 (28%). 76% presented disseminated intravascular coagulation (DIC). Extramedullary deposit was observed in 7 cases, more frequent was central nervous system (CNS). According the Sanz Index, 32/74 (32%) were High Risk, 40/74 (54%) Intermediate Risk, 2 Low Risk. 31/55 (56%) presented t(15,17). 52/74 (70%) patients had complete response. EMR was documented in 8 (15%) (CNS: 5, External Auditory Foramen: 3), 4 were High Risk. Median time to EMR was 11.5 months (7.03–27.3). 55% are alive at date. The following median was 36 months, 41 months of Disease Free Survival (DFS), rate was 62 % to 3 years. Overall survival was 44 months; rate was 83% to 3 years. Conclusions: EMR incidence was 8%, higher report that other series, this event was presented in CNS and external auditory foramen. It suggest to establish EMR risk factors and to include CNS prophylactic treatment. No significant financial relationships to disclose.

16031 Background: To evaluate the clinical behavior and results of treatment of gestational trophoblastic disease at INEN between 1980 to 2005. Methods: This is a retrospective analysis of patients with gestational trophoblastic disease, clinical characteristics, results of treatment, toxicity, objective response and survival from January 1980 to December 2005. Descriptive statistics and Kaplan-Meier for survival analysis were performed. Results: Since Jan 1980 to Dec 2005. 595 patients were admitted at INEN; Hydatidiform mole 254 (42.7%) choriocarcinoma 201 (33.8%) invasive mole 41(6.8%). FIGO scoring System, high risk (score >6): 247 (41.5%), low risk (score 1–6): 348 (58.5%). Age ranged from 14 to 54 years, with 255 (44%) cases between 20 to 29 years. The sities of metastasis: lung 67.3%, vaginal 17.9%, brain 8.7%, liver 5.1%. The patients with low risks received treatment with Metotrexate 0.4mg/kg x day x 5 days po, reach disease control with a mean course of 6 (1 - 14), complete remission in 66.1% cases and 97% the overall survival rate to 20 years. Patients with high risk received treatment with: MAC 77 patients, MEC 19 patients, EMACO 48 patients and BEP 14 patients and achieved complete remission in 32.5%, 36.8%, 50% and 25% respectively. On the high risk group we detected two groups according to score > 12 and < 12, with diferent probability of survival at 20 years, for the group with score 12, 48%. 98 patients were identified with score >12, and the age of these patients ranged from 15 to 51 years, with a mean age of 36.5 years. The blood B- HCG titers of these patients ranged from 198 to 6710,500. Liver and brain metastasis in 26 cases, number metastasis mayor 8 in 78 cases. Conclusions: Gestational trofhoblastic disease is highly curable. Patients of low risk achieved a 97% overall survival rate to 20 years. There are differences in the overall survival rate between patients of high risk with a score < 12 (80%) and score >12 (48%). This group presented with brain and liver metastasis, and it is important to define the best treatment for this group of patients No significant financial relationships to disclose.

6726 Background: Acute lymphatic leukemia (ALL) is one of the most curable neoplasia in children, but the results in adults are poor. We evaluated the response, relapse, disease-free survival (DFS)...

6690 Background: Patients with stage III-IV non-Hodgkin’s Lymphoma (NHL) have poor prognosis in disease-free survival (DFS) at treatment with conventional chemotherapy, usually CHOP regimen. In pat...

PURPOSE It has been suggested that age is associated with chemotherapy-related death in patients with non-Hodgkin's lymphoma (NHL) treated with doxorubicin-containing chemotherapy. The purpose of this study was to evaluate the relative influence of increasing age and other clinical parameters on the occurrence of treatment-related death in elderly patients with intermediate- or high-grade NHL treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy. METHODS A retrospective study of patients 60 years of age or older with intermediate- or high-grade NHL treated with CHOP chemotherapy in a single cancer center. The following variables were recorded: age (60 to 69, 70 to 79, and 80 to 94 years), histology (Working Formulation [WF] D, E, F, G, and H), Ann Arbor stage, B symptoms, extranodal involvement, bulky disease (> 7 cm), performance status (Eastern Cooperative Oncology Group [ECOG] scale), International Prognostic Index (IPI score), serum lactate dehydrogenase (LDH) level and doxorubicin relative dose-intensity (RDI). The relationship between these features and treatment-related death was assessed in univariate and multivariate logistic regression analysis. RESULTS From 1982 to 1991, 267 consecutive patients were treated. Median age was 70 years (range, 60 to 94 years). There were 35 toxic deaths. Sixty-three percent of the deaths occurred after the first cycle. Infection accounted for 82% of the toxic deaths. In the univariate analysis, the features associated with an increased risk of toxic death were ECOG performance status 2 to 4 (relative risk [RR], 7.82), B symptoms (RR, 3.38), diffuse large-cell histology (RR, 3.06), bulky disease (RR, 2.58), serum levels of LDH (RR, 2.53), and IPI score (RR, 2.46). The age groups did not show significance. In the regression model, performance status 2 to 4 was the only independent predictor of treatment-related death (RR, 3.52; 95% confidence interval [CI], 2.98 to 4.06). CONCLUSION Our results show that in elderly patients with NHL treated with doxorubicin-based chemotherapy the risk for treatment-related death is associated with poor performance status rather than with increasing chronologic age.