Chemotherapy For Solid Tumors Research Articles

Risk for HBV Reactivation With and Without Prophylaxis During Solid Tumor Chemotherapy

We know that hepatitis B virus (HBV) reactivation is a risk of chemotherapy, particularly with rituximab-based regimens. In the current systematic

Chemotherapy-Induced Nausea and Vomiting: An Oncology-Day Unit Experience

Introduction: Chemotherapy-induced nausea and vomiting are the most common side-effects feared by patients. Although significant advances have been made, chemotherapy-induced nausea and vomiting remain an important adverse effect of treatment. Purpose: The purpose of our study was to evaluate the prevalence of chemotherapy-induced nausea and vomiting in an oncology day unit in France. We described then the management of this side-effect. Methods: This retrospective mono-centric observational study assessed 65 patients in our oncology day unit. They all were on chemotherapy for solid tumors and should have had already received one cycle of chemotherapy. Patients were metastatic or treated with a curative intent. During three days, patients were asked if they had experienced nausea and/or vomiting after their last cycle of treatment. Results: 65 patients were enrolled, 45 women (69%) and 20 men (31%). The median age was 63 years. 20 patients were elderly people. 48 patients were metastatic (74%) and 17(26%) were on neo-adjuvant or adjuvant therapy. 24 people (37%) experienced nausea (20 patients) or vomited (4 patients). Nausea was essentially grade I (60%). All patients received anti-emetic therapies. In the 24 patients who suffered from adverse effects, only 6 had corticosteroids, 15 had NK1 receptor inhibitors, 12 received 5-HT3 receptor inhibitors and 12 anti D2 treatments. 9 patients (14%) experienced refractory nausea and vomiting. Conclusion: Even if guidelines exist and despite many therapeutics agents have improved patients’ quality of life in terms of nausea and vomiting, in some cases it seems not to be enough.

Olanzapine combined with normal antiemetic drugs in patients on solid tumor chemotherapy: Antiemetic effect and impact on quality of life

Olanzapine combined with normal antiemetic drugs in patients on solid tumor chemotherapy: Antiemetic effect and impact on quality of life

Agreement analysis between three different short geriatric screening scales in patients undergoing chemotherapy for solid tumors.

Comprehensive geriatric assessment (CGA) in routine practice is not logistically feasible. Short geriatric screening tools are available for selecting patients for CGA. However none of them is validated in India. In this analysis we aim to compare the level of agreement between three commonly used short screening tools (Flemish version of TRST (fTRST), G8 and VES-13. Patients ≥65 years with a solid tumor malignancy undergoing cancer directed treatment were interviewed between March 2013 to July 2014. Geriatric screening with G8, fTRST and VES-13 tools was performed in these patients. G8 score ≤14, fTRST score ≥1 and VES-13 score ≥3 were taken as indicators for the presence of a high risk geriatric profile respectively. R version 3.1.2 was used for analysis. Cohen kappa agreement statistics was used to compare the agreement between the 3 tools. p value of 0.05 was taken as significant. The kappa statistics value for agreement between G8 score and fTRST, between VES-13 and fTRST and between VES-13 and G8 were 0.12 (P = 0.04), 0.16 (P = 0.07) and 0.05 (P = 0.45) respectively. It was found that maximum agreement was observed for VES-13 and fTRST. The agreement value of VES-13 and fTRST observed was 59.44 %(39.63% for high risk profile and 19.81% for low risk profile). The agreement value of G-8 and fTRST was 39.62% (2.83% only for high risk profile and 36.79% for low risk profile). The lowest agreement was between G8 and VES-13, 35.84% (7.54% for high risk detection and 28.30% for low risk detection). There was poor agreement (in view of kappa value been below 0.2) between the 3 short geriatric screening tools. Research needs to be directed to compare the agreement level between these 3 scales and CGA, so that the appropriate short screening tool can be selected for routine use.

Development and validation of a questionnaire to measure preferences and expectations of patients undergoing palliative chemotherapy: EXPECT questionnaire.

The objective was to design and validate the questionnaire for capturing palliative chemotherapy-related preferences and expectations. Single arm, unicentric, prospective observational study. EXPECT questionnaire was designed to capture preferences and expectations of patients undergoing palliative chemotherapy. This questionnaire underwent a linguistic validation and then was tested in patients. Ten patients are undergoing chemotherapy for solid tumors who fulfilled the inclusion and exclusion criteria self-administered the EXPECT questionnaire in regional language. After filling this questionnaire, they self-administered quick questionnaire-10 (QQ-10). SPSS version 16 (IBM New York) was used for analysis. Completion rate of EXPECT questionnaire was calculated. The feasibility, face validity, utility and time taken for completion of EXPECT questionnaire was also assessed. The completion rate of this questionnaire was 100%. All patients completed questionnaire within 5 min. The QQ-10 tool confirmed the feasibility, face validity and utility of the questionnaire. EXPECT questionnaire was validated in the regional language, and it's an effective tool for capturing patient's preferences and expectation from chemotherapy.

Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial.

There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, but evidence of impact on clinical outcomes is limited. We randomly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the discretion of clinicians. Those with home computers received weekly e-mail prompts to report between visits. Treating physicians received symptom printouts at visits, and nurses received e-mail alerts when participants reported severe or worsening symptoms. The primary outcome was change in health-related quality of life (HRQL) at 6 months compared with baseline, measured by the EuroQol EQ-5D Index. Secondary endpoints included emergency room (ER) visits, hospitalizations, and survival. Among 766 patients allocated, HRQL improved among more participants in the intervention group than usual care (34% v 18%) and worsened among fewer (38% v 53%; P < .001). Overall, mean HRQL declined by less in the intervention group than usual care (1.4- v 7.1-point drop; P < .001). Patients receiving intervention were less frequently admitted to the ER (34% v 41%; P = .02) or hospitalized (45% v 49%; P = .08) and remained on chemotherapy longer (mean, 8.2 v 6.3 months; P = .002). Although 75% of the intervention group was alive at 1 year, 69% with usual care survived the year (P = .05), with differences also seen in quality-adjusted survival (mean of 8.7 v. 8.0 months; P = .004). Benefits were greater for participants lacking prior computer experience. Most patients receiving intervention (63%) reported severe symptoms during the study. Nurses frequently initiated clinical actions in response to e-mail alerts. Clinical benefits were associated with symptom self-reporting during cancer care.

Geriatric Assessment Metrics Are Associated with Hospital Length of Stay in Pre-Bone Marrow Transplant Myeloma Patients

A geriatric assessment (GA) is a global approach to improve healthy aging, wherein occult problems are assessed and intervened upon using a multidisciplinary method. A GA is feasible and can predict chemotherapy-induced toxicity and overall survival in cancer patients. Biomarkers of aging are also being explored as objective and reproducible measures of health and fitness. p16INK4a (p16) is a marker of cellular senescence that rises exponentially with chronologic age and is influenced by factors such as physical activity, smoking, and solid tumor chemotherapy. Here, we investigated the relationship of both the GA and molecular (i.e. p16) metrics in pre-bone marrow transplant (BMT) multiple myeloma (MM) patients. We selected this group for our studies as BMT patients are a vulnerable cohort in which transplant eligibility is subjective and age related. BMT patients are also at high risk for adverse events and treatment toxicity. In this preliminary analysis, we explored the predictive value of GA metrics and p16 with inpatient length of stay (LOS) during autologous BMT.Methods: We performed a pilot prospective cohort study on 55 MM patients during their pre-transplant evaluation. MM patients >18 years completed GA assessments related to physical function, distress, comorbidities, social support, and cognition. Patients completed surveys using the Brief Fatigue Inventory (BFI) (scale 1-10; moderate fatigue 4-6, severe fatigue 7+); Hospital Anxiety and Depression (HADS) (borderline case 8-10, definite case 11+); medical outcome study-social support survey (MOS-SSS) (scale 0-100, higher scores indicated greater support), Human Activity Profile (HAP) maximum activity score (MAS) and HAP-adjusted activity score (AAS), a 94-item questionnaire ranking tasks according to energy use validated in the BMT population, with higher scores indicating higher activity (Herzberg BBMT 2010). Objective measures of physical activity were measured using the Short Physical Performance Battery (SPPB) (range 0-12; impairment <9) and cognition was evaluated using the Modified Mini Mental Status exam (3MS). At the pre-transplant evaluation, p16 mRNA was measured in peripheral blood T-cells using established laboratory techniques (Liu Aging Cell 2009). The association between GA metrics and p16 were evaluated using Spearman's correlation coefficient. Univariable generalized linear models were fit to model LOS as a function of GA metrics or p16.Results: The median patient age was 61 (range 42-76). Most patients exhibited early stage disease (ISS Stage 1 53%) with minimal comorbidities (HCT-CI median 1; range 0-8) and a median of 2 prior lines of treatment (range 1-11). Pre-transplant Karnofsky Performance Status (KPS) was reported as 70% (n=10), 80% (n=10), 90% (n=15) and 100% (n=12). 7 patients did not proceed with BMT, 1 inpatient for BMT. Patients reported moderate fatigue by BFI (median 4.3; range 0-9.8), with minimal anxiety or depression as measured by the HADS. Self-reported physical activity by HAP-MAS was 73 (range 30-94) and HAP-AAS was 64 (range 20-94). Patients reported high levels of social support (median 86.7%; range 18.2-100) by MOS-SSS. Objective measures of physical function were also high as measured by the SPPB (median 10; range 4-12) and no cognitive impairment was identified by the 3MS. p16 expression was adjusted for age and did not correlate with GA tools including BFI, HADS, HAP-AAS, HAP-MAS, MOS-SSS, SPPB or 3MS. The median length LOS during transplant was 16 days (range 12-36). Univariate analysis revealed that SPPB score was significantly associated with LOS, where each one unit increase in physical performance corresponded to an average LOS decrease of 0.63 days (p=0.04). Self-reported activity by HAP-AAS also correlated with LOS (p=0.05). LOS was not influenced by p16, age, KPS or HCT-CI. Age and HCT-CI had no relationship with SPPB scores, but KPS did (p=0.03727).Conclusions: A comprehensive GA can be used to identify factors that contribute to BMT outcomes. Physical function appears to be most predictive of hospital LOS as measured by SPPB or a detailed self-report of physical function. Baseline p16 levels had no relationship with GA metrics in this selected population. A standardized approach for determining patient fitness including SPPB and HAP-AAS assessments may improve treatment tolerance, reduce hospital LOS, and decrease the risk for adverse outcomes in BMT populations. DisclosuresJaglowski:Immunomedics: Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy, Research Funding; Seattle Genetics: Consultancy.

Overview of French Routine Clinical Practice for the Management of Chemotherapy-Induced Anemia (CIA) with Biosimilar Epoetin Alfa in 563 Patients with Lymphoid Malignancies: A National Observational Study (The OncoBOS study)

▪Background. OncoBOS is a prospective, non-interventional study conducted in France to describe modalities of treatment with Binocrit® in routine clinical practice setting, for the correction of hemoglobin (Hb) in patients with CIA receiving chemotherapy (CT) for solid tumors, lymphoma or myeloma. This analysis focuses on patients with lymphoid malignancies (LM).Patients & methods. Patient ≥18 years old with LM, CIA and eligible for treatment with Binocrit® were included. This analysis reports patients characteristics along with anemia-related data such as Hb outcomes, Binocrit® treatment characteristics and concomitant treatments received, at baseline, 3-4 weeks and 12 (± 1) weeks later. Factors associated with a Hb increase ≥2 g/dL in patients with LM were analyzed by means of univariate and multivariate analyses.Results. 563 evaluable patients (302 males (53.6%), mean age 67.9 (SD 14.0) years were recruited from 34 sites, between September 2011 and July 2014. Non-Hodgkin lymphoma (NHL) (281 patients; 49.9%) and multiple myeloma (165 patients; 29.3%) were most prevalent. Among patients with NHL, 46.0% had a diffuse large B cell lymphoma, 11.5% a follicular lymphoma and 11.1% a mantle cell lymphoma. 62.5% of patients with NHL had a stage IV disease and bone marrow was involved by NHL in 45.2% of patients. A vast majority of patients (84.3%) suffering from multiple myeloma had a Durie-Salmon stage III myeloma. Mean baseline Hb was 9.5 (SD 1.0) g/dL, which increased by an average of 0.9 (SD 1.4) g/dL and 1.9 (SD 1.7) g/dL after 1 and 3 months, respectively. A Hb increase ≥1 g/dL was achieved by 51.3% of patients after 3-4 weeks of treatment with Binocrit®. About half of patients (53.0%) achieved a Hb increase ≥2 g/dL at week 12 (± 1). Patients received a mean Binocrit® dose of 31252.4 ± (SD 5815.9; median: 30000) UI once-weekly, over an average time span of 10.8 (SD 3.2; median: 13) weeks. Iron status (serum ferritin and transferrin saturation coefficient) was assessed in 29.1% of subjects at baseline. In total, 2.8% and 1.4% of patients concomitantly received oral or intravenous iron, respectively, during the follow-up period. 12.1% and 11.6% of patients received a folate supplementation at week 3-4 and 12, respectively. Moreover, 16.2% and 15.0% of patients received red blood cells transfusion over the 3-4 first weeks, and over the next 2 months, respectively. Over the treatment period, no treatment‐related adverse reaction was recorded. Factors negatively/positively associated with a Hb increase ≥2 g/dL (p<0.05) in the multivariate analysis were: prior radiotherapy [HR 0.16 (CI95% 0.04;0.64)]; history of venous thrombotic disease [HR 1.93 (1.14;3.28)]; administration of folate during the follow-up [HR 2.43 (1.69;3.49)]; a Hb level < 8 or [8;10[ g/dL at inclusion [HR 3.04 (1.97;4.69) and HR 1.62 (1.25;2.11), respectively]; 2 units of red blood cells received over the treatment period [HR 2.82 (1.91;4.16)].Conclusions. This study indicates that in real-life clinical conditions Binocrit® increases effectively Hb, without any adverse drug reaction, in anemic patients with lymphoid malignancies, whatever chemotherapy received. The effect of treatment with Binocrit® is rapid, with mean hemoglobin increase of 0.9 (SD1.4) g/dL seen as early as 3 or 4 weeks following the start of therapy. DisclosuresKarlin:Janssen: Honoraria; BMS: Honoraria; Amgen: Honoraria; Sandoz: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria. Metges:Sandoz: Consultancy. Khobta:Sandoz: Membership on an entity's Board of Directors or advisory committees. Boschetti:Sandoz: Membership on an entity's Board of Directors or advisory committees. Toledano:Sandoz: Membership on an entity's Board of Directors or advisory committees. Aubron-Olivier:Sandoz: Employment. Fernet:Sandoz: Employment. Fitoussi:Sandoz: Membership on an entity's Board of Directors or advisory committees.

Method of hyperthermia and tumor size influence effectiveness of doxorubicin release from thermosensitive liposomes in experimental tumors

Systemic chemotherapy of solid tumors could be enhanced by local hyperthermia (HT) in combination with thermosensitive liposomes (TSL) as drug carriers. In such an approach, effective HT of the tumor is considered essential for successful triggering local drug release and targeting of the drug to the tumor. To investigate the effect of HT method on the effectiveness of drug delivery, a novel laser-based HT device designed for the use in magnetic resonance imaging (MRI) was compared systematically with the frequently used cold light lamp and water bath HT. Long circulating phosphatidyldiglycerol-based TSL (DPPG2-TSL) with encapsulated doxorubicin (DOX) were used as drug carrier enabling intravascular drug release.Experiments were performed in male Brown Norway rats with a syngeneic soft tissue sarcoma (BN 175) located on both hind legs. One tumor was heated while the second tumor remained unheated as a reference. Six animals were investigated per HT method. DPPG2-TSL were injected i.v. at a stable tumor temperature above 40°C. Thereafter, temperature was maintained for 60min. Total DOX concentration in plasma, tumor tissue and muscle was determined post therapy by HPLC. Finally, the new laser-based device was tested in a MRI environment at 3T using DPPG2-TSL with encapsulated Gd-based contrast agent.All methods showed effective DOX delivery by TSL with 4.5–23.1ng/mg found in the heated tumors. In contrast, DOX concentration in the non-heated tumors was 0.5±0.1ng/mg. Independent of used HT methods, higher DOX levels were found in the smaller tumors. In comparison water bath induced lowest DOX delivery but still showing fourfold higher DOX concentrations compared to the non-heated tumors. With the laser-based applicator, a 13 fold higher DOX deposition was possible for large tumors and a 15 fold higher for the small tumors, respectively. Temperature gradients in the tumor tissue were higher with the laser and cold light lamp (−0.3°C/mm to −0.5°C/mm) compared to the water bath (−0.1°C/mm and −0.2°C/mm). Visualization of HT in the MRI demonstrated successful localized heating throughout the entire tumor volume by contrast agent release from DPPG2-TSL.In conclusion, HT triggered drug delivery by using DPPG2-TSL is a promising tool in chemotherapy but effectiveness markedly depended on the method of heating and also on tumor size. Local HT using a cold light lamp or the new laser applicator allowed more efficient drug delivery than using a regional water bath heating. MR-compatibility of the new applicator gives the opportunity for future experiments investing drug delivery in more detail by MRI at low technical efforts.

Prophylactic Biosimilar Filgrastim Treatment during Cytotoxic Chemotherapy in Patients with Malignant Diseases: The Venice Observational Study

▪Introduction: Among other serious adverse events, febrile neutropenia (FN) is a serious, frequent complication associated with cytotoxic chemotherapy (CT). Biosimilar filgrastim (NivestimTM, Hospira Inc.) is a granulocyte-colony stimulating factor (G-CSF)approved for use in Europe since 2010 for the reduction in the duration of neutropenia and the incidence of FN in patients treated with cytotoxic CT for malignancy. The VENICE study was conducted to observe the tolerability, safety and efficacy of prophylactic treatment using biosimilar filgrastim among in-patients receiving cytotoxic CT for cancer outside the clinical trial setting in the context of real-life, day-to-day medical practice. This study is of particular relevancy due to the propensity for biosimilar G-CSF to lower overall costs of cancer treatment. ClinicalTrials.gov Identifier: NCT01627990Study Design: The study was conducted as a prospective, non-interventional study at 48 sites in Germany. Patients being treated for solid tumors or malignant hematologic tumors except for chronic myeloid leukemia (CML) or myelodysplastic syndrome (MDS) who had provided informed consent and for whom cytotoxic CT and biosimilar filgrastim treatment was planned were enrolled in the study. Data on demographics, clinical characteristics, treatment-related data on efficacy and safety (AEs including FN) and hospitalizations were collected. Three study visits were planned: at recruitment, at end of first biosimilar filgrastim administration and at end of CT or end of study.Results: The study included 386 adult patients undergoing cytotoxic CT who were treated with biosimilar filgrastim prophylactically to reduce the duration of neutropenia and to reduce incidence of chemotherapy-induced FN. Patients were 81% female with a mean age of 60 years. At baseline, 43% of the patients had already received CT and previous FN was reported by only 3% of patients. A total of 338 patients (88%) had solid tumors and 49 (13%) had hematological malignancies. Antibiotic prophylaxis was taken by 13% of patients at inclusion. Only 9% of the patients had received G-CSF from the first cycle. The majority (64%) of patients received biosimilar filgrastim as primary prophylaxis and 36% as secondary prophylaxis.At least one hospitalization was reported by 24 (6%) of 382 patients in the safety analysis set and the median hospital stay for these patients was 10 days. Hospitalization due to FN or infection was reported for 2% of patients.Only 1% of patients had a delay in their CT due to FN after the first biosimilar filgrastim treatment and for only 5% of patients, the CT in any subsequent CT cycle was delayed due to neutropenia. Reduction of CT dose after first biosimilar filgrastim treatment due to FN was reported for only 1% of patients and reduction of CT dose in any subsequent cycle due to neutropenia was reported for only 5% of patients.The median duration between the last dose of CT and treatment with biosimilar filgrastim was 5 days. The majority of patients were prescribed the 30 million units (MU) dose of biosimilar filgrastim administered SC. The median duration of treatment was 4 days. Most patients administered the biosimilar filgrastim injection themselves at both treatment visits (78% at first visit and 69% at last visit). Most of the self-applicators reported that the application was easy or very easy.During the study, 24% of patients experienced ≥1 AE that was at least possibly related to biosimilar filgrastim treatment. The treatment related AEs reported most frequently were musculoskeletal and connective tissue disorders (11%); general disorders and administration site conditions (5%); and blood and lymphatic system disorders (5%).Conclusions: The VENICE non-interventional study aimed to evaluate the use of biosimilar filgrastim according to the label approved usage of the biosimilar filgrastim in order to collect additional real world data on the tolerability, safety and efficacy in cancer patients. Biosimilar filgrastim was effective and well-tolerated in both the primary and secondary prophylactic settings in patients undergoing chemotherapy for solid tumors and hematological malignancies. DisclosuresErdlenbruch:Hospira Germany: Employment.

Prevalence of hepatitis B and C and sensibility of a selective screening questionnaire in patients receiving chemotherapy for solid tumors.

BackgroundReactivation of hepatitis B or C virus can occur in patients undergoing chemotherapy. Recommendations for selective or systematic hepatitis B virus testing prior chemotherapy for solid tumors differ. The primary aim was to determine the seroprevalence of hepatitis B or C in a low endemic country. The second objective was to assess the relevance of a questionnaire on hepatitis B/C risk factors to consider a selective screening.MethodsPatients were prospectively tested for hepatitis B/C markers. HBs antigen positive patients and isolated anti-HBc positive patients with detectable viral load received antiviral preventive treatment. Patients or physicians completed the questionnaire on infection risk factors.ResultsAmong the 450 patients included, 388 were tested for all serological markers and had gastrointestinal (63.7 %), lung (31.2 %) and skin (4.6 %) cancers. The prevalence of subjects exposed to hepatitis B virus was 8.5 % (33/388). One patient tested positive for HBs antigen and received preventive treatment. Prevalence of subjects exposed to hepatitis C was 1.3 % (5/388). The questionnaire sensitivity was 45.5 %, 100 % and 50 % for detecting carriers of hepatitis B, C and one or the other, respectively.ConclusionsSeroprevalence of hepatitis B was low. Selective screening with the questionnaire was insufficiently sensitive. Systematic screening with serological tests prior to chemotherapy in patients with solid tumors is therefore relevant.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-015-2033-z) contains supplementary material, which is available to authorized users.

376PD The multicenter, prospective observational study of the 5-HT3 receptor antagonist and dexamethasone as prophylaxis of chemotherapy- induced nausea and vomiting (CINV) in moderately emetic chemotherapy (MEC) for solid tumors

376PD The multicenter, prospective observational study of the 5-HT3 receptor antagonist and dexamethasone as prophylaxis of chemotherapy- induced nausea and vomiting (CINV) in moderately emetic chemotherapy (MEC) for solid tumors

Advances in drug delivery system for platinum agents based combination therapy.

Platinum-based anticancer agents are widely used as first-line drugs in cancer chemotherapy for various solid tumors. However, great side effects and occurrence of resistance remain as the major drawbacks for almost all the platinum drugs developed. To conquer these problems, new strategies should be adopted for platinum drug based chemotherapy. Modern nanotechnology has been widely employed in the delivery of various therapeutics and diagnostic. It provides the possibility of targeted delivery of a certain anticancer drug to the tumor site, which could minimize toxicity and optimize the drug efficacy. Here, in this review, we focused on the recent progress in polymer based drug delivery systems for platinum-based combination therapy.

Enhanced antitumoral activity of doxorubicin against lung cancer cells using biodegradable poly(butylcyanoacrylate) nanoparticles.

Doxorubicin (Dox) is widely used for the combined chemotherapy of solid tumors. However, the use of these drug associations in lung cancer has low antitumor efficacy. To improve its efficacious delivery and activity in lung adenocarcinoma cells, we developed a biodegradable and noncytotoxic nanoplatform based on biodegradable poly(butylcyanoacrylate) (PBCA). The reproducible formulation method was based on an anionic polymerization process of the PBCA monomer, with the antitumor drug being entrapped within the nanoparticle (NP) matrix during its formation. Improved drug-entrapment efficiencies and sustained (biphasic) drug-release properties were made possible by taking advantage of the synthesis conditions (drug, monomer, and surfactant-agent concentrations). Dox-loaded NPs significantly enhanced cellular uptake of the drug in the A549 and LL/2 lung cancer cell lines, leading to a significant improvement of the drug’s antitumoral activity. In vivo studies demonstrated that Dox-loaded NPs clearly reduced tumor volumes and increased mouse-survival rates compared to the free drug. These results demonstrated that PBCA NPs may be used to optimize the antitumor activity of Dox, thus exhibiting a potential application in chemotherapy against lung adenocarcinoma.

Hepatitis B Virus Reactivation and Prophylaxis During Solid Tumor Chemotherapy: A Systematic Review and Meta-analysis.

Solid tumor chemotherapy regimens pose a risk for hepatitis B virus (HBV) reactivation, but screening and antiviral prophylaxis remains controversial because of insufficient evidence. To determine the risk for HBV reactivation with and without antiviral prophylaxis and the effectiveness of prophylaxis in adults with solid tumors and chronic or resolved HBV infection. MEDLINE through 1 July 2015 and Web of Science, Cochrane Central Register of Controlled Trials, TOXNET, and Scopus through 1 March 2015. 26 English-language observational studies and randomized, controlled trials in patients with chronic or resolved HBV receiving chemotherapy for solid tumors. Study characteristics, quality, and risk of bias were assessed by 1 researcher and verified by another independent researcher. Random-effects model meta-analyses were used to estimate the risk and odds ratio (OR) of reactivation with versus without antiviral prophylaxis. Reactivation in chronic HBV without prophylaxis ranged from 4% to 68% (median, 25%) with substantial heterogeneity. Prophylaxis reduced the risk for HBV reactivation (OR, 0.12 [95% CI, 0.06 to 0.22]), HBV-related hepatitis (OR, 0.18 [CI, 0.10 to 0.32]), and chemotherapy interruption (OR, 0.10 [CI, 0.04 to 0.27]). In 3 studies of patients with resolved HBV infection, none received HBV prophylaxis and reactivation risk ranged from 0.3% to 9.0%. Significant heterogeneity in underlying study populations and treatment regimens, incomplete baseline data, possibility of publication bias, and limited study quality. Most studies were observational and from Asia. In patients with chronic HBV receiving solid tumor chemotherapy, the risk for HBV reactivation is similar to the risk with other types of immunosuppressive therapy. Results support HBV screening and antiviral prophylaxis before initiation of chemotherapy for solid tumors. National Center for Advancing Translational Sciences and National Institutes of Health.

A72: Particular qualities of the expression of markers of sensitivity to cytostatics at patients various solid tumours

Background To evaluate the expression of markers of sensitivity to chemotherapy in patients various solid tumors. Materials and methods The work includes paraffin blocks NSCLC patients (n = 486); CRC (n = 262); Breast cancer (n = 55); cervical cancer (n = 19); kidney (n = 35); squamous head and neck cancer (n = 15); stomach (n = 51); ovarian (n = 25); melanoma (n = 58); soft tissue sarcomas (n = 52). On our panel discussed the spectrum of expression of enzymes DPD, TP, TS, ERCC1, β-tubulin. Measurement of the expression of these genes produced by polymerase chain reaction in real time according to the method developed at the Institute of Oncology. NN Petrova. Results The combination of markers of sensitivity to fluoropyrimidine (low levels of DPD, TS, and low/high TP) was observed in patients with NSCLC in 30.9%, 41.9% in colorectal cancer, breast cancer in 31.1%, renal cell carcinona 41.1%, head and neck carcinoma in 14.3%, of gastric cancer in 42.5% melanoma in 39.5% of cases. Marker sensitivity to platinum drugs (low ERCC1) occurs in patients with NSCLC in 68.8%, 57.1% in colorectal cancer, breast cancer in 55.0%, renal cancer in 70.8% of squamous cell carcinoma of the head and neck 50, 0% of gastric cancer in 87.9% in melanoma 63.6% of cases. Marker, is an indirect measure of sensitivity to taxane drugs (low β-tubulin) in patients with NSCLC diagnosed in 72.7% of cases, in 75% of colorectal cancer, breast cancer in 66.7%, renal cancer in 92.3% of gastric cancer to 86.6%, melanoma in 73.5%. Conclusion The expression of markers in tumor tissue is heterogeneous. Significant heterogeneity of expression of predictive marker indicates on one hand the futility of the empirical approach to the choice of therapy, and on the other the need for their determination in all patients. Information about the molecular and genetic features of the tumor can afford to individualize the choice of drug. Objective data about the informativeness of molecular genetic markers can be obtained on the basis of randomized clinical trials.

Glycosylated Hemoglobin A1c and Lack of Association With Symptom Severity in Patients Undergoing Chemotherapy for Solid Tumors.

To assess the effects of high blood sugar at the levels of diabetic or prediabetic states during cancer treatment because patients undergoing chemotherapy (CTX) experience multiple symptoms that vary among individuals and may be affected by glucose levels. Descriptive, cross-sectional. Two comprehensive cancer centers, one Veterans Affairs hospital, and four community-based oncology programs. 244 outpatients with breast, gastrointestinal, gynecologic, and lung cancers. Patients completed demographic and symptom questionnaires. Glycosylated hemoglobin A1c (HbA1c) was evaluated to determine diabetic state. Descriptive statistics and one-way analyses of variance were used in the analyses. HbA1c, symptom severity scores, patient and clinical characteristics (e.g., age, gender, comorbidities, sociodemographic information, body mass index [BMI], lifestyle factors). HbA1c results showed 9% of the sample in the diabetic and 26% in the prediabetic state. Patients in the diabetic state reported a higher number of comorbid conditions and were more likely to be African American. Patients in the prediabetic state were older aged. Patients in the diabetic and prediabetic states had a higher BMI compared to nondiabetic patients. No differences in symptom severity or quality-of-life (QOL) scores were found among the three diabetic states. This study is the first to evaluate for associations between diabetic states and symptom severity and QOL scores in patients receiving CTX. This study confirmed that older age, as well as having higher BMI and having multiple comorbidities, were associated with increased mean glycemic levels. Clinicians should assess and identify patients with diabetes or prediabetes undergoing treatment for cancer. Patients who are older aged, those with a high BMI, and those with multiple comorbid conditions may be at increased risk for higher glycemic states.

N05 - The G8 screening as a tool for malnutrition risk

Background: Incidence of cancer increases with age. In older cancer patients, important information may be missed without a Comprehensive Geriatric Assessment (CGA). A validated screening instrument is needed to identify patients for whom a CGA would be beneficial. G8 is a screening tool (8 questions) for older cancer patients in need of a CGA, it explores functional, cognitive, nutritional status and it takes 5 minutes; a score of ≤14 is considered abnormal.Objectives: To test the performance of the G8 ≤14 in older patients with solid cancer; to identify those who would benefit from a nutritional support when a reduced MNA in the Mini Nutritional Assessment in the CGA was found.Methods: Between January and April 2015, G8 was performed in 488 consecutive patients aged ≥70 years diagnosed with solid cancer at Vito Fazzi Hospital for a total of 963 G8. The G8 was administered 3 times in 78 patients and in 54 with G8 score <14, CGA (including MNA) were completed. MNA involves anthropometric measurements, global assessment, dietary questionnaire, a subjective assessment and it enables a subject to be categorized as normal (adequate nutrition), borderline (risk of malnutrition) or undernutrition. MNA is an 18-item questionnaire comprising anthropometric measurements (BMI, mid-arm/calf circumference, weight loss) combined with a questionnaire regarding dietary intake (number of meals consumed, food-fluid intake, feeding autonomy), a global assessment (lifestyle, medication, mobility, acute stress presence, presence of dementia/depression) and a self-assessment (self-perception of health and nutrition). Patients aged 70 years or older treated with chemotherapy for solid tumor and at risk of malnutrition (MNA) received Nutritional Advice.Results: 54 patients with 76 years median age were included; 31,4% (N = 17) had an abnormal MNA <24, risk factor of malnutrition (5 female, 12 male) for each of them Clinical Nutrition Unit adopted an individualized nutrition program with oral nutritional supplements (ready-made liquids) or in 2 patients parenteral nutrition. In these patients there was an improvement of the G8 due to the increase of the MNA to start the chemotherapy.Conclusion: G8 can be used in order to identify those patients who would benefit from a CGA and those who have a malnutrition risk. The results show that it is important to implement and develop strategies for individual nutritional care, in order to prevent and treat malnutrition in elderly people. Background: Incidence of cancer increases with age. In older cancer patients, important information may be missed without a Comprehensive Geriatric Assessment (CGA). A validated screening instrument is needed to identify patients for whom a CGA would be beneficial. G8 is a screening tool (8 questions) for older cancer patients in need of a CGA, it explores functional, cognitive, nutritional status and it takes 5 minutes; a score of ≤14 is considered abnormal. Objectives: To test the performance of the G8 ≤14 in older patients with solid cancer; to identify those who would benefit from a nutritional support when a reduced MNA in the Mini Nutritional Assessment in the CGA was found. Methods: Between January and April 2015, G8 was performed in 488 consecutive patients aged ≥70 years diagnosed with solid cancer at Vito Fazzi Hospital for a total of 963 G8. The G8 was administered 3 times in 78 patients and in 54 with G8 score <14, CGA (including MNA) were completed. MNA involves anthropometric measurements, global assessment, dietary questionnaire, a subjective assessment and it enables a subject to be categorized as normal (adequate nutrition), borderline (risk of malnutrition) or undernutrition. MNA is an 18-item questionnaire comprising anthropometric measurements (BMI, mid-arm/calf circumference, weight loss) combined with a questionnaire regarding dietary intake (number of meals consumed, food-fluid intake, feeding autonomy), a global assessment (lifestyle, medication, mobility, acute stress presence, presence of dementia/depression) and a self-assessment (self-perception of health and nutrition). Patients aged 70 years or older treated with chemotherapy for solid tumor and at risk of malnutrition (MNA) received Nutritional Advice. Results: 54 patients with 76 years median age were included; 31,4% (N = 17) had an abnormal MNA <24, risk factor of malnutrition (5 female, 12 male) for each of them Clinical Nutrition Unit adopted an individualized nutrition program with oral nutritional supplements (ready-made liquids) or in 2 patients parenteral nutrition. In these patients there was an improvement of the G8 due to the increase of the MNA to start the chemotherapy. Conclusion: G8 can be used in order to identify those patients who would benefit from a CGA and those who have a malnutrition risk. The results show that it is important to implement and develop strategies for individual nutritional care, in order to prevent and treat malnutrition in elderly people.

1601 The multicenter, prospective observational study of the 5-HT3 receptor antagonist and dexamethasone as prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in moderately emetic chemotherapy (MEC) for solid tumors

1601 The multicenter, prospective observational study of the 5-HT3 receptor antagonist and dexamethasone as prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in moderately emetic chemotherapy (MEC) for solid tumors

Chemotherapy in the oldest old: The feasibility of delivering cytotoxic therapy to patients 80 years old and older.

Cancer is predominantly a disease of the elderly. While "older" patients are frequently considered for chemotherapy, little data exist in the population 80 years and older (80+). We investigated outcomes of patients 80+ who received chemotherapy at our institution. A retrospective chart review of patients 80+ initiating chemotherapy for malignant solid tumors from 2005 to 2010 was performed. Baseline demographics, cancer type and chemotherapy data were collected. Primary outcome was the rate of discontinuation due to toxicity. Secondary outcomes included the rate of dose reduction/omission/delay (ROD), hospitalization and blood transfusion. Chemotherapy was initiated in 318 patients. Baseline demographics included the following: median age 82 years (80-92 years), 56% male, 55% ECOG PS 0-1, 43% Charlson index score of 0-1; 38% were taking ≥ 6 prescription medications. Common malignancies were colorectal (32%), lung (20%), and breast (12%). Most patients (68%) had metastatic disease or received palliative intent therapy (71%). Treatment was first line in 89% of patients, and an up front dose reduction was ordered in 41%. Toxicity caused therapy discontinuation in 32% of cases, while 52% experienced dose ROD. Hospitalization occurred in 32%; 18% required blood transfusions. Baseline polypharmacy was associated with increased hospitalization risk (OR 2.28, 95% CI 1.34-3.88, p=0.002), but dose adjustments were not correlated with any outcome. In this study, we observed a high risk of hospitalization or treatment discontinuation due to toxicity, despite frequent dose modifications. As the cancer population ages, validated tools are needed to better select patients for therapy.