bluuebunny/crossref_metadata_2025 huggingface dataset:
Epoetin beta treatment of chemotherapy induced anemia in cancer patients: Results of a large prospective cohort study
Authors: Ray-Coquard I. , Tourani J. , Facon T. , Haïoun C. , Audhuy B. , Mathoulin-Pelissier S. , Ollivier C. , Barbaza M. , Bergougnoux L. , Jenabian A.
Published: March 2020

19582

Background: The efficacy of epoetin beta (E) is well documented in clinical trials in anemic cancer patients (pts). This study was conducted to assess E use, efficacy, safety and effect on quality of life in cancer pts, in usual practice. Methods: This prospective, multicenter, longitudinal, observational French study assessed a 4-month follow-up of informed consent cancer pts (including both solid tumors (ST) and hematological malignancies (H)) treated with E for chemotherapy-related anemia. Data were collected between January 2005 and March 2006. Results: Among 3100 pts enrolled by 423 specialists, 2810 were analysed. Pts’ characteristics were: mean age 63±13 yrs, male 50%, performance status 0 (13%), 1 (46%), =2 (41%). 74% of pts suffered from a ST and 26% from a H. The most frequent cancer types were lung (22%), breast (15%), non-Hodgkin lymphoma (12%), colon (9%), multiple myeloma (7%), ovary (7%), prostate (3%), head and neck (3%) and chronic lymphocytic leukemia (3%). The mean time from diagnosis to inclusion was 2 yrs. 52% of pts received their first line of chemotherapy, 25% their second one. 55% and 10% of ST and H pts received platinum based regimen, respectively. At inclusion, hemoglobin levels were distributed as follows: < 9 g/dl (ST 14%, H 32%), [9–11 [g/dl (ST 70%, H 56%), [11–13 [g/dl (ST 16%, H 11%). Regarding pre-treatment biological tests, endogenous erythropoietin rate was controlled for only 3% of pts (ST 1% and H 7%, median 37 IU/ml [0; 388]), ferritin was available for 15% of pts (ST 11% and H 28%), transferrin saturation for 12% of pts (ST 10% and H 17%) and reticulocytes for 11% of pts (ST 7% and H 24%). At initiation, pts received a median dose of 30000 U/week of E on a once weekly regimen schedule for 98% of pts. E was associated with iron supplementation in 49% and 13% of ST and H pts, and with blood transfusion in 5% and 15% of ST and H pts. Conclusion: These preliminary results describe baseline characteristics of cancer patients treated with epoetin beta. The study suggests very few biological controls before initiation of E in routine practice. Final analyses of hemoglobin evolution and quality of life will be presented.

[Table: see text]
How much cost can one patient bear? The influence of income and education on drug purchasing decisions in Hong Kong Chinese cancer patients
Authors: Chan T. , Chan S. , Poon Y. , Fok J. , Epstein J. , Mak J. , Epstein R.
Published: March 2020

19584

Background: Inflation of anticancer drug prices is a growing problem worldwide. This problem is especially challenging in Asia, where rising healthcare expectations clash with low incomes and weak insurance. To clarify the factors influencing drug purchasing decisions in this context, we conducted a survey of Hong Kong oncology patients. Methods: A questionnaire was designed to assess the effect of cost on purchasing decisions relating to drug variables such as (1) efficacy, (2) tolerability, (3) convenience, (4) safety, (5) novelty and (6) reliability. Validation of the original 33-part survey resulted in a final set of 21 questions that was administered to 51 oncology patients. These respondents were characterised in terms of age, household income, insurance, educational level, family circumstances, occupation, ethnicity, religious beliefs, prognosis, and co-morbidity. Results: Most respondents were Hong Kong (68.8%), mainland Chinese (18.8%) or Caucasian (10.4%). There was a strong correlation between household income and education. Patients from middle-income (US$7,000–14,000 per month) households were most influenced in their decisions by costs and insurance rebates, whereas those from low-income households (less than US$3,000 per month) were keenest to purchase expensive medications, whether Western or traditional Chinese remedies. Demand for drug safety was cost-inelastic across all income groups, independent of gains in efficacy. Even when free treatment was offered, therapeutic uncertainties (e.g., early-phase drugs or randomization) proved unpopular with all income groups. Only the most affluent and well-educated patients valued overall survival above disease-free survival in making decisions, suggesting that less educated cohorts did not understand these concepts. Conclusion: These data suggest that low-income cancer patients and their families may have unrealistic expectations of high-priced medications, based either on misunderstanding or cultural pressures. Greater educational efforts targeting this large population sector may be needed to avoid worsening dissatisfaction and social unrest in the future.

No significant financial relationships to disclose.
Initiating epoetin-alpha (EPO) 120,000 units (U) every three weeks (Q3W) in patients with chemotherapy (CT)-induced anemia (CIA) and a hemoglobin (Hb) of <11 g/dL
Authors: Wilhelm F. E. , Charu V. , Glaspy J. , Moyo V. , Kamin M.
Published: March 2020

19589

Background: Reported here are the final Hb results for the group of patients enrolled under an amendment to a larger study that was the first to compare early vs standard intervention with EPO 120,000 U Q3W in patients with CIA and Hb of 11 to 12 g/dL. The amendment allowed for treatment of patients who had a Hb value <11g/dL at screening. Methods: The larger study was a 16-week open-label randomized study that enrolled patients with non-myeloid malignancy, baseline (BL) Hb =11.0 and =12.0 g/dL, and CT planned for =9 weeks. Patients were randomized (1:1) to receive EPO 120,000 U subcutaneously Q3W immediately (early intervention group, EIG) or when their Hb fell to <11.0 g/dL (standard intervention group, SIG). If, at any dosing visit after the first EPO dose, Hb decreased to <10.0 g/dL, patients were switched to EPO 40,000 U weekly (QW). An amendment was added to the larger study to allow similar patients whose Hb was <11 g/dL at screening to be treated with EPO 120,000 U Q3W. EPO was withheld for Hb >13.0 g/dL at any dosing visit; dose was reduced for Hb >12.0 g/dL or Hb increase >1.5 g/dL in a 3-week period (current prescribing information recommends target Hb not to exceed 12 g/dL). Hb response was analyzed using an observed case approach and Hb data following switch to 40,000 U QW were censored. Results: Fifty patients were enrolled under the amendment. BL characteristics were: mean age, 62.0 years; 67% female; mean Hb 10.1 g/dL. Mean Hb changes over time from BL for patients receiving Q3W dosing are shown in the table . PRBC transfusion rate after 4 weeks on treatment was 24.5%. 18.0% of patients had at least one dose withheld and 22.0% had at least one dose reduction. Five deaths and 6 clinically relevant TVEs were reported. Conclusions: This study shows that EPO is effective in raising Hb when initiated in patients with CIA and a Hb of <11 g/dL at 120,000 U every 3 weeks. Further studies are warranted.

No significant financial relationships to disclose.

[Table: see text]
An attempt to correlate “comprehensive geriatric assessment” (CGA), treatment assignment and clinical outcome in elderly cancer patients: Results of a phase II open study
Authors: Mantovani G. , Massa E. , Astara G. , Madeddu C. , Tanca F. M. , Sanna E. , Spiga C. , Deiana L.
Published: March 2020

19592

Background and Methods: The design was a prospective Phase II open study. Elderly (age =65 years) cancer patients (pts) of different sites were assigned to 3 different CGA categories: “fit”, “intermediate” and “frail”. Therefore, an appropriate treatment was administered and the clinical outcome was assessed. “Fit” pts were assigned standard chemotherapy, “intermediate” pts tailored (chemo-) therapy, “frail” pts monochemotherapy (as “supportive” therapy) or only “supportive care”. The primary endpoint of the study was to correlate CGA with treatment and clinical outcome which was based on: objective clinical response (RECIST), ECOG PS, toxicity (NCI CTC v.3), survival. Patients who completed at least 3 months of treatment were evaluable. At December 2006, 136 pts were enrolled; 114 (mean age 73.6 years) 104 of whom stage IV were evaluable: 36 “fit”, 36 “intermediate” and 42 “frail”. At baseline no difference was found between the CGA categories as for clinical characteristics (M/F ratio, stage, tumor site) except for ECOG PS which was significantly higher in frail pts (ANOVA test). Results: At 3 months the objective clinical response to the assigned treatment was: 9 CR, 9 PR, 13 SD and 5 PD for “fit” pts; 9 PR, 14 SD and 13 PD for “intermediate” pts; 6 PR, 11 SD and 25 PD for “frail” pts. As for the correlation of CGA categories with treatment and clinical outcome: a significantly higher OR, particularly CR, in favor of fit pts was observed, ECOG PS was maintained significantly higher in frail pts, toxicity was the highest in intermediate pts, the dose intensity was highest in fit pts. At the multivariate regression analisys the independent predictive factors for the clinical response were initial CGA and dose intensity. Conclusions: The study confirms: 1) Fit pts should be treated with the most active regimens not differently from adult pts; 2) the “intermediate” group should be probably better assessed as for inclusion criteria; 3) frail pts need a more exhaustive assessment of the quality of life currently not included in the CGA. In conclusion, the CGA assessment is strongly recommended as an essential tool for the clinical evaluation of elderly pts. Large prospective clinical trials in this field are awaited.

No significant financial relationships to disclose.
Mitomycin C in combination with capecitabine (Mi-Cap) as chemotherapy in breast cancer patients with extensive liver metastases and impaired hepatic function: A non-randomized multicentre phase II study
Authors: Loibl S. , Schmidt M. , Marquardt F. , Huober J. , Bischoff J. , von Minckwitz G. , Mehta K. M. , Kaufmann M.
Published: March 2020

19597

Background: Breast cancer patients with an impaired liver function due to liver metastases have very limited, evidence based treatment options. Based on our experience with mitomycin C, 5Fu and folinate (Loibl et al. 2004), we wanted to improve this schedule by including the oral antimetabolite capecitabine. Methods: Breast cancer patients (pts) with liver metastases and elevated liver enzymes defined as AST/ALT = 3×UNL (group A) or liver enzymes = 1.5×UNL and AP = 3×UNL (group B) were enrolled. Further inclusion criteria were as follows: bidimensionally measurable disease, normal hematological values (WBCs = 3×109/L; platelets = 100×109/L; hemoglobin = 10 g/dL), normal renal function. A three weekly cycle with Mitomycin C 8 mg/m2 i.v. on day 1, capecitabine 2,000 mg/m2 day 1–14 and prednison 5 mg day 1–5 orally was given. Primary endpoint is the progression free survival (PFS) measured from the planned 44 eligible patients who received at least one cycle of Mi-Cap. Results: Between April 2004 and December 2006, 35 patients with a median age of 57.1 years (range, 39–76) were enrolled. 29 pts. received an adjuvant or neoadjuvant chemotherapy of whom 20 received anthracyclines and 6 a taxane containing regimen. 9 pts. had no chemotherapy for metastatic disease and 9 pts. had 3 or more chemotherapies for metastatic disease. At the start of chemotherapy 24 pts belonged to group A and 11 to group B and 12 pts had hyperbilirubinemia. 20 pts had liver involvement only. So far 109 cycles had been given. 29 pts. received more than one cycle, 6 pts. received the 6 preplanned cycles so far. Myelosuppression and hand foot syndrome are the most frequent toxicities. 4 patients had a documented partial remission, 18 patients had stable disease or are still under treatment, and 13 patients progressed during treatment. The median time to progression is 6.4 months in all patients who received at least one cycle. The median overall survival for the total population was 8.3 months. Conclusion: Mi-Cap can be safely given. Initial observations show that pts with a decrease in liver enzymes or bilirubin in the first two cycles had a longer PFS.

No significant financial relationships to disclose.
Protective effects of Aloe barbadensis and Myracrodruon urundeuva on 5-fluorouracil-induced oral mucositis in hamsters
Authors: Sant'ana R. O. , Fonseca S. G. , Diogenes C. B. , Macedo R. N. , Alexandre A. , Brito G. C. , Ribeiro R. A.
Published: March 2020

19606

Introduction: Oral mucositis (OM) is a frequent dose-limiting and costly complication of antineoplastic chemotherapy. It's caractherized by ulcerative lesions and cause pain, restrict food and fluids oral intake and substancial risk for sepsis. In severe cases, hospitalization, parenteral nutrition and opiode analgesics are required. Objectives: Evaluate the effects of extracts of two herbal medicines, Aloe barbadensis Miller (Ab) and Myracrodruon urundeuva Allemão (Mu) on 5-fluorouracil-induced OM in hamsters. To evaluate the possible mecanisms by the extracts act, it was performed analysis of intensity of activity of myeloperoxidase (MPO) and analysis of immunohistochemistry for TNFa e iNOS in the mucosa specimes. Methods: Golden siriam hamsters were submitted to intra- peritoneal 60 and 40 mg/Kg injections of 5-fluorouracil (5-FU) in day 1 and 2, respectively. On day 4, animals were submitted to anaesthesia, followed by mecanic trauma with needle to potenciate the effect of 5-FU. After that, the mucosas were treated with topical gel containing Mu extract at 5, 10 or 20%, Ab extract at 25, 50 or 100% (experimental groups) or carbapol gel (control group). The treatments above were mantained twice daily until day 9. On day 10 the animals were sacrified. Diferent parameters were evaluated: macroscopic and microscopic scores of OM, body mass variation and immunohistochemistry for TNFa e iNOS. Results: Mu significantly inhibited macroscopic oral mucositis at 5 and 10% concentrations (5% Mu - Md 2; 10% Mu - Md 3; control - Md 4, p < 0,01). Ab also inhibited OM (25% Ab - Md 1; 50% Ab - Md 1,5; 100% Ab - Md 1; control - Md 4, p < 0,001). These results were confirmed by histological analysis (5% Mu - Md 1,5; 10% Mu - Md 1; 25% Ab - Md 1; 50% Ab - Md 1,5; 100% Ab - Md 1; control - Md 2, p < 0,01). MPO activity was significantly decreased by Mu and Ab compared to control animals. Both Mu and Ab decreased expression of TNFa e iNOS on tissue. It was observed a decrease on ponderal lost in experimental groups. Conclusions: Myracrodruon urundeuva and Aloe barbadensis cause important inhbitory effects in oral mucositis 5-FU induced probably by their antiinflamatory properties.

No significant financial relationships to disclose.
Clinical research of the malignant hydrothorax or hydroperitoneum treated with intracavitary chemotherapy and local thermotherapy
Authors: Song H. , Chen l. , Wang J. , Chu X. , Zhang Q. , Geng H.
Published: March 2020

19615

Background: Malignant hydrothorax or hydroperitoneum are common complications of the cancer. Pure chemotherapy couldn’t get good effect. We combined intracavitary chemotherapy with local thermotherapy to cure malignant hydrothorax or hydroperitoneum. In order to observe the recent effects and toxicity of thermochemotherapy and evaluate the change of the immunologic function, and to investigate the mechanism of thermochemotherapy. Methods: Fifty-two patients were treated with weekly intracavitary chemotherapy, and then combined with local thermotherapy twice a week. As the control, another fifty patients received weekly intracavitary chemotherapy. Treated for two weeks and rest for one week, and then observed the recent effects and toxicity. Test the level of the T cell subset, NK cells and VEGF in serum and effusion Results: Overall response rate of the malignant hydrothorax was 86.9% vs 60.0% (P<0.05), Overall response rate of the malignant hydroperitoneum was 79.3% vs 46.7% (P <0.01).The incidence of myelosuppression was 7.7% vs 24% (P<0.05). After thermochemotherapy, the ratio of CD4/CD8 rose significantly (P<0.01), but the ratio of NK cells decreased significantly (P<0.05) in malignant hydrothorax or hydroperitoneum. While in peripheral blood, all the ratio of CD3, CD4, CD8, CD4/CD8 and NK cells rose significantly (P<0.05). Meanwhile the level of VEGF decreased significantly (P<0.05) whether in effusion or blood. Conclusions: Combined intracavitary chemotherapy with local thermotherapy could control the malignant hydrothorax and hydroperitoneum effectively with less-toxicity. The cellular immune function was elevated and the neovascularization of tumor was probablely inhibited.

No significant financial relationships to disclose.
Clinical analysis of multiple primary cancers
Authors: Lee K. , Jang H. , Choi M. , Kong J. , Lee S. , Kwon J. , Nam E. , Mun Y. , Seong C. , Lee S.
Published: March 2020

19639

Background: Multiple primary cancers are defined as two or more abnormal growths of tissue occurring simultaneously or abnormal growths of tissues that follow a previous neoplasm but are not metastases of the latter in the same individual. The primary objective of this study was to determine the occurrence, clinical characteristics and prognosis of multiple primary cancers in single institution, respectively. Methods: Between January 1995 and June 2006, patients with multiple primary cancers were selected from a review of patients who had been treated and followed-up in our Ewha Womans University Hospital. Demographic data were obtained from medical records. Results: Two hundred seven patients were selected and patients with multiple primary cancers constituted 1.95% of all malignancies. Male to female ratio was 1.84. (male 134 vs. female 73 patients) The median age first cancer diagnosis was 67 years old in male, 57 in female. The incidence of synchronous cancers is higher than metachronous. (108 vs. 99) and the median time to additional cancers in metachronous group was 35 months. The most frequent cancers was gastrointestinal cancers in both sex synchronously and metachronously. In male, colorectal cancer followed by gastric cancer methchronously (9.1%), genitourinary cancer with another genitourinary cancer synchronously (12.7%) were frequently observed. In female, breast cancer followed by colorectal cancer metachronously (6.8%), gastric cancer with colorectal cancer (6.9%) were frequently observed. The median survival duration was 14.4 months totally from the index diagnosis and synchronous cancers showed lower survival duration than metachronous cancers. (7.4 vs. 26.1 months, p=0.017) Conclusions: Adequate investigations including G-I tract should focus in the first 3 years after initial diagnosis to detect second primary cancers earlier.

No significant financial relationships to disclose.
Pattern of malignancies in geriatric patients
Authors: Maddali L. S. , Maddali S.
Published: March 2020

19650

Background: Information regarding pattern of malignancies in geriatric patients in India is not readily available. Methods: Between 1st January 1999 and 31st December 2006 we encountered 832 geriatric patients among a total of 3748 cases. Analysis was done with respect to age, sex and disease. Results: Geriatric patients constituted 832/3748 (22.20%) of our work load. Males 432 (51.92%) Females 400 (48.08%). Hematologic malignancies 214 (25.72%) Solid tumors 618 (74.28%). male preponderance in Hematologic malignancies 141/214 (66.89%); female preponderance in solid tumors 327/618 (52.91%). Top 7 malignancies: Males (432)-NSCLC 60 (13.89%) Prostate 57 (13.19%) NHL 48 (11.11%) Myeloma 39 (9.03%) CLL 31 (7.18%) HNSCC 30 (6.94%) Colon 26 (6.02%); Females (400)- Breast 147 (36.75%) Ovary 50 (12.50%) Uterus 44 (11.00%) NHL 25 (6.25%) Colon 20 (5.00%) NSCLC 11 (2.75%) CML 10 (2.50%). Age groups: (65–70) yrs-517 (62.13%) males 254, females 263; (71–80) yrs-264 (31.73%) males 152 females 112; (81–90) yrs-48 (5.78%) males 24, females 24; >91yrs-3 (0.36%) males 2 female 1. Top 5 malignancies in each age & sex group: Males, (65–70) yrs, 254: NSCLC 39 NHL 30 Prostate 29 Myeloma 24 Colon 19; (71–80) yrs, 152: Prostate 20 NSCLC 19 NHL 17 CLL 15 HNSCC 14; (81–90) yrs, 24: Prostate 7 Myeloma 2 CLL 2 CML 2 AML 2; Females, (65–70) yrs, 263: Breast 99 Ovary 37 Uterus 30 colon 13 NHL 13; (71–80) yrs, 112: Breast 41 Ovary 12 NHL 11 Uterus 10 CLL 9; (81–90) yrs, 24: Breast 7 Uterus 4 CLL 2 Renal cell carcinoma 2 Ovary 1. Conclusions: Solid tumors are the predominant malignancies in geriatric patients 618/832 (74.28%). B Cell neoplasms constitute bulk of the hematologic neoplasms 173/214 (80.84%). Sarcomas are uncommon 20/832 (2.40%). Important solid tumors: Prostate, NSCLC, Colon and HNSCC in males; Breast, Ovary, Uterus and colon in females. Age group (65–70) yrs is the major group 517/832 (62.13%) followed by significant age group (71–80) yrs 264/832 (31.73%). It is imperative to employ curative strategies for malignancies in this ever expanding population.

No significant financial relationships to disclose.
An assessment of cancer-related fatigue in patients (pts) with chemotherapy-induced anaemia (CIA) treated with darbepoetin alfa (DA): Comparison of two quality of life (QoL) questionnaires
Authors: Esquerdo G. , Llorca C. , Cervera J. , Juarez A. , Orts D. , Carrato A.
Published: March 2020

19654

Background: CIA is often associated with debilitating fatigue and reduced QoL. DA can effectively treat CIA when administered once every 3 weeks (Q3W).This study aims to compare the psychometrics of the Functional Assessment of Cancer Therapy Fatigue Subscale (FACT-F) and The Fatigue Symptom Inventory (FSI) in CIA pts treated with DA Q3W. Methods: Longitudinal single- centre prospective study in adult pts with solid tumours undergoing chemotherapy (CT) and with mild to moderate cancer-related fatigue (CRF) (Visual Analogue Scale (VAS) =30 mm). Pts with haemoglobin (HB) levels <11 g/dL were treated with DA 500 mcg Q3W. Key clinical parameters, FACT-F, and FSI measurements were collected at the beginning and end of the CT treatment period. Psychometric indicators for reliability and validity were calculated. Results: A preliminary analysis was conducted in 58 pts: mean age, 61.3 years (SD 12.3), 51.7% women, 25.9% with breast cancer, 91.4% ECOG 0–1, 69.0% IV stage, 63% had no prior CT. At baseline, the mean CRF score by VAS was 58.8 mm (SD 19.4) and the mean Hb was 10.2 g/dL (SD 0.7). Median CT duration was 15.1 weeks (range, 3.3 - 25.7) and all pts received DA treatment during CT (median duration of CT, 6.6 wks [range, 0 - 19]). The median number of DA doses administered was 3 (range, 1–7). The rate of hematopoietic response (Hb ≥ 12 g/dL or Hb rise from baseline ≥ 2 g/dL) was 69.0%. FACT-F and FIS scores improved by 5.6 and 13.0 points respectively during CT. Consistency (Cronbach alpha coefficient - CA) was high and similar for both questionnaires (FACT-F=0.98; FSI=0.97). Conclusions: Both the FACT-F and FIS QoL questionnaires measured a change in fatigue during the study with high and similar consistency. DA administered at a fixed dose of 500 mcg Q3W seems to be effective in clinical practice.

No significant financial relationships to disclose.
Impact of radiotherapy on quality of life in elder women with localized breast cancer. A prospective study
Authors: Arraras J. I. , Arias F. , Manterola A. , Dominguez M. A. , Villafranca E. , Martinez E. , Illarramendi J. J. , Salgado E. , Vera R.
Published: March 2020

19656

Background: the aims of the present study was to evaluate the impact of the radiotherapy in the Quality of Life (QL) in a sample of breast cancer elder patients with localized stages. Methods: The sample size was previously calculated using the program GRANMO 5.2 (Power O.8, a=0.01). During 2005, forty eight patients aged 65 years and older, stages I to III who started radiotherapy with or without hormonetherapy, have filled in the EORTC QLQ-C30 and QLQ-BR23 Quality of Life questionnaires three times: prior, end, and six weeks after the radiotherapy. Demographic data, performance status (Karnfosky scale), Daily Living Activities (DLA) with the IDDD scale, toxicity (CTC v2.0), co-morbidity and other clinical data have also been recorded Statistical analysis: Quality of Life and DLA scores, changes in them among the three assessments (Friedman, with Wilcoxon and Bonferroni criteria) have been calculated. Results: Quality of Life and DLA scores have been high in most dimensions in the three measurements. Moderate limitations (>30 points) have appeared in global Quality of Life, future worries, sexuality scales in the three measurements, and insomnia in the second. There are no significant differences in QL scores between the first and third measurements. In the second measurement there are moderate worsening (between 10 and 20 points) in fatigue, pain and breast symptoms and little (<10) in role, that have recovered in the third measurement. There has also been improvements between the second and third measurement in arm symptoms and global QL. No changes in DLA among the three measurements. Conclusions: Quality of Life in the elder patients has been good and the treatment adequately tolerated. Limited changes have appeared in treatment related areas that have recovered after a short follow-up period. Age should not be the only factor to consider when deciding the treatment protocol to administer. It would be desirable to confirm our results with a bigger sample.

No significant financial relationships to disclose.
Benefit of oncologist and geriatrician collaboration in the management of digestive cancer in elderly patients
Authors: Cudennec T. , Mitry E. , Moulias S. , Lepere C. , Lievre A. , Teillet L. , Rougier P.
Published: March 2020

19667

Background: A standardized geriatric evaluation is essential for the multidisciplinary discussion of elderly patients with gastrointestinal cancer. A geriatric as well as an oncological evaluation are mandatory to offer to these patients the best therapeutic option and improve their prognosis as well as their quality of life. A Geriatric Intervention Team (GIT) composed by nurses and geriatrician is working in our hospital. One of its function is to evaluate elderly patients with digestive neoplasms in collaboration with the Digestive Oncology unit (DOU). Methods: The Mini Mental State Examination, the mini-Geriatric Depression Scale and the Get up and go timed test were used for the geriatric evaluation. Results: GIT was solicited for 124 pts over a 3-year period. Their mean age was 79,1 ± 6,3 years old (65 to 96), 45% were men. The neoplasic localizations were: colorectal (53%), pancreatic (17%), esophagus (11%), hepatic carcinoma (7%) and other (12%). There was a clear prevalence of cognitive disorders identified by the Folstein MMSE. Among 65 workable files (complete MMSE), 61% of the patients had an abnormal (< 26). The observation of a time and/or space disorientation was noticed in 30% of the cases. The mini-GDS used to detect depression, was positive in 43% of the evaluations. The Timed Get Up and Go Test was used to evaluate the walking capacity self-sufficiency and the risk of falls. It was superior to 20 seconds in 40% of cases. For 77 geriatrics evaluation, the GIT was solicited before the decision of the best treatment to choose. In this population, we can clearly identify 3 clusters of patients: well-matched patients (34%) who received chimiotherapy; intermediate patients (26%) who needed a new geriatric assessment before decision; and frailed patients (40%) who received only palliative treatment. In the second group, after geriatrician intervention, 60% of patients finally received a chemotherapy. Conclusions: These results show the benefit of a close collaboration between geriatricians and oncologist. In the daily management of elderly patients, alteration are at least detected in 55% of patients by geriatric assessment. Moreover, the GIT is allow to securely classify the patients between the 3 categories and help to decision in the intermediate group.

No significant financial relationships to disclose.
“Was it worth it?” A pilot study of advanced cancer patients’ retrospective perceptions of benefit from phase I trial participation
Authors: Bruce J. Y. , Hlubocky F. J. , Daugherty C. K.
Published: March 2020

19670

Background: Subjects who enroll in phase I cancer trials generally are those with advanced and terminal disease. Although all such patients (pts) undergo an informed consent process, there is evidence that these pts may not appreciate the primary aims of a phase I trial and have unrealistic expectations of therapeutic benefit. However, these perceptions of benefit have not been described in pts after trial enrollment. Methods: As a pilot study, pts previously enrolled on Phase I trials were interviewed regarding their retrospective perceptions of benefit. A total of 9 pts have been interviewed to date: median age: 72 yr (range: 59–82 yr); 55% male; 77% Caucasian. The interview included open-ended questions assessing patient experiences with the trial, including reasons for enrollment, impressions of quality of life, costs incurred, and other benefits. Pts’ qualitative responses were recorded and analyzed for content and themes. Results: Reasons for enrollment included hope, prior treatment failure, altruism, and family influence. Described perceptions of anticipated benefit included stabilization of disease and close monitoring of their disease. Unexpected costs involved time spent during clinic visits, financial costs, time taken off work by family members, time spent away from family, and additional trial procedures. Issues of quality of life revolved around side effects from the investigational agent. Many interviewed pts (44%) described improved quality of life off the trial as compared to during trial participation. The majority of interviewed pts (67%) believed that the trial had no effect on their survival. Conclusions: Our data suggest that pts’ perceptions of therapeutic benefit after trial enrollment may be different from pre-enrollment expectations. There would also appear to be potentially significant and otherwise undescribed out-of-pocket expenses incurred by subjects as a result of phase I enrollment. Further research is needed to examine how side effects, unexpected costs, and lack of improved survival contribute to these pts’ perceptions of trial benefit.

No significant financial relationships to disclose.
Deep venous thrombosis and cancer (about 68 cases)
Authors: Tahri A. , El Hattaoui M. , Charei N. , El Belghiti M. , Mahmal L. , Tahiri F. , Bouras N.
Published: March 2020

19672

Background: The association between cancer and deep venous thrombosis (DVT) has been known for a century. The goal of this retrospective study is to evaluate the risk factors and the characteristics of patients presenting with a DVT to determine the interest of a malignancy work up. Methods: This is a monocentric retrospective study of 405 DVT’s ± pulmonary embolism reported between January 2003 and July 2006, confirmed by sonogram and spiral CT. The risk factors for the embolic events as well as the diagnosis work up done to determine the origin of the embolism were analyzed. Results: In our population the mean age was 50 years, 300 patients (74 %) presented with at least one risk factor for thrombosis event, 68 cases were found to have a malignancy (16.8%) from which 9 were occult malignancies (found among 109 cases of idiopathic DVT’s).The mean age of the patients diagnosed with cancer was significantly higher with a female predominance. These malignancies were distributed as follow: 50% gynecologic origin, 25% gastrointestinal, 10% pulmonary, 9 % urologic and 6% of hematologic origin. The risk factors identified were: Surgery (OR = 4) and Chemotherapy (OR=6). The occult malignancies were mentioned during the encounter with 6 patients. The physical exam, abdomino-pelvic sonograms were sufficient for the etiologic diagnosis in 8 cases. Other exams like (tumor markers, gastrointestinal endoscopies) were non contributive, a part of the clinical orientation they provided. Conclusions: DVT’s do occur more frequently in operated cancer patients or those who received chemotherapy. The malignancies are more frequently of gynecologic or gastrointestinal origin. It appears that an extensive diagnosis work up is not cost effective, a basic work up including: a thorough history, a complete physical exam, simple blood tests (inflammatory markers and CBC) as well as a abdomino-pelvic sonogram are sufficient for the screening of a malignancy, extensive work up should be done as a second option.

No significant financial relationships to disclose.
Malignancies masquarading as psoas abscesses: An unusual presentation in a developing country
Authors: Singh H. , Chawla S. , Joshi A. J. , Marwaha D. , Saggar R. R. , Joshi M. A.
Published: March 2020

19675

Background: Psoas abscess is regarded as a rare disease in medical literature, more so as primary presentation of malignancy or its recurrence. We describe a series of 10 cancer patients who presented with psoas abscess seen in a 18 month period at a large tertiary care cancer hospital in northern India. They were subsequently diagnosed as having malignancy or recurrence of a past malignancy. Methods: A retrospective study of cancer patients who presented with psoas abscess was undertaken. We reviewed clinical data from patients who presented in the period from April 2005 to December 2006 at the Patel Cancer & Superspeciality hospital, Jalandhar, India. Results: In this period 10 cases of cancer met the diagnosis of psoas abscess at presentation. The average age was 51 years (range 20 to 85) with a male female ratio of 4:1. In 7 patients psoas abscess was the presentation at initial diagnosis while in 3 patients it was the presentation of recurrence/relapse. None of the patients had any predisposing conditions like IV drug use, diabetes mellitus, hematoma or HIV positivity.. Majority (7/10) of primary tumors were genito- urinary cancers (Renal - 2, Ureter - 1, Cervix - 1, Prostate - 1, Dysgerminoma - 1, Penis-1) while 3 were of unknown origin. Squamous cell carcinoma was the commonest histology (4/10), followed by metastatic adenocarcinoma (3/10). Majority of the abscess were left sided (7/10) corresponding to the side of primary lesion. Under lying destruction of iliac bone with metastasis was found in only 2 patients. Most of the patients (9/10) responded poorly to treatment ie chemotherapy and radiotherapy, all of them dying of disease progression within a year. Conclusions: Psoas abscess can be a rare presentation of intra abdominal malignancy. Pre disposing factors may not necessarily be present. Genito-urinary malignancies should be kept in the differential diagnosis of unexplained psoas abscesses. Development of psoas abscess does not always signify metastatic disease but portends a poor prognosis to treatment.

No significant financial relationships to disclose.
A pilot study of myeloablative (MA) autologous stem Cell (Auto SCT) followed by reduced intensity (RI) allogeneic transplantation (AlloSCT) in children with relapsed/refractory(R/R) Hodgkin’s disease (HD)
Authors: Bradley M. , Baldinger L. , Bhatia M. , Garvin J. , George D. , Roman E. , Satwani P. , Martin P. L. , Kurtzberg J. , Cairo M. S.
Published: March 2020

20007

Background: Allo SCT may benefit patients with R/R HD by providing a graft vs lymphoma effect. Peggs et al (Lancet 2005) demonstrated durable engraftment and reduced non relapse mortality (NRM) in HD pts post RI Allo SCT. Carella et al (JCO2000) and Gutman et al (BMT2005) demonstrated the success of MA Auto SCT followed by RI AlloSCT in adults with refractory lymphoma. We investigated the feasibility of MA Auto SCT followed by RI Allo SCT in children with R/R HD. Methods: MA conditioning prior to AutoSCT was CTX 1,500 mg/m2 x 4 d, BCNU 100 mg/m2 x 3d, VP-16 800 mg/m2 x 3d. AlloSCT conditioning was fludarabine 30 mg/m2 x 5d, busulfan 3.2 mg/kg x 2d, and R ATG 2 mg/kg x 4d (unrel. donor). CD20+ patients received rituximab (375 mg/m2/wk x4) and all pts received involved field radiotherapy (IFRT). Results: Ten pts have enrolled, 2 pts did not proceed (parental withdrawal) to RI AlloSCT (Donors: 1 MRD, 2 MUD, 5 UCB). Median time to RI AlloSCT after MA Auto SCT was 142 d (97–219). The median cell dose was 3.43 x 107 TNC/kg for UCB grafts (n=5). Engraftment was achieved at a median of 20.5 d for PMN and 46.5 d for PLT. Donor chimerism reached ≥ 95% in all pts by day 100 with a median follow up of 703d (128–2025). Toxicities were grade (3) hematuria (n=1), (3–4) infection (n=7), (4) pulmonary fibrosis (n=1), (4) hearing loss (n=1), (4) neurotoxicity (n=1). GVHD: grade II-III aGVHD (3/8), cGVHD (3/8). Six patients are alive and NED post allo SCT. There has been one NRM (cGVHD) and one relapse mortality. The OS at one year is 66.7%. Conclusions: MA AutoSCT followed by RI AlloSCT is feasible and well tolerated in pediatric pts with R/R HD. A larger study with longer follow up is required to determine if this approach will reduce relapse, long term toxicity and/or improve survival.

No significant financial relationships to disclose.
Advances in management of childhood acute leukemia (AML, ALL): Experience at a developing country, National Guard hospital, western region of Kingdom of Saudi Arabia
Authors: Khattab T. M. , Atra A. A. , Felimban S. K. , Fryer C.
Published: March 2020

20020

Background: The outcome of children with acute myeloid leukemia (AML) has improved over last two decades. The main factors behind this are increasing intensity of chemotherapy and improved measures of supportive care. While white blood cell count and age are major factors for risk classification in childhood acute lymphoblastic leukemia (ALL), therapy remains the single most prognostic factor. Objectives: To assess survival with each regimen of chemotherapy and causes of treatment failure. Methods: we retrospectively reviewed the details of treatment and outcome of all children with AML from 1986- 2005 (20 yr.) and ALL from 1989–2003 (15yr.) at King Abdulaziz Medical City, Jeddah, Saudi Arabia. Results: AML 54 patients, 23 boys with median age 5 yr. (range 0.5–14 yr.). Five (9%) had CNS leukemia. Between 1986–1995, 22 pts were treated with BFM based chemotherapy, remaining 32 received UK-AML 10 between 1996–2005. 8/22 (36%) & 5/32 (16%) died of toxicity and 12 (54%) and 8 (25%) died of AML during 1st & 2nd era respectively. With a median follow up of 3 year (.5–10 yr.). The overall survival is 9% in 1st era and 59% in 2nd era. ALL 297 patients were registered. Male 165 pts., median age 5 yr. (range 1–14), WBCs >50,000x109, 55 pts. (19%). T-cell 36 (12%), pre-B 222 (75%) and 29 (10%) unknown. NCI risk classification according to age & WBCs count at presentation as HR 84 (28%), SR 204 (69%). Causes of death; 50/297 (17%) disease recurrence which failed 2nd line chemotherapy, 12/297 (4%) induction death and 11/297 (4%) died of toxicity. Survival by different regimens of chemotherapy were showing UKALL-X 1989–1993, 67 pts.as 55%; UKALL-XI/BFM (1994–1998) 98 pts. As 72%; MRC-97/CCG1991 (1999–2003) 132 pts.87% as overall 5 yr survival. Conclusions: This single center study confirmed that the outcome of children with AML/ALL has improved over last decade. Increasing local experience, advances in supportive care and chemotherapy have contributed to this improvement.

No significant financial relationships to disclose.
Contemporary patients with hemophagocytic lymphohistiocytosis: An institutional experience
Authors: Niece J. A. , Ahmad N. , Rogers Z. R.
Published: March 2020

20022

Background: Hemophagocytic lymphohistiocytosis (HLH) is a rare and complex disease whose treatment has improved in the last decade. We report a single institutional experience with HLH to investigate current survival and prognostic significance of common clinical markers at presentation. Methods: Institutional hematology/oncology and pathology databases were searched to identify patients newly diagnosed with HLH, malignant histocytosis or hemophagocytic syndrome from 1995–2006. Patients meeting HLH 2004 diagnostic criteria: fever, cytopenias of >2 cell lines, hypofibrinogenemia, splenomegaly, elevated ferritin, triglycerides, abnormal natural killer cell function and/or soluble interleukin (IL) 2 receptor were included. Labs, age, ethnicity, treatment and outcome were recorded. Univariate analyses were performed. Results: Nine patients (6 female, 3 male) met inclusion criteria. The median age at diagnosis was 3 yrs (range 9 mo-17 yrs). Five patients (56%) were of Hispanic ethnicity. Acute EBV infection was identified in 7 pts (78%) and CMV in 1 (11%). Diagnostic labs revealed median platelet count of 22,000/mm3, hyperbilirubinemia in 7 pts median 7.0 mg/dl, and ALT/AST elevation with median 241/180 U/L. Ferritin elevation and hypofibrinogenemia were prominent in all patients with a median ferritin of 9,092 ng/ml (range 345–130,334) and fibrinogen of 96 mg/ml. Soluble IL-2 receptor was markedly elevated; median 6,403 U/ml (range 4551–27,469). Pts were treated as per HLH 1994 or 2004, with a combination of steroids, IVIG, cyclosporine and VP16. At median follow-up of 12 mo (range 2–49) 8 pts are alive: 4 CR (1 after BMT), 4 PR clinically well with abnormal labs. Death from invasive Rhizopus infection during immunosuppressive therapy in 1. There were no predictive variables for survival identified. Conclusion: The 88% survival of these patients treated with modern HLH therapy significantly exceeds the 55% in prior reports. The large proportion of patients of Hispanic ethnicity distinguishes this from prior series. Whether this ethnic difference accounts for improved survival will need to be studied in larger population. HLH is no longer uniformly fatal, and should be actively sought in critically ill children.

No significant financial relationships to disclose.
Optic pathway gliomas in children: A single institution study
Authors: Kebudi R. , Ayrancı O. , Tuncer S. , Ayan I. , Peksayar G. , Gorgun O. , Darendeliler E.
Published: March 2020

20024

Background: Optic pathway gliomas (OPG) constitute 1–5% of childhood brain tumors, they can occur in patients with NF1. The aim of this study is to evaluate our patients with OPG through a 16 year period. Methods: We reviewed the medical records of 22 patiens treated between Dec. 1990- Dec. 2006. Results: 12 girls and 10 boys (6 mo-19 yrs, median 5yrs) were diagnosed with OPG. 13 patients had NF1.Two had diencephalic syndrome. In 10 the tumor extended to the hypothalamus.Two had leptomeningeal disease, both died despite therapy.Median follow up was 56 months (6–147 mo). 3 patients had stable disease and were followed without treatment, 6 underwent surgery (4 total tumor resection, 2 ventriculoperitoneal shunt; 5 had no additional therapy). 2 patients (14 and 19 years old ) were treated with radiotherapy and 12 (6 mo-9 yrs) received chemotherapy. 3 patients, with stable disease, remained stable. 4 patients, who had total tumor resection, an one with VPS were followed more than 26 months. In two patients , treated with radiotherapy because of progressive disease, clinical response was attained and remained stable. 12 patients recieved chemotherapy, 11 had vincristine 1.5 mg/m2 and carboplatinum 560 mg/m2 in one day every 28 days. Of these 11 patients, 10 patients had clinical response/stable disease after chemotherapy, 1 died of progressive disease. Two patients had hypersensitivity to carboplatinum after 8 courses. There were no other major side effects of treatment. In a patient who had vincristine, CCNU,CTX and PCZ, 7 months after achievement of stable disease with chemotherapy, progressive disease occured, and died. Conclusion: OPG are rare childhood central nervous system tumors. The rarity ot these tumors and their variable course make assesment and standardization of treatment methods difficult. Conservative management can be suggested for asymptomatic or stable cases. Based on the primary location of the tumor and age of the patient; surgery, radiotherapy and chemotherapy can be used as a single treatment modality or in combination. Treatment should be planned on an individual basis. In young children with progressive disease chemotherapy with vincristine, carboplatinum once a month seems to be effective and provides a good quality of life during treatment.

No significant financial relationships to disclose.
Three years experience of infantile Wilms tumour at a single institute in a developing country
Authors: Patel A. A. , Patel K. M. , Shah S. A. , Shah P. M. , Shukla S. N. , Parikh B. J. , Anand A. S. , Talati S. S. , Srivastav R. K. , Kattimani K. A.
Published: March 2020

20028

Background: Wilms tumor (nephroblastoma) is the second most common malignant retroperitoneal tumor. It is the most common primary renal tumour of childhood and is a paradigm for multimodal treatment of a pediatric malignant solid tumor. The median age at diagnosis is 4 years and it is uncommon in infancy. We present a three year retrospective analysis of Wilms tumor in infants treated at out institute. Methods: A total of 16 cases of Wilms tumor were diagnosed in pediatric patients aged one and below between January 2003 to December 2005. Out of these, 11 patients were evaluable. All of them were given treatment as per the National Wilms Tumor Study- 5 protocol. Results: The median age of presentation was 10.8 months, one child was 5 months old rest all were between 10 and 12 months. The male to female ratio was 2.3:1. The most common presenting complaint was mass per abdomen, which was seen in 10 patients, one patient presented with pain in abdomen and hematuria. None of the patients had evidence of any other systemic involvement. 7 patients were in Stage I, 2 each were in stage II and stage III. Triphasic classical type (favorable) was the histopathological subtype in 9 patients and 2 had unfavorable histopathological subtypes. All the 10 cases underwent total Nephrectomy [three at our institute and the rest elsewhere] of the diseased kidney followed by treatment as per the National Wilms Tumor Study- 5 protocol with 50% dose reduction. 7 cases (70%) showed complete remission and presently are under observation. Three cases were lost to follow up after surgery. One patient with stage three disease was given anterior chemotherapy but was lost to follow up after 9 weeks of chemotherapy. Conclusion: Wilms tumor presenting in infancy when treated appropriately has a good outcome although not as good as in older children.

No significant financial relationships to disclose.