bluuebunny/crossref_metadata_2025 huggingface dataset:
Potential of COX-2 inhibitors in lowering chemotherapy-induced neutropenia: Results from a randomized trial
Authors: Chow L. W. , Yip A. Y. , Lam C. , Toi M.
Published: March 2020

19509

Background: This study was to evaluate the effect of celecoxib on the regimen 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) combination, followed by docetaxel in neoadjuvant setting. Patients and Methods: Twenty-three female patients with operable breast cancer were randomized into two groups: group A (n=12), four cycles of FEC (500 mg/m2, 100 mg/m2, 500 mg/m2) followed by four cycles of docetaxel (100 mg/m2) with concurrent celecoxib (400 mg twice daily); group B (n=11), same chemotherapy regimen but without concurrent celecoxib. These combined chemotherapies were administered 3-weekly. Results: 22 (96%) patients completed all cycles except that one (4%) omitted the fourth cycle of FEC owing to repeated incidences of febrile neutropenia. Received dose intensity (RDI) of group A and B for FEC (90% vs. 80%, p=0.035) and docetaxel (93% vs. 96%, p=0.414) showed significant difference in first four cycles of FEC between groups. Limiting hematological toxicity, severe neutropenia including febrile neutropenia, was significantly different between group A and B (33.3% vs 90.9%, p=0.005) during the first four cycles of FEC. Other toxicities commonly observed in chemotherapy receiving patients were manageable. Conclusion: Neoadjuvant use of FEC followed by docetaxel with concurrent celecoxib is safe for treatment of operable invasive breast cancer. COX-2 inhibitor likely lowers the incidence of chemotherapy-induced neutropenia. We believe that further investigation might provide more evidence on the use of COX-2 inhibitors in breast cancer.

No significant financial relationships to disclose.
XELOX regimen in elderly patients with metastatic colorectal cancer (MCRC), a FNCLCC French Collaborative Group GERICO 02 phase II study
Authors: Viret F. , Bugat R. , Ducreux M. , Cvitkovic F. , Carola E. , Gisselbrecht M. , Esterni B. , Gouttenoire F. , Rousseau F.
Published: March 2020

19513

Background: Xelox regimen is an active combination in 1st line MCRC. In elderly patients, independence measured by the 6-items Activity of Daily Living Katz scale (ADL) determines whether an elderly can eventually live alone. We wanted to evaluate, the impact of Xelox regimen on independence of elderly patients measured by ADL after 3 and 6 cycles (CY), the response rate and safety profile. Methods: Elderly patients above 70 with histological proven MCRC were treated with an adapted XELOX regimen capecitabine (CPT) 750 mg/m2 orally bid d1–14 + oxaliplatin (OXP) 90 mg/m2 iv d1,q3w). After 3 CY with no significant toxicity, OXP and CPT were increased to 120 mg/m2 iv d1 and 1,000 mg/m2 bid d1–14 respectively. Results: 60 patients were enrolled at 6 centers over 36 months, of the 53 analyzed to date: M/F, 30/23, median age 78 years, Karnofsky index 80, 88.68% patients had comorbidity. Metastatic sites were liver (70.59%), lung (43.14%) and bone (9.8%). 39 % of patients (20) stopped treatment prematurely: progressive disease (6), toxicity (11), patients wish (3). Median ADL baseline was high (5.5; 1.5–6). Primary endpoint was achieved: after 3 CY 32/35 (91%) had no ADL decrease (median 6; 3.5–6) and unilateral Wilcoxon tested on paired data showed ADL improvement (p=0.0001). After 6 CY, 96% of patients had no ADL decrease. Median number of CY administered was 6 (1–6) with 88.24% of patients received ≥ 3 cycles. The dose of chemotherapy OXP and/or CPT was increased in 31.6 % of the elderly patients. Efficacy analysis: 1 patient achieved CR, 19 PR, 11 SD, 11 PD, 9 NE. Toxicity was moderated: diarrhea (g3/4: 13%), neurotoxicity (g1/2: 67%, g3/4: 2%), hand-foot syndrome (g1/2:19%, g3/4: 0%) and haematological (g3/4: 12%). Conclusions: This study shows that Xelox regimen does not impair independence measured by ADL in MCRC elderly patients. It is also a safe, well tolerated (in 1st line treatment) and active regimen in this population of patients.

[Table: see text]
Chemotherapy administration associated errors before and after use of electronic order entry and decision support
Authors: Kirlin D. L. , DeVoe M. G. , Brennan L. V. , Drosick D. R. , Essell J. H. , Hawley D. K. , Bowman R. M. , Heaton D. , Neuss M. N. , Guo J. J.
Published: March 2020

19528

Chemotherapy Administration Associated Errors Before and After Use of Electronic Order Entry and Decision Support Background: Chemotherapy administration is an important part of oncology practice and as treatment plans have evolved, their complexity has increased. Our practice has developed a software program that incorporates decision support and safety checks. Here we report the errors we have noted before and after utilization of this system. Methods: Drug administration errors are tracked through a mandatory “incident report” process that requires staff to report whenever an error is recognized. All reports from 2003 (the year before utilization of the chemotherapy software) and 2006 were reviewed. We compared the number and type of errors from the two time periods. Results: • Statistically significant *increase or † decrease at alpha level 0.05. • 1rate is expressed per 100,000 treatments • 2 “Other” errors are those which could not be classified otherwise and had no impact on the patient Conclusions: The frequency of recognized errors associated with chemotherapy administration is very low (0.03%) and while still unacceptable, much lower than the 5% reported for medication administration in general. (Kaushal, Arch Int Med 163:1409 2003) A computerized software support system did not make a statistically significant change in the total frequency of administration errors but did significantly decrease wrong drug errors even as the complexity of treatment protocols increased. A class of error “Planned Drug Missed” was recognized because of a formal declaration of treatment plan. There may be significant reporting bias consequent to increased recognition and subsequent reporting of errors when a computerized system and formal declaration of treatment plan is in place. However, no matter the system, the human/computer interface remains a potential source of error.

[Table: see text]

No significant financial relationships to disclose.
Patients with breast cancer feel empowered by their participation in online support groups
Authors: Smit W. M. , van Uden-Kraan C. F. , Drossaert C. H. , Seydel E. R. , Taal E. , van de Laar M. A.
Published: March 2020

19544

Background: People often join support groups when they find themselves in stressful circumstances such as serious health conditions. With the increase in the availability and popularity of the Internet, the opportunity to join support groups online has arisen. Ever since the rise of online support groups, much is expected of the potential empowering effect of taking part in these groups for patients. However, thus far, there is no direct evidence. Therefore the purpose of this study was to explore if and how people with breast cancer feel empowered by their participation in online support groups and which processes that take place in online support groups contribute to these outcomes. Methods: We have sent a posting with a link to an online survey to 7 online support groups for patients with breast cancer. In total 214 participants responded to the request to fill in the survey. Results: The majority of the respondents were women (n=211). The mean age of the respondents was 46 years (SD 8.9 years). The respondents were diagnosed 3 years ago on average, with a range of 0 to 15 years. The respondents felt empowered in several ways by their participation. First of all, most respondents (74%) felt better informed. They indicated that as a result of their participation, they had received adequate information to deal with their disease (60%). Additionally, most participants felt more confident in the relation with their physician. The participants indicated that they knew better which questions to ask their physician (69%) and that they felt better prepared for a consult with their physician (61%). For some of the respondents, participation in an online support group enabled easier acceptation of the disease (48%) and helped them to “open up” about their disease (49%). The main processes that contributed to these outcomes were: exchanging information, comparing with other participants and encountering social support. Conclusions: This study suggests that participation in online support groups can make a valuable contribution to the emergence of empowered patients, who set their own health agendas and who take control of their own health status, as is deemed necessary in the current transformation towards a modern health care consumer model.

No significant financial relationships to disclose.
Relationship between fatigue and cytokine levels in patients age 50+ with acute myeloid leukemia (AML)
Authors: Panju A. , Kelvin D. , Minden M. D. , Alibhai S. M.
Published: March 2020

19566

Background: Fatigue is the most common and disabling symptom affecting patients with AML; effective prevention or treatment measures have yet to be found. Cytokines, biological markers of inflammation, may represent a major cause of fatigue, but published data are limited. Methods: Patients age 50 or older with AML were recruited between May and September 2006. All patients were fluent in English, within one year of diagnosis, and free of any other active malignancy. Fatigue was measured using the Functional Assessment of Cancer Therapy (FACT) Fatigue subscale, a single-item global fatigue scale, and the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30. Blood was simultaneously drawn for quantitative measurement of a panel of 13 cytokines. Repeat measurements were done 4–6 weeks later. Correlational analysis was used to examine relationships between individual cytokines and fatigue scores. Changes in fatigue scores between time points were correlated with changes in cytokine levels. Results: 34 patients (23 men; 11 women) were enrolled (mean age 67 y; range 52–84). 27% had not started chemotherapy or were receiving best supportive care, while the rest were undergoing active chemotherapy. At baseline, a weak correlation (r=0.332, p=0.059) was seen with interleukin (IL)-6 and at least one fatigue measure. No correlations (r<0.30) were observed with any of the other cytokines (interferon (IFN)-?, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IP-10, MCP-1, MiG, and tumor necrosis factor-a) and any fatigue measure. Follow-up data were available for 29 patients. A statistically significant correlation with fatigue was seen with IL-2 (r=0.407, p=0.032), and clinically-important correlations that did not achieve conventional statistical significance were seen with IFN-? (r=0.331, p=0.085), IL-5 (r=0.344, p=0.073), and IL-10 (r=0.326, p=0.091). Conclusions: Based on these data, the most promising cytokine-fatigue relationship was noted with IL-2. However, IFN-?, IL-5, IL-6, and IL-10 also showed potentially important relationships with fatigue. Given our small sample size and patient enrolment at differing time points during their treatment course, further controlled studies are warranted.

No significant financial relationships to disclose.
Chemotherapy in non-selected elderly patients: Factors influencing dose-intensity and toxicity
Authors: Lemare F. , Mateus C. , Camps S. , Montheil V. , Henguelle E. , Cacheux W. , Bezian E. , Di Loreto R. , Dauphin A. , Goldwasser F.
Published: March 2020

19585

Background: Chemotherapy (CT) is the treatment of choice for most metastatic cancers. Frequent functional impairment and comorbidities in the elderly increase the risk of chemotherapy-related acute complications. The applicability of clinical trials data to the elderly population is exposed to multiple bias. Informations extracted from non-selected treated patients (pts) may be useful. Methods: A serie of consecutive elderly cancer pts (>73 years) treated over 3 years in the oncology outpatient unit, and receiving CT were included for analysis and assessed using prechemotherapy evaluation of cancer in the elderly (including performance status, comorbidities, glomerular filtration rate, liver tests, hemogram, nutritional status, inflammation tests). Relationship between preCT evaluation and acute complications, unscheduled hospitalisation, mortality were investigated by univariate analyses. Comparison between planned and realised dose- intensity of CT protocols could be extracted for the CT prescription software. Results: 108 pts with a median age of 78 years (73- 89; 44% over 80) were identified. Characteristics included performance status (PS) ≥ 2 (44%), chronic renal insufficiency (47%) ; ≥2 comorbidities (75%). Primary tumour was urologic (31%), gastro-intestinal (29%), mammary and gynaecologic (20%); pulmonary (16%) or other (4%). Disease stage was metastatic for 82% of pts. Most CT regimens contained a platinum derivative (55%), gemcitabine (25%), 5-FU (20%), taxanes (17%), vinorelbine (15%). Transfusion requirements were higher in PS≥2 pts (p<0.0001). Febrile neutropenia correlated with PS, lymphocytopenia and PINI =(CRP×AAG)/(albumin×pre-albumin)>10 (p<0. 05). Unscheduled hospitalisation correlated with PS, lymphocytopenia, PINI, more than 2 co-morbidities, more than 4 co-medications. Oxaliplatin- and paclitaxel-containing CT protocols were associated with significant reduction of dose-intensity because of reduced number of cycles due to neurosensory toxicity (p=0.01). Conclusions: Lymphocytopenia, PS, and PINI were the most relevant prognosticators of short-term CT outcome. Elderly pts characteristics are associated with higher risk of acute toxicity and increased sensitivity to neurosensory cumulative toxicity.

No significant financial relationships to disclose.
Comparison between gemcitabine-based combination (G) and single-agent chemotherapy (S) for elderly patients (EP) with advanced non-small cell lung cancer (NSCLC): A literature-based meta-analysis
Authors: Carreca I. , Bellomo F. , Bronte G. , Burgio M. , Carreca A. , Piazza D. , Rizzo S. , Russo S. , Balducci L.
Published: March 2020

19586

Background: It was estimated that a quarter of all patients who have a diagnosis of NSCLC worldwide are more than 70 years old. This meta-analysis tries to shed light on the controversial results of phase III trials evaluating in NSCLC EP doublets against third generation S. Methods: We performed a literature search using MEDLINE and Cochrane Library. We selected only clinical trials responding to the question of our meta-analysis. Outcomes recorded were 1-year survival rate (1-y SR), overall response rate (ORR) and haematological toxicity (HT). Fixed-effects and random-effects models were used to calculate pooled odds ratios (OR). An OR greater than 1 indicates that doublet is more effective for 1-y SR and ORR and more toxic for HT. Results: Three published randomized controlled phase III trials (SICOG 9909; MILES; AISCAP-SICOG) were selected yielding a total of 1082 patients (G: 426; S: 655) clustered in seven comparisons. Drugs delivered to randomized patients included gemcitabine, vinorelbine and paclitaxel. EP treated with doublets showed respect to control patients a pooled estimate for 1-y SR advantage of 36%, not statistically significant (OR=1.356; 95% CI=0.925–1.990; p>0.05). The pooled estimate for ORR advantage was 57% and statistically significant (OR=1.559; 95% CI=1.220–2.015; p<0.05). However G showed not significant difference for HT (OR=1.168; 95% CI=0.685–1.992; p>0.05). Conclusions: These data confirm in EP superior efficacy and equal tolerability of G in comparison with S previously demonstrated for adult patients. Anyway G seems to not change prognosis of NSCLC EP. It is worthy to note that all the trials analysed showed some biases: early closure of the study, second-line therapy or crossover, lower dosage of drugs in combination regimen, inclusion of unfit or strongly comorbid patients. This meta-analysis doesn’t solve troubles in decision-making of treatment for EP, but suggest to design a better phase III trial including more patients and improving accrual criteria for reducing biases. An indication of a potentially active combination regimen (gemcitabine + paclitaxel) is suggested in SICOG 9909 trial.

No significant financial relationships to disclose.
Polymicrobial bloodstream infections (PBI): An under-realized complication in patients with cancer (2005–2006)
Authors: Safdar A. , Rodriguez G. H. , Raval D. S. , Bodey G. P. , Rolston K. V.
Published: March 2020

19590

Background: Little attention has been directed to PBI in cancer patients. Methods: Fifty-four PBI episodes were evaluated retrospectively in 51 patients after obtaining IRB approval. PBI was defined as ≥ 2 organisms isolated from a single blood culture or sample(s) obtained within 72 hrs after the initial positive culture. All values are given as median ± s.d. Results: The age was 57 ± 16 years. Thirty-four patients had hematologic malignancy of whom, 73% had acute leukemia. Nearly half (47%) of the patients had refractory or relapsed cancer. Thirty-two (63%) were neutropenic (ANC 0 ± 144 cells/UL) and 31 patients (61%) had lymphocytopenia (ALC 0 ± 86 cells/UL). At the time of infection diagnosis, APACHE II score was 16 ± 5 and 5 (10%) patients were receiving systemic corticosteroids (> 600 mg prednisone equivalent dose). Thirty-one PBI episodes (57%) occurred while patients were receiving systemic antimicrobial agents for prophylaxis or treatment. In 83% of PBI episodes, positive specimens were collected from central venous catheter (CVC). Catheter-related infection necessitating CVC removal occurred in nearly half of these cases (24/45). Twenty-two (41%) PBI episodes were associated with high bacterial load (> 100 CFU/ml). The overall response to treatment was 86%. In 39 of 42 episodes (77%) treated with concordant antimicrobial therapy infection resolved. Whereas, in only 5 episodes (9%) treated with discordant antimicrobial therapy, infection resolution occurred (P = 0.07). There were no differences in PBI outcomes in patients with hematologic malignancies vs. solid-organ cancers, patients > 50 years vs. < 50 years of age or among neutropenic patients who had recovery of neutropenia during infection episode vs. patients in whom neutropenia persisted. Conclusions: The overall high response of concordant antimicrobial therapy for even high-risk cancer patients with PBI looks encouraging.

No significant financial relationships to disclose.

[Table: see text]
Quality of life: An independent prognostic variable in a general population of cancer patients receiving chemotherapy
Authors: Grutsch J. F. , Gupta D. , Granick J. , Wodek T. , Lis C. G.
Published: March 2020

19596

Background: It is uncertain whether the current Quality of Life (QL) instruments can facilitate clinical decision-making in oncology. Since the most important outcome in oncology is survival, we investigated QL domains from 2 contrasting QL instruments, EORTC QLQ-C30 and the Quality of Life Index (QLI) to determine if these instruments can partition a heterogeneous population of cancer patients into distinct prognostic groupings. Methods: 1,200 patients consented to participate in Cancer Treatment Center of America's QL program between Mar ‘01 and May ’05. We identified 494 deaths in this group. Most common tumors were breast (n=319), colon (n=159), and lung (n=209). Among 434 patients undergoing definitive treatment 159 had stage 4 and 49 had stage 3 disease, the other patients had failed definitive therapy. The median survival was 39 weeks for newly diagnosed patients and 29.9 weeks for patients with recurrent disease. We used cutpoint analysis using statistical strength of association with QL scores to determine the association between QL score and survival. This information was then used in a recursive partitioning analysis to group our cancer patient population into mutually exclusive prognostic groups. Results: We found several QL domains had a non-linear relationship with survival, which indicates that a relatively small change in QL score could result in a large change in survival. QLI Health/Functioning domain, had the strongest association with survival. Subsequent iterations of the recursive partitioning found that a combination of clinical and QL domain scores partitioned the patient population into distinct groups, whose median survival ranged from 13–100 weeks. Patients with the best prognosis had high QLI health satisfaction scores health and had hormonally dependent tumors. The patients with the poorest survival had intermediate QLI health satisfaction scores, poor appetite, and poor emotional function. Conclusion: This retrospective analysis found specific combination of QL domains and scores that partitioned patients with advanced cancer into distinct prognostic groupings. This analysis indicates that our current instruments have the potential to be developed into tools that could facilitate clinical decision-making.

No significant financial relationships to disclose.
Palliative percutaneous nephrostomy in recurrent cervical cancer: Retrospective analysis of 50 consecutive cases
Authors: Pinto C. S. , Small I. A. , Ferreira C. G. , Dienstmann R.
Published: March 2020

19609

Background: Cervical cancer is a public health problem in Brazil, with annual incidence rates of 20 to 40 cases/ 100.000 women. Most patients with recurrent disease have local symptoms and develop renal failure. There are no clear guidelines to predict which patients in palliative care derive benefit from percutaneous nephrostomy (PN) in terms of survival and quality of life. This study aims to evaluate the outcome of patients with recurrent cervical cancer in palliative care submitted to PN and thereby identify those who can potentially benefit from this intervention. Methods: Retrospective chart review of all patients assisted in the Palliative Care Unit of Brazilian National Cancer Institute from January 2002 to October 2006 and submitted to PN. Results: Fifty patients received unilateral PN. Median age was 44 years (26 - 67). All patients were previously treated with radiotherapy with or without chemotherapy and brachytherapy. At relapse, 50 presented with locally advanced disease and 7 also had metastatic disease. Twenty-four patients (49%) had improvement of uremic symptoms and/ or lumbar pain after PN and seven (14%) in Performance Status (PS). Median creatinine levels before and after PN were 6.4 and 3.7 mg/dl, respectively (p < 0.05). Twenty-five patients (50%) had improvement in renal function. Until December 2006, 49 patients have died. Median overall survival after PN was 9.1 weeks (95% CI: 8.0 - 10.2). Median survival was 10 weeks (9.0 - 11.0) in 40 patients with baseline PS 1 - 3 and 1.7 weeks (0 - 3.7) in 10 patients with PS 4 (log rank, p = 0.04). Median survival in patients with and without improvement of renal function after PN was 10.7 weeks (8.6 - 12.8) and 8.1 weeks (4.8 - 11.5), respectively (log rank, p = 0.02). Twenty-nine patients (58%) died due to renal failure. Complications of PN were mainly urinary tract infection (n: 10), catheter loss (n: 9) and bleeding (n: 1). Conclusions: These data suggest that PN can be of clinical benefit for patients with recurrent cervical cancer and PS 1 to 3, but not PS 4. In fact, improvement of renal function after PN did prolong survival. Complications of PN are frequent and most patients still die in renal failure. However, our data indicate that carefully selected patients can derive benefit from this procedure.

No significant financial relationships to disclose.
Docetaxel and fluid retention: Use of single-dose dexamethasone
Authors: Montoya M. E. , Markowitz A. B. , Klementich F. , Palacio D.
Published: March 2020

19635

Background: Docetaxel (T) is generally well tolerated but fluid retention has been reported following therapy. This can be prevented with dexamethasone (D) but dexamethasone has its own side effects. Methods: Retrospective IRB-approved review of adult patients (pts) treated with T between March 2003 and February 2006 receiving single dose D prior to T. End point was development of fluid retention: edema, weight gain and/or pleural effusion (measured by Common Toxicity Criteria). Pts with congestive hearth failure, renal failure, chronic edema or on diuretics were excluded. Prostate cancer was excluded because chemotherapy included daily prednisone Results: 94 charts were reviewed; 64 pts included. Total T dose ranged from 80 to 1,350 mg/m2 and pretreatment D dose from 8 to 20 mg. See table 1 for demographics and reason for patient exclusion. Edema developed in 7 pts (10.9 %); arms and legs were affected equally. Only 2 pts with edema had weight gain (less than grade III). Including these 2 pts weight gain developed in 5 pts: 3 grade I and 2 grade II (3.1 %). New pleural effusions occurred in 3 pts. All were asymptomatic and none required management. Effusions were small or moderate as confirmed by radiology review. 4 pts had pretreatment pleural effusions. These either became smaller or resolved after T. Conclusions: The incidence of moderate fluid retention (measured by weight gain) with single dose D was lower (3.1 %) compared with published data (6% with 3 days of D). Development of pleural effusions was infrequent and not clinically significant. Single dose D prior to T is recommended to avoid hypersensitivity reactions.

No significant financial relationships to disclose.

[Table: see text]
Incidence of febrile neutropenia (FN) is not altered by the day of administration of pegfilgrastim (PEG)
Authors: Athar U. , Rajan A. , Gajra A. , Lynch T. P.
Published: March 2020

19636

Background: Chemotherapy induced neutropenia can significantly increase patient morbidity and mortality and decrease the efficacy of treatment either due to a decrease in dose density and/or dose intensity of chemotherapy. Based on small studies in breast cancer and Non-Hodgkin's Lymphoma (NHL) there is concern regarding increased risk of FN if PEG is used on the same day as chemotherapy rather than 24 hours later. In our predominantly rural elderly patient population an extra visit to the infusion area can contribute to poor compliance. Hence we retrospectively analyzed patients treated at the Syracuse VA medical center who received PEG with chemotherapy to ascertain if differences existed in the incidence of FN. Methods: All patients who received PEG with cytotoxic chemotherapy between August 2002 and July 2006 were identified from hospital pharmacy records. We analyzed this population for cancer diagnosis, type and number of chemotherapy cycles, comorbidities (diabetes and COPD), use of prior or concurrent radiation, incidence of febrile neutropenia and the day of administration of PEG (Day 1 or Day >1 defined as administration of PEG 24 hours or more after chemotherapy). Results: A total of 64 patients were identified and PEG was administered with a total of 212 cycles. The mean age of our patients was 70 years and 66 (97%) were males. The most common diagnoses were NHL (42 %), small cell lung cancer (18%) and non-small cell lung cancer (14 %). Other diagnoses included Hodgkin's disease, carcinoma of unknown primary and multiple myeloma (4% each). Comorbidities included diabetes mellitus and COPD (31% each). A total of 17 patients (27%) received prior or concurrent radiation therapy. PEG was given on Day 1 with 112 cycles (53%) and on Day >1 with 100 cycles (47%) of chemotherapy. FN developed with 5 of 112 (4.5%) cycles when PEG was given on day 1 and 5 of 100 (5%) cycles when given on Day > 1. Conclusions: In this single institution, retrospective cohort of patients the timing of PEG administration (day 1 or > 1) did not affect the incidence of FN. If confirmed in larger prospective series, then current guidelines may be altered to include PEG administration on the day of chemotherapy as an acceptable standard. This would enhance patient comfort and may improve compliance with PEG therapy.

No significant financial relationships to disclose.
Effect of melatonin on taxane-induced neuropathy in breast cancer patients
Authors: Sweany S. , Lafollette J. , Pruemer J. , Swango M. , Clark M. , Wainino A. , Nahleh Z.
Published: March 2020

19640

Background: Neurotoxicity caused by taxane chemotherapies(CT) can be dose limiting and can cause a decrease in quality of life. Melatonin has been evaluated for its use in decreasing adverse reactions of CT. Preclinical data suggests that melatonin has neuroprotective capability. The objective of this study is to determine if melatonin will decrease the incidence and severity of taxane-related neuropathy. Methods: Fifty patients beginning CT for any stage of breast cancer with paclitaxel, albumin-bound paclitaxel, or docetaxel will be enrolled. Patients should have no underlying neuropathy. Melatonin is given at 21 mg at bedtime on Day 1 and continued for 28 days after the last taxane dose. Every 28 days, neuropathy is assessed using the NCI-CTC 3.0 scale and possible side effects of melatonin are evaluated. Quality of life (QOL) is analyzed using the FACT-Taxane QOL assessment. Outcomes analyzed included the incidence and severity of neuropathy, and changes in QOL. Results: Currently 17 patients have been enrolled with 12 having completed taxaneCT and melatonin. Five have withdrawn due to non-medical reasons and were evaluated for toxicities. The mean age is 49 years (range 36–67 years). The end of study FACT-Taxane score was available for 11 of the 12 patients, with an average score of 135 (range 106–168). The average baseline QOL score was 131 (range 99–148). The average change in QOL score was +4. Eleven have completed paclitaxel with an average dose of 862 mg/m2 (range 525–1620 mg/m2). One patient received docetaxel t 450 mg/m2. Five patients self- reported adverse effects including night-time sedation (2), hot flashes (1), headache (1), constipation (1), nail darkening (1), and fatigue (1). Neuropathy distribution was as follows : 50 % (6) of patients had grade 0, 33% (4) grade 1, and 16% (2) grade 2 neuropathy. The mean change in neuropathy score was +0.67. Conclusion: Melatonin appears promising as a neuroprotective agent in patients receiving taxane-based chemotherapy. No patient developed grade 3 or 4 neuropathy compared to historical controls of 22–33%. Fifty percent of patients treated with melatonin while on taxane CT developed no neuropathy, and those who did, had grade 1 or 2 neuropathy.QOL was maintained. Melatonin's neuroprotective effect should be further evaluated.

No significant financial relationships to disclose.
Sexual dysfunction in patients with cancer
Authors: Colmano C. M. Bonini , Molnar S. , Salvano L. M. , Barrios G. Molina , Arevalo M. , Di Marco P. , Rizzi M. L. , Dubersarsky C. , Lavarda M. , Jarchum G. D.
Published: March 2020

19653

Background: Malignant diseases have a strong influence in quality of life, being sexuality one of the most affected variables. The objetive is to determine the prevalence of sexual dysfunction in a cohort of patients with cancer and its relationship with the following: pain, fatigue, nausea, vomiting, mechanisms of adaptation to stress, anxiety and depression. Methods: Anonymous questionnaires were used, including: treatment, adverse events, Zimong and Snaith depression and anxiety scale, sexual dysfunction questionnaire, coping strategies of Tobin David, Hopwood body image scale and the analogical visual test for pain evaluation. Results: Between January and August 2006, sixty four patients were evaluated; 72% were women; median age: 50 years old. Libido was absent in 50%; this was associated with gender (better in men; p=0,05) and the presence of pain (p=0,05) and fatigue (p=0,05) but not with age. All patients who had intact libido also had arousal and orgasms; this was more prevalent in men than in women and in subjects younger than 60 years. Arousal was absent in 47% of cases. Forty four percent of men had erectile dysfunction; this was present in all patients older than 60 years. Frequency of intercourses was decreased in 75%. Fifty eight percent of patients said that their sexuality was better before the diagnosis of their disease. Interestingly, 85% didn’t talk to their doctors about their sexual problems. Conclusions: One out of 2 patients had sexual dysfunction, predominantly women. Sexuality was affected mainly by pain and fatigue. Although normal libido was present in all ages, subjects older than 60 years had less arousal and orgasms.

No significant financial relationships to disclose.
SF-36 quality of life questionaire evaluation in a large cohort of women with breast cancer treated with hormonotherapy
Authors: Morgenfeld E. L. , Rolnik B. , Cassab L. , Gercovich D. , Negro F. , Calarame J. C. , Tognelli F. , Rivarola E. , Deza E. Gil , Gercovich F. G.
Published: March 2020

19657

Background: Hormonotherapy (H) is the most widely used treatment against breast cancer (BC). The aim of this study is a prospective evaluation with an enriched the SF-36 questionnaire, of the QOL of BC patients (pt) treated with H at the IOHM. Specific questions regarding menopausal symptoms and body weight were added. Methods: Between Aug 2005 and Nov 2006, all pt that were undergoing H, were requested to fill out a SF-36 self-evaluation form. The SF-36 is a multi-purpose, short-form health survey, with 36 questions about functional health and well-being. The answers were tabulated. The pre-treatment and post-treatment body weight of each pt was registered. Results: Three Hundred and Twenty-six pt were invited to participate, and all of them accepted, and signed a consent form. Characteristics of the population: Diagnosis: DCIS: 36 pt; LCIS: 5 pt; IDC 250 pt; ILC: 35 pt. All cases expressed hormonal receptors. The H was adjuvant in 254 pt (78%) mostly treated with T and palliative in 72 pt (22%) mostly treated with AI. Median age was 62 years, however 63 pt (19%) were pre-menopausal. The median time under treatment was 33 months (range 1–71 m). The pt reported: General evaluation of Quality of life: Very good or excellent: 154 pt (47%) , Good: 134 pt (41%), Poor: 34 pt (11%). Severe limitations for demanding physical activities: 43 pt (13 %). A reduction of time spent on the job: 66 pt (22%). Severe pain during the last four weeks prior to answering the questionnaire: 24 pt (8 %). Weight increase perception: 153 pt (47%). Actual increase of weight: 192 pt (60%) (Median: 4 kg). Menopausal symptoms: Daily Hot Flushes: 132 pt (40%). Vaginal discharge 110 pt (33%) Decrease of libido: 98 pt (30%), Vaginal dryness 76 pt (23%), Nightly sweats: 40 pt (12%). Sixty pt (18%) suffered from and received treatment for menopausal symptoms. Conclusions: 1) The SF-36 is a useful tool to measure the BC patients’ quality of life 2) Although in our cohort most of the patients (88,3%) rated their general QOL as “good to very good”, a third of the pt presented severe menopausal symptoms, and 18% received non hormonal medication for symptoms relief 3) Sixty percent of the pt had a median body weight gain of 4 Kg.

No significant financial relationships to disclose.
Ulcerative keratitis in gatrointestinal stromal tumor patients treated with perifosine
Authors: Esmaeli B. , Trent J. , Espandar L. , Hatef E. , Kim S. K. , Song D.
Published: March 2020

19664

Background: Perifosine is a novel, oral, alkylphospholipid with antiproliferative properties attributed to Akt inhibition. We describe the ocular findings in 5 patients enrolled in phase I/phase II trials of perifosine in combination with imatinib for treatment of advanced GIST. Methods: The medical records of 5 patients who developed peripheral ulcerative keratitis while receiving perifosine and imatinib were retrospectively reviewed. Results: 1 man and 4 women ranged in age from 43 to 72 (median, 57 years). The ocular symptoms included redness, irritation, tearing, photophobia and a gradual decrease in vision. Slit lamp biomicroscopy in each case revealed a peripheral, paralimbal, ring-shaped, superficial stromal infiltration and ulcerative keratitis (UK), reminiscent of the autoimmune keratitis in conditions such as rheumatoid arthritis. The best corrected visual acuity in the affected eye(s) ranged from 20/25 to 20/300 (median 20/70). The UK was unilateral in 3 and bilateral in 2 patients; it was NCI grade II in all. All 6 patients had imatinib-resistant metastatic GIST and had continued on the highest dose of imatinib tolerated and initiated therapy with perifosine 100 mg daily or 900 mg weekly. Time from start of perifosine therapy to diagnosis of UK ranged from 1 to 3 months (median, 2). A combination of topical steroids, topical antibiotics and lubricating drops were used to manage UK. In the first 3 patients, UK was initially treated with topical antibiotics without improvement, but subsequently improved significantly once topical steroids were added. In 5 of 6 patients, the visual acuity improved with this regimen. Conclusions: UK may occur as a side effect of perifosine and shares features of autoimmune forms of keratitis. It is possible that imatinib in combination with perifosine is contributing to this toxicity. Topical steroids improve the signs and symptoms of UK and early treatment with topical steroids may lessen the potential risk of permanent corneal scarring and visual loss. The visual loss associated with perifosine can be reversible with close monitoring and judicious use of topical steroids, topical antibiotic coverage, and lubrication.

No significant financial relationships to disclose.
Use of biological drugs in elderly cancer patients: A sustainable reality? A mono-institutional experience
Authors: Fratino L. , Crivellari D. , Spina M. , Bearz A. , Simonelli C. , Berretta M. , Michieli M. G. , Maso L. Dal , Trovò M. G. , Tirelli U.
Published: March 2020

19665

Background: Several new biological anti-cancer drugs have been recently licensed, and some of them have shown impressive positive results particularly in tumors that express the targets for these agents (e.g., ERBB2 receptor in breast cancer, KIT mutations in gastrointestinal tumors, and the CD20 expression in NHL). However, the use of these drugs in elderly cancer patients is a matter of debate. The aim of this study was to quantify the use of biological drugs according to age and type of cancer. Methods: We analyzed data regarding patients diagnosed with metastatic breast cancer, NSCLC or colo-rectal cancer and NHL treated with biological drugs (i.e., bevacizumab, cetuximab, rituximab, trastuzumab, erlotinib, geftinib) at the National Cancer Institute of Aviano, North-east Italy, between 2002 and 2006. Patients were stratified according to age (i.e., <=69 years or >=70 years) and type of biological agent used. Results: Overall, 687 patients were treated with biological agents (360 with rituximab, 149 with trastuzumab, 114 with geftinib, 23 with bevacizumab, 21 with erlotinib and 20 with cetuximab). Older patients (n=103) had a median age of 74 years (range: 70–86 years): they represented 17.5% of those treated with rituximab, 7.4% of those treated with trastuzumab, 20.2% of those treated with geftinib. Moreover, one elderly cancer patient in each of the three groups of drugs less frequently used (i.e., bevacizumab, erlotinib and cetuximab) was treated with biological agents. Conclusions: In our Institute, nearly 20% of cancer patients is aged 70 years or older. Our findings suggest that elderly cancer patients are not denied biological therapies because of their age. This is particularly true for NHL patients treated with rituximab (17.5%) and for patients with NSCLC treated with geftinib. The low percentage of elderly women treated with trastuzumab is likely to depend from the biological (e.g. hormonal receptors) and clinical characteristics (e.g., pre-existing cardiovascular conditions and life expectancy) of breast cancer in elderly women. The increasing number of cancer in the elderly, asks for a proper selection of patients who should have access to biological agents according to clinical studies and cost-effectiveness evaluation.

No significant financial relationships to disclose.
Renal safety of zoledronic acid administration beyond 24 months in breast cancer patients with bone metastases
Authors: Altundag M. K. , Dincer M. , Harputluoglu H. , Aksoy S. , Ozisik Y. , Guler N. , Tekuzman G.
Published: March 2020

19669

Background: Zoledronic acid (ZA) delays the onset or reduces the incidence of skeletal complications in breast cancer patients with bone metastases. However there are few data on the long-term renal safety of ZA. Methods: We retrospectively evaluated 43 breast cancer patients with bone metastases who received ZA more than 24 months. The following parameters measured prior to first ZA use and after the last dose of ZA administration were compared: serum creatinine (SCr), blood urea nitrogen (BUN), alkaline phosphatase (ALP), calcium (Ca), and phosphorous (P). Results: Forty-three breast cancer patients with documented bone metastases were evaluated. Median age at the start of treatment was 53 years (range, 37 to 77). Median overall duration of ZA administration was 36 months (25 to 62). There were no statistically significant differences in the pre- and post-treatment levels of SCr, BUN, Ca and P. However, ALP levels after long-term ZA administration were decreased significantly (P <0.05). Conclusion: More than 24 months of ZA administration did not adversely affect the renal function. ZA can be used safely in breast cancer patients with bone metastases beyond 2 years.

[Table: see text]

No significant financial relationships to disclose.
Abnormality of growth hormone and insulin-like growth factor I axis in advanced cancer patients
Authors: Takahata T. , Munakata M. , Sakata Y. , Nakagawa K. , Mukaiyama T. , Ishitani K. , Tamura K.
Published: March 2020

19671

Background: Pituitary and thyroid hormones are known to be altered in anorexia nervosa, but few hormonal studies have been performed in cancer anorexia-cachexia syndrome. This study focused on growth hormone (GH) and Insulin-like Growth Factor (IGF)-I axis in cancer patients. Methods: To investigate the relationship among performance status (PS), nutritional and hormonal status, blood sampling was performed to measure GH, IGF-I, IGF-binding protein 3(IGFBP-3), T3, T4, complete blood counts and blood chemistry profiles for 15 cancer patients in each of PS0–1, PS2, PS3 and PS4 after the informed consent was obtained. Results: A total of 58 patients were evaluated including 15 patients in PS0–1, PS2 and PS3 and 13 in PS4. Hemoglobin and albumin levels went down along with progression of PS. GH level was high and T3 was low in poor PS. T4 and IGFBP-3 were lower in PS4 than those of other PS. There is a tendency of low IGF-I and thyroid hormones and high GH levels in poor PS as compared with those of good PS (p=0.0064 for IGF-I, p<0.001 for T3, and T4, not significant for GH analyzed by ANOVA). Conclusions: Abnormal GH - IGF-I axis was more pronounced in poor PS. It is conceivable that normalization of this abnormality can improve cancer anorexia-cachexia syndrome and new drug development for such normalizing agents is warranted.

No significant financial relationships to disclose.
Retrospective analysis on patients with male breast cancer
Authors: Alvarez A. M. , Quiroga M. N. Gandur , Cinat G. , Iturbe J. , Nissi T. Said , Lacava J. , Cuartero V. , Vallejo C. , Leone B. , Mickiewicz E.
Published: March 2020

19681

Background: Male breast cancer is uncommon, 1%(0.7 %)of all breast cancer. Nevertheless, the incidence has climbed 26% over the past 25 years. Objetive: Analyze the form of presentation and clinical evolution of patients with male breast cancer studied from 1977 to 2005. Methods: From 1977 to 2005 53 charts were analyzed: age, clinical presentation, stage (st), histological characteristics and nodal involvement. Results: Age: 33 years to 83 years (median= 59 years). Mean durations of symptoms before presentations: 11 months (m) (range 1 - 84 m.) . Forty-six (86.7%) patients (pts) had history of breast lumps, 9 (17%) were painful. Skin involvement and ulceration were present in 5 (9.43%) and 4 (7.54 %) respectively. One case of bilateralism was found. Seven (13.2%) st. I; 18 (33.96%) st. II; 20 (37.73%) st. III and 7 (13.2%) st. IV. Radical mastectomy was done in 41 pts (77.35%). Invasive ductal carcinoma was the most common histological type in 45 (84.9%). One case of lobular carcinoma was found. 60.4% of tumours expressed hormonal receptor. Adyuvant treatment: Adriamycin-based chemotherapy in 20 pts and CMF in 8 pts. Hormonotherapy was offered in 10 (19%) pts of the previous group, radiotherapy to 12 pts. twenthy pts (37.73%) presented recurrence; most common was bone in 10. The st. I and II estimated 5-year survival rate was 68% IC 95% (44–84%), st. III was 44% IC 95% (23 - 67%), st. IV (median = 24 m) with range (16 - 56 m). The 72% IC 95% (48–88%) patients st. I and II was free of disease at the 5-years, st. III was free 24% IC 95% (9–49%), st. IV (median = 7,5 m) with range (7–14 m). Conclusions: The media age at diagnosis was 59 years (10 years less than the international bibliography). (IB). Our group had longer time to presentation: 11 vs. 6 m., (IB) and most of them where in st. III. Hormonal receptore were positive in 60%.

No significant financial relationships to disclose.
Effect of consolidation with arsenic trioxide (As
2
O
3
) on event-free survival (EFS) and overall survival (OS) among patients with newly diagnosed acute promyelocytic leukemia (APL): North American Intergroup Protocol C9710
Authors: Powell B. L.
Published: March 2020

2

Background:
This randomized phase III study was designed to evaluate the benefit and toxicity of two 25-day courses of As
2
O
3
as first post-remission therapy for newly diagnosed patients with APL.
Methods:
Adult patients were randomized to receive 2 courses of As
2
O
3
(0.15 mg/kg/d for 5d each wk for 5 wk) as a first consolidation if they achieved remission (CR or PR) after induction with oral tretinoin (ATRA; 45 mg/m
2
/d), daunorubicin (50 mg/m
2
IV × 4d), and cytarabine (200 mg/m
2
CIV × 7d); by study design, all but 2 children were assigned to the non-As
2
O
3
arm. Subsequent consolidation on both arms included 2 courses of ATRA (45 mg/m
2
× 7d) + daunorubicin (50 mg/m
2
× 3d; 2d for age < 15 yr). CR patients were then randomized to 1 yr of ATRA maintenance (7d repeated every other wk) with or without 6- mercaptopurine (daily) + methotrexate (weekly).
Results:
518 adults (15–79 yr) and 64 children (<15 yr; 11%) with untreated APL were enrolled by 5 cooperative groups (CALGB, ECOG, SWOG, COG, NCIC-CTG). Eligibility required demonstration of
PML-RARA
in one of 3 central labs; 37 adults and 7 children were ineligible and not included in the analyses. Patient characteristics and toxicity data have been reported (ASH 2006; Blood 108:171a). Median follow up is now 29 mos. Overall CR rate for adults was 89% and did not differ by treatment arm; CR rate for children was 89%. There were 41 deaths (8%) within 60 days. EFS, the primary endpoint, was 77% at 3 yrs on the As
2
O
3
arm (median, not reached) compared to 59% at 3 yrs on the standard arm (median, 63 mos; p=0.0013). Overall, 84% of adults were alive at last follow up. OS was 86% at 3 yrs on the As
2
O
3
arm compared to 77% at 3 yrs on the standard arm (medians not reached; p=0.029); EFS and OS for pediatric patients did not differ statistically from the adult arm without As
2
O
3
. Among 452 CR pts, there have been only 71 post-CR events (16%) so disease- free survival has not yet been analyzed by treatment arm.
Conclusion:
The addition of 2 courses of As
2
O
3
consolidation following remission induction significantly improves EFS and OS in adults with APL.

No significant financial relationships to disclose.