Ghadiany, M., Rahimi, H., Rezvani, H., Mohammad Alizadeh, A., Zamani, N., Mehdizadeh, M., & Foratyazdi, M. (2016). Prophylaxis of neutropenic fever with ciprofloxacin in patients with acute myeloid leukemia treated with intensive chemotherapy. Asia-Pacific Journal of Clinical Oncology, 12, e11–e15.
To compare outcomes between patients with acute myeloid leukemia (AML) who did or did not receive prophylactic ciprofloxacin 500 mg twice per day for neutropenic fever
Administration of prophylactic ciprofloxacin 500 mg twice daily for the prevention of neutropenic fever
PHASE OF CARE: Active antitumor treatment
Retrospective, medical record, cross-sectional evaluation
Outcome measurements included rate of neutropenic fever episodes, microbiologic findings, patterns of resistance, and mortality. Independent variables included demographic data, type of AML, and administration or absence of the intervention (prophylactic ciprofloxacin). Administration of granulocyte–colony-stimulating factors were also included in the analyses.
No statistically significant differences were found in any of the outcome variables between patients who received prophylactic ciprofloxacin compared to patients who did not receive the prophylactic treatment. Specifically 80% of the treatment group and 82% of the control had neutropenic fevers. Although mortality rates were lower among those who received the prophylactic ciprofloxacin compared to those who did not, the differences were not statistically significant.
There is no benefit of prophylactic ciprofloxacin for the prevention of neutropenic fever among patients undergoing induction chemotherapy for AML. These findings aligned with other similar studies with the exception of one that the researchers found in the literature.
Understanding the ineffectiveness of prophylactic ciprofloxacin for the prevention of febrile neutropenia in patients undergoing induction chemotherapy for AML can aid in treatment decisions and promote the use of more effective interventions.
Gewandter, J.S., Mohile, S.G., Heckler, C.E., Ryan, J.L., Kirshner, J.J., Flynn, P.J., . . . Morrow, G.R. (2014). A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): A University of Rochester CCOP study of 462 cancer survivors. Supportive Care in Cancer, 22, 1807–1814.
To determine the effectiveness and safety of the topical application of a combined 2% ketamine and 4% amitriptyline (KA) cream for reduction of chemotherapy-induced peripheral neuropathy (CIPN) in patients who have completed chemotherapy
One week prior to enrollment, subjects completed a seven-day daily pain, numbness, and tingling diary over the past 24 hours. Subjects answered the question for any of the three symptoms in either their hands or feet. At enrollment, subjects were instructed to use a measuring device for application of 4 g of either KA or placebo cream twice daily to each area of hands or feet with any pain, numbness, or tingling. The seven-day daily pain, numbness, and tingling diary for pain over the past 24 hours, by numeric rating scale (NRS), was completed at three and six weeks after enrollment. A secondary analysis for pain using NRS was done at baseline, three, and six weeks.
No therapeutic effect was observed with the application of KA cream to the affected areas on hands or feet for reduction of pain, numbness, and tingling (p = 0.363). Secondary analysis for pain alone did not show a statistically significant difference between groups comparing means at 95% CI (KA cream, 4.64; placebo, 4.68). Patients in the treatment regimen group of prior taxanes, regardless of receiving study treatment with either KA or placebo, reported a reduction in pain, numbness, and tingling at six weeks (p = 0.042). No statistically significant adverse events were reported for the KA treatment group compared to the placebo group.
This study showed no therapeutic benefit for the topical application of KA cream for CIPN.
Further studies need to be done to investigate if any combination or separate topical compound targeting specific nociceptive pathways has a therapeutic benefit for CIPN.
Gergich, N.L.S., Pfalzer, L.A., McGarvey, C., Springer, B., Gerber, L.H., & Soballe, P. (2008). Preoperative assessment enables the early diagnosisand successful treatment of lymphedema, Cancer 112, 2809–2819.
To investigate the efficacy of a surveillance method for the diagnosis and management of subclinical lymphedema in patients with early-stage breast cancer
Diagnostic criteria for lymphedema included a volume increase of 3% in the affected upper limb compared with the patient’s preoperative measurement and with consideration of the contralateral limb volume changes. When lymphedema was diagnosed, garments were prescribed for daily wear. No activity limitations were placed for the duration of the intervention. At follow-up, when limb volume decreased, women were advised to continue wearing the garment only when completing strenuous exercise or activity, during air travel, with symptoms of heaviness, or if visible swelling appeared. Time points of evaluation were the preoperative visit and 1, 3, 6, 9, 12, and 18 months postoperatively.
The study took place at the National Naval Medical Center Breast Care Center in Bethesda, MD.
The study used a case-control design.
The time to onset of lymphedema averaged 6.9 months postoperatively. The subclinical lymphedema group had significantly higher upper-limb volume than the control group when the compression intervention was introduced. After the intervention, a statistically significant mean 48 ml volume decrease was realized (p < 0.0001) in the subclinical lymphedema group with activity-related garment wear only compared with 2.3 ml decrease in the control group. The mean duration of the intervention was 4.4 weeks. Volume reduction was maintained at an average follow-up of 4.8 months after the intervention.
Preoperative assessment in the context of a prospective surveillance model enables the early detection and management of subclinical lymphedema. An early intervention protocol reduces the affected limb volume to near baseline measures and prevents progression to a more advanced stage of lymphedema for at least the first year postoperatively.
The study does not use a randomized controlled design.
Preoperative baseline measurement is vital to successfully diagnosing subclinical lymphedema. However, currently, physical therapists in clinical practice rely on an impairment-based model for diagnosing and treating lymphedema. The paradigm is inadequate and a shift in the current practice pattern in favor of surveillance models is necessary. Further research is warranted to confirm the long-term clinical and cost effectiveness of this surveillance model compared with a traditional impairment-based model in treating breast cancer-related lymphedema.
Gerber, P.A., Meller, S., Eames, T., Buhren, B.A., Schrumpf, H., Hetzer, S., ... Homey, B. (2012). Management of EGFR-inhibitor associated rash: A retrospective study in 49 patients. European Journal of Medical Research, 17(1), 4.
To compare the effectiveness of three established rash-management strategies in EGFR-inhibitor (EGFRI) associated rash development
Rash severity was assessed during the initial presentation to clinic by applying the EGFR-Induced Rash Severity Score (ERSS). Three different EGFRI rash-management strategies were compared, and each targeted the inflammatory and/or the infectious characteristics of the rash. In stage 1 of the study, 21 patients (ERSS 10.3 to 77.9) were treated topically with mometasone furoate cream (a topical anti-inflammatory) twice daily. In stage 2 of the study, 23 patients (ERSS 12.5 to 67.1) were treated topically with nadifloxacin 1% cream (a potent topical fluoroquinolone antibiotic) once daily in the morning, in combination with prednicarbate 0.25% cream (a topical glucocorticosteroid) once daily in the evening. In stage 3 of the study, five patients (ERSS > 50) received topical nadifloxacin and prednicarbate 0.25% cream in combination with the systemic retinoid isotretinoin 10–20 mg/day. Rash severity was reassessed after three weeks of specific therapy to manage the dermatologic reaction.
Retrospective, uncontrolled, comparative study
Patients' EGFRI-associated rash severity improved significantly with all three dermatological treatments, which are aligned with recent expert recommendations: topical mometasone furoate cream (p = 0.00009); nadifloxacin 1% cream and prednicarbate 0.25% cream (p = 0.03); and nadifloxacin 1% cream and prednicarbate 0.25% cream plus systemic isotretinoin (p = 0.015).
In summary, the results demonstrate that EGFRI-associated rashes can be effectively managed by specific dermatologic interventions, including topical glucocorticosteroids, topical antiseptics/antibiotics, and systemic retinoids. Topical mometasone furoate cream was the only therapy that resulted in a complete resolution of all rash symptoms in one patient.
Nurses should consider treating mild to moderate EGFRI skin rashes with basic skin care measures in combination with topical glucocorticosteroids or combined regimens using glucocorticosteroids and antiseptics/antibiotics. Nurses should be aware that more severe or therapy-resistant rashes may respond with the addition of systemic retinoids.
Gerber, B., Koppel, J., Paul, M., Nguyen-Kim, T.D., Frauenfelder, T., Nair, G., . . . Manz, M.G. (2014). Efficacy of anti-fungal but not anti-bacterial prophylaxis in intensive primary AML therapy: a real-world, retrospective comparative single-centre study. Swiss Medical Weekly, 144, w13985.
To assess the effect of primary prophylaxis with posaconazole and levofloxacin on the incidence of invasive fungal infections (IFI) and bacteremia
This was a retrospective, single-center study that evaluated two groups of adult patients with acute myeloid leukemia/acute promyelocytic leukemia (AML/APL) and high-grade myelodysplastic syndrome (MDS) receiving intensive chemotherapy. The primary endpoint was IFI and bacteremia with secondary endpoints of overall survival at day 100 and at two years, time from the initiation of chemotherapy to the onset of IFI, the use of intravenous and oral antifungal and antibacterial therapy, and total duration of antifungal and antibacterial medication.
Retrospective
IFIs were significantly less common in the prophylaxis group after the first chemotherapy cycle (33.3% versus 65.8%; p = 0.0088). IFIs were significantly less common in the prophylaxis group after the last chemotherapy cycle (53.9% versus 88.9%; p = 0.0021). Chemotherapy cycles that were complicated with bacteremia occurred at a rate of 34.6% with prophylaxis and 32.3% in the nonprophylaxis group; p = 0.8. Positive blood cultures were 50 and 43, respectively, with a nonsignificant trend to more gram-negative infections in the nonprophylaxis group (42% versus 14%; p = 0.073) and to more gram-positive infection in the prophylaxis group (86% versus 58%; p = 0.092). Overall survival at 100 days and at two years, as well as the use of antiviral medications, did not differ between the two arms. Fewer fever days (5.6 versus 9.2; p = 0.00032) and less cytarabine toxicity (18.3% versus 35%; p = 0.025) were observed in the prophylaxis arm.
This single-center retrospective study of posaconazole prophylaxis was efficient in reducing the possible IFIs with a number needed to treat to prevent one IFI of only three. This institution had a relatively high rate of IFIs when compared to published data. Posaconazole for prophylaxis was cost-effective. There was no benefit seen in the use of levofloxacin in preventing bacteremia.
Oncology nurses should be aware of facility policies relating to the use of prophylaxis for IFI and bacteremia and should understand the local climate that may affect the rate of IFIs. This facility used posaconazole and levofloxacin as prophylaxis agents. Other agents exist and are currently in use that may produce different outcomes.
Gerber, G.S., Zagaja, G.P., Ray, P.S., & Rukstalis, D.B. (2000). Transdermal estrogen in the treatment of hot flushes in men with prostate cancer. Urology, 55, 97–101.
The study evaluated the efficacy of transdermal estrogen in men in moderating hot flashes after hormonal therapy for prostate cancer.
The study enrolled 12 men with advanced prostate cancer who were receiving leuprolide injections every one or three months. They were experiencing at least three hot flush episodes daily for at least three months.
This was a randomized, multi-dose, crossover trial.
Treatment response was assessed indaily logs. Questionnaires were completed every four weeks, including visual analog assessment. Serum luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone, and estradiol levels were taken every four weeks.
Key outcomes of the study included:
Study limitations included small sample size, absence of placebo arm, short duration.
Gentili, M., Clerico, M., Spizzichino, M., & Fanelli, G. (2016). Use of a checklist to improve pain control in hospitalized cancer patients: The 38Checkpain project. Future Oncology, 12, 199–205.
To evaluate whether use of a checklist dedicated to pain management-related practices would improve pain control in inpatient settings
A checklist (38Checkpain) was developed by a group of patient management experts identifying practices related to pain management outlined in Italian law. The checklist consisted of seven items to remind practitioners of correct steps for assessment, monitoring, management, and treatment of pain. Healthcare centers participating in the program collected information on these aspects of pain management, adverse of effects, and episodes of breakthrough pain for all patients hospitalized that day on the unit for seven days. After, healthcare centers were randomized to use the checklist or to continue current practice without use of the checklist. Checklist items were measuring intensity of pain, checking if pain was 3 or less, modifying therapy if pain intensity was greater than 3, assessing the presence of adverse events with pain treatment, setting a specific therapy of adverse event management, checking for presence of factors that increase acute pain, and setting a specific therapy for treatment of factors that cause acute pain. The checklist was applied in patients with pain twice daily by providers. Data were collected for 21 days.
Mean pain intensity declined in the checklist group over the study period from 3.8–2.7. Mean pain intensity did not decline steadily in the no checklist group and overall was consistently higher. The proportion of patients with effective control of pain increased from 20.1% to 67.6% in the checklist group. In the no checklist group, control of pain increased by 13.8%. The incidence of breakthrough pain episodes decreased by 21.4% in the checklist group but increased by 6.6% in the other group. Compliance with checklist use was reported as at least once daily.
The use of a checklist to remind healthcare providers to make specific assessments and intervention plans for patients with pain appeared helpful in improving overall pain-related patient outcomes.
This study has multiple limitations; however, it does suggest that at least daily use of a checklist reminder for assessment and intervention practices for patients with pain may improve overall pain management and related patient outcomes. Checklists have been used in multiple ways in health care and may be an effective tool in reminding practices to improve various types of patient outcomes.
Genot-Klastersky, M.T., Klastersky, J., Awada, F., Awada, A., Crombez, P., Martinez, M.D., et al. (2008). The use of low-energy laser (LEL) for the prevention of chemotherapy- and/or radiotherapy-induced oral mucositis in cancer patients: Results from two prospective studies. Supportive Care and Cancer, 16(12), 1381–1387.
100 mW laser was delivered to tissues with a 1.2 mm spot size. Treatment areas included inferior and superior lips, right and left cheeks, right and left tongue, palate and velum palate, right and left gums, and tongue frenulum.
Average energy was 2 J/cm2 on all sites, with a calculated mean duration of 33 seconds per site; each treatment lasted six minutes.
(1) Patients with various solid tumors treated with chemotherapy; previous oral mucositis of 2 or higher
26 patients for 90% power
Patients with concomitant RT and those \"expected to be poor compliers to the treatment schedule\" were excluded.
Mean age 51 was years (range = 32–73 years).
20 women; 6 men
(2) Randomized trial for patients with hematologic malignancies who developed mucositis receiving radiochemotherapy prior to HSCT. Therapy started 24 hours after diagnosis of mucositis. Sham laser control was used.
20 patients were needed in each arm for 90% power.
n = 36 (18 patients in each arm)
Grade of mucositis using EORTC scale
Grading was performed by a nurse prior to each treatment session and afterward once a week by an independent blinded professional observer.
All treated areas were examined.
1. 21 of 26 patients were considered to have prevented mucositis (81%, 95% CI = 61%–93%); 4 with no mucositis, and 17 with grade I. Five patients had grade 2 or higher; median duration was 10 days (range = 8–14 days).
2. Grade 3 mucositis was observed in 16 patients in the sham group and in 3 LEL treated patients (p = 0.001). Overall success rate was 15 of 18 (83%, 95% CI = 59%–96%) and 2 of 18 in the control group (11%, 95% CI = 1–35).Time to grade 3 mucositis was calculated (p < 0.0001).
Of 16 patients in the control arm who developed grade 3–4, eight later received laser treatment; regression to grade 1 mucositis was three days in this group and four days in those who did not receive LEL.
Limited sample size, although the prevention trial (1) achieved 90% power.
The heterogeneous population in the prevention trial makes the results difficult to generalize. Oral care and other factors were not reported.
Gennaro, P., Gabriele, G., Mihara, M., Kikuchi, K., Salini, C., Aboh, I., . . . Ungari, C. (2016). Supramicrosurgical lymphatico-venular anastomosis (LVA) in treating lymphoedema: 36-months preliminary report. European Review for Medical and Pharmacological Sciences, 20, 4642–4653.
To evaluate the effects of lymphaticovenular anastomosis (LVA) on patients with lymphedema
APPLICATIONS: Pediatrics, elder care
Retrospective
Measuring tape
The LVA appears to successfully establish alternate lymphatic drainage pathways in the lymph damaged limb. It is minimally invasive requiring considerably less surgery than the lymph node transplantation procedures and potentially better outcomes. The patients tolerate it well and recovery quickly. It is unclear whether patients no longer needed to use compression garments, but the study reported that all had a reduction in compression class. The researchers reported outcomes that did reflect disease progression: Stage IV limbs did not improve, as well as stage II.
The findings suggest that LVA may be helpful for patients to reduce lymphedema. Nurses need to be aware of patient education needs if this procedure is used.
Gennaro, M., Maccauro, M., Sigari, C., Casalini, P., Bedodi, L., Conti, A. R., . . . Bombardieri, E. (2013). Selective axillary dissection after axillary reverse mapping to prevent breast cancer–related lymphoedema. European Journal of Surgical Oncology, 39, 1341–1345.
To assess the occurrence of breast cancer–related lymphedema (BCRL) and the feasibility of selective axillary dissection (SAD) after axillary reverse mapping (ARM)
ARM was performed on 60 patients undergoing SAD. Patients received follow-up after 6–36 months and were assessed for BCRL.
The intervention group participated in the SAD intervention, and the control group usually had axillary lymph node dissection.
SAD was successful in 45 of 60 patients. Four of 45 patients in the intervention group and five of 15 patients in the control group developed lymphedema (p = .072).
BCRL with SAD technique after median follow-up of 16 months had 33% the rate of lymphedema occurence than conventional ALND. SAD technique requires a separate surgery from sentinel lymph node biopsy. Authors concede there may be a learning curve to this technique, and further research is needed to determine appropriate patient selection.
New surgical techniques may result in lowering patient morbidity but does not eliminate the possibility of patients developing BCRL. Education should continue to be provided to all patients regarding early identification of signs and symptoms of BCRL.