Outpatient-based Chemotherapy Research Articles

Surveillance of Symptom Burden Using the Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events in Patients With Various Types of Cancers During Chemoradiation Therapy: Real-World Study

Over 90% of patients with cancer experience 1 or more symptoms caused directly by cancer or its treatment. These symptoms negatively impact on the completion of planned treatment as well as patients' health-related quality of life (HRQoL). It often results in serious complications and even life-threatening outcomes. Thus, it has been recommended that surveillance of symptom burden should be performed and managed during cancer treatment. However, differences in symptom profiles in various patients with cancer have not been fully elucidated for use in performing surveillance in the real world. This study aims to evaluate the burden of symptoms in patients with various types of cancers during chemotherapy or radiation therapy using the PRO-CTCAE (Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events) and its impact on quality of life. We performed a cross-sectional study of patients undergoing outpatient-based chemotherapy, radiation therapy, or both at the National Cancer Center at Goyang or at the Samsung Medical Center in Seoul, Korea between December 2017 and January 2018. To evaluate cancer-specific symptom burden, we developed 10 subsets for using the PRO-CTCAE-Korean. To measure HRQoL, we used the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Participants answered questions prior to their clinic appointments on tablets. Multivariable linear regression was used to analyze symptoms based on cancer type and to evaluate the association between the PRO-CTCAE items and the EORTC QLQ-C30 summary score. The mean age (SD) of the patients was 55.0 (11.9) years, and 39.94% (540/1352) were male. Overall, symptoms in the gastrointestinal category were the most dominant in all cancers. Fatigue (1034/1352, 76.48%), decreased appetite (884/1352, 65.38%), and numbness and tingling (778/1352, 57.54%) were the most frequently reported. Patients reported more local symptoms caused by a specific cancer. In terms of nonsite-specific symptoms, patients commonly reported concentration (587/1352, 43.42%), anxiety (647/1352, 47.86%), and general pain (605/1352, 44.75%). More than 50% of patients with colorectal (69/127, 54.3%), gynecologic (63/112, 56.3%), breast (252/411, 61.3%), and lung cancers (121/234, 51.7%) experienced decreased libido, whereas 67/112 (59.8%) patients with gynecologic cancer and lymphoma/myeloma reported pain during sexual intercourse. Patients with breast, gastric, and liver cancers were more likely to have the hand-foot syndrome. Worsening PRO-CTCAE scores were associated with poor HRQoL (eg, fatigue: coefficient -8.15; 95% CI -9.32 to -6.97), difficulty in achieving and maintaining erection (coefficient -8.07; 95% CI -14.52 to -1.61), poor concentration (coefficient -7.54; 95% CI -9.06 to -6.01), and dizziness (coefficient -7.24; 95% CI -8.92 to -5.55). The frequency and severity of symptoms differed by cancer types. Higher symptom burden was associated with poor HRQoL, which suggests the importance of appropriate surveillance of PRO symptoms during cancer treatment. Considering patients had comprehensive symptoms, it is necessary to include a holistic approach in the symptom monitoring and management strategies based on comprehensive patient-reported outcome measurements.

High Rates of Venous and Arterial Thrombotic Events in POEMS Patients: Results from the UK-Based POEMS Registry, Highlighting the Need for Therapeutic Guidelines

Introduction Arterial and venous events are known to occur in patients with POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, Skin changes) syndrome which may also include myeloproliferation, with a reported rate in the literature of around 20%. This is higher than in the myeloma cohort where the VTE rate from the UK Myeloma XI study was reported as 11.8%. The approach to optimum management of thrombosis in POEMS patients remains undefined. Method The UCLH POEMS Registry is a comprehensive tertiary centre-based UK data repository including patients from 1999 to the present. Data were collated from patients referred in for diagnosis or after treatment and included blood results, neurological and general performance status, previous and active venous thromboembolism (VTE) and arterial events and their management. Results Of the 103 patients in the UCLH POEMS Registry, 20 were excluded due to missing data. Of the 83 patients included, median age was 52 years (31-84) and 54 (65%) were male. Mean haemoglobin at diagnosis was 143 g/L (89-190), platelet count 443 x10^9 (194-741), vascular endothelial growth factor (VEGF) 3536 pg/mL (388-15422), creatinine 75 μmol/L (32-168) and albumin 40 g/L (31-50). Performance status was ≥ 3 in 15 patients. Radiotherapy was used as a treatment modality in 21/83 (25%) and 48/83 (52%) patients received autografts. There were 51 outpatient-based chemotherapy regimens prescribed. Lenalidomide and dexamethasone (LD) was the most common prescription 30/51 (59%), followed by cyclophosphamide and dexamethasone in 10/51 (20%), LD plus cyclophosphamide in 3/51 (6%), melphalan and steroids 3/51 (6%), cyclophosphamide, dexamethasone and thalidomide 2/51 (4%), LD plus ixazomib 1/51 (2%), velcade, thalidomide and dexamethasone 1/51 (2%) and carfilzomib with dexamethasone 1/51 (2%). Of these 51 outpatient-based chemotherapy scripts, 30 received documented thromboprophylaxis (TP). Prophylactic low molecular weight heparin (pLMWH) was prescribed most frequently (17/30) with 16 of these patients receiving an immunomodulatory based chemotherapy regimen. Other TP agents used include: aspirin (6/30), treatment dose LMWH (tLMWH) (2/30), rivaroxaban (2/30), warfarin (2/30) and clopidogrel (1/30). Twenty-five patients experienced a total of 35 clinically apparent arterial or venous events. Seven had more than 1 thrombotic event, 2 of which developed both arterial and venous thromboses. Three patients had a prior history of VTE;1 with historic DVT developed pulmonary emboli, and 2 had arterial events after historic VTE. Eleven patients had 14 VTEs including DVT (6/14), PE (4/14) and 4 PICC-associated DVT occurring during melphalan-based autograft. Most VTEs occurred during active disease with median VEGF 2731 (444-5000). Five venous events occurred on chemotherapy, including 4 during a melphalan-based autograft, and 1 on LD. VTE occurred despite prophylactic LMWH in 3 patients (2 unknown). Treatment comprised LMWH (4), warfarin (4), or the direct oral anticoagulants, rivaroxaban (1) and apixaban (1). One patient did not receive treatment for a PICC-associated DVT. Sixteen patients experienced 21 arterial events including stroke (7/21), peripheral vascular disease (6/21), MI (4/21) and microvascular disease (2/21). Most events occurred during active disease with median VEGF 3155 (637-10640). Three occurred on anti-POEMS therapy: one patient (VEGF 4555) developed a second stroke on LD and LMWH prophylaxis; one patient on LD (VEGF 10640) and prophylactic rivaroxaban 10mg developed PVD, and another on melphalan and prednisolone (VEGF 2000-4000) and warfarin for atrial fibrillation (target INR 2.0-3.0) developed PVD. Conclusion The venous and arterial event rate in this cohort at 35/83 (42%) is over double that previously reported. There were more arterial events than venous, and most occurred in a state of active disease and off anti-POEMS therapy (26/35), suggesting that treatment-related risk factors are less of a driver for thrombosis than the disease itself. There was no discernible relationship with thrombocytosis. Thromboprophylaxis is commonly used in POEMS patients receiving outpatient-based chemotherapy with the most common agent being prophylactic LMWH. With the high incidence of arterial events in the presence of active disease, the role for anti-platelet agents or indeed DOACs remains undefined in this patient group. Disclosures Thomas: Sanofi: Membership on an entity's Board of Directors or advisory committees. D'Sa:Janssen: Honoraria, Research Funding.

Chemotherapy alters subjective senses of taste and smell but not dietary patterns in Japanese lung cancer patients.

To investigate how outpatient-based chemotherapy would alter the senses of taste and smell and affect daily dietary intake in patients with lung cancer. The self-reported taste and smell alteration (TSA) in 35 Japanese patients with lung cancer as well as their patterns of dietary intake at home were tested using a questionnaire. The patients experienced considerable TSA, and smoking was shown to contribute to this alteration. Specifically, current or past smokers were more likely to experience subjective taste change during chemotherapy than never smokers were. Chemotherapy made steamed rice or sushi the most unfavorable food in the patients; on the other hand, Japanese-style noodles were the most preferred during chemotherapy. Nevertheless, the patients maintained their habit of consuming steamed rice at home at least once a day, suggesting the robustness of dietary habits despite the TSA caused by chemotherapy. Nutritional assessment as well as appropriate advice and intervention by dietitians is expected to improve the general conditions and quality of daily living in patients with cancer.

A Nurse-Led Care Program for Breast Cancer Patients in a Chemotherapy Day Center: A Randomized Controlled Trial.

Healthcare providers are facing the challenge of helping cancer patients cope with the impact of outpatient-based chemotherapy. A nurse-led care program was proposed to address this challenge. The aim of this study was to examine the effects of a nurse-led care program for patients receiving outpatient-based chemotherapy. This was a single-center, open-label, 2-arm parallel trial with equal randomization (NCT02228200). Breast cancer patients in Hong Kong were randomly allocated to the intervention arm or the control arm. The control arm received routine hospital care. The intervention arm received the nurse-led care plus the routine hospital care. The quality of life, self-efficacy, symptom distress levels, and satisfaction with care were evaluated with questionnaires before randomization (T0), in the middle of chemotherapy (T1), and 1 month after chemotherapy (T2). Individual interviews were conducted with some participants in the intervention arm at T2. The intervention arm participants reported significantly lower distress levels from oral problems, fatigue, peripheral neuropathy, distressful feelings, and higher satisfaction with care. According to the satisfaction evaluation and the interviews, the participants stated that the service was helpful in providing information and communication opportunities, filling the service gap after drug administration, providing psychological support, relieving discomfort, and building confidence. Breast cancer patients received support from the provision of comprehensive, continuous, and individualized care. The nurse-led care program could be applied to breast cancer patients in other hospitals in Hong Kong. Exploring its applicability to cancer settings in other countries is recommended.

59-Year-Old Man With Fatigue, Weight Loss, and Hepatomegaly

59-Year-Old Man With Fatigue, Weight Loss, and Hepatomegaly

The cost-effectiveness of a nurse-led care program for breast cancer patients undergoing outpatient-based chemotherapy - A feasibility trial.

To evaluate the cost-effectiveness of a nurse-led care program for breast cancer patients receiving outpatient-based chemotherapy. An open-label, single-center randomized controlled trial was conducted. Patients receiving the nurse-led care and those receiving the routine care were compared in terms of quality of life, as well as in health service utilizations and total cost of care. A cost-utility analysis was conducted. A total of 124 patients were recruited. The data of 116 subjects who completed the study were used for the cost-utility analysis. There were 81 unscheduled hospital visits and 43 hospital admissions. The common reasons for utilizing health services were infections and fevers, skin problems, digestive system problems, and mouth/teeth/throat problems. There were no differences in health service utilizations between the nurse-led and routine care groups for subjects receiving four-cycle chemotherapy. For those receiving six-cycle chemotherapy, the estimated number of emergency department visits was 2.188 times (95% Confidence Interval, 1.051 to 4.554) higher for the routine care group when compared with the nurse-led care group (p = .038). The incremental cost-utility ratios were £8856 and £18,936 per quality-adjusted life year gained for subjects receiving four-cycle and six-cycle chemotherapy, respectively. Cancer patients make unscheduled health service visits when receiving outpatient-based chemotherapy, which leads to increased health service costs. The nurse-led care reduces emergency departments visits made by breast cancer patients undergoing six-cycle adjuvant chemotherapy. For breast cancer patients undergoing four-cycle chemotherapy and six-cycle chemotherapy, the nurse-led care could be cost-effective.

A qualitative exploration of the experiences of patients with breast cancer receiving outpatient-based chemotherapy.

The aim of this study was to understand the experiences of patients with breast cancer and their involvement during outpatient-based chemotherapy in Hong Kong. The outcome evaluation using a mixed-methods approach is not common in interventional studies of nurse-led chemotherapy care programmes. A qualitative approach could provide a deep understanding of the experiences of patients. A qualitative study was conducted. This is part of a randomized controlled trial of a nurse-led care programme (NCT02228200). Individual interviews were conducted in 2013 with 10 patients with breast cancer after they had completed the chemotherapy. Qualitative content analysis was adopted to analyse the interviews. Chemotherapy affected the patients in different ways. Some participants completed the chemotherapy treatment smoothly with minimum side effects, while others encountered many problems during the treatment, which had a great impact on their lives. Guided by their coping attitudes, which were affected by the Chinese culture, most participants adopted behavioural, social, cognitive and emotional strategies to actively cope with the chemotherapy. A few tolerated the treatment passively. Some thought that the process of undergoing chemotherapy was physically bearable, while some equated it with suffering. Others regarded it as a chance to get a new start. The experience of patients with breast cancer during chemotherapy can be likened to that of going on a hike. They reach the peak through different paths and bear different burdens. Yet, they have to go through until the end, regardless of how much of a burden they bear and how they achieve the peak.

Efficacy of low dose capecitabine and sorafenib in patients with advanced alfa-fetoprotein secreting hepatocellular carcinoma: a 1year experience.

BackgroundThere is no global consensus for the optimal management of HCC. Most of patients at the time of diagnosis are not candidate for potentially curative therapy. The study aimed to evaluate the efficacy of low dose capecitabine combined with sorafenib in subset of Egyptian HCV patients presented with advanced HCC unfit for surgical or locoregional therapies.Methods15 patients with advanced HCC, unfit for surgical or locoregional intervention, with PS <2 recieved Capecitabine 500 mg/day with sorafeneb 200 mg twice daily till normalization of AFP then the treatment was modified to capecitabine 250 mg every other day and sorafenib 400 mg once daily. They were followed every 3 months for size, number of focal masses and AFP. 30 patients were selected as a control group, they received supportive therapy (n = 15) or sorafenib only (n = 15).ResultsAfter 10 months of therapy, 6 patients showed complete response (40 %) with complete recanalization of portal vein (n = 2) and treatment was stopped and the others (n = 4) showed partial portal vein recanalization so, treatment is continued till now. 1 patient (6.7 %) showed recurrence of the disease and died after 1 month, 8 patients showed partial response (53.3 %) and still on treatment. The control groups showed a highly significant reduction in survival when compared to patients who received capecitabine and sorafenib (12.9 ± 2.1, 7.9 ± 0.9, 4.5 ± 1.3 months, p = 0.000).ConclusionsCombined low dose capecitabine and sorafenib proved to be safe with low toxicity profile and deserves further attention as a convenient, outpatient-based chemotherapy in patients with advanced HCC.

Metronomic capecitabine as maintenance in treatment of hepatocellular carcinoma after localized intervention

Background: Hepatocellular carcinoma (HCC) accounts for between 85 and 90% of primary liver cancer. Surgery is considered curative treatment; however, local ablative technique has a high rate of recurrence. Different attempts are being tried to decrease time of recurrence with less side effects and toxicities. Metronomic chemotherapy is an emerging method of treatment with less side effects and good tolerability. Objectives: The aim of the study was to evaluate the effect and toxicity of metronomic capecitabine in HCC patients after localized intervention. Material and methods: This study included 30 patients with HCC who have been treated with locoregional interference (tranarterial chemoembolization, radiofrequency, or both) and have got complete response (CR) or partial response (PR). The patients were selected from the clinical oncology department, faculty of medicine, Menoufyia University; they received capecitabine 1000 mg/day continuously. Patient characteristics, disease-free survival, time to progression, effect of primary localized intervention on the outcome, and toxicity were evaluated using univariate and multivariable analysis. Results: Most patients were men with mean age of 54 years and hepatitis C virus positive (73%). Median disease-free survival was 8 months for patients who had CR after localized interference. Median time to progression was 8 and 4.4 months for CR and PR patients, respectively, which was statistically significant (P = 0.001). No grade IV toxicity was found. Grade III toxicity was hepatic toxicity (hyperbilirubinemia) and was found in three patients (10%); renal toxicity (elevated creatinine and urea) was found in one patient (3.3%); and one patient stopped due to deterioration of general condition. The most common hematological toxicity was thrombocytopenia grade I (50%) of the studied group. Four patients stopped treatment due to persistent grade III toxicity and one stopped it due to deteriorated performance. Effect of the initial response to localized treatment or the type of this localized intervention on the end outcome was insignificant. Conclusion: Metronomic capecitabine has a modest antitumor efficacy on HCC patients in CR or PR after localized intervention. However, because of its low toxicity profile, it deserves further attention as a convenient, outpatient-based chemotherapy regimen. We recommend more randomized controlled trials and phase III trials with comparative arm in larger populations.

Development and Assessment of the Feasibility of a Nurse-Led Care Program for Cancer Patients in a Chemotherapy Day Center: Results of the Pilot Study.

The increasing number of cancer patients and inadequate communication in clinics are posing challenges to cancer patients receiving outpatient-based chemotherapy and healthcare providers. A nurse-led care program was proposed as one way of dealing with at least some of these challenges. The objectives of the pilot study were to assess the feasibility of the subject recruitment, care, and data collection procedures and to explore the acceptability of this program. A pilot study with a 1-group pretest-posttest design was conducted. Five cancer patients receiving chemotherapy in a chemotherapy day center participated. Each patient had a nurse consultation before chemotherapy and received 2 telephone calls after the first and second cycles of chemotherapy. Four questionnaires were adopted to evaluate the subjects' quality of life, self-efficacy, symptom experiences, and satisfaction with care. Questionnaires were completed before the chemotherapy and after the second cycle. The subjects were also interviewed to understand their comments on the service. The recruitment, care, and data collection procedures were completed smoothly. Slight changes were observed in quality of life and self-efficacy. All 5 subjects were highly satisfied with the care. The nurse-led care program is feasible and acceptable. The effect of the nurse-led care program will be evaluated in a single-center, open, randomized controlled trial. If the encouraging results can be confirmed, it may be an effective approach to improving the quality of ambulatory chemotherapy care. It would also shed light on the development of nurse-led care in other areas.

Efficacy and Toxicity of Metronomic Capecitabine in Advanced Hepatocellular Carcinoma

Background: Hepatocellular carcinoma (HCC) is a hypervascular tumor. Metronomic chemotherapy; the continuous administration of low-dose chemotherapy; has both cytotoxic and antiangiogenic effects with low toxicity profile. We evaluated the efficacy and toxicity of metronomic capecitabine (MC) in patients with advanced HCC. Patients and Methods: From May 2010, we enrolled pts with either metastatic or locally advanced diseases not candidate for ablative or locoregional treatment and have acceptable liver function. Patients received oral MC in dose of 1000 mg/m2 daily in a 21 days cycle without interruption till disease progression or toxicity. Results: The study cohort consisted of 22 patients with a median age of 63 years. The median number of cycles received was 3 cycles (range 1 - 9). From 19 patients were evaluable for response we had 3 partial responders, 10 stable diseases and disease progression in 6 patients. Median time to progression (TTP) was 2.2 months (95% CI 1.4 - 6.24) and median survival time (OS) was 4.8 months (95% CI 1.8 - 7.9). For 20 patients evaluable for safety: no grade III/IV hematological toxic effects were observed. Non-hematological toxic effects included grade III vomiting and diarrhea in one patient and grade III hand-foot syndrome in one patient. There was no treatment-related mortality. Conclusions: Based on the observed response rate, TTP and OS; MC has a modest antitumor efficacy in pts with advanced HCC. However, due to its low toxicity profile it deserves further attention as a convenient, outpatient-based chemotherapy regimen.

Port central venous catheters–associated bloodstream infection during outpatient-based chemotherapy

Central venous catheters (CVCs) are commonly used for the administration of intravenous chemotherapy in outpatient setting. Nevertheless, outbreaks of catheter-associated bloodstream infections had been reported from oncology centers. We describe a large outbreak of CVCs-associated Klebsiella oxytoca bloodstream infection, occurring in an oncology chemotherapy outpatient unit of northern Greece between October 2006 and May 2007. The outbreak involved approximately 10% of the patients with CVCs who were receiving home-based chemotherapy, and it represents the second larger outbreak of CVCs-associated BSIs due to Klebsiella oxytoca in oncology outpatient centers. We retrospectively analyzed the chain of investigations and prophylactic/diagnostic measures taken to eradicate the infection: (1) patients' chart audit, (2) estimation of the infection among asymptomatic patients, (3) implementation of the level of awareness of medical and paramedical personnel, (4) collection of samples from environment, medications and infusion materials, (5) critical appraisal of chemotherapeutical schemes and (6) cooperation with peripheral institutions. The isolation of Klebsiella oxytoca in a chemotherapy solution (infusional 5-FU in dextrose 5% solution within a 48h pump) from a peripheral General Hospital and the prompt transmission of the data to the chemotherapy center played a key role for the management of the infection cluster. This is the first report that evidenced the detection of Klebsiella oxytoca within a chemotherapeutical preparation. Data transmission from peripheral hospitals to the central institution resulted in an important feedback that allowed a better estimation of the infection cluster and more tailored actions for the eradication of the infection.

RCT makes standalization of chemotherapy for advanced gastric cancers including outpatient-based chemotherapy

RCT makes standalization of chemotherapy for advanced gastric cancers including outpatient-based chemotherapy

Multicentre phase II trial of capecitabine plus oxaliplatin (XELOX) in patients with advanced hepatocellular carcinoma: FFCD 03-03 trial

Evaluation of new drug combinations is needed to improve patients' prognosis in advanced hepatocellular carcinoma (HCC). The purpose of this study was to evaluate the safety and efficacy of the capecitabine–oxaliplatine combination (XELOX) in HCC patients. First-line chemotherapy with XELOX regimen consisting of a 3-week cycle of intravenous oxaliplatin (130 mg m−2) on Day 1, and oral capecitabine twice daily from Days 1–14 (1000 mg m−2) was administered in patients with measurable, unresectable HCC. Fifty patients (male, 88%; median age, 68 years) received a total of 295 cycles (median, 6) of treatment. Disease control (three partial responses, 29 stable diseases) rate was 72% (95% CI 57–83%). Median overall and median progression-free (PFS) survival was 9.3 months and 4.1 months, respectively. Progression-free survival rates at 6 and 12 months were 38% (95% CI 26–52%) and 14% (95% CI 7–26%), respectively. Main grade 3–4 drug-related toxicities included diarrhoea (16%), elevation of aminotransferases and/or bilirubin (16%), thrombocytopenia (12%), and neurotoxicity (6%). Capecitabine plus oxaliplatin regimen showed modest anti-tumour activity with tolerable toxicities in patients with advanced HCC. However, the manageable toxicity profile and the encouraging disease control rate deserve further attention for this convenient, outpatient-based chemotherapy regimen.

MP-19.06: Metronomic-maintenance outpatient-based chemotherapy with daily oral 5 ′-DFUR and biweekly low-dose CDDP infusion in advanced urothelial cancer

MP-19.06: Metronomic-maintenance outpatient-based chemotherapy with daily oral 5 ′-DFUR and biweekly low-dose CDDP infusion in advanced urothelial cancer

Use of electronic pagers to recall patients undergoing outpatient-based chemotherapy

Long waiting times while receiving chemotherapy in an outpatient setting have been identified as contributing to patient dissatisfaction and discomfort by a number of authors. Following an observation of this practice in a non-medical establishment, and as part of our service improvement program, we introduced the use of message pagers to recall patients in our chemotherapy outpatient service. We audited the impact of this intervention by means of questionnaires directed at patients and nursing staff. Our audit found that this intervention was particularly popular with female patients. Perceived benefits included more freedom of movement, less boredom, and peace of mind at being contactable. There were no reported problems with pager operation. Nursing staff were keen promoters of the pagers to patients as they felt that their use gave them more control over work intensity and less disruption from patients enquiring about remaining "waiting time". We concluded that this intervention may benefit other outpatient chemotherapy services.