Administration Of Chemotherapy In Patients Research Articles

Optimizing (neo)adjuvant treatment of HER2-positive breast cancer.

The development of human epidermal growth factor 2 (HER2)-directed therapy has resulted in significant improvement in outcomes for patients with early-stage HER2-overexpressing (HER2+) breast cancer. In recent years, newer HER2-directed agents and novel treatment strategies have been developed with ongoing improvements in overall outcomes. However, with the addition of newer agents, there is an increasing need to risk stratify patients to maximize efficacy and minimize toxicity of treatment. De-escalation of therapy with the potential to shorten the duration of adjuvant therapy and minimize chemotherapy administration in patients with favorable disease can be considered. On the other hand, escalation of therapy with the addition of novel HER2-directed agents and extended duration of therapy in patients at high risk of relapse can help improve long-term cure rates. Herein, we discuss recent developments in neoadjuvant and adjuvant strategies for the treatment of potentially curable HER2+ breast cancer.

565O_PR Predictors of financial catastrophe following cancer in a high-middle-income Asian country

Background Cancer is an important driver of catastrophic expenditures. We examined the risk and predictors of financial catastrophe (FC) following cancer in Malaysia, an upper middle-income country with universal health coverage. Methods Through the 2012-2014 ASEAN Costs in Oncology Study, 1662 Malaysian cancer patients were followed-up for 1 year following initial diagnosis. FC was defined as out-of-pocket health costs_ 30% of annual household income. Logistic regression analysis was used to identify the independent predictors of FC. Results Median age was 52 years; 60% were women. 51% of patients were from general hospitals, 43% from academic and 6% from private centers. 27% had some type of health insurance. Excluding 430 patients with hematologic malignancies, 60% of patients had stage III or stage IV cancer at initial diagnosis. Only 58% of eligible patients with non-metastatic cancers received surgery. Chemotherapy administration in patients with solid tumors was 79%. At 1-year, 8% of patients with solid tumors, and 24% of patients with hematological malignancies had died. Of those who were alive, 51% experienced FC. Factors independently associated with FC were low-income status (odds ratio [OR]: 23.21, 95%CI: 15.01-35.89, vs. high-income), attending private or academic hospitals (OR: 6.41, 95%CI: 2.88-14.24, and OR: 4.76, 95%CI: 3.32-6.81, respectively vs. general hospitals), lack of health insurance (OR: 1.61, 95%CI: 1.14-2.28, vs. having health insurance), and lack of surgery (OR: 1.41, 95%CI: 1.02-1.94, vs. receipt of surgery). Lower risk of FC was observed in patients with hematologic malignancies (OR: 0.15, 95%CI: 0.07-0.33, vs. solid tumors), and those without chemotherapy (OR: 0.54, 95%CI: 0.36-0.80, vs. chemotherapy). Analyses confined to patients with non- metastatic breast and colorectal cancers did not change inferences. Conclusions A high proportion of Malaysians suffer FC due to cancer. Key policy changes need to focus on improvements in early cancer detection, and delivery of main modalities of cure and control. The government must also re-evaluate the existing health-financing mechanism to increase financial risk protection, especially for the poor, and ensure practice of Value Based Medicine. Legal entity responsible for the study Medical Research and Ethics Committee, Malaysia Funding Roche Malaysia Disclosure N. Bhoo Pathy, C-H. Yip: Received honorarium and travel grant from Roche Malaysia. M. Kimman: Received honorarium and travel grant from Roche Asia Pacific. All other authors have declared no conflicts of interest.

Stereotactic catheter placement for Ommaya reservoirs

Ommaya reservoirs are an important surgical therapy for the chronic intrathecal administration of chemotherapy for patients with leptomeningeal carcinomatosis. Surgical accuracy is paramount in these patients with typically normal sized ventricles, and may be improved with stereotactic guidance. This paper aimed to review a large series of stereotactic Ommaya catheter placements, examining accuracy and complications. We conducted a retrospective review of 109 consecutive adult patients who underwent stereotactic Ommaya catheter placement for leptomeningeal carcinomatosis or central nervous system lymphoma at Columbia University Medical Center, USA, from 1998–2013. The rate of accurate placement in the ventricular system was 99%, with the only poor catheter position due to post-placement migration. The rate of peri-operative complications was 6.4%. Hemorrhagic complications occurred in patients with thrombocytopenia or therapeutic anti-coagulation pre-operatively or during the post-operative period. Use of stereotaxy for catheter placement of Ommaya reservoirs is safe and effective, and should be considered when placing a catheter into non-hydrocephalic ventricles.

Mesenchymal chondrosarcoma: Prognostic factors and outcome in 113 patients. A European Musculoskeletal Oncology Society study

BackgroundMesenchymal chondrosarcoma (MCS) is a distinct, very rare sarcoma with little evidence supporting treatment recommendations. Patients and methodsSpecialist centres collaborated to report prognostic factors and outcome for 113 patients. ResultsMedian age was 30years (range: 11–80), male/female ratio 1.1. Primary sites were extremities (40%), trunk (47%) and head and neck (13%), 41 arising primarily in soft tissue. Seventeen patients had metastases at diagnosis. Mean follow-up was 14.9years (range: 1–34), median overall survival (OS) 17years (95% confidence interval (CI): 10.3–28.6). Ninety-five of 96 patients with localised disease underwent surgery, 54 additionally received combination chemotherapy. Sixty-five of 95 patients are alive and 45 progression-free (5 local recurrence, 34 distant metastases, 11 combined). Median progression-free survival (PFS) and OS were 7 (95% CI: 3.03–10.96) and 20 (95% CI: 12.63–27.36) years respectively. Chemotherapy administration in patients with localised disease was associated with reduced risk of recurrence (P=0.046; hazard ratio (HR)=0.482 95% CI: 0.213–0.996) and death (P=0.004; HR=0.445 95% CI: 0.256–0.774). Clear resection margins predicted less frequent local recurrence (2% versus 27%; P=0.002). Primary site and origin did not influence survival. The absence of metastases at diagnosis was associated with a significantly better outcome (P<0.0001). Data on radiotherapy indications, dose and fractionation were insufficiently complete, to allow comment of its impact on outcomes. Median OS for patients with metastases at presentation was 3years (95% CI: 0–4.25). ConclusionsPrognosis in MCS varies considerably. Metastatic disease at diagnosis has the strongest impact on survival. Complete resection and adjuvant chemotherapy should be considered as standard of care for localised disease.

1000 Port-A-Cath ® placements by subclavian vein approach: single surgeon experience.

Totally implantable venous access ports are widely used for the administration of chemotherapy in patients with cancer. Although there are several approaches to implantation, here we describe Port-A-Cath(®) (PAC) placement by percutaneous puncture of the subclavian vein with ultrasonographic guidance. Data on our vascular access service were collected prospectively from June 2004. This service included port-a-caths and Hickman lines. Once 1000 consecutive port-a-caths(®) had been reached the study was closed and data analysed for the port-a-caths(®) alone. The left subclavian vein was the preferred site for venous access, with the right subclavian and jugular veins being the alternative choices if the initial approach failed. Patients were followed up in the short-term, and all the procedures were carried out by a single surgeon at each one of two institutions. Venous access by PAC was established in 100 % of the 1,000 cases. Of the 952 patients where the left subclavian vein was chosen for the first attempt of puncture, the success rate of PAC placement was 95 % (n = 904). Pneumothorax occurred in 12 patients (1.2 %), and a wound haematoma occurred in 4 (0.4 %) out of the total 1,000 patients. No infections were recorded during the immediate post-operative period but only in the long-term post-operative use with 8 patients requiring removal of the PAC due to infection following administration of chemotherapy. This is a very large series of PAC placement with an ultrasound-guided approach for left subclavian vein and X-ray confirmation, performed by a single surgeon, demonstrating both the safety and effectiveness of the procedure.

No improvement in median survival for patients with metastatic gastric cancer despite increased use of chemotherapy

BackgroundGastric cancer often presents in a metastasized stage. We conducted a population-based study to evaluate trends in systemic treatment and survival of metastatic noncardia gastric cancer. Patients and methodsAll patients with noncardia adenocarcinoma of the stomach, diagnosed between 1990 and 2011 in the Eindhoven Cancer Registry area in the Netherlands were included (N = 4797). We conducted multivariable logistic regression analysis to evaluate trends in administration of palliative chemotherapy and multivariable proportional hazards regression analyses to evaluate trends in crude overall survival. ResultsThe proportion of patients presenting with metastatic gastric cancer increased from 24% in 1990 to 44% in 2011 (P < 0.0001). The use of palliative chemotherapy increased, from 5% in 1990 to 36% in 2011, with a strong increase in particular after 2006 (P < 0.0001). Younger patients [<50 years: adjusted odds ratio (ORadj) 3.9, P < 0.001; 50–59 years: ORadj 1.7, P = 0.01] and patients with a high socioeconomic status (ORadj 1.7, P = 0.01) more often received chemotherapy. In contrast, older patients (70–79 years: ORadj 0.3, P < 0.001; 80+ years: ORadj 0.02, P < 0.001), patients with comorbidity (ORadj 0.6, P = 0.03), linitis plastica (ORadj 0.5, P = 0.03) and multiple distant metastases (ORadj 0.5, P = 0.01) were less often treated with chemotherapy. A large hospital variation was observed in the administration of palliative chemotherapy (9%–27%). Median overall survival remained constant between 15 [95% confidence interval (CI) 11.9–17.7] and 17 (95% CI 15.0–20.0) weeks (P = 0.10). ConclusionsThe increased administration of chemotherapy in patients with metastatic gastric cancer did not lead to an increase in population-based overall survival. Identification of the subgroup of patients which benefits from palliative chemotherapy is of utmost importance to avoid unnecessary treatment.

R-CHOP every 21 days for diffuse large B-cell lymphoma: still the standard of care?

Evaluation of: Cunningham D, Hawkes EA, Jack A et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a Phase 3 comparison of dose intensification with 14-day versus 21-day cycles. Lancet 381(9880), 1817-1826 (2013). Therapy of newly diagnosed diffuse large B-cell lymphoma is largely unchanged for the past 30 years. Investigators have evaluated if modification of the schedule of drug administration may have a positive effect on outcomes. This article focuses on a recent Phase III clinical trial, which compared every 2- versus 3-week administration of chemotherapy in patients with newly diagnosed diffuse large B-cell lymphoma. The trial found that there was no significant difference between the two dosing schedules. We evaluate the data from this and other trials, and give our recommendations for future studies.

Towards a better understanding of Kaposi sarcoma-associated immune reconstitution inflammatory syndrome

Towards a better understanding of Kaposi sarcoma-associated immune reconstitution inflammatory syndrome

P-0020 - No Improvement in Median Survival for Patients with Metastasized Gastric Cancer Despite Increased Use of Chemotherapy

Background: Gastric cancer often presents late in an irresectable or metastasized stage. We conducted a population-based study to evaluate trends in systemic treatment and survival of metastasized non-cardia gastric cancer. Methods: All patients with non-cardia adenocarcinoma of the stomach, diagnosed between 1990 and 2011 in the Eindhoven Cancer Registry area in the Netherlands were included (N = 4797). We conducted multivariable logistic regression analysis to evaluate trends in administration of palliative chemotherapy and multivariable proportional hazards regression analyses to evaluate trends in crude overall survival. Results: The proportion of patients presenting with metastasized gastric cancer, defined as stage IV according to the TNM classification in the respective period, increased from 25% in 1990 to 44% in 2011 (p < 0.0001). The use of palliative chemotherapy increased, from 5% in 1990 to 36% in 2011, with a strong increase in particular after 2006. Younger patients aged < 50 (46%, adjusted odds ratio (ORadj) 4.3, p < 0.001) or between 50-59 (23%, ORadj 1.7 and p = 0.02) and patients with a high socioeconomic status (25%, ORadj 1.5, p = 0.02) received more chemotherapy. In contrast, patients aged 70-79 years (10%, ORadj 0.28, p < 0.001) or 80+ years (1%, ORadj 0.02, p < 0.001), patients with comorbidity (17%, ORadj 0.6 p= 0.02), linitis plastica (19%, ORadj 0.6, p = 0.04) and multiple distant metastases (18%, ORadj 0.5 P = 0.007) were less often treated with chemotherapy. A large variation was observed between 10 community hospitals in the administration of palliative chemotherapy, varying between 9% and 27%. Median overall survival remained constant between 16 (CI 12.3-18.6) and 18 (CI 15.4-21.1) weeks (p = 0.10). In addition, female sex (HR 0.8, p = 0.001), poor or undifferentiated tumor grade (HR 1.2, p = 0.001), liver metastases (HR 1.6, p < 0.001, multiple distant metastases (HR 1.5, p < 0,001) and administration of chemotherapy (HR 0.6, p < 0,001) had an independent effect on survival. Conclusion: The increased administration of chemotherapy in patients with metastasized gastric cancer did not lead to an increase in population-based overall survival. Identification of the subgroup of patients who benefit from palliative chemotherapy is of utmost importance to avoid unnecessary treatment.

Administration of Cisplatin-Based Chemotherapy for Advanced Urothelial Carcinoma in the Community

BackgroundRenal dysfunction, poor performance status, and comorbidities may preclude frontline cisplatin-based chemotherapy in patients with advanced urothelial carcinoma (UC). The frequency of cisplatin-based chemotherapy administration in patients with advanced UC in community-based cancer centers is unknown. Patients and MethodsA retrospective study was conducted to evaluate chemotherapy regimens administered to patients with the AJCC (American Joint Committee on Cancer) stage-4 UC who, from 2001 to 2010, presented to Texas Oncology Cancer Centers. Frontline chemotherapy was classified as cisplatin based, carboplatin based, nonplatinum based, and as no chemotherapy administered. ResultsA total of 298 patients were eligible for analysis, of whom 197 (66.1%) were men. The median age was 70 years (range, 28-97 years), and the primary sites of disease were bladder (243 [81.5%]), renal pelvis (41 [13.8%]), and ureter (14 [4.7%]). Overall, the regimens administered were cisplatin based in 107 patients (35.9%), carboplatin based in 81 (27.2%), and nonplatinum based in 25 (8.4%); no chemotherapy was administered in 71 (23.8%), and data were not available in 14 patients (4.7%). Cisplatin administration was more common in patients aged ≤70 years (62/150 [41.3%]) as opposed to >70 years (45/148 [30.4%]) (P = .05). Noncisplatin regimens or no chemotherapy were trending to be more commonly administered to patients >70 years (64.2 vs. 54.7%; P = .10). Limitations of a retrospective database study apply. ConclusionA first-line cisplatin-based regimen was administered to 35.9% of patients who presented with AJCC stage 4 UC in a community-based cancer center network. Drug development focused on tolerable single-agent therapy or combination regimens without a cisplatin backbone should be a priority.

Conventional Pre-operative Chemoradiotherapy and Post-operative Adjuvant Chemotherapy with Induction Chemotherapy Followed by Chemoradiotherapy and Surgery in Locally Advanced Rectal Cancer

In locally advanced rectal cancer, pre-operative combined-modality treatment with 5-fluorouracil and radiation has become standard, as it improves locoregional control. However, to date, no improvement has been demonstrated in terms of survival outcomes. Phase III trials published in the past decade included clinically staged populations of heterogeneous risk, and one recurring finding was that there was poor adherence to the adjuvant chemotherapy treatment after surgery. No randomized studies have been able to show that the administration of adjuvant chemotherapy in patients undergoing pre-operative radiochemotherapy improves outcomes, compared to observation. One strategy to address this is to give upfront chemotherapy prior to pre-operative chemoradiotherapy. Compared with post-operative chemotherapy, the upfront strategy does not appear to improve pathological complete response, but it has been found to have a better toxicity profile, improve compliance with treatment, and provide greater exposure to systemic treatment. This can be important for patients at higher risk of distant disease relapse. Introducing a systemically active combination chemotherapy prior to chemoradiotherapy and surgery in an appropriately selected high-risk population may well be the next step in phase III testing in order to improve disease-free survival.

Is a Low Dose of Concomitant Chemotherapy With Extended-Field Radiotherapy Acceptable as an Efficient Treatment for Cervical Cancer Patients With Metastases to the Para-Aortic Lymph Nodes?

Extended-field radiotherapy (EFRT) with the concomitant administration of chemotherapy for patients with advanced cervical cancer has problems regarding its feasibility. The goal of the present study was to assess the tolerability and control rate of low-dose cisplatin with EFRT in patients with imaging-confirmed positive para-aortic lymph nodes (PALs). Sixteen patients with cervical cancer metastatic to the PALs treated with EFRT were evaluated. The patients included those with stages I to III disease according to the International Federation of Gynecology and Obstetrics with positive PALs diagnosed by computed tomographic imaging. The patients were treated with 25 to 30 mg/m weekly of cisplatin concurrently with radiation therapy. Doses of 48.6 to 51.0 Gy were delivered in 1.8-Gy fractions to the pelvis and included the PALs field. In addition, boost doses for the involved nodes of PALs were delivered contiguously for a total dose of 54 to 60 Gy. All patients were treated with a high dose rate of intracavitary brachytherapy combined with external irradiation. All patients completed the radiation therapy. Grade 3 or 4 acute hematologic toxicity occurred in 7 patients, but there were no cases of grade 3 or 4 nonhematologic acute toxicity. As a late toxicity, 1 patient developed a grade 3 small bowel obstruction. No grade 4 or worse late toxicity occurred. The 4-year overall survival rate was 56.3%. The 4-year distant metastasis-free survival rate was 50%. Seven patients had no recurrence. Eight patients developed distant failures, and another had an isolated local intrapelvic recurrence. A dose greater than 54 Gy for positive PALs in EFRT, in combination with intracavitary irradiation and low-dose weekly cisplatin administration, was safely completed by all of our patients. However, half of the patients had distant failure. This study provided relatively favorable local control and survival. Further considering modifications of the treatment should therefore be encouraged.

The Effect of Oncotype Dx® Recurrence Score on Treatment Recommendations for Patients with Early Stage Estrogen Receptor Positive Breast Cancer.

Abstract Background: Current guidelines recommend administration of chemotherapy for patients with breast carcinomas &amp;gt;1 cm in size, with consideration for patient age, comorbidities and tumor grade. However, it is unknown which patients actually benefit from therapy and overtreatment of a significant proportion of patients is a major concern. We investigated the impact of the Oncotype Dx® Recurrence Score (RS) on chemotherapy recommendations in early stage estrogen receptor (ER) positive breast cancer patients.Methods: We selected 154 patients with early stage ER positive breast cancer and available RS for the study. Clinicopathologic data, including age, menopausal status, tumor size, type, grade, mitotic activity, presence of lymphatic invasion, nodal status, hormone receptor and HER2 status on all patients were provided to four surgical oncologists, four medical oncologists and three pathologists, specializing in breast cancer diagnosis and management. Assuming that all patients were in good general health and would receive endocrine therapy, participants were asked whether they would also advovate adjuvant chemotherapy based on clinicopathologic data with and without knowledge of the RS, and to provide the three salient clinicopathologic features on which their recommendations were based. Changes in recommendations of participants following inclusion of RS data were compared.Results: Based on RS results, 95 (61.7%), 45 (29.2%) and 14 (9.1%) tumors were of low (RS &amp;lt;18), intermediate (RS 18-30) and high (RS ≥31) risk, respectively. The results are summarized in Table 1. Assuming that the hypothesis previously put forward that patients with low to intermediate risk RS are not likely to benefit from chemotherapy, 82.3 ± 1.3% (75.5 - 89.0%) and 69.0 ± 6.9% (5.9 - 85.7%) of patients for whom chemotherapy was recommended by the participants would be "overtreated" without and with the use of RS results (p = 0.0322). No statistically significant difference was found among surgeons, medical oncologists and pathologists. Participants ranked patient age/menopausal status, hormone receptor status and tumor stage/nodal status to be the most important features when recommending chemotherapy.Conclusions: Although current recommendations for adjuvant chemotherapy for early stage ER positive breast cancer patients are largely in line with published guidelines, inclusion of RS alters recommendations in about 25% of cases. While medical oncologists recommended chemotherapy more frequently compared to surgeons and pathologists, they were more likely to change recommendations in light of RS results.Table 1. Summary of results SurgeonsMedical oncologistsPathologistsp* Mean ± SEMRangeMean ± SEMRangeMean ± SEMRange Chemo without RS (%)29.2 ± 1.824.0 - 31.859.0 ± 5.046.8 - 70.846.8 ± 3.741.6 - 53.90.0156Chemo with RS (%)27.0 ± 5.611.0 - 36.438.6 ± 9.517.5 - 63.644.4 ± 5.833.8 - 53.90.1794No change (%)75.3 ± 7.054.5 - 85.766.7 ± 6.851.3 - 83.885.9 ± 6.478.6 - 98.70.3682Add chemo (%)11.2 ± 4.13.2 - 22.76.5 ± 1.93.2 - 11.75.8 ± 3.20.6 - 11.70.6882Avoid chemo (%)13.5 ± 3.94.5 - 22.726.8 ± 7.94.5 - 41.68.2 ± 4.50.6 - 16.20.2186*Kruskal-Wallis test Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4058.

Long-term follow-up (&gt;20 years) for one of the original randomized prospective trials evaluating adjuvant chemotherapy in patients with high-grade operable osteosarcoma

10514 Background: Neoadjuvant and adjuvant chemotherapy is now standard practice for patients who present with localized osteosarcoma. We present the long-term follow-up (&gt;20years) for one of the original prospective randomized trials that compared adjuvant chemotherapy to no treatment in patients with high-grade operable osteosarcoma. Methods: The original study was performed at UCLA from 1981 to 1984. During this time, 59 patients with high-grade, operable, non-metastatic osteosarcoma were randomized to receive adjuvant chemotherapy (MSKCC T-10B protocol)(N=32; 24 men, 8 women, median age 15 yrs) vs. expectant management (N=27; 20 men, 7 women, median age 18 yrs). All patients received one neoadjuvant course of intra-arterial doxorubicin hydrochloride (90mg) and radiation (1750cGy). At a median follow-up of 2 years, there was a statistically significant improvement in both disease-free (55% vs. 20%, p&lt;.01) and overall survival (80% vs. 48%, p&lt;.01) for those who received immediate adjuvant chemotherapy. Upon recurrence, patients in the T-10B arm received salvage chemotherapy with doxorubicin hydrochloride and cisplatin while those in the expectant arm received the T-10B protocol. 27 years after the initiation of the trial, long-term follow-up was obtained on all patients. Results: Median follow-up time for survivors was 24 years. 18 patients in the adjuvant chemotherapy arm died of disease (DOD) while 14 have no evidence of disease (NED). 22 patients in the control arm DOD, 1 died of other causes and 4 have NED. The 5, 10, and 20 year disease specific survival (DSS) for the treatment arm (47%, 43%, 43% respectfully) was significantly better than that of the control arm (30%, 26%, 17% respectfully) (p=0.0254). Conclusions: Early administration of chemotherapy in patients with high-grade operable osteosarcoma provides a significant survival benefit that is maintained with long-term (&gt;20 years) follow-up. These results support the idea that early systemic treatment offers the best opportunity to cure patients with this high-risk malignancy. No significant financial relationships to disclose.

The influence of a gene expression profile on breast cancer decisions

11546 Background: Gene expression profiles (such as Oncotype Dx Recurrence Score [RS]) show promise for informing adjuvant therapy recommendations in patients with ER-positive breast cancer. The effects of the test are still being defined. We studied the impact of this test upon our actual administration of chemotherapy in patients with ER-positive, node negative breast cancer as well as the effect of the test upon a panel of 5 breast oncologists. Methods: Recommendations for adjuvant therapy (prior to RS) and actual administration of adjuvant therapy (after RS) for consecutive patients with ER positive breast cancer were recorded. Six months later, with the same clinical information, a panel of oncologists gave recommendations for adjuvant therapy with and without RS results (with a two month interval wash out period). Recommendations were graded on a scale from 1 to 10 (1- strongest against, 10 strongest for). Panel changes, rates of panel non- consensus, and confidence changes (absolute value difference in recommendation from “5”) in panel member recommendations were compared before and after knowledge of the RS. Results: There were 29 patients. Pre RS recommendations were for chemotherapy in 13 (45%) and against in 16 (55%). RS results altered the administration of chemotherapy in in 9 (31%) patients; 7 (54%) patients recommended for chemotherapy did not receive it, and 2 (13%) patients received chemotherapy after it was not initially recommended. The panel initially recommended chemotherapy in 12 patients (41.4%) and against in 17 (59%). RS results changed panel recommendations in 7 cases (24%); 5 (42%) changed to against and 2 (12%) changed to for chemotherapy after test results. The RS reduced non-consensus recommendations of the panel by 10% and changed the confidence in 95 of 145 (65%) of panelist’s recommendations- 55% of which were decreased. Conclusions: RS resulted in chemotherapy administration changes in 31% of actual patients and 24% of panelist’s recommendations using the same medical information. The RS reduced non-consensus recommendations among the panelists but did not improve confidence. The opinions expressed here are those of the authors and do not reflect the official policy or position of the U.S. Navy, Department of Defense, nor the U.S. Government. No significant financial relationships to disclose.

Costs associated with intravenous chemotherapy administration in patients with small cell lung cancer: a retrospective claims database analysis

ABSTRACTObjectives: With new oral chemotherapy drugs emerging, it is useful to understand the costs associated with traditional intravenous (IV) therapy. This study aims to assess costs associated with IV chemotherapy in patients with small cell lung cancer (SCLC) from the perspective of large employer-payers.Study design: Descriptive retrospective claims database analysis.Methods: Using medical claims data from 5.5 million beneficiaries between 01/01/1998 and 01/31/2006, we identified patients with lung cancer (ICD-9 codes 162.3–162.9, 176.4, or 197.0) who received IV chemotherapy. A case-finding SCLC algorithm was then applied which selected patients who were treated with chemotherapies commonly used in SCLC (cisplatin/etoposide, cis­platin/irinotecan, carboplatin/etoposide, topotecan, or cyclophosphamide/doxorubicin/vincristine) and then excluded those who had treatments or procedures indicative of non-small cell lung cancer (NSCLC) (positron emission tomography [PET] scan imaging, lung surgery, common NSCLC chemotherapies). Average total costs paid per day of IV chemotherapy administration were computed, along with separate costs for IV chemotherapy drugs, IV chemotherapy administration procedures, and other drugs and services received on IV visit days. Costs were also estimated per course of treatment based on the assumption of four chemotherapy cycles per course with three visits per cycle.Results: Among 8010 patients with a lung cancer diagnosis, 802 were identified as SCLC. In the SCLC subset, the average total daily cost was $787 ($9449/course), with $395 ($4742/course; 50.2%) attributable to IV chemotherapy drugs, $93 ($1112/course; 11.8%) to IV chemotherapy administration, and $300 ($3595/course; 38.0%) to other drugs and services.Conclusions: The proposed algorithm identified about 10% of patients with lung cancer receiving IV chemotherapy as likely SCLC cases. Future studies should validate this algorithm with medical records data. IV chemotherapy administration and other visit-related drugs and services represented about half of the total cost per IV visit day, with the remainder attributable to direct costs for IV chemotherapy drugs.

Continuous ambulatory peritoneal dialysis: pharmacokinetics and clinical outcome of paclitaxel and carboplatin treatment

PurposeAdministration of chemotherapy in patients with renal failure, treated with hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) is still a challenge and literature data is scarce. Here we present a case study of a patient on CAPD, treated with weekly and three-weekly paclitaxel/carboplatin for recurrent ovarian cancer.ExperimentalDuring the first, second and ninth cycle of treatment, blood, urine and CAPD samples were collected for pharmacokinetic analysis of paclitaxel and total and unbound carboplatin-derived platinum.ResultsTreatment was well tolerated by the patient. No excessive toxicity was observed and at the end of treatment she was in a complete remission. The plasma pharmacokinetics of paclitaxel were unaltered compared to historical data, with neglectable urinary and CAPD clearance. In contrast, the pharmacokinetics of carboplatin were altered, with doubled half-lives compared to patients with normal renal function. Of the administered carboplatin dose, up to 20% was cleared via the dialysate, while only up to 8% was cleared via the urine.ConclusionPaclitaxel and carboplatin can be safely administered to patients with chronic renal failure on CAPD. For paclitaxel the generally applied dose can be administered, and although for carboplatin dose-adjustment is required due to the diminished renal function, the dose can be calculated using Calvert’s formula.

P1-223: Costs associated with intravenous chemotherapy administration in patients with lung cancer

P1-223: Costs associated with intravenous chemotherapy administration in patients with lung cancer

Predicting bacteraemia following chemotherapy administration in patients with hematological cancer (HC)

19543 Background: Infections cause important morbidity and mortality in patients undergoing treatment for cancer. The type and the intensity of chemotherapy play an important role in the risk of infection which manifests itself most often as febrile neutropenia (FN) but regimen-specific risks are not well defined. Since bacteraemia is associated with increased mortality, we tried to determine predictors of it and to validate a classification of aggressiveness of a given chemotherapy regimen (CR) to be used in a risk prediction model in patients with HC. Methods: Patients older than 16 years, diagnosed with HC of any type were prospectively enrolled and followed at the “Institut Jules Bordet” and at the “Cliniques Universitaires Saint-Luc (UCL)” between 2001–2005. Out of the 266 patients, 22.9%, 43.6% and 33.5% were followed respectively during one cycle, 2 to 4 cycles and more than 4 cycles, totalizing 1053 cycles. Relevant patient’s information were collected at the beginning of the first cycle. Before each cycle, the CR score was computed, a blood examination performed and the temperature measured. Bacteraemia was defined according to IDSA criteria. FN was defined as a neutrophil count &lt; 500/μl and fever. Generalized Estimating Equations (GEE) was used for the analysis. Results: Among 1017 evaluable cycles, 148 (14.5%) were followed by an episode of bacteraemia. Among the cycles with FN, 35.5% had bacteraemia. In the final model, adjusted for antimibrobial prophylaxis (R2=0.22), the CR score was the most important predictor of bacteraemia (OR 4.2 [95% CI, 2.3–7.6]), for patients given an aggressive regimen compared to the others. The other predictors associated with bacteraemia were: underlying disease (3.2 [1.9–5.2]), a baseline monocytopenia (&lt;150/μL) (2.7 [1.6–4.3]), a baseline CRP &gt;10 mg/L (2.1 [1.2–3.7]), the first cycle of patient’s treatment (0.3 [0.2–0.7]) and the administration of immunosuppressive agents (2.2 [1.2–4.0]). Conclusions: Bacteraemia was frequent in patients with HC undergoing myelosuppressive chemotherapy, especially in patients with FN. The CR plays an important role but further studies are needed to investigate yet unidentified additional risk factors. Grant given by the FNRS in Belgium (“Fonds National pour la Recherche Scientifique”) No significant financial relationships to disclose.

Costs associated with intravenous (IV) chemotherapy administration in patients with lung cancer

18092 Background: The IV method of chemotherapy administration imposes not only a time burden on patients and facilities, but also has cost implications for payers. This study aims to assess the costs associated with the IV administration of chemotherapies for patients with all forms of lung cancer and for a subset of patients with small cell lung cancer (SCLC) in a large employer-payer claims database. Methods: Using medical claims data from 5.5 million beneficiaries between 01/01/1998 and 01/31/2006, we identified 8,605 patients with lung cancer (ICD-9 codes 162.3–162.9, 176.4, or 197.0) receiving IV chemotherapies. We then identified a subset of 942 patients likely to have SCLC by selecting those receiving chemotherapy regimens primarily used to treat SCLC and excluding patients receiving procedures and treatments often associated with NSCLC. Average total costs per day of IV chemotherapy administration (including drug, administration costs, etc.) were computed for all patients and for the SCLC subset based on the actual amount paid. Costs were also computed separately for: IV chemotherapy drugs, IV chemotherapy administration procedures, and other drugs and services such as IV administration of other drugs to treat side effects of chemotherapies, evaluation and management, and laboratory tests. Results: Average total cost per day of IV chemotherapy administration for all patients was $1,112, with $652 (59%) attributable to IV chemotherapy drugs, $85 (8%) to IV chemotherapy administration procedures, and $375 (34%) to other drugs and services. Among patients with SCLC, average total daily cost was $815, with $423 (52%) attributable to IV chemotherapy drugs, $89 (11%) to IV chemotherapy administration, and $303 (37%) to other drugs and services. Conclusions: IV chemotherapy administration procedures and other visit-related services accounted for 42% and 48% of total costs in patients with all forms of lung cancer and those with SCLC, respectively. The increased availability and use of oral chemotherapy drugs in lung cancer should provide savings to payers by avoiding the costs associated with IV administration. No significant financial relationships to disclose.