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1.  Impact of 5-HT3 receptor antagonists on chemotherapy-induced nausea and vomiting: a retrospective cohort study 
Background
1st generation 5-hydroxytryptamine receptor antagonists (5-HT3 RAs), and palonosetron, a 2nd generation 5-HT3 RA, are indicated for the prevention of chemotherapy (CT)-induced nausea and vomiting (CINV) associated with moderately (MEC) and highly emetogenic CT agents (HEC). This study explores the impact of step therapy policies requiring use of an older 5-HT3 RA before palonosetron on risk of CINV associated with hospital or emergency department (ED) admissions.
Methods
Patients who received cyclophosphamide post breast cancer (BC) surgery or who were diagnosed with lung cancer on carboplatin (LC-carboplatin) or cisplatin (LC-cisplatin) were selected from PharMetrics’ (IMS LifeLink) claims dataset (2005-2008). Patients were followed for 6 months from initial CT administration for CINV events identified through ICD-9-CM codes. Patients were grouped into those initiated with older, generic 5-HT3 RAs (ondansetron, granisetron, and dolasetron) and those initiated and maintained on palonosetron throughout study follow-up. CINV events and CINV days were analyzed using multivariate regressions controlling for demographic and clinical variables.
Results
Eligible patients numbered 3,606 in BC, 4,497 in LC-carboplatin and 1,154 in LC-cisplatin cohorts, with 52%, 40%, and 34% in the palonosetron group, respectively. There was no significant difference between the two 5-HT3 RA groups in age or Charlson Comorbidity Index among the two MEC cohorts (BC and LC-carboplatin). Among the LC-cisplatin cohort, palonosetron users were older with more males than the older 5-HT3 RA group (age: 60.1 vs. 61.3; males, 66.9% vs. 56.9%). Compared to the older 5-HT3 RAs, the palonosetron groups incurred 22%-51% fewer 5-HT3 RA pharmacy claims, had fewer patients with CINV events (3.5% vs. 5.5% in BC, 9.5% vs. 12.8% in LC-carboplatin, 16.4% vs. 21.7% in LC-cisplatin), and had lower risk for CINV events (odds ratios 0.62, 0.71, or 0.71, respectively; p < 0.05). The BC and LC-carboplatin palonosetron groups experienced 50% and 30% fewer CINV days than the generic 5-HT3 RA group (p < 0.05).
Conclusions
Patients with breast or lung cancer initiated and maintained on palonosetron were at significantly lower risk for potentially costly CINV versus those on older 5-HT3 RAs. Further studies on impact of step therapy policy are warranted in order to minimize the clinical and economic burden of CINV.
doi:10.1186/1472-6963-12-215
PMCID: PMC3437203  PMID: 22823909
2.  Comparative clinical effectiveness of various 5-HT3 RA antiemetic regimens on chemotherapy-induced nausea and vomiting associated with hospital and emergency department visits in real world practice 
Supportive Care in Cancer  2011;20(5):941-949.
Purpose
The aim of this study was to compare the risk of chemotherapy-induced nausea and vomiting (CINV) events for various 5-HT3 RAs in patients who received moderately (MEC) or highly emetogenic chemotherapy (HEC) by evaluating hospital or emergency department (ED) admissions.
Methods
PharMetrics claims database was used to identify patients diagnosed with breast cancer (BC) who were initiated on cyclophosphamide-based adjuvant chemotherapy or with lung cancer (LC) initiated on carboplatin-based or cisplatin-based chemotherapy between 2005 and 2008. Patients were stratified in two groups: those initiated and maintained on palonosetron versus those treated with any other 5-HT3 RA regimens in the 6-month post first chemotherapy. Risk for CINV events, identified by ICD-9-CM for nausea, vomiting, and/or dehydration, were estimated using logistic regressions, controlling for age, gender, comorbidity, and total chemotherapy doses or days.
Results
Of the 4,868 cyclophosphamide-treated BC, 5,414 carboplatin-treated LC, and 1,692 cisplatin-treated LC identified, there were 1,864 BC (38.5%), 1,806 carboplatin-treated LC (33.4%), and 390 cisplatin-treated LC (23.0%) in the palonosetron-only group. Palonosetron-only group had significantly lower probability of CINV events associated with ED/hospital admissions in all three cohorts (3.5% vs. 6.3% in BC, 9.5% vs. 13.8% in carboplatin-treated LC, and 16.4% vs. 22.6% in cisplatin-treated LC, all at p < 0.05). Logistic regressions found palonosetron-only group had significantly lower risk of CINV events (odds ratios = 0.550, 0.653, and 0.689 in BC, carboplatin-treated LC and cisplatin-treated LC, respectively, p < 0.05).
Conclusion
Patients with lung or breast cancer receiving MEC or HEC had significantly lower risk of CINV events associated with hospital/ED admissions if initiated and maintained on palonosetron relative to patients receiving 5-HT3 RA regimens.
doi:10.1007/s00520-011-1165-1
PMCID: PMC3313025  PMID: 21533811
CINV; 5-HT3 RAs; Palonosetron; Comparative effectiveness
3.  Zoledronic acid therapy impacts risk and frequency of skeletal complications and follow-up duration in prostate cancer patients with bone metastasis 
Purpose
To evaluate the effects of timing and length of zoledronic acid (ZA) treatment on outcomes for patients with prostate cancer in clinical practice.
Materials and methods
Patients with prostate cancer and first bone metastasis diagnosed from January 2003 to October 2006 were included. Patients were considered ‘untreated’ if no ZA was given, ‘early ZA-treated’ if ZA was initiated before skeletal complication (SC) occurrence or ‘late ZA-treated’ if one or more SC was documented before or at ZA initiation. Patients were classified with short (≤90 days), medium (91–180 days) or long (>180 days) treatment persistence. Assessments included follow-up duration (FUP) and risk of developing one or more SC.
Results
Among eligible patients, 847 were untreated, 243 were early ZA-treated and 218 were late ZA-treated. For untreated versus early ZA-treated groups, median FUP was 263 versus 357 days (p<0.0001), respectively, and time to first SC was 199 versus 273 days (p<0.0001), respectively. ZA treatment was associated with significantly longer FUP and lower SC risk. The early ZA-treated group had significantly longer FUP versus the late ZA-treated group (median days, 357 vs. 299.5); the late ZA-treated group experienced significantly higher SC risk vs. the early ZA-treated group (odds ratio, 1.51). Compared with the long-persistence group, FUP was 56% and 40% shorter in the short and medium groups, respectively (p<0.0001).
Conclusion
Treatment with and early initiation of ZA for patients with prostate cancer and bone metastasis significantly prolonged time to and reduced risk of developing SC, while extending FUP.
doi:10.1185/03007995.2010.535511
PMCID: PMC3047395  PMID: 21083514
Bone metastasis; Prostate; Prostatic neoplasms; Skeletal complication; Zoledronic acid
4.  Zoledronic Acid and Skeletal Complications in Patients With Solid Tumors and Bone Metastases 
Cancer  2008;113(6):1438-1445.
BACKGROUND
Bone is among the most common sites of metastasis in patients with advanced cancer, and the development of bone metastases places patients at increased risk for skeletal complications.
METHODS
This retrospective claims analysis included only patients with a diagnosis of bone metastasis who had a single type of solid tumor of the breast (women), prostate, or lung and experienced ≥1 skeletal complication between January 2002 and October 2005.
RESULTS
The mean follow-up (±standard deviation) for zoledronic acid (ZA)-treated patients versus untreated patients was 12.2 ± 9.05 months versus 8.7 ± 9.28 months, respectively (P <.001). The monthly rate of skeletal complications in ZA-treated patients versus untreated patients was 0.29 ± 0.3 per month versus 0.43 ± 0.4 per month, respectively (P <.001). Persistent ZA use was associated with longer follow-up duration (P <.05) and a greater probability of continuing follow-up. Greater persistency was associated with lower monthly rates of skeletal complications (P <.05). The length of follow-up for ZA use according to the recommended dosing schedule was 17.11 months compared with 9.93 months for nonrecommended schedules and 8.68 months for no treatment (analysis of variance; P <.001). The rate of skeletal complications with ZA use on the recommended schedule was 0.16 events per month versus 0.31 events per month for nonrecommended schedules and 0.43 events per month for no treatment. In the subgroup analysis, the mean time to first complication was 185 ± 210 days in the ZA-treated group versus 98 ± 161 days in the untreated group (P <.0001). The mean time from the first complication to the second complication was 111 ± 124 days in the ZA-treated group versus 86 ± 114 days in the untreated group (P <.05).
CONCLUSIONS
Real-world evidence indicated that ZA reduced the skeletal morbidity rate and delayed the time to skeletal complications.
doi:10.1002/cncr.23775
PMCID: PMC2900766  PMID: 18720527
zoledronic acid; skeletal complications; retrospective claims analysis; persistency; bone; cancer

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