The better bisphosphonate in patients with bone metastasis: Zoledronic acid or ibandronic acid? A study from Eastern India

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20524-e20524
Author(s):  
R. Pandey ◽  
S. Dey ◽  
A. Mukhopadhyay
Keyword(s):  
Zoledronic Acid ◽  
Bone Pain ◽  
Performance Status ◽  
Ibandronic Acid ◽  
Carcinoma Prostate ◽  
Skeletal Related Events ◽  
And Performance ◽  
Skeletal Related Event ◽  
Osteonecrosis Of Jaw

e20524 Background: Ibandronic acid is a third generation bisphosphonate which acts by inhibition of osteoclasts. Zoledronic acid also has a similar mechanism of action. This study was designed to study superiority or inferiority of either agent over other in terms of efficacy in reducing bone pain and complications in patients with bone metastases. Methods: From Jan 2005 to Dec 2008, 240 patients of various malignancies with bone metatstasis were enrolled and were randomized on a 1:1 basis to receive monthly IV infusions of ibandronate or zoledronate and were analysed for pain relief, skeletal related events and adverse events. Results: Patients in both the arms were well matched for their diagnosis, stage of disease, burden of skeletal disease and performance status. Different diagnoses were, carcinoma breast (n=99), carcinoma prostate (n=54), myeloma (n=48), carcinoma lung (n=23), others (n=20). Median follow up was 18 months. At 18 months, mean increases in British Pain Inventory pain scores were lower with zoledronate compared to ibandronate (0.43 vs 0.88 [p=0.02]). Analgesic use as defined by 4 point analgesic scale was less with zoledronate as compared to ibandronate. Incidence of skeletal related events was not significantly different between two arms (33% for zoledronate vs 39% for ibandronate [p=0.2]). Median time to first skeletal related event was not reached in either arm. At 18 months of median follow up, percentage of patients with skeletal related events were 39% in zoledronate arm vs 43% in ibandronate arm (p=0.06). Zoledronate caused fever in 30 (12.5%) patients and hypocalcemia in 10 patients. Ibandronte caused hypocalcemia in 3 patients. No cases of osteonecrosis of jaw were observed. Conclusions: Zoledronate is the preferred bisphosphonate in developing countries for its shorter infusion time and availability of cheaper generic brands. This study also indicates that it may be slightly better than ibandronate in reducing bone pain and preventing skeletal related events. No significant financial relationships to disclose.

Bone modifying agents for patients with bone metastases from breast cancer managed in routine practice setting: Treatment patterns and outcome

2019 ◽  
Vol 26 (4) ◽  
pp. 906-911
Author(s):  
Jamal Zekri ◽  
Kamel Farag ◽  
Osama Yousof ◽  
Yazeed Zabani ◽  
Wael Mohamed ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Treatment Patterns ◽  
Routine Practice ◽  
Related Event ◽  
Modifying Agent ◽  
Skeletal Related Events ◽  
Skeletal Related Event

Introduction Bone metastases are common in patients with breast cancer and can lead to pain and skeletal-related events. Bone modifying agents are licensed to be used for these patients. We report the treatment patterns and outcome of zoledronic acid and denosumab in routine practice. Methodology Women with bone metastases from breast cancer who have started denosumab or zoledronic acid between 2011 and 2016 were eligible. Those with history of bone modifying agent use prior to diagnosis of bone metastases or with switching treatment between zoledronic acid and denosumab were excluded. Details of patients, tumors, bone modifying agent treatment, selected bone modifying agent toxicity, time to skeletal-related event development, and overall survival were collected retrospectively. Results In total, 163 women were eligible and included in this analysis. Number of skeletal-related events prior to starting bone modifying agents was 0, 1, 2, and 3 in 91 (55.8%), 53 (32.5%), 13 (8%), and 6 (3.7%), respectively. Zoledronic acid was started for 107 (65.6%) and denosumab for 56 (34.4%) patients. The proportion of patients receiving denosumab increased from 23.1 to 54.3% in years 2011 and 2016, respectively. Dose delay, reduction, and discontinuation due to toxicity were reported more frequently in patients receiving zoledronic acid. Denosumab delayed time to first on-treatment skeletal-related event compared with zoledronic acid (hazard ratio, 0.64; 95% CI, 0.41–0.98; log rank P = 0.044). There was no significant difference in median survival (zoledronic acid: 62 and denosumab: 58 months; log rank P = 0.956). Conclusion Denosumab is superior to zoledronic acid in reducing risk of skeletal-related events and in tolerance profile. However, overall survival is similar with both treatments. Our findings mirror those reported in scrutinized environment of landmark clinical trials.

scholarly journals A phase II study of palliative radiotherapy combined with zoledronic acid hydrate for metastatic bone tumour from renal cell carcinoma

2020 ◽  
Vol 51 (1) ◽  
pp. 100-105
Author(s):  
Hideyuki Harada ◽  
Naoto Shikama ◽  
Hitoshi Wada ◽  
Nobue Uchida ◽  
Miwako Nozaki ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Palliative Radiotherapy ◽  
Level Increase ◽  
Skeletal Related Events ◽  
Acid Hydrate ◽  
Skeletal Related Event

Abstract Purpose Palliative radiotherapy is the standard of care for bone metastases. However, skeletal-related events, defined as a pathologic fracture, paraplegia, surgery or radiotherapy for local recurrence, or severe pain in previously irradiated bone with radio-resistant histology type still present high incidence. The primary objective of this study was to determine whether zoledronic acid hydrate and palliative radiotherapy could prevent local skeletal-related events. Methods Eligible patients with bone metastases from renal cell carcinoma were treated with zoledronic acid hydrate every 3 or 4 weeks and concurrent palliative radiotherapy of 30 Gy in 3 Gy fractions. The criteria for radiotherapy were established by the treating physician, but patients with complicated bone metastases (impending pathological fracture or spinal cord compression) which needed immediate surgery were excluded. The primary endpoint was the local skeletal-related event-free survival rate at 1 year. Results Twenty-seven patients were included in the study. The median age was 65 (range, 50–84) years. Radiotherapy dose was 30 Gy for all patients except 1 whose radiotherapy was terminated due to brain metastasis progression at 18 Gy. Zoledronic acid hydrate was administered in a median of 12 (range, 0–34) times. The median follow-up period was 12 months and 19 months in patients who were still alive. Of 27 patients in the efficacy analysis, the 1-year local skeletal-related event-free rate was 77.6% (80% confidence interval, 66.2–89.0). Common grade 3 toxicities were hypocalcemia (1 [4%]), sGPT level increase (1 [4%]) and sGOT level increase (1 [4%]). There was no grade 4 or 5 toxicity. Conclusion Zoledronic acid hydrate administration and palliative radiotherapy were a well-tolerated and promising treatment reducing skeletal-related events for bone metastases from renal cell carcinoma.

Results of omacetaxine plus low-dose cytarabine (LD-araC) in older patients with acute myeloid leukemia (AML).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7068-7068
Author(s):  
Tapan M. Kadia ◽  
Naval Guastad Daver ◽  
Farhad Ravandi ◽  
Elias Jabbour ◽  
Naveen Pemmaraju ◽  
...  
Keyword(s):  
Older Patients ◽  
Performance Status ◽  
Intensive Chemotherapy ◽  
Eligibility Criteria ◽  
Normal Organ ◽  
Low Intensity ◽  
Resistant Disease ◽  
Poor Tolerance ◽  
And Performance

7068 Background: Older patients with AML have poor tolerance to intensive chemotherapy and poor prognosis. Omacetaxine is active in AML and is part of standard combination chemotherapy in China under the name of homoharringtonine. Methods: The aim of the study was to evaluate the efficacy of low intensity therapy with omacetaxine and LD-ara C in newly diagnosed older patients (>/= 60 years) with AML or myelodysplastic syndrome (MDS). Older patients with AML not fit or who refuse intensive chemotherapy were eligible. Normal organ functions and performance status </= 2 were required. Other eligibility criteria were standard. Induction therapy consisted of omacetaxine 1.25 mg/m2 subcutaneously twice daily for 3 days and ara-C 20 mg subcutaneously twice daily for 7 days. Maintenance therapy was with the same induction schedule, repeated every 4-6 weeks for up to 2 years. Dose adjustments for prolonged myelosupression or severe non-hematologic toxicities were made by reducing the number of days of omacetaxine (-1 day by level) and cytarabine (-1 to 2 days by level). Results: 30 patients have been treated, with a median age of 71 years (range 64-81); 60% were age 70 years or older. AML post MDS in 20%; chromosome 5 and 7 abnormalities were present in 23%. Overall, 9 patients achieved CR (30%), 5 had CRp (17%) and 1 had PR (3%), for an overall response rate of 50%. Induction mortality was noted in 4 (Day 5, 27, 27, and 70 from start of therapy; 13%); resistant disease in 8 (27%); too early in 4 (13%). With the median follow-up time of 10 months the median survival is 9.3 months and the estimated 1-year survival rate 42%. No serious drug related adverse effects were observed with the combination. Conclusions: Low-intensity therapy with omacetaxine + LD-ara C shows promising activity and is safe in older patients with AML not fit for intensive chemotherapy. Clinical trial information: NCT01272245.

scholarly journals The Effectiveness of Zoledronic Acid and Ibandronic Acid in Delaying Skeletal-Related Events in Multiple Myeloma in Indonesia

2020 ◽  
Vol 10 (3) ◽  
pp. 195
Author(s):  
Nutrisia Aquariushinta Sayuti ◽  
Tri Murti Andayani ◽  
Dwi Endarti ◽  
Kartika Widayati
Keyword(s):  
Multiple Myeloma ◽  
Zoledronic Acid ◽  
Bone Metastasis ◽  
Acid Group ◽  
Cord Compression ◽  
Osteonecrosis Of The Jaw ◽  
Survival Times ◽  
Ibandronic Acid ◽  
Free Survival ◽  
Skeletal Related Events

Zoledronic acid and ibandronic acid are listed in the Indonesian national formulary to prevent skeletal-related events (SRE) in patients diagnosed with bone metastasis in multiple myeloma (MM), with limited evidence to compare their effectiveness. This study aimed to investigate the effectiveness and safety of zoledronic acid and ibandronic acid in delaying SRE. The method was the retrospective, with data obtained from the multicenter study for MM patients with bone metastasis (aged over 18 years), based on medical records between January 2016 and December 2018. Patients were assigned to zoledronic acid and ibandronic acid groups. The clinical outcome was the next SRE which consists of vertebral/bone fracture, spinal cord compression leading to the need for surgery or radiation, and adverse event (AE) due to 2 years of drugs usage. Result of this research was made up of a total of seventy (70) patients with  40  in the zoledronic acid group, and 30 in ibandronic acid. At median treatment duration of 8 months (range: 2 – 24 month), SRE incident in zoledronic acid and ibandronic acid were 20.0 % and 23.3 % respectively. Furthermore, their mean SRE free survival times were 21 months [95% confidence interval (CI) 19 - 23 months], and 19 months [95% CI, 16 – 22 months], respectively. Also, their time intervals were not significantly different (p>0.05). The osteonecrosis of the jaw (ONJ) was AE which occurred more in zoledronic acid than ibandronic acid. The conclusion was zoledronic acid tends to delay SRE time compared to ibandronic acid, although more ONJ occur.

Treatment of locally unresectable cancer of the stomach and pancreas: a randomized comparison of 5-fluorouracil alone with radiation plus concurrent and maintenance 5-fluorouracil--an Eastern Cooperative Oncology Group study.

1985 ◽  
Vol 3 (3) ◽  
pp. 373-378 ◽  
Author(s):  
D J Klaassen ◽  
J M MacIntyre ◽  
G E Catton ◽  
P F Engstrom ◽  
C G Moertel
Keyword(s):  
Cancer Patients ◽  
Pancreas Cancer ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Primary Carcinoma ◽  
Treatment Programs ◽  
Cancer Of The Stomach ◽  
Combined Modality ◽  
And Performance

One hundred ninety-one patients with pathologically confirmed, locally unresectable adenocarcinoma of the stomach (57 patients) and pancreas (91 patients), were randomly allocated to therapy with 5-fluorouracil (5-FU) alone, 600 mg/m2 intravenously (IV) once weekly, or radiation therapy, 4,000 rad, plus adjuvant 5-FU, 600 mg/m2 IV, the first three days of radiotherapy, then follow-up maintenance 5-FU, 600 mg/m2, weekly. Forty-three patients (22%) could not be analyzed because of ineligibility or cancellation, thus 148 patients were evaluable. The median survival time was similar for both treatment programs and for both types of primary carcinoma, and was as follows: gastric primary carcinoma, 5-FU, 9.3 months; 5-FU plus radiotherapy, 8.2 months; pancreatic primary carcinoma, 5-FU, 8.2 months; 5-FU plus radiotherapy, 8.3 months. Substantially more toxicity was experienced by patients treated with the combined modality arm than by those patients receiving 5-FU alone. Severe or worse toxicity experienced by patients with gastric primary carcinoma treated by 5-FU was 19%, and the combined modality arm was 31%. The toxicity experienced by patients with pancreatic primary carcinoma treated with 5-FU was 27%, and the combined modality arm was 51%. Significant prognostic variables included: weight loss in stomach-cancer patients; and performance status, degree of anaplasia, and reduced appetite in pancreas-cancer patients.

Continuous Improvement of Bone Mineral Density Two Years Post Zoledronic Acid Discontinuation in Patients with Thalassemia-Induced Osteoporosis: Long-Term Follow-Up of a Randomized, Placebo-Controlled Trial.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 2768-2768
Author(s):  
Ersi Voskaridou ◽  
Dimitrios Christoulas ◽  
Marialena Konstantinidou ◽  
Evangelos Tsiftsakis ◽  
Eugenia Spyropoulou ◽  
...  
Keyword(s):  
Lumbar Spine ◽  
Zoledronic Acid ◽  
Femoral Neck ◽  
Bone Pain ◽  
Controlled Trial ◽  
Long Term Follow Up ◽  
Group B ◽  
To Receive

Abstract Zoledronic acid is a third generation aminobisphosphonate with proven efficacy in patients with thalassemia major (TM) and osteoporosis. We report here the results of the long-term follow-up (36 months) of our TM patients with osteoporosis who participated in a randomized, placebo-controlled, trial with zoledronic acid. Sixty-six patients with TM-induced osteoporosis (21M/45F; median age 35.5 years) were studied. The majority of patients had pathological fractures and/or bone pain due to osteoporosis. Patients were blindly randomized to receive zoledronic acid at a dose of 4 mg, iv, in 15 min infusion, every 6 months (group A, n=23) or every 3 months (group B, n=21), or to receive placebo every 3 months (group C, n=22) for a period of one year. There was no difference in terms of gonadal dysfunction between the three studied groups. All patients were under oral calcium (500 mg) administration during study period, while hypogonadic patients were allowed to continue their hormonal replacement therapy. After the first 12 months of therapy, patients of groups A and B discontinued zoledronic acid treatment, while patients of group C were allowed to receive zoledronic acid at a dose of 4 mg, every 3 months, for 12 months and then to stop zoledronic acid therapy. Effects were monitored by measuring BMD of the lumbar spine, femoral neck and forearm using DEXA, at baseline, and then after 12 and 36 months post zoledronic acid administration. Patients were also asked to quantify their degree of bone pain on Huskisson’s visual analogue scale and the McGill-Melzack scoring system at baseline, and then every 6 months for 36 months. Patients of groups A and C showed no differences in terms of BMD of all three evaluated sites after 12 months of therapy, while patients of group B achieved a significant increase in their lumbar spine BMD (p=0.028), and a borderline increase in their femoral neck BMD. Zoledronic acid reduced bone pain in groups A+B, while there was no bone pain relief in placebo group after 12 months of therapy. Interestingly, after 36 months, patients of both groups A and B showed a dramatic increase in BMD of all studied sites compared with baseline values (p=0.001, p=0.001, and <0.001 for BMD of lumbar spine, femoral neck, and forearm, respectively). Patients of group C who received zoledronic acid for 12 months after the placebo period showed also a dramatic increase in BMD of all studied sites at 36 month (p=0.008, p=0.018, and <0.001 for BMD of lumbar spine, femoral neck, and forearm, respectively), while they also reduced significantly bone pain scores (p<0.001). At 36 month, there was no difference in terms of BMD of lumbar spine and forearm between patients of groups A and B, while BMD of the femoral neck continued to be higher in group B (either as a T-score absolute value or as a T-score percentage change; p=0.01). No skeletal related events were observed during the study period. This study suggests that zoledronic acid is an effective treatment in increasing BMD in TM-induced osteoporosis. Its effect seems to be continued even 24 months after the discontinuation of the drug. Studies with larger number of patients are required to clarify the best dose and treatment duration of zoledronic acid for the management of TM-induced osteoporosis.

Renal function among cancer patients with bone metastases treated with zoledronic acid in a real world setting

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19540-19540 ◽  
Author(s):  
B. L. Nordstrom ◽  
C. Langer ◽  
A. Hussain ◽  
V. Barghout ◽  
D. Modi ◽  
...  
Keyword(s):  
Renal Function ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Cancer Patients ◽  
Subsequent Treatment ◽  
Community Based ◽  
Skeletal Related Events ◽  
Treatment Changes ◽  
Baseline Levels

19540 Background: Zoledronic acid (ZA) is a bisphosphonate that reduces skeletal related events (SREs) in cancer patients (pts) with bone metastases but can impact renal function in some pts. This retrospective study examined serum creatinine (sCr) elevations and subsequent treatment changes among pts receiving ZA in community based medical practices. Methods: Data were obtained from the Varian Medical Oncology database of electronic medical records from 17 US oncology practices. Cancer pts with bone metastases and at least one ZA infusion in 2002–06 were followed; all available sCr levels were examined. SCr measurements ≤4 weeks after a ZA infusion were considered levels while on ZA. Elevated sCr was defined as an increase over baseline of ≥0.5 mg/dL or a doubling from baseline for pts with baseline levels <1.4 mg/dL (or ≥1.0 mg/dL for higher baseline levels). Pts with a sCr elevation on ZA were followed to observe changes in ZA dosing and sCr. Results: The study included 875 pts (318 with breast cancer, 131 lung, 154 prostate, 23 multiple myeloma, and 249 other or unknown cancer) with ≥1 sCr level during baseline and ≥1 (median 6) while on ZA. Median age was 66, 41% were male, and 90% had baseline sCr under 1.4 mg/dL. Pts received a median of 6 ZA infusions. SCr elevations occurred in 87 pts (10%), at a median of 19 weeks (range 0.6–126) after the start of ZA. Pts with baseline sCr over 2.0 mg/dL were more likely to experience an elevation (11 pts, 33%). Following the elevated sCr, 37 pts (43%) discontinued ZA; dose reductions and delays were infrequent. Among 49 pts who remained on ZA after elevated sCr and had further sCr while on ZA, 20 (41%) returned to within 10% of baseline, at a median of 7 weeks (range 0.3–31) after the first measured elevation. The proportion returning to normal is a conservative estimate given limited follow-up sCr data. Conclusions: The observed incidence of elevated sCr of 10% in this community based study is similar to clinical trials. Most pts either discontinued ZA or returned to baseline levels despite continued ZA treatment. Few practitioners adhered to recommendations to withhold ZA until levels return to within 10% of baseline. No significant financial relationships to disclose.

Epidemiology and 15-Year Follow up after Cladribine Treatment of Patients with Hairy Cell Leukemia (HCL): Population-Based Swedish Data and Long-Term Follow-up of Scandinavian Study Patients Identify Older Patients with Poorer Outcome

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4166-4166
Author(s):  
Henrik Samuelsson ◽  
Dag Heldal ◽  
Mats Jerkeman ◽  
Gunnar Juliusson
Keyword(s):  
Overall Survival ◽  
Older Patients ◽  
Performance Status ◽  
Progression Free Survival ◽  
Population Based ◽  
Female Ratio ◽  
Young Males ◽  
Swedish Cancer Registry ◽  
And Performance

Abstract HCL has been considered to be a disease of predominantly young males with, after the introduction of effective treatment, excellent prognosis. However, although very effective, these therapies introduced in the 1980’s are not curative. The Swedish Lymphoma Registry records all patients diagnosed since year 2000, with a 96 % coverage compared to the Swedish Cancer Registry, which is compulsory since 60 years. In contrast, previously published studies include patients highly selected for inclusion in treatment studies or referral to major medical centers. The Swedish registry data confirms the high male to female ratio, with yearly incidences of 5.3 males and 1.1 females per million. However, the median age at diagnosis was 62 years (range 30–92). The incidence in males rise with age as follows: 3 (30–49 yrs), 11 (50–69 yrs), 16 (70–79 yrs), and 20/million (80–95yrs). The 5-year overall survival of these unselected patients was 81%. Age and performance status had strong influence on survival. If HCL was diagnosed before age 60 the 5-year survival was 94%, whereas it was 70% for patients over 60 years. We also performed a 15-year follow-up of patients included in our first cladribine trials in the early 1990’s. The progression-free survival at 10 years was 60% and at 15 years 55%, irrespective of age. However, the 10 year and 15 year overall survivals were 91% and 82% for patients &lt;60 yrs, in contrast to 65% and 42% for those with diagnosis after age 60 years. We conclude that there is a proportion of older patients with HCL with a similar progressionfree survival after cladribine treatment as the younger, but poorer overall survival. Further analyses, including epidemiology of unselected total populations diagnosed since 1987, age-adjusted survival estimates, and incidence of secondary cancers among the HCL patients will be presented.

Zoledronic acid in patients with adenocarcinoma of the prostate M1

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14623-14623
Author(s):  
F. M. Calais Da Silva ◽  
F. E. Calais Da Silva
Keyword(s):  
Prostate Cancer ◽  
Zoledronic Acid ◽  
Bone Metastases ◽  
Metastatic Prostate Cancer ◽  
Response Duration ◽  
Fast Response ◽  
Symptomatic Improvement ◽  
Primary Objective ◽  
Skeletal Related Events

14623 Background: There is presently clinical evidence that confirms the value of bisphosphonates in metastatic bone disease. Studies have demonstrated that bisphosphonates may reduce bone morbidity and pain, thus increasing the quality of life of patients with multiple mieloma and bone metastases in breast cancer. In metastatic prostate cancer several oral and i.v. bisphosphonates have demonstrated a symptomatic improvement. Zoledronic acid is a bisphosphonate that has proved to diminish the skeletal related events (SRE) in metastatic prostate cancer. Methods: We have initiated a study with two types of patients: patients with bone metastases, With and Without pain, with the primary objective of measuring the efficacy of zoledronic acid in these patients, assessing the time to reduce the pain score or decrease the analgesic score in symptomatic patients and SRE in those non symptomatic, evaluating the time to bone pain and SRE. We started zoledronic acid 4 mg i.v. monthly. Results: We evaluated 87 patients, 16 were not evaluable and 71 evaluable, with at least 3 administrations. From these 70 patients, 11 had no pain with a median follow-up of 9.7 months (3–22 months) out of which 6 (54%) remain pain free (3–18 months). No SRE were registered. The remaining 60 patients had pain at initiation: 24 (40%) were not responsive and 36 (60%) were responsive and registered pain palliation, within an average follow-up of 9.2 months (3–22 months). The average time to response was 3.2 months (1–8 months) and average response duration was 4 months (1–11 months). Only 2 patients required administration of Samarium i.v.; no other SRE. Conclusions: Zoledronic acid is and I.V. bisphosphonate effective in the palliation of pain in patients with bone metastases, which produces decrease of pain and analgesic score with a fast response - in average 3.2 months - and a therapeutic efficacy maintained in average for 4 months. In high-risck patients with bone M1 but without pain, it was also verified that 54% kept pain free at the end of 9.2 months and 45% only started to feel pain again at 6 months. No significant financial relationships to disclose.

Solid tumor cancer patients treated with zoledronic acid experienced reduced skeletal related events as compared to untreated patients in clinical practice claims database

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6596-6596
Author(s):  
H. T. Hatoum ◽  
S. Lin ◽  
M. R. Smith ◽  
V. Barghout ◽  
K. Koukouras ◽  
...  
Keyword(s):  
Zoledronic Acid ◽  
Bone Metastasis ◽  
Prescribing Patterns ◽  
Claims Database ◽  
Co Morbidity ◽  
Label Dose ◽  
Skeletal Related Events ◽  
The Impact ◽  
Delayed Time

6596 Background: Patients (pts) with bone metastasis are at high risk for skeletal related events (SREs), leading to increased morbidity, mortality, and decreased QOL. Methods: To study the impact of zoledronic acid on SRE rates, follow-up duration (from 1st bone metastasis diagnosis to last claim) in treated pts as compared to the experience of non bisphosphonate-treated pts (untreated), and to investigate relative impact of zoledronic acid (ZA) frequency of administration using data from PharMetrics integrated claims database of 80 health plans across the U.S, from Jan 02 to Oct. 05. Results: There were 1,518 ZA treated-pts and 3308 untreated-pts, who met study inclusion criteria of having breast, prostate, or lung cancers, with confirmed bone metastasis and SRE experience. At baseline, breast cancer pts (N=1,799) had lowest Charlson Co-morbidity Index (CCI); lung cancer pts (N=2,413) had highest CCI (p<0.05). Prostate cancer pts (N=622) were significantly older (p<0.05). The average monthly ZA prescription rate (Rx) was 0.73 with average total Rxs of 7.82 over the follow-up duration. ZA use reduced monthly SRE rate by 30% from 0.41 ± 0.4 in untreated pts to 0.29 ± 0.3 in treated pts (p<0.001) and prolonged follow-up durations in months from 9.4 ± 9.8 in untreated to 12.2 ± 9.0 in treated pts (p<0.001). Regression models of SRE rate or follow-up duration as the dependent variable investigating the impact of ZA prescribing patterns indicated that pts who followed ZA label dose of 4 mg every q3, q4 experienced the lowest SRE rate (p<0.001) and had longer follow-up duration (p<0.005) as compared untreated pts. ZA use almost doubled time to 1st SRE from 101±165 days in untreated pts, to 185±210 days in treated pts (p<0.0001). ZA also delayed time between 1st to 2nd SRE from 85 days in untreated to 111 days in treated pts (p<0.05). Conclusion: Zoledronic acid significantly reduced SRE rate in cancer pts with bone metastasis by 30%, increased follow-up duration by almost 3 months, doubled time to 1st SRE, delayed time to 2nd SRE, with its label dose of 4 mg every 3 to 4 weeks achieving the best outcome. No significant financial relationships to disclose.

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