US Community Oncology Setting Research Articles

Real-world treatment patterns of adult multiple myeloma patients treated with carfilzomib in the US community oncology setting.

e19513 Background: The purpose of this retrospective cohort study was to describe the treatment regimens received by adult multiple myeloma (MM) patients who were exposed to carfilzomib (K) in the US Oncology Network (USON). Methods: Eligible patients received K-based regimens for MM at least once between 11/01/2013 and 02/29/2016, were ≥18 years old, were not in a clinical trial, and had at least 2 visits at a USON clinic. Data on systemic therapies, lines of therapy (LOT), clinic visits and treatment administration dates were abstracted from the electronic health records (EHR). Treatment sequencing logic was used to identify progression by LOT. Sequencing rules were based on regimens, duration, and administration dates. Treatment regimens utilized at any time during the study period were analyzed by LOT. Results: 718 MM patients received a K-containing regimen at least once over the course of treatment. The frequency distribution of regimens for K-exposed patients by LOT (2 to 5) are provided (see Table). Among these patients, K-based regimens comprised 66.6% of LOT2 regimens, 55.3% of LOT3 regimens, and 45.9% of regimens used beyond LOT3. K+ lenalidomide + dex (KRd) was the most common K-containing regimen used in LOT2 (24.7%). K-triplets containing an immunomodulatory agent were most frequent in LOT 2 and K-doublets (Kd) were most frequent in LOT 3. Conclusions: In our study, K-based regimens were used across LOTs 2 to 5 with highest frequency observed in LOT2. K-triplets with immunomodulatory drugs were more common in earlier LOTs. [Table: see text]

Real-world outcomes in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) receiving second-line (2L) chemotherapy (CT) vs alternative androgen receptor-targeted agents (ARTA) after lack of response to first-line (1L) ARTA in US community oncology practices.

214 Background: The relationship between treatment sequence and mCRPC outcomes is unclear. This retrospective study assessed if 2L CT vs alternative ARTA is associated with improved outcomes in pts with lack of response to 1L ARTA in the US community oncology setting. Methods: Using Altos electronic medical records, we identified 345 mCRPC pts with lack of response to 1L ARTA (abiraterone or enzalutamide) who received 2L docetaxel or cabazitaxel (CT cohort N = 147), or alternative ARTA (ARTA cohort N = 198) from May 2011 to Oct 2014. Outcomes were evaluated from start of 2L therapy and compared for 2L CT vs ARTA cohorts using one-sided tests. Prostate-specific antigen (PSA) response ( ≥ 50% reduction) and overall survival (OS) were assessed using logistic and Cox proportional hazard regression models adjusted for year, age, metastases, opioid use, ECOG performance score, PSA, hemoglobin (Hb), alkaline phosphatase (ALP), lactate dehydrogenase (LDH) and albumin (Alb) levels. Results: At start of 2L therapy, pts receiving CT vs ARTA were younger (median age, 74 vs 79 yr) and had a worse prognosis: higher mean PSA (439 vs 231 ng/mL), LDH (344 vs 234 U/L) and ALP (241 vs 166 U/L), lower mean Hb (11 vs 12 g/dL), higher mean Halabi risk score (159 vs 137; JCO 2014:32;671–7), increased opioid use (42 vs 22%), and more pts had Alb < lower limit of normal (LLN; 25 vs 15%); all p < 0.01. More pts in the CT vs ARTA cohort had a PSA response (adjusted odds ratio = 2.27, p = 0.005) and there was a non-statistically significant trend toward improved OS for 2L CT vs ARTA (adjusted hazard ratio [aHR] = 0.81, p = 0.148). Among pts with poor prognostic features, those in the CT cohort had significantly improved OS (Halabi intermediate–high risk score: aHR = 0.55 p = 0.009; Hb < 11 g/dL: aHR = 0.41 p = 0.002; LDH > upper limit of normal: aHR = 0.18 p = 0.014; Alb < LLN: aHR = 0.42 p = 0.020), compared with those in the ARTA cohort. Conclusions: Treatment with 2L CT, vs 2L ARTA, may be more suitable for pts with a lack of response to 1L ARTA, particularly in pts with a poor prognosis. Funding: Sanofi Genzyme.

Predictors of long-term responders in patients treated with pazopanib for advanced renal cell carcinoma (aRCC).

524 Background: The objective of this study was to characterize the long term responders to pazopanib (PAZ) treatment in aRCC patients treated in a real-world community oncology setting. Methods: This retrospective study used US Oncology’s (USON) iKnowMed electronic health record database (Nov 2009 – Oct 2014), supplemented with chart review. Eligible patients: Age ≥ 18 at first diagnosis of aRCC, treated with PAZ as first-line between 11/1/2009 – 8/31/2012, and had at least 2 office visits during the follow-up period. Patients were excluded if they were enrolled in a clinical trial and diagnosed or treated for other primary cancers during the study period. Long-term responders were defined as patients with progression free survival (PFS) ≥18 months. Predictors of long-term responders to PAZ were assessed using multivariate logistic regression analysis. Results: A total of 153 PAZ patients were included of which, 33 patients (22%) were identified as long-term responders. The median PFS in long-term responders and non-long-term responders was 27.2 months (95% CI: 23.0, 35.2) vs. 6.9 months (95% CI: 5.03-8.55), respectively. Long-term responders were more likely to have Eastern Cooperative Oncology Group (ECOG) score=0 at baseline (42.4% vs. 18.3%, p=0.004), and a history of nephrectomy (81.8% vs. 57.5%, p=0.010) than non-long-term responders. Other patient characteristics including age, gender, or comorbidities did not differ significantly between the two groups even though long-term responders tend to be slightly younger (mean 64.7 vs. 66.2), female (33% vs. 25%), and less likely to have a comorbid condition (36.4% vs. 51.7%) compared to non-long-term responders. In the multivariate analysis, the only predictors of long-term response were ECOG = 0 at baseline (vs. ECOG = 1 (OR: 0.38; 95% CI 0.16-0.89) and vs. ECOG≥2 (OR: 0.07, 95% CI: 0.01-0.54) and history of nephrectomy (OR: 3.33; 95% CI 1.28-8.65). Conclusions: A subset (22%) of PAZ patients had clinically relevant long term responses in a US community oncology setting. ECOG score of 0 and history of nephrectomy were predictors of long term response in PAZ.

Comparative Effectiveness and Resource Usage in Patients Receiving First-line Taxane-based Chemotherapy for Stage IV Non–Small-cell Lung Cancer in a US Community Oncology Setting

BackgroundWeekly (qw) nanoparticle albumin-bound (nab)-paclitaxel was approved for advanced non–small-cell lung cancer based on the results from a phase III trial in which nab-paclitaxel/carboplatin demonstrated a significantly greater response rate compared with paclitaxel/carboplatin every 3 weeks (q3w). Little information exists on relative real-world results. Materials and MethodsThe present retrospective study used data from a national electronic medical record database. Patients receiving first-line nab-paclitaxel qw, paclitaxel qw, or paclitaxel q3w for stage IV non–small-cell lung cancer (NSCLC) were identified. The total cumulative dose, time to treatment discontinuation (TTD), and database persistence (a proxy measure for survival) were analyzed for all patients and for the squamous and elderly subgroups. ResultsA total of 114, 208, and 153 patients received nab-paclitaxel qw, paclitaxel qw, and paclitaxel q3w, respectively. In the corresponding treatment arms, the median age was 72, 69, and 67 years; 56%, 48%, and 37% were aged ≥ 70 years; and 75%, 43%, and 23% had squamous cell NSCLC. The total cumulative dose was significantly greater with nab-paclitaxel qw. The TTD was longer with nab-paclitaxel qw than with paclitaxel qw (hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.40-0.72; P < .001) or with paclitaxel q3w (HR, 0.53; 95% CI, 0.38-0.73; P < .001). Database persistence was longer with nab-paclitaxel qw than with paclitaxel qw (HR, 0.56; 95% CI, 0.39-0.79; P = .001) or with paclitaxel q3w (HR, 0.52; 95% CI, 0.34-0.78; P = .002). The TTD after experiencing any hematologic adverse event was longer with nab-paclitaxel qw. The findings were consistent across the subgroup analyses. ConclusionIn a real-world setting, nab-paclitaxel qw was associated with a significantly greater cumulative dose and significantly longer TTD and database persistence compared with paclitaxel qw and paclitaxel q3w.

Comparative effectiveness of pazopanib and sunitinib as first-line therapy for patients with advanced/metastatic renal cell carcinoma in a U.S. community oncology setting.

567 Background: The COMPARZ trial demonstrated that pazopanib was non-inferior to sunitinib regarding their efficacy as first line of therapy (LOT) for advanced/metastatic RCC (aRCC). However, no studies have compared the effectiveness of pazopanib to sunitinib outside the clinical trial setting. The purpose of this study was to compare the clinical outcomes of the two therapies in a US community oncology setting. Methods: A retrospective study was conducted using US Oncology’s (USON) iKnowMed electronic health record (EHR) database, supplemented with chart review. Patient eligibility criteria included: ≥ 18 years of age at first diagnosis of aRCC, treated with pazopanib or sunitinib as the 1st LOT between 11/1/2009 – 8/31/2012 in the USON with ≥ 2 office visits. A propensity score (PS) matching was performed to match patients receiving pazopanib to sunitinib. Clinical outcomes including progression free survival (PFS), overall survival (OS) and adverse events (AEs) were compared. Results: A total of 177 patients on pazopanib and 739 patients on sunitinib were identified from the EHR database. After PS matching, 153 pts were included in pazopanib and sunitinib cohort respectively. The mean age, gender distribution, and the Heng disease risk groups were similar between the two cohorts (p&gt;0.05). No significant difference in PFS was observed with pazopanib (median: 9.3 [95%CI, 7.0 to 11.8] months) compared to sunitinib (median: 8.3 [95%CI, 6.4 to 10.9] months, p = 0.43). Similarly, no significant difference was observed in OS for pazopanib (median: 22.3 [95% CI, 16.2 to 31.7] months) compared to sunitinib (median: 26.3 [95% CI, 16.4 to 38.2, p = 0.76] months). AEs (any grade) including diarrhea, hypertension, nausea, vomiting, fatigue were significantly lower in sunitinib (p&lt;0.05) while anorexia was lower in pazopanib (p&lt;0.05). Conclusions: Consistent with the results of COMPARZ, no significant difference was observed in PFS and OS among aRCC patients treated with pazopanib or sunitinib as the 1st LOT in the real world. AEs seemed to be less common with sunitinib, and this may be partially attributed to the limitation of retrospective data.

First-Line and Sequential Use of Pazopanib Followed by Mammalian Target of Rapamycin Inhibitor Therapy Among Patients With Advanced Renal Cell Carcinoma in a US Community Oncology Setting

BackgroundClinical trials have demonstrated that pazopanib prolongs progression-free survival (PFS), with an acceptable safety profile, for patients with advanced renal cell carcinoma (aRCC). The efficacy of second-line mammalian target of rapamycin (mTOR) inhibitors in pazopanib-treated patients has also been evaluated in clinical trials; however, few studies have evaluated first-line pazopanib or second-line mTOR inhibitors in real-world settings. The present study evaluated the outcomes of first-line pazopanib, and pazopanib followed by mTOR inhibitors, in a community oncology setting. Patients and MethodsThe present study was a retrospective analysis of eligible patients in US Oncology's iKnowMed electronic health records database who had been treated for aRCC from November 1, 2009 to August 31, 2012. The patients received first-line therapy with pazopanib (cohort 1), followed by second-line therapy with either everolimus or temsirolimus (cohort 2). The key outcomes included overall survival (OS), PFS, adverse events (AEs), treatment patterns, and healthcare resource use. ResultsThe median OS in cohort 1 (n = 177) was 22 months, and the median PFS was 8.5 months. The most common AEs were fatigue (56%), diarrhea (52%), vomiting (44%), and nausea (40%). The median persistence was 151 days with pazopanib. The median OS in cohort 2 (n = 35) was 16 months; the median PFS was 5.7 months. The most common AEs were fatigue (51%) and nausea (34%). The median persistence was 93 days with everolimus and 49 days with temsirolimus. ConclusionThe outcomes for the patients treated with first-line pazopanib in the community setting were consistent with those reported by previous prospective and retrospective studies. Although the second-line cohort was small, the results of mTOR inhibitors after pazopanib were also consistent with those of previous observations.

Observational study of treatment patterns among patients initiating first-line treatment for chronic lymphocytic leukemia in the U.S. community oncology setting.

e18023 Background: For patients (pts) able to tolerate the combination, fludarabine, cyclophosphamide, and rituximab (FCR) is preferred in first-line chronic lymphocytic leukemia (CLL) (NCCN, 2014). However, other regimens are suggested for pts with advanced age and/or significant comorbidities. This study compared pts who received full-dose fludarabine (F, 25mg/m2) as part of their first-line treatment from those who did not in the US community oncology setting. Methods: This multicenter, retrospective study analyzed 404 pts who initiated CLL treatment between 1/1/2007 and 7/1/2013. Comparisons were made between demographic/clinical factors and treatment using t-tests or Fisher Exact Test, or a non-parametric equivalent. Results: F-containing regimens were used in 36% of the full cohort (147 of 404), and other common regimens contained/consisted of chlorambucil (21%, n=86), bendamustine (20%, n=79), or single-agent rituximab (17%, n=69). From 2007 to 2013, the percent receiving F declined from 41% to 20%...

A comparison of toxicity and health care resource use between eribulin, capecitabine, gemcitabine, and vinorelbine in patients with metastatic breast cancer treated in a community oncology setting

Capecitabine (C), gemcitabine (G), and vinorelbine (V) are commonly used as single agents in patients with metastatic breast cancer. Eribulin (E) is one of the most recent cytotoxic agents to gain regulatory approval for metastatic breast cancer in the United States as a single agent. EMBRACE - a large randomized trial demonstrated the safety and overall survival benefit of eribulin in heavily pretreated metastatic breast cancer patients compared to treatment of physician's choice. In this analysis, toxicity and the associated health care resource use were compared between the four agents in a sample of metastatic breast cancer patients treated in a US community oncology setting. This study identified 411 patients (C=144, G=81, V=96, and E=90) who were treated in 19 community oncology clinics over the preceding two-year period. Data collection included baseline patient and disease characteristics, duration of therapy, use of supportive care drugs, type of dose limiting toxicities, and their impact on overall health care resource use. The median lines of therapy for C, G, V, and E were second, third, third, and fourth, respectively. Patients were comparable with respect to baseline comorbidities, performance status, serum creatinine, hemoglobin, neutrophil, and platelet counts. The proportion reporting at least one adverse event (any grade) with C, G, V, and E was 45%, 65%, 75%, and 63%. The most commonly reported toxicities (regardless of grade) for C, G, and V were diarrhea (19.4%), anemia (34.6%), and neutropenia (50.0%), respectively. The most common toxicity for E was neutropenia (32.2%). Overall, 5.6%, 19.8%, 22.9%, and 22.2% of patients receiving C, G, V, and E required at least one medical intervention to manage a toxic event. Toxicity was the cause of treatment discontinuation in 25.7%, 8.6%, 11.5%, and 8.9% of C, G, V, and E patients, respectively. The primary cause for treatment discontinuation in all four cohorts was disease progression. Eribulin demonstrated a comparable patient safety profile to gemcitabine and vinorelbine, even when administered after three lines of prior therapies. Capecitabine was generally used in earlier lines, had less neutropenia and anemia, but more treatment discontinuations due to toxicity.

Efficacy and Safety Of Three Bortezomib-Based Induction and Maintenance Regimens In Previously Untreated, Transplant-Ineligible Multiple Myeloma (MM) Patients (Pts): Final Results From The Randomized, Phase 3b, US Community-Based UPFRONT Study (NCT00507416)

Efficacy and Safety Of Three Bortezomib-Based Induction and Maintenance Regimens In Previously Untreated, Transplant-Ineligible Multiple Myeloma (MM) Patients (Pts): Final Results From The Randomized, Phase 3b, US Community-Based UPFRONT Study (NCT00507416)