Quanhong Ni

Comparative effectiveness and resource utilization of nab -paclitaxel plus gemcitabine vs FOLFIRINOX or gemcitabine for the first-line treatment of metastatic pancreatic adenocarcinoma in a US community setting

Introduction Despite a clinically relevant, statistically significant survival benefit with nab-paclitaxel plus gemcitabine and FOLFIRINOX vs single-agent gemcitabine for metastatic pancreatic cancer (mPC), little is known regarding their real-world effectiveness. We analyzed patients with mPC using a nationally representative electronic medical records database to address this unmet need. Methods This retrospective analysis of the Navigating Cancer database compared outcomes among patients who received first-line nab-paclitaxel plus gemcitabine, FOLFIRINOX, or gemcitabine for mPC. Effectiveness, safety, and supportive care use were examined. nab-Paclitaxel plus gemcitabine was the reference for statistical comparisons. Results Baseline characteristics were similar except age (oldest patients were in the gemcitabine cohort followed by nab-paclitaxel plus gemcitabine, then FOLFIRINOX). Patients receiving nab-paclitaxel plus gemcitabine (n=122) demonstrated similar time to treatment discontinuation (TTD; median, 3.4 vs 3.8 months; P=0.947) and database persistence (DP; median, 8.6 vs 8.6 months; P=0.534) vs FOLFIRINOX (n=80); however, TTD (median, 3.4 vs 2.2 months; P<0.001) and DP (median, 8.6 vs 5.3 months; P=0.030) were significantly longer with nab-paclitaxel plus gemcitabine vs gemcitabine (n=46). There were more any-grade adverse events with FOLFIRINOX or gemcitabine vs nab-paclitaxel plus gemcitabine (95% or 89% vs 84%, respectively). Conclusion This real-world analysis confirms the phase III MPACT trial findings and demonstrates that nab-paclitaxel plus gemcitabine has effectiveness similar to that of FOLFIRINOX but greater tolerability for treating mPC despite younger patients being in the FOLFIRINOX cohort. These findings support nab-paclitaxel plus gemcitabine as an appropriate first-line treatment option for patients with mPC.

Comparative effectiveness of early-line nab -paclitaxel vs. paclitaxel in patients with metastatic breast cancer: a US community-based real-world analysis

Background Real-world analyses of treatments for patients with metastatic breast cancer are limited. We evaluated the comparative effectiveness of nab-paclitaxel vs. paclitaxel in patients with metastatic breast cancer using data from an electronic medical record database from community practices across the USA. Methods We performed a retrospective cohort study using fully de-identified data from an independent US electronic medical record platform of patients with metastatic breast cancer initiating single-agent nab-paclitaxel or paclitaxel as a first- or second-line treatment from December 1, 2010 to October 6, 2014. The clinical efficacy objectives were time to treatment discontinuation (TTD) and time to next treatment (TTNT). Subgroup analyses were performed in patients with 2 types of metastatic breast cancer as follows: 1) hormone receptor-positive and human epidermal growth factor receptor 2 negative, and 2) triple-negative disease. Results This analysis included 925 patients. Patients receiving nab-paclitaxel vs. paclitaxel had significantly longer TTD (median 4.2 vs. 2.8 months, P<0.0001) and TTNT (median 6.0 vs. 4.2 months, P<0.0001); similar outcomes were observed for patients with hormone receptor-positive/human epidermal growth factor receptor 2 negative disease. Compared with paclitaxel, nab-paclitaxel was associated with significantly longer TTD in patients with triple-negative disease. nab-Paclitaxel was associated with significantly less all-grade neuropathy, anemia, pain, and diarrhea than paclitaxel. Antiemetic and antihistamine use were significantly less frequent with nab-paclitaxel vs. paclitaxel, whereas use of granulocyte colony-stimulating factor, hydrating agents, and bone-directed therapy to decrease skeletal-related events were more frequent. Conclusion nab-Paclitaxel demonstrated improved clinical effectiveness compared with paclitaxel when examining TTD and TTNT in patients with metastatic breast cancer in a real-world setting.

Comparative effectiveness of early-line nab-paclitaxel (nab-P) versus eribulin in patients (pts) with metastatic breast cancer (MBC): A U.S. real-world analysis.

293 Background: In a phase III study in MBC, nab-P demonstrated anti-tumor activity across lines of therapy. Eribulin is indicated for the treatment (Tx) of MBC in pts who have previously received ≥ 2 chemotherapeutic regimens. This analysis evaluated Tx patterns and effectiveness of nab-P and eribulin in pts with MBC in a real-world community-based setting. METHODS A retrospective cohort study was performed using fully de-identified data from a US electronic medical record platform of 1300 community oncology physicians. The analysis included women aged ≥ 18 years with MBC who started on nab-P or eribulin monotherapy as 1L or 2L Tx from 12/4/10 to 10/6/14 (≥ 1 cycle of nab-P or eribulin required). The primary objective was to examine duration of Tx (DOT, including time to Tx discontinuation [TTD]; censored if last administration > 30 days from the last date in the database) and time to next Tx (TTNT; day 1 from drug 1 to drug 2). Incidence of adverse events (AEs) and supportive care used during Tx were also examined. RESULTS Pt characteristics were similar between groups. Mean age was 59 years. Most pts had hormone receptor + (62%), HER2- (82%) disease, and 1L therapy (60%). More pts received nab-P vs eribulin. Slightly more pts receiving nab-P vs eribulin were treated in 1L (63% vs 55%). DOT, TTNT, and TTD were significantly longer in the nab-P vs eribulin group (Table). Thrombocytopenia and anemia were numerically lower in the nab-P vs eribulin group (P = 0.11 for each). Nausea/vomiting was less common with eribulin vs nab-P (P = 0.009). Granulocyte-colony stimulating factor, hydrating agents, and antiemetics were used less often in pts receiving nab-P (P < 0.01 for each). CONCLUSIONS DOT, TTNT, and TTD were significantly longer for pts treated with nab-P vs eribulin. Moreover, pts receiving nab-P experienced fewer hematologic AEs and utilized fewer doses of supportive care. [Table: see text].